Proposals to Amend the  New 
Zealand ( Maximum Residue 
Levels for Agricultural 
Compounds ) Food Notice   
 
New Z ealand  Food Safety Discussion  Paper  No: 2022/0x 
 
 
 
Prepared for public consultation  
By New Zealand Food Safety  
 
 
ISBN No: xxx-x-xx-xxxxxx -x (online)  
ISSN No: xxxx-xxxx (online)  
 
 
 
 
1 December  2022 
 
 
Disclaimer  
 
While every effort has been made to ensure the information in this publication is accurate, the  
Ministry for Primary Industries  does not accept any responsibility or liability for error of fact, omission, 
interpretation or opinion that may be present, nor  for the consequences of any decisions based on this 
information.  
 
This publication is available on the Ministry for Primary Industries  website at  
http://www.mpi.govt.nz/news -and-resources/publications/   
 
 
© Crown Copyright - Ministry for Primary Industries   
New Zealand  Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice • 1 Contents  Page 
 
1 Request for submissions  2 
2 Introduction  3 
2.1 Establishing Maximum Residue Levels  3 
2.2 Summary of Proposed Amendments  7 
3 Proposals  8 
3.1 Proposal to amend the MRLs for Triclabendazole  8 
3.2 Proposal to delete th e Notice entry for Pirlimycin  Error! Bookmark not defined.  
3.3 Proposal to set an entry for S -Abscisic acid in Schedule 2  9 
3.4 Proposal to set an entry for Alfafa extract in Schedule 3  10 
 
   
2 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  1 Request for s ubmissions  
New Zealand Food Safety  invites public comment on this discussion document, which 
outlines proposals to amend the New Zealand (Maximum Residue Levels for Agricul tural 
Compounds) Food Notice  (Notice) . 
 
For each compound  you are commenting on, please clearly answer the following questions.  
 
Do you agree or disagree with the proposed addition, amendment or deletion?  
 
For compounds listed in Schedule 1 , do you agree or disagree with the proposed 
MRL (s)?  
 
For compounds listed in Schedule s 2 or 3, do you agree or disagree with the listing or 
the conditions?  
 
Please feel free to include with your answers above, any supporting discussion, data or 
examples that you feel is relevant.  
 
Submissions close at 5 pm on  XX XXX 2023. Your c omments should be sent to:  
MRL Amendments  
New Zealand Food Safety  
Ministry for Primary Industries  
PO Box 2526  
Wellington 6140  
Email: MaximumResidueLevels@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 infor mation are 
outlined in the OIA.  Submitters may wish to indicate any grounds for withholding information 
contained in their submission.  Reasons for withholding information could include that 
information is commercially sensitive or that the submitters wis h personal information such 
as names or contact details to be withheld.  The Ministry for Primary Industries  will take such 
indications into account when determining whether  to release information.  Any decision to 
withhold information requested under the OIA may be reviewed by the Ombudsman.  
   
New Zealand  Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice • 3 2 Introduction  
Agricultural compounds are natural or synthetic substances used in the  direct  management 
of plants and animals , and include all agricultural chemicals (e.g. fungicides, herbicides,  and 
insecticides) , veterinary medicines, and other compounds used to maintain plant and animal 
health and productivity.  Growers and farmers use these agricultural compounds to manage 
disease in animals and crops, protect the food supply, and maximise the quantity and quality 
of the food they grow.  
Agricultural compound  use can leave residues in the food harvested from treated crops and 
animals. To manage these residues, it is important to ensure that only the appropriate 
amount of an agricultural compound is used to achieve its intended purpose  and leave the 
smallest amount of residue practicable without compromising the compound’s efficacy. The 
set of principles and methods used to manage that balance is known as good agricultural 
practice (GAP ). These pri nciples apply to  the production of safe and good quality 
horticultural , agricultural,  and animal products.  Maximum residue levels (MRLs) are then 
established for each compound/food commodity combination by evaluating the residues left 
in food  commoditie s as a result of the highest authorised GAP use  (the ‘critical GAP’) .  This 
value is compared against the health -based guidance value  before  a maximum level of 
agricultural compound residue allowable in that food commodity  is set . How the MRLs are 
determined, and how they are used once they have been set, are explained in more detail 
below.   
MRLs are the maximum legal levels for residues of agricultural compounds permitted in food 
for sale in New Zealand. They are established bas ed on domestic uses of a particular 
compound, and are used to monitor GAP compliance in New Zealand while ensuring food 
safety. Because they are based on New Zealand authorised uses according to domestic 
GAP, MRLs may differ from those established overseas  for a similar use because their GAP 
may be different.  However, as noted below, imported food can also comply with Codex 
MRLs.  
To meet New Zealand’s obligations under the Agreement on the Application of Sanitary and 
Phytosanitary Measures (the SPS Agreeme nt), proposals for new and amended MRLs are 
notified to the World Trade Organization. Any country may choose to comment if they believe 
a proposed MRL represents a barrier to their trade.  
2.1 ESTABLISHING MAXIMUM RESIDUE LEVELS  
2.1.1 Regulatory Structure  
MRLs  are th e maximum legal levels of agricultural compound residues  permitted in food for 
sale in New Zealand  and are set out in the Notice. Th e Notice is updated up to four times a 
year to reflect changes in the use of agricultural compounds in the production of foo d. The 
Notice is available from the Ministry for Primary Industries (MPI) New Zealand Food Safety 
website at: https://www.mpi.govt.nz/dmsdocument/19550 -maximum -residue -levels -for-
agricultural -compounds .  
New Zealand Food Safety administers the Notice, with the final decision on any changes to 
the Notice resting with the Director -General of MPI. The Notice is issued under section 405 
of the Food Act 2014. When setting or amending MRLs, the Director -General must follow, as 
far as p racticable, international best practice on dietary intake assessment and setting of 
maximum residue  levels.  The requirements for the content of the Notice are set out in Part 6 
of the Food Regulations 2015  (the Food Regulations) , allowing for the setting  of MRLs for 
agricultural compounds as well as specifying compounds to which no MRL applies .   
4 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  In addition to establishing the requirements for domestically produced foods, Part 6 of the 
Food Regulations  also outlines the residue level compliance requirements for imported 
foods. Regulation  144 states that food must not contain residues of agricultural compounds  
unless the residue level  does not exceed : 
- the MRLs specified for that food in a notice set under  the Food Act 2014 
(regulation  144(1)(a)); or  
- the default MRL of 0.1 mg/kg ( regulation  144(1)(c)); or  
- for imported food, 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) ( regulation  144(1)(d)).  
These provisions  allow for New Zealand Food Safety to set MRLs for impor ted food 
commodities when such levels are required. As imported food commodities can comply with 
either a Codex MRL or a MRL established in the Notice, New Zealand’s obligations under the 
SPS Agreement are met.  
On the whole, the  Food  Regulations allow for the management of residues in all foods 
consumed in New Zealand.  
2.1.2 Determining Maximum Residue Levels  
The first step in determining MRLs for an agricultural compound is establishing GAP for the 
use of the compound in the target speci es or crop. New Zealand Food Safety establishes 
GAP by evaluating public health, crop safety, animal health and safety, occupational , and 
environmental safety considerations for the range of treatments and use patterns  approved 
and proposed for each compou nd. Once GAP has been established for an agricultural 
compound, the residues resulting from the highest authorised dose or application rate  and 
use pattern , which is likely to give rise to  the highest residues  (the ‘critical GAP’ ) is then used 
to determine  the MRLs in food commodities from  treated  crops  and animals.   
Although the primary function of MRLs is to ensure conformance with established New 
Zealand GAP, the MRLs also play a role in managing dietary exposure and risks to trade in 
food commodities. T o ensure the MRLs w ill effectively manage residues related to those 
risks, a national estimated daily intake or NEDI calculation is conducted to evaluate 
consumption risk  and a  review of all international MRLs for the compound/commodity 
combinations being considered is completed to evaluate trade risk. If it is found that the MRL 
being considered may pose a food safety or trade risk,  the proposed MRL is not progressed.   
Where it  has been determined that MRLs can be set, those MRLs are proposed for inclusion 
in the Notice  for approved or proposed agricultural compound uses . For veterinary 
medicines, MRLs may be proposed for animal products from a specific species ( e.g., cattle, 
chicken) or a species group ( e.g., mammalian, poultry) depending on the residue and 
metabolism profile of the agricultural compound being considered. Similarly,  for agricultural 
chemicals, an MRL may be set for an individual crop or crop product ( e.g., avoca dos, wheat 
grains) or for a crop grouping ( e.g., pome fruits). When it has been determined that assigning 
an MRL to a crop grouping is appropriate, the grouping used aligns with the Codex 
classifications of foods and animal feeds.  
For a gricultural chemical s used on a crop from which both food and animal feed commodities 
are derived, MRLs are proposed for both the food commodities intended for human 
consumption  from the treated crop , and animal commodities for th e species or species group  
to which the feed commodity is fed.  If the compound for which the MRLs are set is also used 
as a veterinary medicine, all approved veterinary and agricultural chemical uses are  
New Zealand  Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice • 5 considered when setting the animal commodity MRLs.  If an agricultural chemical is  used on 
a crop from which only animal feed is harvested (e.g., pasture, fodder crops) , only animal 
commodity MRLs will be proposed.   
2.1.3 Estimat ing Chronic Dietary Exposure    
National estimated daily intake  
The objective of the  estimated chronic dietary exposure  is to determine whether residues in 
food commodities will pose an unacceptable risk to consumers as a result of the authorised 
use of an agricultural compound according to established GAP. This exposure is estimated 
by calculating the national estimated d aily intake  (NEDI ) in accordance with Guidelines for 
predicting dietary intake of pesticide residues (revised) [World Health Organization, 1997] . 
The N EDI calculation  uses  the total residues in food derived from all New Zealand authorised 
uses of an agricultura l compound , including all toxicologically significant residues,  and 
regional d ietary consumption data derived from the 1997 National Nutritional Survey for 
adults and the 1995 National Nutrition Survey of Australia for children . The calculated NEDI 
is then  compared with the health based guidance value (HBGV)  associated with the 
compound ; if the total residues derived from all uses of the agricultural compound is 
estimated to be less than the HBGV, the dietary exposure is unlikely to pose a health risk to 
consumers.   
Health Based Guidance Values  
The HBGV used in determining the estimated dietary exposure may be either a Potential 
Daily Exposure (food) (PDE (food)) or an Acceptable Daily Intake (ADI). The ADI and PDE (food) 
are largely equivalent as they are determined using the same set of toxicology data and 
through a very similar scientific proces s. Both values are reported as milligrams of compound 
per kilogram bodyweight per day (mg/kg bw/d).  
A PDE (food) is a value determined by a toxicological evaluation by the New Zealand 
Environmental Protection Authority ( NZ EPA) as part of its responsibility for managing public 
health under the Hazardous Substances and New Organisms Act 1996.  A PDE (food) gives the 
potential daily exposure  to a substance that  a person may be subject to via food, and is the 
food-specific part of a set of values for different exposure pathways comprising the NZ EPA’s 
assessment of acceptable daily exposure (ADE) for an agricultural compound.  
An ADI is defined by the World Health Organization (WHO) as “the daily intake which, during 
an entire li fetime, 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 estab lished 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 
international MRLs.  
New Zealand Food Safety  uses the PDE (food) set by the NZ EPA as the HBGV for the 
estimation of dietary exposure when one is available. If there is no PDE (food), the NEDI  is 
compared with an ADI set by the  WHO/FAO joint expert committees, the Australian 
Pesticides and Veterinary Medicines Authority, the European Food Safety Authority, or 
another regulatory authority. If none of these are available, the HBGV used will be a New 
Zealand Food Safety -determined ADI.    
6 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  2.1.4 International MRLs and Trade  
Because  New Zealand MRLs are based on domestic GAP, they may differ from th e MRLs  
established overseas  for the use of the same compound  in the same target species or crop  if 
the GAP us ed to set those  MRLs are different . To ensure the New Zealand MRLs will not 
unduly impact trade, the MRLs set by Codex and a selection of other international regulatory 
bodies  are reviewed to evaluate trade risk.  
For animal commodities, the MRLs set by Australia, Canada, China, Codex, the European 
Union, Japan, and the United States  are commonly  reviewed and compared; for horticultural 
commodities, MRLs set by Codex and Australia are  commonly  reviewed and compared. 
Other international MRLs  may also be reviewed and compared if there is a particular trade 
risk to be considered for those regions  for any exported commodity .  
Where there are  relevant international MRLs to be considered in the trade assessment  for 
the proposal , these are included in a table in the “Relevant International MRLs” section of 
each proposal entry. This table includes all MRLs for the agric ultural compound /food 
commodit y combinations for which new or amended New Zealand MRLs are being 
proposed ; international MRLs for other commodities for which New Zealand MRLs already  
exist are not included. If there are no MRLs set by an international authority for a particular 
compound/commodity combination, the authority is not listed in the table.  
2.1.5 Agricultural Compounds for Which No Maximum Residue Level Applies   
Not all agricultu ral compounds require a n MRL to manage their use in crops or animals . This 
may be because there are no residues present due to the  properties of the  compound  such 
as rapid elimination from the plant, animal, or their environment,  or because there are no 
food safety or trade risk s associated with the residues that are present. Regulation  141 of the 
Food Regulations allow s for the listing of specified compounds that fit these criteria as 
agricultural chemicals or veterinary medicines for which no MRL applies. These compounds 
are listed in Schedule 2 and Schedule 3 of the Notice, respectively , and the conditions of 
listing c an be set  for a particular use, a particular animal or crop, or general use as an 
agricultural chemical or veterinary medicine .  
Agricultural chemicals and veterinary medicines being considered for  listing as compounds 
for which no MRL applies underg o a similar scientific assessment of their use  as that 
undertaken for MRL assessment. This assessment is done in accordance with international 
methodologies published by the Organisation for Economic Cooperation and Development 
(OECD), International Cooperation on Harmonisation of Technical Requirements for 
Registration of Veterinary Medicinal Products (VICH), or FAO. It includes establishing the 
GAP use of the compound, the relevant metabolism and residue information, and the 
potential risks posed to public heal th and trade.  The assessment may also include an 
assessment of dietary exposure  when considered necessary to fully assess the risks.  
Where New Zealand Food Safety has determined that a n MRL is not required, the compound 
is proposed for listing in Schedule  2 (for agricultural chemicals)  or Schedule 3 (for veterinary 
medicines) with conditions on their use to ensure the listing applies only to those situations 
that have been evaluated. If a compound listed in Schedule 2 or 3 is used in a way that does 
not meet the specified condition, the default MRL of 0.1 mg/kg will apply to food derived from 
treated plants  or animals. Each proposal for inclusion in  Schedule 2 or 3 includes a 
discussion of the rationale behind the considerations for listing , and a discussion of the 
assessed risks  and proposed conditions .   
New Zealand  Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice • 7 2.2 SUMMARY OF PROPOSED AMENDMENTS  
The proposed MRLs have been thoroughly assessed in accordance wit h international 
methodologies published by the O ECD, VICH, or FAO . Information on the technical 
assessment of each proposal is included in this document (refer section 3) and covers:  
• the new or amended entry proposed for inclusion in the Notice;  
• the ration ale for the new entry or amendment being proposed ; 
• New Zealand good agricultural practice  for the compound and target crop or species ; 
• the relevant residues information  used in determining the proposed MRLs ; 
• a summary of the dietary risk  and public health assessment ; and 
• the MRLs set by Codex and other authorities  that are  relevant to the new or amended 
entry.  
Where an existing entry is proposed for revision, new or revised entry content is listed  in bold 
print, and  content proposed for removal is  identified by a strikethrough.  
The MRL compliance and dietary risk assessment residue definitions are included in the 
residues information section of the proposal . The HBGV used to compare to the NEDI 
calculation and determine the potential public health risk is included in the  dietary risk and 
public health assessment section of the proposal .  
2.2.1 Amendments to Schedule 1 : Maximum Residue Levels for Agricultural Compounds  
MPI proposes to make the following changes to Schedule 1 of the Notice : 
• An amendm ent to the entry for triclabendazole, to set an MRL of 0.005 (*) mg/kg in 
milk, and 0.1 mg/kg in goat fat, meat and offal ; and 
• Removal of the entry for pirlimycin.  
2.2.2 Amendment to Schedule 2: Agricultural Chemicals  for which No Maximum Residue Level 
Applies  
• The addition of a new entry for  S-abscisic acid , when used as a plant growth 
regulator.  
2.2.3 Amendment to Schedule 3: Veterinary Medicines  for which No Maximum Residue Level 
Applies  
• The addition of a new entry for alf alfa extract, when used as an aid in the 
management of gastric ulcers in horses.  
   
8 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3 Proposals  
3.1 PROPOSAL TO AMEND THE MRLS FOR TRICLABENDAZOLE   
It is proposed that MRLs for triclabendazole are amended to better support the GAP use of 
the compound in cattle and goats.  
The revised entry in Schedule 1 of the Notice will read:  
Compound 
Common Name  CAS#  Residue to which the 
maximum residue level 
applies  Food  Maximum 
Residue Level 
(mg/kg)  
Triclabendazole  68786 -66-3 Sum of: Triclabendazole, 
triclabendazole sulphoxide, and 
triclabendazole sulphone  
Expressed as: Triclabendazole  Cattle fat  
Cattle meat  
Edible offal of cattle  Cattle offal  
Goat fat  
Goat meat  
Goat offal  
Edible offal of sheep  Sheep offal  
Milk 
Sheep fat  
Sheep meat  0.1 
0.2 
0.3 
0.1 
0.1 
0.1 
0.1 
0.005(*)  
0.1 
0.1 
(*) indicates that the maximum residue level has been set at or about the limit of analytical quantification.  
3.1.1 Amendment Rationale  
Triclabendazole has been approved for use in ruminants in New Zealand for parasite control 
since 1986, with fat, meat, and of fal commodities attracting set withholding periods. The use 
of the compound is however excluded from use in lactating cattle, with milk withholding 
periods set to enforce this exclusion as GAP. The proposed revised entry will better reflect 
the GAP use of triclabendazole in ruminants, with the setting of a milk MRL at the limit of 
analytical quantification and the setting of MRLs for goat commodities.  
Amendment of the food identifiers for cattle and sheep offal is also proposed to align with the 
terminology  used in other entries. The target animal product, and the MRLs that apply to 
them, remain unchanged.   
3.1.2 Good Agricultural Practice  
Triclabendazole is a halogenated benzimidazole fasciolicide which acts by inhibiting 
microtubule formation in the target para site. It is used in veterinary medicine as a treatment 
for Fasciola hepatica  in cattle, sheep, and goats at a dose range of 10 -30 mg/kg, either alone 
or in combination with abamectin, oxfendazole, and/or levamisole. The lower dose rates are 
approved for or al administration, while the higher dose rates are administered in topical 
formulations. Use of this triclabendazole alone or in combination attracts a meat withholding 
period of between 28 and 91 days depending on the use pattern, formulation details, and  
administration route. All registered products also attract milk withholding periods of at least 
35 days to ensure the product is only used in non -lactating dairy animals as per New 
Zealand GAP.  
3.1.3 Residue Information  
The proposed MRLs for goat -derived commo dities are supported by species -specific 
metabolism and residue data that confirm residues in all commodities will conform to 0.1 
mg/kg when used according to GAP and the withholding periods are observed. Because the  
New Zealand  Food Safety  Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice • 9 compound is not permitted for use in la ctating dairy animals, the proposed milk MRL will be 
set to ensure a lack of residues in milk rather than a level conforming to GAP use. As such, it 
was not necessary to evaluate milk residue data for triclabendazole.  
The MRLs for other animal commodities  will remain unchanged.   
3.1.4 Dietary Risk Assessment  
The HBGV  of 0.0015 mg/kg bw/d was considered appropriate for use in the assessment. 
Based on the residue profile expected in food from animals treated with triclabendazole when 
used according to GAP, the NEDI is estimated to total less than 29% of the HBGV.  
New Zealand Food Safety  has therefore determined that the use of triclabendazole  
according to the GAP specified above and complying with the revised MRLs, is unlikely to 
pose any health risks from autho rised use.   
3.1.5 Relevant International MRLs  
Authority  Food  Maximum Residue Level 
(mg/kg)  
Australia  Fat (mammalian)  
Kidney (mammalian)  
Liver (mammalian)  
Meat (mammalian)  
Milks  1 
1 
2 
0.5 
0.01 
European Union  Muscle, all ruminants  
Fat, all ruminants  
Liver, all ruminants  
Kidney, all ruminants  
Milk 0.225  
0.1 
0.25 
0.15 
0.01 
Japan  Other terrestrial mammals, muscle  
Other terrestrial mammals, fat  
Other terrestrial mammals, liver  
Other terrestrial mammals, kidney  
Other terrestrial mammals, edible offal  0.2 
0.1 
0.3 
0.2 
0.3 
3.2 PROPOSAL TO DELETE THE NOTICE ENTRY FOR PIRLIMYCIN   
It is proposed that the following entry is deleted from Schedule 1 of the Notice:  
Compound 
Common Name  CAS#  Residue to which the 
maximum residue level 
applies  Food  Maximum Residue 
Level (mg/kg)  
Pirlimycin  78822 -40-9 Sum of: Pirlimycin, 
pirlimycin sulphoxide, and 
pirlimycin sulphone  Cattle fat  
Cattle kidney  
Cattle liver  
Cattle meat  
Cattle milk  0.05  
0.1  
0.5  
0.05  
0.1 
3.2.1 Amendment Rationale  
The deletion is being proposed because the compound is no longer used as an agricultural 
compound in New Zealand, with the last registered agricultural compound containing 
pirlimycin  de-registered in 2015.  Prior to this, pirlimycin was used as an antibioti c to treat 
mastitis in cattle. MRLs are therefore no longer required to manage the use of pirlimycin as 
an agricultural compound in New Zealand.   
10 • Proposals to Amend the New Zealand (Maximum Residue Levels for Agricultural Compounds) Food Notice  New Zealand Food Safety  3.3 PROPOSAL TO SET AN  ENTRY FOR S-ABSCISIC ACID  IN SCHEDULE 2 
It is proposed that S-abscisic acid  is added to Schedule 2 of the Notice to identify it as a n 
agricultural chemical to which no MRL applies. S-abscisic acid is a naturally occurring plant 
growth regulator  and plays roles  in stress resistance, fruit set, ripening and senescence . 
When used as  an agricultural chemical to regulate plant growth,  the additional amount 
present is negligible compared to naturally occurring amounts and unlikely to present an 
additional hazard  for use in food, or if treated crops or orchards are used for animal feed. It is 
therefore considered that residues do not need to be managed through the application on an 
MRL when the compound is used as a plant growth regulator.  
The proposed new entry in Schedule 2 will read as follows:  
Substance  CAS#  Condition  
S-Abscisic acid  21293 -29-8 When used as a plant growth regulator  
3.4 PROPOSAL TO SET AN ENTRY FOR ALFAFA EXTRACT IN  SCHEDULE 3 
It is proposed that alfalfa extract is added to Schedule 3 of the Notice to identify it as a 
veterinary medicine to which no MRL ap plies.  The process by which the a lfalfa extract  is 
produced is similar to that used to produce silage feed . When the alfalfa extract is then fed to 
horses as either a supplemental feed or total ration, it can act as a veterinary medicine by 
aiding in the prevention and healing of gastric ulcers in affected animals.   
The fermentation process used to produce the alfalfa extract, and the use of that extract as 
an agricultural compound, does not present a hazard with respect to its use in horses that 
would require management through the application of an MRL. As such, an MRL does not 
need to apply to its use in the prevention and treatment of g astric ulcers.   
The proposed new entry in Schedule 3 will read as follows:  
Substance  CAS#  Condition  
Alfalfa extract  84082 -36-0 When used to aid in treat ment  or prevent ion of  
gastric ulceration in horses