E&R Template - Release - EPA
ERMA New Zealand
Evaluation and Review Report
Application for Approval to Import or Manufacture Eurogel for Release
Application Number: HSR09024
Prepared for the Environmental Risk Management Authority
EXECUTIVE SUMMARY
BACKGROUND INFORMATION
• OMNIA PRIMAXA LIMITED IS SEEKING APPROVAL TO MANUFACTURE EUROGEL FOR RELEASE.
• Eurogel is a fungicide containing 15 g/litre tebuconazole, 15 g/litre boric acid and 17.5 g/litre octhilinone in the form of an oil in water emulsion.
• Eurogel is proposed to be used for the control of European canker on pipfruit and Armallaria and Phytophthora on kiwifruit.
• The applicant advises that the method of application will be either painting onto the affected areas of the plants or ground-based spraying.
• When applied as a spray, Eurogel will be applied post harvest leaf fall at a maximum application rate of 10 L/ha (150 g tebuconazole/ha, 150 g/kg boric acid/ha and 175 g octhilinone/ha) with a maximum of 2 applications per year and a minimum application interval of 14 days.
• Tebuconazole, boric acid and octhilinone are present in products currently available in New Zealand.
Classification
• THE AGENCY AND THE APPLICANT HAVE INDEPENDENTLY CLASSIFIED EUROGEL BASED ON THE AVAILABLE INFORMATION ON EUROGEL AND ITS COMPONENTS. THE CLASSIFICATIONS ARE SUMMARISED IN THE TABLE BELOW:
|Hazardous Property |Applicant’s Assessment |Agency’s Assessment |
|Acute Toxicity (Oral) |6.1D |No |
|Skin Irritancy |6.3A |6.3A |
|Eye Irritancy |6.4A |6.4A |
|Skin Sensitisation |6.5B |6.5B |
|Reproductive/developmental Toxicity |6.8B |6.8B |
|Target Organ Toxicity |6.9B |6.9B |
|Aquatic Ecotoxicity |9.1B |9.1B |
• The 6.1D classification proposed by the applicant was based on the Status of Substance advice, which was incorrect.
Risk Assessment
• THE AGENCY NOTES THAT TEBUCONAZOLE HAS BEEN RECENTLY REVIEWED BY E.U., 2008.
• This review will be assessed by the Agency should tebuconazole be reassessed.
• The Agency notes that octhilinone has been recently reviewed by E.U. and was excluded from Annex 1 of the EC Directive 91/414 (PPDB 2007, 2008, 2009).
• This review will be assessed by the Agency should octhilinone be reassessed.
• The Agency’s assessment of the risks posed by Eurogel to the environment and to human health, during the substance’s lifecycle, is based on qualitative assessment and quantitative modelling using the GENEEC2 and German BBA models.
• The Agency considers that the risk assessments indicate that the risks associated with Eurogel are negligible with the proposed controls in place.
• The Agency has evaluated information supplied by the applicant about the benefits of Eurogel and considers that benefits are likely to be realised through the release of this substance.
Controls
• THE AGENCY HAS PROPOSED THAT THE DEFAULT CONTROLS FOR EUROGEL BE MODIFIED, SUCH THAT:
- no Tolerable Exposure Limits (T1), Workplace Exposure Limits (T2) or Environmental Exposure Limits (E1) are set at the present time and any default values are deleted;
- the maximum quantity allowed on passenger service vehicles (T7) is increased from 0.1 L to 1 L;
- the maximum rate for Eurogel shall be 10 L/ha (150 g tebuconazole/ha, 150 g/kg boric acid/ha and 175 g octhilinone/ha) with a maximum of 2 applications per year and a minimum application interval of 14 days;
- an approved handler control is added, but modified to apply to use only;
- further controls regarding stationary containment systems and pipework are added;
- a control which prohibits application of Eurogel onto or into water is added; and
- a control which restricts application of Eurogel to ground-based methods is added.
Agency Conclusion
• IN CONCLUSION, THE AGENCY CONSIDERS THAT THERE ARE NEGLIGIBLE RISKS TO HUMAN HEALTH AND TO THE ENVIRONMENT AND POTENTIAL BENEFITS ASSOCIATED WITH THE RELEASE OF EUROGEL. THEREFORE, THE AGENCY CONSIDERS THAT IT IS EVIDENT THAT THE BENEFITS OF RELEASING EUROGEL OUTWEIGH THE COSTS AND THE APPLICATION MAY BE APPROVED IN ACCORDANCE WITH CLAUSE 26.
TABLE OF CONTENTS
1 Application Details 5
2 Legislative Criteria for the Application 5
3 Application Process 5
4 Notification and Consultation 6
5 Application Synopsis and Information Review 6
6 Hazardous Properties, Thresholds and Classification 9
7 Default Controls 10
8 Risk Assessment 10
9 Assessment of Beneficial Effects 15
10 Controls 16
11 Overall Evaluation of Risks, Costs and Benefits 20
12 Conclusion 20
Appendix 1: Decision Path 21
Appendix 2: Hazard Classification 22
Appendix 3: Risk Assessment 27
Appendix 4: Discussion on Controls 42
Appendix 5: List of Proposed Controls for Eurogel 49
Appendix 6: Scales for Qualitative Risk Assessment 56
Appendix 7: Government Departments, Crown Entities and Interested Parties Notified 59
Appendix 8: Confidential Material 61
1. Application Details
|APPLICATION CODE |HSR09024 |
|APPLICATION TYPE |TO IMPORT OR MANUFACTURE FOR RELEASE ANY HAZARDOUS SUBSTANCE UNDER SECTION 28 OF THE|
| |HAZARDOUS SUBSTANCES AND NEW ORGANISMS ACT 1996 (“THE ACT”) |
|APPLICANT |OMNIA PRIMAXA LIMITED |
|DATE APPLICATION RECEIVED |6 APRIL 2009 |
|SUBMISSION PERIOD |22 APRIL 2009 – 4 JUNE 2009 |
|TO BE CONSIDERED BY |A COMMITTEE OF THE AUTHORITY (‘THE COMMITTEE”) |
|PURPOSE OF THE APPLICATION |TO MANUFACTURE EUROGEL FOR USE AS A HORTICULTURAL FUNGICIDE (CATEGORY A). |
2. LEGISLATIVE CRITERIA FOR THE APPLICATION
1. THE APPLICATION WAS LODGED PURSUANT TO SECTION 28.
2. This report takes into account matters to be considered in section 29; matters specified under Part II of the Act; and the relevant provisions of the Hazardous Substances and New Organisms (Methodology) Order 1998 (“the Methodology”). Unless otherwise stated, references to section numbers in this report refer to sections of the Act and clauses to clauses of the Methodology.
3. Application Process
1. EVALUATION OF THE APPLICATION WAS UNDERTAKEN BY THE ERMA NEW ZEALAND PROJECT TEAM (“THE AGENCY”) WHICH COMPRISED THE FOLLOWING STAFF MEMBERS:
|Haydn Murdoch |Advisor (Hazardous Substances) |
|Apostolos Koutsaftis |Advisor (Hazardous Substances) |
|Sekove Tinalevu |Advisor (Hazardous Substances) |
|Patrick Gemmell |Senior Advisor (Kaupapa Kura Taiao). |
2. The report was reviewed and signed out by:
|Noel McCardle |Senior Advisor (Hazardous Substances). |
3. Timeline
|Application formally received |6 April 2009 |
|Application notified |22 April 2009 |
|Submission closing date |4 June 2009. |
4. Notification and Consultation
1. The Minister for the Environment was advised of the application[1] and given the opportunity to “call-in” the application[2]. This action was not initiated.
2. The Department of Labour (Workplace Group) and the New Zealand Food Safety Authority (Agricultural Compounds and Veterinary Medicines (ACVM) Group) were identified as having a specific interest in the application and were provided with a copy of the application (excluding the confidential information but with the opportunity to access this if necessary).
4.2.1 No comments or submissions were received.
3. Other Government departments, Crown agencies and other interested parties, as listed in Appendix 7, were provided with a copy of the application summary and given the opportunity to comment or to make a submission.
4.3.1 No comments or submissions were received.
4. The application was publicly notified on the ERMA New Zealand website on 22 April 2009 and subsequently advertised in The Dominion Post, the New Zealand Herald, the Christchurch Press and the Otago Daily Times[3].
1. No submissions were received.
5. Application Synopsis and Information Review
INFORMATION SUPPLIED BY THE APPLICANT
1. The applicant supplied the following documents:
• the application;
• a confidential appendix (including full formulation data and a draft label).
Information review
2. The confidential information on the composition of Eurogel has been withheld at the request of the applicant for reasons of commercial sensitivity. The information is provided for the Committee in Confidential Appendix 8.
3. The Agency notes that tebuconazole has been recently reviewed by E.U., 2008. This report highlighted the following environmental concerns:
• It is appropriate to require that tebuconazole should be subjected to further testing for the confirmation of the risk assessment for birds and mammals and such information should be presented by the notifier.
• Moreover, it is appropriate to require that tebuconazole be subjected to further testing of their potential endocrine disrupting properties, as soon as OECD test guidelines on endocrine disruption, or, alternatively, Community agreed test guidelines exist.
This review will be assessed by the Agency should tebuconazole be reassessed.
4. The Agency notes that octhilinone has been recently reviewed by E.U. and was excluded from Annex 1 of the EC Directive 91/414 (PPDB 2007, 2008, 2009). It was phased out by 2006 as a wood preservative and will be phased out by 25/10/2009 as a food and feed area disinfectant. This review will be assessed by the Agency should octhilinone be reassessed.
5. The Agency considers that there are no significant uncertainties sufficient to influence decision making in the scientific and technical information relating to the potential adverse effects of Eurogel[4]. Therefore, the Agency considers that the information constitutes an adequate and appropriate basis for considering the application[5].
Description and use of the substance
6. Eurogel is a fungicide containing 15 g/litre tebuconazole, 15 g/litre boric acid and 17.5 g/litre octhilinone in the form of an oil in water emulsion. Eurogel is proposed to be used for the control of European canker on pipfruit, Armallaria and Phytophthora on kiwifruit.
Lifecycle
Manufacture/Importation
7. The applicant has indicated that Eurogel will be manufactured in New Zealand. Eurogel will be manufactured at Image Holdings Limited at 753 Te Atatu Road, Te Atatu Peninsular in Auckland and stored at Omnia Primaxa Limited’s storage facility at Malcolm Logistics 132 Pavilion Drive Airport Oaks Manukau.
8. While Eurogel will be manufactured in New Zealand, it is possible that the substance could be imported into New Zealand in the future. Consequently, the risks associated with the importation of Eurogel have been evaluated, so that approval of this substance will be applicable to both the importation and manufacture of Eurogel.
Transport, storage and packaging
9. Eurogel will be packed in 10 and 20 litre HDPE drums and stored in Omnia Primaxa Ltd’s Auckland storage facility at Malcolm Logistics 132 Pavilion Drive Airport Oaks Manukau, ready for sale to horticultural growers.
10. The store has procedures in place for managing a wide range of chemical products. The staff are under the control of an approved handler and are trained in and familiar with the protocols for the separation of products according to their characteristics for safe handling and storage and the measures required to be adopted in case of emergency.
11. During the course of sale and distribution the product will be stored on the premises of Omnia Primaxa Limited distribution outlets or delivered direct to users (Horticultural growers). These will all be dedicated pesticide storage facilities. The product will be handled by staff that will be trained in the procedures for managing and storing hazardous substances and in dealing with emergencies that might arise.
12. Eurogel is classified as Dangerous Goods for Road and Sea Transport (9.1B) and as such will be transported using certified DG carriers.
Use
13. Eurogel is recommended for use to treat cankers of European canker on pipfruit trees. Application to trees will be carried out by painting cankers and the immediate area or as 1-2 sprays post harvest during leaf fall. It is also recommended for the treatment of Armallaria as a stem paint and Phytophthora as a stem spray on kiwifruit.
14. The persons applying Eurogel will be required to wear appropriate protective clothing such as waterproof gloves, coat, trousers and eye protection.
15. When applied as a spray, Eurogel will be applied at a maximum application rate of 10 L/ha (150 g tebuconazole/ha, 150 g/kg boric acid/ha and 175 g octhilinone/ha) with a maximum of 2 applications per year and a minimum application interval of 14 days.
16. Spraying will be restricted to ground-based application methods.
Disposal
17. The applicant advises that the normal method of disposal of the substance will be via use.
18. Because of the value of the product, and its chemical stability, any unused material can be held over to the following season.
19. If for some reason product must be disposed of it should be buried 500 mm deep on farm at a site kept for this purpose.
20. In all cases, the substance and its packaging will be disposed of in accordance with the Hazardous Substances (Disposal) Regulations 2001 and the Resource Management Act 1991.
6. Hazardous Properties, Thresholds and Classification
1. THE AGENCY HAS EVALUATED THE INFORMATION SUPPLIED BY THE APPLICANT AND ALSO REFERRED TO OTHER DATA SOURCES IN ASSESSING THE HAZARDOUS PROPERTIES OF EUROGEL. THIS ASSESSMENT IS ATTACHED AS APPENDIX 2.
2. The applicant’s and the Agency’s classification of the hazard profiles of Eurogel are listed in Table 6.1.
Table 6.1: Summary of applicant’s and Agency’s HSNO classification of Eurogel
|Hazardous Property |Applicant’s Assessment |Agency’s Assessment |
|Acute Toxicity (Oral) |6.1D |No |
|Skin Irritancy |6.3A |6.3A |
|Eye Irritancy |6.4A |6.4A |
|Skin Sensitisation |6.5B |6.5B |
|Reproductive/developmental Toxicity |6.8B |6.8B |
|Target Organ Toxicity |6.9B |6.9B |
|Aquatic Ecotoxicity |9.1B |9.1B |
3. The Agency’s classifications are different from the applicant’s proposed HSNO classifications. The 6.1D classification proposed by the applicant was based on the Status of Substance advice which was incorrect.
4. The risk assessment in Section 8 of this report is based on the Agency’s classification of Eurogel.
7. Default Controls
1. BASED ON THE HAZARD CLASSIFICATION SHOWN IN TABLE 6.1, THE SET OF ASSOCIATED CONTROLS HAS BEEN IDENTIFIED. THESE DEFAULT CONTROLS ARE LISTED IN APPENDIX 4.
2. The Authority is able to vary the default controls and impose controls under sections 77 and 77A to produce a set of controls relevant to Eurogel. Variations and additional controls for Eurogel are considered in Section 10 of this report.
8. RISK ASSESSMENT
IDENTIFICATION OF POTENTIALLY NON-NEGLIGIBLE RISKS AND COSTS
1. Potentially non-negligible risks were identified for evaluation following clauses 9 and 11, which incorporate sections 5, 6 and 8.
2. A “cost” is defined in Regulation 2 of the Methodology as “the value of a particular adverse effect expressed in monetary or non-monetary terms”. Thus, these have been assessed in an integrated fashion together with the risks of the adverse effects in the following assessment.
3. The applicant has identified potential sources of risk to the environment and to human health and safety through release, spillage or exposure throughout the lifecycle of the substance. The Agency has also identified potential sources of risk and these, along with those identified by the applicant, are tabulated in Table 8.1.
Table 8.1: Potential sources of risks associated with Eurogel
|Lifecycle Activity |Associated Source of Risk |
|Manufacture / Import |An incident during the manufacture or importation of Eurogel resulting in spillage and |
| |subsequent exposure of people or the environment to the substance. |
|Packing |An incident during the packing of Eurogel resulting in spillage and subsequent exposure of |
| |people or the environment to the substance. |
|Transport or storage |An incident during the transport or storage of Eurogel resulting in spillage and subsequent |
| |exposure of people or the environment to the substance. |
|Use |Application of Eurogel resulting in exposure of users or bystanders or the environment; or an |
| |incident during use resulting in spillage and subsequent exposure of users or the environment to|
| |the substance. |
|Disposal |Disposal of Eurogel or packaging resulting in exposure of people or the environment to the |
| |substance. |
Assessment of potentially significant risks
4. In accordance with sections 5 and 6 and clauses 9 and 12, the Agency has assessed the potentially non-negligible risks of this substance in terms of risks to the environment, to human health and safety, to the relationship of Māori to the environment, to society and the community, to the market economy, and to New Zealand’s international obligations.
5. The Agency notes that the evidence provided by the applicant and additional evidence found by the Agency, relating to the hazardous properties of Eurogel, is largely scientific in nature[6]. However, as some of the evaluation of risks, costs and benefits has been carried out on a qualitative basis, it is recognised that there is a degree of uncertainty in the risk analysis.
6. The analysis of risk takes into account the controls that derive from the HSNO Regulations (in particular the default controls identified in Appendix 4) and from other legislation such as the Resource Management Act 1991 and the Health and Safety in Employment Act 1992. That is, the analysis assumes controls are in place.
7. A quantitative risk assessment has been carried out to evaluate the level of risk to operators, bystanders and the environment arising from the use of Eurogel as an agricultural spray (see Appendix 3).
8. A qualitative assessment has been undertaken for all other stages of the lifecycle. In these cases, the level of risk has been evaluated on the basis of the magnitude and likelihood of adverse effects occurring to people or the environment (see Appendix 3).
Assessment of the risks to the environment
9. The Agency has classified Eurogel as being toxic in the aquatic environment (9.1B). Both tebuconazole and octhilinone are considered persistent in the environment. Thus, a range of organisms in the environment may be adversely affected if exposed to Eurogel.
10. The Agency considers that the likelihood of exposure to the environment is greatest during use of the substance.
11. This quantitative assessment of the environmental risks associated with the use of Eurogel show that it presents a low risk to the aquatic environment and a low risk the terrestrial environment. However, the Agency notes that a there is a lack of aquatic fate data for octhilinone and that octhilinone is considered very toxic and persistent in the aquatic environment.
12. The Agency notes the results of the quantitative modelling and considers that addition of the following controls will reduce the level of risk to the environment to negligible:
• Approved handler controls. The Agency considers that requiring people using the substance to be approved handlers, will minimise the risks associated with exposure to the aquatic and terrestrial environments;
• Prohibiting the application of Eurogel into or onto water;
• Setting a maximum application rate; and
• Restricting the application of Eurogel to ground based methods.
13. The risks of Eurogel to the environment (with controls in place) at various stages of its lifecycle are summarised below in Table 8.2 and discussed more fully in Appendix 3.
Table 8.2: Level of risk of Eurogel to the environment.
|Lifecycle Stage |Potential Adverse Effect |Likelihood of Adverse |Magnitude of |Level of Risk |
| | |Effect Occurring |Adverse Effect | |
|Use |Use resulting in death or |Quantitative assessment indicated that there was a low risk to |
| |adverse effects to aquatic |the aquatic environment from the use of Eurogel. The Agency |
| |organisms in the environment. |considers that the application of controls will reduce this risk|
| | |to negligible. |
|Disposal |Disposal resulting in death or |Highly improbable |Minor |Negligible |
| |adverse effects to aquatic | | | |
| |organisms in the environment | | | |
Assessment of the risks to human health and safety
14. The Agency has classified Eurogel as a skin irritant (6.3A), an eye irritant (6.4A), a skin sensitiser (6.5B), a reproductive/developmental toxicant (6.8B) and a target organ toxicant (6.9B).
15. In the Agency’s opinion, chronic hazards normally require repeated exposure to the substance for the adverse effects to occur and are therefore most relevant to the end-users.
16. The Agency notes that Eurogel can be applied as a paint or as a spray. The Agency considers that human exposure when Eurogel is used as a paint will be less than when it is sprayed. Consequently no modeling of exposures when Eurogel is applied as a paint has been performed.
17. The Agency assessed the health risk to operators via spray application on the basis of the German BBA model predictions for exposure estimates. The quantitative modelling indicates that at the highest application rates the exposure to Eurogel, when used as recommended on the label, is not likely to present a high health risk to the mixers or applicators, as long as “full” Personal Protective Equipment (PPE) is worn during mixing, loading and applying the substance. The use of respirators is not required.
18. The Agency notes that the requirement for PPE is triggered as a default control for Eurogel as a result of its 6.3A, 6.4A, 6.5B, 6.8B and 6.9B classifications. The Agency, therefore, concludes that the health risk to operators, with controls in place, is negligible. Further details on this quantitative assessment are given in Appendix 3.
19. The Agency notes that the main potential source of exposure to the general public from Eurogel (other than via food residues) is via spray drift. The Agency has undertaken an assessment of the risks to public/bystander health using the United Kingdom Pesticide Safety Directorate’s (PSD) current formula to assess public/bystander exposure for pesticides which are of low volatility and which are typically applied as sprays either by boom sprayers, broadcast air assisted sprayers or hand held sprayers. The results of this modelling indicate that the risks posed to bystanders from the use of Eurogel are considered to be at acceptable levels and the default controls triggered by the toxicity hazards associated with the substance are sufficient to mitigate risks. The Agency, therefore, concludes that the health risk to bystanders is negligible. Further details on this quantitative assessment are given in Appendix 3.
20. The risks of Eurogel to human health and safety (with controls in place) at various stages of the lifecycle are summarised below in Table 8.3 and discussed more fully in Appendix 3.
Table 8.3: Level of risk of Eurogel to human health and safety.
|Lifecycle stage |Potential Adverse Effect |Likelihood of |Magnitude of Adverse|Level of Risk |
| | |Adverse Effect |Effect | |
| | |Occurring | | |
| |Skin sensitisation |Highly improbable |Minor to moderate |Negligible |
| |Reproductive/ |Quantitative assessment indicates that the chronic risks to human |
| |Developmental toxicity |health and safety are acceptable when PPE is worn. This reduces |
| |Target organ toxicity |the level of risk to negligible. |
|Importation, transport or |Skin or eye irritancy |Highly improbable |Minimal |Negligible |
|storage | | | | |
| |Skin sensitisation |Highly improbable |Minor to moderate |Negligible |
|Use |Acute effects: operators & bystanders (qualitative assessment) |
| |Skin or eye irritancy |
| |Reproductive/ |Quantitative assessment indicated that the chronic risks to human |
| |Developmental toxicity |health and safety are acceptable if PPE is worn during mixing, |
| |Target organ toxicity |loading and application. The use of PPE reduces the level of risk |
| | |to negligible. |
| |Chronic effects: bystanders (quantitative assessment) |
| |Reproductive/ |Quantitative assessment indicated that the chronic risks to |
| |Developmental toxicity |bystander human health and safety are acceptable and the level of |
| |Target organ toxicity |risk is considered to be negligible. |
|Disposal |Skin or eye irritancy |Highly improbable |Minimal |Negligible |
| |Skin sensitisation |Highly improbable |Minor to moderate |Negligible |
| |Reproductive/ |Quantitative assessment indicates that the chronic risks to human |
| |Developmental toxicity |health and safety during disposal are acceptable and the level of |
| |Target organ toxicity |risk is considered to be negligible. |
Relationship of Māori to the Environment
21. The Agency has considered this application in accordance with the clauses 9(b)(i) and 9(c)(iv) and sections 6(d) and 8. In addition, the framework contained in the ERMA New Zealand user guide “Working with Māori under the HSNO Act 1996” has been used to assess the effects of this application on the relationship of Māori to the environment.
22. The Agency notes that Eurogel triggers a number of hazardous properties giving rise to the potential for cultural risk including the deterioration of the mauri of taonga flora and fauna species, the environment and the general health and well-being of individuals and the community.
23. In addition, the introduction and use of this substance has the potential to inhibit the ability of iwi/Māori to fulfil their role as kaitiaki, particularly in relation to the guardianship of waterways given the highly ecotoxic nature of the substance to aquatic species, and potential risks to the mauri ora of human health under prolonged exposure to this substance.
24. On considering the information outlined here and elsewhere in this report, the Agency considers a minimal impact from Eurogel on the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, wāhi tapu, valued flora and fauna and other taonga to be highly improbable. In addition there is no evidence to suggest that the controlled use of Eurogel will breach the principles of the Treaty of Waitangi.
25. The overall level of risk is therefore considered to be negligible assuming that the substance will be handled, stored, transported, used, and disposed of, in accordance with the explicitly stated default and additional controls proposed in this report, and any other controls required by other legislation.
26. However, the Agency notes that should inappropriate use, or accident, result in the contamination of waterways or the environment generally, that users notify the appropriate authorities including the relevant iwi authorities in that region. This action should include advising them of the contamination and the measures taken to contain and remediate.
Assessment of the risks to society and the community
27. There are not expected to be any significant adverse impacts on the social environment with the controlled use of Eurogel, apart from the health effects and environmental effects already discussed. Consequently, the Agency considers that this aspect of potential risk need not be considered further.
Assessment of the risks to the market economy
28. Taking into account the level of risk to the environment and to human welfare, no sources of additional risk have been identified that could result in an adverse economic impact on a community.
29. The Agency notes that direct economic costs will be borne by the applicant and users of the substance. The HSNO default controls intentionally do not manage direct economic effects. These are for suppliers and users of the substance to address.
New Zealand’s international obligations
30. The Agency does not anticipate that Eurogel will pose any risks to New Zealand’s international obligations.
9. ASSESSMENT OF BENEFICIAL EFFECTS
POTENTIALLY NON-NEGLIGIBLE BENEFITS
1. A “benefit” is defined in Regulation 2 of the Methodology as “the value of a particular positive effect expressed in monetary or non-monetary terms”. Benefits that may arise from any of the matters set out in clauses 9 and 11 were considered in terms of clause 13.
2. The applicant claims that the approval of Eurogel will provide the following benefits:
1. Effective control of European canker in pipfruit and Armallaria control in kiwifruit where alternatives are limited.
2. When used correctly, Eurogel could decrease fungal infections in the wood of horticultural crops improving the general health of these crops with a subsequent monetary gain from improved production and an extended life span of trees/vines resulting from disease reduction.
3. Increase profits and employment opportunities within Omnia Primaxa Limited.
3. The Agency considers that the economic and related benefits to be derived from the use of Eurogel are potentially significant.
Likely effects of the substance being unavailable
4. In accordance with section 29, consideration has been given to the likely effects of Eurogel being unavailable.
5. The Agency notes that there are similar fungicide products already available in New Zealand with a comparable range of hazards, but none that combine the three active ingredients in the same formulation.
6. The likely effects of Eurogel being unavailable would thus be a reduction in consumer choice for end-users and a reduction in sales for Omnia Primaxa Limited and employment opportunities in the company.
Risk reduction implications
7. The applicant has not provided information on any significant risk reduction implications for the import or manufacture of Eurogel for release. The Agency notes that there are other products available in New Zealand which contain tebuconazole, boric acid or octhilinone as active ingredients.
10. Controls
SETTING OF EXPOSURE LIMITS AND APPLICATION RATES
1. Control T1 relates to the requirement to limit public exposure to toxic substances by the setting of Tolerable Exposure Limits (TELs), which are derived from Acceptable Daily Exposure (ADE) values. The Agency notes that based on the proposed use pattern, ADEs are not required to be set for any components of this substance and subsequently this control may be deleted. (See Appendix 4).
2. Control T2 relates to the requirement to limit worker exposure to toxic substances by the setting of Workplace Exposure Standards (WESs). No WES values are proposed for any components of Eurogel at this time (See Appendix 4).
3. Control E1 relates to the requirements to limit exposure of non-target organisms in the environment through the setting of Environmental Exposure Limits (EELs). It is proposed that no EELs are set at this time for Eurogel and the default values are deleted (see Appendix 4).
4. Control E2 relates to the requirement to set an application rate for a class 9 substance that is to be sprayed on an area of land (or air or water) and for which an EEL has been set. As no EEL has been proposed for Eurogel, the Agency is not able to propose the setting of a maximum application rate under this regulation. However, the Agency notes that there is uncertainty caused by a lack of aquatic fate data for octhilinone and that octhilinone is considered very toxic and persistent in the aquatic environment (see Appendix 3). The Agency, therefore, considers it appropriate to set a maximum application rate under section 77A (see paragraph 10.5).
Proposed additions and modifications to controls
5. The Agency notes that the risk quotients derived from the quantitative modelling and a lack of aquatic fate data for octhilinone, indicate that restrictions on the use of Eurogel are necessary to mitigate the potential risks to the environment (refer Appendix 3). Accordingly, the Agency considers that the application of controls addressing these risks will be more effective than the specified (default) controls in terms of their effect on the management, use and risks of the substance (section 77A(4)(a)). Consequently, the following additional control is proposed for Eurogel to restrict the level of risk to the environment:
1. “The maximum application rate for Eurogel shall be 10 L/ha (150 g tebuconazole/ha, 150 g/kg boric acid/ha and 175 g octhilinone/ha) with a maximum of 2 applications per year and a minimum application interval of 14 days”.
2. “Eurogel shall not be applied onto or into water”
3. “The method of application of Eurogel shall be limited to ground based application only.”
6. The Agency notes that the specified controls do not address the risks associated with stationary container systems, nor do they allow for dispensation where it is unnecessary for any associated pipework to have secondary containment. Accordingly, the Agency considers that the application of controls addressing these risks will be more effective than the specified (default) controls in terms of their effect on the management, use and risks of the substance[7]. The proposed controls are shown in Table 5.1 of Appendix 5.
7. Control EM12 relates to the requirements for secondary containment of pooling substances[8]. The EM12 secondary containment requirements have been triggered for Eurogel as a result of its 9.1B classification. The Agency considers that the risks associated with the containment of substances which are not class 1 to 5 substances (i.e. do not ignite or explode) are different to those associated with class 1 to 5 substances. Consequently the Agency considers that the secondary containment requirements can be reduced. The Agency considers that these reduced secondary containment measures are adequate to manage the risks of a spillage of Eurogel. Therefore, the proposed additional control, which varies the EM12 control, is more cost-effective in terms of managing the risks of the substance. The proposed controls are shown in Table 5.1 of Appendix 5.
8. The Agency considers that the following control should be added to Eurogel as the lack of aquatic fate data for octhilinone (refer Appendix 3) means that the adverse effects of exposure to Eurogel may be greater than the adverse effects which would usually be associated with a substance given a 9.1B classification[9]:
1. “(1) Eurogel must be under the control of an approved handler when the substance is –
(a) applied in a wide dispersive manner; or
(b) used by a commercial contractor.
(2) However, Eurogel may be handled by a person who is not an approved handler if –
(a) an approved handler is present at the place where the substance is being handled; and
(b) the approved handler has provided guidance to the person in respect of the handling; and
(c) the approved handler is available at all times to provide assistance, if necessary, to the person while the substance is being handled by the person.”
9. Control I16[10] includes a requirement to identify certain toxic components on product labels. The Agency, consistent with the guidance provided by the Global Harmonised System (GHS), considers that regulation 25(e) should be varied such that the concentration cut-offs that apply to a component with a hazard classification of 6.5, 6.6, 6.7, 6.8 or 6.9, for the purpose of triggering this requirement, should be as follows:
|HSNO Classification of Component |Concentration Cut-off for Label (%) |
|6.5A, 6.5B |0.1[11] |
|6.6A, 6.7A |0.1 |
|6.6B, 6.7B |1 |
|6.8A, 6.8C |0.3 |
|6.8B |3 |
|6.9A, 6.9B |10 |
10. The Agency considers that the following controls should be varied under section 77(4)(b) for Eurogel, as the variations will not significantly increase the adverse effects of the substance:
1. Control T7 relates to restrictions on the carriage of hazardous substances on passenger service vehicles. The Agency notes that the trigger quantity for this control was varied for the sensitisation hazard for pesticides transferred to the Act under the Hazardous Substances (Pesticides) Transfer Notice 2004. Consequently, the Agency considers that the quantity of Eurogel triggering these requirements should likewise be varied from 0.1 L to 1 L.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
1.
2.
3.
4.
5.
6.
7.
8.
11. The Agency considers that the following controls may be combined[12] for Eurogel as they relate to the same requirements:
1. Controls T4 and E6 which relate to requirements for equipment used to handle hazardous substances.
2. Controls P13 and P15 which relate to requirements for packaging hazardous substances.
3. Controls D4 and D5 which relate to requirements for disposal of Eurogel.
Control precedents
12. The Agency considered the Authority’s approvals given to pesticides under Part 5 of the Act as well as those transferred to the Act under the Hazardous Substances (Pesticides) Transfer Notice 2004 (as amended).
Summary of controls
13. The Agency considers that the customised controls listed in Appendix 5 should apply to Eurogel.
Environmental user charges
14. Section 96 provides that the Authority may identify and report to the Minister where it considers that a reduction in the likely occurrence of adverse effects similar to that achieved by the controls attached to any substance could be achieved by any environmental user charge, or a combination of an environmental user charge and controls.
15. The Agency considers that use of controls is the most effective means of managing the risks throughout the lifecycle of Eurogel. The imposition of an environmental user charge instead of, or in combination with controls, is therefore not required at this time.
11. OVERALL EVALUATION OF RISKS, COSTS AND BENEFITS
1. THE AGENCY CONSIDERS THE RISKS OF EUROGEL TO THE ENVIRONMENT AND HUMAN HEALTH TO BE NEGLIGIBLE.
2. The Agency does not consider there to be significant risks to Māori cultural wellbeing, society and the community, the market economy, or to New Zealand’s international obligations.
3. The Agency has taken the type and severity of the risks, and the characteristics of such risks into account, and considers that the overall level of risk posed by the substance is negligible.
4. The Agency considers that there are benefits associated with the release of Eurogel as are specified in Section 9 of this report.
5. Thus, the Agency considers that it is evident that the benefits of releasing Eurogel outweigh the costs.
12. Conclusion
1. OMNIA PRIMAXA LIMITED HAS APPLIED FOR APPROVAL TO MANUFACTURE FOR RELEASE IN NEW ZEALAND THE SUBSTANCE IDENTIFIED AS EUROGEL.
2. The Agency considers Eurogel triggers the following hazard classifications:
• 6.3A Skin irritancy
• 6.4A Eye irritancy
• 6.5B Skin sensitisation
• 6.8B Reproductive/developmental toxicity
• 6.9B Target organ systemic toxicity
• 9.1B Aquatic ecotoxicity.
3. The Agency considers that there are negligible risks to the environment and human health and benefits associated with the release of Eurogel. Therefore, the Agency considers that it is evident that the benefits of releasing Eurogel outweigh the costs and the application may be approved in accordance with clause 26.
4. The Agency considers the controls listed in Appendix 5 should apply to Eurogel.
Appendix 1: Decision Path
[pic]
APPENDIX 2: HAZARD CLASSIFICATION
CLASSIFICATION OF EUROGEL
Data from effects testing of the formulation were not provided for any hazard endpoint for Eurogel so classification was estimated using information on the effects of the components and mixture rules. A summary of the physical, toxicity and ecotoxicity hazard classification associated with Eurogel and its components is provided in Table A2.1 to A2.3. The relevant sections of the User Guide to Thresholds and Classifications under the HSNO Act (ERMA 2008a) that describe the mixture rules are listed in Table A2.4.
Data quality – overall evaluation
The Agency has adopted the Klimisch et al (1997) data reliability scoring system for evaluating data used in the hazard classification and risk assessment of chemicals (section 1.2.4 in ERMA 2008a). The data used by The Agency to classify Eurogel are predominantly the classifications which have been officially gazetted during the transfer process and are publicly available through the HSNO Chemical Classification Information Database (CCID) (ERMA 2008b). Some of these data are low quality by current international standards.
The Agency acknowledges that there are frequently data gaps in the hazard classification for chemicals which have been in use internationally for a long time. International programmes such as the OECD High Production Volume programme (OECD 1990) and REACH (EU 2006) are progressively working towards filling these data gaps. As new information becomes available, and resources permit, The Agency will endeavour to update the HSNO classifications for those substances.
The effect of the lower quality data on the overall evaluation of the effects of Eurogel was significant because of the uncertainties generated due to the lack of sufficient data to model the environmental fate of one of the active ingredients. As a result an environmental risk assessment could only be performed for two of the active ingredients.
Table A2.1: Summary of the physical hazard classifications of Eurogel
|Endpoint |Class 1 |Class 2 |Class 3 |Class 4 |Class 5 |Class 8.1 |
|Component | | | | | | |
|Tebuconazole |NA |NA |NA |ND |NA |ND |
|Boric acid |No |NA |NA |No |No |ND |
|Octhilinone |No |NA |No |NA |No |No |
|A |No |NA |No |NA |ND |ND |
|B |No |NA |No |NA |No |ND |
|C |ND |NA |No |ND |ND |ND |
|D |No |NA |ND |NA |ND |ND |
|E |No |NA |ND |ND |ND |ND |
|F |No |No |No |No |No |No |
ND = no data/insufficient data/inconclusive data
NA = not applicable
*Formulation test data provided
#Classification based on data from components
[add additional notes as necessary]
Table A2.2: Summary of the toxicity hazard classifications of Eurogel
|Endpoint |6.1 |
|Component |(oral) |
|Subclass 6.1 Acute Toxicity |Part V, Chapter 10, Page 12 |
|Subclass 6.3/8.2 Skin Irritancy/Corrosivity |Part V, Chapter 11, Page 7 |
|Subclass 6.4/8.3 Eye Irritancy/Corrosivity |Part V, Chapter 12, Page 9 |
|Subclass 6.5 Contact and Respiratory Sensitisation |Part V, Chapter 13, Page 8 |
|Subclass 6.6 Mutagenicity |Part V, Chapter 14, Page 5 |
|Subclass 6.7 Carcinogenicity |Part V, Chapter 15, Page 8 |
|Subclass 6.8 Reproductive Developmental Toxicity |Part V, Chapter 16, Page 11 |
|Subclass 6.9 Target Organ Systemic Toxicity |Part V, Chapter 17, Page 10 |
|Subclass 9.1 Aquatic Ecotoxicity |Part VI, Chapter 19, Page 18 |
|Subclass 9.2 Soil Ecotoxicity |Part VI, Chapter 20, Page 8 |
|Subclass 9.3 Terrestrial Vertebrate Ecotoxicity |Part VI, Chapter 21, Page 7 |
|Subclass 9.4 Terrestrial Invertebrate Ecotoxicity |Part VI, Chapter 22, Page 5 |
References
ERMA New Zealand (2008a) User Guide to HSNO Thresholds and Classifications. ERMA New Zealand, Wellington.
ERMA New Zealand (2008b) HSNO Chemical Classification Information Database (CCID)
European Union (2006) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
Klimisch, HJ, Andreae, E, Tillman, U (1997). A systematic approach for evaluating the quality of experimental and ecotoxicological data. Regulatory Toxicology and Pharmacology 25: 1–5.
OECD (1990) Manual for Investigation of HPV Chemicals. Retrieved 23 January 2008.
Appendix 3: Risk Assessment
INTRODUCTION
Quantitative risk assessments have been carried out to evaluate the level of risk to operators, bystanders and the environment arising from the use of Eurogel as an agricultural spray.
Qualitative assessments have been undertaken for all other stages of the lifecycle. In these cases, the level of risk has been evaluated on the basis of the magnitude and likelihood of adverse effects occurring to people or the environment (see Appendix 6 for a description of the scales used for qualitative assessment).
Human health risk assessment
Assessment of risks to human health – manufacture and packaging
The Agency has qualitatively assessed the risks of Eurogel to human health and safety during manufacture and packaging and considers the risks to be negligible.
This assessment is based on the following considerations:
• Manufacturing and packaging facilities for Eurogel will be required to meet the HSNO requirements for equipment, emergency management and provision of information (e.g. Safety Data Sheets (SDS)) as well as the requirements of Good Manufacturing Practice (GMP) and the Health and Safety in Employment Act (H&SE Act).
• The Agency considers that it is highly improbable that workers will suffer skin or eye irritancy from Eurogel, given requirements for personal protective equipment (PPE), and compliance with HSNO information provisions (e.g. labels, advertising, SDS). Furthermore, the magnitude of skin and eye irritancy is considered minimal, given the temporary nature of effects.
• The Agency considers that it is highly improbable that workers will receive skin sensitisation from Eurogel, given requirements for PPE and compliance with the HSNO information provisions (e.g. labels, advertising and SDS). The magnitude of skin sensitisation is considered minor to moderate based on the sensitivity of the exposed parties.
• Quantitative assessment of the chronic risks to human health associated with exposure to Eurogel during use, indicated an acceptable level of risk as long as PPE was used. As workers involved in manufacture and packing of Eurogel will be required to comply with the requirements for PPE as well as comply with Department of Labour (DoL) requirements for health and safety, the Agency considers the level of risk to workers to be negligible.
• The Agency considers the risk of repeated exposure to bystanders during manufacture is sufficiently remote that it is not necessary to address, given that the general public are normally excluded from manufacturing facilities.
Assessment of risks to human health – importation, storage and transport
The Agency has qualitatively assessed the risk of Eurogel to human health and safety during importation, transportation and storage and considers the risks to be negligible.
This assessment is based on the following considerations:
• Workers and bystanders could only be exposed to the substance during transport and storage in isolated incidents where spillage occurs.
• The Agency considers that it is highly improbable that a spillage of Eurogel will occur during importation, transport or storage and workers or bystanders will suffer skin or eye irritancy, given adherence to the HSNO controls (e.g. packaging, identification and emergency management) and the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994 (as applicable). Furthermore, the magnitude of skin and eye irritancy is considered minimal, given the temporary nature of effects.
• The Agency considers that it is highly improbable that a spillage of Eurogel will occur during importation, transport or storage and workers or bystanders will suffer skin sensitisation, given adherence to the HSNO controls (e.g. packaging, identification and emergency management) and the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994 (as applicable). The magnitude of skin sensitisation is considered minor to moderate based on the sensitivity of the exposed parties.
• The Agency considers the risk of reproductive/developmental or target organ effects from Eurogel during importation, transport or storage to be sufficiently remote that it is not necessary to address, given that exposure could only occur in isolated spillage incidents.
Assessment of risks to human health - disposal
The Agency has qualitatively assessed the risk to human health and safety during disposal of Eurogel, and considers the risks to the health and safety of people to be negligible.
This assessment is based on the following considerations:
• If Eurogel is disposed of by means other than use, this will be in accordance with the requirements of the Hazardous Substances (Disposal) Regulations 2001 and the Resource Management Act 1991.
• The Agency considers that it is highly improbable that workers will suffer skin or eye irritancy from Eurogel during disposal, given that Eurogel will generally be disposed of by use. Furthermore, the magnitude of skin and eye irritancy is considered minimal, given the temporary nature of effects.
• The Agency considers that it is highly improbable that workers will suffer skin sensitisation from Eurogel during disposal, given that Eurogel will generally be disposed of by use. The magnitude of skin sensitisation is considered minor to moderate based on the sensitivity of the exposed parties.
• The Agency notes that quantitative assessment of the chronic risks to operators associated with exposure to Eurogel during use indicated an acceptable level of risk as long as PPE is used. This assessment includes the possibility of prolonged and repeated exposure to Eurogel during use. The Agency considers it is less likely that workers or bystanders could be repeatedly exposed to Eurogel during disposal to such an extent that target organ toxicity effects occur and therefore considers the chronic risk to human health during disposal of Eurogel to be negligible.
Assessment of risks to human health - use
The Agency has qualitatively assessed the acute risks of Eurogel to human health and safety during use and considers the risks to be negligible.
This assessment is based on the following considerations:
• The Agency considers that it is highly improbable that users will suffer skin or eye irritancy from Eurogel, given the HSNO requirements for PPE, approved handlers and provision of hazard and precautionary information on the product label. Furthermore, the magnitude of skin and eye irritancy is considered minimal, given the temporary nature of the effects.
• The Agency considers that it is highly improbable that users will suffer skin sensitisation from Eurogel, given the HSNO requirements for PPE, approved handlers and provision of hazard and precautionary information on the product label. The magnitude of skin sensitisation is considered minor to moderate based on the sensitivity of the exposed parties.
Operator Exposure Assessment
The Agency notes that Eurogel can be applied as a paint or as a spray. The Agency considers that human exposure when Eurogel is used as a paint will be less than when it is sprayed, noting that the T5 personal protective equipment control is triggered. Consequently no modeling of exposures when Eurogel is applied as a paint has been performed.
For the spray application of Eurogel, the Agency has undertaken an assessment of risks to operator health using the United Kingdom Pesticide Safety Directorate’s interpretation of the German BBA Model to estimate operator exposure to Eurogel. This model estimates the exposure of workers to a pesticide during mixing, loading and during spray application, in mg/kg person/day (). The derived values consider both dermal and inhalation exposure routes.
The BBA model can use either the geometric mean or the 95th percentile model - the geometric mean was used for assessing Eurogel. The BBA model provides for a range of different spray applications (tractor-mounted/trailed sprayers and hand-held sprayers) and formulation types (liquid, wettable powder and wettable granule). Additionally, the BBA model also allows flexibility to vary protective clothing (hands, head and body). Five different scenarios were modeled for Eurogel as shown in Table A3.1.
The Agency has only assessed exposure to tebuconazole since the AOEL of tebuconazole is significantly lower than the AOEL of the other active ingredients. The applicant states that the maximum application rate of Eurogel is 10L Eurogel/ha which is equivalent to 0.15 kg tebuconazole./ha.
Table A3.1 details the estimated exposure for each scenario modeled. The following points have been taken into account for the purposes of calculating the estimated exposure. For each model only the conservative scenario as described below, has been addressed:
• an application rate of 0.15 kg ai/ha;
• the substance is sprayed using a tractor mounted/trailed broadcast air-blast sprayer;
• a work rate of 8 hectares per day (the default value for orchard spraying used in the German BBA model) is used in the absence of specific work rate data in the New Zealand context;
• a 13% percutaneous absorption value was used based on EFSA Report 2008 and
• the bodyweight for operators is set at 70 kg.
Table A3.1: Estimated exposure to tebuconazole for 70 kg operator under five different exposure scenarios as predicted from the UK PSDs interpretation of the BBA Model
|Exposure scenario |Estimated operator Exposure (mg/kg bw/day) |
|No personal protective clothing and equipment (PPE) during |0.03 |
|mixing, loading and application | |
|Gloves only during mixing and loading |0.026 |
|Gloves only during application |0.03 |
|Full PPE during mixing, loading and application (excluding |0.0016 |
|respirator) | |
|Full PPE during mixing, loading and application (including |0.0012 |
|respirator – A1P2) | |
Calculation of Acceptable Operator Exposure Level (AOEL)
The toxicological endpoint for assessment of occupational (worker) and bystander risks is the AOEL (Acceptable Operator Exposure Level). The AOEL is the maximum daily dose considered to be without adverse health effect for operators, workers and bystanders. It is based on the most appropriate NOAEL from relevant studies and is calculated by dividing the NOAEL by one or more uncertainty (safety) factors selected on the basis of the extent and quality of the available data, the species for which data are available and the nature of the effects observed.
AOEL = NOEL (most relevant study)
Safety Factors
Selection of NOEL:
From the 90-day dog study an overall NOAEL of 3 mg/kg bw/d was derived based on findings of hypertrophy in zona fasciculata cells of the adrenals. No adverse effects were seen in a dermal study in rabbits up to the highest dose of 1000 mg/kg bw/d.
With respect to assigning an appropriate NOAEL to calculate the AOEL, The Agency has taken the likely duration and frequency of worker exposure into consideration. Given these factors, The Agency considers it appropriate to use the NOAEL of 3 mg/kg bw/day from the study detailed above.
In calculating the AOEL, The Agency has used a combined safety factor of 100 to account for intra- and interspecies variation. In the absence of specific oral absorption data for tebuconazole, the Agency has assumed 100% oral absorption.
AOEL = 3 mg/kg bw/day x 100% = 0.03 mg/kg bw/day.
100
Calculation of Risk Quotients and Operator Risk Assessment
To assess the risks to operators The Agency has divided the estimated exposure values as calculated from the exposure modeling by the AOEL to derive a risk quotient (RQ) for each exposure scenario modeled (Table A3.2).
RQ = Estimated Operator (or Bystander) Exposure
AOEL
An RQ > 1 indicates the likelihood of a risk to the operator (or bystander).
Table A3.2: Risk quotients determined for each exposure scenario for Eurogel.
|Exposure scenario |Estimated operator exposure |RQ |
| |(mg/kg bw/day) | |
|No PPE during mixing, loading and application |0.03 |1 |
|Gloves only during mixing and loading |0.026 |0.87 |
|Gloves only during application |0.03 |1 |
|Full PPE during mixing, loading and application |0.0016 |0.05 |
|(excluding respirator) | | |
|Full PPE during mixing, loading and application |0.0012 |0.04 |
|(including respirator) | | |
The only exposure situations in which risks to operators are considered to be acceptable (RQ < 1) are when gloves are worn during mixing and loading and full PPE is worn during mixing, loading and applying the substance. Use of a respirator has little effect on risk quotients. This indicates full PPE should be worn by operators when mixing, loading and/or applying Eurogel. The Agency notes that PPE is triggered as a default control for Eurogel as a result of its 6.3A, 6.4A, 6.5B, 6.8B and 6.9B classifications.
Operator exposure assessment – Boric acid and octhilinone
Since the NOAEL for boric acid and octhilinone are greater than for tebuconazole, the Agency considers that the use of full PPE as indicated for the tebuconazole assessment as well as other controls like labelling will adequately manage the risks from all the active ingredients and protect the operator.
Public health exposure and risk assessment
The main potential source of exposure to the general public from Eurogel (other than via food residues which will be considered as part of the registration of this substance under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997) is via spray drift. The results from the quantitative modeling of operator exposure indicate there is a risk to operators from Eurogel if gloves and full PPE is not worn during mixing and loading and loading and applying the substance respectively.
The Agency has undertaken an assessment of risks to public/bystander health using the United Kingdom Pesticide Safety Directorate’s (PSD) current formula to assess public/bystander exposure for pesticides which are of low volatility and which are typically applied as sprays either by boom sprayers, broadcast air assisted sprayers or hand held sprayers () (PSD, 2008).
Systemic exposure = (PDE x SC x %absorbed) + (PIE x SC x 100%)/BW
| |PDE |SC |% absorbed |PIE |BW (bodyweight (70 kg). |
| | | |(percentage dermal | | |
| | | |absorption) | | |
|Tractor-mounted/trailed |3.7 ml spray |0.15 mg/ml |13% |0.002ml spray |70 kg |
|boom sprayer: hydraulic | | | | | |
|nozzles | | | | | |
• PDE (potential dermal exposure): 3.7 ml spray
• SC (concentration of tebuconazole in spray) calculation: Draft label recommends maximum application rate: 10000 ml product/ha with 1000 L of water/ha.
SC (tebuconazole) =10000/1000 x % a.i/100
= 10000/1000 x 1.496/100
= 0.15 g/L or 0.15 mg/ml
• PIE (potential inhalation exposure): 0.002 ml spray
The following measurements as used by PSD have been adopted by the Agency for the purposes of calculating the estimated exposure from spray drift:
• For broadcast air-assisted spray, the average potential dermal exposure for a bystander, positioned 8 metres downwind from the sprayer and the average amount of spray passing through the breathing zone were 3.7 and 0.002 ml spray/person, respectively.
Using these data, exposure to tebuconazole from the use of Eurogel can be estimated as follows assuming no protection from clothing and 100% inhalation, retention and absorption of PIE:
Systemic exposure = (PDE x SC x % absorbed + (PIE x SC x 100%).
BW
= (3.7 x 0.15 x 0.13)+ (0.002 x 0.15 x 1)
70
= 0.001 mg/kg bw/day
AOEL = 0.03 mg/kg bw/day
RQ = 0.03
Risks to the general public are considered to be at acceptable levels (RQ < 1) from ground based applications.
Bystander exposure assessment – Boric acid and octhilinone
Given that boric acid and octhilinone are less toxic than tebuconazole and that risks to bystander are acceptable, the Agency considers that risks to the general public from exposure to boric acid and octhilinone will not be significantly different from exposure to tebuconazole.
Summary and conclusions of the human risk assessment
The outcome of the quantitative assessment of risks posed to operators from the use of Eurogel indicates that a significant risk to health of operators is likely to be posed without gloves during mixing and loading and full PPE during mixing, loading and applying of the substance. Therefore, gloves during mixing and loading and full personal protective equipment during spraying is required. This will be provided for on the label and in the T5 control.
Also the T5 control will be sufficient to protect operators during the paint application of Eurogel.
Quantitative assessments of risks posed to the general public from the use of Eurogel are considered to be at acceptable levels and the default controls triggered by the toxicity hazards associated with the substance are sufficient to mitigate risks.
Environmental exposure and risk assessment
Assessment of environmental risks - manufacture, importation, transport and storage
The Agency has qualitatively assessed the risks to the environment of Eurogel during manufacture, importation, transportation and storage and considers the risks to be negligible.
This assessment is based on the following considerations:
• The magnitude of adverse effects on the environment from a spillage during manufacture, importation, transport or storage are considered by the Agency to be moderate, as although the substance is toxic to the aquatic environment, any spill would involve small quantities which would lead to localised effects only.
• The Agency also considers such an event to be highly improbable given adherence to the HSNO controls (e.g. packaging, identification and emergency management) and the Land Transport Rule 45001, Civil Aviation Act 1990 and Maritime Transport Act 1994 (as applicable).
Assessment of environmental risks – disposal
The Agency has qualitatively assessed the risks to the environment of disposal of Eurogel and considers the risks to be negligible.
This assessment is based on the following considerations:
• Eurogel will generally be disposed of by normal use as a fungicide.
• If Eurogel is disposed of by means other than use, this will be in accordance with the requirements of the Hazardous Substances (Disposal) Regulations 2001 and the Resource Management Act 1991. The Agency considers the likelihood of adverse effects to the environment arising from disposal to be highly improbable and the magnitude of such effects minor.
Assessment of environmental risks - use
For Class 9 substances, irrespective of the intrinsic hazard classification, the ecological risk can be assessed for a substance by calculating a risk quotient based on an estimated exposure concentration. Such calculations incorporate toxicity values, exposure scenarios (including spray drift, application rates and frequencies), and the half lives of the component(s) in soil and water. The calculations provide an Estimated Environmental Concentration (EEC) which, when divided by the LC50 or EC50, gives a risk quotient (RQ).
Acute RQ = EECshort term Chronic RQ = EEClong term
LC50 or EC50 NOEC
If the RQ exceeds a predefined level of concern, this suggests that it may be appropriate to refine the assessment or to apply the approved handler control (AH1) control and/or other controls to ensure that appropriate matters are taken into account to minimize off-site movement of the substance. Conversely, if a worst-case scenario is used, and the level of concern is not exceeded, then in terms of the environment, there is a presumption of low risk which is able to be adequately managed by such things as label statements (warnings, disposal). The AH1 control can then be removed on a selective basis.
Levels of concern (LOC) developed by the US EPA (Urban and Cook 1986) and adopted by the Agency, to determine whether a substance poses an environmental risk are provided in Table A3.3.
Table A3.3: Levels of concern as adopted by the Agency.
|Endpoint |LOC |Presumption |
|Aquatic (fish, invertebrates) |
|Acute RQ≥ |0.5 |High acute risk |
|Acute RQ |0.1-0.5 |Risk can be mitigated through restricted use |
|Acute RQ< |0.1 |Low risk |
|Chronic RQ≥ |1 |High chronic risk |
| | | |
|Plants (aquatic and terrestrial) |
|Acute RQ≥ |1 |High acute risk |
| | | |
|Mammals and birds |
|Acute dietary RQ≥ |0.5 |High acute risk |
|Acute oral dose [granular|0.5 |High acute risk |
|products] RQ≥ | | |
|Chronic RQ≥ |1 |High chronic risk |
Aquatic risk
Assessment of Expected Environmental Concentration
The Agency has used the Generic Estimated Environmental Concentration Model v2 (GENEEC2) surface water exposure model (US EPA 2001) to estimate the EEC of tebuconazole, boric acid and octhilinone in surface water which may potentially arise as a result of spray drift and surface runoff from the applicant’s proposed New Zealand use pattern.
GENEEC Input parameters-Tebuconazole
The parameters used in the GENEEC2 modeling are listed in Table A3.4 and represent the recommended use on pip fruit (highest rate), a conservative estimate.
Table A3.4: Input parameters for GENEEC2 analysis.
| |Tebuconazole |Reference |
|Application rate |0.150 kg ai/ha |Product label |
|Application frequency |2 times per season |Product label |
|Application interval |14 days |Product label |
|Koc |803 (lowest value) |Fritz 1988, 1993 |
|Aerobic soil DT50 |770 days |PMRA, 2006 |
|Pesticide wetted in? |No |Product label |
|Methods of application |Airblast |Product label |
|‘No spray’ zone |No |Product label |
|Water solubility |32 ppm |PMRA, 2006 |
|Aerobic aquatic DT50 |1386 days |PMRA, 2006 |
|Aqueous photolysis DT50 |590 days |PMRA, 2006 |
Output from the GENEEC2 model.
The output from GENEEC2 modeling is shown in Table A3.5.
Table A3.5 GENEEC2 output tebuconazole
RUN No. 1 FOR Tebuconazole ON Pipfruit * INPUT VALUES *
-----------------------------------------------------------------
RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP
ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)
-----------------------------------------------------------------
.134(.265) 2 14 803.0 32.0 ORCHAR(9.7) .0 .0
FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)
--------------------------------------------------------------------
METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED
(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)
--------------------------------------------------------------------
770.00 2 N/A 590.00-73160.00 ********* 1360.23
GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001
--------------------------------------------------------------------
PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC
--------------------------------------------------------------------
7.92 7.89 7.72 7.35 7.09
The Estimated Environmental Concentrations (EEC’s) for tebuconazole as estimated by GENEEC2 are:
Peak EEC 7.92 µg/L=0.00792 mg/L
Chronic EEC (21-days) 7.72 µg/L=0.00772 mg/L
Chronic EEC (90-days) 7.09 µg/L=0.00709 mg/L
Assessment of acute risk
Table A3.6: Aquatic Ecotoxicity endpoints to be used in risk assessment.
|Acute risk |Chronic risk |
|Species |LC/EC50 (mg/L) |Species |NOEC (mg/L) |
|Fish |4.4 |Fish |0.012 |
|Crustacea |4 |Crustacea |0.12 |
|Algae |0.1444 | | |
Table A3.7: Acute risk quotients derived from the GENEEC2 model and toxicity data.
| |Peak EEC from GENEEC2 (mg/L) |LC50 or EC50 |RQ (Acute) |
| | |(mg/L) |EEC/ LC50 or EC50 |
|Fish |0.00792 |4.4 |0.00180 |
|Crustacea | |4 |0.00198 |
|Algae | |0.1444 |0.05484 |
When compared against the relevant acute levels of concern (Table A3.3), the acute RQs derived from the GENEEC2 modeling for [active] indicate the following:
For fish and crustacean: the acute risk is low
For algae: the acute risk is low
Assessment of chronic risk
Table A3.8: Chronic risk quotients derived from the GENEEC2 model and chronic aquatic toxicity data.
| |90 days - EEC from GENEEC2 (mg/L) |NOEC |RQ (Chronic) |
| | |(mg/L) |EEC/ NOEC |
|Fish |0.00711 |0.012 |0.5908 |
| |21 days - EEC from GENEEC2 (mg/L) |NOEC |RQ (Chronic) |
| | |(mg/L) |EEC/ NOEC |
|Crustacea |0.00772 |0.12 |0.0643 |
When compared against the relevant chronic levels of concern (Table A3.3), the chronic RQs derived from the GENEEC2 modeling for tebuconazole indicate the following:
For fish and crustacean: the chronic risk is low
For algae: As no chronic ecotoxicity data was available for tebuconazole, no estimation of chronic risk was able to be made.
Based on the acute RQs for fish, crustacean and algae and chronic RQs for fish and crustacean, the risk of tebuconazole as used in Eurogel is considered low.
GENEEC Input parameters-Boric acid
The parameters used in the GENEEC2 modeling are listed in Table A3.4 and represent the recommended use on pip fruit (highest rate), a conservative estimate.
Table A3.9: Input parameters for GENEEC2 analysis.
| |Boric acid |Reference |
|Application rate |0.150 kg ai/ha |Product label |
|Application frequency |2 times per season |Product label |
|Application interval |14 days |Product label |
|Koc |62 |HERA, 2005 |
|Aerobic soil DT50 |0 days |Default* |
|Pesticide wetted in? |No |Product label |
|Methods of application |Airblast |Product label |
|‘No spray’ zone |No |Product label |
|Water solubility |59400 ppm |HERA, 2005 |
|Aerobic aquatic DT50 |0 days |Default* |
|Aqueous photolysis DT50 |0 days |Default* |
*Default = stable (0) (USEPA EFED 2001)
Output from the GENEEC2 model.
The output from GENEEC2 modeling is shown in Table A3.10.
Table A3.10 GENEEC2 output boric acid
RUN No. 1 FOR Boric Acid ON pipfruit * INPUT VALUES *
--------------------------------------------------------------------
RATE (lb/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP
ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)
--------------------------------------------------------------------
.134(.267) 2 14 62.0 59400.0 ORCHAR(9.7) .0 .0
FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)
--------------------------------------------------------------------
METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED
(FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)
--------------------------------------------------------------------
.00 2 N/A .00 .00 .00
8
GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001
--------------------------------------------------------------------
PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY
GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC
--------------------------------------------------------------------
14.84 14.84 14.80 14.73 14.67
The Estimated Environmental Concentrations (EEC’s) for tebuconazole as estimated by GENEEC2 are:
Peak EEC 14.84 µg/L=0.01484 mg/L
Chronic EEC (21-days) 14.80 µg/L=0.0148 mg/L
Chronic EEC (90-days) 14.67 µg/L=0.01467 mg/L
Assessment of acute risk
Table A3.11: Aquatic Ecotoxicity endpoints to be used in risk assessment.
|Acute risk |Chronic risk |
|Species |LC/EC50 (mg/L) |Species |NOEC (mg/L) |
|Fish |800 |Fish |ND |
|Crustacea |133 |Crustacea |ND |
|Algae |290 | | |
Table A3.12: Acute risk quotients derived from the GENEEC2 model and toxicity data.
| |Peak EEC from GENEEC2 (mg/L) |LC50 or EC50 |RQ (Acute) |
| | |(mg/L) |EEC/ LC50 or EC50 |
|Fish |0.01484 |800 |0.00001855 |
|Crustacea | |133 |0.00011157 |
|Algae | |290 |0.00005117 |
When compared against the relevant acute levels of concern (Table A3.3), the acute RQs derived from the GENEEC2 modeling for [active] indicate the following:
For fish and crustacean: the acute risk is low
For algae: the acute risk is low
Assessment of acute risk
There are no available chronic aquatic toxicity data on boric acid; therefore an assessment of acute risk was not performed.
Based on the acute RQs for fish, crustacean and algae the risk of boric acid as used in Eurogel is considered low.
Environmental Risk Assessment-octhilinone
The data available are not sufficient to estimate the EECs using the GENEEC model for this active ingredient of Eurogel.
For octhilinone chronic toxicity (35 days) NOEC value of 0.0085 mg/L for fathead minnow was found. This substance is generally considered to be very toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment (NCLASS, 1996). In addition, it is not considered to be rapidly biodegradable. However, there is insufficient data on its aquatic and terrestrial degradation in CCID, therefore its environmental fate could not be modelled. The Agency therefore recommends that the approved handler control be applied to mitigate this uncertainty.
Overall aquatic risk assessment
Although approved handler requirements have not been triggered for Eurogel as a result of its ecotoxicity classifications, there is a potential for adverse environmental effects on aquatic organisms if the substance moves off-target due to the high chronic toxicity of the active octhilinone and the uncertainty caused by the lack of aquatic degradation data.
TERRESTRIAL RISK
Spray Drift Modelling - Phytotoxicity
Tebuconazole is sprayed at a maximum application rate of 0.15 kg a.i./ha or 15 mg a.i./m2.
Soil-based exposure
If it assumed that tebuconazole is dispersed to a depth of 0.05 m and the density of soil is 1500 kg/m3, then the 15 mg a.i./m2 tebuconazole will be dispersed within 75 kg of soil/m2 giving 15/75 = 0.2 mg/kg.
If it is assumed that 9.7% (spray scenario, i.e. aerial/high boom) of tebuconazole will reach directly outside the target area (an assumption based on GENEEC2 modeling), then the concentration of tebuconazole adjacent to a sprayed field would be 0.2 x 0.097 = 0.0194 mg/kg soil.
Tebuconazole generates an EC50 value of 1381 mg/kg for earthworm. Consequently, tebuconazole from air blast spray results in a risk quotient RQ of 0.000014. The risk to soil organisms is low.
With respect to the risk to the terrestrial environment, regarding tebuconazole the risk to soil organisms is low and no estimation of this risk was able to be made for the active ingredients boric acid and octhilinone due to the lack of available soil toxicity data on them. No estimation was able to be made regarding the risk generated by the active ingredients to bees.
Summary and conclusions of the ecological risk assessment
Based on the risk assessment for the aquatic and terrestrial environment as set out above, no risks to aquatic organisms have been identified.
However, the uncertainty caused by lack of aquatic fate data for octhilinone that is considered to be very toxic to aquatic organisms and not rapidly degradable has led The Agency to apply the approved handler control.
References
EFSA Report on Tebuconazole (2008)
ERMA New Zealand (2008a) User Guide to HSNO Thresholds and Classifications. ERMA New Zealand, Wellington.
Fritz, R. (1988) Adsorption/desorption of Folicur (TM) (~IWG 1608) on soils. Report No. PF2923. Bayer AG, Germany. Unpublished.
In:
Fritz, R. (1993) Adsorption/Desorption of Tebuconazole on Lysimeter Soils Originated from "Borstel" and "Laacher Hof". Report No. PF3875. Bayer AG, Germany. Unpublished.
In:
HERA (2005) Human and Environmental Risk Assessment on ingredients of Household Cleaning Products. Substance: Boric Acid -Edition 1.0-
PMRA Regulatory Note REG2006-11: Tebuconazole (2006)
Urban DJ, Cook, NJ (1986) Hazard Evaluation Division Standard Evaluation Procedure: Ecological Risk Assessment. EPA 540/9-85-001. United States Environmental Protection Agency Office of Pesticide Programs, Washington DC, USA.
USEPA (2001) Generic Estimated Environmental Concentration Model v2 (GENEEC2). United States Environmental Protection Agency Office of Pesticide Programs, Washington DC, USA
USEPA EFED (2001) Generic Estimated Environmental Concentration Model v2 (GENEEC2). User’s Manual. United States Environmental Protection Agency, Environmental Fate and Effects Division, Office of Pesticide Programs, Washington DC, USA
NCLASS (1996) The Nordic council of Ministers in collaboration with European Chemicals Bureau, The N-CLASS Database on Environmental Hazard Classification version 6.3,
Appendix 4: Discussion on Controls
Based on the hazard classification as shown in Table 6.1, the set of associated controls has been identified. These default controls, expressed as control codes[13], are listed in Table A4.1.
Table A4.1: List of default controls for Eurogel
|Toxicity Controls |
|T1 |Limiting exposure to toxic substances through the setting of TELs |
|T2 |Controlling exposure in places of work through the setting of WESs |
|T4 |Requirements for equipment used to handle substances |
|T5 |Requirements for protective clothing and equipment |
|T7 |Restrictions on the carriage of toxic or corrosive substances on passenger service vehicles |
|Ecotoxicity Controls |
|E1 |Limiting exposure to ecotoxic substances through the setting of EELs |
|E2 |Restrictions on use of substances in application areas |
|E6 |Requirements for equipment used to handle substances |
|Identification Controls |
|I1 |Identification requirements, duties of persons in charge, accessibility, comprehensibility, clarity and durability |
|I3 |Priority identifiers for ecotoxic substances |
|I9 |Secondary identifiers for all hazardous substances |
|I11 |Secondary identifiers for ecotoxic substances |
|I16 |Secondary identifiers for toxic substances |
|I17 |Use of generic names |
|I18 |Requirements for using concentration ranges |
|I19 |Additional information requirements, including situations where substances are in multiple packaging |
|I21 |General documentation requirements |
|I23 |Specific documentation requirements for ecotoxic substances |
|I28 |Specific documentation requirements for toxic substances |
|I29 |Signage requirements |
|Packaging Controls |
|P1 |General packaging requirements |
|P3 |Criteria that allow substances to be packaged to a standard not meeting Packing Group I, II or III criteria |
|P13 |Packaging requirements for toxic substances |
|P15 |Packaging requirements for ecotoxic substances |
|PG3 |Packaging requirements equivalent to UN Packing Group III |
|PS4 |Packaging requirements as specified in Schedule 4 |
|Disposal Controls |
|D4 |Disposal requirements for toxic or corrosive substances |
|D5 |Disposal requirements for ecotoxic substances |
|D6 |Disposal requirements for packages |
|D7 |Information requirements for manufacturers, importers and suppliers, and persons in charge |
|D8 |Documentation requirements for manufacturers, importers and suppliers, and persons in charge |
|Emergency Management Controls |
|EM1 |Level 1 information requirements for suppliers and persons in charge |
|EM6 |Information requirements for toxic substances |
|EM7 |Information requirements for ecotoxic substances |
|EM8 |Level 2 information requirements for suppliers and persons in charge |
|EM11 |Level 3 emergency management requirements: duties of person in charge, emergency response plans |
|EM12 |Level 3 emergency management requirements: secondary containment |
|EM13 |Level 3 emergency management requirements: signage |
|Tank Wagon and Transportable Containers Controls |
| |The Hazardous Substance (Tank Wagons and Transportable Containers) Regulations 2004 prescribe a number of controls |
| |relating to tank wagons and transportable containers. |
Those controls which require calculations, derivations or extended discussion are considered in the following sections.
Toxicity Controls
Setting of TELs (Control Code T1)
Tolerable Exposure Limits (TELs) are designed to limit the extent to which the general public is exposed to hazardous (toxic) substances. A TEL represents the maximum concentration of a substance legally allowable in a particular medium, and can be set as either a guideline value or an action level that should not be exceeded. For the purposes of setting TELs, an environmental medium is defined as air, water, soil or a surface that a hazardous substance may be deposited onto.
TELs are established from PDE (Potential Daily Exposure) values, which are themselves established from ADE (Acceptable Daily Exposure) values or reference doses (RfD) which are similar to ADE but are used to protect against a specific toxic effect of concern.
Human exposure may also occur through food or drinking water. Exposure through food is managed via the establishment of Maximum Residue Limits (MRLs) as set by the Minister of Food Safety on the advice of the New Zealand Food Safety Authority (NZFSA). Exposure through drinking water is managed via the establishment of Maximum Acceptable Values (MAVs) as set by the Ministry of Health. MRLs and MAVs are also established from ADE values.
Setting of PDEs
If an ADE or RfD value is set for a substance, or component of a substance, a PDE value for each relevant exposure route must also be set. A PDE is an amount of substance (mg/kg bodyweight/day), calculated in accordance with Regulation 23, that estimates the relative likelihood of particular exposures. A PDE for any single exposure route is a fraction of the ADE or RfD, and the sum of all PDE values from all possible exposures must be less than or equal to the ADE or RfD.
The main routes of exposure considered are ingestion (food, water, air, soil), inhalation (air) and skin contact (surface deposition, water, soil).
Setting of ADEs
An ADE is an amount of a hazardous substance (mg/kg bodyweight/day), that, given a lifetime of daily exposure, would be unlikely to result in adverse human health effects. An RfD (reference dose) is a similar measure that can be used to protect against a specific toxic effect of concern.
Regulation 11(1) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001 determines when an ADE/RfD is required to be set:
(1) This regulation applies to a class 6 substance if-
(a) it is likely to be present in-
(i) 1 or more environmental media; or
(ii) food; or
(iii) other matter that might be ingested; AND
(b) it is a substance to which a person is likely to be exposed on 1 or more occasions during the lifetime of the person; AND
(c) exposure to the substance is likely to result in an appreciable toxic effect.
If all three requirements of regulation 11(1) are met, then an ADE/RfD should be set for the relevant component(s), and PDE and TEL values subsequently established for each relevant exposure route.
The toxicity (Class 6) classifications of Eurogel that trigger the need to consider setting a TEL are 6.3A, 6.4A, 6.5B, 6.8B and 6.9B classifications.
The Agency notes that based on the proposed use pattern, Eurogel does not contain any components that meet the requirement of Regulation 11(1)(a). As all three requirements of Regulation 11 are not met, ADEs are not required to be set for any components of this substance, and subsequently no TELS are set.
Setting of WES (Control Code T2)
Workplace Exposure Standards (WES) are designed to protect persons in the workplace from the adverse effects of toxic substances. A WES is an airborne concentration of a substance (expressed as mg substance/m3 of air, or ppm in air), which must not be exceeded in a workplace and only applies to places of work (Regulation 29(2), Hazardous substances (Classes 6, 8 and 9 Controls) Regulations 2001).
Regulation 29(1) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001 determines when a WES is required to be set. If all three of the requirements of this regulation are met then a WES is required to be set.
Regulation 29 states:
(1) This regulation and regulation 30 apply to a class 6 substance if,-
(a) under the temperature and pressure the substance is to be used in, it can become airborne and disperse in air in the form of inspirable or respirable dust, mists, fumes, gases or vapours; AND
(b) human exposure to the substance is primarily through the inhalation or dermal exposure routes; AND
(c) the toxicological and industrial hygiene data available for the substance is sufficient to enable a standard to be set.
When setting WES, the Authority must either adopt a value already proposed by the Department of Labour or already set under HSNO or derive a value by taking into account the matters described in Regulation 30(2) of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001.
The Agency typically adopts WES values listed in the Workplace Exposure Standards (Effective from 2002) document (refer to the link below).
The Agency notes that no Department of Labour and/or HSNO WES values have been set for any of the components of Eurogel. Also, no values have been found to have been set by any relevant overseas body that the Agency monitors. This indicates that the conditions of Regulation 29(1)(c) are not met as the Agency is not aware of industrial hygiene data for Eurogel that would enable a WES to be set for any of the constituent components. Therefore no WES values are proposed for any components of Eurogel at this time.
Ecotoxicity Controls
Setting of EELs (Control code E1)
Regulation 33 of the Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001 specify that an environmental exposure limit (EEL) may be set for a class 9 substance for one or more environmental media if organisms that live in that environment may be exposed to the substance. An EEL is the (maximum) concentration of a substance in an environmental medium that will present a negligible risk of adverse environmental effects to organisms (excluding humans) in non-target areas.
As specified by regulation 32, a default EEL of 0.1 µg/L water is set for any class 9.1 substance, and 1 µg/kg soil (dry weight) for any class 9.2 substance.
For the purposes of setting EELs, an environmental medium is defined as water, soil or sediment where these are in the natural environment, or a surface onto which a hazardous substance may be deposited.
An EEL can be established by one of three means:
• Applying the default EELs specified in regulation 32
• Adopting an established EEL as provided by regulation 35(a)
• Calculating an EEL from an assessment of available ecotoxicological data as provided by regulation 35(b).
The Hazardous Substances and New Organisms (Approvals and Enforcement) Act 2005 added a new section (s77B) to the HSNO Act, which, amongst other things provided the Authority with the ability to set EELs as guideline values, rather than the previous pass/fail values.
However, until ERMA New Zealand has developed formal policy on the implementation of s77B, it proposes not to set EELs for any components of Eurogel at this time. It is also proposed that the default EEL water and soil values be deleted until the policy has been established.
Approved Handler Controls- Highly ecotoxic substances (AH1, E7)
The approved handler requirements have not been triggered for Eurogel as a result of its 9.1B classification and the outcome of the ecological risk assessment (refer Appendix 3) indicates that there is no potential for acute or chronic adverse environmental effects on aquatic organisms if tebuconazole moves off-target (i.e. RQ ................
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