Human Health Considerations in the Use of Btk-Based Insecticide … · Prepared for the Ministry of...

Prepared for the Ministry of Health

Health Considerations in Aerial Spray Programmes for Moth Control Page 1 of 45

October 2003

Human Health Considerations in the Use of Btk-Based Insecticide Foray 48B for Asian Gypsy Moth in Hamilton

Summary report prepared for the Ministry of Health, Ministry of Agriculture and Forestry,

and Waikato DHB Public Health Unit.

October 2003

Auckland Regional Public Health Service



October 2003

Contents Contents .........................................................................................................................................2 1 Outline......................................................................................................................................3 2 Foray 48B and Btk-based insecticides......................................................................................3 3 Previous Health Risk Assessments and Related Reports .........................................................5 4 Published literature on Btk-based sprays and spray programmes since 2002 HRA..................6 5 Health Monitoring and Support During the 2 Spray Programmes in Auckland ..........................7 6 Health Effects and Concerns Related to Foray 48B/Btk............................................................7 7 Other information and commentary sources ...........................................................................12 8 Projections of health service utilisation for Hamilton ...............................................................12 9 Appendices.............................................................................................................................15

A. Abbreviations .................................................................................................15 B. Material Safety Data Sheet for Foray 48B (US Version) .................................16 C. Summary of Foray 48B Information from MAF ...............................................17 D. Summary of reports published since the 2002 Auckland HRA ........................30 E. Excerpt from PAM Health Service Reports to MAF and Ministry of Health......34 F. Summary of Letters on Health Related Concerns to Waitakere City Council, 2003. 40 G. Is Commercial Btk Product Associated With Gastro-Enteritis In Humans? .....42 H. Demographic Comparisons between Auckland and Hamilton Spray Zones....43

10 Annexes ..............................................................................................................................45

1 Health Risk Assessment of the 2002 Aerial Spray Eradication Programme for the Painted Apple Moth .............................................................................................................................45 2 Health Surveillance following Operation Ever Green: .......................................................45

3 Health Risk Assessment of the Proposed 1997-1998 Control Programme for the White-Spotted Tussock Moth............................................................................................................45

4 Health Risk Assessment of Btk spraying in Auckland’s Eastern Suburbs to Eradicate White-Spotted Tussock Moth (Orgyia thyellina), September 1996 with Addendum.................45 5 Clarification of issues raised in “Our Case Against moth Spraying” – 1998. .....................45

6 Report of Health Surveillance Activities, Aerial Spraying for Asian Gypsy Moth – May 2000, Seattle, WA...................................................................................................................45 7 Human Health Surveillance During the Aerial Spraying for Control of North American Gypsy Moth on Southern Vancouver Island, British Columbia, 1999 ......................................45 8 Pearce M, Habbick B, Williams J, Eastman M, Newman M. The effects of aerial spraying with Bacillus thuringiensis Kurstaki on children with asthma.. .................................................45



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1 Outline This document compiles and summarises available information on the human health issues related to the use of Btk-based sprays for aerial application in moth control operations. The information comes from a number of sources, including:

• health risk assessments (HRAs) prepared for the 2 aerial spray programmes in Auckland

• HRAs prepared for moth control programmes in North America and Europe

• Research information on the biology, ecology and human health effects of the Bacillus thuringiensis organism

• Toxicological information on spray ingredients

• Health surveillance and research information from New Zealand and elsewhere, including preliminary analysis of records from the Painted Apple Moth Health Service in Auckland

• Reports and community feedback related to the PAM eradication programme

As with the 3 HRAs carried out for the Auckland spray programmes, ARPHS has had access to the ingredient list for Foray 48B, but not to information held by ERMA and ACVM supplied by the company as part of product registration. We have prepared some preliminary projections of health service use and health issues that might be expected in Hamilton. However, caution is needed in interpretation because of the different population and community characteristics and spray programme differences.

2 Foray 48B and Btk-based insecticides Biology of Btk as an insecticide

The biology, ecology and safety of Bacillus thuringiensis, are extensively described in a monograph by Glare and O’Callaghan from AgResearch, Lincoln1. In summary: Bacillus thuringiensis var kurstaki is a relatively widespread soil organism which is used primarily as a biological insecticide against caterpillars of Lepidoptera (moths and butterflies). In soil it is found as a spore, with an associated protein crystal inclusion, which contains an insecticidal delta-endotoxin, the main biologically active agent. The delta-endotoxin is activated in the gut of caterpillars, and severely disrupts gut function by binding with a specific receptor, disrupting water and nutrient absorption and also allowing spore germination. The Btk endotoxin is highly specific for Lepidoptera caterpillars and has little effect on other insect genera or non-target organisms. There is no equivalent effect on mammals because of the absence of receptors and the different conditions in the mammalian gastrointestinal tract. Btk is not used as an adult insecticide.

Although the organism persists in the environment after spraying (mostly in soil and leaf litter), the main effect on target caterpillars is from direct ingestion of spores adhering to leaves. There seems to be little or no medium or long-term larvicidal protection for target plants, hence the need for repeated application.

1 Glare TR, O’Callaghan M. Bacillus thuringiensis Biology, Ecology and safety. 2000. Chichester.

John Wiley and sons Ltd.



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General description of Foray 48B:

• biological insecticide based on Bacillus thuringiensis kurstaki, a soil organism with wide distribution.

• Manufacturer: Valent Biosciences (previously Abbott Laboratories), part of Sumitomo Corporation.

• F48B is mainly used in commercial and non-commercial forestry protection and urban tree protection, mostly by aerial application.

The Material Safety Data Sheet is included in Appendix B, and summary of physical, chemical and toxicological information prepared for the Ministry of Agriculture and Forestry is included in Appendix C. Formulation

The manufacturer has not released the formulation or ingredient list publicly. It has been released to ERMA and ACVM as part of product registration, and to selected Ministry of Health, ARPHS and AerAqua Medicine staff, and the Minister and Associate Minister of Biosecurity. We understand that the Hamilton Medical Officer of Health has been briefed in general terms, but has not seen the ingredient list. General information on Foray 48B production and ingredients is given in the 2002 Health Risk Assessment and Appendix C. Registration

Foray 48B was registered under the Pesticides Act, and is in process for transfer to the HSNO regime under ERMA. The Agricultural Compounds and Veterinary Medicines (ACVM) group at the NZ Food Safety Authority holds current registration information. ERMA NZ considered that the new formulation did not change the hazard profile and the two formulations could be considered to be the same for the purposes of the HSNO Act. Use in Hamilton

We understand that the Hamilton moth spray operation will use the same material and application rate as the PAM operation, i.e. undiluted liquid F48B, as manufactured, with an application rate of 5-7 litres per hectare. Other Btk formulations in New Zealand

• DIPEL ES, suspension concentrate, Sumitomo Chemical Co Ltd/Nufarm NZ Ltd

• DIPEL DF water dispersible granules, Sumitomo Chemical Co Ltd/Nufarm NZ Ltd

• DELFIN, water dispersible granules, Mitsui & Co (NZ) Ltd

• Bactur, water dispersible granules, Grosafe Chemicals Ltd DiPel has organic certification for horticultural use Other Bt insecticides registered in New Zealand

• Bt aizawai - Xentari (Nufarm NZ Ltd)

• Bt aizawai with Btk - Agree (Elliott)

• Bti – Vectobac (Nufarm NZ Ltd)

Bti products are used for mosquito control, and would be expected to have similar manufacture and formulation to Btk products such as F48B.



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3 Previous Health Risk Assessments and Related Reports A number of Health Risk Assessments have been prepared on Foray 48B and Btk-based sprays both in New Zealand and elsewhere. The following reports are attached: New Zealand Reports

• Health Risk Assessment of the 2002 Aerial Spray Eradication Programme for the Painted Apple Moth in Some Western Suburbs of Auckland: a Report to the Ministry of Agriculture and Forestry. Public Health Service, Auckland District Health Board, March 2002

• Health Risk Assessment of Btk spraying in Auckland’s Eastern Suburbs to Eradicate White-Spotted Tussock Moth (Orgyia thyellina). Report to the Ministry of Health and the Ministry of Forestry, commissioned by the Northern Regional Health Authority, North Health, 4 September 1996 (ISBN 0-473-05908-8), with Addendum

• Health Risk Assessment of the Proposed 1997-1998 Control Programme for the White-Spotted Tussock Moth in the Eastern Suburbs of Auckland, Report to the Ministry of Forestry, Public Health Protection Service, Auckland Healthcare Ltd, September 1997

• Aer’aqua® Medicine Ltd (formerly Jenner Consultants Ltd). Health Surveillance following Operation Ever Green: A programme to eradicate the white-spotted tussock moth from eastern suburbs of Auckland, May 2001 (also available on the MAF website)

In summary, the main conclusions of these reports are that:

• Btk is not a human pathogen. Bt species have rarely been found as an opportunistic organism, mainly in wounds. Btk is not pathogenic for people with immunocompromising conditions or those on stomach acid-suppressing medication.

• The Btk delta endotoxin is not active in mammalian gut and has no other known effect on mammals

• The quality control processes in F48B manufacture and testing required by regulatory processes in NZ and the USA (where the material is made) are sufficient to prevent contamination by other organisms and Bacillus toxins, including bacillus enterotoxins, B cereus and B anthracis. Toxin production is determined by plasmids, and the culture and QA processes would prevent introduction of these plasmids.

• The inert ingredients are variously registered for use in cosmetics, pharmaceuticals and food in NZ, and their concentrations in F48B are within regulatory requirements.

• Some people may experience minor eye, nose, throat and respiratory irritation. The HRAs raised the possibility of asthma aggravation of asthma, which was considered biologically plausible, although epidemiological research and surveillance from the WSTM operation did not support this.

• The HRAs raised the possibility of atopic/allergic reactions for previously sensitised people, although MoH toxicological advice was that the exposure would be insufficient for people to become sensitised.

• Some people would find the odour of F48B unpleasant. Some people may experience nausea, headache or other symptoms if exposed to unpleasant smells. The PAM HRA raised this as a possibility, but there was no research or surveillance information on this.

• Available evidence does not support any effects during pregnancy on either mother or fetus, or effects on prematurity, miscarriage rates, birth weights, congenital abnormalities.



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In particular, the evidence (epidemiological and toxicological) is against a causal link between F48B exposure and congenital hypothyroidism.

• There is no evidence that F48B exposure causes thyroid dysfunction, gastroenteritis, neurological or autoimmune effects. An immunological response has been observed following exposure in some situations, but always in the absence of clinical infection.

• Spray programmes are likely to cause considerable anxiety, particularly around exposure during pregnancy, children’s exposure and fear of long term effects.

• Long term effects have not been described in published literature, and there is little reliable information. There are no known or suspected carcinogens, mutagens or teratogens in the ingredient list, and the spent culture material would not be expected to be carcinogenic, mutagenic or teratogenic.

• Risks of skin irritation from exposure to caterpillar stellae are small, except when there is massive caterpillar proliferation.

• Noise from low flying aircraft can be annoying and could produce anxiety in people with war experience. Aircraft crashes are rare, and aircraft have to meet CAA requirements.

• The HRAs included advice and recommendations on risk communication, reducing exposure and support for people with various pre-existing medical conditions. The HRAs recommended a precautionary approach for reducing exposure.

Other NZ reports attached:

• Clarification of Issues raised in “Our Case Against Moth Spraying”. Report to the Ministry of Forestry, Jenner Consultants Ltd. January 1998.

This report analysed the claims made on the Canadian STOP website about Btk/F48B. While there was some valid material on the website, many claims were based on invalid interpretations of research, and misquotation and distortion was common. Risk assessments and related reports on Btk-based insecticides from other countries include:

• International Programme On Chemical Safety (IPCS). Environmental health criteria for Bacillus thuringiensis. WHO/IPCS 1999 (available from http://www.inchem.org)

• Report of Health Surveillance Activities, Aerial spraying for Asian Gypsy moth – May 200, Seattle, WA. Washington State Department of Health, July 2001 (attached – available from www.doh.wa.gov/ehp/ts/pest.htm)

Many of the references cited in the HRAs are available on the internet, and all would be available through libraries.

4 Published literature on Btk-based sprays and spray programmes since 2002 HRA

Appendix D summarises research and other literature published since the preparation of the HRA for the PAM Aerial Spray programme, plus one review (no original research) not included in the PAM report. AerAqua and ARPHS have undertaken periodic literature searches. Separate Medline/PubMed and internet searches were done by ARPHS for this report. The more recent literature does not identify new health effects, but gives some further quantification in some cases. Most health risk assessment documents from other countries use similar source materials to the 3 Auckland HRAs.



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5 Health Monitoring and Support During the 2 Spray Programmes in Auckland

Operation Evergreen During Operation Evergreen, health enquiries were largely handled by the Public Health service and primary care services. A health surveillance programme was set up after the spray programme, and included: review and analysis of two sentinel general practices to assess whether there was any pattern of illness related to spraying, and epidemiological analysis of available health information sources, including hospital admissions, birth effects, and infectious diseases. No patterns could be found to indicate an effect at the population level. A copy of the surveillance report is attached (Health Surveillance Following Operation Evergreen, May 2001), and available from the MAF website. Painted Apple Moth Health Service The PAM Health Service was set up prior to the start of the PAM spray programme to provide health advice and support services. A detailed analysis of information gathered by the service is underway currently. An excerpt from a recent report is attached (Appendix E), indicating the range of enquiries and health concerns which people have contacted the PAM Health Service about. Note: the tables in that report give numbers of people seen about each health concern, but this does not indicate the number of people with clinically significant reactions following spray exposure. Practical Support Plans, including those for temporary relocation, are precautionary and pre-emptive in most cases. Most people have not had reactions at all because they have been prevented from any exposure to the spray. The severity table in Appendix E refers to severity of underlying condition, such as past history of specific food allergies, and not severity of reaction following spray exposure since most people in the table have had no reaction. It is not known whether these people would actually have a reaction if they were to be exposed. Waitakere City Council Early in 2003, the Waitakere City Council invited people to write to the Council, describing symptoms they may have had following spraying. In all, about 200 people wrote in. A summary (prepared by ARPHS) is included in Appendix F. The symptoms were mostly as described in the HRA (see below re asthma).

6 Health Effects and Concerns Related to Foray 48B/Btk This section summarises the current understanding of each of the health topics. The information is drawn from the 3 NZ HRAs and surveillance report from Operation Evergreen, North American HRAs, WHO reports and research papers, along with knowledge gained from the 2 spray operations in Auckland. Clinical information is from the PAM Health Service.

Condition Analysis

Asthma and respiratory conditions

Asthma is often raised as a potential risk factor. The spray is moderately acidic and is (mildly) irritant to mucosae, so an effect is plausible. The HRAs took a cautious approach and recommended people with asthma update their asthma management plans and seek advice. Epidemiological field research however, shows no detectable effect. The only epidemiological study with control group is from



October 2003

Vancouver Island, British Colombia, Canada, where asthmatic children inside and outside the spray area were assessed before, during and after a spray programme and no effect on symptoms or peak flows from spray exposure was found. The children were recruited via a hospital asthma programme, and had varying severity of symptoms, with 31% on daily inhaled steroids and a mean of 1.1 hospitalisations in the previous year (paper attached). The Operation Evergreen health surveillance programme did not find any increase in asthma presentations to GPs or hospital after spray days. The paper by Petrie et al in Auckland found no significant increase in asthma symptoms among asthmatics. Diagnosis of past or current asthma used by the PAM Health Service is based on:

• self reported statement of doctor's diagnosis

• anyone on asthma preventive medication

• confirmation from person's own GP

• specialist diagnosis via letter

• or PAM health service GP diagnosis after clinical assessment

When the PAM Health Service receives a report of possible asthma aggravation they actively follow up for medical diagnosis with GP assessments and referral to specialists if there is any possibility. No asthma aggravation events have been confirmed by the respiratory specialists. Among the people with asthma justification for a practical support plan there is one person with asthma triggered by eating some maize products who had asthma aggravated on the first two sprays days, and has since been in relocation for spray day itself with no further exacerbations. One person with asthma as a justification for a Practical Support Plan and a relevant allergy history had asthma symptoms after inadvertent outdoor exposure, but these settled without medical intervention. This person had been in relocation and returned home on the understanding that spraying was complete. However the following day a second spray was delivered to a localised area by helicopter while the person was outside. Symptoms settled with normal medication and without medical intervention. One person had a history of asthma with very impaired peak flows and symptoms on spray days, who was referred to a specialist, had sequential assessments with lung function tests over several sprays with no change found. A few people with self-managed mild asthma have experienced irritant type short term symptoms while outdoors during spraying, eg in cars, and have since avoided the area completely on spray days. All such events settled spontaneously on the day with self management.



October 2003

Severe, unstable asthmatics have been advised to avoid exposure, as a precaution, rather than being based on research evidence or history of reaction to the spray. 192 of the 629 people with practical support plans had asthma or asthma + eczema as the reason for support. These support plans were based on taking precaution for these people, rather than effects from exposure.

As part of the Waitakere City Council’s request for people to write in about symptoms, six people with possible new adult onset asthma were identified. These people were offered independent assessment, and 3 people took up the offer. They were seen by a doctor nominated by the Asthma Society, and were assessed as not having new adult onset asthma. Spray can cause throat or large airway irritation, which is generally mild and short lived. The spray droplet size is calibrated for ~120 µm, far larger than respirable size of <10µm. Approximately 0.17% of the volume of spray is <14 µm in size in bench tests done for MAF/AgriQual. Droplet sizes may change after spraying depending mainly on humidity (evaporation would be expected to reduce droplet size to some degree, although one of the “inerts” is a humectant). The make-up of the smaller particles may differ from the larger droplets, which are more likely to consist of solids and materials clumped by the sticking agent. Small particles would include water, spores (which are about 2-5 µm) and soluble components. Hyperventilation syndrome

A number of people have been diagnosed with hyperventilation, which can present with symptoms similar to asthma. This diagnosis is based on written opinion from a specialist or respiratory physiotherapist after appropriate clinical assessments.

Congenital hypothyroidism

A possible cluster was identified by a critic of the WSTM programme following discussions with a local pharmacist. Using the Ministry of Health’s guidelines for cluster investigation, ARPHS reviewed information from the National Testing Centre. 8 cases of congenital hypothyroidism were identified among children born in the spray area between 1993 and 2001. One of these children had a genetic condition, which could not have been caused by spray exposure, and so was excluded. A baby of a woman who had been in the spray zone frequently during the spray programme was also included, although her exposure was more than a year prior to pregnancy. The cluster started over a year before the WSTM operation in 1997 (3 cases prior to spraying) and only 1 case was exposed during the thyroid developmental period. The expected pattern of sub-types of congenital hypothyroidism was evident, rather than an increase in one type which might have been expected in a cluster with a single cause. A link with spray is not considered plausible.

Thyroid disease The possibility of thyroid effects was raised by a WSTM programme critic, but without any indication of a cluster existing.



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This was assessed by inviting people who had recently developed thyroid conditions to contact the PHU. Twenty on people were interviewed and information obtained from their GPs, but no unusual pattern could be detected, and no evidence of a cluster could be found, using the MoH Guideline for cluster investigation.

Infection No evidence of Btk being a pathogen. Some Bt subspecies/serovars have been found in opportunistic infections in unusual circumstances, usually involving wounds (often as a co-infection) – e.g. land mine explosion, accidential injection (mixed culture, with known pathogenic organism), eye injury of high pressure spray in spray worker. These are not comparable to exposure during aerial spray operations. Studies of agricultural workers using Bt-based spray have not found evidence of infection, although persistence or temporary colonisation in bowel, nose and conjunctiva has been found.

Bt species can be found transiently on mucosal surfaces (eye, nose, bowel), but with no evidence of invasive disease. Infection in immunocompromised people has not been shown in research literature. In the PAM programme, the 30 people listed as avoiding the spray because they are medically immuno-compromised include those with SLE, Sjogrens Syndrome, a range of cancers, HIV, poorly controlled diabetes, hepatitis C, cytomegalovirus, fibromyalgia, inflammatory bowel disease, epilepsy, polyarthritis, dermatomyositis, Hashimoto's thyroiditis (predating the spray), and rheumatoid arthritis. The disease alone is often not the complete explanation for their relocation. Situational factors may also contribute. None has had an infection related to the spraying. None is in an avoidance plan because they have had exacerbation of their illness.

There are published reports of Bt species being found in cultures obtained from normally sterile sites, not necessarily in association with spray programmes. These have generally been in mixed cultures, and the microbiologists and clinicians involved have concluded that the Bt is a contaminant rather than a pathogen, based on clinical and laboratory evidence. Antibody response has been found in people with large exposure to Bt products (e.g. spray workers), as could occur to any antigen, but consistently in the absence of infection.

Gastrointestinal: nausea, diarrhoea, wind

Feeding studies of Btk products show no increase in GI symptoms including diarrhoea. Btk can persist in the bowel, but do not appear to cause gastroenteritis. Nausea and intestinal gas have been reported by people calling the PAM Health Service and in information requested by the Waitakere City Council and spray opponents. Enterotoxins. Some Bacillus species, including Bt, can produce



October 2003

enterotoxins. Foray 48B production and QA methods are aimed at excluding enterotoxins. See attached summary of research information prepared for MAF (Appendix G).

Irritation (eyes, skin, mucosa)

Spray is mildly irritant probably because of pH and organic breakdown products of culture broth, or being hypertonic. Usually transient (few seconds). The MSDS identifies transient skin and eye irritation, but no corrosive or toxic effect.

Allergy and related

Spent broth material was identified as a potential trigger for an allergic response in people already sensitised and highly allergic. PAM Health Service criteria for accepting diagnosis of past or current allergy are: • self reported statement of doctor's diagnosis or

• confirmation from person's own GP or

• specialist diagnosis via letter or

• PAM health service GP diagnosis after clinical assessment

• NOT self diagnosis or by naturopath

Among the 55 people listed as having a food or non food product allergy as a justification for relocation or warning call, a few have had a possible reaction to the product. (a) A young person with a previously undiagnosed food allergy developed symptomatic illness during the early sprays. A specialist physician (allergist) concluded that the reaction may have been to peanuts (which is not an ingredient of the spray) and the spray was coincidental. (b) a person had urticaria during spraying and it was possibly related although specialist immunologist did not confirm this (c) a person with multiple food allergies had aggravation of general symptoms over the months of spraying. There are a small number of other people (approximately 10) with symptoms that have a temporal association to possible Foray 48B exposure but a causative relationship cannot be confirmed or excluded until patch testing is implemented. A suitable patch test antigen is being prepared.

Other people with known severe allergies to broth components have been assisted to avoid exposure, so the true rate of serious reactions is not known.

Headaches, other constitutional symptoms

Headache has been reported relatively commonly.

Several people with “multiple chemical sensitivity/chronic fatigue”-spectrum have contacted the PAM Health Service re change of symptoms. Assessments done by immunologists and rheumatologists have not identified a link with spray exposure (e.g. symptoms deteriorated without exposure, no temporal pattern).

Situational stress

This is common. Spray programmes are disruptive – to home, work, school, transport, walking etc. 70/629 people with support

l h h d th b f it ti l t



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plans have had these because of situational stress.

Pregnancy Miscarriages

No increase or unusual pattern of birth defects found following the WSTM spray programme. There are no known teratogens or mutagens in the spray ingredients. No effect on gestation or birth weight could be found from the WSTM health surveillance. Concern about miscarriage is often raised. Miscarriage is common, and would be expected to occur commonly during the spray programme. There is no evidence that miscarriages increase following spray programmes from international or NZ sources.

Endocrine disruption

This concern is commonly raised, but without evidence being presented. The inert ingredients are not known endocrine disrupters.

7 Other information and commentary sources Schools: Two surveys have been done. The NZEI conducted a survey of members, and found a proportion had experienced irritant symptoms, and that children had been off school during spray days. In the second survey, done for ARPHS, 25 school principals or secretaries were contacted post spray. This survey found that the spraying had not caused significant disruption to school functioning, although were some student and staff absences. Report by Hana Blackmore: see separate review Report by Meriel Watts: see separate review

The Health Advisory Group (HAG) has been established to advise MAF on a health surveillance and research programme. Highest priority has been given to analysis of PAM Health service information and doing research on social impact of the PAM programme.

8 Projections of health service utilisation for Hamilton, based on PAM Health Service information

Population

Appendix H shows a comparison between the population structures of the spray zones in Hamilton with those of the initial PAM spray zone and the Operation Evergreen spray zone in the Eastern suburbs of Auckland. The Hamilton population is intermediate between the others, with the PAM spray zone population being younger, and the Evergreen population being on average older. The Hamilton area has a higher proportion of Maori than the two zones in Auckland, but lower proportion of Pacific people. The PAM HRA only covered the initial spray programme, and population figures were not revised for the expanded programme. NZDep Index of socio-economic status was included in the PAM HRA, but not the Operation Evergreen HRA. NZDep was charted for each Census Area Unit in the PAM HRA report, and not reported as an average or detailed table given. Projections of the scope of health and support service utilisation are based on information from the PAM Health Service. Appendix E includes tables from a recent PAM Health Service monthly report showing (1) the number of people who have contacted the service;



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(2) the number of people who have had practical support plans developed with the PAM Health Service (which range from phone calls informing people of day of spraying, to breakfast venues outside the spray area, to social supports, to relocation during and after spray days), and;

(3) assessed medical severity of risk, which includes a small number of those who have had reactions, but is mainly those considered to be at risk because of pre-existing conditions.

Extrapolation to the Hamilton situation has a number of major caveats.

• The denominator population in West Auckland varies significantly, in part because of the change of spray programme size, but also because of the large numbers of people going in and out of the spray zone (e.g. commuters to Auckland City).

• The spray areas have different population characteristics - socio-demographics, community characteristics etc – which could affect people’s response to the spray programme and access to health and support services.

• The spray programmes are very different. The PAM programme has involved nearly 2 years of spraying, initially on a limited area, but then expanding to a larger urban area, with spraying at approximately 3-4 week intervals. The Hamilton operation is shorter (approximately 2 months), but with more frequent spraying (weekly).

The West Auckland spray zone population is approximately 160,000, and approximate figures of possible health support service demand have been calculated compared with the 30,600 population in the Hamilton spray zone. The resident population in the WSTM spray area was approximately 80,000. Projections (with a 95% confidence interval) in the following tables might be expected for a spray programme equivalent to the PAM programme.

Activity PAM Health Service Hamilton Projection (95% CI) Practical Support Plans 633 117 (96-138)

Medical Assessment 1265 237 (207-267)

Specialist assessment 196 36 (24-48)

Primary medical justification for a practical support plan: Condition PAM

HS Rate/1000 total population

Hamilton Projection (95% CI)

Allergy – prior history of allergy to relevant food or preservative

55 0.34 10 (4-16)

Asthma – prior history of any severity 192 1.2 36 (24-48)

Skin condition including eczema, but not concomitant asthma

34 0.19 6 (1-10)

Lower or upper respiratory but not asthma 45 0.28 8 (3-14)

General symptoms including irritant type at spray time

122 0.76 23 (13-32)

CFS or chemical sensitivities 64 0.4 12 (5-19)

Medical illness with immune suppression 30 0.19 6 (1-10)

Situational stress or pregnancy 87 0.54 16 (8-24)



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Description of health events Medical severity among those who receive Practical Support Plans, based on proportional extrapolation from the PAM Health Service. These figures do not represent the number of people who have had a reaction, rather the severity of the identified risk condition.

Severity Description % of PAM HS PSPs

Rate per 1000 population

Hamilton Projection

Highest severity Eg anaphylaxis to relevant foods, multiple severe food allergies in child, very severe asthma

7% 0.27 8 (3-14)

Significant medical Eg definite or unstable asthma, eczema or upper respiratory with significant severity

29% 1.1 33 (22-44)

Other medical Eg short-term irritant symptoms or mild respiratory, mild skin problems, headaches,

29% 1.1 33 (22-44)

Precautionary because of previous medical diagnosis

Eg lower respiratory: alveolitis, emphysema, bronchiectasis; lichen planus, immune disorders, rheumatoid arthritis, SLE, past/current history of Chronic Fatigue Syndrome, and major medical problems not known to be at specific risk of aggravation by spray exposure

19% 0.74 22 (13-31)

Mainly psychosocial justification

Eg pregnancy or situational stress as justification, general concerns about spraying

16% 0.62 19 (10-27)



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9 Appendices

A. Abbreviations

ACVM Agricultural Compounds and Veterinary Medicines Group of the NZ Food Safety Authority, which administers pesticide regulations.

F48B Foray 48B, the Btk-based insecticide used in the 3 aerial spray operations in New Zealand to date.

PAM HS Painted Apple Moth Health Service, operated by Aer’aqua Medicine Ltd

PSP Practical Support Plans, developed for individuals with concerns about or reactions to F48B spray. Range from phone calls on spray mornings, assistance with closing windows, social supports for transport, to providing alternative day-time venue outside the spray area, to relocation in motels during and after spray day

WSTM White Spotted Tussock Moth. Operation Evergreen was the programme to eradicate the WSTM in the eastern suburbs of Auckland in 1996/97. An extension was proposed, but not needed in 1998.



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B. Material Safety Data Sheet for Foray 48B (US Version)



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C. Summary of Foray 48B Information from MAF

Report prepared for MAF by Aer’Aqua Medicine

Foray 48 B The following tables and references provide the most up to date information available on the properties, components and effects of Foray 48B. The Ministry of Agriculture and Forestry has commissioned the preparation of this information in order to provide the public with a definitive source of scientific data on the spray used in the Painted Apple Moth eradication programme.

Foray 48B: Statement of Use and Ingredients from the Manufacturer Foray 48B is formulated with an understanding of its potential for widespread use. To ensure minimal risk to the environment and health of exposed individuals, careful consideration is given to minimizing the quantity of inert ingredients added and ensuring that the inerts used have been thoroughly tested and pose minimal risk. The majority of the formulation, more than half, is made up of water. In addition to residual fermentation growth material and food carbohydrate, preservatives and anti-evaporants are added to maintain formulation stability and ensure it can be adequately dispersed in order to maximize effectiveness at the lowest possible use rate. The inerts used in preserving the formulation are all approved for use in pesticides by the US Environmental Protection Agency (EPA). None appear on the US EPA’s list 1,inerts of toxicological concern, or list 2, inerts considered potentially toxic and a high priority for further testing. All except for one of the inerts used are approved by the US Food and Drug Administration (FDA) as food additives in the U.S. and appear in the US Federal Register as general food additives or as preservatives Generally Recognized as Safe (GRAS). Similarly, most of these components are also listed in the Canada Food and Drugs Act as Class II preservatives approved for food use.

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l P

age

19 o

f 45

Oct

ober

200

3

FOR

AY 4

8B: P

HYS

ICAL

AN

D C

HEM

ICA

L C

HAR

AC

TER

ISTI

CS

Char

acte

ristic

Da

ta

Refer

ence

Name

: (Tr

ade N

ame)

: Fo

ray

(For

ay 48

B)

Valen

t BioS

cienc

es, In

c., 20

00

Activ

e ing

redie

nt:

2.1%

- Ba

cillus

thur

ingien

sis su

bsp.

kurst

aki, L

epido

ptera

n Acti

ve to

xin

Valen

t BioS

cienc

es, In

c., 20

00

Inert

ingre

dients

: 97

.9%

“For

ay’s

inert

ingre

dients

, whic

h inc

lude v

ariou

s car

riers,

susp

ensio

n age

nts, a

nd st

abiliz

ers a

re cl

assif

ied by

the E

nviro

nmen

tal

Prote

ction

Age

ncy (

EPA)

as in

ert in

gred

ients

of mi

nimal

toxico

logica

l con

cern

to no

n-tar

get o

rgan

isms a

nd th

e env

ironm

ent (

EPA’

s Lis

t 4B

and 3

)”

“All i

nert

ingre

dients

in F

oray

form

ulatio

ns ar

e inc

luded

in 40

CFR

180.1

001.

This

list h

as be

en de

signe

d by t

he E

PA as

‘exe

mpt

from

the re

quire

ments

of a

resid

ue to

leran

ce on

raw

agric

ultur

al co

mmod

ities”

VBC

verifi

es th

at no

ne of

its B

tk for

mulat

ions c

ontai

n tox

ic ine

rt ing

redie

nts, s

uch a

s ben

zene

, xyle

ne, o

r for

malde

hyde

”

Valen

t BioS

cienc

es, In

c., 20

00

Valen

t BioS

cienc

es, In

c., 20

01

EPA

Reg.

No.

7304

9-46

Va

lent B

ioScie

nces

, Inc.,

2000

EPA

Est. N

o.

3376

2-IA

-001

Va

lent B

ioScie

nces

, Inc.,

2000

Appe

aran

ce

Tan t

o ligh

t colo

ured

liquid

Va

lent B

ioScie

nces

, Inc.,

2001

Poten

cy

10 60

0 IU/

mg or

48 B

IU/ga

l (12.7

BIL/

L)

Valen

t BioS

cienc

es, In

c., 20

01

Spec

ific gr

avity

1.1

4 ±0.0

5 Va

lent B

ioScie

nces

, Inc.,

2001

Weig

ht 9.5

1 ±0.4

2 lbs

/gal (1

.14 ±

0.05 k

g/L)

Valen

t BioS

cienc

es, In

c., 20

01

PH

4.7 ±

0.3

Valen

t BioS

cienc

es, In

c., 20

01

Disp

ersib

ility

Disp

erse

s rea

dily i

nto w

ater

Valen

t BioS

cienc

es, In

c., 20

01

Visc

osity

@ 25

ºC

Visc

osity

@ 5º

C 15

0 – 80

0 cP

(centi

poise

) 15

0 – 10

00 cP

Va

lent B

ioScie

nces

, Inc.,

2001

* BIU

– Bi

llion I

ntern

ation

al Un

its

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

20 o

f 45

Oct

ober

200

3

ENVI

RO

NM

ENTA

L C

HAR

ACTE

RIS

TIC

S Ch

arac

teris

tic

Envir

onm

ent/

Stud

ied

Orga

nism

Da

ta re

porte

d Re

fere

nce

Conc

entra

tion

Air d

uring

spra

y ca

mpaig

n / B

tk Oc

cupa

tiona

l exp

osur

e res

ults r

ange

d fro

m 0 t

o 560

0 CFU

/m3 o

f sam

pled a

ir Ge

nera

l pub

lic ex

posu

re re

sults

rang

ed fr

om 0

to 16

00 C

FU/m

3 of s

ample

d air

Spra

y wor

kers

expe

rienc

ed m

ean e

xpos

ures

from

3000

to 5.

9 x 10

6 CFU

/m3 o

f sam

pled a

ir

Sieg

el, 20

01 [E

lliott e

t al.,

1988

] Si

egel,

2001

[Nob

le et

al., 1

992]

* CFU

– Co

lony F

orming

Unit

s

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

21 o

f 45

Oct

ober

200

3

TOXI

CO

LOG

ICA

L C

HA

RAC

TER

ISTI

CS

Char

acte

ristic

Da

ta

Refe

renc

e

δ-en

dotox

ins an

d the

ir eff

ect o

n the

targ

et or

ganis

ms

Bt pr

oduc

es a

para

spor

al inc

lusion

body

durin

g spo

rulat

ion us

ually

refer

red t

o as a

crys

tal. T

his cr

ystal

is m

ade o

f pro

teins

. A la

rge n

umbe

r of r

elated

cry

stal p

rotei

ns ar

e kno

wn an

d mor

e tha

n one

prote

in typ

e can

co-a

ssem

ble in

one c

rystal

. The

se cr

ystal

ised p

rotei

ns ne

ed to

be s

olubil

ized i

n a

cater

pillar

’s gu

t in or

der t

o be a

ctiva

ted as

toxin

s Ca

terpil

lars n

eed t

o ing

est th

e Btk

crysta

l in or

der t

o be k

illed b

y it.

Upon

inge

stion

, the c

rystal

s solu

bilise

in th

e high

ly alk

aline

envir

onme

nt of

the ho

st ins

ect m

idgut.

Pro

ducin

g the

frag

ments

. (δ

-end

otoxin

s) tha

t actu

ally e

xerts

the t

oxic

effec

t in th

e lar

vae.

The

toxin

s bind

s to s

pecif

ic rec

eptor

s pre

sent

on th

e gut

memb

rane

s of th

e cate

rpilla

r’s ep

itheli

al mi

dgut

cells

. Fina

lly, th

e mem

bran

e-bo

und

δ-en

dotox

in ind

uces

the f

orma

tion o

f por

es (h

oles)

in the

midg

ut ep

itheli

al ce

ll mem

bran

e. As

a re

sult o

f por

e for

matio

n the

cells

die,

even

tually

lead

ing to

death

of th

e lar

vae.

Joun

g & C

ote,

2000

alkali

solub

ilizati

on is

a lab

orato

ry ge

nera

ted

proc

ess.

Simi

lar

proc

esse

s nev

er oc

cur

in the

envir

onme

nt no

r in

mamm

als

(mam

malia

n “gu

t” is

acidi

c)

Alka

li-solu

ble fr

actio

n fro

m the

para

spor

al cry

stal d

elta-

endo

toxin

of B.

thurin

giens

is va

r. ku

rstak

i sho

wed n

o in v

itro or

in vi

vo to

xicity

, and

no ha

emoly

tic

activ

ity.

Thom

as &

Ella

r, 19

83

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

22 o

f 45

Oct

ober

200

3

HU

MAN

HEA

LTH

OU

TCO

MES

FR

OM

EXP

OSU

RE

TO B

tk

Hum

an H

ealth

Out

com

es F

or O

ral E

xpos

ure

Dose

/ Lev

el of

expo

sure

[d

urat

ion]

St

udied

(e

xpos

ed)

grou

p

Effe

cts o

bser

ved

Refe

renc

e

Hum

an st

udies

:

1 gra

m of

formu

lated

Btk

(3 x

109 v

iable

spor

es B

tk)

per g

ram)

in ca

psule

s [da

ily fo

r 5 da

ys]

18 vo

luntee

rs Al

l of th

e sub

jects

rema

ined w

ell du

ring t

he co

urse

of th

e exp

erim

ent.

The p

hysic

al ex

amina

tions

(a de

tailed

histo

ry an

d rec

ords

of

heigh

t, weig

ht, te

mper

ature

, bloo

d pre

ssur

e, re

spira

tory r

ate, p

ulse r

ate im

media

tely a

fter e

xerci

se an

d 30 a

nd 60

seco

nds

there

after

, eva

luatio

ns of

the g

enito

urina

ry, th

e gas

troint

estin

al, th

e car

diore

spira

tory,

and t

he ne

rvous

syste

ms) b

efore,

at th

e en

d of th

e 5th d

ay te

st pe

riod a

nd in

4 or

5 we

eks l

ater,

did no

t sho

w an

y adv

erse

effec

ts. A

ll lab

orato

ry fin

dings

(inclu

ding r

outin

e ur

inalys

is, w

ith qu

alitat

ive an

d qua

ntitat

ive (w

hen i

ndica

ted) u

robil

inoge

n dete

rmina

tion,

comp

lete b

lood c

ount,

sedim

entat

ion ra

te,

blood

urea

nitro

gen,

gluco

se, b

ilirub

in, an

d thy

mol tu

rbidi

ty tes

ts) w

ere n

egati

ve.

Fishe

r R &

L.

Rosn

er, 1

959

Anim

al st

udies

:

Dose

s up t

o 24 g

rams

of

formu

lated

Btk

(2 x

1012

via

ble sp

ores

of B

tk pe

r kil

ogra

m of

body

weig

ht)

Grou

ps of

10

rats

No fa

talitie

s occ

urre

d nor

wer

e the

re an

y outw

ard s

ympto

ms of

toxic

ity. G

ross

and h

istolo

gical

exam

inatio

n of ti

ssue

s rev

ealed

no

differ

ence

s fro

m the

tissu

es of

contr

ol an

imals

. Fis

her R

& L.

Ro

sner

, 195

9

1012

spor

es of

Btk

[daily

for

5 mo

nths]

(cumu

lative

do

se: 1

.5 x 1

014 C

FU)

Mixe

d Ra

mbou

illet

/Mer

ino sh

eep,

male

No si

gns o

f illne

ss w

ere r

epor

ted

Sieg

el, 20

01

[Had

ley et

al.,

1987

]

5000

mg o

f For

ay 48

B (co

mmer

cial p

rodu

ct co

ntaini

ng B

.t.k

spor

es)/k

g bod

y weig

ht

Rats

No

oral

toxici

ty ha

s bee

n dem

onstr

ated

Valen

t Bi

oScie

nces

, Inc.,

20

01

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

23 o

f 45

Oct

ober

200

3

108 B

tk CF

U Ra

ts A

dose

did n

ot ca

use a

ny to

xic or

patho

genic

effec

ts Va

lent

BioS

cienc

es, In

c.,

2001

1.4 x

107 C

FU of

Btk

(was

hed c

ells,

24-h

lab

orato

ry gr

own c

ultur

e)

per a

nimal

[acute

ex

posu

re]

Fema

le Sp

ragu

e-Da

wley

rats

No m

ortali

ty re

porte

d W

HO, 1

999

[Sha

dduc

k, 19

80]

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

24 o

f 45

Oct

ober

200

3

Hum

an H

ealth

Out

com

es F

or In

hala

tion

Ris

k

Dose

/ Lev

el of

ex

posu

re

[dur

atio

n]

Stud

ied

(exp

osed

) gr

oup

Effe

cts o

bser

ved

Refe

renc

e

Hum

an st

udies

:

100 m

g. of

formu

lated

Bt

k (3 x

109 v

iable

spor

es pe

r gra

m) [d

aily

for 5

days

]

5 volu

nteer

s Al

l of th

e sub

jects

rema

ined w

ell du

ring t

he co

urse

of th

e exp

erim

ent.

The p

hysic

al ex

amina

tions

(a de

tailed

histo

ry an

d rec

ords

of

heigh

t, weig

ht, te

mper

ature

, bloo

d pre

ssur

e, re

spira

tory r

ate, p

ulse r

ate im

media

tely a

fter e

xerci

se an

d 30 a

nd 60

seco

nds

there

after

, and

vital

capa

city,

evalu

ation

s of th

e gen

itour

inary,

the g

astro

intes

tinal,

the c

ardio

resp

irator

y, an

d the

nervo

us sy

stems

as

well

as x-

ray e

xami

natio

ns) b

efore,

at th

e end

of th

e 5th d

ay te

st pe

riod a

nd in

4 or

5 wee

ks la

ter, d

id no

t sho

w an

y adv

erse

eff

ects.

All l

abor

atory

findin

gs (in

cludin

g rou

tine u

rinaly

sis, w

ith qu

alitat

ive an

d qua

ntitat

ive (w

hen i

ndica

ted) u

robil

inoge

n de

termi

natio

n, co

mplet

e bloo

d cou

nt, se

dimen

tation

rate,

bloo

d urea

nitro

gen,

gluco

se, b

ilirub

in, an

d thy

mol tu

rbidi

ty tes

ts) w

ere

nega

tive

Fishe

r R &

L.

Rosn

er, 1

959

3.0 x

103 t

o 5.9

x 106

Btk s

pore

s/ m3

samp

led

air. (

maxim

al ex

posu

re

value

s: 5.4

x 10

6 to 7

.2 x 1

07 or

ganis

ms)

Spra

y ope

rator

s Ge

nera

l po

pulat

ion

Durin

g the

spra

y pro

gram

me, s

ome w

orke

rs ex

perie

nced

chap

ped l

ips, d

ry sk

in, ey

e irrit

ation

, and

nasa

l drip

and s

tuffin

ess,

but

no se

rious

healt

h pro

blems

repo

rted.

The

symp

toms w

ere t

rans

ient a

nd fr

eque

ntly o

ccur

red d

uring

the b

eginn

ing of

a sp

ray r

un

and w

hen B

tk sp

ray c

once

ntrati

ons w

ere i

ncre

ased

. No s

ignific

ant d

iffere

nces

wer

e fou

nd w

ith re

spec

t to ge

nder

or sm

oking

sta

tus.

Near

ly all

the w

orke

rs ex

pose

d to h

igher

conc

entra

tions

for s

ever

al sh

ifts (5

to 20

) wer

e cult

ure-

posit

ive fo

r Bt; m

ajority

of th

e wo

rkers

rema

ined c

ultur

e-po

sitive

for 1

4 to 3

0 day

s. O

f thos

e who

wer

e cult

ure p

ositiv

e, eig

ht wo

rkers

reve

rted t

o a cu

lture

-ne

gativ

e stat

us du

ring a

proje

ct or

with

in 30

days

of pr

oject

comp

letion

. Ex

amini

ng th

e rec

ords

of 35

00 ho

spita

l eme

rgen

cy ro

om ad

miss

ions,

1140

fami

ly pr

actic

e pati

ents,

over

400 b

acter

ial cu

lture

s fro

m 10

hosp

itals

show

ed no

evide

nce f

or co

mmun

ity ill

ness

or in

fectio

ns at

tribute

d to B

tk

WHO

, 199

9 [N

oble

et al.

, 19

92]

Comm

ercia

l pro

duct:

Fo

ray 4

8B

Wor

kers

No

over

t sym

ptoms

of to

xicity

have

been

repo

rted b

y ind

ividu

als du

ring t

he us

e of th

is or

othe

r Btk

conta

ining

prod

ucts

Va

lent

BioS

cienc

es, In

c.,

2001

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

25 o

f 45

Oct

ober

200

3

Aeria

l spr

aying

of

Bacil

lus th

uring

iensis

va

r. ku

rstak

i

Resid

ents

of Or

egon

, Lan

e Co

unty

(198

5 yea

r -

abou

t 800

00

peop

le; 19

86

year

– ab

out

4000

0 peo

ple)

Of 95

subc

ultur

es of

Bac

illus s

pecie

s obta

ined f

rom

patie

nt cu

lture

s (18

diffe

rent

body

sites

or flu

ids),

55 w

ere i

denti

fied a

s B.t –

posit

ive cu

lture

s and

52 (9

5%) o

f the B

.t. iso

lates

wer

e ass

esse

d to b

e pro

bable

conta

mina

nts an

d not

the ca

use o

f clin

ical

illnes

s. F

or th

ree p

atien

ts, B

.t. co

uld ne

ither

be ru

led in

nor o

ut as

a pa

thoge

n. E

ach o

f thes

e 3 B

.t. po

sitive

patie

nts ha

d pre

-ex

isting

med

ical p

roble

ms: a

n elde

rly im

muno

comp

romi

sed p

erso

n with

unde

rlying

lung

dise

ase (

B.t. c

ultur

ed fr

om bl

ood)

; a

menta

lly re

tarde

d per

son w

ith a

spas

tic he

miple

gia an

d seiz

ure d

isord

er se

cond

ary t

o bila

teral

subd

ural

hemo

rrhag

es su

ffere

d in

a moto

r veh

icle a

ccide

nt 10

year

s befo

re (B

.t. cu

lture

d from

gallb

ladde

r con

tents)

; an i

ntrav

enou

s dru

g use

r (B.

t. cult

ured

from

an

antec

ubita

l abs

cess

. Te

lepho

ne su

rveilla

nce d

id no

t rev

eal a

ny pa

ttern

of pr

edom

inanc

e of a

ny on

e sym

ptom

comp

lex or

of in

volve

ment

of an

y sing

le or

gan s

ystem

. Sym

ptoms

wer

e tho

se co

mmon

to an

y com

munit

y (e.g

., nau

sea,

head

ache

/ dys

phor

ia, ra

sh, a

ngioe

dema

)

Gree

n et a

l., 19

90

Aeria

l app

licati

ons o

f Fo

ray 4

8B (c

ontai

ning

Bacil

lus th

uring

iensis

str

ain H

D1) o

ver 1

2 203

ha

in V

ictori

a, Br

itish

Colum

bia, C

anad

a

Resid

ents

of Vi

ctoria

regio

n, (a

ppro

x. 75

,420

peop

le)

The s

tudy i

denti

fied b

acter

ia wi

th ge

netic

patte

rns c

onsis

tent w

ith th

ose o

f Bac

illus t

hurin

giens

is su

bsp.

kurst

aki H

D1 in

9102

of

1065

9 (85

.4%) is

olates

obtai

ned f

rom

the ai

r sam

ples,

13 of

440 (

2.9%

) isola

tes ob

taine

d from

the w

ater s

ample

s, an

d 131

of 17

1 (7

6.6%

) isola

tes fr

om th

e nas

al sw

ab sa

mples

. The

analy

sis da

ta su

gges

t tha

t bac

teria

with

gene

tic pa

ttern

s con

sisten

t with

tho

se of

Bac

illus t

hurin

giens

is su

bsp.

kurst

aki H

D1 w

ere p

rese

nt bo

th in

the en

viron

ment

and i

n the

huma

n pop

ulatio

n of V

ictor

ia pr

ior to

aeria

l app

licati

ons o

f For

ay 48

B. T

he pr

esen

ce of

Bac

illus t

hurin

giens

is su

bsp.

Kurst

aki H

D1-lik

e bac

teria

in hu

man n

asal

pass

ages

incre

ased

sign

ifican

tly af

ter th

e app

licati

on of

For

ay 48

B, bo

th ins

ide an

d outs

ide th

e spr

ay zo

ne. D

espit

e this

ex

posu

re, t

he hu

man h

ealth

surve

illanc

e pro

gram

faile

d to d

etect

any c

orre

lation

betw

een t

he ae

rial a

pplic

ation

of B

acillu

s th

uring

iensis

subs

p. ku

rstak

i HD1

and s

hort-

term

healt

h effe

cts in

the g

ener

al ad

ult po

pulat

ion, in

emer

genc

y roo

m vis

its, o

r in

aggr

avati

on of

asthm

a sym

ptoms

in ch

ildre

n. W

hile B

acillu

s thu

ringie

nsis

subs

p. Ku

rstak

i HD1

-like b

acter

ia we

re de

tected

in th

e na

res o

f the h

uman

popu

lation

, the a

vaila

ble ev

idenc

e sug

gests

that

its pr

esen

ce w

as tr

ansie

nt, as

clini

cal s

ympto

ms of

activ

e na

sal-p

haryn

geal

infec

tion w

ere n

ot re

porte

d. O

vera

ll, the

huma

n hea

lth su

rveilla

nce p

rogr

am di

d not

detec

t any

shor

t-ter

m ch

ange

in he

alth s

tatus

that

could

be as

socia

ted w

ith th

e aer

ial ap

plica

tion o

f For

ay 48

B.

Valad

ares

de

Amor

im et

al.,

2001

[the C

apita

l He

alth R

egion

Of

fice,

1999

- 20

01]

Aeria

l and

Gro

und

spra

ying a

pplic

ation

of

Btk (

1996

/1997

)

A ur

ban

popu

lation

of

over

8000

0, of

whom

appr

ox.

5000

wer

e su

bject

to lon

ger d

urati

on

spra

ying

“A co

mpre

hens

ive he

alth s

urve

illanc

e pro

gram

me ha

s exa

mine

d hea

lth ou

tcome

s for

a pe

riod o

f two y

ears

after

ward

s –us

ing

indivi

dual,

loca

l, reg

ional

and n

ation

al he

alth i

nform

ation

. This

inclu

ded i

nves

tigati

ng re

siden

ts’ se

lf-rep

orted

healt

h con

cern

s, co

nsult

ation

rates

at se

ntine

l fami

ly do

ctors,

and a

revie

w of

healt

h data

sour

ces t

o esta

blish

birth

outco

mes a

nd ot

her e

vents

of

comm

unity

conc

ern.

No ad

verse

healt

h patt

erns

wer

e fou

nd, o

nce p

atter

ns w

ere e

xami

ned a

t a po

pulat

ion le

vel.

The f

requ

ency

of oc

curre

nce o

f the

follow

ing w

as no

diffe

rent

from

natur

al va

riatio

n: ea

rly bi

rths;

small

babie

s; bir

th de

fects;

cons

ultati

on ra

tes w

ith se

ntine

l fami

ly do

ctors

for as

thma,

other

resp

irator

y pro

blems

, hea

dach

es, s

kin or

eye s

ympto

ms, a

nd au

toimm

une d

isord

ers.

Ther

e was

a pa

ttern

of se

lf-rep

orts

by re

siden

ts for

irrita

nt re

spira

tory,

skin

and e

ye sy

mptom

s at th

e tim

e of s

pray

ing an

d a le

vel

of ex

pres

sed c

once

rn ab

out p

otenti

al fut

ure d

iseas

e. A

volun

tary r

egist

er of

resid

ents

expo

sed t

o the

long

er du

ratio

n pro

gram

me

MAF,

2001

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

26 o

f 45

Oct

ober

200

3

was w

ell su

ppor

ted an

d has

been

plac

ed in

the N

ation

al Ar

chive

s (Au

cklan

d Reg

ional

Offic

e) to

assis

t with

any f

uture

healt

h stu

dies.”

Aeria

l spr

aying

of F

oray

48

B co

ntaini

ng B

. th

uring

iensis

su

bspe

cies k

ursta

ki HD

1 as t

he ac

tive

ingre

dient

86 ch

ildre

n with

as

thma

Ther

e wer

e no d

iffere

nces

in as

thma s

ympto

m sc

ores

betw

een s

ubjec

ts an

d con

trols,

neith

er be

fore n

or af

ter th

e spr

ay; n

or w

ere

there

sign

ifican

t cha

nges

in P

eak E

xpira

tory F

low R

ates f

or su

bjects

after

the s

pray

perio

d. Pe

arce

, M. 2

002

Anim

al st

udies

:

10 gr

ams o

f form

ulated

Bt

k sam

ple (9

x 10

9 via

ble sp

ores

per g

ram)

[4 tim

es ov

er a

perio

d of

6 day

s; du

ratio

n of

each

expo

sure

- 15 m

in]

10 m

ice

Durin

g rep

eated

expo

sure

s of th

e mice

to in

halat

ion of

the t

est m

ateria

l, no u

ntowa

rd re

actio

n was

obse

rved i

n eith

er gr

oup.

Ob

serva

tions

of an

imals

’ well

-bein

g thr

ough

out th

e tes

t per

iod sh

owed

no de

partu

re fro

m no

rmal

in eit

her g

roup

, as w

as

demo

nstra

ted al

so by

norm

al we

ight g

ains f

or bo

th gr

oups

. Gro

ss pa

tholog

y find

ings w

ere n

egati

ve.

Fishe

r R &

L.

Rosn

er, 1

959

Appr

ox. 1

08 C

FU of

Btk

/L of

air

[4 ho

urs]

Rats

The l

ow pa

thoge

nic po

tentia

l was

demo

nstra

ted

Valen

t Bi

oScie

nces

, Inc.,

20

01

Appr

ox. 7

mg o

f For

ay/L

air

[4 ho

urs]

Rats

No

toxic

effec

ts we

re ob

serve

d Va

lent

BioS

cienc

es, In

c.,

2001

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

27 o

f 45

Oct

ober

200

3

Hum

an H

ealth

Out

com

es F

or S

kin

Expo

sure

Dose

/ Lev

el of

ex

posu

re

[dur

atio

n]

Stud

ied

(exp

osed

) gr

oup

Effe

cts o

bser

ved

Refe

renc

e

Hum

an st

udies

:

Bacil

lus th

uring

iensis

va

r. ku

rstak

i (co

mmer

cial p

rodu

ct)

Spra

y pro

ject

worke

r Af

ter a

splas

h of B

tk mi

xture

to fa

ce an

d eye

s, a w

orke

r dev

elope

d der

matiti

s, se

vere

itchin

g (pr

uritis

), bu

rning

, swe

lling a

nd

eryth

ema,

with

conju

nctiv

al inj

ectio

n. B.

t. was

cultu

red f

rom hi

s con

juncti

va. A

fter t

he tr

eatm

ent o

f eye

lid an

d skin

with

ster

oid

cream

, sym

ptoms

disa

ppea

red.

Gree

n et a

l., 19

90

Anim

al st

udies

:

Form

ulated

Btk

(app

roxim

ately

9 x 10

9 via

ble sp

ores

per g

ram)

20 w

hite m

ale

guine

a pigs

“A

dmini

strati

on of

a co

mmer

cial B

tk pr

oduc

t by i

njecti

on or

by ap

plica

tion t

o abr

aded

skin

caus

ed a

sligh

t eryt

hema

and e

dema

, ind

icativ

e of lo

cal ir

ritatio

n. Th

ere w

as no

reac

tion f

rom

its ap

plica

tion o

n inta

ct sk

in. T

here

was

no ev

idenc

e of a

ny al

lerge

nic

resp

onse

by an

y rou

te of

admi

nistra

tion.”

Fishe

r R &

L.

Rosn

er, 1

959

2.5 gr

am of

For

ay/ k

g of

body

weig

ht [si

ngle

dose

expo

sure

]

Rats

No

toxic

effec

ts we

re ob

serve

d Va

lent

BioS

cienc

es, In

c.,

2001

Fora

y 48B

[4

hour

s] Ra

bbits

Ve

ry mi

ld, te

mpor

ary d

erma

l irrita

tion w

as se

en. A

ll sign

s of ir

ritatio

n clea

red i

n all a

nimals

with

in 2 d

ays a

fter a

pplic

ation

Va

lent

BioS

cienc

es, In

c.,

2001

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

28 o

f 45

Oct

ober

200

3

Hum

an H

ealth

Out

com

es F

or O

cula

r Exp

osur

e

Dose

/ Lev

el of

ex

posu

re

[dur

atio

n]

Stud

ied

(exp

osed

) gr

oup

Effe

cts o

bser

ved

Refe

renc

e

Hum

an st

udies

:

Dipe

l [Btk

prod

uct]

A far

mer

Corn

eal u

lcer d

evelo

ped a

fter a

n acc

identa

l spla

sh of

the p

rodu

ct in

the fa

ce. T

o reli

eve i

rritati

on in

his e

ye, th

e far

mer a

pplie

d a

cortic

oster

oid oi

ntmen

t for 7

days

befor

e the

ulce

r dev

elope

d. Th

e ulce

r hea

led fo

llowi

ng in

jectio

n of g

entam

icin a

nd ce

phaz

olin.

In thi

s cas

e it is

diffic

ult to

evalu

ate w

hat a

ctuall

y cau

sed t

he ul

cer fo

rmati

on fo

r the

follo

wing

reas

ons:

- co

rticos

teroid

s may

have

contr

ibuted

to th

e for

matio

n of th

e ulce

r (on

e of th

e side

effec

ts of

cortic

oster

oids i

s dela

yed

flatte

ning a

nd m

ovem

ent o

f the c

orne

al ep

itheli

um, w

hich i

s ess

entia

l to w

ound

heali

ng);

- the

poss

ibility

that

Bt m

ay ha

ve si

mply

persi

sted i

n the

farm

er’s

eye f

ollow

ing ex

posu

re an

d tha

t a di

ffere

nt mi

cro-

orga

nism

was r

espo

nsibl

e for

the u

lcer.

Sieg

el, 20

01

[Sam

ples &

Bu

ettne

r, 19

83]

Anim

al st

udies

:

109 C

FU of

Btk

Ra

bbits

Fo

ray w

as m

oder

ately

irrita

ting i

n a ra

bbit e

ye irr

itatio

n tes

t. No

appa

rent

redn

ess o

r othe

r ocu

lar fin

dings

rema

ined 7

days

after

the

appli

catio

n of r

epor

ted do

se of

Btk

to the

eye.

Valen

t Bi

oScie

nces

, Inc.,

20

01



October 2003

REFERENCES Elliot L.J. et al., (1988) An exposure characterization of a large scale application of a biological insecticide, Bacillus thuringiensis. Appl. Ind. Hyg. 3, 119-122 Fisher R. and L. Rosner (1959) Toxicology of the Microbial Insecticide, Thuricide. Agricultural and Food Chemistry; 7(10); pp. 686-688 Green M. et al., (1990) Public Health Implications of the Microbial Pesticide Bacillus thuringiensis: An Epidemiological Study, Oregon, 1985-86. AJPH; 80(7); pp. 848-852 Hadley W.M et al., (1987) Five-month oral (diet) toxicity/infectivity study of Bacillus thuringiensis insecticides in sheep. Fund. Appl. Toxicol; 8, 236-242 Joung K.B. and J.C. Cote (2000) A review of the environmental impacts of the microbial insecticide Bacillus thuringiensis. Technical Bulletin No.29. Agriculture and Agri-Food Canada, 2000

MAF (2001) Health Surveillance following Operation Ever Green: A programme to eradicate the white-spotted tussock moth from the eastern suburbs of Auckland. Report to the Ministry of Agriculture and Forestry, May 2001, prepared by AerAqua Medicine. Noble M.A. et al., (1992) “Microbiological and Epidemiological Surveillance Programme to Monitor the Health Effects of Foray 48B Btk Spray.” Ministry of Forests, Province of British Columbia

Pearce, M. et al. (2002) The Effects of Aerial Spraying with Bacillus thuringiensis Kurstaki on Children with Asthma. Canadian Journal of Public Health; 93(1); pp. 21-25 Samples J.R. and Buettner H. (1983) Ocular infection caused by a biological insecticide. J Infect. Dis. 148, 614

Shadduck J.A. (1980) Bacillus thuringiensis serotype H-14 maximum challenge and eye irritation safety tests in mammals. Geneva, World Health Organisation, pp 1-21 (WHO/VBC/80.763)

Siegel J.P. (2001) The Mammalian Safety of Bacillus thuringiensis –Based Insecticides. Journal of Invertebrate Pathology; 77; pp 13-21 Thomas W.E and D.J. Ellar (1983) Bacillus thuringiensis var israelensis crystal delta-endotoxin: effects on insect and mammalian cells in vitro and in vivo. J Cell Sci; Mar, 60:181-97 Valadares de Amorim G. et al., (2001) Identification of Bacillus thuringiensis subsp. kurstaki Strain HD1-Like Bacteria from Environmental and Human Samples after Aerial Spraying of Victoria, British Columbia, Canada, with Foray 48B. Applied and Environmental Microbiology; 67(3); pp. 1035-1043

ValentBioSciences (2000) Foray 48B. Valent BioSciences Corporation, 04-3310/R2, October, 2000

ValentBioSciences (2001) Foray , DiPel Forest Technical Manual. Valent BioSciences Corporation, AG5137/R2, 2001 WHO, Environmental Health Criteria 217 Bacillus thuringiensis. World Health Organization, Geneva, 1999.

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

30 o

f 45

Oct

ober

200

3

D. S

umm

ary

of re

port

s pu

blis

hed

sinc

e th

e 20

02 A

uckl

and

HR

A

Ref

eren

ce

Abst

ract

/Sum

mar

y an

d C

omm

ent

Pear

ce M

, Hab

bick

B, W

illiam

s J,

Ea

stm

an M

, New

man

M.

The

effe

cts

of a

eria

l spr

ayin

g w

ith

Baci

llus

thur

ingi

ensi

s Ku

rsta

ki o

n ch

ildre

n w

ith a

sthm

a.

Can

J P

ublic

Hea

lth. 2

002

Jan-

Feb;

93(1

):21-

5.

Abst

ract

: OBJ

ECTI

VE: T

o de

term

ine

if ae

rially

spr

ayin

g a

biol

ogic

al p

estic

ide

was

ass

ocia

ted

with

an

incr

ease

in th

e sy

mpt

oms

or c

hang

e in

the

Peak

Exp

irato

ry F

low

Rat

e of

chi

ldre

n w

ith a

sthm

a. M

ETH

OD

S: A

pre

/pos

t mat

ched

pai

rs

coho

rt de

sign

was

use

d. C

hild

ren

livin

g in

the

spra

y zo

ne w

ere

mat

ched

with

chi

ldre

n ou

tsid

e of

the

spra

y zo

ne. P

eak

Expi

rato

ry F

low

Rat

es, a

sthm

a sy

mpt

oms

and

non-

asth

ma

sym

ptom

s w

ere

reco

rded

in d

iarie

s. R

ESU

LTS:

The

re w

ere

no d

iffer

ence

s in

ast

hma

sym

ptom

sco

res

betw

een

subj

ects

and

con

trols

, nei

ther

bef

ore

nor a

fter t

he s

pray

; nor

wer

e th

ere

sign

ifica

nt c

hang

es in

Pea

k Ex

pira

tory

Flo

w R

ates

for s

ubje

cts

afte

r the

spr

ay p

erio

d. C

ON

CLU

SIO

NS:

No

evid

ence

of a

dver

se e

ffect

s fro

m th

e us

e of

the

biol

ogic

al p

estic

ide

was

foun

d. W

e be

lieve

that

this

is th

e fir

st p

aper

to

addr

ess

the

issu

e of

whe

ther

or n

ot a

eria

l spr

ayin

g w

ith B

tk h

as a

har

mfu

l effe

ct o

n ch

ildre

n w

ith a

sthm

a.

Com

men

t: Th

is p

rosp

ectiv

e co

hort

stud

y fo

und

no a

ffect

on

child

ren

with

pre

-exi

stin

g as

thm

a fro

m F

oray

48B

spr

ay

expo

sure

. It

is th

e la

rges

t stu

dy o

f thi

s ty

pe to

dat

e. T

he P

AM H

RA

was

mor

e ca

utio

us in

its

reco

mm

enda

tion

for p

eopl

e w

ith a

sthm

a as

it s

eem

ed b

iolo

gica

lly p

laus

ible

that

the

irrita

nt e

ffect

of t

he s

pray

cou

ld a

ffect

peo

ple

with

pre

-exi

stin

g as

thm

a. (m

ore

sum

mar

y re

sev

erity

of t

he a

sthm

a in

the

stud

y po

pula

tion)

Petri

e K,

Tho

mas

M, B

road

bent

E.

Sym

ptom

com

plai

nts

follo

win

g ae

rial s

pray

ing

with

bio

logi

cal

inse

ctic

ide

Fora

y 48

B.

N Z

Med

J. 2

003

Mar

14

;116

(117

0):U

354.

Abst

ract

: AIM

: To

inve

stig

ate

the

effe

ct o

f aer

ial B

acillu

s th

urin

gien

sis

(For

ay 4

8B) s

pray

ing

on s

elf-r

epor

ted

sym

ptom

co

mpl

aint

s, h

ealth

per

cept

ions

, and

vis

its to

hea

lthca

re p

rovi

ders

. MET

HO

DS:

Tw

o hu

ndre

d an

d ni

nety

two

resi

dent

s w

ithin

the

Min

istry

of A

gric

ultu

re a

nd F

ores

try (M

AF) W

est A

uckl

and

spra

y zo

ne w

ere

recr

uite

d by

a d

oor-t

o-do

or s

urve

y of

hom

es w

ithin

the

mos

t int

ensi

vely

spr

ayed

are

a te

n w

eeks

prio

r to

the

first

aer

ial s

pray

ing.

Par

ticip

ants

com

plet

ed a

sy

mpt

om c

heck

list a

nd a

que

stio

nnai

re m

easu

ring

heal

th p

erce

ptio

ns. T

hree

mon

ths

afte

r the

sta

rt of

spr

ayin

g, 1

81

(62%

) of t

he o

rigin

al p

artic

ipan

ts re

spon

ded

to a

sim

ilar p

osta

l que

stio

nnai

re. S

ympt

om re

ports

, hea

lth p

erce

ptio

ns a

nd

visi

ts to

hea

lthca

re p

rovi

ders

wer

e co

mpa

red

betw

een

the

base

line

and

the

follo

w-u

p qu

estio

nnai

re. R

ates

of s

ympt

om

com

plai

nts

in re

spon

dent

s w

ith p

revi

ousl

y di

agno

sed

asth

ma,

hay

feve

r, or

oth

er a

llerg

ies

wer

e co

mpa

red

to th

ose

in

resp

onde

nts

with

out t

hese

prio

r hea

lth c

ondi

tions

. RES

ULT

S: S

ympt

om c

ompl

aint

s in

crea

sed

sign

ifica

ntly

follo

win

g th

e ae

rial s

pray

ing,

in p

artic

ular

: sle

ep p

robl

ems,

diz

zine

ss, d

iffic

ulty

con

cent

ratin

g, ir

ritat

ed th

roat

, itc

hy n

ose,

dia

rrhoe

a,

stom

ach

disc

omfo

rt, a

nd g

as d

isco

mfo

rt. A

naly

ses

show

ed a

sig

nific

ant i

ncre

ase

in s

ympt

oms

in th

ose

parti

cipa

nts

with

a

prev

ious

his

tory

of h

ay fe

ver.

Whi

le o

vera

ll se

lf-ra

tings

of h

ealth

dec

reas

ed fo

llow

ing

the

spra

ying

, mos

t res

iden

ts s

aw

thei

r hea

lth a

s un

affe

cted

by

the

spra

y pr

ogra

mm

e, a

nd th

ere

was

no

sign

ifica

nt in

crea

se in

vis

its to

gen

eral

pra

ctiti

oner

s or

alte

rnat

ive

heal

thca

re p

rovi

ders

. CO

NC

LUSI

ON

S: A

eria

l spr

ayin

g w

ith F

oray

48B

is a

ssoc

iate

d w

ith s

ome

adve

rse

heal

th c

onse

quen

ces

in te

rms

of s

igni

fican

t inc

reas

es in

upp

er a

irway

, gas

troin

test

inal

, and

neu

rops

ychi

atric

sym

ptom

s,

as w

ell a

s a

redu

ctio

n in

ove

rall

perc

eptio

n of

hea

lth in

the

expo

sed

popu

latio

n.

Com

men

t: Th

is p

aper

pro

duce

d us

eful

info

rmat

ion

on th

e le

vel o

f sym

ptom

s in

the

com

mun

ity.

Irrita

nt s

ympt

oms

(irrit

ated

thro

at, i

tchy

eye

s) w

ere

desc

ribed

in th

e PA

M H

RA.

The

gas

troin

test

inal

sym

ptom

s w

ere

not e

xpec

ted

(feed

ing

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

31 o

f 45

Oct

ober

200

3

stud

ies

of B

tk-c

onta

inin

g pr

epar

atio

ns h

ave

not f

ound

GI s

ympt

oms,

eve

n at

hig

h ex

posu

re le

vels

), an

d th

e si

gnifi

canc

e of

the

othe

r sym

ptom

s w

ould

nee

d fu

rther

ass

essm

ent b

ecau

se o

f the

met

hodo

logi

cal l

imita

tions

of t

he s

tudy

. In

tere

stin

gly,

no

sign

ifica

nt d

iffer

ence

was

foun

d in

resp

irato

ry s

ympt

oms,

con

sist

ent w

ith o

ther

rese

arch

.

The

mai

n lim

itatio

n w

ith th

e st

udy

is th

e ab

senc

e of

a n

on-e

xpos

ed c

ontro

l gro

up fo

r con

tem

pora

neou

s co

mpa

rison

. Th

e tw

o su

rvey

s w

ere

carri

ed o

ut n

early

3 m

onth

s ap

art,

and

seve

ral o

f the

sym

ptom

s in

clud

ed in

the

stud

y ha

ve s

easo

nal

varia

tion.

A re

peat

stu

dy w

ith c

ontro

l gro

up h

as b

een

prop

osed

by

the

PAM

HAG

as

part

of th

e he

alth

sur

veilla

nce

prog

ram

me.

Sieg

el J

P.

The

mam

mal

ian

safe

ty o

f Bac

illus

th

urin

gien

sis-

base

d in

sect

icid

es.

J In

verte

br P

atho

l. 20

01

Jan;

77(1

):13-

21.

Abst

ract

: The

Uni

ted

Stat

es E

nviro

nmen

tal P

rote

ctio

n Ag

ency

bet

wee

n th

e ye

ars

1961

and

199

5 re

gist

ered

177

pro

duct

s co

ntai

ning

via

ble

Baci

llus

thur

ingi

ensi

s (B

t). N

umer

ous

labo

rato

ry s

tudi

es h

ave

dem

onst

rate

d th

at B

t and

Bt p

rodu

cts

are

noni

nfec

tious

and

are

toxi

c to

mam

mal

s on

ly a

t a d

ose

> or

=10

(8) c

olon

y fo

rmin

g un

its (c

fu) p

er m

ouse

(a h

uman

eq

uiva

lent

bas

ed o

n th

e w

eigh

t of >

10(1

1) c

fu).

In c

ontra

st, a

s fe

w a

s th

ree

vege

tativ

e ce

lls o

f Bac

illus

anth

raci

s ca

n ki

ll m

ice

(a h

uman

equ

ival

ent o

f >10

(3) c

fu).

Ther

e ar

e on

ly tw

o lit

erat

ure

repo

rts o

f Bt i

nfec

tion

in m

an b

etw

een

the

year

19

97 a

nd th

e pr

esen

t, an

d al

l inf

ecte

d in

divi

dual

s ha

d ex

perie

nced

eith

er e

xten

sive

bur

ns o

r a b

last

inju

ry, w

hich

pr

edis

pose

d th

em to

infe

ctio

n. T

wo

epid

emio

logy

stu

dies

con

duct

ed d

urin

g la

rge-

scal

e ae

rial B

t ser

ovar

kur

stak

i spr

ay

cam

paig

ns re

porte

d no

incr

ease

d in

cide

nce

of il

lnes

s. S

ome

rece

nt p

aper

s ha

ve e

xpre

ssed

con

cern

abo

ut th

e pr

oduc

tion

of B

acill

us c

ereu

s en

tero

toxi

ns b

y Bt

isol

ates

. Lab

orat

ory

stud

ies

foun

d no

evi

denc

e of

illn

ess

in ra

ts a

nd s

heep

fed

Bt

prod

ucts

, nor

hav

e ep

idem

iolo

gy s

tudi

es fo

und

incr

ease

d in

cide

nce

of d

iarrh

ea d

urin

g Bt

aer

ial s

pray

cam

paig

ns.

Incr

ease

s in

hum

an a

ntib

ody

leve

ls fo

llow

ing

expo

sure

to B

t pro

duct

s ha

ve b

een

repo

rted

but t

here

was

no

incr

ease

d in

cide

nce

in a

sthm

a or

oth

er il

lnes

s. B

ased

on

labo

rato

ry s

tudi

es a

nd fi

eld

expe

rienc

e, B

t ins

ectic

ides

hav

e an

exc

elle

nt

safe

ty re

cord

.

Com

men

t: Th

is is

one

of s

ever

al re

view

s of

rese

arch

lite

ratu

re o

n Bt

pro

duct

saf

ety.

The

info

rmat

ion

iden

tifie

d in

this

pa

per w

as in

clud

ed in

the

Auck

land

HR

As fr

om o

ther

sou

rces

.

Smith

RA,

Bar

ry J

W.

Envi

ronm

enta

l per

sist

ence

of

Baci

llus

thur

ingi

ensi

s sp

ores

fo

llow

ing

aeria

l app

licat

ion.

J In

verte

br P

atho

l. 19

98

May

;71(

3):2

63-7

.

Abst

ract

: Soi

l and

leaf

pop

ulat

ions

of B

acillu

s th

urin

gien

sis

(Bt)

wer

e m

onito

red

follo

win

g ae

rial a

pplic

atio

n of

com

mer

cial

Bt

form

ulat

ions

at t

he ra

te o

f 72

billio

n in

tern

atio

nal u

nits

per

acr

e pe

r yea

r dur

ing

a 5-

year

per

iod.

Dat

a fro

m s

oil s

ampl

e sp

ore

coun

ts s

ugge

sted

that

Bt s

pore

s pe

rsis

ted

in W

asat

ch fo

rest

soi

ls fo

r up

to 2

yea

rs b

ut th

ey d

id n

ot p

rolif

erat

e. B

t is

olat

es w

ere

reco

vere

d fro

m le

af s

ampl

es 1

2 m

onth

s po

st a

pplic

atio

n fro

m s

pray

ed, p

revi

ousl

y sp

raye

d an

d fro

m

nons

pray

ed a

reas

. The

freq

uenc

y an

d di

vers

ity o

f Bt i

sola

tes

reco

vere

d fro

m le

aves

was

inde

pend

ent o

f sam

ple

area

sp

ray

hist

ory.

In a

ccor

danc

e w

ith U

.S. F

ores

t Ser

vice

crit

eria

, aer

ial a

pplic

atio

n of

Bt d

urin

g a

5-ye

ar p

erio

d re

sulte

d in

th

e er

adic

atio

n of

gyp

sy m

oth

(Lym

antri

a di

spar

, L) f

rom

the

Was

atch

Fro

nt re

gion

of t

he W

asat

ch M

ount

ain

Ran

ge,

Uta

h.

van

Net

ten

C, e

t al

The

mea

sure

men

t of v

olat

ile

The

full

repo

rt be

hind

this

pap

er is

refe

renc

ed in

the

PAM

HR

A –

refe

renc

e 85

.

The

rese

arch

ers

wer

e at

tem

ptin

g to

iden

tify

a vo

latil

e co

mpo

nent

in F

48B

to u

se a

s a

mar

ker f

or a

sses

sing

spr

ay d

rift,

Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

32 o

f 45

Oct

ober

200

3

cons

titue

nts

in F

oray

48B

, an

inse

ctic

ide

prep

ared

from

Bac

illus

th

urin

gien

sis

var.

kurs

taki

.

Sci T

otal

Env

iron.

200

0 D

ec

18;2

63(1

-3):1

55-6

0.

sinc

e Bt

k w

as w

ides

prea

d in

the

envi

ronm

ent.

Fie

ld s

ampl

es fr

om a

n ai

rcra

ft fly

over

did

not

det

ect a

ny v

olat

ile m

arke

rs.

The

sam

ples

from

the

vapo

ur in

the

F48B

con

tain

ers

was

ana

lyse

d an

d co

ntai

ned

a ra

nge

of 3

8 vo

latil

e or

gani

c co

mpo

unds

.

Com

men

t: O

nly

2 of

the

38 id

entif

ied

com

poun

ds w

ere

in th

e in

gred

ient

list

for F

48B,

the

othe

rs p

resu

mab

ly w

ere

from

th

e sp

ent b

roth

mat

eria

l, or

may

be

prod

uced

dur

ing

sam

ple

proc

essi

ng (w

hich

incl

udes

hea

ting

the

sam

ple

to 2

80o C

). At

le

ast t

en (m

ostly

silo

xane

s) m

ay b

e re

late

d to

pla

stic

s us

ed fo

r sto

rage

or s

ampl

ing.

Onl

y 2

(ace

tic a

cid

and

benz

oic

acid

) ar

e on

the

EPA

list 4

B. T

he li

st in

clud

ed b

utyl

ated

hyd

roxy

tolu

ene

(BH

T), a

nd tr

imet

hyl p

hosp

ine,

but

nei

ther

are

am

ong

the

liste

d in

gred

ient

s. T

he a

naly

sis

was

not

abl

e to

det

ect 5

of t

he s

even

list

ed in

gred

ient

s no

r did

it q

uant

ify

conc

entra

tions

.

Dew

hurs

t IC

.

Toxi

colo

gica

l ass

essm

ent o

f bi

olog

ical

pes

ticid

es.

Toxi

col L

ett.

2001

Mar

31;

120(

1-3)

:67-

72.

Pest

icid

es S

afet

y D

irect

orat

e,

Mal

lard

Hou

se, K

ings

Poo

l, YO

1 7P

X, Y

ork,

UK.

i.c

.dew

hurs

t@ps

d.m

aff.g

si.g

ov.u

k

Abst

ract

: The

maj

ority

of p

estic

ides

are

bas

ed o

n sy

nthe

tic c

hem

ical

s. R

egul

ator

y as

sess

men

ts a

re p

erfo

rmed

by

com

parin

g th

e fin

ding

s in

a ra

nge

of ro

utin

e to

xici

ty s

tudi

es, d

esig

ned

for t

estin

g ch

emic

als,

with

est

imat

es o

f exp

osur

es.

Rec

ently

ther

e ha

ve b

een

sign

ifica

nt m

oves

tow

ards

dev

elop

ing

natu

ral/b

iolo

gica

l alte

rnat

ives

. Bio

logi

cal p

estic

ides

(th

ose

base

d on

via

ble

orga

nism

s) p

rese

nt th

e re

gula

tor w

ith a

diff

eren

t set

of c

halle

nges

to th

ose

rais

ed b

y m

ost

chem

ical

pes

ticid

es. T

he c

once

rns

asso

ciat

ed w

ith b

iolo

gica

l pes

ticid

es c

an v

ary

grea

tly fr

om o

ne o

rgan

ism

to a

noth

er,

requ

iring

an

alm

ost c

ase-

by-c

ase

appr

oach

. The

kno

wn

toxi

city

of c

erta

in b

io-m

olec

ules

and

the

path

ogen

icity

of c

erta

in

orga

nism

s un

derli

nes

the

need

for a

risk

ass

essm

ent o

f bio

logi

cal p

estic

ides

. The

mai

n as

pect

s of

a h

ealth

risk

as

sess

men

t are

cha

ract

eris

atio

n of

the

orga

nism

, inf

ectiv

ity, p

atho

geni

city

, sen

sitis

atio

n an

d pr

oduc

tion

of to

xic

seco

ndar

y m

etab

olite

s. O

btai

ning

info

rmat

ion

or d

ata

on th

ese

area

s is

not

alw

ays

easy

as

ther

e ar

e no

wid

ely

acce

pted

te

st s

chem

es o

r pro

toco

ls fo

r org

anis

ms,

thou

gh g

uide

lines

are

bei

ng d

evel

oped

for t

he E

urop

ean

Com

mis

sion

(EC

). Pr

edic

ting

expo

sure

follo

win

g pe

stic

idal

use

of a

n or

gani

sm is

mad

e m

ore

com

plex

if it

mul

tiplie

s or

sec

rete

s to

xic

met

abol

ites.

Rel

iabl

e da

ta o

n ef

fect

s (la

ck o

f) as

soci

ated

with

nat

ural

ly o

ccur

ring

(bac

kgro

und)

exp

osur

es c

an s

omet

imes

pr

ovid

e co

nsid

erab

le re

assu

ranc

e. T

his

pape

r des

crib

es th

e ba

ckgr

ound

to th

e pr

opos

ed E

C s

chem

e, w

hich

has

muc

h in

co

mm

on w

ith c

urre

nt U

K pr

actic

es, a

nd p

rese

nts

thre

e ex

ampl

es o

f bio

logi

cal p

estic

ides

whi

ch h

ave

been

ass

esse

d un

der t

he e

xist

ing

UK

proc

edur

es.

Com

men

t: Th

e pa

per d

iscu

sses

ass

essm

ent f

ram

ewor

ks fo

r bio

logi

cal p

estic

ides

, and

onl

y br

iefly

des

crib

es th

e ap

prov

al

of a

bac

illus

-spe

cies

bas

ed p

rodu

ct fo

r use

on

crop

s, b

ased

on

biol

ogic

al re

sear

ch a

nd e

pide

mio

logy

.

Asse

ssm

ent o

f Env

ironm

enta

l an

d H

uman

Hea

lth E

ffect

s fro

m

Prop

osed

App

licat

ion

of F

oray

48

B in

Was

kesi

u, P

rince

Alb

ert

Nat

iona

l Par

k of

Can

ada:

dra

ft fo

r pu

blic

con

sulta

tion,

Pre

pare

d fo

r: Pa

rks

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ada

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tern

Reg

ion

This

is a

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t pre

pare

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gram

me

in A

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ta, C

anad

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t doe

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new

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info

rmat

ion.

Prep

ared

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lth

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h C

ontro

l P

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ronm

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fo

r Bac

illus

cere

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ke b

acte

ria in

feca

l sam

ples

and

on

biom

onito

ring

filte

rs. B

acte

ria w

ith th

e fo

llow

ing

char

acte

ristic

s w

ere

isol

ated

from

eig

ht in

divi

dual

s: in

trace

llula

r cry

stal

line

incl

usio

ns c

hara

cter

istic

of B

. thu

ringi

ensi

s, g

enes

for a

nd

prod

uctio

n of

B. c

ereu

s en

tero

toxi

ns, a

nd p

ositi

vity

for c

ry11

as

dete

rmin

ed b

y PC

R. D

NA

finge

rprin

ts o

f the

feca

l iso

late

s w

ere

iden

tical

to th

ose

of s

train

s is

olat

ed fr

om th

e co

mm

erci

al p

rodu

cts

used

. Wor

k pr

oces

ses

(i.e.

, spr

ayin

g) c

orre

late

d w

ith th

e pr

esen

ce o

f B. t

hurin

gien

sis

in th

e fe

cal s

ampl

es (1

02 to

103

CFU

/g o

f fec

es).

How

ever

, no

gast

roin

test

inal

sy

mpt

oms

corre

late

d w

ith th

e pr

esen

ce o

f B. t

hurin

gien

sis

in th

e fe

cal s

ampl

es.

Com

men

t: Th

is re

sear

ch is

con

sist

ent w

ith th

at re

porte

d in

the

PAM

HR

A, th

at B

t spe

cies

can

col

onis

e hu

man

inte

stin

e w

ithou

t pro

duci

ng g

astro

inte

stin

al s

ympt

oms.

Thi

s re

port

conc

erns

the

use

of 2

Bti

prod

ucts

; occ

upat

iona

l exp

osur

e w

ould

hav

e be

en h

ighe

r tha

n in

the

PAM

spr

ay a

rea.

Bac

illus

ent

erot

oxin

s w

ere

dete

cted

in th

is s

tudy

. F48

B m

anuf

actu

ring

qual

ity a

ssur

ance

pro

gram

me

incl

udes

test

ing

for e

nter

otox

ins

and

exot

oxin

s (s

ee p

23

of P

AM H

RA)

. EP

A re

gula

tions

incl

ude

crite

ria fo

r acc

epta

nce.

ER

MA/

ACVM

sho

uld

have

det

ails

on

regu

lato

ry re

quire

men

ts fo

r NZ.



October 2003

E. Excerpt from PAM Health Service Reports to MAF and Ministry of Health

The report contains the numbers and estimated rates of:

• people who have called and/or been assessed by the PAM Health Service

• reasons for people having Practical Support Plans; and

• Severity of the reasons for the Plans

These figures do not represent the number of people who have had actual reactions to the spray – this is far fewer (see table in Section 6). The information has been supplied by the PAM Health Service, Aer’aqua Medical Services.

Numbers of people assessed by the PAM Health Service

The following table summaries the information contained in Appendix A “Health Service Activity Report. A denominator of 160,000 resident population is assumed for the entire programme although any particular spray will involve some varying proportion of the overall population.

Cumulative number of new people calling the service with health concerns (from 30 Dec 01 to 28 Sept 03)

3,385 21 per thousand

Cumulative number of new people with Practical Support Plans (from 30 Dec 01 to 28 Sept 03)

633 3.9 per thousand

Cumulative number of residents assessments by a doctor in conjunction with the PAM support service (from 30 Dec 01 to 28 Sept 03)

1,265 7.9 per thousand

Cumulative number of specialist medical assessments to 28 Sept 03 196 1.2 per thousand

A practical support plan includes anything from a warning call to inform of spray schedule to relocation in a motel



October 2003

Primary medical justification for a practical support plan:

Allergy – prior history of allergy to relevant food or preservative


Asthma – prior history of any severity 192 1.2 per thousand

Skin condition including eczema, but not concomitant asthma


Lower or upper respiratory but not asthma 45 0.28 per thousand

General symptoms including irritant type at spray time 122 0.76 per thousand

CFS or chemical sensitivities 64 0.4 per thousand

Medical illness with immune suppression 30 0.19 per thousand

Situational stress or pregnancy 87 0.54 per thousand



October 2003

Medical justification for the Practical Support Plans

The “justification” listed is the one overriding reason for each person to receive a PSP, not the presence or otherwise of each condition or occurrence of a reaction Note: Epidemiological patterns, among the residents with self-reported concerns, is part of Health Service Monitoring and reported separately

Patterns of justification cumulative to date

Food allergy relevant to spray constituents, including asthma from food and multiple food allergies in young children where there is a likelihood of further manifestations of allergy developing.

38

Allergy relevant to non-food constituents of the spray, includes specific medically recognised allergy to preservatives etc.

17

Skin condition, pre-existing skin condition where precautions to prevent direct spray contact are in place, includes eczema.

34

Asthma, medical history of asthma of any severity and spray exposure precautions are in place. This is not a measure of people with aggravation of asthma due to spraying.

161

Asthma and eczema, Both asthma and eczema are medical problems and spray exposure precautions are in place.

31

Lower respiratory other than asthma, where there is a medical diagnosis of such conditions as bronchiectasis, congenital lung conditions, emphysema, alveolitis and spray exposure precautions are in place.

24

Upper respiratory, where there is a medical diagnosis of such pre-existing conditions as chronic sinusitis, tonsillitis, rhinitis, and spray exposure precautions are in place.

21

Irritant symptoms post spray including confirmed, suspected or clearly not spray related, includes sore or puffy eyes, sneezing, cough, sore throat, nausea, headaches, gastric upset, itching, transient rash, also odour problems.

122

Chronic fatigue syndrome or multiple chemical sensitivities, including self declared ME, history of spray poisonings, fibromyalgia not associated with underlying connective tissue disorder, sensitive to sprays.

64

Immune suppression of medical significance including leukaemia, HIV, post chemotherapy, SLE, fibromyalgia secondary to underlying connective tissue disorder, autoimmune disease.

30

Situational stress associated with contemporaneous medical illness or underlying psychological morbidity relevant to spraying for example war trauma, anxiety disorder.

70

Pregnancy and baby where there is no other medical problem and spray exposure precautions are in place.

17

Total* 629



October 2003

* This figure represents the total number of people who have had any category of justification at any point where they have a Practical Support Plan.

Some people may have consecutive justifications. The total is slightly greater than the number of people who have ever had a Practical Support Plan (626).

Description of health events Medical severity among those who have ever received Practical Support Services

All householders who have ever had a Practical Support Plan have been assigned one of the following categories of severity: Highest severity Eg anaphylaxis to relevant foods, multiple

severe food allergies in child, very severe asthma

7% 0.27 per thousand

Significant medical Eg definite or unstable asthma, eczema or upper respiratory with significant severity


Other medical Eg short-term irritant symptoms or mild respiratory, mild skin problems, headaches,


Precautionary because of previous medical diagnosis

Eg lower respiratory: alveolitis, emphysema, bronchiectasis; lichen planus, immune disorders, rheumatoid arthritis, SLE, past/current history of Chronic Fatigue Syndrome, and major medical problems not known to be at specific risk of aggravation by spray exposure


Mainly psychosocial justification

Eg pregnancy or situational stress as justification, general concerns about spraying


Prep

ared

for t

he M

inis

try o

f Hea

lth

Hea

lth C

onsi

dera

tions

in A

eria

l Spr

ay P

rogr

amm

es fo

r Mot

h C

ontro

l P

age

39 o

f 45

Oct

ober

200

3

HE

ALTH

SER

VICE

MED

ICAL

UPD

ATE

Totals

Jan-02

Feb-02

Mar-02

Apr-02

May-02

Jun-02

Jul-02

Aug-02

Sep-02

Oct-02

Nov-02

Dec-02

Jan-03

Feb-03

Mar-03

Apr-03

May-03

Jun-03

Jul-03

Indi

vidu

als

with

new

med

ical

con

ditio

n

00

00

00

00

00

00

00

00

00

0

Indi

vidu

als

with

pre

-exi

stin

g co

nditi

on a

ggra

vate

d by

spr

ay

0

00

00

00

00

00

00

00

00

00

Med

ical

pro

blem

s as

sess

ed

No

of n

ew re

side

nts

with

hea

lth c

once

rns

20

612

181

4542

3342

2712

650

449

240

318

942

329

017

492

2327

Cum

ulat

ive

no. o

f res

iden

ts w

ith h

ealth

con

cern

s 3,

340

No

of n

ew P

SPs

15

1435

1618

023

37

7482

110

3068

5861

53

4

Cum

ulat

ive

no. o

f PSP

s 62

6

No

asse

ssed

by

GP

– PA

M s

uppo

rt se

rvic

e

5929

2738

2313

59

2770

127

184

9010

118

456

106

5134

Cum

ulat

ive

no. a

sses

sed

by G

P 1,

233



October 2003

F. Summary of Letters on Health Related Concerns to Waitakere City Council, 2003.

Summary prepared by ARPHS for Waitakere City Council

The 200 or so letters concern the symptoms from approximately 235 people. In the table below, the first number relates to the main or first symptom reported in a letter, and the number in brackets to the number of other people reporting these symptoms. Numbers are approximate, as some people had several symptoms but the table is generally indicative of the scope of symptoms:

Irritant symptoms

• Nose, throat, sinuses

• Eyes and eyelids

• Mouth

• Nose bleeds

51 (19)31 (8)

1 (1)3 (4)

Headache and migraine 28 (14)

Respiratory

• Asthma exacerbation (2 with evacuation recommendation from chest specialist)

• Possible new asthma (no previous asthma)

• Cough

• ‘Flu-like symptoms

• Short of breath, other breathing symptoms

• Other

29 (4)

3 (1)15 (6)5 (1)

10 (2)1 (1)

Gastrointestinal

• Nausea (some with vomiting)

• Diarrhoea

• Abdominal ache/pain

• Bloating

• Mouth ulcers

6 (5)3 (2) (1) (1)1 (1)

Dermatological (skin conditions)

• Rash

• Rash from specific spray component (fish)

• Eczema (mostly exacerbation)

• Exacerbation of other skin condition

15 (7)1 61

Allergy-related

• Reaction with previous history of allergy

• Positive allergy tests (including fish)

1 (2)2



October 2003

• Hayfever-type symptoms, sneezing 3

Pregnancy

• Miscarriage 3

Constitutional symptoms

• Fatigue

• ME/Chemical sensitivity/chronic fatigue

• Faintness/dizziness

• Anxiety

• Sleep disturbance

9 (3)4 (1)2 (2)

SeveralSeveral

Other symptoms Joint ache Taste in mouth Voice loss

(1)1 (1)

1

Ten writers described effects on pets.

The writers are mainly reporting irritant symptoms (eye, nose, throat and skin irritation and rashes, cough, airways irritation). These symptoms are largely as outlined in the PAM health risk assessment report (HRA), and the previous HRA for the White Spotted Tussock Moth spray programme in 1996/7. Exacerbation of existing asthma was one of the commonest symptoms, but for three people the primary complaint was of new asthma symptoms. Further assessment would be needed to differentiate between new asthma (which has long term health implications) and short term irritant effects. The PAM HRA was cautious about asthma, indicating that asthmatics could be affected, although the HRA didn’t expect severe exacerbation to be common. For instance, there was no increase in hospital or GP presentations for asthma during the 1996/7 White Spotted Tussock Moth spray programme in Auckland City, and Canadian research found no increase in asthma among children compared with those outside the spray zone. The PAM Health Service has been assisting a number of people with severe allergies (producing skin or anaphylactic reactions), several of whom wrote to the Council detailing their symptoms. These have primarily been people with known allergies. Others with allergies have been relocated as a precaution (rather than because of symptoms), and so avoided (or reduced) their risk of reaction. Three women reported miscarriages. Unfortunately, miscarriage is very common in the general population (around a quarter of pregnancies are affected), and the information to hand from North America and the Tussock Moth programme does not indicate a link between Foray 48B or other Bt insecticides and effects on pregnancy. Many writers had found the spray programme disruptive for daily activities, especially those who left the area (several writers were on the PAM Health Service temporary relocation scheme). They also reported disruption to schooling, work, business, transport around the area, and recreational activities etc. Some also described additional expenses, mainly for health services.



October 2003

G. Is Commercial Btk Product Associated With Gastro-Enteritis In Humans?

Bacillus thuringiensis, like other bacteria, produces a number of different toxins (WHO, 1999; Glare 2000; Siegel, 2001). These toxins may include enterotoxins (diarrhoeal type) ‘similar to those produced by B. cereus’ (Glare, 2000). However, as a condition for registration for pesticide use on food in the USA, Bt active ingredients must be tested to show the absence of metabolites that are considered hazardous to humans and the environment (Laird, 1990; EPA RED, 1998; WHO, 1999; Glare 2000). Although, the Bacillus thuringiensis species is very close to B. cereus in its cultural and biochemical characters, it differs by the ability of Bt to produce parasporal crystalline inclusions known for their insecticidal activity. Bt isolates can be easily and quickly identified by H-serotyping, which is not a routine laboratory test (WHO, 1999; de Barjac H). Pathogenic B. cereus is characterised by the presence of specific plasmids, which are not present in Btk. These plasmids are the primary determinants of the toxins, which cause the specific pathogenicity of B. cereus. Evidence to date suggests that food poisoning associated with Bt exposure would be unlikely to occur. Siegel offers an explanation why Bt isolates have not been associated with food borne illness in man. He suggested that either the isolates used in commercially produced Bt did not produce enterotoxins under commercial fermentation conditions, or that enterotoxins were absent from the final product because they were degraded by the end of the fermentation run. His argument was supported by the numerous laboratory safety studies that were used to register Bt insecticides (Siegel, 2001). Foray 48B uses a long established specific strain of Btk known to produce a relatively low amount (if any) of enterotoxin. There is no valid evidence to link commercial Btk product with any episodes of diarrhoea.

References de Barjac H, Identification of H-serotypes of Bacillus thuringiensis, chapter 3, pp 37-43) EPA (1998) Bacillus thuringiensis. Registration Eligibility Decision (RED) EPA738-R-98-004, March 1998 Laird M. et al, Safety of Microbial Insecticides, CRC Press, Inc. Boca Raton, Florida, 1990 Siegel J.P (2001) The Mammalian Safety of Bacillus thuringiensis - Based Insecticides, Journal of Invertebrate Pathology, 77, pp 13 –21 Travis R. Glare and M. O’Callaghan Bacillus thuringiensis: Biology, Ecology and Safety, John Wiley & Sons, Ltd., 2000, p.350 WHO, Environmental Health Criteria 217 Bacillus thuringiensis. World Health Organization, Geneva, 1999



October 2003

H. Demographic Comparisons between Auckland and Hamilton Spray Zones

Age Structure

Hamilton PAM, initial zone Eastern Suburbs Numbers % Numbers % Numbers %

Age group

Age group

0-4 2298 7.5 1236 9.0 0-4 5889 7.35-9 2145 7.0 1161 8.4 5-14 10299 12.810-14 2322 7.6 984 7.2 15-19 2676 8.7 957 7.0 15-64 52836 65.620-29 5409 17.7 2484 18.1 30-39 4683 15.3 2376 17.3 40-49 4026 13.1 1725 12.5 50-59 3006 9.8 1251 9.1 60-69 1884 6.1 855 6.2 65-74 6342 7.970-79 1461 4.8 564 4.1 75-84 4020 5.080+ 735 2.4 153 1.1 85+ 1209 1.5

Total 30645 100 13746 100 80595 100Source WDHB (Census

2001) PAM HRA (Census 96)

WSTM HRA (Census 91)



October 2003

Ethnicity profile of 3 spray zones

Ethnicity Hamilton (%) PAM 1 (West Auckland) (%)

Evergreen (Eastern suburbs) (%)

Pakeha/European 70 56.8 75.2

Maori 21 13.7 8.8

Pacific 4 15.9 8.9

Asian 5 8.1

Other or not specified

1 7.4 7.1



October 2003

10 Annexes These Annexes include reports produced in New Zealand, technical materials and a small number of papers requested by reviewers. Other papers referred to in the HRAs and other reports are readily available through libraries (particularly university libraries) and internet services. Major health risk assessment reports from North America are available on the internet, and are referred to in the NZ Health Risk Assessments. 1 Health Risk Assessment of the 2002 Aerial Spray Eradication Programme for the Painted

Apple Moth in Some Western Suburbs of Auckland: a Report to the Ministry of Agriculture and Forestry. Public Health Service, Auckland District Health Board, March 2002

2 Health Surveillance following Operation Ever Green: A programme to eradicate the white-spotted tussock moth from eastern suburbs of Auckland, May 2001, Aer’aqua® Medicine Ltd (formerly Jenner Consultants Ltd). (also available on the MAF website)

3 Health Risk Assessment of the Proposed 1997-1998 Control Programme for the White-Spotted Tussock Moth in the Eastern Suburbs of Auckland, Report to the Ministry of Forestry, Public Health Protection Service, Auckland Healthcare Ltd, September 1997

4 Health Risk Assessment of Btk spraying in Auckland’s Eastern Suburbs to Eradicate White-Spotted Tussock Moth (Orgyia thyellina). Report to the Ministry of Health and the Ministry of Forestry, commissioned by the Northern Regional Health Authority, North Health, 4 September 1996 (ISBN 0-473-05908-8), with Addendum

5 Clarification of issues raised in “Our Case Against moth Spraying” – 1998. (needs clearance from MAF as not previously published)

6 Report of Health Surveillance Activities, Aerial Spraying for Asian Gypsy Moth – May 2000, Seattle, WA. Washington State Department fo Health, Environmental Health Programs – (www.doh.wa.gov/ehp/pest.htm accessed October 2003)

7 Human Health Surveillance During the Aerial Spraying for Control of North American Gypsy Moth on Southern Vancouver Island, British Columbia, 1999

8 Pearce M, Habbick B, Williams J, Eastman M, Newman M. The effects of aerial spraying with Bacillus thuringiensis Kurstaki on children with asthma. Can J Public Health. 2002 Jan-Feb;93(1):21-5.

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