Proposals to Amend the Maximum 
Residue Levels for Agricultural 
Compounds Food Notice 2016  
 
MPI Discussion Paper No: 2016/22  
 
 
 
Prepared by the Systems Audit, Assurance and Monitoring 
Directorate of the Ministry for Primary Industries   
 
ISBN No: 978- 1-77665 -322-5 (online)  
ISSN No: 2 253-3907 (online)  
  
 
 
July 2016  
 
 
 
 
 
Disclaimer  
 
Every effort has been made to ensure the information in this document is accurate.  
 
MPI does not accept any responsibility or liability whatsoever for any error of fact, omission, 
interpretation or opinion that may be present, however it may have occurred.  
Requests for further copies should be directed to:  
 Publications Logistics Officer  
Ministry for Primary Ind ustries  
PO Box 2526  
WELLINGTON 6140  
 
Email: brand@mpi.govt.nz
 
Telephone: 0800 00 83 33  
Facsimile: 04 -894 0300  
 
This publication is also available on the Ministry for Primary Industries website at  
http://www.mpi.govt.nz/news -resources/publications.aspx  
  
© Crown Copyright -  Ministry for Primary Industries   
 
 
Contents  Page 
 
1 Submissions  2 
2 Introduction 3 
2.1 Background  3 
2.2 Summary of proposed amendment  4 
3 Proposals  6 
3.1 Proposal to set MRLs for abamectin 6 
3.2 Proposal to set an MRL for aviglyci ne 7 
3.3 Proposal to set an MRL for bixafen  9 
3.4 Proposal to amend an MRL for cephapirin  10 
3.5 Proposal to set MRLs for cyproconazole  11 
3.6 Proposal to set MRLs for diclazuril  13 
3.7 Proposal to amend the residue definition for emamectin 15 
3.8 Proposal  to set an MRL for fenpyrazamine  16 
3.9 Proposal to set an MRL for fluopyram  17 
3.10 Proposal to amend an MRL for fluxapyroxad  19 
3.11 Proposal to set MRLs for indoxacarb and amend the residue definition 20 
3.12 Proposal to set MRLs for meloxicam  22 
3.13 Proposal  to set an MRL for metamitron 24 
3.14 Proposal to s et an MRL for methoxyfenozide  25 
3.15 Proposal to amend the MRLs and residue definition for prothioconazole  26 
3.16 Proposal to set an MRL for spirotetramat  28 
3.17 Proposal  to set MRLs for thiamethoxam  39 
3.18  Proposal to set MRLs for trifloxystrobin  31 
3.19 Proposal to set MRLs for trinexapac -ethyl and corre ct errors in its Notice entry  33 
3.20 Proposal to set MRLs for tulathromycin  35 
3.21 Proposal to except mixtures of chito -oligosaccharides and oligogalacturonan s from compliance 
with an MRL 36 
3.22 Proposal to except ozone from compliance with an MRL  36 
3.23 Proposal to except polyoxin D zinc sal t from compliance with an MRL 37 
3.24 Proposal to except prohydrojasmon f rom compliance with an MRL 37 
3.25 Proposal to amend the Schedule 2 substance description for ‘M icrobial Pesticide Organisms’  37 
3.26 Proposal to amend the exceptoin for ‘Bismuth and its salts’ to include use as an                  
intramammary  teat sealant  38   
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 1  
1 Submissions  
The Ministry for Primary Industries (MPI) invites public comment on this discussion 
document, which outlines proposals to amend the New Zealand (Maximum Residue Levels  
for Agricultural Compounds) Food Notice . 
 
 
For each compound you are commenting on, please c learly answer the following qu estions. 
Any additional comment is welcome, along with supporting discussion,  and data or examples 
to illustrate particular points.  
 
On balance, do you oppose any of the commodity MRLs proposed for this compound?  
 
Do you oppose an MRL being set at all  for this compound for the commodity?  
 
If an MRL is to be set for this compound for the commodity, do you disagree with the 
particular level proposed? If so, why do you disagree?  
 
Submissions close at 5pm on  4 September  2016 .  Your comments should be sent to:  
 
MRL Amendments  
ACVM Programmes and Appraisals  
MPI Systems Audit, Assurance and Monitoring Directorate  
PO Box 2526  
Wellington 6140  
 
Email: ACVM.Consultation@mpi.govt.nz  
 
Please include your name and address on your submission. If you are making comments on 
behalf of an organisation, also include your title and the name of the organisation.  
 
Please make sure your comments can be clearly read, as a number of copies of your 
submission  may be made . 
 
The Official Information Act  
The Official Information Act 1982 (the OIA) states that information is to be made available 
unless there are grounds for withholding it. The grounds for withholding information are 
outlined in the OIA.  Submitters may wish to i ndicate any grounds for withholding information 
contained in their submission.  Reasons for withholding information could include that 
information is commercially sensitive or that the submitters wish personal information such 
as names or contact details t o be withheld.  MPI will take such indications into account when 
determining whether or not to release information.  Any decision to withhold information 
requested under the OIA may be reviewed by the Ombudsman.  
  
2 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
2 Introduction  
Maximum residue l evels (MRLs)  are the maximum legal levels  for residues of agricultural 
compounds and veterinary medicines in food for sale in New Zealand. MRLs are primarily a 
tool for monitoring the use of agricultural compounds in accordance with good agricultural 
practice (GAP). G AP is not explicitly defined or regulated, but is the generally accepted 
means for producing safe primary produce in a particular location while taking account of 
climate, pests or diseases and other environmental factors. MRLs are used to minimise risks 
to public health by ensuring that chemical residues in food are as low as practicable, without 
compromising the ability of the chemical to successfully do what is intended.  
2.1 BACKGROUND  
MRLs are set out in the New Zealand (Maximum Residue Levels for Agricultural 
Compounds) Food Notice. The MRL Food Notice is  amended a number of times each year 
to reflect changes in the use of agricultural compounds in the production of food. The MRL 
Food Notice is  available from the Ministry for Primary Industries (MPI) Foodsa fety website at: 
http://www.foodsafety.govt.nz/elibrary/industry/register -list-mrl-agricultural -compounds.htm .  
 
MPI administers the MRL Food Notic e, with the final decision on any changes to the Notice  
resting with the  Director -General  of MPI.  The Food Notice is issued under sections 405 and 
406(1) of the Food Act 2014. When setting or amending MRLs, the Director -General mu st 
take into account:  
• the need to protect public health;  
• the desirability of avoiding unnecessary restrictions on trade;  
• the desirability of maintaining consistency between New Zealand's food standards and those applying internationally;  
• New Zealand's obligations under any relevant  international treaty, agreement, 
convention, or protocol, and, in particular, under the Australia- New Zealand Joint 
Food Standards Agreement; and 
• such other matters as appropriate.  
 
Once the amended MRL Food Notice is in place, official chemical residue m onitoring 
programmes are reviewed and are amended as necessary.  
 
Possible implications for public health are considered during the toxicological and dietary risk 
assessments, by comparing the estimated dietary intake with a Potential Daily Exposure 
(food) (PDE
(food)). Where there is no PDE (food), the estimated dietary intake is compared with 
the Acc eptable Daily Intake (ADI). PDE (food) and ADI are described below.  
 A PDE
(food) is a value determined by a toxicological evaluation by the Environmental 
Protect ion Authority (EPA) as part of its responsibility for managing public health under the 
Hazardous Substances and New Organisms Act 1996 (the HSNO Act).  A PDE (food) gives the 
potential daily exposure a person may be subject to from a substance, via food. MP I uses a 
PDE (food) where it is available, rather than the internationally -determined ADI, as required by 
the HSNO Act in New Zealand. The ADI and PDE (food) are largely equivalent, as they are 
determined using the same set of toxicology data and through a v ery similar scientific 
process.  
 
An ADI is defined by the World Health Organization (WHO) as: “the daily intake which, during an entire lifetime, appears to be without appreciable risk on the basis of all the known facts at 
the time”. “Without appreciable risk” has been further defined as: “the practical certainty that 
injury will not result even after a lifetime of exposure”. ADIs are established by the WHO and 
Food and Agriculture Organization (FAO) of the United Nations joint expert committees, 
which are made up of toxicologists and residue specialists. The ADI information from these 
joint committees also feeds into the Codex Alimentarius Commission (Codex), which sets 
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 3  
international MRLs.  Where an internationally -determined ADI is not available, an ADI may be 
calculated by MPI to quantify  the dietary exposure risk.  
 
The chronic dietary exposure to a substance is estimated by the National Estimated Dietary 
Intake (NEDI) calculation, encompassing all registered uses of the chemical and food consumption data  based upon the 1997 National Nutritional Survey for adults and the 1995 
National Nutrition Survey of Australia, for children. The NEDI calculation is made in accordance with Guidelines for predicting dietary intake of pesticide residues (revised) 
[World H ealth Organization, 1997]. The NEDI calculation provides an estimation of the 
portion of the  PDE
(food) or ADI that can be expected from consumption of food containing 
residues complying with existing and proposed MRLs to determine whether the chronic 
dietary exposure risk is acceptable  
Clause 144 of the Food Regulations 2015 states that imported food must contain residues of 
agricultural compounds no greater than the MRLs specified for that food in a notice set under 
the Food Act 2014 (section (1)(a)), the default MRL of 0.1 mg/kg (section (1)(c)), or the 
current editions of either the Maximum Residue Limits (MRLs) and Extraneous Maximum  
Residue Limits (EMRLs) for Pesticides (Codex Pesticides Residues in Food Online 
Database), or the Maximum Residue Limits for Veterinary Drugs in Food (Codex Veterinary 
Drug Residue in Food Online Database) (section (1)(d)).  
  
To meet New Zealand’s obligations under the Agreement on the Application of Sanitary and 
Phytosanitary Measures the proposed MRL will be notified to the World Trade Organization. 
Any country may choose to comment if they believe the proposed MRL represents a barrier 
to their trade.  
 
2.2 SUMMARY OF PROPOSED AMENDMENT  
The proposed MRLs have been thoroughly assessed in accordance with international 
methodolog ies such as those utilised by the expert committees advising Codex. Information 
on the technical assessment of each proposal is included in this document (refer section 3) 
and covers:  
 
• rationale;  
• chemical information;  
• good agricultural practice;  
• residues i nformation;  
• dietary risk assessment;  
• toxicological/public health assessment; and  
• MRLs set by Codex and other countries . 
 MPI reviewed the estimated dietary exposure assessments for the application of the 
proposals in this discussion paper and compared them with the appropriate reference health 
standard (the PDE
(food) or the ADI). MPI has determined that the residues associat ed with the 
proposed MRLs do not present any public health or food  safety concerns.  
2.2.1 New and Amended MRLS  
MPI proposes to add the following new MRLs to the MRL Notice and/or amend the existing entries for certain compounds : 
• Abamectin: 0.01 (*) mg/kg when us ed on bulb onions, and 0.02 mg/kg when used on 
green onions.  
• Aviglycine: 0.02 mg/kg when used on cherries.  
• Bixafen : 0.05 mg/kg when used on barley.  
• Cephapirin : 0.06 mg/kg in  cattle  milk. 
4 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
• Cyproconazole : 0.05 mg/kg (*) when used on grapes ; and 0.5 mg/kg in edible offal 
(mammals), 0.02 mg/kg in fat (mammalian), and 0.01 mg/kg in milk as a result of use 
in beets . 
• Diclazuril: 1.0 mg/kg in cattle and sheep fat, 2.0 mg/kg in cattle and sheep kidney, 0.5 
mg/kg in cattle and sheep muscle, and 3.0 mg/kg in cattle and sheep liver.  
• Fenpyrazamine: 0.05 mg/kg when used on grapes.  
• Fluopyram : 1.0 m g/kg when used on fruiting vegetables (except cucurbits ). 
• Fluxapyroxad : 0.02 mg/kg when used on pome fruits (apples and pears) . 
• Indoxacarb : 0.5 mg/kg when used on brassica vegetables (except cabbage); 3 mg/kg 
when used on cabbage; and 3 mg/kg when used on head lettuce.  
• Meloxicam : 0.01 mg/kg in sheep fat and muscle, and 0.065 mg/kg in sheep liver and 
kidney.  
• Metamitron: 0.01 mg/kg (*) when used on apples.  
• Methoxyfenozide: 0.4 mg/kg when used on stone fruit.  
• Prothioconazole : 0.1 mg/kg when used on barley.  
• Spirotetramat : 0.2 mg/kg in apples.  
• Thiamethoxam : 0.01 (*) mg/kg in bulb onions, and 0.2 mg/kg in green onions.  
• Trifloxystrobin: 0.05 mg/kg in fat (mammalian), 0.04 mg/kg in k idney (mammalian), 
and 0.05 mg/kg in liver (mammalian) when used on sugar beets and fodder grown for animal feed.  
• Trinexapac -ethyl : 0.05 mg/kg (*) of 4 -(cyclopropyl -α-hydroxy -methylene) -3,5-dioxo -
cyclohexanecarboxylic acid
 when used on cereal crops , and 0.2 mg/kg of trinexapac 
(acid) when used on cereal crops  (except maize and sweet  corns).  
• Tulathromycin: 0.45 mg/kg in sheep muscle, 0.25 mg/kg in sheep fat, 5.4 mg/kg in 
sheep liver, and 1.8 mg/kg in sheep kidney.  
 
Note: (*) indicates that the maximu m residue level has been set at or about the limit of analytical 
quantification.  
2.2.2 New Ex ceptions from Maximum Residue Levels 
MPI proposes  to add the following ex ceptions from Maximum Residue Levels for Agricultural 
Chemicals (Schedule 2) : 
• Mixtures of chito- oligosaccharides and oligogalacturonans , for use on fruits and 
vegetables . 
• Ozone, for use as an agricultural chemical.   
• Polyoxin D zinc salt , for use as an agricultural chemical . 
• Prohydrojasmon , when used as a colour enhancer on apples . 
MPI proposes to amend  the following exceptions from Maximum Residue Levels for 
Agricultural Chemicals  (Schedule 2):  
• Amend the entry for ‘ Microbial Pesticide Organisms ’ to change the classification of 
these substances to ‘Microbial Active Ingredients’ . 
 
MPI proposes to am end the following exceptions from Maximum Residue Levels for 
Veterinary Medicines (Schedule 3):  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 5  
• Amend the entry for ‘Bismuth and its salts’ to include the use of intramammary teat 
sealants in cattle.  
2.2.3 Other Amendments  
MPI proposes to amend the residue defi nition s for the following compounds:  
• Emamectin, to harmonise  with overseas trading partners and Codex.  
• Indoxacarb, to harmonise with the current definition set by Codex.  
• Prothioconazole, to harmonise it with the current definition set by Codex  in 2008.  
• Trinexapac -ethyl, to correct errors in the current Notice entry.  
3 Proposals  
3.1 PROPOSAL TO SET MRL S FOR ABAMECTIN  
It is proposed that  MRL s are set for abamectin  to support the good agricultural practice 
(GAP) use on bulb onions and green onions.  
The current entry for  abamectin in Schedule 1 of the MRL Notice  is: 
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted  
Residue Level (mg/kg)  
Abamectin  71751 -42-2  Sum of :  
avermectin B1a  
avermectin B1b  
(Z)-8,9 avermectin B1a  
(Z)-8,9 avermectin B1b  Avocados  
Cattle fat  
Cattle liver  
Cattle meat  
Kiwifruit  
Pome fruits  
Sheep fat  
Sheep kidney  
Sheep liver  
Sheep meat  
Strawberries  
Tomatoes  0.02(*)  
0.02  
0.015  
0.01  
0.02(*)  
0.02(*)  
0.05  
0.02  
0.025  
0.02  
0.02(*)  
0.1 
 
The revised entry for abamectin in Schedule 1 of the MRL Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food  Maximum Permitted  
Residue Level (mg/kg)  
Abamectin  71751 -42-2  Sum of :  
avermectin B1a  
avermectin B1b  (Z)-8,9 avermectin B1a  
(Z)-8,9 avermectin B1b  Avocados  
Bulb onions  
Cattle fat  Cattle liver  
Cattle meat  
Green onions  
Kiwifruit  
Pome fruits  Sheep fat  
Sheep kidney  
Sheep liver  
Sheep meat  
Strawberries  
Tomatoes  0.02(*)  
0.01 
0.02  
0.015  
0.01  
0.02 
0.02(*)  
0.02(*)  
0.05  
0.02  
0.025  
0.02  
0.02(*)  
0.1 
 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
6 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.1.1 Amendment Rationale  
The proposed MRL represents the expansion of use of a currently registered active 
ingredient. The proposed MRL will manage the use of abamectin  as an insecticide  on bulb 
onions and green onions,  and in accordance with the application rates and withholding 
periods that are proposed as good agricultural practice GAP.  
3.1.2 Chemical Information  
Common name of compound  Abamectin  
Use of compound  Insecticide  
Chemical Abstract Services (CAS) Registry number  71751 -42-2 
Type of compound  Avermectin  
Administration method  Spray  
3.1.3 Good Agricultural Practice  
Abamectin  is proposed for use as an insecticide o n bulb and green onions  to be applied at a 
rate of 27gai/ha to  treat infestation with thrips ( Thrips tabaci ), with the first application  
indicated by reaching the thr eshold level for the insect. Treatment is repeated at seven day 
intervals as a cluster of three or four sequential applications, with a maximum of four applications per year.  The withholding period is 14 days . 
3.1.4 Residue Information 
The residue data for the c rops support an MRL of 0. 01 mg/kg in bulb onions and 0.02 mg/kg 
in green onions after treatment with abamectin.  The MRL s are proposed to support GAP.  
3.1.5 Dietary Risk Assessment  
The PDE (food) of 0.0 02 mg/kg bw/d was considered appropr iate for use in the assessment.  
Based on the residues expected in food from crops treated according to existing and proposed GAP uses, the NEDI for abamectin  is equivalent to  less than 7.5% of the PDE
(food). 
It is therefore concluded that the chronic dietary exposure is small  and the risk is acceptable.  
3.1.6 Toxicological/Public Health Assessment  
It has been determined that the use of abamectin on bulb and green onions , according to the 
GAP specified above, is  unlikely to pose any health risks from consumption of treated 
produce.  
3.1.7 Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
Australia  Bulb vegetables  0.05 
European Union Onions  
Spring onions/green onions and 
Welsh onions  0.01 
0.01 
United States  Bulb onion 
Green onion  0.01 
0.08 
 
3.2 PROPOSAL  TO SET  AN MRL FOR AVIGLYCINE  
It is proposed that an MRL is set for aviglycine  to support the GAP use on cherries .  
The current entry for aviglycine in Schedule 1 of the MRL  Notice  is: 
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 7  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted  
Residue Level (mg/kg)  
Aviglycine  49669 -74-1  Aviglycine  Pome fruits  
Stone fruits (except cherries)  0.1  
0.1 
 
The revised entry for aviglycine  in Schedule 1  of the MRL Notice  will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted  
Residue Level (mg/kg)  
Aviglycine  49669 -74-1  Aviglycine  Pome fruits  
Stone fruits (except cherries)  
Cherries  0.1  
0.1 
0.02 (*) 
(*) indicates that the maximum residue limit has been set at or about the  limit of analytical quantification.  
3.2.1 Amendment Rationale  
The proposed MRL represents the expansion of use of a currently registered active 
ingredient. The proposed MRL will manage the use of aviglycine on cherries as a plant 
growth regulator  and in accordance with the application rates and withholdin g periods that 
are proposed as GAP  in New Zealand.  
3.2.2 Chemical Information  
Common name of compound  Aviglycine  
Use of compound  Plant growth regulator  
Chemical Abstract Services (CAS) Registry number  49669 -74-1  
Type of compound  Aminoethoxyvinylglycine  
Administration method  Spray  
3.2.3 Good Agricultural Practice  
Aviglycine  is proposed for use as  a plant growth regulator on cherries  to be applied at 
830gai/ha in 1000 -1500L/ha to extend flower viability by delaying senescence. The active is 
to be applied at 30- 60% flowering, and is to be used no later than full bloom.  
3.2.4 Residue Information 
The residue data for the crop supports an MRL of 0. 02(*) mg/kg fo r use of aviglycine on 
cherries.   The MRL is proposed to support GAP.  
3.2.5 Dietary Risk Assessment  
The ADI of 0.006 mg/kg bw/d was considered appropriate for use in the assessment and is consistent with overseas reputable regulatory bodies.  
Based on the residu es expected in food from crops treated according to existing and 
proposed GAP uses, the NEDI for aviglycine is equivale nt to less than 3% of the ADI. It is 
therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.2.6 Toxicological/Public Health Assessment  
It has been determined that the use of aviglycine on cherries , according to t he GAP specified 
above, is unlikely to pose any health risks from consumption of treated produce.  
  
8 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.2.7 Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
Australia  Cherries  0.05 
Japan  Cherries  0.2 
3.3 PROPOSAL  TO SET  AN MRL FOR BIXAFEN  
It is proposed that an MRL is set for bixafen to support the GAP use  on barley.   
The current entry for bixafen  in Sc hedule 1 of the MRL  Notice  is: 
Compound 
Common 
Name  CAS#  Residue to which the maximum 
residue limit applies  Food Maximum Permitted  
Residue Level (mg/kg)  
Bixafen  581809 -46-3 Plant commodities: Bixafen  
Animal commodities: Bixafen plus its 
metabolite desmethyl  bixafen 
expressed as bixafen  Cereal grains  
Mammalian fat  
Mammalian kidney  
Mammalian meat  
Mammalian liver  
Milk  0.01(*)  
0.4  
0.3  
0.15  
1.5  
0.04  
 
The revised entry for bixafen in Schedule 1 of the MRL Notice will read:  
Compound 
Common 
Name  CAS#  Residue to which the maximum 
residue limit applies  Food Maximum Permitted  
Residue Level (mg/kg)  
Bixafen  581809 -46-3 Plant commodities: Bixafen  
Animal commodities: Bixafen plus its 
metabolite desmethyl bixafen 
expressed as bixafen  Barley grain  
Cereal gr ains (except barley 
grain)   
Mammalian fat  
Mammalian kidney  
Mammalian meat  
Mammalian liver  
Milk 0.05 
0.01(*)  
0.4  
0.3  
0.15  
1.5  
0.04 
 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.3.1 Amendment Rationale  
The proposed MRL has arisen from a review of the current MRL for cereal grain as it 
pertained to barley grain after an application was submitted to revise the approved 
withholding period in that c rop. The proposed MRL will manage the use of bixafen on barley 
as a fungicide and in accordance with the application rates and approved withholding periods 
that are considered GAP in New Zealand.  
3.3.2 Chemical Information  
Common name of compound  Bixafen  
Use of compound  Fungici de 
Chemical Abstract Services (CAS) Registry number  581809 -46-3 
Type of compound  Pyrazole  
Administration method  Spray  
3.3.3 Good Agricultural Practice  
Bixafen  is use d as a fungicide in barley and other cereal  crops . On barley, it is used at an 
application rate of 700- 1000 mL/ha at the first sign of disease, with a second application 3- 4 
weeks later if needed. Bixafen is used to treat scald, net blotch, ramularia leaf spot, and leaf 
rust in barley, and will attract a wi thholding period of 56 days when used on this commodity.  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 9  
3.3.4 Residue Information 
The residue data for the crop supports an MRL of 0.0 5 mg/kg for bixafen  in barley . The MRL 
is proposed to support GAP.  
3.3.5 Dietary Risk Assessment  
The ADI of 0.0 2 mg/kg bw/d was considered appropriate for use in the assessment.  
Based on the residues expected in food from crops treated according to existing and 
proposed GAP uses, the NEDI for bixafen  is equivalent to less than 2 % of the  ADI. It is 
therefore conclude d that the chronic dietary exposure is small and the risk is acceptable.  
3.3.6 Toxicological/Public Health Assessment  
It has been determined that the use of bixafen  on barley , in accordance with the GAP 
specified above, is unlikely to pose any health risks from consumption of treated produce  
with the proposed MRL in place.  
3.3.7 Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
Australia  Barley  0.3 
European Union Barley  0.5 
3.4 PROPOSAL TO AMEND  AN MRL FOR CEPHAPIRIN   
It is proposed that  the existing MRL  for cephapirin in cattle milk is amended  to support GAP .   
The current entry for cephapirin in Schedule 1  of the MRL Notice  is: 
Compound 
Common 
Name  CAS#  Residue to which the maximum 
residue limit applies  Food Maximum Permitted  
Residue Level (mg/kg)  
Cephapirin  21593 -23-7 Sum of:  
Cephapirin  
Des-acetylcephapirin  
Expressed as:  
Cephapirin  Cattle fat  
Cattle meat  
Cattle milk  Edible offal of cattle  0.1  
0.1  
0.01  
0.1  
 
The revised entry for cephapirin in Schedule  1 of the MRL Notice  will read: 
Compound 
Common 
Name  CAS#  Residue to which the maximum 
residue limit applies  Food Maximum Permitted  
Residue Level (mg/kg)  
Cephapirin  21593 -23-7 Sum of:  
Cephapirin  
Des-acetylcephapirin  
Expressed as:  
Cephapirin  Cattle fat  
Cattle meat  
Cattle milk  
Edible offal of cattle  0.1  
0.1  
0.06  
0.1  
3.4.1 Amendment Rationale  
The proposed revision to the milk  MRL  will align the New Zealand limit with that used 
overseas. The proposed MRL will manage the use of cephapirin as an antibiotic in dairy 
cattle in accorda nce with the dose rates, use patterns, and  withholding periods that are 
proposed as GAP in New Zealand.  
10 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.4.2 Chemical Information  
Common name of compound  Cephapirin  
Use of compound  Antibiotic  
Chemical Abstract Services (CAS) Registry number  21593 -23-7 
Type of compound  Cephalosporin  
Administration method  Intramammary and intrauterine infusion  
3.4.3 Good Agricultural Practice  
Cephapirin is used as a dry cow therapy intramammary infusion for the treatment and 
prevention of mastitis in dairy cow s, and as an intrauterine infusion for the treatment of 
endometritis in cows. For mastitis, treatment is administered by infusing 300 mg cephapirin 
per teat at the end of the final milking (at “drying off”); treatment is to be administered at least 
28 days before calvi ng, and if calving occurs within that 28 days, the full 28 days plus a 
further eight milkings must elapse before milk can enter the food chain. For endometritis, 
treatment is administered by a single dose of 500 mg cephapirin directly into the uterus; a ni l 
milk withholding period currently applies for products approved to treat endometritis.  
3.4.4 Residue Information 
The residue data for the use of cephapirin as a mastitis treatment  supports  the revision of the 
milk MRL to 0.06 mg/kg.  This MRL  is proposed to sup port GAP.  
3.4.5 Dietary Risk Assessment  
The microbiological ADI of 0.002 54 mg/kg bw/d  was considered appropriate for use in the 
assessment.  
Based on the residues expected in food from animals treated according to existing and 
proposed GAP uses, the NEDI for ce phapirin is equivalent to less than 20 % of the ADI.  It is 
therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.4.6 Toxicological/Public Health Assessment  
For veterinary medicines intended for use in dairy animals, GAP is the shortest withholding 
period that will manage all associated risks; although the proposed MRL exceeds that set by 
Canada, Australia, and the United States, the proposed MRL of 0.06 mg/kg meets that set in 
the EU and can be considered acceptable from a dietary intake perspective. It is therefore 
considered representative of GAP.  
It has been determined that the use of cephapirin in dairy cows when treated  according to 
GAP, is unlikely to pose any health risks from consumption of treated produce.  
3.4.7 Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
Australia  Cattle milk  0.01 
Canada  Milk 0.02 
European Union Bovine milk  0.06 
United States  Milk, Dairy cattle  0.02 
3.5 PROPOSAL TO SET MRLS FOR CYPROCONAZOLE  
It is proposed that MRLs are  set for cyproconazole to support the GAP use  on fodder and 
sugar beets, and grapes.  This includes proposed MRLs for animal commodities resulting 
from use of cyproconazole on animal feeds.  
 
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 11  
The current entry for cyproconazole in Schedule 1  of the Food Notic e is: 
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Cyproconazole  94361 -06-5  Cyproconazole, sum of isomers  Bulb onions  
Garlic  
Peas  0.01(*)  
0.01(*)  
0.01(*)  
 
 
The revised  entry for cyproconazole in Sc hedule 1 of the Food Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Cyproconazole  94361 -06-5  Cyproconazole, sum of isomers  Bulb onions  
Edible offal (mammalian)  
Fat (mammalian)  
Garlic  
Grapes  
Meat (mammalian)  
Milk 
Peas  
 0.01 (*) 
0.5 
0.02 
0.01 (*) 
0.05 (*)  
0.02 
0.01 
0.01(*)  
 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.5.1.1  Amendment Rationale  
The proposed MRL is required to support the additional use of a currently registered active 
ingredient on fodder and sugar beets. The proposed MRLs will manage the use of 
cyproconazole on fodder and sugar beets  in accordance with the application rates and 
withholding periods that are proposed as GAP in New Zealand. This is because fodder and 
sugar beets are used only as animal feed in New Zealand, and therefore the proposed MRLs 
for commodities from animals that c onsume the crops will be reflective of GAP.  
The proposed MRL in grapes reflects a current use pattern which has not previously had a 
specific MRL set. The proposed MRL of 0.05 mg/kg (the limit of quantification when the data 
was generated) is in accordance  with the application rates and withholding periods that are 
currently considered as good agricultural practice (GAP) in New Zealand.   
3.5.2 Chemical Information  
Common name of compound  Cyproconazole  
Use of compound  Fungicide  
Chemical Abstract Services (CAS) Registry number  94361 -06-5 
Type of compound  Triazole – Demethylation inhibitor (DMI)  
Administration method  Spray  
3.5.2.1  Good Agricultural Practice  
The proposed use of cyproconazole is to control foliar fungal diseases in fodder and sugar 
beets using 2 foliar sprays of 56gai/ha, with a 42 day WHP, in combination with 
trifloxystrobin.  In NZ,  fodder and  sugar beets are grown as animal feeds, for which MRLs are 
not required.   
The current use in grapes is up to 4 applications of 1.5gai/100 litres of water, to cont rol 
powdery mildew. The product is recommended in rotation with fungicides with alternative 
modes of action in order to manage resistance. A 28 day WHP has been proposed in 
accordance with Good Agricultural Practice.  
3.5.2.2  Residue Information 
The residue data f or beets and sugar beets supports MRLs for cyproconazole in animal 
commodities of 0.5, 0.02, 0.02 and 0.01 mg/kg for edible offal (mammalian), fat 
12 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
(mammalian), meat (mammalian),  and milk, respectively. The MRLs are proposed to support 
GAP.  
The residue dat a for grapes supports an MRL of 0.05 mg/kg in accordance with GAP . 
3.5.2.3  Dietary Risk Assessment  
The ADI of 0.02 mg/kg bw/d was considered appropriate for use in the assessment  of dietary 
exposure for all crops,  and is consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from crops treated according to existing and 
proposed GAP uses, the NEDI  for cyproconazole in animal commodities is equivalent to less 
than 7 % of the ADI . It is therefore concluded that the chronic dietary exposure from all 
sources is small and the risk is acceptable.  
The NEDI for cyproconazole  when used on grapes  is equivalent to less than 6 % of the ADI.  
3.5.2.4  Toxicological/Public Health Assessment  
It has been determined that the use of cyproconazole on fodder and sugar beet, and grapes, 
according to the GAP specified above, is very unlikely to pose any health risks from consumption of treated produce.  
3.5.2.5  Other International MRLs  
Country  Food  Maximum Residue 
Limit    (mg/kg)  
Australia  Edible Offal (mammalian)  1 
 Meat (mammalian)  0.03 
 Milks  0.01 
Codex  Edible offal (mammalian)  0.5 
 Fat (mammalian)    0.02 
 Meat (from mammals other than marine 
mammals)  0.02 
 Milk 0.01 
European Union  Grapes  0.20 
 Muscle (all animal species)  0.05 
 Edible offals (other than liver & kidney)  0.5 
 Liver  0.5 
 Kidney  0.5 
 Fat tissue  0.05 
 Milk 0.05 
Japan  Grapes  0.20 
United States  Cattle and sheep by -products  0.01 
 Cattle and sheep fat  0.01 
 Cattle and sheep kidney  0.01 
 Cattle and sheep liver  0.5 
 Milk 0.02 
3.6 PROPOSAL TO SET MRLS FOR DICLAZURIL  
It is proposed that MRLs are set for diclazuril when used in sheep and cattle (calves and 
lambs)  to support GAP .  
This compound currently has no entry in Schedule 1  of the MRL Notice.   
  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 13  
The proposed entry  for diclazuril in Schedule 1 of the MRL Notice will read:  
Compound 
Common Name  CAS#  Residue to which the 
maximum residue limit 
applies  Food Maximum Permitted 
Residue Level 
(mg/kg)  
Diclazuril  1019831 -37-2 Diclazuril  Cattle fat  
Cattle kidney  
Cattle muscle  
Cattle liver  
Sheep fat  
Sheep kidney  
Sheep muscle  
Sheep liver  1.0 
2.0 
0.5 
3.0 
1.0 
2.0 
0.5 
3.0 
3.6.1 Amendment Rationale  
The proposed MRLs represent the registration of a new product for use in production 
animals. The proposed MRLs will manage the use of diclazuril as a treatment for coccidiosis 
in calves and lambs, with dose rates and withholding periods that are proposed as good 
agricultural practice (GA P) in New Zealand.  
3.6.2 Chemical Information  
Common name of compound  Diclazuril  
Use of compound  Coccidiostat  
Chemical Abstract Services (CAS) Registry number  1019831 -37-2 
Type of compound  Benzeneacetonitrile derivative  
Administration method  Oral 
3.6.3 Good Agricultural Practice 
Diclazuril is proposed for use as an aid in the control of coccidiosis in lambs and calves at a 
proposed dose rate of 2.5 mg/kg body weight by a single oral dose.   
3.6.4 Residue Information 
The residue data for the target species  supports MRLs of diclazuril of: 1.0 mg/kg in cattle and 
sheep fat; 2.0 mg/kg in cattle and sheep kidney; 0.5 mg/kg in cattle and sheep muscle; and 3.0 mg/kg in cattle and sheep liver. These MRLs are proposed to support GAP.  
3.6.5 Dietary Risk Assessment  
The ADI of 0.03 mg/kg bw/d was considered appropriate for use in the assessment and is 
consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from animals treated according to proposed GAP 
uses, the NEDI  for diclazuril is equivalent to less than 5 % of the ADI. It is therefore 
concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.6.6 Toxicological/Public Health Assessment  
It has been determined that the use of diclazuril as a coccidiostat in the management of 
intestinal parasites in sheep and cattle, when administered in accordance with GAP , is very 
unlikely to pose any health risks from consumption of treated produce.  
3.6.7 Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
Codex  Sheep Muscle  
Sheep Fat 
Sheep liver  0.5 
1 
3 
14 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.7 PROPOSAL TO AMEND TH E RESIDUE DEFINITION FOR EMAMECTIN 
BENZOATE  
It is proposed that the residue definition for emamectin benzoate is amended.  
The current entry for emamectin benzoate in Schedule 1  of the MRL Notice is:  
Compound 
Com mon Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Emamectin 
benzoate 155569 -91-8  
 Sum of:  
emamectin B1a  emamectin B1b  
(Z)-8,9 emamectin B1a  
(Z)-8,9 emamectin B1b  
Expressed as:  
emamectin  Avocados  
Grapes  
Kiwifruit  
Pome fruits  0.005  
0.002(*)  
0.002(*)  
0.001(*)  
The revised entry for emamectin benzoate in Schedule One of the MRL Notice will read:  
Compound Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Emamectin 
benzoate 155569 -91-8  
 Sum of:  
emamectin B1a  
emamectin B1b  
Expressed as:  
emamectin  Avocados  
Grapes  
Kiwifruit  
Pome fruits  0.005  
0.002(*)  
0.002(*)  
0.001(*)  
 
 (*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
 
3.7.1 Amendment Rationale  
In 2010, the residue definition for emamectin benzoate was amended in Australia to only the 
sum of emamectin B1a and B1b wit hout the inclusion of the 8,9- Z isomers. This was based 
on a lack of significant residues of the 8,9- Z isomers, and the lack of any quantifiable 
residues of toxicological significance associated with these isomers.  This approach has also 
been taken by Codex and the EU, who have determined residue definitions based on either emamectin B1a alone expressed as emamectin, or the sum of  emamectin B1a and B1b 
(Australia ).  
In New Zealand, there is also a notable lack of detectable residues for the 8,9- Z isomers, and 
with no toxicologically significant residues associated with these isomers there is no need to 
continue to include them in the New Zealand residue definition.     
3.7.2 Chemical Information  
Common name of compound  Emamectin benzoate  
Use of compound  Insecticide  
Chemical Abstract Services (CAS) Registry number  155569 -91-8  
Type of compound  4’-deoxy -4’-epi-methylamino derivative of 
avermectin B1  
Administration method  Spray  
3.7.3 Good Agricultural Practice  
Emamectin is used as an insecticide in apples, pears, avocados, grapes and kiwifruit. The 
current use patterns, withholding periods, and MRLs are still considered appropriate to 
support GAP and will not change.  
3.7.4 Residue Information 
The residue data for the approved crops support the current MRLs, and demonstrate 
consistently low levels of total emamectin residues and levels of the 8,9- Z isomers below the 
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 15  
limit of detection. It is therefore considered that the residue  data supports the change in the 
residue definition.   
3.7.5 Other International MRLs  
Country  Food Maximum Residue 
Limit (mg/kg)  Residue Definition  
Australia  Grapes  0.002  Sum of emamectin B1a and emamectin B1b  
Codex  Grapes  
Pome fruits  0.03 
0.02 Emamectin B1a benzoate  
European 
Union  Avocados  
Grapes (all types)  
Kiwi fruits (green, red, 
yellow)  
Pome fruits (all types)  0.01 
0.05 
0.01 
 
0.02 Emamectin benzoate B1a, expressed as emamectin  
USA Apples  
Grapes, wine  
Pears  0.025  
0.03 
0.025   Sum of emamectin (a mixture of a minimum of 90% 4' -
epi-methylamino- 4'-deoxyavermectin B1a and maximum 
of 10% 4' -epi-methylamino- 4'-deoxyavermectin B1b) 
and its metabolites 8,9- isomer of the B 1a and B1b 
component of the parent (8,9- ZMA), or 4' -deoxy -4'-epi-
amino- avermectin B1a and 4' -deoxy -4'-epi-amino-
avermectin B1b; 4' -deoxy -4'-epi-amino avermectin B1a 
(AB 1a); 4' -deoxy -4'-epi-(N-formyl -N-methyl)amino-
avermectin (MFB 1a); and 4' -deoxy -4'-epi-(N-
formyl)amino- avermectin B 1a (FAB 1a), calculated as 
the stoichiometric equivalent of ema mectin.  
3.8 PROPOSAL TO SET  AN MRL FOR FENPYRAZAMINE  
It is proposed that an MRL is set for fenpyrazamine to support the GAP use  on grapes .  
There is currently no entry in S chedule 1 of the MRL Notice.  
The proposed entry for fenpyrazamine in Schedule 1  of the MRL Notice  will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Fenpyrazamine  473798 -59-3 Fenpyrazamine (parent only)   Grapes  
 0.05 
 
3.8.1 Amendment Rationale  
The proposed MRL  represent s the registration of a new active ingredient for use on grapes.  
The proposed MRL will manage the use of fenpyrazamine as a fungicide on grapes  in 
accordance with the application rates and withholding periods that are proposed as GAP in 
New Zealand.  
3.8.2 Chemical Information  
Common name of compound  Fenpyrazamine  
Use of compound  Fungicide  
Chemical Abstract Services (CAS) Registry number  473798 -59-3 
Type of compound  Hydroxyanilide  
Administration method  Spray  
3.8.3 Good Agricultural Practice  
Fenpyrazamine is proposed for use on wine grapes for the treatment of grey mould ( Botrytis 
cinerea)  at up to 2 foliar sprays of 40 gai/100L, applied to full coverage up to full bunch 
closure. This is considered GAP as part of a season- long control programm e. The applicable 
withholding period is use up to pre- bunch closure but not less than 65 days before harvest.  
16 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.8.4 Residue Information 
The residue data for t he crops supports an MRL for fenpyrazamine in grapes of 0.05 mg/kg. 
This MRL is proposed to support GAP .  
3.8.5 Dietary Risk Assessment  
The PDE (food) of 0.091 mg/kg bw/d was considered appropriate for use in the assessment and 
is consistent with overseas reputable regulatory bodies.  
 Based on the residues expected in food from crops treated according to the proposed GAP 
use, the NEDI  for fenpyrazamine is equivalent to less than 0.2 % of the PDE (food). It is 
therefore concluded that the chronic dietary exposure is small and the risk is  acceptable.  
3.8.6 Toxicological/Public Health Assessment  
It has been determined that the use of fenpyrazimine as a fungicide for use on wine grapes, 
when applied according to GAP, is very unlikely to pose any health risks from consumption of 
treated produce.  
3.8.7 Other International MRLs  
Country  Food Maximum Residue 
Limit (mg/kg)  
Australia  Dried Grapes (currants, raisins, and sultanas)  
Table Grapes  
Wine Grapes  10 
2 
0.05 
European Union Table Grapes  
Wine Grapes  3 
3 
United States  Table grapes (no set MRL for wine grapes)  3 
3.9 PROPOSAL TO SET  AN MRL FOR FLUOPYRAM  
It is p roposed that an MRL is set for fluopyram  to support the GAP use on fruiting vegetables 
(except cucurbits).  
The current entry for fluopyram in Schedule 1  of the  MRL Notice is:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Fluopyram  658066 -35-4 Plant commodities: Fluopyram  
Animal commodities: Sum of fluopyram and 2- (trifluoromethyl) 
benzamide, expressed as fluopyram  Bulb onions  
Grapes  
Mammalian meat  
Mammalian offal  
Milk  0.01(*)  
0.05  
0.1  
0.7  
0.07  
 
The revised  entry for fluopyram  in Sc hedule 1  of the  MRL Notice will read:  
Compound Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Fluopyram  658066 -35-4 Plant commodities: Fluopyram  
Animal commodities: Sum of fluopyram and 2- (trifluoromethyl) 
benzamide, expressed as fluopyram  Bulb onions  
Fruiting vegetables (except cucurbits)  
Grapes  
Mammalian meat  
Mammalian offal  
Milk  
 0.01(*)  
1.0 
 
0.05  
0.1  
0.7  
0.07  
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 17  
3.9.1.1  Amendment Rationale  
The proposed MRL represents an  additional use of a currently registered active ingredient. 
The proposed MRL will manage the use of the fungicide fluopyram  on greenhouse fruiting 
vegetables  (except cucurbits)  in accordance with the application rates and withholding 
periods that are proposed as GAP in New Zealand.  
3.9.2 Chemical Information  
Common name of compound  Fluopyram  
Use of compound  Fungicide  
Chemical Abstract Services (CAS) Registry number  65806 -35-4 
Type  of compound  Succinate Dehydrogenase Inhibitor (SDHI)  
Administration method  Spray  
3.9.2.1  Good Agricultural Practice  
The proposed use of fluopyram is to control Botrytis  in greenhouse fruiting vegetables 
(except cucurbits) using up to 2 foliar sprays of 300gai/ha.  The product is recommended in 
rotation with fungicides with alternative modes of action in order to manage resistance. A one  
day WHP has been proposed in accordance with common greenhouse practice for fruiting 
vegetables.  
3.9.2.2  Residue Information 
The residue data for the crop supports an MRL of 1.0 mg/kg for fluopyram on  fruiting 
vegetables (except cucurbits).  The MRL is proposed to support GAP.  
3.9.2.3  Dietary Risk Assessment  
The PDE (food) of 0.0084 mg/kg bw/d was considered appropriate for use in the assessment 
and is consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from crops treated according to existing and 
proposed GA P uses, the NEDI  for fluopyram is equivalent to less than 8 % of the PDE (food). It 
is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.9.2.4  Toxicological/Public Health Assessment  
It has been determined that the use of f luopyram in greenhouse fruiting vegetables (except 
cucurbits), according to the GAP specified above, is very unlikely to pose any health risks 
from consumption of treated produce.  
3.9.2.5  Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
Australia  Tomatoes  0.90 
Codex  Tomatoes  0.40 
European Union  Eggplants  
Peppers (sweet)  
Tomatoes  0.90 
0.90 
0.80 
China  Tomatoes  1.0 
Japan  Tomatoes  0.40 
United States  Eggplants  
Peppers (sweet)  
Tomatoes  4.0 
1.0 
4.0 
18 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.10 PROPOSAL TO AMEND  AN MRL FOR FLUXAPYROXAD   
It is proposed that an  MRL is set  for fluxapyroxad to support the GAP use in pears.   
The current entry for fluxapyroxad in Schedule 1  of the MRL Notice is:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Fluxapyroxad  907204 -31-3 Fluxapyroxad  Apples  
Barley grain  
Mammalian fat  
Edible offal  
Mammalian meat  
Milk  
Wheat grain  0.02  
0.3  
0.05  
0.03  
0.01(*)  
0.005  
0.1  
 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
 
The revised  entry for fluxapyroxad Schedule 1  of the MRL Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Fluxapyroxad  907204 -31-3 Fluxapyroxad  Apples  
Barley grain  
Edible offal  
Mammalian fat  
Mammalian meat  
Milk  
Pears  
Wheat grain  0.02 
0.3  
0.03  
0.05  
0.01(*)  
0.005  
0.02  
0.1  
 
(*) indicates that the maximum residue limit has been set at  or about the limit of analytical quantification.  
3.10.1 Amendment Rationale  
The proposed MRL change  represent s the expansion of use of a currently registered active 
ingredient  to include pears . The proposed MRLs will manage the use of fluxapyroxad as a 
fungicide  on apples and pears in accordance with the application rates and withholding 
periods that are pr oposed as GAP in New Zealand.  
3.10.2 Chemical Information  
Common name of compound  Fluxapyroxad  
Use of compound  Fungicide  
Chemical Abstract Services (CAS) Registry number  907204 -31-3 
Type of compound  Pyrazole -carboxamide  
Administration method  Spray  
3.10.3 Good Agricultural Practice  
Fluxapyroxad is proposed for use a fungicide for the treatment of black spot and powdery 
mildew on apples, and for black spot on pears. The fruit is treated at a rate of 6gai/100L of 
water at 7 to 10 day intervals from green tip to 21 days after petal fall . The withholding period 
applied to use of the product in  apples and pears  is that it must not be applied later than 21 
days after petal fall or after fruitlets reach 25mm in diameter, whichever is sooner.   
3.10.4 Residue Information 
The residue data for the crops supports  the extension of the MRL previously promulgated for 
apples at 0.02 mg/kg to all pome fruits.  This MRL  is proposed to support GAP.  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 19  
3.10.5 Dietary Risk Assessment  
The PDE (food) of 0.014 mg/kg bw/day was considered appropriate for use in the assessment 
and is consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from crops treated according to existing and 
proposed GAP uses, the NEDI  for fluxapyroxad is equivalent to less than I % of the PDE (food). 
It is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.10.6 Toxicological/Public Health Assessment  
It has been determined that the use of fluxapyroxad as a fungicide in pome fruits, when 
treated  according to GAP, is very unlikely to pose any health risks from consumption of 
treated produce.  
3.10.7 Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
Australia  Pome fruits  0.8 
Codex  Pome Fruits  0.9 
European Union Pome Fruits  0.9 
United States  Apple s 
Pear s 0.8 
0.8 
3.11 PROPOSAL TO SET MRLS FOR INDOXAC ARB  AND AMEND THE RESIDUE 
DEFINITION  
It is proposed that  the MRL s for indoxacarb are revised to set a separate MRL for cabbage 
(previously included as part of the brassica vegetables group), to amend the MRL set for 
head lettuce, and to  amend the residue definition in light of new information.  
The current entry for indoxacarb in Sch edule 1  of the MRL Notice  is: 
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Indoxacarb  173584 -44-6 Indoxacarb, sum of isomers  Brassica vegetables  
Grapes  
Head lettuce  
Pome fruits  0.5 
0.5 
1 
0.5 
 
 
The revised entry for indoxacarb in Schedule One of the MRL Notice  will read:  
Compound Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Indoxacarb  173584 -44-6 Sum of indoxacarb and its R 
enantiomer  Brassica vegetables (except 
cabbage)  
Cabbage  
Grapes  
Head lettuce  
Pome fruits  0.5 
 3 
0.5 
3 
0.5 
 
3.11.1 Amendment Rationale  
The proposed MRLs are the result of new data and information indicating that the previous 
MRLs were no longer sufficient to manage GAP. The revisions in the MRLs for brassica 
vegetables and head lettuce, as well as the establishment of a separate MRL for c abbage, 
are the result of the assessment of that new information. The proposed MRLs will manage 
20 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
the use of indoxacarb as an insecticide on brassicas and head lettuce in accordance with the 
application rates and withholding periods t hat are proposed as GAP in New Zealand.  
The amendment of the residue definition is to allow for harmonisation with the residue 
definition established by Codex. The amended residue definition is in effect the same as is 
currently established, but expressed in a different way.  
3.11.2 Chemical Information  
Common name of compound  Indoxacarb  
Use of compound  Insecticide  
Chemical Abstract Services (CAS) Registry number  173584 -44-6 
Type of compound  Oxadiazine  
Administration method  Spray  
3.11.3 Good Agricultural Practice  
Indoxacarb is  approved for use as an insecticide on head lettuce, cabbage, cauliflower, 
broccoli, and Brussels sprouts for the control of caterpillars  of diamondback moth, cabbage 
white butterfly, and soybean looper. Crops are to be treated with a maximum of four 
applications at 7- 14 day intervals from the first sign of insect presence at a dose rate of 
75gai/ha. The withholding period applicable to all crops is to not apply within three days of 
harvest.  
3.11.4 Residue Information 
The new residue data support  the amendment of  indoxacarb MRL for head lettuce to 
3mg/kg, and the setting of a cabbage- specific MRL of 3 mg/kg for cabbage. These 
amendments, resulting from review of the new data, also require the exclusion of cabbage 
from the brassica crop grouping. The new  MRLs are proposed to su pport GAP.   
3.11.5 Dietary Risk Assessment  
The ADI of 0.01 mg/kg bw/d was considered appropriate for use in the assessment and is 
consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from crops treated according to existi ng and 
proposed GAP uses, the NEDI  for indoxacarb is equivalent to less than 5 % of the ADI. It is 
therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.11.6 Toxicological/Public Health Assessment  
It has been determined that the use of indoxacarb as an insecticide for brassica vegetables 
and head lettuce, when treated according to GAP, is very unlikely to pose any health risks 
from consumption of treated produce.  
  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 21  
3.11.7 Other International MRLs  
Country  Food  Maximum Residue 
Limit (mg/kg)  Residue Definition  
Australia  Brassica (cole or 
cabbage) vegetables, 
head cabbages and 
flowerhead brassicas  
Lettuce, head  2.0 
 
 
3.0 Sum of indoxacarb and its R -isomer  
Codex  Broccoli  
Cabbages, head  
Cauliflower  
Lettuce, head  0.2 
3.0 
0.2 
7 Sum of indoxacarb and its R enantiomer  
European 
Union  Broccoli  
Cauliflowers  
Other flowering 
brassica  
Brussels sprouts  
Head cabbages  
Other head brassica 
Chinese cabbage  
Kales  
Other leafy brassicas  
Lettuces  0.3 
0.3 
0.3 
0.06 
0.2 
0.02 
3.0 
0.4 
0.4 
3.0 Sum of indoxacarb and its R enantiomer  
USA Broccoli, all varieties  
Brussels Sprouts  
Cabbage, all 
varieties  
Cauliflower  
Lettuce, head   12 
12 
12 12 
14  Indoxacarb, (S) -methyl 7-chloro -2,5-dihydro -2-
[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]indeno[1,2-
e][1,3,4][oxadiazine- 4a(3H) -carboxylate, and its R -
enantiomer, (R) -methyl 7- chloro- 2,5-dihydro- 2-
[[(methoxycarbonyl)[4-
(trifluoromethoxy)phenyl]amino]carbonyl]i ndeno[1,2-
e][1,3,4][oxadiazine -4a(3H) -carboxylate  
3.12 PROPOSAL TO SET MRLS FOR MELOXICAM  
It is proposed that MRL s are  set for meloxicam when used in sheep for the management of 
inflammation and pain to support the GAP .  
The current entry for meloxicam  in Sch edule 1 of the MRL Notice is: 
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Meloxicam  71125 -38-7 Meloxicam  Cattle kidney  
Cattle liver  
Cattle meat  
Milk  
Pig kidney  
Pig liver  
Pig meat  0.035  
0.05  
0.025  
0.015  
0.2  
0.1  
0.01  
 
  
22 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
The revised entry for  meloxicam  in Schedule 1 of the MRL Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Meloxicam  71125 -38-7 Meloxicam  Cattle kidney  
Cattle liver  Cattle meat  
Milk  
Pig kidney  
Pig liver  
Pig meat  
Sheep fat  
Sheep kidney  
Sheep liver  
Sheep meat  
 0.035  
0.05  
0.025  
0.015  
0.2  
0.1  
0.01  
0.01 
0.065  
0.065  
0.01 
3.12.1 Amendment Rationale  
The proposed MRLs represent the expansion of use of a currently registered active 
ingredient. The proposed MRLs will manage the use of meloxicam when administered to 
sheep in the management of inflammation, fever and pain, in accordance with the dose  rates  
and withholdin g periods that are proposed as GAP in New Zealand.  
3.12.2 Chemical Information  
Common name of compound  Meloxicam  
Use of compound  Non-steroidal anti -inflammatory  
Chemical Abstract Services (CAS) Registry number  71125 -38-7 
Type of compound  Oxicam (enolic acid)  
Administration method  Injection  
3.12.3 Good Agricultural Practice  
Meloxicam is proposed for use in the treatment of pain and inflammation in sheep  at a dose 
rate of 1 mg/kg bodyweight. The withholding period applicable to this species is 11 days from 
the last treatment.   
3.12.4 Residue Information 
The residue data for the  target species  support MRLs of 0.01 mg/kg in muscle and fat and 
0.065 mg/kg in kidneys and liver from treated sheep.   These MRLs are proposed to support 
GAP.  
3.12.5 Dietary Risk Assessment  
The ADI of 1.25 µg/kg bw/day or 75 µg/person/day  was considered appropriate for use in the 
assessment and is consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from animals treated according to existing and 
proposed GAP uses, the NEDI  for meloxicam is equivalent to less than 5 % of the ADI. It is 
therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.12.6 Toxicological/Public  Health Assessment  
It has been determined that the use of meloxicam as an anti -inflammatory, anti -pyret ic, and 
analgesic in sheep, when treated according to GAP, is unlikely to pose any health risks from consumption of treated produce.  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 23  
3.12.7 Other International MRLs  
There are currently no international  MRLs for use of meloxicam in sheep. It is noted however 
that the proposed MRLs were determined during a global joint review of the approval of the 
use of meloxicam in sheep, and the same MRLs that are  proposed for promulgation in New 
Zealand will also be proposed for promulgation in Canada. Australia will be promulgating 
MRLs of 0.01 mg/kg for all sheep tissues.  
3.13 PROPOSAL TO SET AN MRL FOR METAMITRON  
It is proposed that an MRL is set for metamitron  to support the GA P use  on apples.  
There is no current entry in Schedule 1  of the MRL Notice for metamitron.  
The proposed entry for metamitron in Schedule 1 of the MRL Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Metamitron  41394 -05-2 Metamitron  Apples  0.01 (*)  
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.13.1 Amendment Rationale  
The proposed MRL represents the expansion of use of a currently registered herbicide active 
ingredient. The proposed MRL will manage the use of metamitron as a plant growth regulator  
on apples  in accordance with the application rates and withholding periods that are propos ed 
as GAP in New Zealand.  
3.13.2 Chemical Information  
Common name of compound  Metamitron  
Use of compound  Plant growth regulator  
Chemical Abstract Services (CAS) Registry number  41394 -05-2 
Type of compound  Triazinones  
Administration method  Spray  
3.13.3 Good Agricultural Practice  
Metamitron is proposed for use as a plant growth regulator on apples at a rate of 25- 37 
gai/100L of water with a minimum interval of five days between applications. The applicable 
withholding period for this use is application up to 30 days after full bloom.  
3.13.4 Residue Information 
The residue data for the crop proposed supports  an MRL of 0.01 mg/kg in apples. This MRL 
is proposed to support GAP.   
3.13.5 Dietary Risk Assessment  
The ADI of 0.03 mg/kg bw/d was considered appropr iate for use in the assessment and is 
consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from crops treated according to the proposed GAP 
use, the NEDI  for metamitron is equivalent to less than 0.05 % of the ADI. It is therefore 
concluded that the chronic dietary exposure is small and the risk is acceptable.  
24 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.13.6 Toxicological/Public Health Assessment  
It has been determined that the use of metamitron as a plant growth regulator in apples, 
when used according to GAP  is very unlikely to pose any health risks from consumption of 
treated produce.  
3.13.7 Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
European Union Apples  
 0.1 
3.14 PROPOSAL TO SET  AN MRL FOR METHOXYFENOZIDE  
It is proposed that an MRL is set for  methoxyfenozide  to support the GAP use on stone fruit.   
The current entry for methoxyfenozide  in Schedule 1 of the MRL Notice  is: 
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Methoxyfenozide  161050 -58-4 Methoxyfenozide  Avocados  
Blueberries  
Kiwifruit  
Nectarines  
Peaches  
Pome fruit  0.1  
0.8  
0.5  
0.2  
0.2  
0.5  
 
 
The revised entry for methoxyfenozide  in Schedule 1  of the MRL Notice  will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Methoxyfenozide  161050 -58-4 Methoxyfenozide  Avocados  
Blueberries  
Kiwifruit  
Pome fruit  
Stone f ruit 0.1  
0.8  
0.5   
0.5  
0.4 
3.14.1 Amendment Rationale  
The proposed MRLs represent the expansion of use of a currently registered active 
ingredient  from approval for the treatment of nectarines and peaches to all stone fruit . The 
proposed MRL will manage the use of  methoxyfenozide  as an insecticide on stone fruit  in 
accordance with the application rates and withholding periods that are proposed as  GAP in 
New Zealand.  
3.14.2 Chemical Information  
Common name of compound  Methoxyfenozide  
Use of compound  Insecticide  
Chemical Abstract Services (CAS) Registry number  161050 -58-4 
Type of compound  Dia-cylhydrazine  
Administration method  Spray  
3.14.3 Good Agricultural Practice  
Methoxyfenozide is propos ed for use as an insecticide on stone fruit at 6 gai/100L water at 
2000L water/ha for a maximum of four applications per season at no less than 14 day 
intervals commencing at petal fall. This is the same use pattern currently approved for 
nectarines and peaches. A 14 day withholding period applies to this use.  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 25  
3.14.4 Residue Information 
The residue data for the crops supports  a methoxyfenozide MRL in stone fruit of 0.4 mg/kg. 
This MRL is proposed to support GAP.  
3.14.5 Dietary Risk Assessment  
The PDE (food) of 0.08 mg/k g bw/d was considered appropriate for use in the assessment and 
is consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from crops treated according to existing and 
proposed GAP uses, the NEDI  for Methoxyfenozide is equivalent to less than 1 % of the 
PDE (food). It is therefore concluded that the chronic dietary exposure is small and the risk is 
acceptable.  
3.14.6 Toxicological/Public Health Assessment  
It has been determined that the use of methoxyfenoz ide as an insecticide for stone fruit, 
when  treated according to GAP, is very unlikely to pose any health risks from consumption of 
treated produce.  
3.14.7 Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
Australia  Plums (including prunes)  
Stone fruits [except plums 
(including prunes)]  0.3 
3 
Codex  Stone fruits  2.0 
European Union Apricots  
Cherries (sweet)  
Peaches  
Plums  
Others  2.0 
2.0 
2.0 
2.0 
2.0 
United States  Apricots  
Cherries, all varieties  
Mangoes  
Nectarines  
Peaches  
Plums, all varieties  3.0 
3.0 
0.6 
3.0 
3.0 
3.0 
 
3.15 PROPOSAL TO AMEND THE MRLS  AND RESIDUE DEFINITION FOR 
PROTHIOCONAZOLE  
It is proposed that an MRL is set for prothioconazole  to support the GAP use on barley , that 
the current MRL for cereal grains is amended to exclude barley as a result, and that  the 
residue definition for prothioconazole is amended to align with that set by Codex.   
The current entry for prothioconazole in Schedule 1  of the MRL Notice  is: 
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Prothioconazole  178928 -70-6 Sum of:  
Prothioconazole  
Prothioconazole- desthio  
Expressed as:  
prothioconazole  Cereal grains  
 0.02 (*)  
 
 
26 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
The revised entry for prothioconazole in Schedule 1  of the MRL Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Prothioconazole  178928 -70-6 Prothioconazole -desthio   Barley  grain  
Cereal grains (except barley grain)  
 0.1 
0.01 (*)  
 
 
 (*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.15.1 Amendment Rationale  
The proposed new MRL has arisen from a review of the current MRL for cereal grain as it 
pertained to barley grain after an application was submitted to revise the approved 
withholding period for barley . The proposed MRL will manage the use of prothioconazole on 
barley as a fungicide and in accordance with the application rates and approved withholding 
periods that are considered GAP in New Zealand.  
In 2008, the JMPR adopted the residue definition ‘prothioconazole- desthio’  for both plant and 
animal products, and for dietary  intake estimation. It is considered appropriate to amend the 
New Zealand residue definition to align with the JMPR definition given that the parent prothioconazole  has not been detected in treated commodities, and both parent and 
metabolite are possibly present at or below the limit of quantification (LOQ) of 0.01mg/kg. 
The residue definitions for international MRLs are listed in section 3.1 5.7. 
To reflect this change of the residue definition, it is also proposed that the MRL for cereal 
grains  (except bar ley grain)  is reduced to the LOQ of the new metabolite at 0.01 (*) mg/kg .   
  
3.15.2 Chemical Information  
Common name of compound  Prothioconazole  
Use of compound  Fungicide  
Chemical Abstract Services (CAS) Registry number  178928 -70-6 
Type of compound  Triazolinthione  
Administration method  Spray  
3.15.3 Good Agricultural Practice  
Prothioconazole is used as a fungicide on barley and other small grain cereals excluding 
maize and sweetcorn. In barley, it is used at an application rate of 150 gai/ha for up to two 
applications at 3- 4 week intervals. The withholding period is 56 days.  
3.15.4 Residue Information 
The residue data for t he crop  supports  a prothioconazole MRL of 0.1 mg/kg on  barley.  This 
MRL  is proposed to support GAP.  
3.15.5 Dietary Risk Assessment  
The ADI of 0.008 mg/kg bw/d was considered appropriate for use in the assessment and is 
consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from crops treated according to existing and proposed GAP uses, the NEDI  for prothioconazole is equivalent to less than 1% of the ADI. It 
is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.15.6 Toxicological/Public Health Assessment  
It has been determined that the use of prothioconazole as a fu ngicide on barley, when used 
according to GAP, is unlikely to pose a ny health risks from consumption of treated produce.  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 27  
3.15.7 Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  Residue Definition  
Australia  Cereal bran, unprocessed  
Cereal grains  0.5 
0.3 Sum of prothioconazole and 
prothioconazole desthio (2- (1-
chlorocyclopropyl) -1-(2-
chlorophenyl) -3-(1H-1,2,4- triazol -1-
yl)-propan- 2-ol), expressed as 
prothioconazole  
Codex  Barley  0.2 Prothioconazole -desthio  
United States  Barley grain  0.35 Prothioconazole and its metabolite 
prothioconazole- desthio, or alpha- (1-
chlorocyclopropyl) -alpha- [(2-
chlorophenyl)methyl] -1H-1,2,4 
triazole- 1-ethanol, calculated as 
parent in or on the commodity.  
3.16 PROPOSAL TO AMEND THE MRLS  FOR SPIROTETRAMAT  
It is proposed that an MRL is set for s pirotetramat  to support the GAP use on apples , and 
that the current MRL for pome fruits is amended to exclude apples as a result .  
The current entry for spirotetramat  in Sch edule 1 of the MRL Notice  is: 
Compound 
Common Name  CAS#  Residue to which the maximum 
residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Spirotetramat  203313 -25-1 Sum of: Spirotetramat and its enol 
metabolite Expressed as: 
Spirotetramat  
 Blueberries  
Citrus  
Grapes  
Kiwifruit  
Pome fruits  
Potatoes  
Tomatoes  0.7  
1 
0.02(*)  
0.1  
0.02(*)  
0.5  
0.3  
 
The revised entry for spirotetramat in Schedule 1  of the MRL Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food  Maximum Permitted 
Residue Level (mg/kg)  
Spirotetramat  203313 -25-1 Sum of: Spirotetramat and its enol 
metabolite Expressed as: 
Spirotetramat  
 Apples  
Blueberries  
Citrus  
Grapes  
Kiwifruit  
Pome fruits (except apples)  
Potatoes  
Tomatoes  0.2 
0.7  
1 
0.02(*)  
0.1  
0.02(*)  
0.5  
0.3  
 
 (*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
 
3.16.1 Amendment Rationale  
The proposed MRLs represent the expansion of use of a currently registered active 
ingredient. The proposed MRLs will manage the use of spirotetramat  as an insecticide on 
apples  at the application rates and withholding periods that are proposed as GAP in New 
Zealand.  
  
28 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.16.2 Chemical Information  
Common name of compound  Spirotetramat  
Use of compound  Insecticide  
Chemical Abstract Services (CAS) Registry number  203313 -25-1 
Type of compound  Ketoenols  
Administration method  Spray  
3.16.3 Good Agricultural Practice  
Spirotetramat is proposed for use as an insecticide on apples for the control of apple 
leafcurling  midge and armoured scales at a dose rate of 4.8 gai/100 litres of water and a 
minimum application rate of 960mL water/ha. Spirotetramat is applied to coincide with 
periods of peak midge egg laying, and at other points between mid- November and early 
February to control subsequent generations. Similar timing is used to control armoured 
scales. The withholding period for apples is 35 days.  
3.16.4 Residue Information 
The residue data for spirotetramat use on apples supports the MRL of 0.2 mg/kg. This MRL 
is proposed to support GAP.   
3.16.5 Dietary Risk Assessment  
The PDE (food) of 0.09 mg/kg bw/day was considered appropriate for use in the assessment 
and is consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from crops treated accor ding to existing and 
proposed GAP uses, the NEDI  for spirotetramat is equivalent to less than 5 % of the 
PDE (food). It is therefore concluded that the chronic dietary exposure is small and the risk is 
acceptable.  
3.16.6 Toxicological/Public Health Assessment  
It has been determined that the use of s pirotetramat  as an insecticide on apples, when used 
according to GAP, is very unlikely to pose any health risks from consumption of treated produce.  
3.16.7 Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
Australia  Pome fruits  0.5 
Codex  Pome fruits  0.7 
European Union Apples  1.0 
United States  Apples  0.7 
3.17 PROPOSAL TO SET MRLS FOR THIAMETHOXAM  
It is proposed that MRLs are set fo r thiamethoxam  to support the GAP use on bulb onions 
and green onions.   
  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 29  
The current entry for  thiamethoxam  in Sched ule 1 of the MRL  Notice  is: 
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Thiamethoxam  153719 -23-4 Thiamethoxam  
 Kiwifruit  
Leafy vegetables  
Maize  
Pome fruits  
Potatoes  
Sweetcorn  
 1 
5  
0.02(*)  
0.1  
0.02(*)  
0.02(*)  
 
The revised entry for thiamethoxam  in Schedule 1  of the MRL Notice  will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Thiamethoxam  153719 -23-4 Thiamethoxam  
 Bulb onions  
Green onions  
Kiwifruit  
Leafy vegetables  
Maize  
Pome fruits  
Potatoes  
Sweetcorn  
 0.01(*) 
0.2 
1 
5  
0.02(*)  
0.1  
0.02(*)  
0.02(*)  
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
3.17.1 Amendment Rationale  
The proposed MRLs represent the expansion of use of a currently registered active 
ingredient. The proposed MRLs will manage the use of thiamethoxam  as an insecticide on 
bulb and green onions  in accordance with the application rates and withholding periods that 
are proposed as GAP in New Zealand.  
3.17.2 Chemical Information  
Common name of compound  Thiamethoxam  
Use of compound  Insecticide  
Chemical Abstract Services (CAS) Registry number  153719 -23-4 
Type of compound  Neonicotinoid  
Administration method  Spray  
3.17.3 Good Agricultural Practice  
Thiamethoxam is proposed for use as an insecticide on bulb and green onions to be applied 
at a rate of 54gai/ha to treat infestation with thrips ( Thrips tabaci ), with the first application 
indicated by reaching the threshold level for the insect. Treatment is repeated at seven day intervals as a cluster of three or four sequential applications, with a maximum of four 
applica tions per year. The withholding period is 14 days.  
3.17.4 Residue Information 
The residue data for the crops supports thiamethoxam MRLs at 0.01(*) mg/kg for bulb onions  
and 0.2 mg/kg for green onions. These MRLs are proposed to support GAP.  
3.17.5 Dietary Risk Assessment  
The PDE (food) of 0.016 mg/kg bw/d was considered appropriate for use in the assessment and 
is consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from crops treated according to existing and 
proposed GAP uses, t he NEDI  for thiamethoxam is equivalent to less than 2.1% of the 
30 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
PDE (food). It is therefore concluded that the chronic dietary exposure is small and the risk is 
acceptable.  
3.17.6 Toxicological/Public Health Assessment  
It has been determined that the use of thiamethoxam  as an insecticide for onions, when 
treated according to GAP, is very unlikely to pose any health risks from consumption of 
treated produce.  
3.17.7 Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
European Union Onions  
Spring onions/green onions 
and Welsh onions  0.1 
0.05 
United States  Onion, bulb  0.03 
 
3.18 PROPOSAL TO SET MRL S FOR  TRIFLOXYSTROBIN  
It is p roposed that MRL s are  set for residues in animal commodities when  trifloxystrobin is  
used on fodder  beets (including sugar beets ) to support the GAP . 
The current entry for trifloxystrobin in Sc hedule 1 of the Food Notice is:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Trifloxystrobin  141517 -21-7 Sum of:  
trifloxystrobin and its free acid 
metabolite.  
Expressed as:  
trifloxystrobin equivalents  Cereal grains  
Citrus fruits (except Clementine and Satsuma mandarins)  
Cucurbits (inedible peel)  
Grapes  
Kiwifruit  
Mandarins (Clementine and Satsuma)  
Pome fruit s  
Stone fruits (except cherries)  0.05(*)  
0.3  
  
0.02(*)  
0.02(*)  
0.02(*)  
0.02(*)  
 
0.02(*)  
0.02(*)  
 
The revised entry for trifloxystrobin  in Schedule1  of the MRL Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Trifloxystrobin  141517 -21-7 Sum of:  
trifloxystrobin and its free acid 
metabolite.  
Expressed as:  
trifloxystrobin equivalents  Cereal grains  
Citrus fruits (except Clementine and Satsuma 
mandarins)  
Cucurbits (inedible peel)  
Fat (mammalian)  
Grapes  
Kidney (mammalian)  
Kiwifruit  
Liver (mammalian)  
Meat (mammalian)  
Mandarins (Clementine and 
Satsuma)  
Pome fruits  
Stone fruits (except cherries)  0.05(*)  
0.3  
 
 
0.02(*)  
0.05 
0.02(*)  
0.04 
0.02(*)  
0.05 
0.05 
0.02(*)  
 0.02(*)  
0.02(*)  
 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 31  
3.18.1.1  Amendment Rationale  
The proposed MRL is required to support  the additional use of a currently registered active  
ingredient on fodder and sugar beets. The proposed MRL will manage the use of 
trifloxystrobin  on fodder and sugar beets in accordance with the application rates and 
withholding periods  that are proposed as  GAP in New Zealand. This is because fodder and 
sugar beets are used only as animal feed in New Zealand, and therefore the proposed MRLs 
for commodities from animals that consume the crops will be reflective of GAP.  
3.18.2 Chemical Information  
Common name of compound  trifloxystrobin  
Use of compound  Fungicide  
Chemical Abstract Services (CAS) Registry number  141517 -21-7 
Type of compound  Oximino acetate - Quinone outside Inhibitor  
Administration method  Spray  
3.18.2.1 Good Agricultural Practice  
The proposed use of trifloxystrobin is to control is to control foliar fungal diseases in fodder and sugar beets using 2 foliar sprays of 131gai/ha, with a 42 day WHP, in combination with 
cyproconazole.  In N ew Zealand,  fodder and sugar beets are grown as animal feeds, for 
which MRLs are not required.  
3.18.2.2  Residue Information  
The residue data for beets and sugar beets supports trifloxystrobin MRLs in animal 
commodities at 0.05 mg/kg in f at (mammalian) , 0.04 mg/kg in kidney (mammalian) , 0.05 
mg/kg in liver , and 0.05 mg/kg in meat (mammalian) . These MRLs are proposed to support 
GAP.  
3.18.2.3  Dietary Risk Assessment  
The ADI of 0.04 mg/kg bw/d was considered appropriate for use in the assessment and is 
consistent with overseas reputable regulatory bodies.  
Based on the resi dues expected in food from crops treated according to existing and 
proposed GAP uses, the NEDI for trifloxystrobin is equi valent to less than 4 % of the ADI . It 
is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.18.2.4  Toxicological/Public Health Assessment  
It has been determined that the use of trifloxystrobin in fodder and sugar beets, according to 
the GAP specified above, is very unlikely to pose any health risks from consumption of 
treated produce.  
  
  
32 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.18.2.5 Other International MRLs  
Country  Food  Maximum Residue Limit 
(mg/kg)  
Australia  Edible offal (mammalian)  
Meat (mammalian)  
Milks  0.05 
0.05 
0.02 
Codex  Kidney of cattle, goats, pigs 
and sheep 
Liver of cattle, goats, pigs, 
and sheep 
Meat (from mammals other 
than marine mammals)  
Milks  0.04 
 
0.05 
 
0.05 
 
0.02 
European Union  Swine (all tissues)  
Muscle (except swine)  
Fat (except swine)  
Liver (except swine)  
Kidney (except swine)  
Edible offals other than liver 
and kidney (except swine) 
Other tissues (except swine)  
Milks  0.04 
0.04 
0.06 
0.07 
0.04 
0.07 
 
0.02 
0.02 
United States  By products (except swine)  
Fat (except swine)  
Kidney (except swine)  
Liver (except swine)  
Meat (except swine)  
Swine (all tissues)  0.1 
0.1 
0.1 
0.1 
0.1 
0.05 
3.19 PROPOSAL TO SET MRLS FOR TRINEXAPAC- ETHYL  AND CORRECT 
ERRORS IN ITS NOTICE ENTRY  
It is proposed that an amended MRL is set for trinexapac -ethyl to support the GAP use on 
certain small grain cereal  crops, and errors in the chemical name and CAS number be 
corrected.  
The current entr y for trinexapac -ethyl in Schedule 1 of the Food Notice is:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Trinexpac -ethyl  104273 -73-6 4-(cyclopropyl -α-hydroxy -methylene) -
3,5-dioxo- cyclohexanecarboxylic acid  Cereal grains  0.05(*)  
The revised  entry for trinexapac -ethyl in Schedule 1  of the Food Notice will read:  
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Trinexapac -ethyl  95266 -40-3 Trinexapac (acid)  Cereal grains, except maize 
and sweet  corns  0.2 
(*) indicates that the maximum residue limit has been set at or about the limit of analytical quantification.  
 
3.19.1.1  Amendment Rationale  
The proposed MRL represents the extension of existing uses of a currently registered active 
ingredient to a new formulation type. The proposed MRL will manage the use of the plant 
growth regulator trinexapac -ethyl on cereals , in accorda nce with the application rates and 
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 33  
withholding periods that are proposed as GAP in New Zealand. The typographical errors to 
be corrected are the spelling of the common name and the CAS number of the compound.  
3.19.1.2  Chemical Information  
Common name of compound  Trinexapac -ethyl  
Use of compound  Plant growth regulator  
Chemical Abstract Services (CAS) Registry number  95266 -40-3 
Type of compound  Cyclohexanecarboxylate derivative  (or 
‘unclassified’)  
Administration method  Spray  
3.19.1.3  Good Agricultural Practice  
Trinexapac -ethyl is currently used as a plant growth regulator on certain small grain cereals 
at 100 gai/ha to prevent lodging,  with a single application at BBCH 31 (1st node visible) . Use 
of trinexapac -ethyl attracts a  42 day withholding period for forage. The use pattern will 
remain the same, but information supplied in support of a new formulation type (dispersible 
concentrate) supports a higher MRL than the current MRL of 0.05 mg/kg.  
3.19.1.4  Residue Information  
The residue data for the crop supports an MRL of 0.2 mg/kg for trinexapac -ethyl in cereal 
grains  (except maize and sweet  corns). The MRL is proposed to support GAP.  
3.19.1.5  Dietary Risk Assessment  
The ADI of 0.3 mg/kg bw/d was considered appropriate for use in the assessment and is 
consistent with overseas repu table regulatory bodies.  
Based on the residues expected in food from crops treated according to existing and 
proposed GAP uses, the NEDI  for trinexapac -ethyl is equivalent to less than 5 % of the ADI. 
It is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.19.1.6  Toxicological/Public Health Assessment  
It has been determined that the use of trinexapac -ethyl in cereal and ryegrass, according to 
the GAP specified above, is very unlikely to pose any health risks from consumption of 
treated produce.  
3.19.1.7  Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
Australia  Cereal grains  0.20 
Codex  Barley grain  
Oat grain  
Wheat grain  3.00 
3.00 
3.00 
European Union  Barley grain  
Corn grain  
Oat grain  
Rye grain  
Wheat grain  3.00 
0.02 
3.00 
0.50 
3.00 
China  Wheat grain  0.05 proposed  
Japan  Barley grain  
Oat grain  
Rye grain  
Wheat grain  0.60 
0.60 
0.60 
0.60 
United States  Barley grain  
Oat grain  
Rye grain  
Wheat grain  2.00 
4.00 
4.00 
4.00 
34 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
3.20 PROPOSAL TO SET MRLS FOR TULATHROMYCIN  
It is proposed that an MRL is set for tulathromycin  when used in sheep  to support the GAP .  
The current entry for tulathromycin in Sch edule 1  of the MRL Notice  is: 
Compound 
Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Tulathromycin  217500 -96-4 (2R,3S,4R,5R,8R,10R,11R,12S, 
13S,14R) -2-ethyl -3,4,10,13-
tetrahydroxy -3,5,8,10,12,14-
hexamethyl -11-[[3,4,6trideoxy -
3(dimethylamino) -β-Dxylo -
hexopyranosyl]oxy] -1-oxa- 6-
azacyclopentadecan- 15-one 
expressed as tulathromycin 
equivalents  
 Cattle meat  
Cattle fat  
Cattle kidney  
Cattle liver  Pig meat  Pig fat/skin  
Pig kidney  
Pig liver  0.1  
0.1  
3 
3  
0.5  
0.3  
3 
2  
 
The revised  entry for  tulathromycin in Sc hedule 1  of the Food Notice will read:  
Compound Common Name  CAS#  Residue to which the maximum residue limit applies  Food Maximum Permitted 
Residue Level (mg/kg)  
Tulathromycin  217500 -96-4 (2R,3S,4R,5R,8R,10R,11R,12S, 
13S,14R) -2-ethyl -3,4,10,13-
tetrahydroxy -3,5,8,10,12,14-
hexamethyl -11-[[3,4,6trideoxy -
3(dimethylamino) -β-Dxylo -
hexopyranosyl]oxy] -1-oxa- 6-
azacyclopentadecan- 15-one 
expressed as tulathromycin 
equivalents  
 Cattle meat  
Cattle fat  
Cattle kidney  
Cattle liver  
Pig meat  
Pig fat/skin  Pig kidney  
Pig liver  
Sheep meat  
Sheep fat  
Sheep liver  
Sheep kidney  0.1  
0.1  
3 
3  
0.5  
0.3  
3 
2 
0.45 
0.25 
5.4 
1.8  
3.20.1 Amendment Rationale  
The proposed MRLs represent the expansion of use of a currently registered active 
ingredient. The proposed MRLs will manage the use of the antibiotic tulathromycin  in sheep 
when administered in accordance with the dose rates and withholding periods that are 
proposed as GAP in New Zealand.  
3.20.2 Chemical Information  
Common name of compound  Tulathromycin  
Use of compound  Antibiotic  
Chemical Abstract Services (CAS) Registry number  217500 -96-4 
Type of compound  Macrolide antimicrobial  
Administration method  Injection  
3.20.3 Good Agricultural Practice  
Tulathromycin is proposed for use in sheep for the treatment of footrot at a dose rate of 2.5 
mg/kg by a single intramuscular injection. Use of tulathromycin in sheep will attract a 
withholding period of 21 days.   
3.20.4 Residue Information 
The residue data for the  target species sheep supports  tulathromycin MRLs of  0.45 mg/kg for 
sheep meat, 0.25 mg/kg for sheep fat, 5.4 mg/kg for sheep liver, and 1.8 mg/kg for sheep kidney.  These MRLs are proposed to support GAP.  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 35  
3.20.5 Dietary Risk Assessment  
The ADI of 0.011 mg/kg bw/d was considered appropriate for use in the assessment and is 
consistent with overseas reputable regulatory bodies.  
Based on the residues expected in food from animals treated according to existing and 
proposed GAP uses, the NEDI  for tulathromycin is equivalent to less than 2 % of the ADI. It 
is therefore concluded that the chronic dietary exposure is small and the risk is acceptable.  
3.20.6 Toxicological/Public Healt h Assessment  
It has been determined that the administration of tulathromycin to sheep for the treatment of 
footrot, when used according to GAP, is unlikely to pose health risks from consumption of 
treated produce.  
3.20.7 Other International MRLs  
Country  Food Maximum Residue Limit 
(mg/kg)  
European Union  Sheep muscle  
Sheep fat  
Sheep liver  
Sheep kidney  0.45 
0.25 
5.4 
1.8 
 
3.21 PROPOSAL TO EXCEPT M IXTURES OF CHITO -OLIGOSACCHARIDES AND 
OLIGOGALACTURONANS F ROM COMPLIANCE WITH AN MRL  
It is proposed that an exception from compliance with an MRL is established for the use of 
mixtures of chito- oligosaccharides and oligogalacturonans when used in horticulture. Chito-
oligosaccharides and oligogalacturonans are derived from chitosan and pect in, and 
depolymerise in the environment to glucosamine and galacturonic acid monomers. The 
monomers will further mineralise into C02, CH4, and H2, with no detectable residues of toxicological concern. In addition, chitosan is already listed in Schedule 2 w ith no condition of 
use.  
There is currently no entry in Schedule 2 for mixtures of chito -oligosaccharides and 
oligogalacturonans.   
The proposed entry in Schedule 2 will read:  
Substance CAS#  Condition  
Mixtures of chito -oligosaccharides 
and oligogalacturonans  n/a No condition of use applies  
3.22 PROPOSAL TO  EXCEPT OZONE FROM CO MPLIANCE WITH AN MRL   
It is proposed that an exception from compliance with an MRL is established for the use of 
ozone in kiwifruit when used as a biocide and fungicide. The use of ozone in this manner 
does not result in detectable residues in treated produce, and degradation products consist of oxygen and water.  
In addition, FSANZ Standard 1.3.3 – Processing Aids allows for the direct contact of ozone 
with food, further s upporting the lack of any residue or food safety risks associated with its 
use.  
There is currently no entry in Schedule 2 for ozone.  
 
36 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
The proposed entry in Schedule 2 will read:  
Substance CAS#  Condition  
Ozone  10028 -15-6 When  used as an agricultural chemical  
 
3.23 PROPOSAL TO EXCEPT P OLYOXIN D ZINC SALT FROM COMPLIANCE WITH 
AN MRL  
It is proposed that an exception from compliance with an MRL is established for the use of 
polyoxin D zinc salt  when used as a fungicide on apples and grapes . Polyoxin D zinc salt is 
highly water soluble, resulting in low plant surface residence time and rapid degradation once 
washed off crop surfaces. The toxicity of the compound has also been determined to be 
negligible, and there are no dietary intake  concerns.  
In addition, polyoxin D zinc salt has been ex empted from compliance with an MRL in the 
United States.  
There is currently no entry in Schedule 2 for polyoxin D zinc salt .  
The proposed entry in Schedule 2 will read:  
Substance CAS#  Condition  
Polyoxin D zinc salt  10028 -15-6 When used as a n agricultural chemical  
 
3.24 PROPOSAL TO EXCEPT P ROHYDROJASMON FROM C OMPLIANCE WITH AN 
MRL  
It is proposed that an exception from compliance with an MRL is established for the use of prohydrojasmon  when used as a pre-harvest colour enhancer for red varieties of apples. 
Prohydrojasmon is a natural derivative of jasmonic acid, and has been demonstrated to have low toxicity and to be of no significant dietary intake concern. Environmental degradation is 
rapid, with th e compound being hydrolysed and then decomposed to C O
2.  
The default MRL of 0.01 mg/kg applies to prohydrojasmon in the European Union, and a Japanese MRL of 0.05 mg/kg applies for its use in apples and grapes. It is considered that, 
due to the use pattern proposed as GAP, the lack of any toxicity concerns for this use, and 
the degradation profile of the compound, exception from an MRL will not preclude 
compliance to overseas limits.
 
There is currently no entry in Schedule 2 for prohydrojasmon.  
The proposed entry in Schedule 2 will read:  
Substance CAS#  Condition  
Prohydrojasmon  158474 -72-7 When used as a colour enhancer in 
apples  
 
3.25 PROPOSAL TO AMEND TH E SCHEDULE 2 SUBSTANCE DESCRIPTION FOR 
‘MICROBIAL PESTICIDE ORGANISMS ’ 
It is proposed that the substance description for the exception for ‘Microbial Pesticide Organisms’ is amended to align with revised terminology associated with this type of 
substance.  
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 37  
As part of the drafting  of the information requirements document Micro bial Agricultural 
Chemicals Information Requirements for Registration of Microbial Organisms used as 
Agricultural Chemicals , the term ‘Microbial Active Ingredients’ was developed  to be more in 
line with the industry understanding of these substances and was better repres entative of 
their status under the A gricultural Compounds and Veterinary Medicines (A CVM ) Act 1997. 
The change to the exception  is proposed to ensure all references to these substances use 
the same terminology.  
 
The current entry in Schedule 2 of the MRL Notice is:  
Substance  CAS#  Condition  
Microbial Pesticide Organisms 
(consisting of either: whole organism, 
organism organelles, organism spores 
or occlusion bodies and genetically modified serotypes and strains)                n/a Except where otherwise stated in this 
standard Where an organism is registered under the Agricultural Compounds and Veterinary Medicines Act 1997 and 
intended for use as a plant compound, 
and; Where organism leaves no 
quantifiable residue of toxins or 
metabolites exceeding that of expected 
background levels, and; Where organism has been determined to be non-
pathogenic or non -toxic to humans  
 
 
The revised entry in Schedule 2 of the MRL Notice will read:  
Substance CAS#  Condition  
Microbial Active Ingredients  
(any organism classified as a 
microorganism including but not limited 
to bacteria, protozoa, fungi and viruses,  or the genetically modified or 
naturally occurring mutants of any of these microorganisms . This  includes 
whole organisms (either viable or non-
viable), organism organelles, organism 
metabolites, organism spores , or 
occlusion bodies .)                n/a Except where otherwise stated in this 
Notice: : 
Where a Microbial Active Ingredient  is in a 
product  registered under the Agricultural 
Compounds and Veterinary Medicines Act 
1997 and is intended for use as an 
agricultural chemical , and;  
Where a Microbial Active Ingredient  
leaves no quantifiable residue of toxins or metabolites exceeding that of expected  
background levels, and;  
Where a Microbial Active Ingredient  has 
been determined to be non- pathogenic or 
non-toxic to humans ; 
But does not include metabolites produced by a micro organism that have 
been isolated as an independent active 
ingredient.  
3.26 PROPO SAL TO AMEND THE EXCEPT ION FOR ‘ BISMUTH AND ITS SALTS ’ TO 
INCLUDE USE AS A N INTRAMAMMARY  TEAT SEALANT   
It is proposed that the current exception from compliance with an MRL for ‘bismuth and its 
salts’ is extended to include the use of bismuth salts (bismuth subnitrate) as a teat sealant in 
dairy cattle. The presence of bismuth in milk, colostrum, and dairy products is not a concern 
for fo od safety as the oral bioavailability and absorption of bismuth is negligible. Trade risks 
posed by its presence, specifically related to dairy and dairy product quality, are outside the 
scope of GAP and can be sufficiently managed by other controls under the Animal Products 
Act. In addition, the use of bismuth subnitrate as a teat sealant has been exempted from 
compliance to an MRL in Australia, the European Union, and China.  
 
  
38 • Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  Ministry for Primary Industries   
The current entry in Schedule 3 of the MRL Notice is:  
Substance CAS#  Condition  
Bismuth and its salts  7440 -69-9 Oral use as a gastrointestinal antacid 
agent  
 
 
 
The revised entry in Schedule 3 of the MRL Notice will read:   
Substance CAS#  Condition  
Bismuth and its salts  7440 -69-9 Used as an oral gastrointestinal antacid 
agent or as an intramammary teat sealant  
 
 
Ministry for Primary Industries   Proposed Amendment  to the Maximum Residue Levels for  Agricultural Compounds Food Notice 2016  • 39