EXPLANATORY STATEMENT
Australia New Zealand Food Standards Code - Schedule 20 -Maximum residue limits Amendment Instrument No. APVMA 1, 2016
Section 82 of the Food Standards Australia New Zealand Act 1991(FSANZ Act), was part of amendments which commenced on 1 March 2011, that implemented a 2008 reform agreed to by the Council of Australian Governments (COAG) calling for the recognition by Food Standards Australia New Zealand (FSANZ) of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) residue risk assessment and the promulgation of the resulting MRLs in the Code, for domestically grown produce. The reform was designed to streamline current regulatory processes and to eliminate duplication by allowing the APVMA to directly vary maximum residue limits in maximum residue limits Standard.
The APVMA is an independent statutory authority of the Commonwealth. Amongst other things, the APVMA is responsible for ensuring agricultural and veterinary (agvet) chemicals used in Australia are not harmful to public health due to residues in food.
Subsection 82(1) of the FSANZ Act provides that the APVMA may vary Schedule 1 of the Maximum Residue Limits Standard to include or change a permitted maximum residue limit. The Maximum Residue Limits Standard in the Australia New Zealand Food Standards Code (Code) is Schedule 20 — Maximum residue limits.
On 1 March 2016, Schedule 20 – Maximum residue limits commences. This Instrument is the Principal Instrument being amended by this Amendment Instrument. It has existed in various forms since before the Code was first published in 1987.
Subsection 11(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 provides that the APVMA may, by writing under its common seal, delegate to a member of the staff of the APVMA all or any of its powers. By written instrument under the seal of the APVMA of 7 June 2011, the APVMA has delegated to the holder of the office of Executive Director, Scientific Assessment and Chemical Review its powers under subsection 82(1) of the Food Standards Australia New Zealand Act 1991.
The Agreement between the Government of Australia and the Government of New Zealand concerning a Joint Food Standards System excludes MRLs for residues of agvet chemicals in food from the system setting joint food standards. Australia and New Zealand independently and separately develop MRLs for agvet chemicals in food.
Assessment and Determination of MRLs
MRLs are regulatory standards which help to monitor that the agvet chemical product has been used in accordance with the approved label instructions. If an MRL is exceeded, it usually indicates a misuse of the chemical but does not normally indicate a public health or safety concern.
In evaluating the safety and performance of agvet chemicals, the APVMA’s assessment also includes a determination of an MRL for the chemical in relation to relevant crops and animals. The APVMA uses data from a series of residue trials and calculates whether the application of the minimum amount of chemical that is required to achieve effective pest or disease control will leave any residue in the plant or animal commodity. In order to legitimise the presence of these residues, MRLs are established by the APVMA by entry into the APVMA’s MRL Standard (available at http://www.comlaw.gov.au).
If there are small amounts of chemical residue in produce, the APVMA uses the toxicological evaluation and the dietary exposure assessment to examine the potential occurrence of adverse effects on human health when the produce is consumed.
Dietary exposure assessments undertaken by the APVMA as part of the registration of the relevant chemical products indicate that the MRL variations being made by the Amendment Instrument do not present any public health and safety concerns.
Schedule 20 lists the maximum level of the residues of an agvet chemical that may occur in foods. Including limits for residues of agvet chemicals in foods in the Code has the effect of allowing the sale of food containing legitimate residues, where any residues do not exceed these limits. Variations in MRLs reflect the changing use patterns of agvet chemicals available to chemical users including food producers. These changes include both the development of new products and crop uses, and the withdrawal of older products following review by the APVMA. This Instrument incorporates variations in MRLs that were previously made to the former Standard 1.4.2 (which ceases to have effect on 1 March 2016) with other variations that have previously been open for public comment.
Regulatory Impact Assessment
The proposed changes to regulation are minor and machinery in nature involving necessary technical variations to the Code. In November 2010, the Office of Best Practice Regulation provided a standing exemption from the need to assess if a Regulatory Impact Statement is required for applications relating to variations to MRLs.
The proposed MRL amendments are an essential consequence of the decision by the APVMA to register agvet chemical products (or to vary and extend their approved label instructions); or to issue a permit in relation to an agvet chemical product; or an outcome of a review decision by the APVMA to withdraw or restrict older agvet chemical products. The setting of an MRL and its incorporation in the Code is a science-based outcome arising from these decisions and for which there is only very limited discretion on the part of the APVMA decision maker.
The proposal to vary MRLs in the Code is likely to have negligible impacts on business, individuals, regulatory agencies or the economy. Primary producers understand the need to use only registered agvet chemical products and to use those products strictly in accordance with approved label instructions. In doing so, produce grown will be within the MRL set by the APVMA and, with the incorporation of those MRLs into the Code by this Amendment Instrument, the sale of the produce containing residues that do not exceed the MRL will be lawful. To this extent, the incorporation of APVMA approved MRLs into Schedule 20 of the Code benefits rather than burdens primary producers and consumers.
Consultations
The APVMA seeks the wider community’s involvement through public consultation as part of its evaluation process for the registration of new agvet chemical products or a major extension of the use of existing products to new crops and target animals. During this consultation phase any person may comment or raise concerns about any relevant aspect of the intended registration, sale and use of the chemical product, including proposed MRLs and the dietary exposure assessment. The APVMA addressed any concerns that were raised at the time as part of the registration and approval process.
More specifically, by way of notices in the Agricultural and Veterinary Chemicals Gazette (No. APVMA 20 and 22) on 6 October 2015 and 3 November 2015 the APVMA notified that it was proposing to incorporate these variations to MRLs into Schedule 1 of Standard 1.4.2 and it invited public comment on the proposals. Comment received in response to those notices has been addressed. The changes notified in the Gazette on 6 October 2015 have already been incorporated into Schedule 1 of Standard 1.4.2 and this Instrument will incorporate those variations together with the variations notified in the Gazette on 3 November 2015 into the new Schedule 20.
FSANZ also made Sanitary and Phytosanitary notification to the World Trade Organization (WTO) in relation to the variations to MRLs and no comment was received in response to those notices.
Variations to MRLs are Legislative Instruments
Pursuant to subsection 82(2) of the FSANZ Act, the variations to MRLs made by the Amendment Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003, but it is neither subject to the disallowance nor sunsetting provisions.
NOTES ON ITEMS
Item 1 Name of Instrument
1. This item states that the full name of the Amendment Instrument is the Australia New Zealand Food Standards Code — Schedule 20 — Maximum residue limits Amendment Instrument No. APVMA 1, 2016.
Item 2 Commencement
2. Subsection 82(8) of the Food Standards Australia New Zealand Act 1991 has the effect that, despite the provisions in the Legislative Instruments Act 2003, a legislative instrument made by the APVMA varying Schedule 20 commences on the day a copy of the variation is published in the Gazette. This item states that this Instrument will commence immediately after the Food Standards (Proposal M1013 – Schedule 20 – MRLs – Consequentials & Corrective Amendments) Variation takes effect.
3. A Note to the item records that a copy of the variations made by the Amendment Instrument is to be published in Special Gazette,1 March 2016.
Item 3 Object
4. This item provides that the object of this Amendment Instrument is for the APVMA to vary Schedule 20 of the Code to include or change MRLs pertaining to agricultural and veterinary chemical products.
Item 4 Interpretation
5. This item defines the APVMA and the Principal Instrument.
6. The APVMA is the Australian Pesticides and Veterinary Medicines Authority established by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992.
7. The Principal Instrument is Schedule 20 — Maximum residue limits in the Australia New Zealand Food Standard Code as defined in Section 4 of the Food Standards Australia New Zealand Act 1991 being the code published in Gazette
No. P 27 on 27 August 1987 together with any amendments of the standards in that code.
8. The definition of Principal Instrument also notes that Schedule 20 was published in the Food Standards Gazette FSC 96 on Thursday 10 April 2015 and was registered as a legislative instrument on 1 April 2015 F2015L00468.
Item 5 Variations to Schedule 20
9. This item provides that the Schedule to this Amendment Instrument sets out the variations to Schedule 20 – Maximum residue limits in the Code.
10. The variations to MRLs made by the Amendment Instrument include variations made by the APVMA to the MRL Standard for January 2015 comprising amendment numbered 1.
By Authority:
Chief executive Officer of the APVMA
February 2016
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Australia New Zealand Food Standards Code — Schedule 20 —
Maximum Residue Limits Amendment Instrument No. APVMA 1, 2016
This Legislative Instrument made by the Australian Pesticides and Veterinary Medicines Authority (APVMA) is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Requirement for a Statement of Compatibility with Human Rights
This Legislative Instrument made by the APVMA is not a disallowable instrument pursuant to section 82(2) of the Food Standards Australia New Zealand Act 1991 and therefore the Statement of Compatibility with Human Rights is not strictly required. Nonetheless, to accord with the spirit of the Human Rights (Parliamentary Scrutiny) Act 2011, the APVMA provides this Statement of Compatibility.
Overview of the Legislative Instrument
This Legislative Instrument makes variations to Schedule 20— Maximum residue limits in the Australia New Zealand Food Standards Code to include or change maximum residue limits (MRLs) pertaining to agricultural and veterinary chemical products. The variations made to Schedule 20 in this Amendment Instrument put into the Code MRLs previously approved by the APVMA as part of the registration of the relevant chemical products. The variations have the effect of allowing the sale of food containing residues within the approved maximum limits but do not present any public health or safety concerns. The variations also do not affect the rights or freedoms of any humans.
Human rights implications
This Legislative Instrument does not engage any of the applicable rights or freedoms.
Conclusion
This Legislative Instrument is compatible with human rights as it does not raise any human rights issues.
Kareena Arthy, Chief Executive Officer, APVMA