PROPOSAL M1002

Maximum Residue Limits (January, February, March 2008)

EXPLANATORY STATEMENT

Executive Summary

Purpose

The purpose of this Proposal is to consider varying maximum residue limits (MRLs) in the Australia only Standard 1.4.2 of the Australia New Zealand Food Standards Code (the Code) for residues of agricultural and veterinary chemicals that may legitimately occur in food. This includes MRL variations gazetted by the Australian Pesticides and Veterinary Medicines Authority (APVMA) in January, February and March 2008. The MRL variations will permit the sale of legally treated foods and protect public health and safety by minimising residues in foods consistent with the effective control of pests and diseases.

Food Standards Australia New Zealand’s (FSANZ’s) role in the regulation of agricultural and veterinary chemicals is to protect public health and safety by ensuring that any potential residues in food are within appropriate safety limits and to support industry and compliance agencies by maintaining MRLs in the Code that reflect legitimate residues in food.

Dietary exposure assessments indicate that in relation to current reference health standards, the MRL variations do not present any public health and safety concerns. This Proposal includes consideration of an MRL for the antibiotic florfenicol in fish. The residues associated with the proposed MRL do not pose a risk in terms of the development of antimicrobial resistance.

The Agreement between the Government of Australia and the Government of New Zealand concerning a Joint Food Standards System (the Treaty), excludes MRLs for residues of agricultural and veterinary chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for residues of agricultural and veterinary chemicals in food.

FSANZ made a Sanitary and Phytosanitary notification to the World Trade Organization (WTO). Comments were received from the California Table Grape Commission (CTGC). FSANZ has addressed the issues raised in section 9.2 of this Report.

This Proposal has been assessed under the General Procedure.

Assessing the Proposal

In assessing the Proposal, FSANZ has had regard to the section 18 objectives and the following matters as prescribed in section 59 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act):

• whether costs that would arise from a food regulatory measure developed or varied as a result of the Proposal outweigh the direct and indirect benefits to the community, Government or industry that would arise from the development or variation of the food regulatory measure;

• whether other measures would be more cost-effective than a variation to a food regulatory measure;

•              any relevant New Zealand standards; and

• any other relevant matters.

Reasons for Decision

This Proposal has been assessed against the considerations provided for in section 59 of the FSANZ Act. FSANZ recommends approving the amended draft variations to Standard 1.4.2 for the following reasons:

• MRLs serve to protect public health and safety by minimising residues in food consistent with the effective control of pests and diseases.

• Dietary exposure assessments indicate that the MRL variations do not present any public health and safety concerns.

• This approach ensures openness and transparency in relation to the residues that could reasonably occur in food.

• The variations will benefit stakeholders by maintaining public health and safety while permitting the legal sale of food treated with agricultural and veterinary chemicals to control pests and diseases and improve agricultural productivity.

• The APVMA has assessed appropriate residue, animal transfer, processing and metabolism studies, in accordance with The Manual of Requirements and Guidelines – MORAG – for Agricultural and Veterinary Chemicals 1 July 2005 to support the use of chemicals on commodities as outlined in this Proposal.

• The Office of Chemical Safety (OCS) has undertaken a toxicological assessment of each chemical and has established an acceptable daily intake (ADI) and where appropriate an acute reference dose (ARfD).

• FSANZ has undertaken a regulation impact assessment and concluded that the draft variations are necessary, cost-effective and beneficial.

• The draft variations would remove discrepancies between agricultural and food standards and provide certainty and consistency for producers, importers and Australian, State and Territory compliance agencies.

• The variations are consistent with the FSANZ objectives under s18 of the FSANZ Act.

Consultation

FSANZ has now completed the assessment of Proposal M1002 and undertaken a round of public consultation. The Board has approved the draft amendments to the Code and this decision has been notified to the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council). If the Ministerial Council does not request FSANZ review the draft amendments to the Code, an amendment to the Code will be published in the Commonwealth Gazette and the New Zealand Gazette and adopted by reference and without amendment under State and Territory food legislation.

Amendments Following Public Consultation

FSANZ sought public comment on the draft variation at Attachment 1C. Taking into account the comment received in response to the World Trade Organization (WTO) Notification, FSANZ has amended the draft variations (see Attachment 1A - unmarked version or Attachment 1B - marked version).

The amendment to the draft variations is to insert an MRL for fluorine of 7 mg/kg for grapes. This will in fact retain the current MRL for grapes as FSANZ progresses the deletion of the fruit entry for fluorine and associated MRL of 7 mg/kg as requested by the APVMA. This reflects the CTGC request that FSANZ consider retaining an MRL of 7 mg/kg for fluorine in grapes on the basis that this would minimise potential trade disruption.

On the basis of the points raised in the CTGC comments, the currently available information and as an interim measure until discussions with the APVMA can occur, FSANZ considers that this a practical approach.

CONTENTS

Introduction

1. The Issue / Problem

2. Current Standard

2.1 Background

3. Objectives

4. Assessment Approach

RISK ASSESSMENT

5. Risk Assessment Summary

Risk Management

6. Options

7. Impact Analysis

7.1 Affected Parties

7.2 Benefit Cost Analysis

7.3 Comparison of Options

Communication and Consultation Strategy

8. Communication

9. Consultation

9.1 Issues raised in submissions

9.2 World Trade Organization

9.3 Codex Alimentarius Commission MRLs

9.4 New Zealand MRL Standards

9.5 Imported Foods

9.6 Commodity classifications for MRLs notified for veterinary chemicals

Conclusion

10. Conclusion and Decision

10.1 Reasons for Decision

11. Implementation and Review

Attachment 1A - Draft variations to the Australia New Zealand Food Standards Code

Attachment 1B - Draft variations to the Australia New Zealand Food Standards Code (Changes Marked)

Attachment 1C - Draft variations to the Australia New Zealand Food Standards Code (at Assessment)

Attachment 2 - A summary of MRLs under consideration in Proposal M1002

Attachment 3 - Summary of Submissions

Attachment 4 - Safety Assessment Methodology

Attachment 5 - Background Information

Introduction

Notifications were received from the Australian Pesticides and Veterinary Medicines Authority (APVMA) on 5 February, 19 February and 6 March 2008 seeking to vary the Australia New Zealand Food Standards Code (the Code). The proposed variations to the Australia only Standard 1.4.2 – Maximum Residue Limits would align maximum residue limits (MRLs) in the Code for certain agricultural and veterinary chemicals with the MRLs listed in the APVMA MRL Standard and permit the sale of relevant foods legitimately treated during production.

This Proposal includes consideration of MRL variations for azoxystrobin, bifenazate, bifenthrin, chlorpyrifos, closantel, clothianidin, cyanamide, cyprodinil, dimethenamid-P (new chemical), florfenicol (antibiotic), fludioxonil, fluorine (inorganic salts), glyphosate, isoxaben, maldison, methomyl, metsulfuron-methyl, phosphorous acid, propiconazole, prosulfocarb, prothioconazole, pyrasulfotole, ractopamine, sulfuryl fluoride (new chemical) thiamethoxam, toltrazuril and tolylfluanid.

This Proposal does not include an MRL for mancozeb in herbs gazetted by the APVMA in March 2008 as consideration of that MRL is ongoing. Rather than delay progressing the other MRL variations, the mancozeb MRL has been excluded from this Proposal and will be included in a subsequent proposal.

The draft variations to the Code are at Attachment 1 and the proposed variations and dietary exposure estimates are outlined in Attachment 2. A summary of comments received on the Assessment Report is provided in Attachment 3. The safety assessment methodology is outlined in Attachment 4 and the background information in Attachment 5; this includes an explanation of terms used in this Report.

FSANZ’s role in the regulation of agricultural and veterinary chemicals is to protect public health and safety by ensuring that any potential residues in food are within appropriate safety limits and to support producers, importers and compliance agencies by maintaining MRLs in the Code that reflect legitimate residues in food.

In considering the issues associated with MRL variations, it should be noted that the MRL is the maximum level of a chemical that may be in a food and it is not the level that is usually present in a treated food. Incorporating the MRL into food legislation means that the residues of a chemical are minimised (i.e. must not exceed the MRL), irrespective of whether the dietary exposure assessment indicates that higher residues would not be a risk to public health and safety.

MRLs and variations to MRLs in the Code do not permit or prohibit the use of agricultural and veterinary chemicals. Other Australian Government, State and Territory legislation regulates use and control of agricultural and veterinary chemicals.

1. The Issue / Problem

Including MRLs in the Code has the effect of allowing legally treated produce to be sold legally, where any residues are at or under the MRL. Variations in MRLs reflect the changing patterns of agricultural and veterinary chemicals available to chemical product users (e.g. food producers). These changes include both the development of new products and crop uses, and the withdrawal of older products following review. Where residues do not pose health or safety concerns, MRLs are also varied in line with international standards to allow legitimately treated foods to be imported.

Internationally, food producers face different pest and disease pressures and climatic conditions and therefore agricultural and veterinary chemical use patterns may vary.

2. Current Standard

2.1 Background

Standard 1.4.2 lists the limits for agricultural and veterinary chemical residues which may occur in foods. If an MRL is not listed for a particular agricultural or veterinary chemical/commodity combination, there must be no detectable residues of that chemical in that food. This general prohibition means that in the absence of the relevant MRL in the Standard, legitimately treated produce may not be sold where there are detectable residues.

Variations to the Standard are required to permit the sale of foods legitimately treated during production. A dietary exposure assessment is conducted before the Standard is varied to ensure that MRL variations do not present any public health or safety concerns.

Further background information on MRLs, the regulatory framework for agricultural and veterinary chemicals and the FSANZ assessment process for incorporating MRLs, including MRLs for antibiotic substances, in the Code is provided at Attachment 5.

3. Objectives

In assessing this Proposal, FSANZ aims to ensure that approving the proposed draft variations does not present public health and safety concerns and that the sale of legally treated food is permitted.

Subsection 18(1) of the FSANZ Act provides that the objectives (in descending priority order) of FSANZ in developing or reviewing food regulatory measures and variations of food regulatory measures are:

• the protection of public health and safety;

• the provision of adequate information relating to food to enable consumers to make informed choices; and

• the prevention of misleading or deceptive conduct.

Subsection 18(2) provides that FSANZ must also have regard to:

• the need for standards to be based on risk analysis using the best available scientific evidence;

• the promotion of consistency between domestic and international food standards;

• the desirability of an efficient and internationally competitive food industry;

• the promotion of fair trading in food; and

• any written policy guidelines formulated by the Ministerial Council.

For the reasons set out in this Report, the proposed draft variations to Standard 1.4.2 are consistent with the FSANZ Act section 18 objectives.

4. Assessment Approach

FSANZ’s primary role in developing food regulatory measures for agricultural and veterinary chemicals is to ensure that the potential residues in treated food are within reference health standards. FSANZ conducts and reviews dietary exposure assessments in accordance with internationally accepted practices and procedures.

In assessing the public health and safety implications of chemical residues, FSANZ considers the dietary exposure to chemical residues from all potentially treated foods in the diet by comparing the dietary exposure with the relevant reference health standard. FSANZ will not approve MRL variations to the Code where dietary exposure to the residues of a chemical could be a risk to public health and safety.

The steps undertaken in conducting a dietary exposure assessment are:

• determination of the residues of a chemical in a treated food; and

• calculating the dietary exposure to a chemical from relevant foods, using food consumption data from national nutrition surveys and comparing this to the acceptable reference health standard.

The estimated dietary exposure to a chemical is compared to the relevant reference health standard/s for that chemical in food (i.e. the acceptable daily intake (ADI) and/or the acute reference dose (ARfD) or provisional tolerable weekly intake (PTWI) or upper level (UL)). FSANZ considers that dietary exposure to the residues of a chemical is acceptable where the best estimate of this exposure does not exceed the relevant health standard/s.

The safety assessment methodology is further outlined in Attachment 4.

RISK ASSESSMENT

5. Risk Assessment Summary

FSANZ has reviewed the dietary exposure assessments submitted by the APVMA to assess the notified MRL variations. FSANZ also conducted a dietary exposure assessment for sulfuryl fluoride and fluorine. This included consideration of retaining an MRL of 7 mg/kg for fluorine in grapes only as requested by the California Table Grape Commission (CTGC) (refer section 9.2).

Using the best available scientific data and internationally recognised risk assessment methodology, and considering other dietary sources of fluoride, FSANZ concluded that in relation to current reference health standards, varying the MRLs as notified by the APVMA and retaining an MRL for fluorine in grapes only, does not present any public health and safety concerns.

The additional safety factors inherent in calculation of the ADI, ARfD, PTWI and UL mean that there is negligible risk to public health and safety when estimated exposures are below these reference health standards.

The proposed MRL for antibiotic substance florfenicol does not pose a risk in terms of development of antimicrobial resistance.

Risk Management

6. Options

1. Option 1 – approve the draft variations

2.              Option 2 – approve the draft variations subject to such amendments as FSANZ considers necessary

3.              Option 3 – reject the draft variations

7. Impact Analysis

The impact analysis represents likely impacts based on available information. The impact analysis is designed to assist in the process of identifying affected parties and any alternative options consistent with the objective of the proposed changes. Information from public submissions is used in assessing the proposed changes.

7.1 Affected Parties

The parties affected by proposed MRL amendments include:

• consumers;

• growers and producers;

• importers of agricultural produce and food products; and

• Australian Government, State and Territory agencies involved in monitoring and regulating the use of agricultural and veterinary chemicals in food and the potential resulting residues.

7.2 Benefit Cost Analysis

7.2.1 Option 1 – approve the draft variations

This option may contribute to community confidence that regulatory authorities are maintaining standards to minimise residues in the food supply. FSANZ does not consider there to be any dietary exposure implications associated with the proposed approval. The risk assessment has determined that there are no public health or safety concerns associated with the proposed variations. No additional costs to consumers have been identified.

Progressing this option benefits growers and producers in that foods produced in accordance with agricultural Standards and legislation may be sold under food legislation. Omitting or reducing MRLs is unlikely to result in any costs for producers as changes in use patterns are made as required; current proper use results in compliance with these variations already.

Importers may benefit or be disadvantaged by the approval of the approved draft variations. Additional or increased MRLs may benefit importers and consequently consumers in that this may extend the options to source safe foods. Any MRL deletions or reductions have the potential to restrict importation of foods and could potentially result in higher food prices and a reduced product range available to consumers.

Interested parties are invited to comment on these impacts during the public consultation period. This is to ensure that any adverse consequences of the proposed variations can be addressed. Further discussion on the submissions received and impacts in relation to imported foods and Codex MRLs are addressed in section 9. of this Report.

This option benefits Australian Government, State and Territory agencies in that it serves to further harmonise agricultural and food standards, this is of particular assistance to compliance agencies. Achieving further consistency between agricultural and food legislation would minimise compliance costs to primary producers and assist in efficient enforcement of regulations. This option is unlikely to result in discernable costs to Government agencies, although an awareness of changes in the standards for residues in food would be needed and there may be minimal impacts associated with slight changes to residue monitoring programs.

7.2.2 Option 2 – approve the draft variations subject to such amendments as FSANZ considers necessary

This option has similar costs and benefits as option 1. FSANZ has assessed comments provided by the California Table Grape Commission and has decided to retain an MRL for fluorine in grapes. This continues to permit the importation and sale of grapes legitimately treated with a chemical product in the United States.

7.2.3 Option 3 – reject the draft variations

This option would allow discrepancies between agricultural and food legislation to perpetuate as the Code would not reflect legitimate use of chemical products as determined by the APVMA. This may result in foods legitimately treated during production not being permitted for sale. In addition this may also create uncertainty, inefficiency and confusion in the enforcement of regulations. This would impact negatively on all affected parties and industry and compliance agencies in particular.

Importers may benefit if proposed MRL deletions or reductions are not progressed as the continuity of existing limits could be relied upon. However, there is scope under current processes to retain specific MRLs where the necessity for the MRL to continue to allow the importation and sale of safe food is identified through consultation. This is discussed in sections 9.2 and 9.5 of this Report. Importers and consequently consumers may be disadvantaged where proposed additional or increased MRLs are not progressed as this may unnecessarily limit sources of food.

In summary, FSANZ conducted an Office of Best Practice Regulation Preliminary Assessment and concluded that business compliance costs and other impacts on business, individuals, regulatory agencies and the economy are low or nil. The regulatory proposal does not impose impacts on business, individuals, regulatory agencies or the economy that warrant further analysis. The changes to regulation are mechanical in nature involving technical variations to the Standard which will not have appreciable impacts and are consistent with existing policy.

7.3 Comparison of Options

In assessing proposed variations to the Code, FSANZ considers the impact of various regulatory and non-regulatory options on all sectors of the community, including consumers, food industries and governments in Australia.

FSANZ recommends approving option 2 – approve the draft variations subject to such amendments as FSANZ considers necessary for the following reasons:

• There are no public health and safety concerns associated with the proposed MRL variations (this benefit also applies to option 1).

• This approach ensures openness and transparency in relation to the residues that could reasonably occur in food.

• The changes would minimise potential costs to primary producers, rural and regional communities and importers in terms of permitting the sale of legitimately treated food.

• The changes would minimise residues in food consistent with the effective use of agricultural and veterinary chemicals to control pests and diseases.

• The changes would remove discrepancies between agricultural and food standards and assist compliance agencies.

• The necessity to retain an MRL to continue to allow for the importation and sale of safe food was identified through consultation and further assessment.

Option 1 is not recommended as consultation and further assessment identified a need to amend the proposed draft variations (refer section 9.2 of this Report).

Option 3 is an undesirable option because potential substantial costs to primary producers may result. Additional costs may impact negatively on their viability and in turn the viability of the rural and regional communities that depend upon the sale of agricultural produce.

This option may restrict the opportunity for importers to source safe produce or foods internationally and potentially impact consumers through higher food prices and limited choice. Also, consequent discrepancies between agricultural and food legislation could have negative impacts on compliance costs for producers, perception problems in export markets and undermine the efficient enforcement of standards for chemical residues.

The benefits of progressing option 2 outweigh any associated costs.

Communication and Consultation Strategy

8. Communication

FSANZ consideration of amending MRLs in the Code does not normally generate public interest. FSANZ adopts a basic communication strategy, with a focus on alerting the community that a change to the Code is being contemplated.

FSANZ publishes the details of proposed changes and subsequent assessment reports on its website, notifies the community of the period of public consultation through newspaper advertisements, and issues media releases drawing attention to proposed Code amendments. Once the Code has been amended, FSANZ incorporates the changes in the website version of the Code and, through its email and telephone information service, responds to industry enquiries.

Should the media show an interest in any of the chemicals being assessed, FSANZ or the APVMA can provide background information as required.

9. Consultation

Public comment was sought on the proposed changes to the Code outlined in this Report to assist in finalising the assessment. Comments were invited on, but not limited to, any impacts (costs/benefits) of the proposed variations, in particular the likely impacts on importation of food if specific variations are advanced; any public health and safety considerations associated with the MRL variations; and any other affected parties to this Proposal.

Submissions were received from the Food Technology Association of Australia (FTAA), the National Council of Women of Australia (NCWA), the Queensland Government, Unilever Australasia, the Food and Beverage Importers Association (FBIA), and the Australian Food and Grocery Council (AFGC). FSANZ notified this proposal to the WTO and received comments from the CTGC. The comments provided are summarised in Attachment 3.

Submissions from the FTAA and NCWA support approving the proposed draft variations. The FBIA, AFGC, and Unilever Australasia proposed MRLs for tea for bifenthrin, chlorpyrifos, glyphosate and propiconazole for inclusion in the Code on the basis that MRL variations for these chemicals for commodities other than tea were included in this Proposal. The Queensland Government considered that fluoride ion MRLs should not be included in Schedule 1 of Standard 1.4.2. The CTGC requested that FSANZ consider retaining an MRL of 7 mg/kg for fluorine in grapes on the basis that this would minimise potential trade disruption.

9.1 Issues raised in submissions

9.1.1 Request for MRLs for Tea

The FBIA, AFGC, and Unilever Australasia requested that FSANZ consider including MRLs for tea for bifenthrin, chlorpyrifos, glyphosate and propiconazole in the Code. This was on the basis that MRL variations for these four chemicals were under consideration in this Proposal for other commodities and these chemicals are currently used on tea in producer countries as pest management chemicals, weed control chemicals or fungicides.

The submissions note that tea is an international commodity and it is important to ensure that there is consistency in standards on an international basis. The submissions provided a summary of tea MRLs for these four chemicals in tea producing countries (China, India, Taiwan, Sri Lanka, Argentina), importing countries (European Union, Japan, United States) and noted that there is a relevant Codex standard for chlorpyrifos.

The submissions also stated that the request was based on the principles of the Tea Global Plant Protection Initiative; in particular the progression towards ensuring that tea is produced and traded in a compliant manner across international boundaries.

9.1.1.1 FSANZ Evaluation

Proposal M1002 does not include consideration of MRLs for tea for the chemicals requested and as such, public consultation on these MRLs has not been conducted. The public consultation period for this Proposal has concluded and for these reasons, FSANZ does not consider it is appropriate to consider the MRLs for tea proposed by the FBIA, AFGC, and Unilever Australasia as part of this Proposal.

FSANZ considers that an application is the appropriate mechanism to seek consideration of including tea MRLs for bifenthrin, glyphosate and propiconazole in the Code.

This will allow FSANZ to consider the dietary exposure to residues associated with the proposed MRLs for tea; the legitimate use of the chemical on the commodity and the relevant MRLs internationally; as well as the views of the APVMA and the impacts of including these MRLs in the Code. An application will also ensure appropriate public consultation on variations to the Code. This approach will allow regard to be given to the request without delaying the progression of the other MRL amendments being considered in the present Proposal.

FSANZ acknowledges that there is a Codex MRL for chlorpyrifos residues in tea. This chemical is currently under review by the APVMA. For this additional reason, FSANZ does not consider it appropriate to consider this MRL for inclusion in the Code until this review is complete. However, FSANZ may consider this MRL in a future Proposal. Further information about the chlorpyrifos review can be found at the APVMA website at: http://www.apvma.gov.au/chemrev/chlorpyrifos.shtml

9.1.2 Fluoride ion MRLs

The submission from the Queensland Government considered that fluoride ion should not be included in Schedule 1 of Standard 1.4.2. The submission noted that:

• fluoride ion originates from sources other than sulfuryl fluoride and it is not particularly useful for controlling the use of sulfuryl fluoride; and
• this will set a 'zero tolerance' for all the other food commodities not contained in Standard 1.4.2 and natural concentration of fluoride in foods therefore would become violative levels.

This submission also included reference to information that some imported commodities such as herbs, spices, pulses, oilseeds and cereals may be affected as there are other commodities that can be effectively fumigated by sulfuryl fluoride in other countries.

9.1.2.1 FSANZ Evaluation

The presence of naturally occurring fluoride in food is not restricted by the provisions in Standard 1.4.2 as the interpretation of ‘chemical’ in the Standard excludes substances that are naturally present in food. The interpretation of ‘chemical’ in Standard 1.4.2 states:

chemical means an agricultural or veterinary chemical, whether or not listed in bold type in the shaded boxes in Schedules 1 or 2, but excludes –

(a) a substance naturally present in food, for example, water or salt, before the food is processed; and

(b) a substance in the food when naturally formed during processing, for example, heat treating, of the food; and

(c) ingredients, food additives and processing aids that are permitted in this Code to be present in food.

On this basis, the inclusion of specific MRLs in Standard 1.4.2 for fluoride ion does not apply a ‘zero tolerance’ to naturally occurring fluoride in food and does not mean that the natural presence of fluoride in food, in the absence of a specific MRL, should be regarded as a breach of the Code.

The concern raised regarding fluoride ion limits for monitoring product use has been referred to the APVMA. This is because the current fluorine MRLs have been in place for many years and removing them may have unforeseen consequences from the perspective of chemical product use.

FSANZ notes that while fluorine MRLs may not be particularly useful for control of use purposes as fluoride ions may be present in foods from other sources, the MRLs notified by the APVMA need to be included in the Code to ensure that foods legitimately treated with sulfuryl fluoride can be legally sold. If the APVMA considers that an alternative approach is appropriate for fluoride ions then any amended MRLs may be considered in a future MRL Proposal.

In the meantime, FSANZ considers it appropriate to include the APVMA MRL variations for fluorine in the Code to ensure that legitimately treated foods can be sold under food legislation.

FSANZ notes the information indicating that sulfuryl fluoride may be used in other countries. However, there are no Codex MRLs for sulfuryl fluoride for commodities other than those requested by APVMA and industry has not provided any information requesting different MRLs from those notified by the APVMA. On this basis, FSANZ considers that it is appropriate to approve the MRL variations as notified by the APVMA. If industry wishes to extend sulfuryl fluoride MRLs then this may be done by making an application to FSANZ.

9.2 World Trade Organization

As a member of the World Trade Organization (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.

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

This Proposal included consideration of MRL variations that are relevant to the international Codex standard. MRL variations in the Proposal also relate to chemicals used in the production of heavily traded agricultural commodities that may indirectly have a significant effect on trade of food products between WTO members.

FSANZ made a Sanitary and Phytosanitary (SPS) notification to the WTO for this Proposal in accordance with the WTO Agreement on the Application of SPS Measures. The primary objective of the measure is to support the regulation of the use of agricultural and veterinary chemical products to protect human, animal and plant health and the environment.

9.2.1 Comment provided by the California Table Grape Commission

The CTGC commented that Australia is an increasingly important market for table grapes, noting that since the market opened in 2001, Australia has become the industry’s 6th largest export market, valued at over $40 million USD. The CTGC raised concern that the proposed deletion of the fluorine MRL for fruit would pose an impediment to the export of table grapes to Australia.

The CTGC stated that it recognised Australia’s right to establish nationally appropriate standards; however, it requested that FSANZ consider retaining an MRL for fluorine in grapes which would encompass residues of fluorine in table grapes up to 7 mg/kg. This was on the basis that an MRL of 7 mg/kg would be consistent with the approved use in the United States of cryolite, a mineral compound which breaks down into fluoride, sodium and aluminium ions.

Cryolite is used by the Californian table grape industry as an efficacious means of insect control, particularly for leaf eating pests. Currently, the predominant use of cryolite is on grapes, potatoes and citrus fruits. The current US tolerance of 7 mg/kg for fluorine is associated with the use of cryolite on table grapes and was established after a comprehensive review by the US Environmental Protection Agency (USEPA) in 1996 http://www.epa.gov/oppsrrd1/REDs/0087.pdf.

In summary, the CTGC requested that FSANZ consider retaining an MRL of 7 mg/kg for fluorine in grapes on the basis that this would minimise potential trade disruption.

9.2.2.1 FSANZ Evaluation

The CTGC identified a trade issue in relation to the deletion of the fluorine MRL for fruit of 7 mg/kg proposed by the APVMA. The APVMA has also proposed a level of 5 mg/kg for dried fruits for inclusion in the Code.

In the development or variation of food regulatory measures FSANZ must have regard to:

• the promotion of consistency between domestic and international food standards; and

• the promotion of fair trading in food.

These matters encompass a consideration of international trade issues, such as the one raised by the CTGC. There is a tolerance for fluorine residues in grapes of 7 mg/kg listed in United States food standards. This is associated with the approved use of cryolite in grape production there. Grapes are imported into Australia from the United States and could legitimately contain fluorine residues consistent with the current fluorine MRL for fruit in the Code. Fluorine MRLs that apply to grapes internationally are listed in the table below.

FSANZ has also given careful consideration to public health and safety issues and noted that dietary exposure assessments indicate that an MRL for fluorine in grapes of 7 mg/kg does not present any public health and safety concerns. The estimated dietary exposure to fluorine including any residues that may occur in grapes at 7 mg/kg, does not exceed the acceptable reference health standard. The dietary exposure estimates are outlined in Attachment 2.

FSANZ has identified no public health and safety concerns with retaining an MRL of 7 mg/kg for grapes in the Code.

9.2.2.2 Views of the APVMA on the MRLs requested by the CTGC

The CTGC comments have been provided to the APVMA to consider and for future discussion regarding retaining the requested MRL. This will allow for any impacts of including an MRL in the Code where the APVMA has not listed a corresponding MRL in the MRL Standard to be appropriately addressed.

9.2.2.3 Summary

On the basis of the points raised by the CTGC, the currently available information and as an interim measure until discussions with the APVMA can occur, FSANZ has decided to:

• progress with deletion of the fruit MRL for fluorine of 7 mg/kg;
• progress the MRL for fluorine for dried fruits of 5 mg/kg as requested by the APVMA; and
• retain an MRL for fluorine of 7 mg/kg for grapes only.

Should it be necessary to amend the MRL for fluorine in grapes in the future, FSANZ can include this in a future Proposal and seek public comment at that time on the proposed amendment.

9.3 Codex Alimentarius Commission MRLs

Codex standards are used as the relevant international standard or basis as to whether a new or changed standard requires a WTO notification. The following table lists MRL variations where there is a corresponding MRL in the Codex standard.

Submitters did not raise any issues in terms of the specific MRL variations listed below, including in relation to Codex or other international standards. The FBIA, AFGC, and Unilever Australasia requested consideration of an MRL for chlorpyrifos in tea on the basis of an existing Codex MRL (refer section 9.1.1).

9.4 New Zealand MRL Standards

All imported and domestically produced food sold in New Zealand (except for food imported from Australia) must comply with the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standards 2008 and amendments (the New Zealand MRL Standards).

Under the New Zealand MRL Standards, agricultural chemical residues in food must comply with the specific MRLs listed in the Standards. The New Zealand MRL Standards also include a provision for residues of up to 0.1 mg/kg for agricultural chemical / commodity combinations not specifically listed. If the food is imported, it may also comply with Codex MRLs. Further information about the New Zealand MRL Standards is available on the New Zealand Food Safety Authority website at: http://www.nzfsa.govt.nz/acvm/registers-lists/nz-mrl/index.htm.

MRLs in the Code and in the New Zealand MRL Standards may differ for a number of legitimate reasons including differing use patterns for chemical products as a result of varying pest and disease pressures and varying climatic conditions.

The following table lists the proposed variations to MRLs and includes the corresponding MRL in the New Zealand MRL Standards.

9.5 Imported Foods

Internationally, countries set MRLs according to good agricultural practice (GAP) or good veterinary practice (GVP). Agricultural and veterinary chemicals are used differently in different countries as pests, diseases and environmental factors differ and because product use patterns differ. This means that residues in imported foods may legitimately be different from those in foods produced or treated with chemical products in Australia.

Deletions or reductions of MRLs may impact imported foods that comply with existing MRLs, even though these existing MRLs are no longer required for food produced or treated with chemical products in Australia. These impacts may be relevant where imported foods may legitimately contain residues consistent with the MRLs that are proposed for deletion or reduction.

FSANZ is committed to ensuring that the implications of MRL variations are considered. Under the current process for considering variations to the Code, FSANZ encourages submissions including specific data demonstrating a need for certain MRLs to be retained or varied.

FSANZ will consider retaining MRLs proposed for deletion or reduction where these MRLs are necessary to continue to allow the sale of safe food; and where the MRLs are supported by adequate data or information demonstrating that the residues associated with these MRLs do not raise any public health or safety concerns. Further information on data requirements may be obtained from FSANZ.

To assist in identifying possible impacts on imported foods, FSANZ has compiled the following table of foods where the MRLs are proposed for deletion or reduction. No submitters raised any issues in relation to these specific variations and the issues raised concerning MRLs for tea and grapes have been discussed above. All the proposed MRL variations to the Code are at Attachment 1A and the requested changes are outlined in more detail in Attachment 2.

9.6 Commodity classifications for MRLs notified for veterinary chemicals

This Proposal includes consideration of an MRL notified by the APVMA for ‘Cattle muscle’. This commodity classification is consistent with the Joint Food and Agriculture Organization / World Health Organization Expert Committee on Food Additives (JECFA) approach for determining residue limits for veterinary chemicals in food. The JECFA approach is internationally accepted as best practice for setting MRLs for veterinary chemicals.

The APVMA adopted the approach used by JECFA for setting MRLs for veterinary chemicals in July 2006. The decision to adopt the JECFA approach followed a review of evaluation processes conducted by an external body and consultation with industry and regulatory authorities.

FSANZ and the APVMA are discussing implementation issues associated with incorporating JECFA commodity classifications in the Code for MRLs notified for veterinary chemicals. Commodity classifications used for veterinary and agricultural chemicals differ, reflecting the different approaches used to determine MRLs in agricultural as opposed to veterinary situations.

As an interim measure, FSANZ has decided to progress the MRLs requested by the APVMA with JECFA commodity classifications. These may be varied through a future Proposal depending on the outcome of considerations and further consultation on the practical implications of including JECFA commodity classifications in the Code.

Conclusion

10. Conclusion and Decision

This Proposal has been assessed in accordance with section 59 of the FSANZ Act.

The decision is to adopt option 2 to approve the amended draft variations to Standard 1.4.2.

10.1 Reasons for Decision

FSANZ recommends approving the amended draft variations to Standard 1.4.2 for the following reasons:

• MRLs serve to protect public health and safety by minimising residues in food consistent with the effective control of pests and diseases.

• Dietary exposure assessments indicate that the MRL variations as notified by the APVMA do not present any public health and safety concerns.

• This approach ensures openness and transparency in relation to the residues that could reasonably occur in food.

• The draft variations will benefit stakeholders by maintaining public health and safety while permitting the legal sale of food treated with agricultural and veterinary chemicals to control pests and diseases and improve agricultural productivity.

• The APVMA has assessed appropriate residue, animal transfer, processing and metabolism studies, in accordance with The Manual of Requirements and Guidelines – MORAG – for Agricultural and Veterinary Chemicals 1 July 2005 to support the use of chemicals on commodities as outlined in this Proposal.

• The Office of Chemical Safety (OCS) has undertaken a toxicological assessment of each chemical and has established an acceptable daily intake (ADI) and where appropriate an acute reference dose (ARfD).

• FSANZ has undertaken a regulation impact assessment and concluded that the draft variations are necessary, cost-effective and beneficial.

• The draft variations would remove discrepancies between agricultural and food standards and provide certainty and consistency for producers, importers and Australian, State and Territory compliance agencies.

• The variations are consistent with the FSANZ objectives under s18 of the FSANZ Act.

11. Implementation and Review

The use of chemical products and MRLs are under constant review as part of the APVMA Chemical Review Program. In addition, regulatory agencies continue to monitor health, agricultural and environmental issues associated with chemical product use. Residues in food are also monitored through:

• State and Territory residue monitoring programs;

• Australian Government programs such as the National Residue Survey; and

• dietary exposure studies such as the Australian Total Diet Study.

These monitoring programs and the continual review of the use of agricultural and veterinary chemicals mean that there is considerable scope to review MRLs.

It is proposed that the MRL variations in this Proposal should take effect on gazettal and that the MRLs be subject to existing monitoring arrangements.

ATTACHMENTS

1A. Draft variations to the Australia New Zealand Food Standards Code (at Approval)

1B. Draft variations to the Australia New Zealand Food Standards Code (Changes Marked)

1C.  Draft variations to the Australia New Zealand Food Standards Code (at Assessment)

2. A Summary of MRLs under consideration in Proposal M1002

3. Summary of Submissions

4. Safety Assessment Methodology

5. Background Information

Attachment 1A

Draft variations to the Australia New Zealand Food Standards Code

(at Approval)

Section 87(8) of the FSANZ Act provides that standards or variations to standards are legislative instruments, but are not subject to disallowance or sunsetting

To commence:  on gazettal

[1] Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by –

[1.1] omitting from Schedule 1 the chemical residue definition for the chemical appearing in Column 1 of the Table to this sub-item, substituting the chemical residue definition appearing in Column 2 –

[1.2] inserting in Schedule 1 –

[1.3] omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –

[1.4] inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –

[1.5] omitting from Schedule 1, under the entries for the following chemicals, the Maximum Residue Limit for the food, substituting –

Attachment 1B

Draft variations to the Australia New Zealand Food Standards Code

(Changes Marked)

Section 87(8) of the FSANZ Act provides that standards or variations to standards are legislative instruments, but are not subject to disallowance or sunsetting

To commence:  on gazettal

[1] Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by –

[1.1] omitting from Schedule 1 the chemical residue definition for the chemical appearing in Column 1 of the Table to this sub-item, substituting the chemical residue definition appearing in Column 2 –

[1.2] inserting in Schedule 1 –

[1.3] omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –

[1.4] inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –

[1.5] omitting from Schedule 1, under the entries for the following chemicals, the Maximum Residue Limit for the food, substituting –

Attachment 1C

Draft variations to the Australia New Zealand Food Standards Code

(at Assessment)

Section 87(8) of the FSANZ Act provides that standards or variations to standards are legislative instruments, but are not subject to disallowance or sunsetting

To commence:  on gazettal

[1] Standard 1.4.2 of the Australia New Zealand Food Standards Code is varied by –

[1.1] omitting from Schedule 1 the chemical residue definition for the chemical appearing in Column 1 of the Table to this sub-item, substituting the chemical residue definition appearing in Column 2 –

[1.2] inserting in Schedule 1 –

[1.3] omitting from Schedule 1 the foods and associated MRLs for each of the following chemicals –

[1.4] inserting in alphabetical order in Schedule 1, the foods and associated MRLs for each of the following chemicals –

[1.5] omitting from Schedule 1, under the entries for the following chemicals, the Maximum Residue Limit for the food, substituting –

Attachment 2

A summary of MRLs under consideration in Proposal M1002

The following is an example of an entry and the proposed MRL is not being considered in this Proposal.

Data from the 19th and 20th ATDS are provided when available because they provide an indication of the typical exposure to chemicals in table ready foods. The ATDS results are more realistic because analysed concentrations of the chemical in foods as consumed are used; the NEDI and NESTI calculations are theoretical calculations that conservatively overestimate exposure. Small variations may be noted in the exposure assessment between different ATDSs. These variations are minor and typically result because of the different range of foods in the individual studies.

Chemical name     The NEDI is an assessment of the chronic

exposure which is compared to the

acceptable daily intake (ADI).

Information about the use of the chemical is provided
so the community can see the reason why the
residues may occur in food.

Food/s for which the      The NESTI is an assessment of the proposed MRL is to apply.                                                                      acute exposure which is compared

to the acute reference dose (ARfD).

Whether the proposed MRL

is being added or deleted.   The ‘*’ means that the MRL is at the limit of

       quantification and detectable residues

       should not occur.

The ‘T’ means the MRL is

temporary and under review.