23 February 2000
10/00
INFORMATION SUMMARY
The Australia New Zealand Food Authority has received an application on
3 December 1999 to amend the AustralianFood Standards Codeon the above matter. The Authority's Preliminary Assessment Report is attached and provides further detail. The Authority now invites public submissions on any issue raised in the Report for the purposes of making a full assessment.
In accordance with the transitional arrangements for food standards between Australia and New Zealand, individual country MRLs for agricultural and veterinary chemicals continue to apply for these standards and this application proposes changes for MRLs for food sold in Australia, whether imported or domestically produced.
Food sold in Australia which is either domestically produced or imported (other than from New Zealand) must comply with the Australian MRLs (ie in theFood Standards Code). Food imported from New Zealand must comply with either the New Zealand MRLs (ie in the New ZealandFood Regulations 1984) or the Australian MRLs.
Food sold in New Zealand which is either domestically produced or imported (other than from Australia) must comply with the MRL provisions in the New ZealandFood Regulations 1984.Food imported from Australia must comply with either the New Zealand MRLs or the Australian MRLs.
PRELIMINARY ASSESSMENT REPORT
SUBJECT: APPLICATION A 405
Maximum Residue Limits - December 1999 MRLs
Applicant: National Registration Authority for Agricultural and Veterinary Chemicals (NRA).
Date received: 3 December 1999
BACKGROUND:
The NRA has registered or varied the registration of specific chemicals. This application seeks to include:
· MRLs for theantibioticsflavophospholipol (new MRL), lasalocid (extension of use) and neomycin (extension of use).
· MRLs for thenew chemicals aminoethoxyvinylglycine, azoxystrobin, imazamox, isoxaflutole, kresoxim-methyl, metasulfuron-methyl, oxydemeton-methyl.
· new MRLs (extensions of use) for abamectin, bifenthrin, bromoxynil, chlorpyrifos, clorsulon, diflufenican, emamectin benzoate, fipronil, fluvalinate, glyphosate, imazapic, imidacloprid, iprodione, oxyfluorfen, phosphorous acid, procymidone, propaqizafop, tebufenozide.
· changesto existing MRLs for abamectin, bifenthrin, cyfluthrin, emamectin benzoate, fenitrothion, fluquinconazole, imazalil, imidacloprid, ivermectin, pymetrozine, iprodione.
· deletionsto existing MRLs for cyfluthrin; fenitrothion.
The requested changes to Schedule 1 of Standard A14 are summarised atAttachment 1. The evaluation reports sent to ANZFA from the NRA justifying the proposed MRL changes are available upon request (these will be emailed or posted to interested parties).
ANTIBIOTIC MRLS
This application requests MRL amendments for three antibiotics, flavophospholipol, lasalocid and neomycin.
Flavophospholipolis a new antibiotic used to improve milk production in lactating dairy cattle. There has been no ADI established, however, overseas residue trials indicated that residues were undetectable in cattle tissues and milk under the proposed use pattern. The Working Party on Antibiotics (WPA) raised no objections to the proposed MRLs. The WPA concluded that flavophospholipol did not appear to have a human analogue and that the proposed uses do not seem to have the capacity to expose humans to dietary intake of the drug.
An MRL for an extension of use for the antibioticlasalocidfor treatment of coccidosis in cattle has been proposed. Lasalocid is currently registered with claims for liveweight gains and feed conversion efficiency in growing cattle and lot fed beef cattle, reduction of faecal shedding of coccidia and the control of clinical signs of coccidosis in cattle. The Working Party on Antibiotics raised no objections to the proposed MRL.
An MRL for an extension of use for the antibioticneomycinfor treatment of bacterial enteritis (scours) has been proposed. The WPA raised no objections to the proposed temporary MRLs recommended by the Joint Expert Committee on Food Additives (JECFA) until a special review of neomycin is conducted.
OBJECTIVE
The objective of this application is to vary Standard A14 - Maximum Residue Limits (MRLs) by changing the MRL list as indicated in Attachment 1 to allow maximum flexibility for producers whilst encouraging good agricultural practice. The chemicals indicated in these Attachments have been cleared by the NRA and registered for the uses associated with the requested MRLs.
POSSIBLE OPTIONS
Option 1.Accept the application and list the requested MRLs in Schedule 1 of Standard A14. This outcome would be based on a risk assessment, which indicated no public health and safety concerns at the predicted levels of intake.
Option 2.Remain with the status quo. If a possible risk to public health and safety is identified the MRLs will be referred back to the NRA for further consideration.
IDENTIFICATION OF AFFECTED PARTIES
The parties affected by this application include:
- growers and producers of domestic and export food commodities;
- consumers, including domestic and overseas customers;
- importers of agricultural produce and foods; and
- Commonwealth, State and Territory agencies involved in monitoring agricultural and veterinary chemicals in food.
POTENTIAL REGULATORY IMPACTS
Option1:-
greater flexibility for producers and importers;
no additional public health risk resulting from consumption of commodities with the recommended MRLs; and
no additional impact for government monitoring programs.
Option 2:-
less flexibility for producers and importers;
possibility of reducing the range and quality of commodities for consumers; and
Discrepancy between agricultural and health legislation regarding permitted MRLs.
Registration has been granted for the chemicals listed in Attachment 1 for specified purposes. The listing of MRLs in Schedule 1 of Standard A14 will allow food containing residues up to the MRL of the listed chemicals to be traded. This has an obvious advantage to food producers. consumers will also be advantaged by potential improvements in the variety of available food. The proposed changes to Standard A14 will complete the regulatory requirements regarding the changes to the use of these agricultural and veterinary chemicals.
CONSIDERATION OF ISSUES UNDER SECTION 13
(a) This application relates to a matter that may require a variation to a standard.
(b) This application is not so similar to a previous application that it ought not be accepted.
(c) The application contains adequate information for independent assessment.
(d) There are no other relevant matters
CONCLUSIONS
The above applications fulfill the requirements for preliminary assessment as prescribed in section 13 of theAustralia New Zealand Food Authority Act 1991.
Based on the preliminary assessment report, the Authority has determined that this application would result in a change of minor significance and complexity to theFood Standards Codeand that no one would be adversely affected if the Authority omitted under section 36 of theAustralia New Zealand Food Authority Act 1991to delete the second round of public comments and proceed directly to Inquiry. Should significant issues arise out of the initial public round of comments ANZFA will proceed only to the Full Assessment stage and undertake another round of comments to enable these issues to be addressed fully.
If accepted by the Authority and agreed to by the Australia New Zealand Food Standards Council, an amendment to the Code, as suggested by the applicant, would be included in Standard A14, which would allow food to be sold containing residues of the chemicals up to the limit of the MRL.
REGULATION IMPACT ANALYSIS
The Authority develops food regulation suitable for adoption in Australia and New Zealand. It is required to consider the impact, including compliance costs to business, of various regulatory (and non-regulatory) options on all sectors of the community which includes the consumers, food industry and governments in both countries. The regulation impact assessment will identify and evaluate, though not be limited to, the costs and benefits of the regulation, and its health, economic and social impacts. In the course of assessing the regulatory impact, the Authority is guided by the AustralianGuide to Regulation(Commonwealth of Australia 1997) andNew Zealand code of Good Regulatory Practice.
To assist in this process, comment on potential impacts or issues pertaining to these regulatory options are sought from all interested parties in order to complete the development of the regulation impact statement. Public submissions should clearly identify relevant impact(s) or issues and provide support documentation where possible.
WORLD TRADE ORGANIZATION (WTO) NOTIFICATION
Australia and New Zealand are members of the WTO and are bound as parties to WTO agreements. In Australia, an agreement developed by the Council of Australian Governments (COAG) requires States and Territories to be bound as parties to those WTO agreements to which the Commonwealth is a signatory. Under the agreement between the Governments of Australia and New Zealand on Uniform Food Standards, ANZFA is required to ensure that food standards are consistent with the obligations of both countries as members of the WTO.
In certain circumstances Australia and New Zealand have an obligation to notify the WTO of changes to food standards to enable other member countries of the WTO to make comment. Notification is required in the case of any new or changed standards which may have a significant trade effect and which depart from the relevant international standard (or where no international standard exists).
Matters relating to public health and safety may be notified as a Sanitary or Phytosanitary (SPS) notification, and other matters as a Technical Barrier to Trade (TBT) notification. A decision on whether to make a notification to the WTO will be made during the Authority's full assessment of this matter.
FOOD STANDARDS SETTING IN AUSTRALIA AND NEW ZEALAND
The Governments of Australia and New Zealand entered an Agreement in December 1995 establishing a system for the development of joint food standards. The Australia New Zealand Food Authority is now developing a jointAustralia New Zealand Food Standards Codewhich will provide compositional and labelling standards for food in both Australia and New Zealand.
Until the jointAustralia New Zealand Food Standards Codeis finalised the following arrangements for the two countries apply:
· Food imported into New Zealand other than from Australia must comply with either the AustralianFood Standards Code, as gazetted in New Zealand, or the New ZealandFood Regulations 1984,but not a combination of both. However, in all cases maximum residue limits for agricultural and veterinary chemicals must comply solely with those limits specified in the New ZealandFood Regulations 1984.
· Food imported into Australia other than from New Zealand must comply solely with the AustralianFood Standards Code.
· Food imported into New Zealand from Australia must comply with either the AustralianFood Standards Codeor the New ZealandFood Regulations 1984,but not a combination of both.
· Food imported into Australia from New Zealand must comply with the AustralianFood Standards Code. However, under the provisions of the Trans-Tasman Mutual Recognition Arrangement, food may be imported into Australia from New Zealand if it complies with the New ZealandFood Regulations 1984orDietary Supplements Regulations 1985.
· Food manufactured in Australia and sold in Australia must comply solely with the AustralianFood Standards Code, except for exemptions granted in Standard T1.
In addition to the above, all food sold in New Zealand must comply with the New ZealandFair Trading Act 1986and all food sold in Australia must comply with the AustralianTrade Practices Act 1974,and the respective Australian State and TerritoryFair Trading Acts.
Any person or organisation may apply to ANZFA to have theFood Standards Code amended. In addition, ANZFA may develop proposals to amend the AustralianFood Standards Codeor to develop joint Australia New Zealand food standards. ANZFA can provide advice on the requirements for applications to amend theFood Standards Code.
INVITATION FOR PUBLIC SUBMISSIONS
Written submissions containing technical or other relevant information which will assist the Authority in undertaking a full assessment on matters relevant to the application, including consideration of its regulatory impact, are invited from interested individuals and organisations. Technical information presented should be in sufficient detail to allow independent scientific assessment.
Submissions providing more general comment and opinion are also invited. The Authority's policy on the management of submissions is available from the Standards Liaison Officer upon request.
The processes of the Authority are open to public scrutiny, and any submissions received will ordinarily be placed on the public register of the Authority and made available for public inspection. If you wish any confidential information contained in a submission to remain confidential to the Authority, you should clearly identify the sensitive information and provide justification for treating it in confidence. TheAustralia New Zealand Food Authority Act1991requires the Authority to treat in confidence trade secrets relating to food and any other information relating to food, the commercial value of which would be or could reasonably be expected to be, destroyed or diminished by disclosure.
Following its full assessment of the application the Authority may prepare a draft standard or draft variation to a standard (and supporting draft regulatory impact statement) , or decide to reject the application. If a draft standard or draft variation is prepared, it is then circulated to interested parties, including those from whom submissions were received, with a further invitation to make written submissions on the draft. Any such submissions will then be taken into consideration during the inquiry which the Authority will hold to consider the draft standard or draft variation to a standard.
All correspondence and submissions on this matter should be addressed to the
Project Manager - Application A405at one of the following addresses:
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Australia New Zealand Food Authority |
Australia New Zealand Food Authority |
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PO Box 7186 |
PO Box 10559 |
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Canberra Mail Centre ACT 2610 |
The Terrace WELLINGTON 6036 |
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AUSTRALIA |
NEW ZEALAND |
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Tel (02) 6271 2222 Fax (02) 6271 2278 |
Tel (04) 473 9942 Fax (04) 473 9855 |
The Authority should receive submissions by 5 April 2000.
ATTACHMENT 1
A summary of the requested MRLs for each chemical and an outline of the justification supporting the requested changes to Standard A14 is provided below. Full evaluation reports are available from the Project Manager ofA405. These will be sent to interested parties by email or posted.
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CHEMICAL Food |
MRL (mg/kg) |
JUSTIFICATION |
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PLANT GROWTH REGULATOR/PROMOTANTS |
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HERBICIDES |
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Bromoxynil Grapes |
0.01* |
An extension of useto pastures grown as cover crops in vineyards. NTMDI2 = 21% ADI |
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Diflufenican Grapes |
0.002* |
An extension of useto pastures grown as cover crops in vineyards. NTMDI = 0.1% ADI |
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Glyphosate Pulses Chick-pea (dry) Pulses (except chick-peas) |
0.1 (Deletion) T5 0.1* |
An extension of useto control broad leaf weeds and grasses. NEDI=4%ADI |
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Imazamox Field pea, dry Peanut Soya bean, dry |
0.05* 0.05* 0.05* |
New chemical,to be used for post emergent control of certain annual grasses and broadleaved weeds in field peas, peanuts and soya beans. Imazamox is the active constituent in two formulations, Raptor and Raptor WG. ADI (draft) = 2.8 mg/kg/day NTMDI = 0.001% ADI |
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CHEMICAL Food |
MRL (mg/kg) |
JUSTIFICATION |
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Imazapic Peanut |
T0.1* |
An extension of useto control grass, nutgrass and broadleaf weeds. Imazapic is the ISO alternatively approved name for imazameth.(A369). NEDI=0.05%ADI |
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Isoxaflutole Sugar cane Milks Meat (mammalian) Edible offal (mammalian) |
T0.01* T0.05* T0.05* T0.05* |
New chemical (MRL)for control of grasses and weeds. NEDI=3% of ADI |
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Metasulfuron-methyl Chick-pea (dry) |
T0.05* |
New chemical (MRL)for control of grasses and weeds. NEDI=11%ADI |
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Oxyfluorfen Cotton seed Brassica (cole or cabbage) vegetables, Head cabbages, Flowerhead brassicas Tropical and sub-tropical fruit (inedible peel) |
0.05* 0.05* 0.01* |
An extension of usefor use as a pre-emergent herbicide prior to sowing of cotton and for the control of annual broad-leaved weeds in fields of brassicas and tropical and sub-tropical fruits. NEDI=1.8%ADI |
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Propaquizafop Meat (mammalian) Edible offal (mammalian) Milks |
0.02* 0.02* 0.01* |
An extension of useto control grasses in pastures including lucerne, clover and vetch. Animal commodity MRLs requested as grazing may occur in these areas. NTMDI=1.7%ADI |
INSECTICIDES and ACARACIDES |
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Bifenthrin Citrus fruits Cotton seed Grapes |
0.05* 0.05 to 0.1 0.01* (from temporary to a permanent MRL) |
An extension of useto control insects on citrus fruits and grapes. Anincreaseto the cotton seed MRL in order to lower the withholding period from 7 weeks to 14 days. NEDI=68%ADI |
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CHEMICAL Food |
MRL (mg/kg) |
JUSTIFICATION |
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Cyfluthrin Beans, except broad bean and soybean Broad bean (green pods and immature seeds) Rape seed |
0.05* |
An extension of useto control mites on rape seed. Deletionsto existing commodity MRLs to reflect current registration status. NTMDI = 49% ADI |
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Chlorpyrifos Coffee beans |
T0.5 |
An extension of usefor the control of pests. NEDI = 83% ADI |
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Clorsulon Cattle milk |
1.5 |
An extension of usefor the control of roundworms, lungworms, eyeworms, lice, mites and adult liver fluke. NTMDI=68%ADI |
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Emamectin benzoate Brassica (cole or cabbage) vegetables. Head cabbages, flowerhead brassica Cotton seed Meat, mammalian Edible offal, mammalian Milks |
0.02 0.005 0.002* 0.002* 0.005* |
An extension of use for the control of Diamondback Moth in brassica crops andHelicoverpain cotton(temporary MRLs set as permanent and increased for brassica). MRLs have been set for animal food commodities to account for residues in animal feeds. TMDI = 1.85% ADI |
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Fenitrothion Apple Cabbages, head Cacao beans Cherries Fruits [except apples, cherries, grapes] Grapes Lettuce, head Lettuce, leaf Meat [mammalian] Rice, polished Soya bean (dry) Sugar Cane Tea, green, black Tomato Tree nuts |
Following the outcomes of a review on fenitrothion the NRA has recommended deletions of some MRLs and retaining of others until new data has been evaluated. The increases in MRLs for fruit and vegetables are restricted to a narrow period (late spring-summer) to control locusts. NEDI = 97% ADI |
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CHEMICAL Food |
MRL (mg/kg) |
JUSTIFICATION |
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Fenitrothion cont. Vegetables[except cabbage, head; lettuce, head; lettuce, leaf; soya bean (dry); tomato] Fruits Meat (mammalian)[in the fat] Rice bran, unprocessed Vegetables |
1 T0.05* T20 0.5 |
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Fipronil Strawberry Peppers |
T0.5 T0.1 |
Anextension of usefor an off-label permit for control of Western flower thrip. NEDI=67% ADI |
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Fluvalinate Asparagus |
T0.5 |
A trial permit for anextension of useto control garden weevil in asparagus. NTMDI=6%ADI |
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Imidacloprid Edible offal (mammalian) Meat (mammalian) Milks Maize Sweet corn (corn-on-the-cob) |
0.05 to 0.2 0.02 to 0.05 0.02 to 0.05 T0.02 to 0.05 0.02* |
An increasein the previously requested MRLs and anextension of useto control insects. NTMDI=4%ADI |
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Ivermectin Cattle milk |
0.02 to 0.05 |
An increaseto the MRL following re-evaluation of trial residue data for the control of roundworms, lungworms, eyeworms, lice, mites and adult liver fluke. NTMDI=70%ADI |
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Oxydemeton-methyl Brassica (cole or cabbage) vegetables, Head cabbages, Flowerhead cabbages |
0.5 |
New chemical (MRL)for control of aphids. NEDI=47%ADI |
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CHEMICAL Food |
MRL (mg/kg) |
JUSTIFICATION |
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Oxydemeton-methyl cont. Cotton seed Cotton seed oil, crude Eggs Edible offal (mammalian) Lupins (dry) Meat (mammalian) Milks Poultry, edible offal of Poultry meat |
0.01* 0.01* 0.01* 0.01* 0.01* 0.01* 0.01* 0.01* 0.01** |
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Pymetrozine Brassica (cole or cabbage) vegetables, Head cabbages, Flowerhead brassicas Potato |
T0.1 to T0.02* T0.02 to 0.02* |
Changed MRLs following re-evaluation of residue trial data. NEDI=3%ADI |
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Tebufenozide Coffee beans |
T0.05 |
Anextension of usefor control of leaf rollers and looper in coffee. NEDI=16%ADI |
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FUNGICIDES |
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Azoxystrobin Grapes Dried grapes Edible offal (mammalian) Meat (mammalian) Milks Fruit vegetables, cucurbits Tomatoes Potatoes |
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