HSR07151 - EPA



ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

13 February 2008

|Application code: |HSR07151 |

|Application type |Importation or manufacture of a hazardous substance for release under Section |

| |28A(2)(a) of the Hazardous Substances and New Organisms Act 1996 |

|Applicant: |Energy Efficiency & Conservation Authority (EECA) |

|Purpose of the application |To import or manufacture B21-B99 Biodiesel / Mineral Diesel Blends containing |

| |greater than 20% to less than 100% Biodiesel as a fuel. (similar) |

|Date application received: |21 December 2007 |

|Consideration date |12 February 2008 |

|Considered by |Rob Forlong (Chief Executive, ERMA New Zealand) |

1 Summary of decision

1 The application to import or manufacture B21-B99 biodiesel/mineral diesel blends for release is approved with the controls as set out in Appendix 1. This approval has been given in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the Act), the relevant HSNO Regulations, and the HSNO (Methodology) Order 1998 (the Methodology), based on the proposed substance having a similar composition and similar hazardous properties to a substance that has been approved under the Act.

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

B21-B99 biodiesel/mineral diesel blends

2 Legislative criteria for the application

1 Unless otherwise stated, references to section numbers in this decision refer to sections of the Act. The application was lodged pursuant to section 28. The decision was determined in accordance with section 28A(2)(a), taking into account the requirements of that section and matters specified under Part II of the Act.

2 Unless otherwise stated, references to clauses in this decision refer to clauses of the Methodology. Consideration of the application followed the relevant provisions of the Methodology.

3 Application process

1 The purpose of this application is to gain approval to import or manufacture B21-B99 biodiesel/mineral diesel blends as a fuel.

2 The application was formally received on 21 December 2007.

3 The Department of Labour Workplace Group and the Ministry of Health were advised of the application (clause 2(2)(e)).

1 No responses were received.

4 Evaluation of the application was undertaken by the ERMA New Zealand project team which comprised the following staff members:

|Margaret Keane |Advisor (Hazardous Substances) |

|Sekove Tinalevu |Advisor (Hazardous Substances) |

|Dr Peter Dawson |Principal Scientist (Hazardous Substances). |

5 The application was considered by the Chief Executive of ERMA New Zealand as provided for by a delegation from the Environmental Risk Management Authority (“the Authority”) under section 19(2)(d).

4 Consideration

Sequence of the consideration

2 Energy Efficiency & Conservation Authority (EECA) seeks approval, under section 28, to import or manufacture B21-B99 biodiesel/mineral diesel blends for release in New Zealand as a fuel.

3 A substance can be assessed by rapid assessment procedures, under section 28A(2)(a), if it can be shown that a substance having a similar composition and similar hazardous properties has been approved by the Authority.

4 The approach adopted when considering this application was:

• to review the information provided;

• to identify the composition and hazardous properties of the proposed substance and of the reference substance;

• to determine whether the proposed substance has a similar use to the reference substance; and

• to determine whether the reference substance is one that has been approved by the Authority and whether the proposed substance has a similar composition and similar hazardous properties to the reference substance.

5 And then:

• to consider whether the risks posed by the proposed substance are the same as, less than or greater than those posed by the reference substance;

• to consider whether there are any effects that mean the proposed substance should not be approved under section 28A; and

• to consider whether the controls that apply under the Act to the reference substance, modified according to the hazardous properties of the proposed substance, will adequately prevent or manage any adverse effects.

Information review

6 The project team has reviewed all the information supplied by Energy Efficiency & Conservation Authority (EECA), and considers that the information constitutes an adequate and appropriate basis for assessing the application (clause 8). They also consider that there are no significant uncertainties (ie sufficient to influence decision making) in the scientific and technical information relating to the risks of the proposed substance (clauses 29 and 30).

Identification of the proposed substance

7 The proposed substance is a combination of biodiesel and mineral diesel where the biodiesel may be present at a concentration between 20% and less than 100%. Biodiesel is defined as a fuel comprising of methyl or ethyl esters of long chain, fatty acids (predominantly C16-C18) derived from vegetable oils and animal fats with a minimum flash point of 100oC. The proposed substance will also contain various additives of the type and concentration typically found in mineral diesel fuel

Identification of the reference substance

8 The applicant identified mineral diesel and biodiesel as reference substances with which they consider B21-B99 biodiesel/mineral diesel blends may be compared. However, biodiesel (as defined in paragraph 4.6 above) does not have a HSNO approval as it is not considered to be a hazardous substance.

9 The project team considers another substance to be preferable as a reference substance and has used it as such in this application. This substance was transferred under the generic substance description “Diesel fuel (automotive gas oil and marine diesel fuel)” on 1 April 2004 and given the approval code HSR001441. The description of this substance allows for the presence of up to 20% of biodiesel.

Composition of the proposed substance compared to that of the reference substance

10 Both B21-B99 biodiesel/mineral diesel blends and the reference substance are mixtures of a complex combination of hydrocarbons (mineral diesel) and biodiesel (as defined above), although the reference substance can contain no biodiesel.

11 The mineral diesel component of B21-B99 biodiesel/mineral diesel blends would be the major hazardous component conferring the hazard classifications to it. Biodiesel is not considered to be a hazardous substance. However, it is possible that if biodiesel contained a significant level of residual methanol from the manufacturing process, it could have a flash point inside the flammability threshold of 98oC. The level of methanol required for this to occur, however, would take the biodiesel well outside acceptable specifications for a diesel fuel blending component. Mineral diesel is also the major hazardous component for the reference substance.

12 The total concentration of the major hazardous component in B21-B99 biodiesel/mineral diesel blends will, in all cases, be less than that of the reference substance since the proposed substance is essentially the reference substance blended with the non-hazardous biodiesel component.

Hazardous properties of the proposed substance compared to those of the reference substance

13 The hazard classifications for the proposed substance are set out in Table 4.1 for comparison against the reference substance.

Table 4.1: Comparison of hazard classifications

|Hazardous property |Proposed substance |Reference substance |

|Flammability |3.1D |3.1D |

|Acute Toxicity (Oral) |6.1E |6.1E |

|Skin Irritation/Corrosion |6.3B |6.3B |

|Carcinogenicity |6.7B |6.7B |

|Aquatic Ecotoxicity |9.1B |9.1B |

14 The project team have read-across the hazard classifications of the reference substance to the proposed substance as there are factors concerning the composition of the proposed substance, which make the hazardous properties difficult to quantify. These factors include the type and origin of fatty acid ester, its level of content in the blend and the possible presence of a residual level of methanol. In spite of these factors, however, and as discussed in paragraph 4.10, the project team considers that the proposed substance is likely to be less hazardous than the reference substance.

Comparison of the uses of the proposed substance and the reference substance

1 Like the reference substance, B21-B99 biodiesel/mineral diesel blends is intended to be used as a fuel for internal combustion engines. The project team notes that the uses of the proposed and the reference substances are similar.

2 The project team considers that there are no substantial differences in the lifecycles, uses, purposes and presentations between the proposed substance and the reference substance.

Meeting the criteria for rapid assessment under section 28A(2)(a)

3 Based on the comparison and assessment detailed above, the project team considers that the criteria for rapid assessment under section 28A(2)(a) have been met through the proposed substance having a similar composition and similar hazardous properties to a substance that has been approved under the Act.

Comparison of the adverse effects of the proposed substance and the reference substance

4 Given the similarities in lifecycle and use of the proposed and reference substances, the project team does not expect an increase in potential exposure to occur. Therefore the project team considers that the risks posed by the proposed substance will be similar to those of the reference substance.

5 The project team considers there are no other matters that would prevent this application from being approved under section 28A.

Controls

6 A set of controls was applied to the reference substance when it was approved under the Act. It is noted that changes that have been made in legislation subsequent to the approval of the reference substance now also apply to it (section 77(2)(a)).

7 The following default control triggered by the intrinsic hazards of the proposed and reference substances is not applied for the reason as stated below:

|Control |Comment |

|T8 |Regulation 28[1] is not applicable as B21-B99 biodiesel/mineral diesel blends is not intended for |

| |use as a vertebrate toxic agent. |

8 Given the similarities in use and hazard profile of the proposed and reference substances, the project team considers the variations (deletions, additions, modifications) made to the default controls under either section 77 or 77A when the reference substance was approved are equally applicable to the proposed substance. The most significant of these variations are:

1 The controls relating to the setting of exposure limits are varied as follows:

|Controls |Comment | |

|T1 |This control is deleted (see 4.20.4 below). |

|T2 |No WES values are set for any component of B21-B99 biodiesel/mineral diesel blends as no WES values |

| |for any component have been set by the Department of Labour and there is insufficient toxicological |

| |and industrial hygiene data available for this substance to enable any values to be set. |

|E1 |This control is deleted (see 4.20.4 below). |

|E2 |As control E1 is deleted, this control is not triggered and does not apply. |

2 The following controls are added:

|Controls |Comment | |

|EM12 |The following subclauses are added after subclause (3) of regulation 36[2]: |

| |(4) For the purposes of this regulation, and regulations 37 to 40, where this substance is contained |

| |in pipework that is installed and operated so as to manage any loss of containment in the pipework |

| |it— |

| |(a) is not to be taken into account in determining whether a place is required to have a secondary |

| |containment system; and |

| |(b) is not required to be located in a secondary containment system. |

| |(5) In this clause, pipework— |

| |(a) means piping that— |

| |(i) is connected to a stationary container; and |

| |(ii) is used to transfer a hazardous substance into or out of the stationary container; and |

| |(b) includes a process pipeline or a transfer line. |

|Sch 8, Sch 9,|The controls relating to stationary container systems, secondary containment and unintended ignition |

|Sch 10 |of flammable substances, as set out in Schedules 8, 9 and 10 of the Hazardous Substances (Dangerous |

| |Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement to the New Zealand Gazette, 26|

| |March 2004, No. 35, page 767), as amended, are set for this substance, notwithstanding clause 1(1) of|

| |schedules 8 and 9 and clause (1) of Schedule 10. |

3 The following controls are varied for the reasons as stated below:

|Control |Comment | |

|F6 |Regulation 61[3] is varied as follows: |

| |Subclauses (3), (4), and (5) of this regulation do not apply to a vehicle at the dispensing unit of a|

| |refuelling outlet if, when fuel is being delivered to the fuel tank of the vehicle– |

| |(a) the engine of the vehicle is turned off; and |

| |(b) no source of ignition is brought within 3 metres of the fuel tank of the vehicle. |

|EM10 |Regulation 21[4] applies to an unattended dispensing station where there is B21-B99 biodiesel/mineral|

| |diesel blends for self service refuelling as if the items in Schedule 3 of the regulations relating |

| |to classifications 3.1A, 3.1C and 3.1D were omitted. |

|EM11 |Regulation 25[5] applies to a place where there is stored: |

| |(a) at a farm of not less than 4 hectares, B21-B99 biodiesel/mineral diesel blends in total |

| |quantities of less than 2000 litres and or located so that any spillage will not endanger any |

| |building, or flow into any stream, lake or natural water; or |

| |(b) B21-B99 biodiesel/mineral diesel blends in total quantities of less than 2000 litres, contained |

| |in a tank wagon or in secure containers, each individual container with a capacity of less than 250 |

| |litres, located so that any spillage will not endanger any building, or flow into any stream, lake or|

| |natural water and where the proposed or actual duration of the storage is for a continuous period of |

| |less than 14 days, |

| |as if the item in Schedule 4 of the regulations relating to classifications 3.1A and 9.1B were |

| |omitted and the following substituted: |

| |3.1A and 9.1B 2000 L |

4 The following controls are deleted for the reasons as stated below:

|Control |Comment | |

|T1 |The requirements of regulation 11(1)(a)[6] are not met as B21-B99 biodiesel/mineral diesel blends is |

| |not likely to be present in any environmental media, food or other matter that might be ingested. |

|E1 |Regulation 32[7] applies as if subclauses (1) and (2) were omitted; this means that a environment |

| |exposure limit is not required to be set. |

|I30 |The requirements of regulation 53[8] are omitted so that there are no specific controls on the |

| |advertising of B21-B99 biodiesel/mineral diesel blends. |

5 The following controls are combined for the reasons as stated below:

|Controls |Comment | |

|F2, T7 |both relate to equipment used to carriage in passenger vehicles |

|T4, E6 |both relate to equipment used to handle substances |

|P3, P13, P15 |all relate to packaging requirements |

|D2, D4, D5 |all relate to disposal requirements |

9 With respect to the remaining controls applied to the reference substance, the project team notes that these will be equally applicable to the proposed substance.

10 Taking into account the control modifications referred to in paragraphs 4.20 to 4.22, the proposed controls for the proposed substance are detailed in Appendix 1.

6 Environmental user charges

1 The project team considers that use of controls on the proposed substance is an effective means of managing risks associated with them. At this time, no consideration has been given to whether or not environmental user charges should be applied to this substance as an alternative or additional means of achieving effective risk management. Accordingly, no report has been made to the Minister for the Environment.

7 Decision

1 Pursuant to section 28A, I have considered this application to import or manufacture a hazardous substance for release made under section 28.

2 Having considered the composition, hazardous properties, and proposed use of the proposed substance, I am satisfied that the proposed substance meets the criteria for rapid assessment under section 28A(2)(a) in that it has a similar composition and similar hazardous properties to a substance that has been approved under the Act.

3 I am satisfied with the hazard classifications identified by the project team in paragraph 4.12 and confer them accordingly to the proposed substance.

4 As the risks posed by the proposed substance are similar to those of the reference substance, I consider that applying the same suite of controls to the proposed substance with the variations proposed in paragraphs 4.20 to 4.22, will ensure adequate management of any adverse effects.

5 In this consideration, I have also applied the following criteria in the Methodology:

• clause 9 – equivalent of sections 5, 6 and 8;

• clause 12 – risk assessment;

• clause 21 – the decision accords with the requirements of the Act and regulations;

• clause 24 – the use of recognised risk identification, assessment, evaluation and management techniques;

• clause 25 – the evaluation of risks; and

• clause 35 – the costs and benefits of varying the default controls.

6 The application for importation and manufacture of the hazardous substance, B21-B99 biodiesel/mineral diesel blends, for release is thus approved with controls as detailed in Appendix 1.

|Rob Forlong |Date: 13 February 2008 |

|Chief Executive, ERMA New Zealand |

|B21-B99 biodiesel/mineral diesel blends |

|ERMA New Zealand Approval Code: |HSR007902 |

Appendix 1: Controls applying to the proposed substance

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

Table A1.1: Controls – codes, regulations and variations

|Control Code[9]|Regulation[10] |Topic |Variations |

|Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001 -Flammability Property Controls |

|F2 |8 |Restrictions on the carriage of flammable |Controls F2 and T7 are combined. |

|T7 |10 (Classes 6, 8 |substances on passenger service vehicles | |

| |and 9 Controls) | | |

|F6 |60-70 |Requirements to prevent unintended ignition of |Regulation 61 is varied (see paragraph 4.20.3). |

| | |class 2.1.1, 2.1.2 and 3.1 substances | |

|F11 |76 |Segregation of incompatible substances | |

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

|T2 |29, 30 |Controlling exposure in places of work through the|No WESs are set for B21-B99 biodiesel/mineral |

| | |setting of WESs |diesel blends at this time. |

|T4, E6 |7 |Requirements for equipment used to handle |Controls T4 and E6 are combined. |

| | |hazardous substances | |

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

|Hazardous Substances (Identification) Regulations 2001 |

|I1 |6, 7, 32-35, 36 |General identification requirements | |

| |(1)-(7) | | |

| | |Regulation 6 – Identification duties of suppliers | |

| | | | |

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

| | |charge | |

| | | | |

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

| | |information | |

| | | | |

| | |Regulations 34, 35, 36(1)-(7) – Comprehensibility,| |

| | |Clarity and Durability of information | |

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

|I5 |11 |Priority identifiers for flammable substances | |

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

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

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

|I13 |22 |Secondary identifiers for flammable substances | |

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

|I17 |26 |Use of generic names | |

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

|I19 |29-31 |Alternative information in certain cases | |

| | | | |

| | |Regulation 29 – Substances in fixed bulk | |

| | |containers or bulk transport containers | |

| | | | |

| | |Regulation 30 – Substances in multiple packaging | |

| | | | |

| | |Regulation 31 – Alternative information when | |

| | |substances are imported | |

|I21 |37-39, 47-50 |Documentation required in places of work | |

| | | | |

| | |Regulation 37 – Documentation duties of suppliers | |

| | | | |

| | |Regulation 38 – Documentation duties of persons in| |

| | |charge of places of work | |

| | | | |

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

| | |documentation | |

| | | | |

| | |Regulation 47 – Information not included in | |

| | |approval | |

| | | | |

| | |Regulation 48 – Location and presentation | |

| | |requirements for documentation | |

| | | | |

| | |Regulation 49 – Documentation requirements for | |

| | |vehicles | |

| | | | |

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

| | |request | |

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

| | |substances | |

|I25 |43 |Specific documentation requirements for flammable | |

| | |substances | |

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

| | |substances | |

|I29 |51-52 |Duties of persons in charge of places with respect| |

| | |to signage | |

|Hazardous Substances (Packaging) Regulations 2001 |

|P1 |5, 6, 7(1), 8 |General packaging requirements | |

|P3, P13, P15 |9, 19, 21 |Packaging requirements for substances packed in |Controls P3, P13 and P15 are combined. |

| | |limited quantities | |

|PG3 |Schedule 3 |Packaging requirements equivalent to UN Packing | |

| | |Group III | |

|PS4 |Schedule 4 |This schedule describes the minimum packaging | |

| | |requirements that must be complied with for this | |

| | |substance | |

|Hazardous Substances (Disposal) Regulations 2001 |

|D2, D4, D5 |6, 8, 9 |Disposal requirements for the proposed substances |Controls D2, D4 and D5 are combined. |

|D6 |10 |Disposal requirements for packages | |

|D7 |11, 12 |Disposal information requirements | |

|D8 |13, 14 |Disposal documentation requirements | |

|Hazardous Substances (Emergency Management) Regulations 2001 |

|EM1 |6, 7, 9-11 |Level 1 information requirements for suppliers and| |

| | |persons in charge | |

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

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

|EM8 |12-16, 18-20 |Level 2 information requirements for suppliers and| |

| | |persons in charge | |

|EM9 |17 |Additional information requirements for flammable | |

| | |and oxidising substances and organic peroxides | |

|EM10 |21-24 |Fire extinguisher requirements |Regulation 21 is varied (see paragraph 4.20.3). |

|EM11 |25-34 |Level 3 emergency management requirements: duties|Regulation 25 is varied (see paragraph 4.20.3). |

| | |of person in charge, emergency response plans | |

|EM12 |35-41 |Level 3 emergency management requirements: |Subclauses (4) and (5) are added after subclause |

| | |secondary containment |(3) of regulation 36 (see paragraph 4.20.2). |

|EM13 |42 |Level 3 emergency management requirements: | |

| | |signage | |

|Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 |

|Regulations 4 to 43 where |The Hazardous Substances (Tank Wagons and Transportable Containers) Regulations 2004 prescribe a |

|applicable |number of controls relating to tank wagons and transportable containers and must be complied with as|

| |relevant. |

|Additional controls set under s77A |

|Subclauses (4) and (5) are added after subclause (3) of regulation 36 (Control EM12). |

|The controls relating to stationary container systems, secondary containment and unintended ignition of flammable substances, as set out|

|in Schedules 8, 9 and 10 of the Hazardous Substances (Dangerous Goods and Scheduled Toxic Substances) Transfer Notice 2004 (Supplement |

|to the New Zealand Gazette, 26 March 2004, No. 35, page 767), as amended, are added for this substance, notwithstanding clause 1(1) of |

|schedules 8 and 9 and clause (1) of Schedule 10. |

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

[1] Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001

[2] Hazardous Substances (Emergency Management) Regulations 2001

[3] Hazardous Substances (Classes 1 to 5 Controls) Regulations 2001

[4] Hazardous Substances (Emergency Management) Regulations 2001

[5] Hazardous Substances (Emergency Management) Regulations 2001

[6] Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001

[7] Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001

[8] Hazardous Substances (Identification) Regulations 2001

[9] 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 the ERMA New Zealand website t.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO Control Regulations.

[10] 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.

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