ENVIRONMENTAL RISK MANAGEMENT
AUTHORITY DECISION
23 June 2006
Application code
HSR06028
Application type
To import or manufacture any hazardous substance under Section
28A(2)(b) of the Hazardous Substances and New Organisms Act
1996 (the HSNO Act)
Applicant
Adria New Zealand Limited
PO Box 535
Kumeu
AUCKLAND
Purpose
Bio-Save 11LP Postharvest Bioprotectant: To import a post-harvest
fungal disease control agent to protect pome fruit, sweet potatoes
and potatoes. (Rapid least degrees of hazard)
Date received
3 May 2006
Consideration date
22 June 2006
Considered by
Chief Executive of ERMA New Zealand
1
Summary of Decision
1.1
The application to import or manufacture Bio-Save 11LP Postharvest
Bioprotectant is approved in accordance with the relevant provisions of the
HSNO Act, the HSNO Regulations, and the HSNO (Methodology) Order 1998
(the Methodology).
1.2
The substance has been given the following unique identifier for the ERMA
New Zealand Hazardous Substances Register:
Bio-Save 11LP Postharvest Bioprotectant
1.3
ERMA New Zealand has adopted the European Union use classification
system as the basis for recording the nature and uses of the substances
approved. The following use categories are recorded for this substance:
Main Category:
Industrial category:
Function/Use category:
3
1
38
Non-dispersive use
Agricultural industry
Pesticides
2
Legislative Criteria for Application
2.1
The application was lodged pursuant to section 28 of the HSNO Act. The
decision was determined in accordance with section 28A(2)(b) (rapid
assessment), taking into account matters relevant to the purpose of the HSNO
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.
2.2
Consideration of the application followed the relevant provisions of the
Methodology. Unless otherwise stated, references to clauses in this decision
refer to clauses of the Methodology.
2.3
In accordance with section 28A(2)(b), and clause 24, the approach adopted
when considering this application was to determine whether the substance had
one or more hazardous properties and if each of those hazardous properties
meet the criteria for least degree of hazard for that property. Then, having
regard to the default controls triggered by the classification, potentially
significant risks were identified to determine whether they provided any reason
why this substance should not be approved by rapid assessment. Finally, the
default controls were reviewed to address their application to this substance
(clause 35), and to address any residual risks.
3
Application Process
3.1
The purpose of the application is to manufacture Bio-Save 11LP Postharvest
Bioprotectant as a post-harvest fungal disease control agent.
3.2
The application was formally received on 3 May 2006 and included the
following documents:
 The Application
 Confidential appendices, including composition, label and safety data sheet.
3.3
The Agricultural Compounds & Veterinary Medicines Group (ACVMG), the
Ministry of Health and the Department of Labour Workplace Group were
advised of the application (clause 2(2)(e)).
3.4
A response was received from the ACVMG indicating that:
“As this application will be considered under the ACVM Act, any issues which
may arise under the Acts administered by MAF/NZFSA will be considered as
part of that application.”
3.5
Project Team:
Margaret Keane
Applications Advisor (Hazardous
Substances)
Julia Fediaeva
Science Advisor (Hazardous Substances)
Peter Jackson
Advisor (Maori Unit)
Environmental Risk Management Authority Decision: HSR06028
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Report review and sign-out by:
Dr Robin Toy
Science Team Leader (Hazardous
Substances)
3.6
The requirement for the application to be considered within 10 working days
was waived under section 59 to allow time to determine whether Pseudomonas
syringae is a new organism to New Zealand.
3.7
In a decision issued on 16 June 2006 (S2606002) the Authority determined that
Pseudomonas syringae is not a new organism to New Zealand.
4
Identification and Use
4.1
The active ingredient in Bio-Save 11LP, Pseudomonas syringae strain ESC-11,
is a natural strain of bacteria that occurs on many kinds of plants throughout
the world. It was originally isolated and identified from apples. It is applied to
certain fruits before storage in order to protect the fruits from several fungal
diseases. Although the exact method of disease control is unknown, these
harmless bacteria probably out-compete the fungi for space and nutrients on
the fruit, thereby preventing the fruit from rotting before it can be used.
4.2
Bio-Save 11LP Postharvest Bioprotectant will be imported into New Zealand
as a post-harvest fungal disease control agent to protect pome fruit, sweet
potatoes and potatoes. Bio-Save 11LP Postharvest Bioprotectant will be
transported by refrigerated transport to Mainfreight Logistics, Penrose,
Auckland and distributed on dry ice directly to produce pack houses. It will
then used in post-harvest dipping baths according to label advice.
4.3
The product is packed into a double-bagged foil pouch and stored at frozen or
refrigerated temperatures. Storing above refrigeration temperatures will reduce
the product’s effectiveness.
4.4
Bio-Save 11LP Postharvest Bioprotectant will be used in pack houses on pome
fruit, sweet potatoes and potatoes destined for the export market. This product
is to replace an existing chemical which is now banned for use in the European
Union.
4.5
The product is applied after the fruit is harvested. The target pests are various
moulds and rots that attack the fruits during storage.
4.6
After the fruit is harvested and cleaned, its surface is exposed to a solution
containing the ESC-11 bacterium. The applicator can apply the solution by
spraying, or by dipping the fruit into the solution. These applications are
considered indoor uses, since they take place in enclosed areas.
4.7
Wastes resulting from use of Bio-Save 11LP Postharvest Bioprotectant will be
disposed of on site in the water recycling treatment plant.
4.8
Spills are soaked up with absorbent material and shovelled into a waste
container and covered for disposal via a local collection service.
Environmental Risk Management Authority Decision: HSR06028
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4.9
The applicant advises that goggles and insulated gloves are to be worn when
mixing and loading and good general ventilation is sufficient.
5
Hazard Classification
5.1
Bio-Save 11LP Postharvest Bioprotectant is an off-white to tan powder with a
bread like odour. The substance has a neutral pH and is insoluble in water. No
physical hazard classifications are triggered.
5.2
The applicant provided a safety data sheet (SDS) for Bio-Save 11LP
Postharvest Bioprotectant that provided information on acute toxicity but no
chronic toxicity data.
5.3
The oral LD50 in rats is greater than 5000 mg/kg. No skin irritation was noted
in a primary dermal irritation study in rabbits. No local or systemic toxicity
was noted in an acute dermal toxicity study in rabbits. (LD50 greater than
5010 mg/kg). No information is available on acute inhalation effects for the
mixture. However, no mortality or irreversible signs of toxicity were produced
by the active ingredient, Pseudomonas syringae, in an inhalation toxicity study
in rats. Given the preceding criteria, no acute toxicity classification is
considered necessary.
5.4
No skin irritation was noted in a primary dermal irritation study in rabbits.
5.5
Based on an eye irritation study in rabbits producing mild, reversible eye
irritation, a 6.4A classification is conferred.
5.6
No ecotoxicological information is available from the applicant; however
Pseudomonas syringae, ESC 11, is not classified as a plant pathogen by
USDA/APHIS. Based on the intended uses of Bio-Save 11LP Postharvest
Bioprotectant as a biological fungicide, a 9.1D classification is conferred.
5.7
Accordingly, I am satisfied that Bio-Save 11LP Postharvest Bioprotectant
should be classified as 9.1D and 6.4A.
6
Evaluation Against the Criteria for Least
Degree of Hazard
6.1
The classification categories 6.4A and 9.1D meet the least degree of hazard
criteria.
6.2
Accordingly, based on the classifications that can be assigned (6.4A and 9.1D),
Bio-Save 11LP Postharvest Bioprotectant is considered eligible for rapid
assessment under section 28A(2)(b).
Environmental Risk Management Authority Decision: HSR06028
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7
Default Controls
7.1
The default controls1 associated with the hazard classification for Bio-Save
11LP Postharvest Bioprotectant are listed below.
Toxicity Controls
T1
Limiting exposure to toxic substances through the setting of TELs
T2
Controlling exposure in places of work through the setting of WESs.
T4
Requirements for equipment used to handle substances
T7
Restrictions on the carriage of toxic or corrosive substances on passenger
service vehicles
Ecotoxicity Controls
E1
Limiting exposure to ecotoxic substances through the setting of EELs
E2
Restrictions on use of substances in application areas
E6
Requirements for equipment used to handle substances
Identification Controls
I1
Identification requirements, duties of persons in charge, accessibility,
comprehensibility, clarity and durability
I9
Secondary identifiers for all hazardous substances
I11
Secondary identifiers for ecotoxic substances
I16
Secondary identifiers for toxic substances
I19
Additional information requirements, including situations where substances
are in multiple packaging
I21
General documentation requirements
I28
Specific documentation requirements for toxic substances
I29
Signage requirements
Packaging Controls
P1
General packaging requirements
P3
Criteria that allow substances to be packaged to a standard not meeting
Packing Group I, II or III criteria
P13
Packaging requirements for toxic substances
PS4
Packaging requirements as specified in Schedule 4
Disposal Controls
D4
Disposal requirements for toxic and corrosive substances
D5
Disposal requirements for ecotoxic substances
D6
Disposal requirements for packages
D7
Information requirements for manufacturers, importers and suppliers, and
persons in charge
D8
Documentation requirements for manufacturers, importers and suppliers, and
persons in charge
Emergency Management Controls
EM1 Level 1 information requirements for suppliers and persons in charge
EM6 Information requirements for toxic substances
EM7 Information requirements for ecotoxic substances
EM8 Level 2 information requirements for suppliers and persons in charge
EM11 Level 3 emergency management requirements: duties of person in charge,
emergency response plans
EM13 Level 3 emergency management requirements: signage
1
Default controls are set under section 77 of the HSNO Act 1996 and the associated Hazardous
Substances regulations.
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8
Identification and Assessment of the
Significant Risks and Costs
8.1
I note that the applicant has not provided complete information on human
toxicity, the host specificity of Bio-Save 11LP Postharvest Bioprotectant or its
effects on beneficial insects. However, I am satisfied that this lack of
information can be managed by HSNO controls.
8.2
In considering the risks associated with Bio-Save 11LP Postharvest
Bioprotectant that may arise from their classifications, I have considered the
risks to human health, to the environment and to Māori.
Human Health Risks
8.3
The applicant submitted data relating to acute toxicity and skin and eye
irritation with the resulting classification of 6.4A (eye irritancy) being
assigned. However, no data were presented to determine whether the substance
presents a risk in terms of sensitisation or chronic toxicity.
8.4
Furthermore, the bacteria cannot survive at temperatures above 32oC (90oF)
and therefore cannot grow in humans or birds whose body temperatures are
considerably higher. No health risks to humans are expected from use of this
substance when label directions are followed.
8.5
The applicant has advised that Pseudomonas syringae Strain ESC-11 is
registered and licensed for sale and distribution in the USA with an overall
conclusion that it is not expected to harm either humans or the environment
when used in pesticide products. With this in mind, I am satisfied that BioSave 11LP Postharvest Bioprotectant poses little or no risk to human health.
Environmental Risks
8.6
Bio-Save 11LP Postharvest Bioprotectant is classified as 9.1D ecotoxic
because it is designed for biocidal action. There is little additional information
available to determine other environmental effects of the substance other than
that Pseudomonas syringae are bacteria occurring naturally on many kinds of
plants throughout the world. This substance is not expected to cause harm to
the environment because the pome fruit, sweet potatoes and potatoes are
treated in an pack houses, therefore exposures to the environment, including
wildlife, soil, and water, are not expected.
Effects on Māori
8.7
I have considered the potential Māori cultural effects of this application in
accordance with sections 6(d) and 8 of the HSNO Act, and the assessment
framework contained in the ERMA New Zealand User Guide “Working with
Māori under the HSNO Act 1996”.
8.8
From the information provided, I consider that it is unlikely that Bio-Save
11LP Postharvest Bioprotectant could have any impact on Māori culture or
traditional relationships with ancestral lands, water, sites, wāhi tapu, valued
Environmental Risk Management Authority Decision: HSR06028
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flora and fauna or other taonga. This is on the condition that the substance is
used in accordance with the HSNO controls established for this application,
and in accordance with any other relevant controls applying under other
legislation.
8.9
I have identified no evidence to suggest that the use of this substance will
breach the principles of the Treaty of Waitangi and I see no requirement for the
applicant to consult with Māori regarding this application.
8.10
This assessment is made on the condition that the substance is handled, stored,
transported, used, and disposed of in accordance with the explicitly stated
HSNO controls, and any controls stipulated in other applicable Acts.
However, should inappropriate use, or an accident, result in the contamination
of waterways or the environment, it is suggested that the appropriate
authorities are notified, including the relevant iwi authorities in that region.
This action should include advising them of the contamination and the
measures taken to contain and remedy it.
International Obligations
8.11
As previously stated, Bio-Save 11LP Postharvest Bioprotectant has been
accepted for use by the US Environment Protection Agency.
8.12
It is the applicant’s view that a growing number of post-harvest fungicides are
being banned for use on export produce due to residue concerns and Bio-Save
11LP is a solution to this as it is based on a naturally occurring bacteria with
very low toxicity and no residue. It is also readily degradable and it cannot
survive at room temperature for more than several days – unlike synthetic
fungicides which can persist for months.
9
Controls
9.1
Under section 77(3), (4) and (5), the default controls determined by the
hazardous properties of the substance may be varied.
9.2
The following variations apply to Bio-Save 11LP Postharvest Bioprotectant:
9.3
Control T1 relates to limiting exposure to toxic substances. The properties and
use of the substance are such that the requirement to set an Acceptable Daily
Exposure (ADE) is not met (specifically, exposure of the substance to
bystanders will not result in an appreciable toxic effect), and thus this control
is not applicable.
9.4
Control T2, relates to the requirement to set Workplace Exposure Standards
(WES). I note that there is an absence of relevant industrial hygiene data with
respect to the use of the substance in New Zealand to enable a HSNO WES to
be calculated. Therefore no WES are set for Bio-Save 11LP Postharvest
Bioprotectant and/or its components at this time.
9.5
Controls T4 and E6 are combined (section 77(5)) as they both relate to the
same regulation relating to equipment used to handle hazardous substances.
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9.6
Control E1 requires that an Environmental Exposure Limit (EEL) is
established. As the risks to the environment associated with this product are
negligible, no EEL has been established for Bio-Save 11LP Postharvest
Bioprotectant and so this control, along with the default EEL values for water,
soil, and sediment, is deleted under section 77(4)(a).
9.7
Control E2 relates to specifying requirements relating to application areas.
Since no EELs have been set for the substance, this control is deleted under
section 77(4)(a).
9.8
Controls P3 and P13 are combined under section 77(5) as they both relate to
packaging requirements for Bio-Save 11LP Postharvest Bioprotectant.
9.9
Controls D4 and D5 are combined (section 77(5)) as they both relate to
disposal requirements.
10
Decision
10.1
In accordance with section 28A(2)(b) of the HSNO Act and clause 24 of the
Methodology, the approach adopted when considering this application was to
evaluate the substance to determine whether the substance has one or more
hazardous properties and if each of those hazardous properties meet the criteria
for least degree of hazard for that property. Then, having regard to the default
controls triggered by the classification, potentially significant residual risks
and associated costs were identified for assessment in accordance with clauses
12, 13, 33 and 34. Finally, the default controls were reviewed to address their
application to this substance (clause 35) and to address any residual risks.
10.2
Having considered the risks associated with the lifecycle of Bio-Save 11LP
Postharvest Bioprotectant, I am satisfied that the residual risks or costs
associated with this substance is sufficiently low to be acceptable (clause 34).
10.3
Having considered the hazardous properties, I am satisfied that Bio-Save 11LP
Postharvest Bioprotectant meets the criteria for least degree of hazard, and the
criteria for rapid assessment under section 28A(2)(b) of the HSNO Act.
10.4
In accordance with clause 36(2)(b) of the Methodology, I relied in particular
on section 28(2)(b) of the Act and also applied the following criteria in the
Methodology:
 clause 9 - equivalent of sections 5, 6 and 8;
 clause 12 – evaluation of assessment of risks;
 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.
 clause 33 – risk characteristics;
 clause 34 – evaluating the combined impacts of risks, costs and benefits;
and
 clause 35 – the costs and benefits of varying the default controls.
Environmental Risk Management Authority Decision: HSR06028
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10.5
The application is accordingly approved pursuant to section 28A(2)(b) of the
HSNO Act with controls as specified in Appendix 1.
Rob Forlong
Date
23 June 2006
Chief Executive, ERMA New Zealand
ERMA New Zealand Approval Code
Bio-Save 11LP Postharvest Bioprotectant
Environmental Risk Management Authority Decision: HSR06028
HSR002696
Page 9 of 19
Appendix 1: Controls that apply to Bio-Save
11LP Postharvest Bioprotectant
Control
Code1
Regulation2
Explanation3
Hazardous Substances (Classes 6, 8 and 9 Controls) Regulations 2001 -Toxic Property
Controls
T2
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 and
applies to every place of work.
No WES are set for Bio-Save 11LP Postharvest Bioprotectant
and/or its components at this time.
T4, E6
7
Requirements for equipment used to handle hazardous substances
Any equipment used to handle toxic and ecotoxic substances (e.g. spray
equipment) 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.
T7
10
Restrictions on the carriage of hazardous substances on passenger
service vehicles
In order to limit the potential for public exposure to Bio-Save 11LP
Postharvest Bioprotectant, the maximum quantity per package of BioSave 11LP Postharvest Bioprotectant permitted to be carried on
passenger service vehicles is 3 kg.
Hazardous Substances (Identification) Regulations 2001
The Identification Regulations prescribe requirements with regard to
identification of Bio-Save 11LP Postharvest Bioprotectant in terms of:
 information that must be “immediately available” with Bio-Save
11LP Postharvest Bioprotectant (priority and secondary
identifiers). This information is generally provided by way of the
product label;
 documentation that must be available in the workplace, generally
provided by way of SDS;
 signage at a place where there is a large quantity of Bio-Save 11LP
Postharvest Bioprotectant.
I1
6, 7, 32-35,
General identification requirements
36 (1)-(7)
These controls relate to the duties of suppliers and persons in charge of
Bio-Save 11LP Postharvest Bioprotectant with respect to identification
(essentially labelling) (Regulations 6 and 7), accessibility of the
required information (Regulations 32 and 33) and presentation of the
required information with respect to comprehensibility, clarity and
durability (Regulations 34, 35, 36(1)-(7))
Regulation 6 – Identification duties of suppliers
Suppliers of Bio-Save 11LP Postharvest Bioprotectant must ensure it is
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 the ERMA
New Zealand website www.ermanz.govt.nz/resources and is also contained in the ERMA New Zealand User Guide to the HSNO
Control Regulations.
2
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.
Environmental Risk Management Authority Decision: HSR06028
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Control
Code1
Regulation2
Explanation3
labelled with all relevant priority identifier information (as required by
Regulations 8-17) and secondary identifier information (as required by
Regulations 18-30) before supplying it to any other person. This
includes ensuring that the priority identifier information is available to
any person handling Bio-Save 11LP Postharvest Bioprotectant within
two seconds (Regulation 32), and the secondary identifier information
available within 10 seconds (Regulation 33).
Suppliers must also ensure that no information is supplied with BioSave 11LP Postharvest Bioprotectant (or its packaging) that suggests it
belongs to a class or subclass that it does not in fact belong to.
Regulation 7 – Identification duties of persons in charge
Persons in charge of Bio-Save 11LP Postharvest Bioprotectant must
ensure it is labelled with all relevant priority identifier information (as
required by Regulations 8 to 17) and secondary identifier information
(as required by Regulations 18 to 30) before supplying it to any other
person. This includes ensuring that the priority identifier information is
available to any person handling Bio-Save 11LP Postharvest
Bioprotectant within two seconds (Regulation 32), and the secondary
identifier information is available within 10 seconds (Regulation 33).
Persons in charge must also ensure that no information is supplied with
Bio-Save 11LP Postharvest Bioprotectant (or its packaging) that
suggests it belongs to a class or subclass that it does not in fact belong
to.
Regulations 32 and 33 – Accessibility of information
All priority identifier Information (as required by Regulations 8 to 17)
must be available within two seconds, e.g. on the label
All secondary identifier Information (as required by Regulations 18 to
30) must be available within 10 seconds, e.g. on the label.
I9
18
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 or 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;
 any information provided must be in a durable format i.e. the
information requirements with respect to clarity must be able to be
met throughout the lifetime of the (packaged) substance under the
normal conditions of storage, handling and use.
Secondary identifiers for all hazardous substances
This control relates to detail required for Bio-Save 11LP Postharvest
Bioprotectant on the product label. This information must be accessible
within 10 seconds (Regulation 33) and could be provided on secondary
panels on the product label. The following information is required:
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Control
Code1
Regulation2
I11
20
I16
25
I19
29-31
Explanation3
 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 any 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 or subclass, a description of each likely change and
the date by which it is likely to occur.
Secondary identifiers for ecotoxic substances
This control relates to the additional label detail required for Bio-Save
11LP Postharvest Bioprotectant. This information must be accessible
within 10 seconds (Regulation 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.
Secondary identifiers for toxic substances
This control relates to the additional label detail required for Bio-Save
11LP Postharvest Bioprotectant. This information must be accessible
within 10 seconds (Regulation 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
(irritating to the eye);
 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.
Alternative information in certain cases
Regulation 29 – Substances in fixed bulk containers or bulk transport
containers
This Regulation relates to alternative ways of presenting the priority
and secondary identifier information required by Regulations 8 to 25
when Bio-Save 11LP Postharvest Bioprotectant is contained in fixed
bulk containers or bulk transport containers.
Regulation 29(1) specifies that for fixed bulk containers, it is sufficient
compliance if there is available at all times to people near the container,
information that identifies the type and general degree of hazard of
Bio-Save 11LP Postharvest Bioprotectant.
Regulation 29(2) specifies that for bulk transport containers, it is
sufficient compliance if Bio-Save 11LP Postharvest Bioprotectant is
labelled or marked in compliance with the requirements of the Land
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Control
Code1
Regulation2
Explanation3
Transport Rule 45001, Civil Aviation Act 1990 or Maritime Transport
Act 1994.
Regulation 30 – Substances in multiple packaging
This Regulation relates to situations when Bio-Save 11LP Postharvest
Bioprotectant is in multiple packaging and the outer packaging
obscures some or all of the required substance information. In such
cases, 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
 bear the EU pictogram “Dangerous to the Environment” (‘dead fish
and tree’ on orange background); or
 bear the relevant class or subclass label assigned by the UN Model
Regulations.
I21
37-39, 47-50
Regulation 31 – Alternative information when substances are imported
This Regulation relates to alternative information requirements for BioSave 11LP Postharvest Bioprotectant that is imported into New
Zealand in a closed package or in a freight container and will be
transported to its 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.
Documentation required in places of work
These controls relate to the duties of suppliers and persons in charge of
places of work with respect to provision of documentation (essentially
Safety Data Sheets) (Regulations 37, 38 and 50); the general content
requirements of the documentation (Regulation 39 and 47); the
accessibility and presentation of the required documentation with
respect to comprehensibility and clarity (Regulation 48).
These controls are triggered when Bio-Save 11LP Postharvest
Bioprotectant is held in the workplace in quantities equal to or greater
than 50 kg.
Regulation 37 – Documentation duties of suppliers
A supplier must provide documentation containing all relevant
information required by Regulations 39 to 48 when selling or supplying
to another person a quantity of Bio-Save 11LP Postharvest
Bioprotectant equal to or greater than 50 kg, if Bio-Save 11LP
Postharvest Bioprotectant 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 Bio-Save 11LP
Postharvest Bioprotectant is present in quantities equal to or greater
than those specified in Regulation 38 (and with reference to Schedule 2
of the Identification Regulations), must ensure that every person
handling the substance has access to the documentation required for
each hazardous substance concerned. The person in charge must also
ensure that the documentation does not contain any information that
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Control
Code1
Regulation2
Explanation3
suggests that the substance belongs to a class or subclass it does not in
fact belong to.
Regulation 39 – General content requirements for documentation
The documentation provided with Bio-Save 11LP Postharvest
Bioprotectant must include the following information:
 the unequivocal identity of Bio-Save 11LP Postharvest
Bioprotectant (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 Bio-Save
11LP Postharvest Bioprotectant;
 if the Bio-Save 11LP Postharvest Bioprotectant’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 any 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
Bio-Save 11LP Postharvest Bioprotectant;
 the date on which the documentation was prepared.
Regulation 47 – Information not included in approval
This Regulation relates to the provision of specific documentation
information (e.g. as provided on an SDS). If information required by
Regulations 39 to 46 was not included in the information used for the
approval of Bio-Save 11LP Postharvest Bioprotectant by the Authority,
it is sufficient compliance with those Regulations if reference is made
to that information requirement along with a comment indicating that
such information is not applicable to that substance.
Regulation 48 – Location and presentation requirements for
documentation
All required documentation must be available to a person handling BioSave 11LP Postharvest Bioprotectant 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 Bio-Save 11LP Postharvest Bioprotectant 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 Bio-Save 11LP Postharvest Bioprotectant is present) if asked to
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Control
Code1
Regulation2
I28
46
I29
51-52
Explanation3
do so by that person.
Specific documentation requirements for toxic substances
The documentation provided with Bio-Save 11LP Postharvest
Bioprotectant must include the following information:
 its general degree and type of toxic hazard (irritating to the eye);
 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;
 a summary of the available acute and chronic (toxicity) data used
to define the (toxic) 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;
 any TELs or WESs set by the Authority.
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 Bio-Save 11LP
Postharvest Bioprotectant is held in quantities exceeding 10,000 kg.
Signs are required:
 at every entrance to the building and/or location (vehicular and
pedestrian) where Bio-Save 11LP Postharvest Bioprotectant is
present
 at each entrance to rooms or compartments where Bio-Save 11LP
Postharvest Bioprotectant is present;
 immediately adjacent to the area where Bio-Save 11LP Postharvest
Bioprotectant is located in an outdoor area.
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 of hazard of each substance (e.g.
flammable);
 where the signage is immediately adjacent to Bio-Save 11LP
Postharvest Bioprotectant storage areas, describe the precautions
needed to safely manage the substance (e.g. a 'No Smoking'
warning near flammable substances).
Hazardous Substances (Packaging) Regulations 2001
P1
5, 6, 7 (1), 8
General packaging requirements
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 Bio-Save 11LP Postharvest Bioprotectant with any
previous contents of the packaging.
Regulation 5 – Ability to retain contents
Packaging for Bio-Save 11LP Postharvest Bioprotectant must ensure
that, when the package is closed, there is no visible release of it, 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
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Control
Code1
Regulation2
Explanation3
its remaining contents if part of the contents is removed from the
package and the packaging is then re-closed. The packaging in direct
contact with Bio-Save 11LP Postharvest Bioprotectant 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 Bio-Save 11LP Postharvest Bioprotectant 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 1, 2 or 3
(Packaging Regulations) respectively; 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 Bio-Save 11LP Postharvest Bioprotectant, 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 to 21.
Regulation 8 – Compatibility
Bio-Save 11LP Postharvest Bioprotectant must not be packed in
packaging that has been previously packed with substances with which
it is incompatible unless all traces of the previous substance have been
removed.
P3, P13
PS4
9, 19
Schedule 4
Regulation 9A and 9B – Large Packaging
Large packaging may be used to contain Bio-Save 11LP Postharvest
Bioprotectant in New Zealand if it has been constructed, marked and
tested as a large package as provided in Chapter 6.6 of the 13th revised
edition of the UNRTDG, 2003.
“Large Packaging” does not include:
 a tank, tank wagon or transportable container (as defined in the
Hazardous Substances (Tank Wagons and Transportable
Containers) Regulations 2004; or
 a stationary container system, a stationary tank or a tank (as
defined in the Hazardous substances (Dangerous Goods and
Scheduled Toxic Substances) Transfer Notice 2004.
Packaging requirements for Bio-Save 11LP Postharvest
Bioprotectant
Bio-Save 11LP Postharvest Bioprotectant must be packaged according
to Schedule 4 when in quantities equal to or less than 400 kg.
Bio-Save 11LP Postharvest Bioprotectant that is offered for sale in a
package of less than 2.5 L must be in child resistant packaging (i.e.
toxic substances liable to be in homes). However, if the substance is for
use in a place of work to which children do not have access, this
requirement is not mandatory.
This schedule describes the minimum packaging requirements that
must be complied with for this substance.
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Hazardous Substances (Disposal) Regulations 2001
D4, D5
8, 9
Disposal requirements for toxic and ecotoxic substances
Bio-Save 11LP Postharvest Bioprotectant must be disposed of by:
 treating it 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 Bio-Save 11LP
Postharvest Bioprotectant with any other substance prior to
discharge to the environment; or
 discharging Bio-Save 11LP Postharvest Bioprotectant 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 (tolerable
exposure limit) set by the Authority for that substance; or
 exporting the substance from New Zealand as a hazardous waste.
D6
10
Disposal requirements for packages
This control gives the disposal requirements for packages that
contained Bio-Save 11LP Postharvest Bioprotectant and are no longer
to be used for that purpose. Such packages must be either
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 Bio-Save 11LP
Postharvest Bioprotectant. In addition, the manner of disposal must
take into account the material that the package is manufactured from.
D7
11, 12
Disposal information requirements
These controls relate to the provision of information concerning
disposal (essentially on the label) that must be provided when selling or
supplying a quantity of Bio-Save 11LP Postharvest Bioprotectant that
exceeds 0.1 kg.
D8
13, 14
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
Bio-Save 11LP Postharvest Bioprotectant within 10 seconds and must
comply with the requirements for comprehensibility, clarity and
durability as described in Regulations 34-36 of the Identification
Regulations (code I1).
Disposal documentation requirements
These controls relate to the provision of documentation concerning
disposal (essentially in an SDS) that must be provided when selling or
supplying Bio-Save 11LP Postharvest Bioprotectant that exceeds
50 kg.
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 Bio-Save 11LP Postharvest
Bioprotectant at a place of work within 10 minutes and must comply
with the requirements for comprehensibility and clarity as described in
Regulations 48(2), (3) and (4) of the Identification Regulations (code
I21).
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Hazardous Substances (Emergency Management) Regulations 2001
EM1
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 BioSave 11LP Postharvest Bioprotectant when present in quantities equal
to or greater than 0.1 kg.
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 required by the Identification Regulations (code I1,
Regulations 6, 7, 32–35, 36(1)-(7)).
EM6
8(e)
EM7
8(f)
EM8
12-16, 18-20
Regulation 11 provides for the option of complying with the
information requirements of the transport rules when Bio-Save 11LP
Postharvest Bioprotectant is being transported.
Information requirements for toxic substances
The following information must be provided when Bio-Save 11LP
Postharvest Bioprotectant is present in quantities equal to or greater
than 0.1 kg:
 a description of the first aid to be given;
 a 24-hour emergency service telephone number.
Information requirements for ecotoxic substances
The following information must be provided with Bio-Save 11LP
Postharvest Bioprotectant when present in quantities equal to or
greater than 1 kg:
 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
Bio-Save 11LP Postharvest Bioprotectant from entering or
affecting those parts of the environment.
Level 2 emergency management information requirements
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 Safety Data Sheets). This documentation
must be provided where Bio-Save 11LP Postharvest Bioprotectant is
sold or supplied, or held in a workplace, in quantities equal to or
greater than 50 kg.
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 Bio-Save 11LP Postharvest
Bioprotectant is being transported, and regulation 16 specifies
requirements for general contents of the documentation.
Regulation 18 prescribes location and presentation requirements for the
documentation, i.e. it must be available within 10 minutes, be readily
understandable, comprehensible and clear. These requirements
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EM11
EM13
25-34
42
correspond with those relating to documentation required by the
Identification regulations (code I21).
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
Bio-Save 11LP Postharvest Bioprotectant is held (or reasonably likely
to be held on occasion) in quantities greater than 10,000 kg.
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 to 30. Requirements relating to the
availability of equipment, materials and people are provided in
Regulation 31, requirements regarding the availability of the plan are
provided in Regulation 32 and requirements for testing the plan are
described in Regulation 33.
Level 3 emergency management requirements – signage
This control relates to the provision of emergency management
information on signage at places where Bio-Save 11LP Postharvest
Bioprotectant is held at quantities equal to or greater than 10,000 kg.
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.
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