Federal Register of Legislation - Australian Government

Primary content

Food Standards as made
This instrument amends food standards in the Australia New Zealand Food Standards Code.
Administered by: Health
General Comments: This instrument varies the Australia New Zealand Food Standards Code by inserting Standard 4.2.1 - Primary Production and Processing Standard for Seafood (Australia Only).
Exempt from sunsetting by the Legislative Instruments Act 2003 s 54(1), Food Standards Australia New Zealand Act 1991 s 82(2)
Registered 26 May 2005
Tabling HistoryDate
Tabled HR31-May-2005
Tabled Senate14-Jun-2005
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014
Table of contents.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EXPLANATORY STATEMENT

 

 

 

 

 

 

APPLICATION A539

 

MAXIMUM RESIDUE LIMITS –

AVILAMYCIN (ANTIBIOTIC)

 

 

 

 

 

 

 

 

 


FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ)

FSANZ’s role is to protect the health and safety of people in Australia and New Zealand through the maintenance of a safe food supply.  FSANZ is a partnership between ten Governments: the Australian Government; Australian States and Territories; and New Zealand.  It is a statutory authority under Commonwealth law and is an independent, expert body.

FSANZ is responsible for developing, varying and reviewing standards and for developing codes of conduct with industry for food available in Australia and New Zealand covering labelling, composition and contaminants.  In Australia, FSANZ also develops food standards for food safety, maximum residue limits, primary production and processing and a range of other functions including the coordination of national food surveillance and recall systems, conducting research and assessing policies about imported food.

The FSANZ Board approves new standards or variations to food standards in accordance with policy guidelines set by the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) made up of Australian Government, State and Territory and New Zealand Health Ministers as lead Ministers, with representation from other portfolios.  Approved standards are then notified to the Ministerial Council.  The Ministerial Council may then request that FSANZ review a proposed or existing standard.  If the Ministerial Council does not request that FSANZ review the draft standard, or amends a draft standard, the standard is adopted by reference under the food laws of the Australian Government, States, Territories and New Zealand.  The Ministerial Council can, independently of a notification from FSANZ, request that FSANZ review a standard.

The process for amending the Australia New Zealand Food Standards Code is prescribed in the Food Standards Australia New Zealand Act 1991 (FSANZ Act).  The diagram below represents the different stages in the process including when periods of public consultation occur.  This process varies for matters that are urgent or minor in significance or complexity.

 

 



Final Assessment Stage (s.36)

 

FSANZ has now completed the assessment of the Application A539 and held a single round of public consultation under section 36 of the FSANZ Act.  This Final Assessment Report and its recommendations have been approved by the FSANZ Board and notified to the Ministerial Council.

 

If the Ministerial Council does not request FSANZ to review the draft amendments to the Code, an amendment to the Code is published in the Commonwealth Gazette and the New Zealand Gazette and adopted by reference and without amendment under Australian State and Territory food law.

 

Further Information

 

Further information on this Application and the assessment process should be addressed to the FSANZ Standards Management Officer at one of the following addresses:

 

Food Standards Australia New Zealand       Food Standards Australia New Zealand

PO Box 7186                                                  PO Box 10559

Canberra BC   ACT   2610                            The Terrace   WELLINGTON   6036

AUSTRALIA                                                 NEW ZEALAND

Tel (02) 6271 2222                                         Tel (04) 473 9942

www.foodstandards.gov.au                            www.foodstandards.govt.nz

 

Assessment reports are available for viewing and downloading from the FSANZ website www.foodstandards.gov.au or alternatively paper copies of reports can be requested from FSANZ’s Information Officer at info@foodstandards.gov.au including other general enquiries and requests for information.

 


CONTENTS

Executive Summary and Statement of Reasons. 5

Statement of Reasons. 5

1.     Introduction.. 7

1.1       Summary of the proposed MRLs for avilamycin.. 7

1.2       Limit of Quantification.. 7

1.3       MRLs for Permits. 7

1.4       The National Estimated Dietary Intake. 8

1.5       Acute dietary exposure. 8

1.6       Expert Advisory Group on Antimicrobial Resistance. 8

1.7       Antibiotics as allergens. 8

2.     Regulatory Problem... 8

2.1       Current Regulations. 8

3.     Objective.. 9

3.1       Consideration of issues under section 10 of the Food Standards Australia New Zealand Act 1991. 9

4.     Background.. 10

4.1       The use of agricultural and veterinary chemicals. 10

4.2       Maximum Residue Limit applications. 10

4.3       Maximum Residue Limits. 11

4.4       Food Standards-setting in Australia and New Zealand.. 12

4.5       Trans Tasman Mutual Recognition Arrangement. 12

5.     Evaluation of Issues Raised in Public Comment.. 12

6.         Regulatory Options. 12

6.1       Option 1 – status quo – no change to the existing MRLs in the Code. 12

6.2       Option 2 – adopt the changes to include new MRLs for avilamycin. 12

7.         Affected Parties. 12

8.         Impact Analysis. 13

7.1       Option 1 – status quo – no change to the existing MRLs in the Code  13

7.2       Option 2 – adopt the changes to include new MRLs for avilamycin   14

9.         Consultation.. 14

9.1       WTO consultation.. 14

10.       Conclusion.. 15

11.       Implementation and Review... 15

Attachment 1 - Draft Variation to the Australia New Zealand Food Standards Code.. 17

Attachment 2 - Notes on Terms. 18

Attachment 3 - Background To Dietary Exposure Assessments. 19

Attachment 4 - Summary of Submissions Received.. 22


Executive Summary and Statement of Reasons

 

This Application (A539) seeks the establishment of Maximum Residue Limits (MRLs) for pig meat and offal, for the antibiotic avilamycin into the Australia New Zealand Food Standards Code (the Code).  It is an application from the Australian Pesticides and Veterinary Medicines Authority (APVMA) to update the Code in order to reflect the current registration status of agricultural and veterinary chemicals in use in Australia.

 

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

 

The chronic dietary exposure assessment indicates that the residues associated with the proposed MRLs for avilamycin for pig meat and offal do not represent an unacceptable risk to public health and safety.

 

FSANZ made a Sanitary and Phytosanitary (SPS) notification to the World Trade Organization (WTO). No WTO member has made a submission on this Application.

 

Statement of Reasons

 

FSANZ recommends progressing this Application for the following reasons:

 

·               The dietary exposure assessment indicates that the residues associated with the proposed MRLs for avilamycin for pig meat and offal do not represent an unacceptable risk to public health and safety. 

 

·               APVMA has already registered avilamycin and the rejection of the proposed MRLs would result in products from legally treated pigs not being able to be legally sold.  Therefore, the requested changes will benefit all stakeholders by maintaining public health and safety while permitting the legal sale of pig products treated with avilamycin to treat diseases and improve agricultural productivity.

 

·               APVMA has assessed appropriate toxicology, residue, animal transfer, processing and metabolism studies, in accordance with the Guidelines for Registering Agricultural and Veterinary Chemicals, the Ag and Vet Requirements Series, 1997, to support the use of avilamycin on pigs. 

 

·               The Office of Chemical Safety (OCS) of the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Ageing has undertaken an appropriate toxicological assessment of avilamycin and has established an acceptable daily intake (ADI).

 

·               The Expert Advisory Group on Antimicrobial Resistance (EAGAR) has evaluated the impact of the potential residues of avilamycin in the food supply and has concluded that the proposed use pattern of the avilamycin product for pigs is acceptable.

 


·               FSANZ has undertaken a regulation impact assessment process.  That process concluded that the amendment to the Code is necessary, cost effective and of benefit to both producers and consumers.

 

·               None of FSANZ’s section 10 objectives of food regulatory measures are compromised by the proposed changes. 


1.        Introduction

 

This Application was received from APVMA on 15 April 2004 seeking amendments to Standard 1.4.2 of the Code.  The proposed amendments to the Standard would align MRLs in the Code for the antibiotic avilamycin with the MRLs in the APVMA MRL Standard.

 

1.1         Summary of the proposed MRLs for avilamycin

 

The MRL amendments under consideration in this Application for avilamycin are as follows: 

 


Chemical

Food

MRL

(mg/kg)

Information

Avilamycin

Pig meat

Pig, edible offal of

 

Add

Add

 

T*0.05

T*0.05

 

Avilamycin is the generic name of an oligosaccharide antibiotic of the orthosmycin group.  APVMA has issued a permit for avilamycin to be used as a prophylactic to control colibacillosis in pigs.  EAGAR concluded that the proposed use pattern of the avilamycin product in pigs is acceptable.  Avilamycin does not have a human analogue.

NEDI = <1% of ADI.

 

1.2         Limit of Quantification

 

The proposed MRLs for avilamycin for pig meat and offal in this Application are at the limit of quantification (LOQ) and are indicated by an * in the above table.  The LOQ is the lowest concentration of an agricultural or veterinary chemical residue that can be identified and quantitatively measured in a specified food, agricultural commodity or animal feed with an acceptable degree of certainty by a regulatory method of analysis.  The inclusion of the MRLs at the LOQ means that no detectable residues of avilamycin should occur.  FSANZ incorporates MRLs at the LOQ in the Code to assist in identifying a practical benchmark for enforcement and to allow for future developments in methods of detection that could lead to a lowering of this limit.

 

1.3         MRLs for Permits

 

The proposed MRLs in this Application are temporary and are indicated by a ‘T’ in the above table. These MRLs may include uses associated with:

 

·               the minor use program;

 

·               off-label permits for minor and emergency uses; or

 

·               trial permits for research.

 

FSANZ does not issue permits or grant permission for the temporary use of agricultural and veterinary chemicals.  Further information on permits for the use of agricultural and veterinary chemicals can be found on APVMA’s website at www.apvma.gov.au/ or by contacting APVMA on +61 2 6272 5158.


1.4         The National Estimated Dietary Intake

 

The National Estimated Dietary Intake (NEDI) for avilamycin is equivalent to less than 1% of the ADI.  This calculation is considered to be a gross overestimate of the actual consumption of avilamycin as it assumes all slaughtered pigs were treated and contain residues at the MRL.  This calculation used summary food consumption figures derived from the National Nutrition Survey 1995 data.  It is concluded that the chronic dietary exposure is less than the ADI and the risk is acceptable.

 

1.5         Acute dietary exposure

 

Neither the OCS nor the Joint FAO/WHO Expert Committee on Food Additives, have set an acute reference dose for avilamycin.

 

1.6         Expert Advisory Group on Antimicrobial Resistance

 

The National Health and Medical Research Council established EAGAR to provide advice to government and regulatory agencies on antibiotic resistance and especially measures to reduce the risks of antibiotic resistance.

 

As part of its application, APVMA has supplied a letter from EAGAR in which EAGAR agreed with the information presented for the temporary MRLs to permit the proposed use pattern for the control of colibacillosis in pigs.

 

1.7         Antibiotics as allergens   

 

APVMA assesses the potential allergenicity of antibiotic residues in food commodities.  While evidence for residues of antibiotics in foods causing allergic reactions is sparse, there is some evidence for rare occurrences of allergic reactions to the ß-lactam antibiotics. 
For this reason ß-lactam antibiotics are only used as therapeutic treatments for individual animals and not as a mass medication. 

 

Avilamycin belongs to the orthosmycin group of antibiotics and not to the ß-lactam group of antibiotics.  Therefore, allergic reactions to the residues of avilamycin in pig meat and/or offal are not expected to occur.  However, FSANZ recognises that the proposed MRLs for avilamycin may be of concern to some of our stakeholders.  FSANZ requested submissions on the data on the occurrence of allergic reactions to residues of avilamycin in pig meat and offal.  No submissions were received addressing this matter.

 

2.        Regulatory Problem

 

2.1         Current Regulations

 

APVMA has approved the use of avilamycin on pigs associated with the proposed MRLs in this Application, and made consequent amendments to the APVMA’s MRL Standard.  The approval of the use of avilamycin now means that there is a discrepancy between the residues associated with the use of avilamycin and the MRLs in the Code.  In turn, this means that where APVMA has included MRLs for pig meat and offal for avilamycin that are not included in the Code, pig meat and offal cannot be legally sold under food legislation if they contain any detectable residues of avilamycin.


3.        Objective

 

The objective of this Application is to ensure that the residues of avilamycin associated with the proposed MRLs do not represent an unacceptable risk to public health and safety and that the proposed MRLs permit the legal sale of food that has been legally treated.  APVMA has already established MRLs under its legislation, and now seeks, by way of this Application to include the amendments in the Code.

 

3.1         Consideration of issues under section 10 of the Food Standards Australia New Zealand Act 1991

 

In developing or varying a food standard, FSANZ is required by its legislation to meet three primary objectives which are set out in section 10 of the FSANZ Act.  These are:

 

3.1.1      The protection of public health and safety

 

OCS has considered and established an ADI for avilamycin.  APVMA and FSANZ carry out estimations of dietary exposure to agricultural and veterinary chemicals and compare them to the TGA standards.  Based on dietary exposure assessments, the residues associated with the proposed MRLs in this Application do not represent an unacceptable risk to public health and safety. 

 

3.1.2      The provision of adequate information relating to food to enable consumers to make informed choices

 

This is not relevant for this Application.

 

3.1.3      The prevention of misleading or deceptive information

 

This is not relevant for this Application.

 

In addition to these objectives, subsection 10(2) requires FSANZ to have regard to a number of matters set out in paragraphs 10(2)(a) to (d). Each of these matters is discussed below.

 

3.1.4      The need for standards to be based on risk analysis using the best available scientific evidence

 

FSANZ considers proposed MRLs in accordance with the best available scientific evidence.   The procedures adopted by FSANZ, the TGA and APVMA are based on a comprehensive examination of detailed scientific information.  That includes a rigorous toxicological assessment and dietary exposure assessments undertaken in accordance with international protocols.

 

3.1.5      The promotion of consistency between domestic and international food standards

 

This is addressed in section 9.1.

 


3.1.6      The desirability of an efficient and internationally competitive food industry

 

The inclusion of the requested MRLs would assist in permitting the legal sale of legally treated food.  Varying the Code to include the proposed MRLs would promote trade and commerce and allow food industries to continue to be efficient and competitive.

 

3.1.7      The promotion of fair trading in food

 

As the MRLs in the Code apply to all food whether produced domestically or imported, the inclusion of the MRLs would benefit all producers equally.

 

3.1.8      Any written guidelines formulated by the Ministerial Council for the purposes of this paragraph and notified to FSANZ

 

To date the Ministerial Council has not made a written notification to FSANZ of any policy guidelines that are relevant to this Application. 

 

4.        Background

 

4.1         The use of agricultural and veterinary chemicals

 

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

 

Before registering such a product, APVMA must be satisfied that the use of the product will not result in residues that would be an undue risk to the safety of people, including people using anything containing its residues. 

 

When a chemical product is registered for use or a permit for use granted, APVMA includes MRLs in its MRL Standard.  These MRLs are then adopted into control of use legislation in some jurisdictions and assist States and Territories in regulating the use of agricultural and veterinary chemicals.

 

4.2         Maximum Residue Limit applications

 

After registering the agricultural or veterinary chemical products, based on their scientific evaluations, APVMA makes applications to FSANZ to adopt the MRLs in Standard 1.4.2 of the Code.  FSANZ reviews the information provided by APVMA and validates whether the dietary exposure is within agreed safety limits. 

 

If satisfied that the residues do not represent an unacceptable risk to public health and safety and subject to adequate resolution of any issues raised during public consultation, FSANZ will then agree to adopt the proposed MRLs into Standard 1.4.2 of the Code.

 

FSANZ then notifies the Ministerial Council of the proposed adoption of the variation into the Code.  If the Ministerial Council does not request FSANZ to review its decision, the MRLs are automatically adopted by reference under the food laws of the Australian States and Territories, after gazettal by FSANZ.


The inclusion of the MRLs in the Code has the effect of allowing legally treated produce to be legally sold, provided that the residues in the treated produce do not exceed the MRL.  Changes to Australian MRLs reflect the changing patterns of agricultural and veterinary chemicals available to farmers.  These changes include both the development of new products and crop uses, and the withdrawal of older products following review.

 

Appropriate toxicology, residue, animal transfer, processing and metabolism studies were provided to APVMA in accordance with the Guidelines for Registering Agricultural and Veterinary Chemicals, the Ag and Vet Requirements Series, 1997 to support the MRLs in the commodities as outlined in this Application. 

 

Full evaluation reports for individual chemicals are available upon request from the relevant Project Coordinator at FSANZ on +61 2 6271 2222.

 

4.3         Maximum Residue Limits

 

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

 

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

 

MRLs are also used as standards for the international trade in food.  In addition, MRLs, while not direct public health limits, act to protect public health and safety by minimising residues in food consistent with the effective control of pests and diseases.  FSANZ will not agree to adopt MRLs into the Code where the dietary exposure to the residues of a chemical could represent an unacceptable risk to public health and safety.  In assessing this risk, APVMA and FSANZ conduct dietary exposure assessments in accordance with internationally accepted practices and procedures.

 

In considering the issues associated with MRLs it should be noted that MRLs and amendments to MRLs do not permit or prohibit the use of agricultural and veterinary chemicals.  The approvals for the use of agricultural and veterinary chemicals and the control of the use of agricultural and veterinary chemicals are regulated by other Australian Government, State and Territory legislation.

 

In summary, the MRLs in APVMA’s MRL Standard are used in some jurisdictions to assist in regulating the use of agricultural and veterinary chemical products under State and Territory ‘control-of-use’ legislation.  Whereas the MRLs in the Code apply in relation to the sale of food under State and Territory food legislation and the inspection of imported foods by the Australian Quarantine and Inspection Service.

 


4.4         Food Standards-setting in Australia and New Zealand

 

The Treaty excluded MRLs for agricultural and veterinary chemicals in food from the joint food standards setting system.  Australia and New Zealand separately and independently develop MRLs for agricultural and veterinary chemicals in food.

 

4.5         Trans Tasman Mutual Recognition Arrangement

 

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

 

·               food produced or imported into Australia, which complies with Standard 1.4.2 of the Code can be legally sold in New Zealand; and

 

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

 

5.        Evaluation of Issues Raised in Public Comment

 

Submissions were received from:

 

·               Food Technology Association of Victoria Inc - supported the Application;

 

·               New South Wales Food Authority – had no issues of concern with the Application; and

 

·               Queensland Health – supported the Application.

 

6.        Regulatory Options

 

6.1         Option 1 – status quo – no change to the existing MRLs in the Code.

 

Under this option, the status quo would be maintained and there would be no changes in the existing MRLs to the Code.

 

6.2         Option 2 – adopt the changes to include new MRLs for avilamycin.

 

Under this option, the addition of the MRLs for avilamycin would be approved for inclusion into the Code. 

 

7.        Affected Parties

 

The parties affected by proposed MRL amendments include:

 

·               consumers, including domestic and overseas customers;

 

·               growers and producers of domestic and export food commodities;

 

·               importers of agricultural produce and foods; 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.

 

8.        Impact Analysis

 

The impact analysis represents likely impacts based on available information.  The impact analysis is designed to assist in the process of identifying the affected parties, any alternative options consistent with the objective of the application, and the potential impacts of any regulatory or non-regulatory provisions. 

 

7.1         Option 1 – status quo – no change to the existing MRLs in the Code

 

7.1.1      Benefits

 

·               for consumers the major benefit would be the maintenance of the existing confidence in the food supply in relation to residues of avilamycin; 

 

·               for producers of domestic and export pig products, the adoption of this option would not result in any discernable benefits; 

 

·               for importers, the adoption of this option would not result in any discernable benefits; and

 

·               for Australian Government, State and Territory agencies, the adoption of this option would not result in any discernable benefits.

 

7.1.2      Costs

 

·               for consumers there are unlikely to be any discernable costs as the unavailability of some meat products from certain producers is likely to be seen as typical seasonal fluctuations in the food supply;

 

·               for producers of domestic and export pig products, the adoption of this option would result in costs resulting from not being able to legally sell food containing residues consistent with increased MRLs or MRL additions for avilamycin.   Primary producers do not produce pigs or use avilamycin to comply with MRLs. They use avilamycin to treat diseases in accordance with the prescribed label conditions, and expect that the resulting residues will be acceptable and that pig products from the legally treated pigs can be legally sold. If the legal use of avilamycin results in the production of pig products that cannot be legally sold under food legislation then primary producers will incur substantial losses. Losses for primary producers would in turn impact negatively upon rural and regional communities;

 

·               for importers, the adoption of this option would not result in any discernable costs; and

 

·               for Australian Government, State and Territory agencies, the adoption of this option would create discrepancies between agricultural and food legislation thereby creating uncertainty, inefficiency and confusion in the enforcement of regulations.


7.2         Option 2 – adopt the changes to include new MRLs for avilamycin

 

7.2.1      Benefits

 

·               for consumers, the major benefit would be potential flow on benefits resulting from the price and availability of pig products if producers can legally sell pig products containing residues consistent with MRL additions;

 

·               for producers of domestic and export pig products, the benefits of this option would result from being able to legally sell pig products containing residues consistent with MRL additions.  Other benefits include the consistency between agricultural and food legislation thereby minimising compliance costs to primary producers;

 

·               for importers, the adoption of this option would result in the benefit that pig products could be legally imported if it contained residues consistent with MRL additions; and

 

·               for Australian Government, State and Territory agencies, the benefits of this option would include the removal of discrepancies between agricultural and food legislation thereby creating certainty and allowing efficient enforcement of regulations.

 

7.2.2      Costs

 

·               for consumers there are no discernable costs;

 

·               for producers of domestic and export pig products, the adoption of this option would not result in any discernable costs;

 

·               for importers, the adoption of this option would not result in any discernable costs; and

 

·               for Australian Government, State and Territory agencies, the adoption of this option would not result in any discernable costs, although there may be minimal impacts associated with slight changes to residue monitoring programs.

 

9.        Consultation

 

9.1         WTO consultation

 

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.

 

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 their relevant MRL set out in the Code cannot legally be supplied in Australia.

In administrative terms and consistent with international practice, MRLs assist in regulating the use of agricultural and veterinary chemical products. MRLs indicate whether agricultural and veterinary chemical products have been used in accordance with the registered conditions of use. 

 


This Application contains variations to MRLs which are not addressed in the international Codex standard.  The proposed MRLs for avilamycin also relate to production of traded pig products that may indirectly have a significant effect on trade between WTO members.

 

This Application was notified as a SPS measure in accordance with the WTO SPS agreement because 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.  No WTO member made a submission in response to the notification.

 

10.      Conclusion

 

Option 1 is a viable option but its adoption would result in:

 

·               potential substantial costs to primary producers that may have a negative impact on their viability and in turn the viability of the rural and regional communities that depend upon the sale of the agricultural produce; and

 

·               discrepancies between agricultural and food legislation which could have negative impacts on the compliance costs of primary producers, perception problems in export markets and undermine the efficient enforcement of standards for chemical residues.

 

FSANZ’s preferred approach is to adopt Option 2 – adopt the changes to include new MRLs for avilamycin. FSANZ prefers this approach because:

 

·               the residues associated with the MRL amendments would not result in an unacceptable risk to public health and safety (this benefit also applies to Option 1);

 

·               the changes would minimise the potential costs to primary producers and rural and regional communities in terms of legally being able to sell legally treated food;

 

·               the changes would minimise residues consistent with the effective use of agricultural and veterinary chemicals to control pests and diseases; and

 

·               the changes would remove discrepancies between agricultural and food legislation and assist enforcement.

 

11.      Implementation and Review

 

The use of chemical products and MRLs are under constant review as part of APVMA’s Existing Chemical Review Program.  In addition, regulatory agencies involved in the regulation of chemical products continue to monitor health, agricultural and environmental issues associated with the use of chemical products.  The 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 surveys such as the Australian Total Diet Survey.


These monitoring programs and the continual review of the use of agricultural and veterinary chemicals mean that considerable scope exists to review MRLs on a continual basis.

 

At this time it is proposed that the proposed MRL amendments should come into effect upon gazettal and continue to be monitored by the same means as other residues in food.

 

ATTACHMENTS

 

1.       Draft variation to the Australia New Zealand Food Standards Code

2.       Notes on Terms

3.       Background to Dietary Exposure Assessments

4.       Summary of Submissions Received


Attachment 1

 

Draft Variation to the Australia New Zealand Food Standards Code

 

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

 

[1.1]       inserting in alphabetical order in Schedule 1, the foods and associated MRLs for the following chemical–

  

Avilamycin

Inhibitory substance, identified as avilamycin

Pig, edible offal of

T*0.05

Pig meat

T*0.05

 

 

 

 


Attachment 2

 

Notes on Terms

 

ADI – Acceptable Daily Intake - The ADI is the daily intake of an agricultural or veterinary chemical, which, during the consumer’s entire lifetime, appears to be without appreciable risk to the health of the consumer. This is based on all the known facts at the time of the evaluation of the chemical.  The ADI is expressed in milligrams of the chemical per kilogram of body weight.

 

ARfD – Acute Reference Dose - The ARfD is the estimate of the amount of a substance in food, expressed on a body weight basis, that can be ingested over a short period of time, usually during one meal or one day, without appreciable health risk to the consumer, on the basis of all the known facts at the time of evaluation. 

 

LOQ  - Limit of Quantification  - The LOQ is the lowest concentration of a pesticide residue that can be identified and quantitatively measured in a specified food, agricultural commodity or animal feed with an acceptable degree of certainty by a regulatory method of analysis.

 

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

 

NESTI - National Estimated Short Term Intake - The NESTI is used to estimate acute dietary exposure. Acute (short term) dietary exposure assessments are undertaken when an ARfD has been determined for a chemical.  Acute dietary exposures are normally only estimated based on consumption of raw unprocessed commodities (fruit and vegetables) but may include consideration of meat, offal, cereal, milk or dairy product consumption on a case-by-case basis.   FSANZ has used ARfDs set by the TGA and Joint FAO/WHO Meeting on Pesticide Residues, the consumption data from the 1995 National Nutrition Survey (NNS) and the MRL when the STMR is not available to calculate the NESTIs.

 


Attachment 3

 

Background To Dietary Exposure Assessments

 

Before an agricultural or veterinary chemical is registered, the Agricultural and Veterinary Chemicals Code, 1994 (Ag Vet Code Act) requires APVMA to be satisfied that there will not be any appreciable risk to the consumer, to the person handling, applying or administering the chemical, to the environment, to the target crop or animal, or to trade in an agricultural commodity. 

 

FSANZ’s primary role in developing food regulatory measures for agricultural and veterinary chemicals is to ensure that the potential residues in treated food do not represent an unacceptable risk to public health and safety.  In assessing the public health and safety implications of chemical residues, FSANZ considers the dietary exposure to chemical residues from all foods in the diet by comparing the dietary exposure with the relevant health standard.  FSANZ will not approve MRLs for inclusion in the Code where the dietary exposure to the residues of a chemical could represent an unacceptable risk to public health and safety.  In assessing this risk, FSANZ conducts dietary exposure assessments in accordance with internationally accepted practices and procedures. 

 

The three steps undertaken in conducting a dietary exposure assessment are the:

 

·               determination of the residues of a chemical in a treated food;

 

·               determination of the acceptable health standard for a chemical in food (i.e. the acceptable daily intake and/or the acute reference dose); and

 

·               calculating the dietary exposure to a chemical from all foods, using food consumption data from nutrition surveys and comparing this to the acceptable health standard.

 

Determination of the residues of a chemical in a treated food

 

APVMA assesses a range of data when considering the proposed use of a chemical product on a food.  These data enable APVMA to determine what the likely residues of a chemical will be on a treated food.  These data also enable APVMA to determine what the maximum residues will be on a treated food if the chemical product is used as proposed and from this, APVMA determines an MRL. 

 

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.  However, 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 represent an unacceptable risk to public health and safety.

 

Determination of the acceptable health standard for a chemical in food

 

TGA assesses the toxicology of agricultural and veterinary chemicals and establishes the ADI and where applicable, the ARfD for a chemical. 

 


Both APVMA and FSANZ use these health standards in dietary exposure assessments.

The ADI is the daily intake of an agricultural or veterinary chemical, which, during the consumer’s entire lifetime, appears to be without appreciable risk to the health of the consumer.  This is on the basis of all the known facts at the time of the evaluation of the chemical.  It is expressed in milligrams of the chemical per kilogram of body weight.

 

The ARfD of a chemical is the estimate of the amount of a substance in food, expressed on a body weight basis, that can be ingested over a short period of time, usually during one meal or one day, without appreciable health risk to the consumer, on the basis of all the known facts at the time of evaluation. 

 

Calculating the dietary exposure

 

APVMA and FSANZ undertake chronic dietary exposure assessments for all agricultural and veterinary chemicals and undertake acute dietary exposure assessments where either the OCS or Joint FAO/WHO Meeting on Pesticide Residues has established an ARfD.

 

APVMA and FSANZ have recently agreed that all dietary exposure assessments for agricultural and veterinary chemicals undertaken by APVMA will be based on food consumption data for raw commodities, derived from individual dietary records from the latest 1995 National Nutrition Survey (NNS).  The Australian Bureau of Statistics with the Australian Government Department of Health and Aged Care undertook the NNS survey over a 13-month period (1995 to early 1996).  The sample of 13,858 respondents aged 2 years and older was a representative sample of the Australian population and, as such, a diversity of food consumption patterns were reported.

 

Chronic Dietary Exposure Assessment

 

The National Estimated Daily Intake (NEDI) represents a realistic estimate of chronic dietary exposure if the chemical residue data are available and is the preferred calculation.  It may incorporate more refined food consumption data including that for specific sub-groups of the population.  The NEDI calculation may take into account such factors as the proportion of the crop or commodity treated; residues in edible portions and the effects of processing and cooking on residue levels; and may use median residue levels from supervised trials rather than the MRL to represent pesticide residue levels.  When adequate information is available, monitoring and surveillance data or total diet studies may also be used such as the Australian Total Diet Survey (ATDS).

 

Where the data is not available on the specific residues in a treated food then a cautious approach is taken and the MRL is used. The use of the MRL in dietary exposure estimates may result in considerable overestimates of exposure because it assumes that the entire national crop is treated with a pesticide and that the entire national crop contains residues equivalent to the MRL.  In reality, only a portion of a specific crop is treated with a pesticide; most treated crops contain residues well below the MRL at harvest; and residues are usually reduced during storage, preparation, commercial processing and cooking.  It is also unlikely that every food for which an MRL is proposed will have been treated with the same pesticide over the lifetime of consumers.

 


In conducting chronic dietary exposure assessments, APVMA and FSANZ consider the residues that could result from the use of a chemical product on all foods.  If specific data on the residues are not available then a cautious approach is taken and the MRL is used.  

The residues that are likely to occur in all foods are then multiplied by the daily consumption of these foods derived from individual dietary records from the latest 1995 National Nutrition Survey (NNS).  These calculations provide information on the level of a chemical that is consumed for each food and take into account the consumption of processed foods e.g. apple pie and bread.  These calculations for each food are added together to provide the total dietary exposure to a chemical from all foods.   

 

This figure is then divided by the average Australian's bodyweight to provide the amount of chemical consumed per day per kg of human bodyweight.  This is compared to the ADI.  It is therefore the overall dietary exposure to a chemical that is compared to the ADI - not the MRL.  FSANZ considers that the chronic dietary exposure to the residues of a chemical is acceptable where the best estimate of this exposure does not exceed the ADI. 

 

Further where these calculations use the MRL they are considered to be overestimates of dietary exposure because they assume that:

 

·               the chemical will be used on all crops for which there is a registered use;

 

·               treatment occurs at the maximum application rate;

 

·               the maximum number of permitted treatments have been applied;

 

·               the minimum withholding period has been applied; and

 

·               this will result in residues at the maximum residue limit. 

 

In agricultural and animal husbandry this is not the case but for the purposes of undertaking a risk assessment, it is important to be conservative in the absence of reliable data to refine the dietary exposure estimates further.

 


Attachment 4

 

Summary of Submissions Received

 




Submitter

Comments raised

Food Technology Association of Victoria

Supported the Application.

New South Wales Food Authority

No issues of concern.

Queensland Health

Supported the Application.