30 May 2001

15/01

APPLICATION A439

MAXIMUM RESIDUE LIMITS

Applicant:National Registration Authority for Agricultural and Veterinary Chemicals.

Date received: 26 March and 10 April 2001.

1 BACKGROUND

An application has been received from the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) seeking amendment to Standards A14 and 1.4.2 for the Food Standards Code. The proposed amendments to Schedule 1 of the Standards would align Maximum Residue Limits (MRL) in the Food Standards Code to the MRLs in the NRA MRL Standard.

1.1 The use of Agricultural and Veterinary Chemicals

In Australia, the NRA is responsible for registering agricultural and veterinary chemical products, granting permits for use of chemical products and regulating the sale of agricultural and veterinary chemical products. Following the sale of these products, the use of the chemicals is then regulated by State and Territory 'control of use' legislation.

Before registering such a product, the NRA must be satisfied that the use of the product will not result in residues that would be an undue risk to the safety of people, including people using anything containing its residues. When a chemical product is registered for use or a permit for use granted, the NRA includes MRLs in their NRA MRL Standard. These MRLs are then adopted into control of use legislation in some jurisdictions and assist States and Territories in regulating the use of agricultural and veterinary chemicals.

Comments have been received by the Australia New Zealand Food Authority (ANZFA), in the past about the use of chemical products on foods. As ANZFA does not regulate the use of agricultural and veterinary chemicals, any comments about the use of these chemicals should be directed to the NRA or the relevant State or Territory.

1.2 Maximum Residue Limits

The MRL is the highest concentration of a chemical residue that is legally permitted or accepted in a food. The MRL does not indicate the amount of chemical that is always present in a treated food but it does indicate the highest residue that could possibly result from the registered conditions of use. The concentration is expressed in milligrams per kilogram (mg/kg) of the food.

MRLs assist in indicating whether an agricultural or veterinary chemical product has been used according to its registered use and if the MRL is exceeded then this indicates a likely misuse of the chemical product.

As stated above, the NRA includes MRLs in their NRA MRL Standard when they register a chemical product for use or grant a permit for use.
MRLs in the Food Standards Code also act both to protect public health and safety by ensuring that chemical residues are no higher than necessary, and as international trading standards.

The NRA then notifies ANZFA of these MRLs so that ANZFA may consider them for inclusion into the Food Standards Code . In summary, the MRLs in the NRA MRL Standard are used in some jurisdictions to assist in regulating the use of agricultural and veterinary chemical products under State and Territory control-of-use legislation whereas the MRLs in the Food Standards Code apply to the sale of food under State and Territory food legislation.

In relation to MRLs, ANZFA s role is to ensure that the potential residues in treated food do not represent an unacceptable risk to public health and safety. ANZFA will not recommend MRLs for inclusion in the Food Standards Code where the dietary exposure to the residues of a chemical could represent an unacceptable risk to public health and safety. In assessing this risk, ANZFA conducts dietary exposure assessments in accordance with internationally accepted practices and procedures.

1.3 Food Standards Setting in Australia and New Zealand

1.3.1 Treaty between the Commonwealth of Australia and New Zealand

The Agreement between the Commonwealth of Australia and the Government of New Zealand in to establish a system for the development of joint food standards (the Treaty), excluded MRLs for agricultural and veterinary chemicals in food from the joint Australia New Zealand food standards setting system. Australia and New Zealand separately develop MRLs for agricultural and veterinary chemicals in food.

1.3.2 Trans Tasman Mutual Recognition Arrangement

Following the commencement of the Trans Tasman Mutual Recognition Arrangement (TTMRA) between Australia and New Zealand on 1 May 1998:

· Food produced in Australia that complies with Standard A14 and Standard 1.4.2 of the Food Standards Code can be legally sold in New Zealand; and

· Food produced in New Zealand that complies with the New Zealand (Maximum Residue Limits of Agricultural Compounds)Mandatory Food Standard, 1999can be legally sold in Australia.

1.3.3 Food Standards Code

On 24 November 2000 the Australia New Zealand Food Standards Council (ANZFSC) adopted the Australia New Zealand Food Standards Code (published as Volume 2of the Food Standards Code). Subsequently all applications to amend MRLs will now also be incorporated into Volumes 1 and 2 of the Food Standards Code (Standard A14 & Standard 1.4.2 respectively). Consequently all references throughout this document to the Food Standards Code are references to both Volumes 1 & 2 of the Food Standards Code.

2 OBJECTIVE

The objective of the proposed amendment is to allow the legal sale of legally treated produce. The NRA has already registered or varied the registration of specific chemical products under the NRA s legislation, and now seeks, by way of this application to include the following amendments to the Food Standards Code .

2.1 Change of name for a chemical

The NRA has advised that the chemical 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylinene-n-nitroamine has had its name changed and will now be known as thiamethoxam. Included in the proposed amendment, for this chemical, is the deletion of the MRL for cotton seed oil and the reduction of the MRLs for cotton seed, maize, sorghum and sweet corn (corn on the cob) from 0.05 mg/kg to 0.02mg/kg at the limit of quantitation.

2.2 MRLs for the extensions of use of chemicals

The NRA has advised that MRLs amendments are required because of extensions of use for the chemicals, cyromazine, diafenthiuron, dithiocarbamates, ethion, glyphosate, phosphorous acid and spinosad.

2.3 Changes to existing MRLs

The NRA has advised that MRL amendments are required because of changes to existing MRLs for the chemicals chlorfenapyr, diafenthiuron, fipronil, indoxacarb, spinosad and thimethoxam.

2.4 Deletions of existing Chemicals

The NRA has advised that MRL deletions are required for the chemicals azinphos-ethyl, EDB, DEF and tribufos.

The requested variation/s to Schedule 1 of Standard A14 of Volume 1 and Standard 1.4.2 of Volume 2 of the Food Standards Codeare summarised at Attachment 1.

3 REGULATORY IMPACT ASSESSMENT

This Regulatory Impact Statement (RIS) is preliminary only and based on information provided by the applicant. The RIS identifies the affected parties, any alternative regulatory options and the potential impacts of any regulatory or non-regulatory provisions. The information needed to make an assessment of this application will include the information from public submissions. This preliminary RIS invites public comment on these areas.

3.1 Objective

To assess the costs and benefits associated with adopting the proposed regulatory change to permit the proposed MRLs.

3.2 Possible Options (Including Alternatives)

3.2.1 Option 1

Vary the Food Standards Code in accordance with the NRA s Application A439. The effect of this option would be that legally treated food could be legally sold or imported if it contained residues consistent with the MRLs in this application.

3.2.2 Option 2

Maintain the status quo and not include the MRLs in the NRA s application. The effect of this option would be that food could not be legally sold or imported if it contained residues greater than those currently stipulated in the Food Standards Code.

3.3 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 and exporters of agricultural produce and foods; and

· Commonwealth, State and Territory agencies involved in monitoring agricultural and veterinary chemicals in food.

4 POTENTIAL REGULATORY IMPACTS

In considering the regulatory impact of the options listed below, it needs to be noted that the inclusion of MRLs in the Food Standards Code only permits the treated food to be legally sold if it contains chemical residues that do not exceed the MRL for the specified chemical(s). The inclusion of an MRL does not on its own permit or prohibit a particular chemical product from being used. This is regulated by other legislation.

The inclusion of MRLs in the Food Standards Code allows food producers to trade food that has been legally treated with registered agricultural and veterinary products. The use of agricultural and veterinary products provides effective pest and disease control. This potentially leads to improved productivity for producers, better quality food for consumers and more competitive primary industries.

Any MRL deletions or reductions have the potential to restrict the importation of foods and could potentially result in higher food costs and a reduced product range available to consumers, as foods containing residues that exceed the newer, lower MRLs could not be legally sold to consumers. To identify any restrictions and possible trade impacts, codex MRLs and data on imported foods have been considered in assessing the reductions and deletions within this application.

Option 1: To Include the Proposed MRLs in the Food Standards Code:

Will:
· permit greater flexibility for producers and importers of food, as food may be legally permitted to contain residues up to the MRL permitted for that food;

· result in a slight impact on government monitoring programs, as more comprehensive monitoring may be needed; and

· potentially permit more variety and more competitively priced food for consumers as food treated with legally registered products can be legally sold.

Option 2: Do not include the proposed MRLs in the Food Standards Code:

Will result in:

· a discrepancy between agricultural and health legislation in that the agricultural legislation will permit the use of agricultural and veterinary products but the food legislation would prohibit the sale of such legally treated food;

· potentially less flexibility for producers and importers as treated food may not be legally sold; and

· the possibility of reducing the range and quality of foods for consumers as the treated food could not then be legally sold.

5 CONSIDERATION OF ISSUES UNDER SECTION 13 OF THE AUSTRALIA NEW ZEALAND FOOD AUTHORITY ACT 1991

Subsection 13(1) of the Australia New Zealand Food Authority Act, 1991 (ANZFA Act) requires ANZFA to make a preliminary assessment of an application. In making that preliminary assessment, subsection 13(2) requires ANZFA to have regard to a number of matters set out in paragraphs 13(2)(a) to (e). Each of these matters is discussed below.

5.1 Paragraph 13(2)(a)

This application relates to a matter that may warrant a variation to a food regulatory measure, because the application seeks an amendment of a standard. Under the ANZFA act, a standard, by definition, is a food regulatory measure.

5.2 Paragraph 13(2)(b)

This application is not so similar to a previous application that it ought not be accepted.

5.3 Paragraph 13(2)(c)

The application does not suggest that the proposed amendment would present any further costs to the community, Government or industry. ANZFA has reviewed the application and has not identified any adverse health effects that would result from the variations being made.
Benefits of the food regulatory measure in this application outweigh the direct and indirect cost to the community, Government and industry (see Option 1 in the Potential Regulatory Impacts).

5.4 Paragraph 13(2)(d)

The nature of the application is such that only an amendment to a standard (i.e. a food regulatory measure) can bring about what the applicant is seeking. No other measures appear to be available.

5.5 Paragraph 13(2)(e)

Other relevant matters for consideration by ANZFA are as follows.

5.5.1 World Trade Organization Notification

As a member of the World Trade Organisation (WTO) Australia is obligated to notify WTO member nations where proposed mandatory regulatory measures are inconsistent with any existing or imminent international standards and the proposed measure may have a significant effect on trade.

The MRLs prescribed in the Australia New Zealand Food Standards Code constitute a mandatory requirement applying to all food products of a particular class whether produced domestically or imported. Food products exceeding their relevant MRL set out in the Food Standardscode cannot legally be supplied in Australia.

In administrative terms and consistent with international practice, MRLs assist in regulating the use of agricultural and veterinary chemical products. MRLs indicate whether agricultural and veterinary chemical products have been used in accordance with the registered conditions of use. MRLs in the Food Standards Code also act both to protect public health and public safety by ensuring that chemical residues are no higher than necessary, and as international trading standards.

This application contains variations to MRLs which are not addressed in the international codex standard. MRLs in this application also relate to chemicals used in the production of heavily traded agricultural commodities, which may indirectly have a significant effect on trade of derivative food products between WTO members. A WTO notification for this application will therefore be made following the endorsement of the Preliminary Assessment.

The application will be notified as a Sanitary and Phytosanitary (SPS) measure in accordance with the WTO SPS agreement as the primary objective of the measure is to support regulating the use of agricultural and veterinary chemical products to protect human, animal and plant health and the environment.

5.5.2 Imported Foods

It should be recognised that agricultural and veterinary chemicals are used differently in other countries than in Australia because of different pests or diseases or because different products may be used. This means that residues in imported food while still being safe for human consumption, may be different from that in domestically produced food.

ANZFA recognises that changes to MRLs have implications for the importation of food, particularly where MRLs are reduced or deleted. To assist in identifying possible situations where imported food may be affected, ANZFA has compiled the following table made of relevant imported food commodities for the years 1999 and 2000. The table also indicates for each of the food commodities the chemicals used on those commodities, such chemicals being the subject of possible reductions and deletions in MRLs as applied for in the NRA s application.

ANZFA requests comment on the significance of the reduction and deletions to MRLs for the imported foods.

Chemical Food	1999	2000
Azinphos-ethyl Cereal grains [1] Citrus fruits Edible Offal, mammalian Meat Mammalian Milk Oilseed Pome fruits Vegetables	7447kt 3947kt 41kt 2627kt 2202kt 12kt 169kt 63574kt	7447kt 4170kt 484kt 4817kt 1805kt 1505kt 134kt 52949kt
EDB Fruits [2] Vegetables	10884kt 63574kt	11858kt 52949kt
Diafenthiuron Cotton seed	0	0
Tribufos Cotton seed	0	0
Thiamethoxam Cotton seed Cotton seed oil Maize Sorghum Sweet corn	0 6 840kt 50 tonne 1378kt	0 22kt 884kt 0 1295kt

6 CONCLUSION

The above application A439 fulfils the requirements for preliminary assessment as prescribed in section 13 of the Australia New Zealand Food Authority Act 1991.

A SUMMARY OF THE REQUESTED MRLS FOR EACH CHEMICAL, AND AN OUTLINE OF THE INFORMATION SUPPORTING THE REQUESTED CHANGES TO THE FOOD STANDARDS code.

The Full Evaluation Reports for individual chemicals are available upon request from the relevant Project Manager at ANZFA.

NOTES ON TERMS USED IN THE TABLE

NEDI - National Estimated Dietary Intake - The NEDI represents a more realistic estimate of dietary exposure and is the preferred calculation. It may incorporate more refined food consumption data including that for specific sub-groups of the population. The NEDI calculation may take into account such factors as the proportion of the crop or commodity treated; residues in edible portions; the effects of processing and cooking on residue levels; and may use median residue levels from supervised trials other than the MRL to represent pesticide residue levels. In most cases the NEDI is still an overestimation because the above data is often not available and in these cases the MRL is used.

NTMDI - National Theoretical Maximum Dietary Intake - The NTMDI is a prediction of the long-term daily intake of a pesticide and is calculated by multiplying the MRLs established and proposed for a chemical by the average daily consumption for each food commodity across the whole population and summing the products. While a useful screening tool, the NTMDI is an overestimate of the true pesticide residue intake because it assumes that the entire national crop is treated with a pesticide and that all the treated produce contains residues equivalent to the MRL.

NESTI - National Estimated Short Term Intake is used to estimate acute dietary exposure. Acute (short term) dietary exposure assessments are undertaken when an acute reference dose (ARfD) has been determined for a chemical. Acute dietary exposures are normally only estimated based on consumption of raw unprocessed commodities (fruit and vegetables) but may include consideration of meat, offal, cereal, milk or dairy product consumption on a case-by-case basis.

The ARfD of a chemical is the estimate of the amount of a substance in food, expressed on a body weight basis, that can be ingested over a short period of time, usually during one meal or one day, without appreciable health risk to the consumer, on the basis of all the known facts at the time of evaluation. ANZFA has used ARfDs set by the TGA and Joint FAO/WHO Meeting on Pesticide Residues, the consumption data from the 1995 NNS and the MRL when the STMR is not available to calculate the NESTIs.

The NESTI calculation incorporates the large portion (97.5^th percentile) food consumption data and can take into account such factors as the highest residue on a composite sample of an edible portion; the supervised trials median residue (STMR), representing typical residue in an edible portion resulting from the maximum permitted pesticide use pattern; processing factors which affect changes from the raw commodity to the consumed food and the variability factor.

PTWI - Provisional Tolerable Weekly Intake represents permissible human weekly exposure to a contaminant which has a cumulative effect on the body and is unavoidably present in otherwise wholesome and nutritious food. PTWI is based on WHO recommendations.

Glossary;

1. ADI Acceptable Daily Intake.

2. ARfD Acute Reference Dose

3. ATDS Australian Total Diet Survey

4. LOQ Limit of Analytical Quantification.

5. NEDI National Estimated Daily Intake.

6. NESTI National Estimated Short Term Intake

7. NTMDI National Theoretical Maximum Daily Intake

8. PTWI Provisional Tolerable Weekly Intake

9. * MRL set at or about the limit of quantitation.

10. T Temporary MRL

CHEMICAL Food	MRL (gm/kg)	INFORMATION
B1. Deletions and reductions
Azinphos-ethyl Cereal grains Citrus fruits Edible offal (mammalian) Meat (mammalian) Milks Oilseed Pome fruits Vegetables	Delete 0.2 Delete 2 Delete *0.05 Delete *0.05 Delete *0.05 Delete *0.05 Delete 2 Delete 1	As these are deletions no dietary estimates data is necessary
EDB Fruits Vegetables	Delete T0.1 Delete T0.1	As these are deletions no dietary estimates data is necessary
Tribufos Cotton seed	Delete *0.1	As this is a deletion no dietary estimates data is necessary
DEF See Tribufos	Delete	As this is a deletion no dietary estimates data is necessary

B2. Drafting errors and technical clarifications
Glyphosate Pulses [except: adzuki; beans; broad beans (dry); chickpeas; field peas (dry); and mung beans(dry)] Pulses [except: adzuki; beans; broad beans (dry); cowpea (dry); chickpeas; field peas (dry); and mung beans(dry)]	Delete*0.1 Add*0.1	The chemical is used to control annual and perennial grasses, and broad leaved weeds in legumes . NEDI = 4.3% of ADI
Indoxacarb Pome fruit	Delete T2 Substitute 2	The chemical is used to control insect pests in pome fruit NEDI = 42.67% of ADI
CHEMICAL Food	MRL (gm/kg)	INFORMATION
B6. MRLs for existing chemicals associated with a dietary exposure less than 90% of the ADI or less than 90% of the Acute Reference Dose where applicable
Chlorfenapyr Brassica (cole or cabbage) vegetables, flowerhead brassicas	Delete T0.5 Substitute 0.5	This chemical is used to control insects in brassica crops. NEDI = 2.39% of ADI
Cyromazine Milks	Add *0.01	This chemical is used to control dipterea larvae in chicken manure. The manure may then be used to fertilize grain/fodder crops which may be fed to dairy herds. NEDI = 1.41% of ADI
Diafenthiuron Cotton Seed Edible offal (mammalian) Meat (mammalian), in the fat Milks	Delete 0.2 Substitute 0.1 Add *0.02 *0.02 *0.02	This chemical is used to control mites, aphids and jassid on various field crops, ornamentals and vegetables. NEDI = 6.22% of ADI
Ethion Cotton seed Cottonseed oil, crude	Add 0.1 Add 0.05	The new use pattern for this chemical involves the control of helicoverpa spp in cotton. NEDI = 73% of ADI (based on the other registered uses, new uses on cottonseed and taking into account possible residues in imports).

Indoxacarb Brassica(cole or Cabbage)vegetables, Head cabbages and flowerhead brassicas	Delete T1 Substitute 2	This chemical is used to control insect pests brassica vegetables. NEDI = 42.67% of ADI
3-(2chlor-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylinede-N-nitroamine Cotton seed Cotton seed oil Maize Sorghum Sweetcorn	Delete T0.05 Delete T0.05 Delete T0.05 Delete T0.05 Delete T0.05	Change of name for this chemical to Thiamethoxam. MRLS are deleted and MRLS proposed for Thiamethoxam.
Thiamethoxam Cotton seed Maize Sorghum Sweetcorn (corn-on-the-cob)	Add *0.02 Add *0.02 Add *0.02 Add *0.02	This chemical is used to control insects. NEDI = 0.009% of ADI
B8. MRLs for permits associated with a dietary exposure less than 90% of the ADI of less than 90% of the Acute Reference Dose where applicable
Dithiocarbamates Tree Tomato	Add T5	This chemical is used to control anthracnose on tree tomatoes. The MRL is associated with a temporary permit for use on a single plantation in northern NSW. The NRA has estimated that the intake for dithiocarbamates from tree tomatoes is equivalent to 0.03% of the ADI. In the 1998 ATDS the estimated dietary exposure to thiram (the dithiocarbamate with the lowest ADI) was at 63% of the ADI. This MRL is for the use of the dithiocarbamate, mancozeb which has a 10 times higher ADI than thiram. Given the small consumption of tree tomatoes, the permit restrictions to a single plantation, the results from the 1998 ATDS and the fact that the permit is for the chemical mancozeb; ANZFA considers that there is not an unacceptable risk to public health and safety with the residues of mancozeb in tree tomatoes.
Fipronil Asparagus	Delete T0.1 Substitute T0.5	The chemical is used to control garden weevil in asparagus. NEDI = 6