ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION APPLICATION DETAILS Application code HSC01001 Application type/category Import any hazardous substance into containment Applicant BASF NZ Ltd Purpose (summary statement) To field test BAS 125 10W to assess the efficacy of the substance in managing plant growth in a wide range of crops. Date application received 30 October 2001 Consideration date 28 November 2001 Considered by Special Committee of the Authority appointed under section 19(2)(b) of the Hazardous Substances and New Organisms Act 1996. SUMMARY OF DECISION The application to import into containment BAS 125 10W, is approved with controls in accordance with the relevant provisions of the Hazardous Substances and New Organisms Act 1996 (the HSNO Act), the HSNO Regulations, and the HSNO (Methodology) Order 1998. The substance has been given the following unique identifiers for the ERMA New Zealand Hazardous Substances Register: BAS 125 10W LEGISLATIVE CRITERIA FOR APPLICATION The application was lodged pursuant to section 31 of the HSNO Act. The decision was determined in accordance with section 32, taking into account 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. 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. APPLICATION PROCESS The application was formally received on 30 October 2001, and verified on 2 November 2001. The application was sent to the Ministry of Health, the Ministry of Agriculture and Forestry (MAF), and the Occupational Safety and Health Service of the Department of Labour for consultation. The only reply received was that from MAF who stated that they had no comments to make. The documents available for the consideration of the application by the Committee included the application (including supporting documentation and confidential information provided), the Evaluation and Review (E&R) report, comments provided by the applicant on the E&R report, and comments provided by ERMA New Zealand on the comments provided by the applicant on the E&R report. In accordance with section 19(2)(b) of the Hazardous Substances and New Organisms Act 1996, the Authority appointed a Special Committee to determine the application. The Committee comprised the following members of the Authority: Jill White (Chairperson), Tony Haggerty, and George Clark. CONSIDERATION Purpose of the application This is an application under s.31 for the importation of a hazardous substance into containment. The substance will be used in trial work to gather sufficient information to determine whether or not the product is suitable for use in New Zealand and to provide data for a future application for approval for release. The trial work also requires provisional registration under the Agricultural Compounds and Veterinary Medicines (ACVM) Act, and the data obtained will similarly be used for application for registration under the ACVM Act. The trials will take place on a range of tree and arable crops (note that the details of the target crops are detailed in the confidential section of the application), in trial sites that will be small parts of larger commercial entities. The trials will involve 5-15 sites at any time and continue for up to three years. 10 kilograms of BAS 125 10W will be imported in 0.25 kilogram containers over the three years. The Committee concluded that importation into containment to evaluate the benefits of the substances constitutes an appropriate purpose under section 30 (ba) of the Act being Research and development on any hazardous substance. Sequence of the consideration In accordance with Section 32 of the Act, the approach adopted by the Committee was to confirm that that application was for one of the purposes specified in section 30 of the Act (namely section 30(ba)), to identify and assess the risks, and to determine whether the substance could be adequately contained. 2 Hazardous properties of the substance The hazardous properties of the substance are as follows – Hazardous property Explosiveness, flammability, corrosiveness, oxidising, and toxicity Ecotoxicity Description The Committee considers that the substance does not exceed the thresholds for explosive, flammable, corrosive, or oxidising properties. The substance triggers the inhibited growth criterion for biocidal action. In response to uncertainty identified in the E&R report as to whether BAS 125 10W would exhibit adverse effects on soil organisms, the applicant provided further information which indicated that there are no adverse effects on earthworms. The Committee is satisfied that there is unlikely to be any significant adverse effects on the soil ecosystems, and that the substance meets the threshold as a hazardous substance solely on the basis of the inhibited growth criterion for biocidal action. Identification of the significant risks of the substance In accordance with sections 5 and 6 of the HSNO Act and clause 9 of the Methodology Order, the Committee has considered the risks of this application throughout the lifecycle of the substances, for each of the following areas – Biological and physical environment Human welfare including health, safety and social environment Maori issues and concerns Economic aspects Environmental, human welfare, and economic issues The Committee considered the risks identified in the application, the E&R report, and the subsequent comments of the applicant. The Committee concluded that the only risk of any significance was that associated with the inhibited growth effects on plants outside of the target area arising from a transport accident or spillage, the unintentional removal from a trial site, spraydrift, and incorrect disposal. It is noted that those effects will be involuntary, not persist over time, will be localised, and that normal growth will resume. It is also noted that this application is for a well-known trial process that the applicant is familiar with. There is limited potential effect and little uncertainty (clause 12 (e)). The Committee considers that the likelihood of the effect occurring is very unlikely and the magnitude of effect would be minimal. The risk is therefore judged to be insignificant. Māori issues and concerns In concluding that there were no significant risks in relation to Māori issues, the Committee is satisfied that since the substance is being imported solely for the purpose of use in containment 3 and will be strictly controlled through its lifecycle, there are no significant risks to the relationship of Māori and their culture and traditions with their ancestral lands, water, sites, waahi tapu, valued flora and fauna and other taonga. Adequacy of the proposed containment controls The Committee considered the controls proposed by the applicant and the proposed controls in the E&R report in the context of clause 12(d) of the Methodology. In addition, the following legislative controls and codes of practice were considered: The Agricultural Compounds and Veterinary Medicines Act 1997. The International Air Transport Association (IATA) Dangerous Goods Regulations. The Land Transport Rule: Dangerous Goods 1999. NZS 5433:1999 Transport of Dangerous Goods on Land. The Health & Safety in Employment Act 1992. The Code of Practice for the Management of Agrichemicals NZS8409:1999. Resource Management Act 1991. In particular, the Committee considered the controls relating to: transport of the substance, disposal, the effects of accidental release and exposure, and spraydrift. Assessment of the significant risks of the substance The Committee is satisfied that, given the controls, the substance can be adequately contained. DECISION The Committee has considered this application under section 31 of the Act to import into containment a hazardous substance, and pursuant to section 32 of the Act, the Committee is satisfied that this application is for one of the purposes specified in section 30(1) of the Act, being section 30(ba) of the Act being Research and development on any hazardous substance. The Committee is satisfied that given the controls, the substance can be adequately contained. In accordance with clause 36(b) of the Methodology the Committee records that, in reaching this conclusion, it has applied the criteria specified in section 32 of the Act. It has also applied the following criteria in the Methodology: clause 9 - equivalent of sections 5, 6 and 8; 4 clause 11 – characteristics of substance; and clause 12 – evaluation of assessment of risks; 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; The application to import into containment the hazardous substance BAS 125 10W is thus approved, with controls, as follows: 5 ANNEX A – CONTROLS 1. TO LIMIT THE LIKELIHOOD OF ESCAPE OF ANY CONTAINED HAZARDOUS SUBSTANCE OR CONTAMINATION BY HAZARDOUS SUBSTANCE 1.1 The trials shall be undertaken in accordance with the Project Plan and Management Plan which accompanied the application except where the following controls direct otherwise. Modifications of the Project Plan or Management Plan may be approved in writing by ERMA New Zealand providing that they comply with the following controls. 1.2 The substance will be applied by way of a hand-held/operator-worn equipment application, using hydraulic pressure or compressed CO2 or air on plots specifically designated and marked for each treatment. 1.3 The trial sites chosen will not be contiguous to any water source. 1.4 All trial sites must be at least 50 metres from buildings where people live or work (commercial and research glasshouses being an exception). 1.5 Spraying must be in accord with Section 5 of NZS8409:1999 Code of Practice for the Management of Agrichemicals. 1.6 Solid waste, namely treated produce, will be disposed of by either ploughing in, mulching or at an appropriate local authority operated landfill. 1.7 No treated produce shall be consumed by people or animals or offered for sale. 1.8 Access to the trial site(s) is by permission of the Trial Director or owner of the property on which it is located. The trial site(s) will be secured by stock proof fencing and all potential access points shall be signed indicating that unauthorised access is not allowed, that the site is subject to a trial, and that the crops should not be removed or disturbed. 1.9 The substance will be securely packed in containers being identified in accordance with the Hazardous Substances (Identification) Regulations 2001 and a MSDS will accompany each shipment. 1.10 The transportation of the substance will comply with The Land Transport Rule: Dangerous Goods 1999 1.11 Storage will be in accordance with the Code of Practice for the Management of Agrichemicals NZS8409:1999. 1.12 Any portion of the substance surplus to requirements will be disposed of by one of the following methods: Returned to BASF. Disposed in an appropriate local authority landfill (pre-treatment at a hazardous waste facility may be required). Diluted with water or soil and spread over a designated non-crop, non-grazed waste area at the trial site. Kept for use once approval for release/ registration is gained. 1.13 The trial site boundaries will be clearly marked and distinctly visible from outside the trial site throughout the life of the trial(s). The existence of the trial will be clearly marked to avoid accidental/incidental access and harvesting of treated crop. 2. TO EXCLUDE ORGANISMS OR CONTROL ORGANISMS 2.1 Grazing animals must be excluded from all trial sites for the duration of the trial period (including the time of residual testing). 6 3. TO EXCLUDE UNAUTHORISED PEOPLE 3.1 Access to each trial site in the first instance will be by access to the privately owned property through the main entrance. The final entrance allowing access to the trial site will be clearly marked by a sign indicating such, and allowing no access without permission of the Trial Director or property owner/manager. 3.2 The number of entrances will be determined by the nature of the secure boundaries, and location of the site therein. 3.3 A log of all persons accessing the trial sites shall be maintained and be available for inspection by the Trial Director. 4. TO PREVENT UNINTENDED RELEASE OF THE SUBSTANCE BY EXPERIMENTERS WORKING WITH THE SUBSTANCE 4.1 The amount of material taken into each trial site will be pre-measured at the storage facility so as to be sufficient for the application to the designated plots. 4.2 Unused material, if any, will be returned to the applicant’s contact person. Handling and disposal of any wastes will be carried out in such a way as not to jeopardise the integrity of the studies, including provision for appropriate collection, storage and disposal facilities, and decontamination and transportation procedures. 4.3 Any surplus mixed product to be disposed of at the trial site(s) by being further diluted and sprayed over a marked and designated non-crop and non-grazed area at the site. 4.4 The equipment used will be rinsed after use with the appropriate detergent or chlorine based decontaminant, and rinsate similarly disposed of. Use of secure labelled containers will be standard procedure. 4.5 The dispensing of the substance from the original imported container will be in a controlled environment (for example, a laboratory) to minimise inadvertent release, spillage, and unnecessary exposure. This dispensing will take place prior to transportation to each trial site for application, and not carried out on the trial site. 4.6 The mixing of the substance will comply with section 5.5 of the Code of Practice for the Management of Agrichemicals NZS8409: 1999 5. TO CONTROL THE EFFECTS OF ANY ACCIDENTAL RELEASE OF THE SUBSTANCE 5.1 Any accidental spillage of the unmixed substance or spray mix shall be either diluted with water, sand or earth, and then spread over a marked and designated non-crop and non-grazed area at the trial site, or taken to an approved landfill. 5.2 To minimise the effects of any accidental release of the substance, the container label will carry appropriate safety precautions and relevant first aid measures for immediate action pending medical attention. 5.3 Should an accidental release and exposure occur, normal precautions (such as the careful washing of hands, face, clothing, and equipment) will be observed. 6 INSPECTION AND MONITORING REQUIREMENTS 6.1 The Trial Director is required to keep track of all use of the substance as per section 5.9.1 of Code of Practice for the Management of Agrichemicals NZS8409: 1999 6.2 Occupational Safety & Health1 (OSH) and ERMA New Zealand are to be informed in writing of the locations, start, and completion of the field trials. 1 Head Office, Attention HSNO Project Manager (or equivalent position) 7 6.3 If for any reason a breach of containment occurs, the Trial Director will notify OSH and ERMA New Zealand immediately the event is noticed (and at least within 24 hours of the breach being detected). 6.4 The Authority or its authorised agent or properly authorised enforcement officers, may inspect the facilities and trial sites at any reasonable time in accordance with the Management Plan. 6.5 The applicant shall provide a completion report to ERMA New Zealand and OSH within one month of the end of each season’s trial, and a final report at the conclusion of the approval period, being three years from the date of this decision. 6.6 Site Close off – The Trial Director shall ensure that there are no unacceptable residues of the test substance in the whole of the trial site, including the area used for disposal of the spray mix. 7 QUALIFICATIONS REQUIRED OF THE PERSON RESPONSIBLE FOR IMPLEMENTING THE CONTROLS 7.1 The personnel applying the substance to the crops will be GROWSAFE certified. Signed on behalf of the Authority: ___________ Chair __________ Date ___________ Name 8