APPENDIX 1. New Zealand National Programme for Monitoring and Surveillance of Residues in Raw Milk

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1 APPENDIX 1 New Zealand National Programme for Monitoring and Surveillance of Residues in Raw Milk

2 Feb 2007 Page 2 1 Contents 1 Contents Submission Executive Summary Raw Milk Sample Numbers Sampling Distribution across the season Preamble Sampling Plan Statistical Confidence Sample Numbers Seasonal Distribution Directed (Targeted) Surveillance Compounds to screen Additional Programme Improvements Sampling Plan for 2007/ Group A: Substances having anabolic effect and unauthorised use Group B: Veterinary drugs and contaminants Substances and residues to be monitored in 2007/

3 Feb 2007 Page 3 2 Submission Enclosed is New Zealand s sampling plan for the National Chemical Residue Monitoring Programme for raw milk for the production year 1 July 2007 to 30 June This submission is in respect of dairy products, to comply with the equivalency provisions of Article 29 of Council Directive 96/23/EC whereby the guarantees must have an effect at least equivalent to those provided for by the Directive. In particular this document gives assurances with respect to compliance with Article 4, and includes assurances with respect to issues covered by Article 11(2) of Council Directive 96/22/EC. This document outlines the sampling plan, including numbers and frequency, and clarifies the rationale used to demonstrate that an equivalent guarantee is achieved.

4 Feb 2007 Page 4 3 Executive Summary In November 2006 the European Union Food and Veterinary Office (FVO) mission audited the New Zealand dairy monitoring and surveillance programme against Council Directive 96/23/EC. In their primary findings, the FVO questioned the number of samples taken in relation to total production and the distribution of sampling across the calendar year. This submission sets out the New Zealand sampling plan for dairy and addresses the concerns raised by the FVO. In doing so it highlights the high rate of sampling by New Zealand when compared to the European Union on a farms basis, acknowledging that sampling occurs on a farm basis. 3.1 Raw Milk Sample Numbers Section 5.1 sets out the statistical basis for the programme and section 5.2 details the justification for the sample numbers applied under the dairy programme. Council Directive 96/23/EC sets out the calculation of sample numbers based on total annual production, with a minimum of 300 samples. However the calculation in 96/23/EC ignores production levels per holding or the volume of milk represented in each sample. The key points highlighted within this submission are that the New Zealand NCCP: is statistically basis following Codex guidelines has a higher ratio of samples to farms, with 1 sample per 30 farms versus an EU estimate ratio of 1 sample per 108 herds (based on the historic 15 countries, with the ratio higher again across all current member states) monitors samples representing, on average, over 7 times the milk volume of each EU sample (averaged across all EU member states). monitors a significantly larger number of substances (245 across 10 substance groups versus an estimated requirement of 11 substances across 4 substance groups) yields a significantly higher number of individual results (93,000 versus an estimated minimum of 3,337) Furthermore, the programme has been amended to capture additional improvements in response to the FVO audit and NZFSA requirements. In doing so the this programme now

5 Feb 2007 Page 5 recognises all banned substances as specified for milk by Council Directive 96/23/EC, as set out in Annex IV to Council Regulation 2377/90/EC. Article 29 of the Directive allows for variation in the national sampling plan provided that third countries provide a guarantee of conformance at least equivalent to that of the Directive. Having consideration for the points above, New Zealand contends that the proposed dairy NCCP monitoring and surveillance programme provides a guarantee of conformance at least equal to that required by Council Directive 96/23/EC. 3.2 Sampling Distribution across the season The FVO highlighted that the sampling period for white milk excluded a 5 month period over the traditional New Zealand dry period for seasonal herds (winter). This period accounts for 7% of total production, much of which is for domestic consumption. None-the-less the programme has been adjusted to include sampling across the full season, with samples to be taken during the winter period under the plan for the 2006/07 production year. This is further elaborated under section 5.3.

6 Feb 2007 Page 6 4 Preamble Dairy monitoring and surveillance programmes for selected substances have been in operation throughout New Zealand for many years, and a programme was introduced in the 1996/97 dairy season to cover the substances for which the EU has concerns. Since this time the programme has become incorporated under the Dairy Industry (National Residue Monitoring Programme) 2002, and administered by the New Zealand Food Safety Authority (NZFSA). New Zealand s monitoring and surveillance programme is designed to audit the effectiveness of the regulatory controls in place for ensuring chemical residues in dairy products do not pose a threat to human health, that good agricultural practices are being followed and that all relevant importing country requirements will be met. In addition surveys aimed at identifying new risk factors or better defining potential issues, are undertaken as necessary. The monitoring programme is regarded as verification, not a primary control measure. It identifies where control(s) may not be working and enables an appropriate investigate to be undertaken to determine the cause and required corrective actions. Regulatory reactions to identified control failures are aimed at motivating not just the individual farmer or factory directly concerned but the whole sector responsible for that control to make the necessary adjustments. The types of chemicals analysed for, the number of samples to be analysed, and the sampling pattern have been determined following consideration of factors relevant to New Zealand farming practices. Due consideration has been taken of historical monitoring results which have thus far indicated the current controls have been effective in ensuring chemical residues in dairy products conform to applicable limits. The level of monitoring to some extent also reflects the severity of sanctions currently applied to transgressors. In New Zealand, dairy risk management programme (RMP) operators apply severe penalties when milk supplies fail the inhibitory substances test, and NZFSA applies strict rules concerning traceback, corrective action and, if any dairy material or product is found to be non-compliant, disposition under NZFSA control.

7 Feb 2007 Page 7 Factors taken into consideration in the design of the programme include: residue and toxicological potential of the substance, potential for misuse or abuse, extent and pattern of use within New Zealand, previous residue non-compliance, and persistence in the environment. Substances which are of interest to importing countries may be included where appropriate, irrespective of whether there is any evidence or likelihood of use or abuse in New Zealand. Action limits are established for all residues of primary interest in the programme. Where MRLs have been set, the action limit is the lower of the New Zealand, Codex, and Importing Country MRLs, including European MRLs established by Council Directive 86/363/EEC and Council Regulation 2377/90. Where a compound is banned or not for use on milking animals the action limit is set at the minimum reporting limit. 5 Sampling Plan Consistent with Codex Alimentarius guidelines, New Zealand utilises a scientifically and statistically justified, risk-based approach to monitoring chemical residues in raw milk. The programme consists of three parts, random monitoring, directed surveillance and surveys. The monitoring programme is a non-biased sampling programme and is designed to provide profile information on the occurrence of residues in raw milk and colostrum on a national basis. Although Directive 96/23/EC allows for some compounds to be screened at the tanker, all random monitoring for raw milk under the New Zealand programme is sampled from the farm bulk milk tank prior to further consolidation or dilution. This ensures that Good Agricultural Practice is monitored as well as MRL conformance.

8 Feb 2007 Page Statistical Confidence Consistent with Codex guidelines, New Zealand uses statistically based sample sizes. In the monitoring component of the NCCP, the numbers of samples taken is aligned with that required to provide a 95% confidence of being able to detect an incidence of non-compliance in the population of 1% or greater. This means that a minimum of 300 official random monitoring samples must be taken each year for analysis of the core compounds to be monitored. This minimum covers all bovine farms producing milk eligible for export. Additional samples are taken for other species (caprine and ovine) and bovine domestic milk. For 2007/08, 350 raw milk and 50 colostrum samples will be taken. While less than the number of production based samples required under Annex IV of Directive 96/23/EC, this does exceed the minimum 300 samples also stipulated by the Directive. 5.2 Sample Numbers In the November 2006 mission, the FVO questioned the sample numbers and distribution of sampling across the calendar year. In 2000 a similar finding noted the lower sample numbers but acknowledged that the number substances monitored greatly exceeded the requirements of the Directive, resulting in more individual analyses. Since 2000 the New Zealand programme has increased the average number of substances monitored almost 4 fold. Overall, a minimum of 350 random raw milk and 50 directed colostrum samples are to be taken by the NCCP in 2007/08. This is an increase in raw milk sampling from 310 samples for 2006/07, and addresses the concern of sample distribution covered under 4.3: Sampling Distribution below. The sampling rate on a milk production basis is lower than the frequency specified in Annex IV of Council Directive 96/23/EC for milk products (1 per tonnes). However Annex IV does not take into consideration the average production per farm holding. Table 1: Farm production comparison European Union New Zealand

9 Feb 2007 Page 9 Litres/farm/season 166,764 1,237,228 Milking animals/farm All raw milk sampling occurs at the farm bulk milk tank and as such is monitoring the contents of the silo. In New Zealand the average milk supply of approximately 5,000 litres per consignment is significantly larger than that of Europe. As such each sample is monitoring a higher percentage of the national production. Monitoring under the New Zealand programme is equivalent to 1 sample per 36,755 tonnes of the annual production of milk, or 1 sample per 30 herds. This compares with a European average of approximately 1 sample per 108 herds (based on 1999 figures). Currently New Zealand also subjects every sample collected to every test scheduled in the particular round, whereas Directive 96/23/EC directs that only a portion of the samples need to be analysed for the minimum substance classes. Thus the higher sampling rate under the Directive is diluted by the streaming of analyses. It is important to note that the purpose of monitoring is to assess the raw milk supply at the farm. Basing sample numbers on total production has the effect of focusing on individual animal numbers and not herds or farm supplies. This creates an anomaly and sets an expectation that a country such as New Zealand with higher per farm production should take a disproportionately higher number of samples. The following table illustrates the higher rates of monitoring actually applied by the programme. In addition, by subjecting all samples to all substances in the round New Zealand is able to assess any farm based relationships or associations that may become apparent from the data. Table 2: Directive 96/23/EC requirements compared to the New Zealand Programme EU Substance Class 96/23/EC Minimum substances NZ Dairy Programme 1 Based on 2001 data. The average herd size fell to 14 milking animals/holding over 25 countries in 2003 (but increased marginally to 32 over a comparable 15 countries)

10 Feb 2007 Page 10 A6, B1, B2(a) & B2(e) 686 samples, 4 substances over at least 3 of the classes 400 samples for: 55 substances over 6 x A6 substances 45 x B1 substances; & 4 x B2(a) substances; 150 samples for: 3 x B2(e) substances 100 samples for: 7 x B2(a) additional substances B3 147 samples, minimum substances not stated 400 samples for: 21 x B3(a) substances 130 x B3(b) substances Other (country discretion) 147 samples, minimum substances not stated 400 samples for: 21 x B2(c) substances; 50 samples for: 1 x B2(f) substance; 150 samples for: 6 x B3(c) substances 1 x B3(d) substance In accordance with the above table, the New Zealand programme for 2007/08 will deliver over 93,000 individual results. This compares with the required 3,337 results based upon the sampling plan in Directive 96/23/EC (assuming 4 x B3 substances). Under the provisions of Article 29 whereby third countries must provide a guarantee of conformance at least equivalent to that of the Directive. New Zealand contends that the sample numbers taken under the programme enable this guarantee to be provided due to both: - higher per farm monitoring; and

11 Feb 2007 Page 11 - greater percentage of milk monitored on the basis of farm milk supplies monitored as a percentage of national production (the average New Zealand milk consignment is approximately 5,000 litres). 5.3 Seasonal Distribution Dairy farming in New Zealand is pasture based and the milk production pattern is seasonal, following a similar curve to pasture production. Figure 1 on the following page illustrates the milk supply curve across the dairy season, while figure 2 illustrates the cumulative milk produced as the season progresses, and is a sigmoid curve rather than a straight line. 93% of milk is produced between August 20 th and April 30 th each season, and accordingly the programme has historically applied all raw milk sampling through this period. The recent FVO residue mission raised a concern regarding sampling through the balance of the season where only colostrum has been sampled previously. Although a significant proportion of the milk supplied in the period May 1 st to August 19 th is for domestic consumption (as liquid milk and chilled dairy products), a proportional number of random supplies will now be sampled over this period. This increase is effective immediately, with sampling in May/June In addition, New Zealand will include one targeted round for colostrum as this continues to be seen as an indicator for residue carryover from treatments and exposures that may have occurred over the dry period.

12 Feb 2007 Page 12 Figure 1: New Zealand Milk Supply Curve 80,000,000 70,000,000 60,000,000 50,000,000 40,000,000 30,000,000 20,000,000 10,000, /06/ /06/2005 Figure 2: Cumulative Milk Supply 16,000,000,000 14,000,000,000 12,000,000,000 10,000,000,000 8,000,000,000 6,000,000,000 4,000,000,000 2,000,000, /06/ /06/ /06/ /07/ /07/ /08/ /08/2005 7/09/ /09/2005 5/10/ /10/2005 2/11/ /11/ /11/ /12/ /12/ /01/ /01/2006 8/02/ /02/2006 8/03/ /03/2006 5/04/ /04/2006 3/05/ /05/ /05/ /06/ /07/ /07/ /08/ /08/2005 7/09/ /09/2005 5/10/ /10/2005 2/11/ /11/ /11/ /12/ /12/ /01/ /01/2006 8/02/ /02/2006 8/03/ /03/2006 5/04/ /04/2006 3/05/ /05/ /05/2006 Series1 Series1

13 Feb 2007 Page Directed (Targeted) Surveillance The surveillance component of the programme is designed to investigate and control the movement of dairy material deemed to be of higher risk based on the risk profile of the material for particular chemical hazards. Targeted sampling is undertaken on the basis of the risk associated with the compound, the existing level of management control, and the likelihood of non-compliance based on information available to NZFSA based on reports, non-compliances, audits and investigations. For 2007/08 targeted sampling will be directed to a minimum of 50 colostrum supplies. 5.5 Compounds to screen As NCCP is risk based, the compounds to be analysed in the monitoring programme are dependent upon the risk profile of the agricultural compounds and veterinary medicines. The compounds screened under the programme are subject to annual review. Factors taken into account for any one compound include: toxicity of the compound; husbandry practices; extent and pattern of use of the chemical (risk prone times); persistence in the environment (risk prone areas); previous monitoring frequencies and results ( across NZFSA and industry programmes); availability of a practical regulatory analytical method; international concern about residues of the compound; and regulatory requirements of international markets. For 2007/2008 the programme will monitor 245 substances across 10 EU substance groups - specifically A6, B1, B2(a), B2(c), B2(e), B2(f), B3(a), B3(b), B3(c) and B3(d). As set out in section 4.2, Directive 96/23/EC requires an estimated 11 substances across at least 4 of the above substance groups.

14 Feb 2007 Page 14 To elaborate, Annex IV of the Directive requires: - 70% of samples to be analysed for 4 different compounds from at least 3 of the groups A6, B1, B2(a) and B2(e); plus - 15% of samples analysed for residues designated in group B3 (no minimum speficed) - 15% of samples allocated according to the situation of the New Zealand The outcome is that the New Zealand programme vastly exceeds the requirements of the Directive for the compounds to be screened and will yield in excess of 93,000 results compared with a required minimum of 3,337 results according to the Directive (with an assumed minimum of 4 x B3 substances). Furthermore, the substantial analyses undertaken per sample enables New Zealand to provide the required guarantee that the programme has an effect at least equivalent to those provided for by the Directive.

15 Feb 2007 Page 15 6 Additional Programme Improvements Further amendments have been made to the NCCP programme to address other issues raised by the FVO auditors. These include: (i) (ii) (iii) (iv) (v) Oversight of Non-Conforming result investigations: Currently under the New Zealand regulatory model the responsibility for verification of the operations under which the non-conformance has occurred rests with the agency recognised to do so by the NZFSA. Effective immediately all non-conforming result investigations will be under the supervision of a NZFSA Animal Products Officer. Action Limits: The auditors noted that some compounds such as Phenylbutazone the action limit should be the limit of detection which was not the case. Consequently action limits have been reviewed and amended as appropriate to meet EU requirements. Interlaboratory Comparison Programmes (ILCP): Although the current ILCPs were acceptable, the FVO suggested consideration being given to alternate programmes. The laboratories have been requested to consider the FVO suggestions. Confirmation Methods absent for some compounds: the FVO highlighted that not every compound monitored had a confirmatory test available. NZFSA acknowledge that a confirmatory method may not be available within New Zealand for some compounds that are not expected to be detected (based on historical findings and use). Should such a compound be detected the sample would be referred to an international reference laboratory for confirmation under secure chain of custody. Test Method Validation: the auditors identified that some of the methods in use had not been fully validated according to EU requirements (in some cases compounds may be screened under multiple methods). For methods that have not been fully validated for all compounds monitored the affected laboratory has been advised that validation is to be completed for the 2007/08 production year or, for compounds included on a discretionary basis, the compound/method will be removed from the Programme.

16 Feb 2007 Page 16 7 Sampling Plan for 2007/2008 The following sets out the rationale and consideration of substances for inclusion in the 2007/08 NCCP, listed according to the grouping of Annex I of Council Directive 96/23/EC. The minimum list of substances included in the NCCP is provided in the following section. 7.1 Group A: Substances having anabolic effect and unauthorised use In relation to the substances covered by Article 11(2) of Council Directive 96/22/EC please refer to the New Zealand s National Chemical Residue Monitoring and Surveillance Programme for live and slaughtered animals. Annex II of Council Directive 96/23/EC specifies that the plan for milk is not required to provide for the detection of the following residues and as these substances are not deemed to represent a risk in New Zealand dairy material they are not included in the NCCP for 2007/08: A1 Stilbenes, stilbene derivatives, and their salts and esters; A2 Antithyroid agents; A3 Steroids; A4 Resorcyclic acid lactones including zeranol; and A5 Beta-agonists. The New Zealand National Chemical Residue Monitoring and Surveillance Programme for live and slaughtered animals includes screening for trenbolone, stilbenes, steroidal substances and β-agonists. A6 Compounds included in Annex IV to Council Regulation (EEC) No 2377/90 of 26 June 1990 There are currently no veterinary medicines containing chloramphenicol registered for use in New Zealand. Registration of chloramphenicol was withdrawn for food producing animals in Use on dairy animals in New Zealand is therefore considered highly unlikely. Nevertheless, due to concerns about illegal use of the compound in other countries chloramphenicol has been included in the NCCP since its inception and will continue to be monitored in 2007/08.

17 Feb 2007 Page 17 Use of Chloroform as an excipient in products was terminated in 2000/01. In the previous year all products were either reformulated to remove chloroform or the licence was cancelled. Chloroform will not monitored by the NCCP for 2007/08 but will be included under random monitoring in the 2009/10 production year providing validated methodology is approved by NZFSA.. Chlorpromazine, colchicine and dapsone are not registered for use in New Zealand, and there are no indications for their use. Nevertheless, due to concerns about illegal use of the compound in other countries dapsone has been included in previous seasons and continues to be included in the NCCP for 2007/08, while Chlorpromazine and colchicine will be included under random monitoring in the 2009/10 production year providing validated methodology is approved by NZFSA. Dimetridazole is currently licensed for use in pigs and poultry under veterinary supervision. New Zealand s extensive pasture-based husbandry practices would make its use in dairy cattle highly improbable. While not included in the NCCP for 2007/08, it will be included in the 2008/09 production year and reviewed thereafter to confirm the appropriate frequency for inclusion which has been tentatively set at one in every four years. Metronidazole is currently exclusively licensed for the treatment of bacterial infections in cats and dogs. While not included in the NCCP for 2007/08, it will be included in the 2008/09 production year and reviewed thereafter to confirm the appropriate frequency for inclusion which has been tentatively set at one in every four years. New Zealand has one nitrofuran with systemic absorption, licensed for use in food producing animals. Furazolidone is licensed for use as an oral formulation in pigs and poultry under veterinary supervision. Furazolidone is not approved for use in cattle, and New Zealand s extensive pasture-based husbandry practices would make its use in dairy cattle very unlikely. Nitrofurazone is licensed for use in ointments for non-food producing species (horses, small animals and ornamental fish). It is a legal requirement that products containing nitrofurazone are not be used on any animal producing or intended to produce food for human consumption, and this is stated clearly on the label of the medicine.

18 Feb 2007 Page 18 The registered products containing furazolidone and nitrofurazone are prescription veterinary medicines and a condition of registration is a specific direction prohibiting off-label use. Nitrofurazone, furazolidone and furaltadone were included in the NCCP previously. However, due to international interest, analyses of the nitrofuran metabolites SEM, AOZ, AMOZ and AHD have been developed and validated for milk and included in the programme since 2004/05, and will continue to be monitored each production season. While there is debate regarding the specificity of these metabolites (in particular semicarbazide which has been shown to be present from sources other than Nitrofurazone), analysis of these metabolites is considered to be more reliable than analysis for the parent drugs which are less stable. Because of the status of the Nitrofurans (no registered use for dairy cattle) any detection of a metabolite in the absence of the parent drug will initiate immediate traceback procedures to determine whether any abuse has occurred. Ronidazole has been licensed for use in New Zealand in cage birds. While not included in the NCCP for 2007/08, it will be included in the 2008/09 production year and reviewed thereafter to confirm the appropriate frequency for inclusion which has been tentatively set at one in every four years. Aristolochia species and preparations containing these botanicals have no intentional use on milking animals and as such will not be monitored by the NCCP in 2007/08, but a small number of samples will be considered for inclusion under directed surveillance in 2008/09 providing validated methodology is approved by NZFSA. 7.2 Group B: Veterinary drugs and contaminants B1 Antibacterial substances, including sulphonamides, quinolones Cows in New Zealand are grazed outdoors on pasture all year round and not housed in feedlots nor fed concentrates at levels of any significance. They are therefore not exposed to the same level or types of veterinary drugs that are associated with these more intensive husbandry practices.

19 Feb 2007 Page 19 The New Zealand national dairy herd has a relatively low level of mastitis, and when it occurs, treatment with antibiotics during lactation is only one of the control methods advocated in the SAMM plan (the seasonal approach to managing mastitis, published by the New Zealand National Mastitis Advisory Committee). Almost all mastitis antibiotics in New Zealand are prescription veterinary medicines and as such are under the control of the veterinary profession. Dairy manufacturers maintain an intensive level of acceptance testing of raw milk. The Animal Products (Dairy) Approved Criteria for Farm Dairies requires risk management programme operators to test milk from each farm at least three times per month using an approved method such as the Delvotest SP Modified method. The action level for farm bulk milk supplies is the limit of detection of the test, IU (1.8 ppb) sodium (or potassium) benzyl penicillin or equivalent per ml, a very stringent standard in comparison with others internationally. With non-compliances, risk management programme operators are required to apply rigorous follow-up procedures, including farm traceback and financial penalties, and achieve a very high level of conformance based on the extensive testing across all operators. For 2007/08 the industry is expected to undertake some 1.3 million Inhibitory Substances tests on an approximate 2.7 million raw milk consignments.. In addition to this routine monitoring, the NCCP will, in 2007/08, screen milk supplies for evidence of penicillins, cephalosporins, aminoglycosides, macrolides, sulphonamides, tetracyclines and diamino pyrimidine derivatives. B2(a) Anthelmintics: The NCCP will, in 2007/08, screen a proportion of milk supplies for evidence of benzimidazoles, levamisole, milbemycins and macrocyclic lactones. B2(b) Anticoccidials, including nitroimidazoles: Due to the outdoor pastoral farming system in New Zealand dairy production, neither anticoccidial nor nitroimidazole compounds are indicated for use. Annex II of Council Directive 96/23/EC specifies that the plan for milk is not required to provide for the detection of these residues. Accordingly, they are not included in the 2007/08 NCCP.

20 Feb 2007 Page 20 B2(c) Carbamates and pyrethroids: Annex II of Council Directive 96/23/EC specifies that the plan for milk is not required to provide for the detection of these residues. The risk of contamination by synthetic pyrethroids in New Zealand milk is lowered due to the extensive grazing-based animal husbandry system. None the less, NCCP will continue to monitor milk supplies for evidence of synthetic pyrethroids. Carbamates have been superseded by other remedies in New Zealand and are currently only registered for topical use in food producing species. However, New Zealand s screening methodology for organophosphates is sensitive to these compounds and all non-identified responses are actively followed up. Additional surveillance samples for either group will be taken where considered appropriate. B2(d) Sedatives: Annex II of Council Directive 96/23/EC specifies that the plan for milk is not required to provide for the detection of these residues. As the potential for these compounds to be present in milk is very low they are not included in the NCCP for 2007/08. B2(e) Non-steroidal anti-inflammatory drugs (NSAIDs): The extensive nature of New Zealand s farming systems, the expense of non-steroidal anti-inflammatory drugs relative to the value of the animals and their prescription veterinary medicine status, does not justify the common use of these products. None-the-less NSAIDs have been included in the NCCP for a number of years and will continue to be monitored in 2007/08 with NCCP monitoring phenylbutazone, flunixin and ketoprofen. B2(f) Other pharmacologically active substances: Annex II of Council Directive 96/23/EC specifies that the plan for milk is not required to provide for the detection of other pharmacologically active substances. Benomyl is used as a pasture spray to control the spores of the fungus Pithomyces chartarum which, when consumed in high quantity by ruminants, result in liver damage and the condition facial eczema. These spores are only present when certain climatic conditions prevail. The surveillance component of the NCCP in 2007/08 may investigate the residues of benomyl in

21 Feb 2007 Page 21 milk if weather conditions are such that there an increased facial eczema risk over past seasons. B3(a) Organochlorine compounds including PCBs: Consistent with previous years, organochlorines will be included in the 2007/08 programme. This is primarily to continue monitoring the slow environmental decay of these compounds. None of the 12 organochlorines that are currently part of the United Nations Environment Programme Persistent Organic Pollutants Programme have been registered or used in New Zealand for a number of years. The sales of dieldrin for use on food animals and or pasture was banned in In 1970, New Zealand became one of the first countries in the world to ban the use of DDT on pastoral land. However, the metabolites of DDT continue to be periodically identified in milk and milk products from livestock grazing land where DDT was historically applied to control grass grub (Costelytra zealandica). Residues of DDE, rather than the parent compound DDT, predominate confirming the historic rather than any recent use of this pesticide in New Zealand. NZFSA will continue to monitor areas where this compound was historically used. Farm dairy risk management programme operators are required to manage the risks under their programmes and, where necessary, to provide practical information on management techniques to minimise the uptake of the metabolites by milking animals. B3(b) Organophosphorus compounds: Organophosphate compounds, as well as synthetic pyrethroids are included in the 2007/08 NCCP. These classes of compounds as licensed veterinary medicines are used primarily for ectoparasite control in food producing animals. Many organophosphates are very unlikely to occur as residues in New Zealand milk, because animal feeds, which may be treated with organophosphate insecticides are not used, and cows are not housed in barns which may require insecticide treatment. The analytical method used in the programme uses internal standards of all organophosphates licensed for use in food producing animals. In addition the methodology will also identify any cholinesterase inhibitor, and further analytical steps can be employed to identify and quantify an organophosphorus compound which is not a licensed veterinary medicine.

22 Feb 2007 Page 22 B3(c) Chemical elements: Given the low level of industrialisation in New Zealand there is little heavy metal environmental contamination. As milk cows graze pasture and receive little or no bought-in feeds, it is unlikely that contamination will occur through the feed supply. In 2007/08 the NCCP will monitor raw milk for arsenic, boron, cadmium, lead, mercury, and selenium at the reduced frequency of 150 samples due to the historic absence of detections. Dairy products that are manufactured using ingredients or additives that may contain metal residues greater than allowable limits are monitored for metal contamination under the appropriate Risk Management Programme. B3(d) Mycotoxins: Aflatoxin M1 is derived from the intake of aflatoxin B1-contaminated feed by the milking animal. New Zealand pasture, conserved feed, grains and concentrates are very unlikely to contain aflatoxin-b1. Year-round suitable climatic conditions ensure that pasture grazing will continue to be the predominant feed supply for New Zealand dairy cows. Conserved pasture, hay and silage are the most commonly supplied additional feed materials. These are harvested on each farm from surplus grass growth during the high growth periods in the spring and early summer (November to January). Imported plant material such as palm kernel has increased over the last 4 years and as this is a higher risk feed the NCCP will continue to monitor for aflatoxin M 1 in 2007/08 at the reduced frequency of 150 samples (3 random monitoring rounds). Sampling will be directed to early and late in lactation when the use of supplements is highest and per cow milk production is lower.. B3(e) Dyes: Annex II of Council Directive 96/23/EC specifies that the plan for milk is not required to provide for the detection of these substances. As these substances are of low risk they are not included in the NCCP for 2007/08. B3(f) Others: New Zealand dairy products are routinely monitored for radionuclide contamination in conjunction with the national survey undertaken by the Ministry of Health National Radiation Laboratory. Additional radionuclide testing may also be undertaken according to the requirements of particular markets.

23 Feb 2007 Page Substances and residues to be monitored in 2007/08 Table 4: Substances and residues to be monitored in the year 1 July 2007 to 30 June 2008 (additional compounds tested on a discretionary basis). Group of Substances Compounds Number Farms to Sample Legal Limit (µg/l) Note 1 EU Limit (µg/l) Minimum Report Level (µg/l) Note 2 Action Limit (µg/l) Note 3 Test Method Group A6 Chloramphenico 400 nd**** 0 LoQ = ** HPLC l Dapsone 400 nd**** 0 LoD = ** Microbiological inhibition Nitrofuran metabolites SEM 400 nd**** 0 LoD = 1 1 ** AOZ 400 nd**** 0 LoD = 1 1 ** AMOZ 400 nd**** 0 LoD = 1 1 ** AHD 400 nd**** 0 LoD = 1 1 ** LC/MS-MS Group B(1) Penicillins Cephalosporins Aminoglycosides Macrolides Benzyl penicillin * 4 LoD = Ampicillin * 4 LoD = Amoxicillin * 4 LoD = Cloxacillin * 30 LoD = Benzyl penicillin * 4 LoD = 2 4 Ampicillin * 4 LoD = 3 4 Amoxicillin * 4 LoD = 2 4 Cloxacillin * 30 LoD = Dicloxacillin * 30 LoD = Nafcillin * 30 LoD = 5 30 Cefuroxime * Not set LoD = Cefacetrile * 125 LoD = Cephalexin * 100 LoD = Cephapirin LoD = 5 10 Cephalonium * 10 LoD = Streptomycin LoD= ** Dihydrostreptomycin LoD= ** Neomycin (including LoD= framycetin) Tylosin * 50 LoD = Erythromycin * 40 LoD = ** Oleandomycin * Not set LoD = ** Lincomycin * 150 LoD= Pirlimycin LoD = Tilmicosin * 50 LoD = Sulphonamides 100 * 100 LoD = Tetracyclines Tetracycline LoD = ELISA Oxytetracycline LoD = Doxycycline * Not for LoD = ** use Diamino pyrimidine Trimethoprim * 50 LoQ = HPLC derivatives Baquiloprim LoD = ** Microbiological inhibition HPLC Microbiological inhibition

24 Feb 2007 Page 24 Group of Substances Compounds Number Farms to Sample Legal Limit (µg/l) Note 1 EU Limit (µg/l) Minimum Report Level (µg/l) Note 2 Action Limit (µg/l) Note 3 Test Method Group B(2)(a) Benzimidazoles Fenbendazole * 10 LoQ = 5 10 HPLC Oxfendazole * 10 LoQ = 5 10 Albendazole * 100 LoQ = Ricobendazole * 100 LoQ = Tetra-hydroimidazoles Levamisole * Not set LoQ = HPLC Milbemycins Moxidectin LoQ = 1 1 HPLC Group B(2)(c) Synthetic pyrethroids Permethrin * 50 LoQ = 5 10 Flumethrin * 30 LoQ = 5 10 Cyhalothrin * 50 LoQ = 5 10 Cyfluthrin * 20 LoQ = 5 10 Cypermethrin * 20 LoQ = 5 10 Deltamethrin * 20 LoQ = 5 10 Fenvalerate * 100 LoQ = 5 10 Propoxur * 50 LoQ = 5 10 GCMS Group B(2)(e) Non-steroidal antiinflammatory Phenylbutazone * Not set LoQ = 7 7 drugs Flunixin * 40 LoQ = 5 40 (NSAIDS) Ketoprofen * 10 LoQ = 5 10 GCMS Group B(2)(f) Other pharmacologically active substances Dexamethazone LoQ ELISA Group B(3)(a) Organochlorines Aldrin LoQ = 5 6 Dieldrin LoQ = 5 6 DDT (including DDE LoQ = 2 40 and DDD) Hexachlorobenzene * 10 LoQ = 5 10 HCH, alpha isomer * 4 LoQ = 2 4 HCH, beta isomer * 3 LoQ = 2 3 HCH, gamma isomer (Lindane) * 8 LoQ = 2 8 Endosulfan sulphate * 4 LoQ = 2 4 GCMS

25 Feb 2007 Page 25 Group of Substances Compounds Number Farms to Sample Legal Limit (µg/l) Note 1 EU Limit (µg/l) Minimum Report Level (µg/l) Note 2 Action Limit (µg/l) Note 3 Test Method Group B(3)(b) Organophosphates Chlorpyriphos * 10 LoQ = Coumaphos Not set LoQ = 5 10 ** Diazinon * 20 LoQ = 5 20 Famphur * Not set LoQ = Fenthion * Not set LoQ = 5 50 *** Phorate * 20 LoQ = 5 20 Phosmet * Not set LoQ = 5 20 *** Propetamphos * Not set LoQ = for bovine Temephos * Not set LoQ = Terbufos * Not set LoQ = 5 10 *** Dichlorvos * Not set LoQ = 5 20 *** Chlorfenvinphos * Not set LoQ = GCMS and cholinesterase inhibition Group B(3)(c) Chemical elements Arsenic 150 No limit set LoD = Boron 150 No limit set LoD = Cadmium 150 No limit set LoD = Lead LoD = Mercury 150 No limit set LoD = 5 30 Selenium 150 No limit set LoD = ICP OES Group B(3)(d) Mycotoxins Aflatoxin M LoD = HPLC Notes: 1 Legal limit is the maximum level permitted under the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standard Minimum report level is the limit of detection or limit of quantification. All levels are expressed as concentrations in milk. 3 Action limit is the level above which traceback and corrective action are required. * Default limit specified by the New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standard ** The action limit is at the lowest level possible according to the sensitivity of the current test method. *** Action limit based on Codex Alimentarius MRL **** nd = not detected