Decision - EPA



ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

16 August 2002

|Application code |HSR02009 |

|Application type |To import or manufacture any hazardous substance under Section 28 the Hazardous Substances and New|

| |Organisms (HSNO) Act 1996 |

|Applicant |Osmose New Zealand |

|Purpose |To manufacture PROTIM ANTIMOULD, a fungicide treatment for timber and wood products |

|Date received |11 March 2002 |

|Consideration date |21 June 2002 |

|Considered by |Hazardous Substance Standing Committee of the Authority. |

1. Summary of Decision

1. The application to import or manufacture PROTIM ANTIMOULD, is approved with controls in accordance with the section 28 of the Hazardous Substances and New Organisms Act 1996 (the HSNO Act), the HSNO Regulations, and the HSNO (Methodology) Order 1998.

2. The substance has been given the following unique identifier, for the ERMA New Zealand Hazardous Substances Register:

PROTIM ANTIMOULD

3. The Committee has adopted a use classification system as the basis for recording the nature and uses of substances approved. The following use categories are recorded for this substance:

|Main category |3 |Non-dispersive use |

|Industry category |0 |Other |

|Function/use category |39 |Pesticides, non-agricultural |

1. Legislative Criteria for Application

1. The application was lodged pursuant to section 28 of the HSNO Act. The decision was determined in accordance with section 29, taking into account additional matters to be considered in that section and matters relevant to the purpose of the Act, as specified under Part II of the HSNO Act. Unless otherwise stated, references to section numbers in this decision refer to sections of the HSNO Act.

2. Consideration of the application followed the relevant provisions of the Hazardous Substances and New Organisms (Methodology) Order 1998 (the Methodology). Unless otherwise stated, references to clauses in this decision refer to clauses of the Methodology.

2. Application Process

1. The application was formally received on 11 March 2002 and verified on 18 March 2002.

2. In accordance with sections 53(1) and 53A of the Act, public notification was made on 20 March 2002. Submissions closed on 6 May 2002.

3. The following written submission was received:

• Carter Holt Harvey raised issues with regard to environmental and/or health risks associated with the handling, use, and disposal of PROTIM ANTIMOULD. In addition, they requested verification of the claim that PROTIM ANTIMOULD offers a timber treatment alternative with a lower hazardous profile.

4. Various government departments (including MAF, OSH and MOH), Crown Entities and interested parties, which in the opinion of the Authority would be likely to have an interest in the application, were notified of the receipt of the application (in accordance with section 53(4) of the HSNO Act and clauses 2(e) and 5 of the Methodology), and provided with an opportunity to comment or make a public submission on the application.

5. The following three written comments were received:

• West Coast Regional Council raised concerns regarding the adequacy of the Department of Labour Approved Code of Practice for the Safe Use of Timber Preservatives and anti-sapstain chemicals (June 1993).

• Fish & Game New Zealand advised that they wanted it to be stated that PROTIM ANTIMOULD is not to be used in such a way that it may contact water.

• The Ministry of Health wished to draw attention to the fact that iodocarb might be expected to have attracted scheduling as a toxic substance.

6. No external experts were used in the considering of this application (clause 17).

7. The statutory time frames for the consideration of the application were subject to three waivers – to reduce the 10-day circulation of the E&R Report, to delay the date of the consideration, and delay the notification of the decision. All three times were waived with the agreement of the applicant (Section 59(4)).

8. Members of the Hazardous Substances Standing Committee of the Authority: Tony Haggerty (Chairperson), Prof. George Clark, and Jill White considered the application (section 19(2)(b)).

9. The information available to the Committee comprised:

• The application plus confidential information on manufacturing details, formulation and data of the components.

• References – IUCLID Datasheet for component A.

-– IARC Database: iodocarb and component A.

• Information from resources on the World Wide Web.

• The ERMA NZ Evaluation and Review Report.

• Submission from Carter Holt Harvey (see 3.3 above)

• Comments from agencies (see 3.5 above).

3. Consideration

Purpose of the Application

1. The purpose of the application is for the manufacture of PROTIM ANTIMOULD, a light organic solvent preservative (LOSP) for the protection of timber and wood products from fungal degrade or disfigurement. The treated wood is intended for use as framing timber.

2. PROTIM ANTIMOULD contains a fungicide (iodocarb 330 g/L) dissolved in a specific hydrocarbon solvent.

3. Following transport to purpose-built wood treatment plants, PROTIM ANTIMOULD is to be diluted with white spirits (final iodocarb concentration is expected to be 0.02-0.5% w/v) before being used in a sealed treatment vessel.

4. PROTIM ANTIMOULD will be registered as a pesticide by the ACVM Group of New Zealand Food Safety Authority. In order to be registered it has to be approved by the Authority (ref. section 21(5) of the Agricultural Compounds and Veterinary Medicines Act 1997).

5. The Committee notes that fifteen other substances containing iodocarb have been registered under the Pesticides Act 1979 and have been used for various timber treatments (13) and as pruning pastes in horticulture (2) in New Zealand since 1992 (the year of the first registration).

Sequence of the Consideration and the Approach Adopted

6. In accordance with clause 24 of the Methodology, the approach adopted by the Committee was to:

• Establish the hazard classifications for the substance and derive the default controls.

• Identify potentially non-negligible risks, costs, and benefits.

• Assess potentially non-negligible risks, costs, and benefits in the context of the default controls and possible variations to those controls. Risks were assessed in accordance with clause 12, and costs and benefits in accordance with clause 13 of the Methodology.

• Consider and determine variations to the default controls arising from the circumstances provided for in sections 77 (3), (4) and (5) of the Act and then consolidate controls.

• Evaluate overall risks, costs, and benefits to reach a decision. The combined impact of risks, costs and benefits was evaluated in accordance with clause 34, and the cost-effectiveness of the application of controls was considered in accordance with Clause 35.

7. The approach used and set out above meets the requirements of clause 24 of the methodology i.e. the need to use recognised risk identification, assessment, evaluation, and management techniques.

Hazard Classification of the Substance

8. In determining the appropriate hazard classifications for the substance, the Committee considered both the classifications proposed by the applicant, and variations to those classifications proposed in the E&R Report. The Committee agreed with the analysis in the E&R Report, (ref: section 6.2 of the E&R Report) and PROTIM ANTIMOULD is therefore classified as follows:

|6.1 D |Acutely toxic (oral) |

|6.4 A |Eye Irritant |

|6.5 B |Contact sensitiser |

|6.9 B |Harmful to human target organs or systems |

|9.1 A |Very ecotoxic in the aquatic environment |

|9.3 C |Harmful to terrestrial vertebrates |

Default Controls

9. The Committee considers that the ERMA New Zealand Project Team correctly assigned default controls associated with above classifications in the E&R Report (at section 6.3), and they are not reproduced here. They were used as the reference for subsequent consideration of the application.

Identification of the Potentially Non-negligible Risks, Costs, and Benefits of the Substance

10. In the following sections, the Committee identifies potentially non-negligible risks, costs and benefits with reference to clauses 9 and 11 of the Methodology, which incorporate relevant material from sections 2, 5, 6, and 8 of the Act.

Identification of risks

11. The Committee reviewed the identification of risks made by the applicant and additional risks identified in the E&R Report. From all these risks, the Committee identified those summarized below as those which were potentially non-negligible and thus warranted more detailed assessment.

Human Health and the Environment

|Lifecycle Activity |Associated source of risk |Potential risks arising |

| | |Human Health |Environment |

|Manufacture |Handling incident leads to |Risk to workers and general public |Risk to aquatic organisms and |

| |spill/accidental discharge |from ingestion, eye or skin |terrestrial vertebrates. [Discussed|

| | |contact. [Discussed in section |in section 6.4.3.2.1 of the E&R |

| | |6.4.3.1.1 of the E&R Report] |Report] |

| |Workers come into contact with |Risk to workers from ingestion, eye| |

| |substance during mixing |or skin contact. [Discussed in | |

| | |section 6.4.3.1.1 of the E&R | |

| | |Report] | |

|Transport of |Vehicle accident between |Risk to workers and general public |Risk to aquatic organisms and |

|substance |manufacturing facility and |from ingestion, eye or skin |terrestrial vertebrates. [Discussed|

| |timber-treatment site leads to |contact. [Discussed in section |in section 6.4.3.2.2 of the E&R |

| |spill |6.4.3.1.2 of the E&R Report] |Report] |

|Storage of substance |Damage to packaging leads to spill|Risk to workers from ingestion, eye|Risk to aquatic organisms and |

| | |or skin contact. [Discussed in |terrestrial vertebrates. [Discussed|

| | |section 6.4.3.1.3 of the E&R |in section 6.4.3.2.3 of the E&R |

| | |Report] |Report] |

|Storage of diluted |Storage tank failure leads to |Risk to workers and general public |Risk to aquatic organisms and |

|substance |spill. |from ingestion, eye or skin |terrestrial vertebrates. [Discussed|

| | |contact. [Discussed in section |in section 6.4.3.2.3 of the E&R |

| | |6.4.3.1.3 of the E&R Report] |Report] |

|Use of substance |Handling incident leads to |Risk to workers from ingestion, eye|Risk to aquatic organisms and |

| |spill/accidental discharge |or skin contact. [Discussed in |terrestrial vertebrates. [Discussed|

| | |section 6.4.3.1.4 of the E&R |in section 6.4.3.2.4 of the E&R |

| | |Report] |Report] |

|Use of treated timber|Workers come into contact with | | |

| |substance during/after dilution | | |

| |with white spirits | | |

| |Builders handling/sawing |Risk to builders/general public | |

| |inadequately dried timber |from inhalation or skin contact. | |

| | |[Discussed in section 6.4.3.1.4 of | |

| | |the E&R Report] | |

| |Exposure to inadequately dried |Risk to general public from | |

| |timber in buildings/homes |inhalation or skin contact. | |

| | |[Discussed in section 6.4.3.1.4 of | |

| | |the E&R Report] | |

|Disposal of substance|Inappropriate disposal (e.g. into | |Risk to aquatic organisms and |

| |drains or waterways). | |terrestrial vertebrates. [Discussed|

| | | |in section 6.4.3.2.5 of the E&R |

| | | |Report] |

|Disposal of treated |Treated timber is burnt in |Risk to human health due to | |

|timber |domestic fireplace or landfill |inhalation of vapours. [Discussed | |

| |incinerator |in section 6.4.3.1.5 of the E&R | |

| | |Report] | |

| |Burning of treated timber/leachate| |Adverse effects on the environment.|

| | | |[Discussed in section 6.4.3.2.5 of |

| | | |the E&R Report] |

|Other |Sabotage leading to release or |Risk to workers and general public |Risk to aquatic organisms and |

| |spill |from ingestion, eye or skin |terrestrial vertebrates. [Discussed|

| |Natural hazard leading to release |contact. [Discussed in Table 4 of |in Table 4 of the E&R Report] |

| |or spill |the E&R Report] | |

Māori Issues

12. Potential risks to Māori culture from possible contamination of waterways arising from the release of the substance into the environment. Such contamination may impact on traditional food resources and water supplies.

Social and community

13. Potential social and community risks arise from possible traffic disruptions in the event of a transporter having a road accident and spills of the substance that disrupt a commercial or recreational fishery.

Economic Risks

14. No further potentially adverse economic risks were identified by the Committee.

Identification of Costs

15. Costs are defined in the Methodology as the value of an adverse effect expressed in monetary or non-monetary terms. In relation to the costs of effects identified in the above table (including health treatment costs associated with any skin or eye contact with the substance), the Committee considered that the following economic costs were potentially non-negligible:

• Costs of clean-up after spillage;

• Disposal costs.

16. The Committee noted the recent discussion and concerns about the rotting of untreated timber in new construction in the Auckland region. No data was available to the ERMA New Zealand review team to consider a cost and benefit study as other factors such as design, construction methods, and construction quality were also involved.

Identification of Benefits

17. The benefits identified in the application and the E&R report arise if, and to the extent that, the substance is used as an alternative to other products. Timbers susceptible to rot can be treated and used in an environment exposed to more adverse conditions. Such timbers can be expected to have longer life and to maintain their strength for the life of the structure. They are part of providing security and shelter in timber constructed dwellings and buildings.

Assessment of the Potentially Non- negligible Risks and Costs of the Substance

18. The risks and costs assessed were those identified above as potentially non-negligible. Risks were assessed in terms of the requirements of clause 12 of the Methodology, including consequences and probabilities, the impact of uncertainty and the impact of risk management. Costs were considered in terms of clause 13 of the methodology. The qualitative descriptors of risk in this decision are as defined in Appendix 5 of the E&R Report.

19. The evidence available was largely scientific in nature and was considered in terms of clause 25(1) of the Methodology. This evidence comprised that provided by the applicant and additional evidence as set out in the E&R Report

Sources of Risk

20. In assessing risk the Committee gave particular consideration to risks arising from the significant hazards of the substances i.e. toxicity and ecotoxicity, and examined the extent to which exposure to hazard would be mitigated by controls. (Clauses 11 and 12 of the Methodology refer).

21. The substance is an acute oral toxicant, eye irritant and skin sensitiser. It is also harmful to human target organs and systems (clause 12(a)).

22. The substance is also very ecotoxic in the aquatic environment and harmful to terrestrial vertebrates (clause 12(a)).

Assessment of Risks to Human Health from Accident Spillage

23. There is the potential for workers (and possibly the general public) to be exposed to the substance in the event of a spillage at a storage facility or when the substance is in transit. Though accidents involving spillages are not at all uncommon, the Committee notes that it is very unlikely that an accident or other event will lead to the exposure of people to this particular substance, particularly having regard to the packaging, labelling and other controls for substances having this classification (clause 12(d)).

24. The Committee concluded that the magnitude of the above effects would be minor as the controls on the substance are such that the effects would be localised and reversible. (clauses 12 (b) and (d). Accordingly, the Committee considers the risk to human health from accidental spillage to be insignificant (clause 12 (c)).

Assessment of Risks to the Environment from Accidental Spillage

25. The Committee recognises that, in the event of an accidental spill, there could be some risk to aquatic life due to the ecotoxic effects of PROTIM ANTIMOULD. However these effects are considered to be localised and to be short term in effect. As it is very unlikely that a spillage will occur, and the magnitude of any effects are considered to be minimal, the Committee is satisfied that the risk to the environment from accidental spillage to be insignificant (clause 12 (c)).

Assessment of Risks to Human Health from Manufacture of the Substance

26. PROTIM ANTIMOULD will be manufactured by dissolving iodocarb in Component A. Stainless steel vessels will be used within a bunded and well-ventilated area. The applicant proposes that batches will not exceed 1000 litre quantities. A handling incident leading to spillage or release is considered unlikely. In the event of spillage or release, exposure to the substance could result in acute toxicity (via inhalation), eye irritation and skin sensitisation. These effects are considered to be minimal.

27. Repeated dermal or oral exposure, however, could result in liver/kidney toxicity and changes in haematological and clinical chemistry parameters. Chronic exposure of this kind is considered to be unlikely; however the effects could be moderate.

28. Accordingly, the Committee considers the risk to human health from the manufacture of PROTIM ANTIMOULD are insignificant-low (clause 12 (c)).

Assessment of Risks to the Environment from Manufacture of the Substance

29. A handling incident leading to significant spillage or release during manufacture is considered unlikely. In the event of spillage or release, exposure of the environment to the substance could result in minor adverse effects to aquatic organisms and minimal adverse effects to terrestrial vertebrates. While there is some uncertainty with respect to soil ecotoxicity, the substance is not thought to be highly persistent or bioaccumulative. There is also uncertainty regarding terrestrial invertebrate toxicity, however, it is considered unlikely that the substance would come into contact with such insects.

30. The HSNO controls include requirements for emergency management (including secondary containment, e.g., bunding). An EELWATER will also be set for the hazardous components (iodocarb and Component A) of PROTIM ANTIMOULD.

31. Accordingly, the Committee considers the risk to the environment from the manufacture of PROTIM ANTIMOULD are insignificant (clause 12 (c)).

Assessment of Risks to Human Health from Use of the Substance

32. As indicated above, the potential health effects relate primarily to eye irritancy and to possible target organ toxicity if there is prolonged repeated exposure to the substance.

33. During the course of their work, it is likely that operators may be exposed to raw materials and to undiluted PROTIM ANTIMOULD. The potential for eye irritation, skin sensitisation, and inhalation of solvent vapour is of concern, however, these effects are considered to be minimal. Repeated dermal or oral exposure could result in liver/kidney toxicity and changes in hematological and clinical chemistry parameters. Such effects are considered to be moderate and precautions would need to be taken to prevent personal contamination.

34. The Committee accepted the analysis in the E&R Report which demonstrated that the dermal exposure of operators is not likely to lead to adverse effects from target organ toxicity, and concluded that this risk was both very unlikely and minimal in effect, and was hence negligible (clause 12(b)&(c)). The Committee reached this conclusion having regard to the controls applying to the substance. Similarly, the risk to other persons from dermal exposure leading to target organ toxicity (within the application area, or beyond it) was considered by the Committee to be negligible.

35. The residual active ingredient in the treated timber is very low and will be bound in the wood. In addition, due to the evaporation of white spirits, the treated timber will not be flammable after drying. In light of this, the magnitude of any toxic effect to end-use workers (e.g. builders) is considered to be minimal. The treated wood is intended for use as interior framing timber in buildings/domestic homes. It is possible that the treated wood may contain a small amount of the solvent; however, neither the applicant nor ERMA New Zealand is aware of any public health issues that have arisen as a result of outgassing. If controls and handling guidelines were not complied with (i.e., the timber drying period was not adhered to), there would be the potential for the public to be exposed to outgassing solvent. Such an event, however, is considered unlikely to occur and, in view of the small amount of substance involved, the magnitude of effect is considered to be minimal.

36. Accordingly, the Committee considers the residual risks, with the controls in place, to be insignificant.

Assessment of Risks to the Environment from Use of the Substance

37. PROTIM ANTIMOULD would be diluted with white spirits before use in a timber preservative system. An incident leading to spillage or release of the diluted/undiluted PROTIM ANTIMOULD during the dilution procedure is considered unlikely. The release of concentrated PROTIM ANTIMOULD outside of the timber treatment plant could result in minor adverse effects to aquatic organisms and minimal adverse effects to terrestrial vertebrates. The release of the diluted PROTIM ANTIMOULD outside of the timber treatment plant could result in minor adverse effects to aquatic organisms (the hazard classification is lowered upon dilution; however, the volume of substance is increased) but is no longer considered a hazard to terrestrial vertebrates.

38. The HSNO controls include requirements for equipment used to handle the substance, along with Emergency Management requirements.

39. ERMA New Zealand considers the residual risks, with the controls in place, to be insignificant.

40. The Committee considered Fish & Game submission of the possible use of treated timber in contact with water and the substance leaching out into the aquatic environment. It was concluded that the concentration of the active ingredient in the timber was very small and if there was a risk of significant leaching there would be significant new grounds for reassessment.

Assessment of Risks to Human Health/Environment from Disposal of the Substance

41. The risks to either human health or to the environment from the disposal of either the substance, the used containers, or surplus diluted substance relate to the potential effects discussed above (clause 12(a)). The disposal controls, together with environmental exposure limits in the controls provide adequate means of managing the risks and, with these controls in place, it is unlikely that effects would occur. If effects were to occur, they would be localised and reversible, and hence minor for the reasons discussed earlier (clause 12(b)). Hence the risk is low (clause 12c).

42. In the event of burning treated timber, decomposition products of PROTIM ANTIMOULD may include carbon dioxide, carbon monoxide, nitrogen oxides and iodine vapour. Given the low residual amount of PROTIM ANTIMOULD in the treated timber, the levels of these by-products would also be low. In addition, no hazardous residues would be left in the ash. The burning of treated timber is considered likely; however, adverse effects on the environment from the decomposition products are considered to be minimal. The residual substance in the treated timber is very low and is bound to the wood. As such, it is not expected to leach out into the environment at levels that would cause adverse effects. Although there is some uncertainty with regard to soil ecotoxicity, the substance is not thought to be highly persistent or bioaccumulative.

43. The HSNO controls include requirements for the disposal of toxic and ecotoxic substances. In addition, the implementation of an EEL establishes the maximum concentration of an ecotoxic substance legally allowable in a particular non-target environmental medium. Incineration of treated timber at a landfill is very unlikely as the majority of local Councils oppose such practice. In addition, the OSH Code of Practice stipulates that LOSP-treated timber should not be burnt. RMA and District Plan controls may also apply.

44. The Committee considers the residual risks, with the controls in place, to be insignificant.

Assessment of the risks to Māori

45. In line with the advice from ERMA New Zealand’s Senior Advisor (Māori Issues), (see Appendix 3 of E&R Report), the Committee is satisfied that the application poses no risk to the relationship between Māori culture and their traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga. This is on the condition, that the product PROTIM ANTIMOULD is used in accordance with the manufactures guidelines for “Light organic solvent preservatives”. In addition, employers of the timber treatment plants must comply with the Occupational Safety and Health Service code of practice “The safe use of timber preservatives and antisapstain chemicals”.

Assessment of the Social and Community risks

46. The Committee considers it unlikely that the substance would have a negative impact on social and community. The magnitude of effects is considered minimal. Accordingly, the Committee considers the social and community risks to be insignificant.

Assessment of the Potentially Non-negligible Costs and Benefits

47. The Methodology and the Act both call for consideration of monetary and non-monetary costs (clause 13 and section 9). In addition to the costs arising from the above risks (primarily non-monetary), the following economic costs are considered below:

• cost of clean up and disposal after spillage;

• cost of disposal of residual substance.

48. The Committee agrees with the E&R report that the identified economic costs accrue primarily to the user (monetary 13(a)) although they are likely to be passed on to the wider community through increased prices. Costs to the community more directly could be incurred if a spillage requires a response from emergency or other community agencies.

49. The benefits of the substance identified in paragraphs 4.17 above are both monetary and non-monetary (clause 13(a)). The magnitude of the benefits depends largely on the degree to which such products will be used instead of the more hazardous alternatives.

50. While the Committee was unable to quantify the extent of this substitution, and hence the magnitude of the benefits (clause 13(b)) it is satisfied that such substitution and the associated benefits can be expected to occur.

51. The applicant stands to benefit economically from product sales. Wider benefits derived from more widespread use of less hazardous products will accrue to end users and their families and to the wider community as a result of the reduction in risks to health and to the environment (clause 13(c)).

Establishment of the Approach to Risk in the Light of Risk Characteristics

52. Clause 33 of the Methodology requires the Authority to have regard for the extent to which a specified set of risk characteristics exist when considering applications. The intention of this provision is to provide a route for determining how cautious or risk averse the Authority should be in weighing up risks and costs against benefits.

• Toxic exposure to the risks of PROTIM ANTIMOULD is involuntary (clause 33(a)) as it was considered that the release of the substance was most likely to occur in an accident in handling or transporting the substance. The adverse effects would occur if the person exposed did not wear the appropriate personal protective equipment.

• The ecotoxic effects of the risk will persist only over a short time until the substance is diluted.(i.e. short term localised acute adverse effects) (clause 33(b)).

• The risk due to an accident or spill would be localised or most likely subject to controllable spread (i.e. secondary containment) and is unlikely to extend its effects beyond the immediate location of incident (clause 33(c)).

• The potential adverse effects are reversible (clause 33(d)).

• Society could be inconvenienced (traffic delay, route change) in the event of a transport accident involving the substance, but the expectation is that this inconvenience would be short term. The long term potential adverse effects are expected to be insignificant (clause 33(e)).

53. In the light of these risk characteristics and with reference to clause 33, the Committee did not adopt an especially risk-adverse approach when considering the application.

Overall Evaluation of Risks, Costs and Benefits

54. The overall evaluation of risks, costs and benefits set out below was carried out having regard to Clauses 22 and 34 of the Methodology and in accordance with the tests in clause 26 of the Methodology and section 45 of the Act. Risks were evaluated taking account of all proposed controls including default controls plus proposed variations to the controls.

55. The risks with controls were determined to be negligible and therefore Section 26 of the methodology was applied by the Committee.

56. In accordance with clause 26, where a substance poses negligible risks to the environment and human health and safety, the Authority may approve a substance if it is evident that the benefits associated with that substance outweigh the costs.

57. The main benefits of PROTIM ANTIMOULD are considered to be its protection of timber from fungal rot. The major cost would be the cost of the substance and treatment of that timber versus the use of alternate treatments or no treatment. The net benefit of introducing PROTIM ANTIMOULD is that it may enhance choice and invoke competition and lead to lower costs for homeowners. There is a range of approved wood treatment substances already available in NZ so expected benefits of adding an additional product to the market maybe very small, except for the applicant.

58. The major costs are those associated with the results of an accident, or the failure to comply with the controls.

59. Benefits to be gained are for timber treatment operations to have an alternative formulation and or competitive economics of another supplier of the active ingredient in the market place.

60. It is realistic to recognise that the public of New Zealand can benefit from having available treated timber to provide long-term security and shelter for dwellings and other timber constructions.

61. No data have been provided to allow a quantitative estimation of costs and benefits. This assessment has been qualitative, but based on the data provided.

62. In light of the above, the Committee is satisfied that the benefits of the substance outweigh the costs.

Variation of Controls

63. Under section 77(3), (4) and (5) of the Act the default controls determined by the hazard classifications of the substance may be varied. Such variations, together with the setting of exposure limits as provided for in controls are discussed below:

64. The Committee accepted the rationale in the E&R report (section 7.1) that an Acceptable Daily Exposure (ADE) and a Tolerable Exposure Limit (TEL) for the substances need not be set as it was highly unlikely that members of the general public would be exposed to either substance, and thus the pre-requisite for setting these controls is not met.

65. Regulation 28 of the Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 (control code T8) relates to the use of any class 6.1 substance that is applied outdoors for vertebrate pest control. This substance is not intended to be used for vertebrate pest control, and it is highly unlikely that it ever would be. However, given the limited statutory discretion to delete controls, it remains as a control on the substances. The Committee expects that it will lie dormant, and not affect the normal use of the substance.

66. The Ecotoxicity classification of 9.1A and 9.3C invokes the default control for setting an Environmental Exposure Limit (EEL). The Committee concluded that the default EELwater for PROTIM ANTIMOULD at 0.0001 mg/l should be set.

67. No EEL for soil was set as the substance does not trigger the soil ecotoxicity threshold. The Committee also decided not to set an EEL value for sediment, surface deposition or secondary poisoning as PROTIM ANTIMOULD will be used in a contained environment and as it has a rapid degradation profile. Accordingly, these controls do not apply to the substance.

68. The acute oral toxicity of PROTIM ANTIMOULD results in it being classified as a 6.1D acute toxicant. WES values are expressed as concentrations of a substance in air and are intended for inhalation exposure scenarios. The Committee considers such a value is not relevant to a substance that is acutely toxic only via ingestion. On this basis, a WES value has not been set for any of the components of PROTIM ANTIMOULD.

69. As the proposed use of PROTIM ANTIMOULD is not as a pesticide spray but in a pressure vessel the restrictions on use within an application area (control code E2) do not apply.

70. With respect to the approved handler (E7 and AH1) and tracking controls (TR1), the Committee notes that both of these controls were triggered by the aquatic ecotoxicity of PROTIM ANTIMOULD. The beneficial use of the substance is to prevent fungal degradation of timber. The active ingredient iodocarb has had a present and past history of use for this purpose in New Zealand with a number of products registered prior to the commencement of HSNO. During manufacture, transportation and use of PROTIM ANTIMOULD it is most unlikely the substance will be significantly exposed to the aquatic environment. The addition of approved handler and tracking controls will be unlikely to significantly reduce the adverse effects of the PROTIM ANTIMOULD to the aquatic environment. Accordingly, these controls are deleted under section 74(4)(b) to retain the benefits of this substance for wood treatment without significantly increasing any adverse aquatic ecotoxicity effects to the environment.

71. The Committee agreed with the proposals in the E&R report that the following controls should be combined as provided for by section 77(5) of the Act. The Committee's view is that the combined controls resulting from these deletions will control all of the adverse effects identified for the substance.

• T7 & E8 - Regulation 10, Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001. For PROTIM ANTIMOULD, the maximum quantity per package that can be carried on public transport is 0.1 L

• I21- General documentation requirements [Regs 37,38]. This control applies to quantities of 1L and greater.

• P13, P15 - Packaging requirements for toxic/ecotoxic substances [Reg 21].

72. The Committee notes that Regulations 8(e) and (f) of the Emergency Management Regulations refer to these regulations applying to toxic and ecotoxic substances and makes reference to Schedule 1 of the Emergency Management Regulations. However, there is no reference in Schedule 1 to toxic or ecotoxic substances. As indicated in the E&R report this omission is due to an error in printing of the Regulations and Schedule 1 was intended to apply to toxic and ecotoxic substances in categories 6.5 B in any amount, 6.4A in quantities above 0.1 litres, and to ecotoxic substances in categories 9.1A in quantities above 0.1 litres and category 9.3C in quantities from 1 litre

73. The relevant control has thus not been set. However, the Committee strongly recommends that the applicant provide the appropriate emergency management information on the label or in some other accessible form for any amount of PROTIM ANTIMOULD.

74. Prior to the Committee’s consideration, the E&R Report that proposed the above variations to controls was provided to the applicant for comment. The provisions of clause 35(b) are effectively met. The controls are thus varied accordingly.

Environmental User Charges

75. In the current absence of comprehensive criteria for undertaking such a consideration, no consideration has been given to whether or not environmental user charges should be applied to the substance which is the subject of this approval.

4. Decision

1. Having considered all the possible effects of the hazardous substance in accordance with section 29 of the Act, pursuant to clause 26 of the Methodology, based on consideration and analysis of the information provided, and taking into account the application of default controls specified in this decision, the view of the Committee is that the adverse effects associated with the importation or manufacture of PROTIM ANTIMOULD are outweighed by the positive effects associated with the importation or manufacture of the substance.

2. In accordance with clause 36(2)(b) of the Methodology, the Committee records that, in reaching this conclusion, it has applied the weighing up tests in section 29 of the Act and clause 26 of the Methodology.

3. The Committee has also applied the following criteria in the Methodology:

• Clause 9 - equivalent of sections 5, 6 and 8;

• Clause 11 - characteristics of substance;

• Clause 12 - evaluation of assessment of risks;

• Clause 13 - evaluation of assessment of costs and benefits;

• Clause 21 - the decision accords with the requirements of the Act and regulations;

• Clause 22 - the evaluation of risks, costs and benefits - relevant considerations;

• Clause 24 - the use of recognised risk identification, assessment, evaluation and management techniques;

• Clause 25 - the evaluation of risks;

• Clause 26 - risks are negligible and costs are outweighed by benefits;

• Clause 33 - risk characteristics;

• Clause 34 - the aggregation and comparison of risks, costs and benefits; and

• Clause 35 - the costs and benefits of varying the default controls.

5.4 The application for the manufacture of the hazardous substance PROTIM ANTIMOULD is thus approved, with controls, as detailed in Appendix 1.

Mr. Tony Haggerty Date 16th August 2002

Chair Hazardous Substances Committee

Appendix: Controls

The controls imposed on PROTIM ANTIMOULD are as follows. The regulations cited should be referred to for definitions and exemptions. The ERMA New Zealand publication “User Guide to HSNO Control Regulations” provides useful guidance on the controls.

|Control |Regulation[2] |Explanation[3] |

|Code[1] | | |

| |

|Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 – Toxic Property Controls |

|T2 |Regulations 29, 30 |Controlling exposure in places of work |

| | |A workplace exposure standard (WES) is 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. |

|T4, E6 |Regulation 7 |Requirements for equipment used to handle substances |

| | |Any equipment used to handle PROTIM ANTIMOULD must retain and/or dispense the substance in the manner intended, i.e. without leakage, and must be accompanied by sufficient |

| | |information so that this can be achieved. |

|T5 |Regulation 8 |Requirements for protective clothing and equipment |

| | |Protective clothing/equipment must be employed when PROTIM ANTIMOULD is being handled. The clothing/equipment must be designed, constructed and operated to ensure that the person |

| | |does not come into contact with the substance. |

| | |People using protective clothing/equipment must have information specifying how the clothing or equipment may be used, and the requirements for maintaining the clothing/equipment.|

|T7, E8 |Regulation 10 |Restrictions on the carriage of hazardous substances on passenger service vehicles |

| | |In order to limit the potential for public exposure to PROTIM ANTIMOULD, the following requirements are prescribed for the carriage on public transport vehicles: |

| | |carriage is restricted to a maximum of 0.1 L per package. |

|T8 |Regulation 28 |Controls on Vertebrate Poisons |

| | |These controls limit the likelihood of a substance laid or applied for vertebrate pest control coming into contact with members of the general public and non-target species, in |

| | |places of public access. |

| | |A person in charge of PROTIM ANTIMOULD that is laid or applied outdoors for the purpose of controlling vertebrate poisons must |

| | |erect warning signs at every normal entry point to the place at least 3 days prior to the bait being applied or laid, and; |

| | |ensure exposure to non-target vertebrate species is limited (see also ecotoxic control E4, Regulations 50 and 51). |

| | | |

|Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 – Ecotoxic Property Controls |

|E1 |Regulations 32–45 |Limiting exposure to ecotoxic substances |

| | |This control relates to the setting of environmental exposure limits (EELs). An EEL establishes the maximum concentration of an ecotoxic substance legally allowable in a |

| | |particular (non target) environmental medium (e.g. soil or sediment or water), |

| | |The EEL water for PROTIM ANTIMOULD is 0.0001 mg/L |

|E5 |Regulations 5, 6 |Requirements for keeping records of use |

| | |A person using a PROTIM ANTIMOULD must keep a written record of that use if 3kg or more of the substance is applied or discharged within 24 hours in an area where the substance |

| | |may enter air or water. The record must be kept for a minimum of 3 years and must be made available to an enforcement officer on request. |

|Hazardous Substances (Identification) Regulations 2001 |

|I1 |Regulations 6, 7, |General identification requirements |

| |32-35, 36 (1)-(7) |These controls relate to the duties of suppliers and persons in charge of PROTIM ANTIMOULD with respect to identification (essentially labelling) (regs 6 and 7), accessibility of |

| | |the required information (regs 32 and 33) and presentation of the required information with respect to comprehensibility, clarity and durability (regs 34, 35, 36(1)-(7)). |

| | |Regulation 6 – Identification duties of suppliers |

| | |Suppliers of any hazardous substance must ensure it is labelled as required by regulations 9 and 14 (priority identifiers for ecotoxic and toxic substances), and regulations 18, |

| | |20 and 25 (secondary identifiers for ecotoxic and toxic substances) of the Identification regulations (see below) before supplying it to any other person. |

| | |Regulation 7 – Identification duties of persons in charge |

| | |Persons in charge of hazardous substances must ensure the substances are identified with all relevant priority identifier information (as required by regs 8 - 17) and secondary |

| | |identifier information (as required by regs 18 - 30) before supplying it to any other person. This includes ensuring that the priority identifier information is available to any |

| | |person handling the substance within 2 seconds (reg 32), and the secondary identifier information available within 10 seconds (reg 33). |

| | |Regulations 32 and 33 – Accessibility of information |

| | |All priority identifier Information (as required by regs 8 - 17) must be available within 2 seconds, e.g. on the label. |

| | |All secondary identifier Information (as required by regs 18 - 30) must be available within 10 seconds, e.g. on the label. |

| | |Regulations 34, 35, 36(1)-(7) – Comprehensibility, Clarity and Durability of information |

| | |All required priority and secondary identifiers must be presented in a way that meets the performance standards in these regulations. In summary: |

| | |any information provided (either written and oral) must be readily understandable and in English |

| | |any information provided in written or pictorial form must be able to be easily read or perceived by a person with average eyesight under normal lighting conditions |

| | |any information provided in an audible form must be able to be easily heard by a person with average hearing |

| | |all required information must continue to be met throughout the lifetime of the (packaged) substance under the normal conditions of storage, handling and use. |

|I3 |Regulation 9 |Priority identifiers for ecotoxic substances |

| | |This requirement specifies that PROTIM ANTIMOULD must be prominently identified as being ecotoxic. |

| | |This information must be available to any person handling the substance within two seconds (reg 32) and can be provided by way of signal headings or commonly understood pictograms|

| | |on the label. |

|I8 |Regulation 14 |Priority identifiers for toxic substances |

| | |This requirement specifies that PROTIM ANTIMOULD must be prominently identified as being toxic. In addition, information must be provided on the general degree and type of hazard|

| | |of the substance (e.g. highly poisonous), and the need to restrict access to children. |

| | |This information must be available to any person handling the substance within two seconds (reg 32) and can be provided by way of signal headings or commonly understood pictograms|

| | |on the label. |

|I9 |Regulation 18 |Secondary identifiers for all hazardous substances |

| | |This control relates to detail required for hazardous substances on the product label. This information must be accessible within 10 seconds (reg 33) and could be provided on |

| | |secondary panels on the product label. The following information is required: |

| | |an indication (which may include its common name, chemical name, or registered trade name) that unequivocally identifies it, and |

| | |enough information to enable its New Zealand importer, supplier, or manufacturer to be contacted, either in person or by telephone, and |

| | |In the case of a substance which, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous |

| | |substance of a different class, a description of each likely change and the date by which it is likely to occur. |

|I11 |Regulation 20 |Secondary identifiers for ecotoxic substances |

| | |This control relates to the additional label detail required PROTIM ANTIMOULD. This information must be accessible within 10 seconds (reg 33) and could be provided on secondary |

| | |panels on the product label. The following information must be provided: |

| | |an indication of the circumstances in which it may harm living organisms |

| | |an indication of the kind and extent of the harm it is likely to cause to living organisms |

| | |an indication of the steps to be taken to prevent harm to living organisms |

| | |an indication of its general type and degree of hazard (e.g. very toxic to aquatic life) |

| | | |

| | |These requirements could be addressed by statements on the label with respect to its action against both target and non-target organisms and the method of application used to |

| | |avoid exposure to non-target organisms. A statement should be included warning against incorrect disposal in sensitive environments. |

|I16 |Regulation 25 |Secondary identifiers for toxic substances |

| | |This control relates to the additional label detail required for PROTIM ANTIMOULD. This information must be accessible within 10 seconds (reg 33) and could be provided on |

| | |secondary panels on the product label. The following information must be provided: |

| | |an indication of its general type and degree of toxic hazard |

| | |an indication of the circumstances in which it may harm human beings |

| | |an indication of the kinds of harm it may cause to human beings, and the likely extent of each kind of harm |

| | |an indication of the steps to be taken to prevent harm to human beings |

| | |the name and concentration of any ingredient that would independently of any other ingredient, cause the substance to be classified as either a class 61 D, 6.5 or 6.9, namely |

| | |iodocarb |

|I17 |Regulation 26 |Use of Generic Names |

| | |This control provides the option of using a generic name to identify iodocarb |

|I18 |Regulation 27 |Requirements for using concentration ranges |

| | |This control provides the option of providing concentration ranges for those ingredients whose concentrations are required to be stated on the product label, namely iodocarb. |

|I19 |Regulations 29–31 |Alternative information in certain cases |

| | |Regulation 29 relates to alternative ways of presenting the priority and secondary identifier information required by regulations 8–25, when PROTIM ANTIMOULD is contained in fixed|

| | |bulk containers or bulk transport containers. The information requirements for fixed bulk containers are specified in reg 29 (1). The information requirements for bulk transport|

| | |containers are specified in reg 29 (2), which essentially states that for HSNO compliance, the substance should be labelled or marked in compliance with the requirements of the |

| | |Land Transport Rule 45001, Civil Aviation Act 1990 or Maritime Transport Act 1994. |

| | |Regulation 30 relates to situations when hazardous substances are in multiple packaging and the outer packaging obscures some or all of the required substance information. The |

| | |outer packaging must : |

| | |be clearly labelled with all relevant priority identifier information i.e. the hazardous properties of the substance must be identified, or |

| | |be labelled or marked in compliance with either the Land Transport Rule 45001, Civil Aviation Act 1990 or the Maritime Safety Act 1994 as relevant, or |

| | |in the case of an ecotoxic substance, it must bear the EU pictogram “Dangerous to the Environment” (‘dead fish and tree’ on orange background), or |

| | |bear the relevant class label assigned by the UN Model Regulations |

| | |Regulation 31 relates to alternative information requirements for hazardous substances that are imported into New Zealand in a closed package or in a freight container and will be|

| | |transported to their destination without being removed from that package or container. In these situations, it is sufficient compliance with HSNO if the package or container is |

| | |labelled or marked in compliance with the requirements of the Land Transport Rule 45001. |

|I20 |Regulation 36(8) |Durability of information for class 6.1 substances |

| | |Any packaging in direct contact with PROTIM ANTIMOULD must be permanently identified as having contained a toxic substance, unless the substance as packaged is restricted to a |

| | |place of work. |

|I21 |Regulations 37–39, |Documentation required in places of work |

| |47–50 |These controls relate to the duties of suppliers and persons in charge of places of work with respect to provision of documentation (essentially Material Safety Data Sheets) (regs|

| | |37, 38 and 50); the general content requirements of the documentation (reg 39 and 47); the accessibility and presentation of the required documentation with respect to |

| | |comprehensibility and clarity (reg 48). |

| | |For PROTIM ANTIMOULD these controls are triggered when the substance is held in the workplace in quantities of 1 L or greater. |

| | | |

| | |Regulation 37 – Documentation duties of suppliers |

| | |A supplier must provide documentation containing all relevant information required by regulations 39 – 46 when: |

| | |selling or supplying a quantity 1 L or more of PROTIM ANTIMOULD; |

| | |if PROTIM ANTIMOULD is to be used in a place of work and the supplier has not previously provided the documentation to that person. |

| | |Regulation 38 – Documentation duties of persons in charge of places of work |

| | |The person in charge of any place of work where PROTIM ANTIMOULD is present in quantities above 0.5 kg must ensure that every person handling the substance has access to the |

| | |documentation containing all relevant information required by regulations 39 – 46. |

| | |Regulation 39 – General content requirements for documentation |

| | |The documentation provided with PROTIM ANTIMOULD must include the following information: |

| | |the unequivocal identity of the substance (e.g. the CAS number, chemical name, common name, UN number, registered trade name(s)) |

| | |a description of the physical state, colour and odour of the substance |

| | |if the substance’s physical state may alter over the expected range of workplace temperatures, the documentation must include a description of the temperatures at which the |

| | |changes in physical state may occur and the nature of those changes. |

| | |in the case of a substance that, when in a closed container, is likely to become more hazardous over time or develop additional hazardous properties, or become a hazardous |

| | |substance of a different class, the documentation must include a description of each likely change and the date by which it is likely to occur |

| | |contact details for the New Zealand supplier/manufacturer/importer |

| | |all emergency management and disposal information required for the substance |

| | |the date on which the documentation was prepared |

| | |the name and concentration of any ingredients that would independently of any other ingredient, cause the substance to be classified as either a class 6.5, or 6.9, namely |

| | |iodocarb. |

| | |Regulation 48 – Location and presentation requirements for documentation |

| | |All required documentation must be available to a person handling PROTIM ANTIMOULD in a place of work within 10 minutes. The documentation must be readily understandable by any |

| | |fully-trained worker required to have access to it and must be easily read, under normal lighting conditions, at a distance of not less than 0.3m. |

| | |Regulation 49 – Documentation requirements for vehicles |

| | |This regulation provides for the option of complying with documentation requirements as specified in the various Land, Sea and Air transport rules when the substance is being |

| | |transported. |

| | |Regulation 50 – Documentation to be supplied on request |

| | |Notwithstanding regulation 37 above, a supplier must provide the required documentation to any person in charge of a place of work (where a PROTIM ANTIMOULD is present) if asked |

| | |to do so by that person. |

|I23 |Reg 41 |Specific documentation requirements for ecotoxic substances |

| | |The documentation provided with PROTIM ANTIMOULD must include the following information: |

| | |its general degree and type of ecotoxic hazard (e.g. very ecotoxic in the aquatic environment) |

| | |a full description of the circumstances in which it may harm living organisms and the extent of that harm |

| | |a full description of the steps to be taken to prevent harm to living organisms |

| | |a summary of the available acute and chronic (ecotoxic) data used to define the (ecotoxic) subclass or subclasses in which it is classified |

| | |its bio-concentration factor or octanol-water partition coefficient |

| | |its expected soil or water degradation rate |

| | |any EELs set by the Authority |

|I28 |Regulation 46 |Specific documentation requirements for toxic substances |

| | |The documentation provided with toxic substances must include the following information: |

| | |its general degree and type of toxic hazard |

| | |a full description of the circumstances in which it may harm human beings |

| | |the kinds of harm it may cause to human beings |

| | |a full description of the steps to be taken to prevent harm to human beings |

| | |if it will be a liquid during its use, the percentage of volatile substance in the liquid formulation, and the temperature at which the percentages were measured |

| | |a summary of the available acute and chronic (toxicity) data used to define the (toxicity) subclass or subclasses in which it is classified |

| | |the symptoms or signs of injury or ill health associated with each likely route of exposure |

| | |the dose, concentration, or conditions of exposure likely to cause injury or ill health |

|I29 |Regulations 51–52 |Duties of persons in charge of places with respect to signage |

| | |These controls specify the requirements for signage, in terms of content, presentation and positioning at places where PROTIM ANTIMOULD is held in quantities exceeding 100 L. |

| | |The information provided in the signage needs to be understandable over a distance of 10 metres and be sufficient to: |

| | |advise that the location contains hazardous substances |

| | |describe the general type and degree of hazard of the substance |

| | |where the signage is immediately adjacent to the hazardous substance storage areas, describe the precautions needed to safely manage the substance |

|I30 |Regulation 53 |Advertising toxic substances |

| | |Any advertisements for PROTIM ANTIMOULD must provide information identifying that it is toxic, specifying the degree of toxicity and the need to restrict access by children. |

| | | |

|Hazardous Substances (Packaging) Regulations 2001 |

|P1 |Regulations 5, 6, 7 |General packaging requirements |

| |(1), 8 |These controls relate to the ability of the packaging to retain its contents, allowable packaging markings (with respect to design approvals), factors affecting choice of suitable|

| | |packaging, and compatibility of PROTIM ANTIMOULD with any previous contents of the packaging. |

| | |Regulation 5 – Ability to retain contents |

| | |Packaging for PROTIM ANTIMOULD must ensure that, when the package is closed, there is no visible release of the substance, and that it maintains its ability to retain its contents|

| | |in temperatures from –10oC to +50oC. The packaging must also maintain its ability to retain its remaining contents if part of the contents are removed from the package and the |

| | |packaging is then re-closed. The packaging in direct contact with the substance must not be significantly affected or weakened by contact with the substance such that the |

| | |foregoing requirements cannot be met. |

| | |Regulation 6 – Packaging markings |

| | |Packages containing PROTIM ANTIMOULD must not be marked in accordance with the UN Model Regulations unless the markings comply with the relevant provisions of that document and |

| | |the packaging complies with the tests set out in Schedule 3 (Packaging Regulations) and the design of the packaging has been test certified as complying with those tests. |

| | |Regulation 7(1) – Requirements when packing hazardous substance |

| | |When packing PROTIM ANTIMOULD, account must be taken of its physical state and properties, and packaging must be selected that complies with the requirements of regulation 5, and |

| | |regulations 9 – 21. |

| | |Regulation 8 – Compatibility |

| | |PROTIM ANTIMOULD must not be packed in packaging that has been previously packed with substances with which it is incompatible. |

|P3 |Regulation 9 |Requirement for substances packed in limited quantities |

| | |PROTIM ANTIMOULD with a may be packaged in packaging that complies with the tests set out in Schedule 4. |

|P13, P15 |Regulation 19, 21 |Packaging requirements for toxic and ecotoxic substances |

| | |The packaging requirements for PROTIM ANTIMOULD are as follows: |

| | |Packages containing more than 1 L (per package) of PROTIM ANTIMOULD must comply with the tests set out in Schedule 3 (UN PGIII). Packages containing less than 1L (per package) |

| | |may be packaged in packaging that complies with the tests set out in Schedule 4. (i.e. Reg 9 above) |

| | |PROTIM ANTIMOULD that is offered for sale in a package of less than 2.5 L must be in child resistant packaging. However, if the substance is for use in a place of work to which |

| | |children to not have access, this requirement is not mandatory. |

|PG3 |Schedule 3 |This schedule provides the test methods for packaging that required to be tested in accordance with this schedule. The tests correlate to the packaging requirements of UN Packing|

| | |Group III. |

|Hazardous Substances (Disposal) Regulations 2001 |

|D4, D5 |Regulation 8, 9 |Disposal requirements for toxic and ecotoxic substances |

| | |PROTIM ANTIMOULD must be disposed of by: |

| | |treating the substance so that it is no longer a hazardous substance, including depositing the substance in a landfill, incinerator or sewage facility. However, this does not |

| | |include dilution of the substance with any other substance prior to discharge to the environment; or |

| | |discharging the substance to the environment (provided that, after reasonable mixing, the concentration of the substance in any part of the environment outside the mixing zone |

| | |does not exceed any TEL set by the Authority for that substance); or |

| | |exporting the substance from New Zealand as hazardous waste |

|D6 |Regulation 10 |Disposal requirements for packages |

| | |This control gives the disposal requirements for packages that contained PROTIM ANTIMOULD and are no longer to be used for that purpose. Such packages must be |

| | |decontaminated/treated or rendered incapable of containing any substance (hazardous or otherwise) and then disposed of in a manner that is consistent with the disposal |

| | |requirements for the substance. |

|D7 |Regulations 11, 12 |Information requirements |

| | |These controls relate to the provision of information concerning disposal (essentially on the label) that must be provided when selling or supplying 1 L or more of PROTIM |

| | |ANTIMOULD. Information must be provided on appropriate methods of disposal and information may be supplied warning of methods of disposal that should be avoided i.e. that would |

| | |not comply with the Disposal Regulations. Such information must be accessible to a person handling PROTIM ANTIMOULD within 10 seconds and must comply with the requirements for |

| | |comprehensibility, clarity and durability as described in Regs 34-36 of the Identification regulations (code I1). |

|D8 |Regulations 13, 14 |Documentation requirements |

| | |These controls relate to the provision of documentation concerning disposal (essentially in a MSDS) that must be provided when selling or supplying more than 1 L of PROTIM |

| | |ANTIMOULD. The documentation must describe one or more methods of disposal (that comply with the Disposal Regulations) and describe any precautions that must be taken. Such |

| | |documentation must be accessible to a person handling PROTIM ANTIMOULD at a place of work within 10 minutes and must comply with the requirements for comprehensibility and clarity|

| | |as described in Regs 48 (2), (3) and (4) of the Identification regulations (code I21). |

|Hazardous Substances (Emergency Management) Regulations 2001 |

|EM1 |Regs 6, 7, 9–11 |Level 1 emergency management information: General requirements |

| | |These controls relate to the provision of emergency management information (essentially on the label) that must be provided with PROTIM ANTIMOULD when present in quantities |

| | |exceeding the trigger levels as listed in Schedule 1 of the Emergency Management Regulations. Schedule 1 does not cover PROTIM ANTIMOULD due to a printing error in the |

| | |regulations. Suppliers and persons in charge of places are recommended to adopt this control |

| | |Regulation 6 describes the duties of suppliers, regulation 7 describes the duties of persons in charge of places, regulation 9 describes the requirement for the availability of |

| | |the information (10 seconds), and regulation 10 gives the requirements relating to the presentation of the information (with respect to comprehensibility, clarity and durability).|

| | |These requirements correspond with those relating to secondary identifiers (see Identification Regulations, regulations 6, 7, 32–35, 36(1)-(7)). |

| | |Regulation 11 provides for the option of complying with the information requirements of the transport rules when the substance is being transported. |

|EM6 |Regulation 8(e) |Information requirements for toxic substances |

| | |The following information must be provided when PROTIM ANTIMOULD is present in quantities exceeding the trigger levels as listed in Schedule 1 of the Emergency Management |

| | |Regulations. Schedule 1 does not cover PROTIM ANTIMOULD due to a printing error in the regulations. Suppliers and persons in charge of places are recommended to adopt this control|

| | |A description of the usual symptoms of exposure |

| | |A description of the first aid to be given |

| | |A 24-hour emergency service telephone number |

|EM7 |Regulation 8(f) |Information requirements for ecotoxic substances |

| | |The following information must be provided with PROTIM ANTIMOULD when present in quantities exceeding the trigger levels as listed in Schedule 1 of the Emergency Management |

| | |Regulations. Schedule 1 does not cover PROTIM ANTIMOULD due to a printing error in the regulations. Suppliers and persons in charge of places are recommended to adopt this control|

| | |a description of the parts of the environment likely to be immediately affected by it |

| | |a description of its typical effects on those parts of the environment |

| | |a statement of any immediate actions that may be taken to prevent the substance from entering or affecting those parts of the environment |

|EM8 |Regulations 12–16, |Level 2 emergency management information requirements |

| |18–20 |These controls relate to the duties of suppliers and persons in charge of places of work with respect to the provision of emergency management documentation (essentially Material |

| | |Safety Data Sheets). This documentation must be provided where PROTIM ANTIMOULD is sold or supplied, or where they are held in a workplace in quantities equal to or greater than 1|

| | |L. |

| | |Regulations 12 and 13 describe the duties of suppliers, regulation 14 describes the duties of persons in charge of places of work, regulation 15 provides for the option of |

| | |complying with documentation requirements of the transport rules when PROTIM ANTIMOULD is being transported, and regulation 16 specifies requirements for general contents of the |

| | |documentation. |

| | |Regulation 18 provides accessibility requirements (documentation to be available within 5 minutes) and regulation 19 provides requirements for presentation with respect to |

| | |comprehensibility and clarity. These requirements correspond with those relating to documentation required by the Identification regulations (code I21). |

|EM11 |Regulations 25–34 |Level 3 emergency management requirements – emergency response plans |

| | |These regulations relate to the requirement for an emergency response plan to be available at any place (excluding aircraft or ships) where PROTIM ANTIMOULD is held (or reasonably|

| | |likely to be held on occasion) in quantities equal to or greater than 100 L |

| | |The emergency response plan must describe all of the likely emergencies that may arise from the breach or failure of controls. The type of information that is required to be |

| | |included in the plan is specified in regulations 29–30. Requirements relating to the availability of equipment, materials and people are provided in regulation 31. Requirements |

| | |regarding the availability of the plan is provided in regulation 32 and requirements for testing the plan are described in regulation 33. |

|EM12 |Regulations 35–41 |Level 3 emergency management requirements – secondary containment |

| | |These regulations relate to the requirement for a secondary containment system to be installed at any fixed location where liquid (or liquefiable) PROTIM ANTIMOULD is held in |

| | |quantities above 100 L. |

| | |Regulation 37 prescribes requirements for places where hazardous substances are held above ground in containers each holding up to 60 L or less. Regulation 38 prescribes |

| | |requirements for places where hazardous substances are held above ground in containers each holding between 60 L and 450 L. Regulation 39 prescribes requirements for places where|

| | |hazardous substances are held above ground in containers each holding more than 450 L. Regulation 40 prescribes requirements for places where hazardous substances are held |

| | |underground. Regulation 41 prescribes requirements for secondary containment systems that contain substances of specific hazard classifications. |

|EM13 |Regulation 42 |Level 3 emergency management requirements – signage |

| | |These controls relates to the provision of emergency management information on signage at places where PROTIM ANTIMOULD is held at quantities equal to or greater than 100 L. |

| | |The signage must advise of the action to be taken in an emergency and must meet the requirements for comprehensibility and clarity as defined in Regulations 34 and 35 of the |

| | |Identification Regulations. |

-----------------------

[1] Note: The numbering system used in this column relates to the coding system used in the ERMA New Zealand Controls Matrix. This links the hazard classification categories to the regulatory controls triggered by each category. It is available from ERMA New Zealand and is also contained in the ERMA New Zealand User Guide to the Controls Regulations.

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These regulations form the controls applicable to this substance. Refer to the cited regulations for the formal specification, and for definitions and exemptions. The accompanying explanation is intended for guidance only.

[3] These explanations are for guidance only. Refer to the cited regulations for the formal specification, and for definitions and exemptions.

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