ENVIRONMENTAL RISK MANAGEMENT AUTHORITY DECISION

advertisement
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
Download