PROPOSAL M1003

MAXIMUM RESIDUE LIMITS (APRIL, MAY, JUNE, AUGUST 2008)

EXPLANATORY STATEMENT

Executive Summary

Purpose

The purpose of this Proposal is to consider incorporating certain limits for residues of agricultural and veterinary chemicals that may legitimately occur in food in the Australia New Zealand Food Standards Code (the Code). This includes maximum residue limits (MRLs) gazetted by the Australian Pesticides and Veterinary Medicines Authority (APVMA) in April, May, June and August 2008. The APVMA did not gazette any MRLs in July. This Proposal also includes consideration of limits requested by industry to further align the Code with international standards. This will permit the sale of foods with legitimate residues 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 limits in the Code that reflect legitimate residues in food.

Dietary exposure assessments indicate that in relation to current reference health standards, the proposed limits do not present any public health and safety concerns. This Proposal includes consideration of MRLs for the antibiotic halofuginone in cattle commodities. The use and residues of halofuginone relating to the proposed MRLs do not pose a risk in terms 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 agricultural and veterinary chemicals in food.

FSANZ made a Sanitary and Phytosanitary notification to the World Trade Organization (WTO). Comments were received from China, Fiji and the United States. FSANZ has addressed the issues raised in section 9 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 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

• there are no other measures that would be more cost-effective than a variation to Standards 1.3.1 and 1.4.2 that could achieve the same end

• any relevant New Zealand standards

• 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 approved the variations to Standards 1.3.1 and 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 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 with legitimate residues of agricultural and veterinary chemicals used 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 variations are necessary, cost-effective and beneficial.

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

• The changes are consistent with the FSANZ Act section 18 objectives.

Consultation

FSANZ has now completed public consultation and further assessment of Proposal M1003.  The Board has approved the draft amendments to the Code, 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 to 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 variations at Attachment 1C. Taking into account public comment, FSANZ amended the draft variations. The amended draft variations are provided at Attachment 1A. The amendments to the draft variations are indicated at Attachment 1B.

FSANZ has completed its assessment and decided to include etoxazole MRLs of 1 mg/kg for cherries and 1.5 mg/kg for dried grapes as requested in submissions rather than remove the limit for cherries and include a limit for dried grapes of 0.2 mg/kg as consulted on at Assessment. FSANZ has also decided to change the status of the temporary etoxazole MRL for grapes to an MRL at the existing level of 0.5 mg/kg. No health or safety concerns were identified in relation to these changes. The amended draft variations minimise potential trade disruption and may benefit industry and consumers through greater choice and access to the relevant foods and food products. FSANZ’s consideration of incorporating these MRLs in the Code is discussed in section 9.1.2 of this Report.

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 (WTO)

9.3 Codex Alimentarius Commission Standards

9.4 New Zealand Standards

9.5 Imported Foods

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 (at Approval)

Attachment 1B - Draft variations to the Australia New Zealand Food Standards Code (Indicating Changes from Drafting at Assessment)

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

Attachment 2 - A summary of limits under consideration in Proposal M1003

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 28 May, 17 June and 14 August 2008 seeking to vary the Australia New Zealand Food Standards Code (the Code). The approved draft variations to the Code align maximum residue limits (MRLs) in the Code for certain agricultural and veterinary chemicals with the APVMA MRLs listed in the MRL Standard and permit the sale of relevant foods with legitimate residues.

This Proposal also included consideration of MRLs for cypermethrin, fenhexamid, fenvalerate and glufosinate-ammonium and extraneous residue limits[1] (ERLs) for dieldrin for a range of commodities as a result of information provided by industry. Anomalies between the Code and international standards may have implications for trade in certain foods. The approved draft variations to the Code would align limits in the Code with Codex and other standards internationally and permit the sale of relevant foods with legitimate residues at levels that do not present health or safety concerns.

This Proposal also included consideration of an MRL for mancozeb in herbs gazetted by the APVMA in March 2008. Rather than delay progressing the other MRLs requested in Proposal M1002 while the assessment of the mancozeb MRL for herbs was finalised, it was excluded from that Proposal.

In summary, this Proposal included consideration of MRLs for abamectin, azoxystrobin, bifenazate, bifenthrin, boscalid, carbofuran, cypermethrin, dithiocarbamates (mancozeb), etoxazole, fenhexamid, fenvalerate, flubendiamide (new chemical), glufosinate-ammonium, halofuginone (antibiotic), indoxacarb, isoxaflutole, lambda-cyhalothrin (cyhalothrin), linuron, methomyl, metribuzin, phosphorous acid, pirimicarb, prochloraz, profoxydim (new chemical), pymetrozine, pyraclostrobin, pyroxsulam (new chemical) and trinexapac-ethyl; ERLs for dieldrin; a maximum permitted level (MPL) for sulphur dioxide and other amendments to maldison and propachlor entries.

The draft variations to the Code are at Attachments 1A, 1B and 1C. The approved variations and dietary exposure assessments are outlined in Attachment 2. A summary of comments received on the Assessment Report is provided at Attachment 3. The safety assessment methodology is outlined in Attachment 4.

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 limits in the Code that reflect legitimate residues in food.

In considering the issues associated with variations to limits in the Code for residues of agricultural and veterinary chemicals in food, it should be noted that the limit is the maximum level of a chemical that may be in a food, not the level that is usually present in a food. Also, the purpose of ERLs in the Code is to recognise residues in food as a result of past historical use without undermining current restrictions on residues in food from contemporary chemical product use. However, incorporating the limit into food legislation means that the residues of a chemical are minimised (i.e. must not exceed the MRL, ERL or other limit), irrespective of whether the dietary exposure assessment indicates that higher residues would not risk public health and safety.

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

1. The Issue / Problem

Including limits for residues of agricultural and veterinary chemicals in foods in the Code has the effect of allowing the sale of food with legitimate residues, where any residues do not exceed these limits. Variations in MRLs reflect the changing use patterns of agricultural and veterinary chemicals available to chemical product users including 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, limits are also varied in line with international standards to reflect requirements for foods with legitimate residues to be imported. Internationally, farmers face different pest and disease pressures and so agricultural and veterinary chemical use patterns may vary.

2. Current Standard

2.1 Background

Standard 1.4.2 – Maximum Residue Limits lists the limits for agricultural and veterinary chemical residues which may occur in foods. Some limits are also listed in Standard 1.3.1 – Food Additives. If a limit 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 limit in the Code, food may not be sold where there are detectable residues.

Variations to the Code may be required to permit the sale of foods containing legitimate residues. A dietary exposure assessment is conducted before the Code is varied to ensure that proposed limits 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 limits, including MRLs for antibiotic substances, in the Code is provided at Attachment 5.

3. Objectives

In assessing this Proposal, FSANZ ensured that approving the draft variations does not present public health and safety concerns and that the sale of food with legitimate residues is permitted.

In developing or varying a food standard, FSANZ is required by its legislation to meet three primary objectives which are set out in section 18 of the FSANZ Act. These, in order of priority, are:

• the protection of public health and safety; and

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

• the prevention of misleading or deceptive conduct.

In developing and varying standards, 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 Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council).

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 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 potentially treated foods in the diet by comparing the dietary exposure with the relevant reference health standard. FSANZ will not approve variations to limits in the Code where dietary exposure to the residues of a chemical could risk public health and safety.

The steps undertaken in conducting a dietary exposure assessment are:

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

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

The safety assessment methodology is further outlined in Attachment 4.

RISK ASSESSMENT

5. Risk Assessment Summary

FSANZ has validated the dietary exposure assessments submitted by the APVMA and conducted dietary exposure assessments to assess the limits requested by industry. Using the best available scientific data and internationally recognised risk assessment methodology, FSANZ concluded that in relation to current reference health standards, setting the approved limits does not present any public health and safety concerns.

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

The use and residues associated with the approved MRLs for the antibiotic substance halofuginone do not pose a risk in terms of development of antimicrobial resistance.

Risk Management

6. Options

The following options were consulted on in the assessment of this Proposal.

1. Option 1 – approve the draft variations

2.             Option 2 – after the submission period, 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 changes. Information from public submissions was used to further assess the proposed changes.

7.1 Affected Parties

The parties potentially affected by the approved amendments include:

• consumers

• growers and producers

• importers of agricultural produce and food products

• the chemical industry

• Australian Government and 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 of agricultural and veterinary chemicals 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 approved variations. No additional costs to consumers have been identified.

Progressing this option benefits growers and producers as agricultural and food Standards are further aligned. This means that foods produced in accordance with agricultural Standards and legislation may be sold under food legislation as MRL variations are incorporated in the Code.

Omitting or reducing MRLs in the Code is consequential to changes made by the APVMA and is, therefore, 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 proposed 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 were invited to comment on these impacts during the public consultation period. This was to ensure that any adverse consequences of the proposed variations could be addressed. 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 – after the submission period, approve the draft variations subject to such amendments as FSANZ considers necessary

This option has similar costs and benefits as option 1. FSANZ assessed the comments provided in submissions and amended the draft variations. This is discussed in section 9.1.2 of this Report and the amended draft variations are provided at Attachment 1A. The amendments to the draft variations are indicated at Attachment 1B.

7.2.3 Option 3 – reject the draft variations

This option would allow inconsistencies between agricultural and food legislation to perpetuate as the Code would not reflect legitimate use of chemical products in Australia as determined by the APVMA. This may result in foods legitimately treated during production not being permitted for sale. Producers would incur significant costs. This may also create uncertainty, inefficiency and confusion in the enforcement of regulations. In addition, the anomalies between the Code and international standards identified by industry would perpetuate and may have implications for trade in certain foods. This would impact negatively on all affected parties and producers, 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 section 9 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 certain foods.

7.2.4 Summary

FSANZ conducted a 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 machinery 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.

For the following reasons, FSANZ recommends approving option 2 – after the submission period, approve the draft variations subject to such amendments as FSANZ considers necessary:

• There are no public health and safety concerns associated with the proposed variations.

• 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 safe 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 further align the Code with international standards.

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

• The necessity to amend the proposed variations to allow for the importation and sale of safe food was identified through consultation and further assessment.

Option 1 was not recommended at the Approval stage as the need to amend the proposed draft variations was identified through consultation and further assessment. This is discussed in section 9.1.2 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, consequential inconsistencies 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 limits in the Code for residues of agricultural or veterinary chemicals in food does not normally generate public interest. FSANZ adopts a basic communication strategy, with a focus on alerting the community that changes to the Code are 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 proposed changes; and any other affected parties to this Proposal.

Submissions were received from the California Cherry Advisory Board (CCAB), the California Table Grape Commission (CTGC), the Food and Beverage Importers Association (FBIA), the Food Technology Association of Australia (FTAA), the NSW Food Authority, the Northwest Horticultural Council (NHC), the Queensland Government and Unilever Australasia (Unilever). FSANZ notified this Proposal to the World Trade Organization (WTO) and received comments from China, Fiji and the United States. FSANZ thanks all submitters and member nations for their comments. The comments provided are summarised in Attachment 3.

Submissions from the FTAA, NSW Food Authority, Queensland Government and Unilever support approving the proposed draft variations. The CCAB and NHC requested that FSANZ consider harmonising with the United States etoxazole MRL for cherries. The CTGC requested FSANZ consider changing the status of the current standard for etoxazole residues in table grapes from a temporary MRL to an MRL. The NHC also requested FSANZ harmonise with United States boscalid, chlorantraniliprole, flubendiamide and pyraclostrobin MRLs for apple, pear and cherries. Unilever proposed bifenthrin, cypermethrin, fenvalerate and lambda-cyhalothrin MRLs for tea for inclusion in the Code as MRL variations for residues of these chemicals in other foods were under consideration in this Proposal. The FBIA supports the proposed cypermethrin and fenvalerate MRLs for berries and other small fruits; and the Unilever submission in regard to the requested tea MRLs. The NSW Food Authority requested consideration of the potential for elevated sulphur dioxide residues on the skin of longans to provoke illness in sensitive consumers.

9.1 Issues raised in submissions

9.1.1 MRL-setting

The FTAA expressed dismay at the lengthy period of time for the variations to be submitted for approval by FSANZ and then await gazettal, noting that the proposed changes have already been approved and gazetted into the equivalent and identical list provided by the APVMA. The FTAA noted that the approved MRLs are already available to primary producers who must immediately comply, whereas food manufacturers and retail outlets for primary produce have to analyse the same foods and comply with the outdated, by 12 months and more, Code. The FTAA considers that although there may be some legislative impediments to aligning the APVMA and FSANZ lists, the delay may be preventing fair trading and placing primary and secondary food producers and retailers in a position of potential conflict of interest. The FTAA stated that this incongruity should be easily resolvable by FSANZ adopting the APVMA changes by reference and removing the double handling of identical material.

The FBIA notes that setting the cypermethrin and fenvalerate MRLs for berries and other small fruit as proposed would be in line with the Ministerial Council Policy Guideline on the Regulation of Residues of Agricultural and Veterinary Chemicals in Food (Policy Guideline). Unilever Australasia commented that the Policy Guideline is a welcome development and anticipates alternative approaches to address the issues surrounding the current ‘zero tolerance’ approach to the regulation of residues of agricultural and veterinary chemicals in food.

9.1.1.1 FSANZ Evaluation

The Council of Australian Governments (COAG) Ministerial Taskforce on chemicals and plastics regulation is addressing the process of setting MRLs and having them recognised in food legislation in Australia. COAG identified reform in this area as a high priority. This work is being progressed by the Department of Health and Ageing and other agencies involved in policy on MRLs.

The time delay between the approval for use of an agricultural or veterinary chemical product by the APVMA and the inclusion of the appropriate MRLs in the Code is a longstanding issue. Policy and legislative change is required to eliminate this delay. Therefore consideration of this aspect is outside the considerations which may be made as part of this Proposal.

FSANZ is cognisant of the potential implications of the time delay for stakeholders and, with the APVMA, continues to examine, and where possible implement administrative change to streamline processes ahead of much anticipated reform in this area.

In relation to the comments received from submitters on the Policy Guideline on the Regulation of Agricultural and Veterinary Chemical Residues in Food, FSANZ notes that consideration of policy issues cannot be made as part of an MRL proposal for varying individual MRLs.

Nonetheless, the current approach allows FSANZ to consider specific residue limits for inclusion in the Code, such as recognition of Codex MRLs and other countries MRLs where requested by interested parties and considered appropriate. FSANZ remains committed to ensuring that practical and flexible mechanisms exist to consider standards for residues in food and encourages interested parties to continue to engage with us on residues issues.

9.1.2 Other MRLs required for Etoxazole Residues in Cherries and Grapes

The CCAB and NHC requested that FSANZ not omit the etoxazole MRL applicable to cherries as proposed and consider harmonising with the United States on the basis that this would minimise potential trade disruption. The NHC supported the proposed limit for pome fruits and asked that New Zealand also harmonise with the United States MRLs for etoxazole residues in apples, pears and cherries.

The United States Government provided comments via the WTO. The United States requested that FSANZ consider an MRL of 1.5 mg/kg, harmonised with the United States etoxazole MRL for raisins.

The CTGC supported the retention of the current etoxazole MRL for grapes at the level of 0.5 mg/kg as etoxazole is important for the California table grape industry’s pest management efforts. The CTGC requested consideration of transitioning the status of the limit from a temporary MRL to an MRL.

9.1.2.1 FSANZ Evaluation

FSANZ consulted on omitting the etoxazole MRL for stone fruits of T0.5 mg/kg and inserting an etoxazole MRL for stone fruits except cherries of 0.1 mg/kg, effectively removing the limit for etoxazole residues in cherries. FSANZ also consulted on retaining the T0.5 mg/kg etoxazole MRL for grapes and inserting an MRL for etoxazole in dried grapes at the level of 0.2 mg/kg.

The CCAB, NHC and United States identified a trade issue in relation to the proposed changes and provided information that an MRL is required for etoxazole residues that may occur in cherries and a higher limit is required for dried grapes. The CTGC requested that FSANZ consider substituting the temporary etoxazole limit for grapes with an MRL at the same level.

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. There are MRLs listed in United States food standards for etoxazole residues of 1 mg/kg in stone fruit except plum and 1.5 mg/kg in raisins. These MRLs relate to the registered use of etoxazole in the production of cherries and grapes there. These foods may be imported to Australia from the United States and could legitimately contain etoxazole residues consistent with the current United States limits.

FSANZ conducted an assessment of potential dietary exposure to etoxazole residues encompassing all foods in which these residues may occur. FSANZ concluded that etoxazole MRLs of 1 mg/kg for cherries, 0.5 mg/kg for grapes and 1.5 mg/kg for dried grapes do not present any public health or safety concerns. The estimated dietary exposure to etoxazole, including any residues that may occur in cherries at 1 mg/kg, grapes at 0.5 mg/kg and dried grapes at 1.5 mg/kg, does not exceed the relevant reference health standards. The dietary exposure estimates are provided at Attachment 2.

As the limit for etoxazole residues in grapes in the Code relates to the registered use and corresponding United States MRL for etoxazole residues that may occur in grapes, FSANZ considered it appropriate to further harmonise with that standard and decided to change the status of the temporary MRL to an MRL. FSANZ notes that Australia is an important market for United States cherries and grapes and that harmonised standards reduce the potential for trade disruption. There are no Codex MRLs established for residues of etoxazole in food.

Australia and New Zealand independently and separately set MRLs. Standard 1.4.2 applies in Australia only. Interested parties seeking to vary New Zealand MRLs may wish to contact the New Zealand Food Safety Authority (NZFSA) directly. Contact details and information about New Zealand MRL Standards are available via the link to the NZFSA website provided in section 9.4 of this Report. Further background is available at Attachment 5.

In summary, FSANZ decided to include MRLs in the Code for cherries, grapes and dried grapes harmonised with United States MRLs applicable to these foods. The amended draft variations minimise potential trade disruption and may benefit industry and consumers through greater choice and access to the relevant foods and food products containing these foods. The amended draft variations to the Code are at Attachments 1A and 1B.

9.1.3 Various MRLs Requested for Residues in Apples, Pears Cherries and Tea

The NHC noted that differing MRLs may create trade issues and that these present challenges to United States Pacific Northwest apple, pear and cherry growers. The NHC noted that Australia is an important trading partner. The NHC supported the proposed boscalid and pyraclostrobin MRLs for apples and requested that these be extended to pome fruits to include pear. The NHC also requested boscalid and pyraclostrobin stone fruit MRLs to include cherries at levels similar to the United States MRLs of 1.7 mg/kg and 0.9 mg/kg respectively. The NHC noted that limits were not proposed for flubendiamide and chlorantraniliprole residues in pome fruit and stone fruit and requested that limits be considered. The NHC noted that the United States flubendiamide MRLs for apples, pears and cherries are 0.7 mg/kg, 0.7 mg/kg and 1.6 mg/kg respectively and the chlorantraniliprole MRLs for these foods are 0.3 mg/kg, 0.3 mg/kg and 1 mg/kg.

Unilever noted that FSANZ has been kept appraised of the tea trade’s concerns with issues regarding plant protection products and participation in the Global Pesticide Initiative on Tea. Unilever noted that this work is supported by the Food and Agriculture Organisation Inter-Governmental Group on Tea. This Group aims to ensure that tea is safe; produced and traded in a compliant manner internationally; and facilitate improved pest management. Unilever provided information on the use of bifenthrin, cypermethrin, fenvalerate and lambda-cyhalothrin in tea production and relevant standards for residues of these chemicals in tea internationally. Unilever requested in its submission and other correspondence that FSANZ consider including MRLs in the Code harmonised with European Union MRLs of 5 mg/kg for bifenthrin, 0.5 mg/kg for cypermethrin, 0.05 mg/kg for fenvalerate and 1 mg/kg for lambda-cyhalothrin residues in tea.

9.1.3.1 FSANZ Evaluation

FSANZ is committed to ensuring that the implications of varying MRLs are considered and that this is done in a transparent manner. The public consultation period on this Proposal has closed. FSANZ did not consult on varying the Standard in respect of the requested chemical/food combinations. For these reasons FSANZ did not consider it appropriate to consider the MRLs requested by the NHC and Unilever at the Approval stage of this Proposal. The APVMA has established chlorantraniliprole MRLs for pome fruits and stone fruits at the levels requested by the NHC. These limits are included for consideration in the next MRL Proposal.

In conclusion, FSANZ has decided that the requests for consideration of boscalid, flubendiamide and pyraclostrobin MRLs for apples, pears and cherries; and bifenthrin, cypermethrin, fenvalerate and lambda-cyhalothrin MRLs for tea will also be considered in the next MRL proposal to allow for public consultation to occur.

9.1.4 Sulphur dioxide residues on longans

The NSW Food Authority requested that FSANZ consider the potential for elevated sulphur dioxide residues on the skin of longans to provoke illness in sensitive consumers.

9.1.4.1 FSANZ Evaluation

FSANZ aims to ensure that legitimate residues in food do not risk public health and safety and that the sale of food containing such residues is permitted. FSANZ recognises that sulphite exposure is an issue for sensitive consumers. Standard 1.2.3 – Mandatory Warning and Advisory Statements and Declarations provides for sulphites in concentrations of 10 mg/kg or more in food to be declared for consumer information.

FSANZ considers that the risk of illness in consumers who may be sensitive to residues on the skin of the fruit is unlikely to increase following the lowering of the APVMA MRL for sulphur dioxide residues in whole longans and possible refinement of the use pattern. This is on the basis of APVMA advice that residues data indicate that levels of sulphur dioxide on the skin of longans are not expected to increase. Two Australian field trials were conducted to determine the level of sulphur dioxide residues in longans. The data were sufficient to support lowering the MRL from a level of 500 mg/kg to 150 mg/kg in the whole fruit. In addition, FSANZ notes that longans are usually peeled and exposure to sulphur dioxide from the inedible skin and edible portion of longans is likely to be minor compared to exposure from other dietary sources.

In conclusion, due to the expected residues being lower in food, the risk to consumers is also likely to be lower.

9.2 World Trade Organization (WTO)

As a member of the 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.

Limits prescribed in the Code constitute a mandatory requirement applying to all food products of a particular class whether produced domestically or imported. Food products with residues exceeding the relevant limit listed in the Code cannot legally be supplied in Australia.

This Proposal included consideration of varying limits in the Code for residues of agricultural and veterinary chemicals in food that are addressed in the international Codex standard. Limits in the Proposal relate to chemical residues that may occur in heavily traded agricultural commodities that may indirectly have a significant effect on trade of derivative food products between WTO members.

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. FSANZ made a notification to the WTO for this Proposal in accordance with the WTO Agreement on the Application of Sanitary and Phytosanitary Measures. WTO members China, Fiji and the United States provided comments.

The United States provided comments on proposed variations to etoxazole MRLs. The comments are addressed above in section 9.1.2 of this Report.

Fiji provided comments in relation to market access for ginger.
FSANZ did not consult on any proposed variations to the Code concerning standards for ginger and market access issues are beyond the scope of this Proposal. FSANZ understands that the Australian Government Department of Agriculture, Fisheries and Forestry is addressing market access for ginger from Fiji as a high priority market access request and has written to Fiji in response to the comments provided. Following an announcement on market access, Fiji would be welcome to raise any issues regarding standards for ginger with FSANZ.

China provided comments in relation to the scientific evidence for the difference between proposed limits for flubendiamide residues in lettuce and sulphur dioxide residues in longans and Codex and other member nation standards. China did not request that FSANZ consider any alternative MRLs for inclusion in the Code. The comments have been provided to the APVMA.

The APVMA has conducted rigorous scientific assessments to establish appropriate MRLs. The APVMA establishes MRLs based on scientific evaluation of appropriate toxicology, residue, animal transfer, processing and metabolism studies and requests that FSANZ include these limits in the Code. FSANZ aims to ensure that any potential residues in food are within appropriate safety limits and to maintain limits in the Code that reflect legitimate residues that may occur in food.

APVMA MRLs reflect Australian good agricultural practice (GAP) and the residues that may occur in foods. Chemical use patterns and MRLs may vary across different regions internationally for a number of reasons including differences in pest pressures and agronomic and environmental factors. Where the APVMA finds a significant change in an MRL due to a new or changed use pattern, the registrant is advised that it is in their interest to submit that data to the Codex Committee on Pesticide Residues/FAO and have it assessed to allow for a limit to be established or a change to the existing Codex MRL to be considered.

In conclusion, FSANZ may consider including MRLs in the Code consistent with international standards for specific food/chemical combinations where residues associated with the controlled use of a chemical product do not present safety concerns and are likely to occur in food available in Australia. This approach ensures openness and transparency in relation to the residues that could reasonably occur in food and that the assessment of dietary exposure to chemical residues is as accurate as possible.

FSANZ advises member nations where there are Codex MRLs relevant to any food/chemical combination for which a MRL variation is proposed and specifically identifies them in consultation documents. This is done with a view to consider impacts identified by member nations exporting relevant food/s to Australia.

9.3 Codex Alimentarius Commission Standards

Codex standards are used as the relevant international standard or basis as to whether a new or changed standard requires a WTO notification.

FSANZ may consider varying limits for residues of agricultural or veterinary chemicals in food in a Proposal where interested parties have identified anomalies between the Code and international standards that may result in adverse impacts. FSANZ must have regard to its WTO obligations, 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 standards and trade issues. The assessment gives careful consideration to public health and safety.

Industry provided information that specific anomalies between the Code and international standards may present barriers to trade in certain foods. This Proposal included consideration of limits for cypermethrin, dieldrin, fenhexamid, fenvalerate and glufosinate-ammonium to address these issues. Further detail is provided at Attachment 2. The approved variations to the Code would align limits in the Code with international standards and permit the sale of relevant foods containing legitimate residues that do not present health or safety concerns.

The following table lists approved limits where there is a corresponding Codex limit.

† Note that a ‘T’ indicates that the limit is temporary and an ‘E’ indicates an ERL.

‡ Higher limit requested by industry; refer Attachment 2.

9.4 New Zealand 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 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

Limits 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 MRLs or ERLs approved in this Proposal where there is a corresponding limit in the New Zealand MRL Standards.

† Note that a ‘T’ indicates that the limit is temporary; an ‘E’ indicates that the limit is an ERL; and an asterisk indicates that the limit is at or about the limit of analytical quantification.

9.5 Imported Foods

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

Deletions or reductions of MRLs may impact imported foods that may comply with existing MRLs even though these existing MRLs are no longer required for domestically produced food. This is because imported foods may contain residues consistent with the MRLs 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 compiled the following table of foods where the MRLs were proposed for deletion or reduction and sought comment on any impacts through the Assessment Report.

The CCAB and NHC submissions raised a trade issue in relation to the proposed variations of etoxazole MRLs. This is discussed in section 9.1.2 of this Report. No comments were received on the other chemicals listed.

Conclusion

10. Conclusion and Decision

This Proposal has been assessed against the considerations provided for in section 59 of the FSANZ Act.

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

10.1 Reasons for Decision

FSANZ approved the amended draft variations to Standards 1.3.1 and 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 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 with legitimate residues of agricultural and veterinary chemicals used 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 ADI and, where appropriate, an ARfD.

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

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

• The changes are consistent with the FSANZ Act section 18 objectives.

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

• 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 limits in the Code.

It is proposed that the variations in this Proposal should take effect on gazettal and that the limits 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 (Indicating Amendments to Proposed Drafting at Assessment)

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

2. A summary of limits under consideration in Proposal M1003

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)

Subsection 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 1.3.1 of the Australia New Zealand Food Standards Code is varied by –

[1.1] inserting in Schedule 1, under item 4.1 Unprocessed fruits and vegetables –

[1.2] omitting from Schedule 1, under item 4.1 Unprocessed fruits and vegetables –

substituting –

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

[2.1] omitting from Schedule 1, the commodity name under the chemical appearing in Column 1 of the Table to this sub-item, substituting the commodity name appearing in Column 2 –

[2.2] 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 –

[2.3] inserting in Schedule 1 –

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

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

[2.6] omitting from Schedule 1, under the entries for the following chemicals, the MRL for the food, substituting –

[2.7] omitting from Schedule 2 the foods and associated ERLs for each of the following chemicals –

[2.8] inserting in alphabetical order in Schedule 2, the foods and associated ERLs for each of the following chemicals –

Attachment 1B

Draft variations to the Australia New Zealand Food Standards Code (Indicating Changes from Drafting at Assessment)

1. Item [2.5]

1.1 At Assessment

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

1.2 At Approval

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

1. Item [2.6]

1.1 At Assessment

No amendment proposed

1.2 At Approval

[2.6] omitting from Schedule 1, under the entries for the following chemicals, the MRL for the food, substituting –

Attachment 1C

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

Subsection 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 1.3.1 of the Australia New Zealand Food Standards Code is varied by –

[1.1] inserting in Schedule 1, under item 4.1 Unprocessed fruits and vegetables –

[1.2] omitting from Schedule 1, under item 4.1 Unprocessed fruits and vegetables –

substituting –

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

[2.1] omitting from Schedule 1, the commodity name under the chemical appearing in Column 1 of the Table to this sub-item, substituting the commodity name appearing in Column 2 –

[2.2] 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 –

[2.3] inserting in Schedule 1 –

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

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

[2.6] omitting from Schedule 1, under the entries for the following chemicals, the MRL for the food, substituting –

[2.7] omitting from Schedule 2 the foods and associated ERLs for each of the following chemicals –

[2.8] inserting in alphabetical order in Schedule 2, the foods and associated ERLs for each of the following chemicals –

Attachment 2

A summary of limits under consideration in Proposal M1003

The following is an example of an entry and the proposed MRL is not being considered in this Proposal. Further information on calculating dietary exposure is provided at Attachment 3.

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 National Estimated Daily Intake (NEDI) and National Estimated Short Term Intake (NESTI) calculations are theoretical calculations that protectively overestimate exposure. Small variations may be noted in the exposure assessment between different ATDSs. These variations are minor and are typically due to 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.

SUMMARY OF MRLS AND ERLS UNDER CONSIDERATION IN PROPOSAL M1003
APVMA MRLS – APRIL, MAY, JUNE, AUGUST 2008 AND INDUSTRY REQUESTS