DECISION
29 June 2012
1. Summary
Substance
DAPI
Application code
APP201371
Application type
To import or manufacture for release any hazardous substance under
section 28 of the Hazardous Substances and New Organisms Act
1996 (“the Act”)
Application sub-type
Category A
Applicant
Bayer New Zealand Limited
Purpose of the application
To import DAPI for use as a raw material in the manufacture of
veterinary medicines for cattle.
Date application formally received
17 May 2012
Consideration date
29 June 2012
Considered by
The Chief Executive of the Environmental Protection Authority (EPA)
Decision
Approved with controls
Approval code
HSR100708
Hazard classifications
6.1C, 6.8C, 6.9A
(refer to Table 1, Section 4)
9.1A, 9.2A, 9.3A, 9.4A
2. Background
2.1.
DAPI is intended for use as an active ingredient in veterinary formulations for the treatment of
parasites in cattle. DAPI is in the form of a white crystalline powder. The applicant has stated DAPI
has similarities with the substance abamectin, as both substances belong to the macrocylic lactone
family and share similar chemical structures.
2.2.
The applicant has described the lifecycle of DAPI as follows:

The substance will be sourced and imported from abroad.

The substance will be transported to New Zealand either by sea or air freight.
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Application for approval to import DAPI for release (APP201371)

The substance will be used in the manufacture of veterinary medicines according to Good
Manufacturing Practice (GMP).

The substance will normally be disposed of by use in the manufacture of other substances. In all
other cases of disposal, the substance will be disposed of in accordance with the requirements of
the Hazardous Substances (Disposal) Regulations 2001 and the Resource Management Act
1991.
2.3.
The lifecycle and use of DAPI is expected to be similar to other veterinary medicine active ingredients
currently available in New Zealand. DAPI is currently present as an active ingredient in a number of
approved formulated veterinary medicines available in New Zealand.
3. Process, consultation and reasons for non-notification
3.1.
The application was lodged pursuant to section 28 of the Act.
3.2.
The application contained sufficient information for the staff of the EPA (“the staff”) to undertake a full
assessment of the substance from a scientific and technical perspective.
3.3.
The Department of Labour, the Ministry for Primary Industries (ACVM Group) and the Ministry of
Health were advised of the application on 25 May 2012 and invited to comment on it by 1 June 2012.
No comments were received.
3.4.
In accordance with section 53(2) of the Act, the application was not publicly notified as the staff
considered that there was unlikely to be significant public interest in it. This is because there are
formulations that contain DAPI as an active ingredient that are already approved for use in New
Zealand. In addition, the lifecycle of the substance is restricted to use within a manufacturing facility
where exposure to people and the environment will be limited.
4. Hazardous properties
4.1.
The staff determined the hazard classification of DAPI based on the information provided by the
applicant and other available information as documented in Appendix A. The classifications
determined by the staff differ to those submitted by the applicant, as shown in Table 1 below. The
difference in the classifications occurred because the applicant used data for abamectin to classify
DAPI, whereas the staff used data for DAPI itself.
Table 1 Hazard classifications of DAPI as proposed by the applicant and the EPA staff
Hazard Endpoint
Applicant classification
EPA classification
Subclass 6.1 Acute toxicity (oral)
6.1B
6.1C
Subclass 6.8 Reproductive/
developmental toxicity
6.8B
No
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Application for approval to import DAPI for release (APP201371)
Subclass 6.8 Reproductive/
developmental toxicity (via lactation)
6.8C
6.8C
Subclass 6.9 Target organ systemic
toxicity
6.9A
6.9A
Subclass 9.1 Aquatic ecotoxicity
9.1A
9.1A
Subclass 9.2 Soil ecotoxicity
9.2A
9.2A
Subclass 9.3 Terrestrial vertebrate
ecotoxicity
9.3A
9.3B
Subclass 9.4 Terrestrial invertebrate
ecotoxicity
9.4A
9.4A
5. Risk and benefit assessment
Assessment of risks to human health and the environment
5.1.
The lifecycle of DAPI is restricted to use within a manufacturing facility where exposure to people and
the environment will be limited. Therefore, the assessment of the risks to human health and the
environment has been limited to a qualitative risk assessment.
5.2.
The identification and qualitative assessment of the risks to human health and the environment
associated with DAPI are set out in Tables 2 and 3 respectively. More information is detailed in
Appendix B.
Relationship of Māori to the environment
5.3.
The staff note that DAPI triggers a number of hazardous properties giving rise to the potential for
cultural risk, including the deterioration of the mauri of taonga flora and fauna species, the
environment and the general health and well-being of individuals and the community.
5.4.
In general, the introduction and use of hazardous substances has the potential to inhibit the ability of
iwi/Māori to fulfil their role as kaitiaki, particularly in relation to the guardianship of waterways, given
the ecotoxic nature of some substances to aquatic species, and potential risks to the mauri ora of
human health under prolonged exposure to some substances.
5.5.
The staff consulted with Kaupapa Kura Taiao1(KKT). Based on the information provided, including the
limited use pattern and default controls for DAPI, KKT consider that the risks to Māori culture or
traditional relationships with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other
taonga are likely to be negligible.
5.6.
In addition, there is no evidence to suggest that the controlled use of DAPI will breach the principles of
the Treaty of Waitangi
1
Kaupapa Kura Taiao are the EPA’s Maori Policy & Operations Group
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Application for approval to import DAPI for release (APP201371)
Table 2: Qualitative assessment of human health risks
Lifecycle
Description
Likelihood
Magnitude
Matrix
Comment
Level of risk
Importation,
transport,
storage
Acute toxicity
(oral)
Highly
improbable
Moderate
Negligible
Workers and bystanders will only be exposed to the substance during this part of
the lifecycle in isolated incidents where spillage occurs. HSNO controls (e.g.
labels, Safety Data Sheets (SDS)) and adherence to the Land Transport Rule
45001, Civil Aviation Act 1990 and Maritime Transport Act 1994 (as applicable)
will apply.
Negligible
Use
Acute toxicity
(oral)
Highly
improbable
Moderate
Negligible
This lifecycle phase will be subject to HSNO requirements for personal protective
equipment, packaging, identification, approved handlers and emergency
management. In addition the operation of the manufacturing facilities will be
subject to the requirements of the Health and Safety in Employment Act 1992 and
the manufacturing processes will comply with Good Manufacturing Practice
(GMP).
Negligible
Reproductive/
developmental
toxicity via
lactation
Highly
improbable
Major
Low
The staff consider that whilst the chronic toxic properties of this substance could
cause major adverse effects, the approved handlers using the substance will have
the necessary skills and knowledge to reduce the level risk from low to negligible
Negligible
Acute toxicity
(oral)
Highly
improbable
Moderate
Negligible
The staff consider that the substance is most likely to be disposed of by use in the
formulation of veterinary medicines. In all other cases of disposal, the substance
will be disposed of in accordance with the requirements of the Hazardous
Substances (Disposal) Regulations 2001 and the Resource Management Act
1991.
Negligible
Reproductive/
developmental
toxicity via
lactation
Highly
improbable
Major
Low
The staff consider that whilst the chronic toxic properties of this substance could
cause major adverse effects, the approved handlers disposing of the substance
will have the necessary skills and knowledge to reduce the level risk from low to
negligible.
Negligible
Target organ
systemic toxicity
Disposal
Target organ
systemic toxicity
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Application for approval to import DAPI for release (APP201371)
Table 3: Qualitative assessment of risks to the environment
Lifecycle
Description
Likelihood
Magnitude
Matrix
Comment
Level of risk
Importation,
transport
and storage
Death or adverse
effects to aquatic
or terrestrial
organisms.
Highly
improbable
Minor
Negligible
The staff consider that given adherence to the HSNO controls (e.g. packaging,
identification and emergency management) and the Land Transport Rule 45001,
Civil Aviation Act 1990 and Maritime Transport Act 1994 (as applicable) any spill
would involve small quantities which would lead to localised effects only.
Negligible
Use
Death or adverse
effects to aquatic
or terrestrial
organisms.
Highly
improbable
Minor
Negligible
The use of DAPI will be restricted to use within manufacturing facilities. These
facilities will be subject to a number of HSNO controls such as emergency
management.
Negligible
Disposal
Death or adverse
effects to aquatic
or terrestrial
organisms.
Highly
improbable
Minor
Negligible
The staff consider that the substance is most likely to be disposed of by use in the
formulation of veterinary medicines. In all other cases of disposal, the substance
will be disposed of in accordance with the requirements of the Hazardous
Substances (Disposal) Regulations 2001 and the Resource Management Act
1991.
Negligible
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Application for approval to import DAPI for release (APP201371)
Assessment of risks to society and the community and the market economy
5.7.
The staff did not identify any risks associated with the approval of DAPI to society, communities or the
market economy.
New Zealand’s international obligations
5.8.
The staff did not identify that the approval of DAPI would impact any of the New Zealand international
obligations.
Overall assessment of risks
5.9.
The staff consider that, with controls in place, the risks associated with DAPI are negligible.
Identification of benefits
5.10. The ability to import DAPI into New Zealand will provide benefits to the veterinary medicine industry
and New Zealand in that it will enable:

the manufacture of new products in New Zealand that would have potential for export earnings;

the manufacture of products in New Zealand, thus providing manufacturers with financial benefits
and a competitive advantage over imported products; and

the production of lower cost products that would be of benefit to farmers.
The effects of the substance being unavailable
5.11. The staff consider that the likely effects of the substance being unavailable are the inability to
manufacture veterinary medicines containing this substance in New Zealand. This causes reliance on
imported veterinary medicines that contain this active ingredient which may be more expensive for
end-users.
Overall assessment of benefits
5.12. The staff are satisfied that the availability of DAPI will provide benefits to New Zealand, as it is likely
that it will provide beneficial effects for the veterinary medicine sector.
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Application for approval to import DAPI for release (APP201371)
6. Controls
6.1.
Based on the hazard classification determined for DAPI (Table 1, Section 4), a set of associated
default controls specified by regulations under the Act has been identified by the staff as being
applicable to DAPI. The default controls form the basis of the controls set out in Appendix C. Based
on the risk assessment, it is considered that the following exposure limits are relevant and that the
additional controls set out below should be applied to DAPI.
The setting of exposure limits
6.2.
Tolerable Exposure Limits (TELs) can be set to control hazardous substances entering the
environment in quantities sufficient to present a risk to people. No TELs have been set for DAPI at
this time as the level of risk to bystanders is considered negligible.
6.3.
The EPA typically adopts Workplace Exposure Standard (WES) values (listed in the Department of
Labour’s Workplace Exposure Standards document2) to control exposure in places of work. No WES
values have been set by the Department of Labour for DAPI at this time.
6.4.
The default controls allow the setting of Environmental Exposure Limits (EELs) to control hazardous
substances entering the environment. No EELs are set for DAPI at this time as the level of risk to the
environment is considered negligible. The default EEL values have been deleted.
6.5.
The default controls require the setting of an application rate for an ecotoxic substance that is to be
sprayed on an area of land (or air or water) and for which an EEL has been set. As DAPI is not
intended for application to an area of land and no EEL has been set, this control has been deleted.
Additional controls
6.6.
The staff note that the risk assessment for DAPI has been limited to the intention to use the substance
to formulate veterinary medicines. The staff note that none of the default controls limit how the
substance may be used. Accordingly, the staff consider that the approval should be restricted to the
use of the substance to the manufacture of veterinary medicines. A control has been added under
section 77A of the Act to limit the use of DAPI.
Variation and deletion of controls
6.7.
The default controls for DAPI include a requirement for keeping records of use for substances that are
applied for the purpose of causing biocidal action in places where members of the public may be
lawfully present or where the substances are likely to enter the air or water and leave the place. The
2
http://www.osh.govt.nz/publications/booklets/wes-dec-2010/wes-dec-2010.pdf
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Application for approval to import DAPI for release (APP201371)
staff consider this control is not applicable to the intended use pattern of DAPI and therefore can be
deleted.
6.8.
Given the highly toxic nature of DAPI, the staff consider that it is appropriate to retain the approved
handler requirements for the substance, and provide an exception for the transportation of packaged
substances by way of a variation to this control. The revised controls are shown in Appendix C.
6.9.
The default controls for DAPI include requirements to protect beneficial terrestrial invertebrates (e.g.
bees). The staff note that the substance is intended for use in manufacturing facilities where bees and
other beneficial terrestrial invertebrates are unlikely to be present. Therefore, this control can be
deleted.
Review of controls for cost-effectiveness
6.10. The staff consider that the proposed controls are the most cost-effective means of managing the
identified potential risks and costs associated with this application. The applicant was given an
opportunity to comment on the proposed controls as set out in this decision. The applicant indicated
that they accept the proposed controls for the substance.
7. Environmental user charges
7.1.
The staff consider that use of controls on DAPI is an effective means of managing risks associated
with this substance. It is considered that it is not necessary to apply environmental user charges 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.
8. Conclusion
8.1.
Taking into account the staff’s assessment of the potential risks, costs and benefits associated with
DAPI (see Section 5), I consider that, with controls in place:

the risks to human health and the environment arising from the hazardous properties (see Table
1, Section 4) of DAPI are negligible;

significant adverse impacts on the social or economic environment with DAPI are not anticipated;

it is unlikely that DAPI could have a significant impact on Māori culture or traditional relationships
with ancestral lands, water, sites, wāhi tapu, valued flora and fauna or other taonga or will breach
the principles of the Te Tiriti o Waitangi/Treaty of Waitangi; and

benefits will be derived for New Zealand by allowing the use of DAPI.
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Application for approval to import DAPI for release (APP201371)
9. Decision
9.1.
Pursuant to section 29 of the Act, I have considered this application to import a hazardous substance
for release made under section 28 of the Act and have applied the relevant sections of the Act and
clauses of the Hazardous Substances and New Organisms (Methodology) Order 1998 (“the
Methodology”) as detailed in the decision path and explanatory notes available from our website3.
9.2.
I am satisfied with the hazard classifications identified by the staff in Table 1 (Section 4) and
accordingly confer them on DAPI.
9.3.
I consider that, with controls in place, the risks to human health and to the environment are negligible,
and there will be benefits associated with the release of DAPI. Therefore, I consider that the
application may be approved in accordance with clause 26, with the controls proposed by the staff and
documented in Appendix C.
9.4.
The import the hazardous substance, DAPI, is thus approved with controls as listed in Appendix C.
Rob Forlong
Date: 29 June 2012
Chief Executive, EPA
3
http://www.epa.govt.nz/publications/er-pr-02-decision-paths.pdf
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Application for approval to import DAPI for release (APP201371)
Appendix A: Staff classification of DAPI
The classifications of DAPI are shown in Appendix Table 1.
Appendix Table 1: Summary of the applicant’s and staff’s hazard classification
Staff’s
classification
Class 1 Explosiveness
No
ND
Class 2, 3 & 4 Flammability
No
ND
Class 5 Oxidisers/Organic Peroxides
No
ND
Subclass 8.1 Metallic corrosiveness
No
ND
Subclass 6.1 Acute toxicity (oral)
6.1B
6.1C
Subclass 6.1Acute toxicity (dermal)
No
ND
Subclass 6.1 Acute toxicity (inhalation)
No
ND
Subclass 6.1 Aspiration hazard
No
ND
Subclass 6.3/8.2 Skin
irritancy/corrosion
No
No
Subclass 6.4/8.3 Eye
irritancy/corrosion
No
No
Subclass 6.5A Respiratory
sensitisation
No
ND
Subclass 6.5B Contact sensitisation
No
ND
Subclass 6.6 Mutagenicity
No
No
Subclass 6.7 Carcinogenicity
No
No
Subclass 6.8 Reproductive/
developmental toxicity
6.8B
No
Subclass 6.8 Reproductive/
developmental toxicity (via lactation)
6.8C
6.8C
Subclass 6.9 Target organ systemic
6.9A
6.9A
Remarks
Mixture
rules4
Applicant’s
classification
Read across
Hazard Class/Subclass
Method of
classification
Substance
data
Substance classification
The applicant based their
classification on
abamectin data
The applicant based their
classification on
abamectin data
4
Use of mixture rules may not adequately take into account interactions between different components in some circumstances
and must be considered of lower reliability than substance (formulation) data.
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Application for approval to import DAPI for release (APP201371)
toxicity
Subclass 9.1 Aquatic ecotoxicity
9.1A
9.1A
Subclass 9.2 Soil ecotoxicity
9.2A
9.2A
Subclass 9.3 Terrestrial vertebrate
ecotoxicity
9.3A
9.3B
Subclass 9.4 Terrestrial invertebrate
ecotoxicity
9.4A
9.4A
According to information
provided by the applicant
on ecotoxicity to birds
(acute toxicity value),
there is an indication that
the classification could be
amended to 9.3A,
however, as there is no:
supporting study behind
the toxicity value, no
summary describing the
study, neither it is clear
which substance was
tested between
abamectin and
doramectin, this
information is not
considered at this
moment and the
classification will remain
9.3B on the basis of
information on toxicity on
mammals.
NA: not applicable
NC: not classified
ND: no data
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Application for approval to import DAPI for release (APP201371)
Appendix B: Staff risk and benefit assessment
The staff have evaluated the potential of DAPI to cause adverse effects to during all stages of the
substance’s lifecycle. A qualitative risk assessment was carried out to assess these risks.
The process by which the risk assessment of substances is undertaken is specified in the Methodology 5.
Guidance on risk assessment is provided on the EPA website6
To facilitate the assessment of risks the applicant and the staff identified the most common potential sources
of risk to the environment and to human health and safety through release, spillage or exposure throughout
the lifecycle of the substance. These are tabulated in Appendix Table 2.
Appendix Table 2: Potential sources of risks associated with hazardous substances
Lifecycle Activity
Associated Source of Risk
Import
An incident during the importation of the substance resulting in
spillage and subsequent exposure of people or the environment to
the substance.
Transport or storage
An incident during the transport or storage of the substance
resulting in spillage and subsequent exposure of people or the
environment to the substance.
Use
An incident during use resulting in spillage and subsequent
exposure of users or the environment to the substance.
Disposal
Disposal of the substance or packaging resulting in exposure of
people or the environment to the substance.
5
6
http://www.epa.govt.nz/publications/methodology.pdf
http://www.epa.govt.nz/Publications/ER-TG-05-02-03-09-(Decision-Making).pdf
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Appendix C: Controls applying to DAPI
Notes:

The controls for this substance apply for unlimited duration of the approval of this substance.

Please refer to the Hazardous Substances Regulations7 for the requirements prescribed for each control
and the modifications listed as set out in Section 6 of this document.
Appendix Table 3: Controls for DAPI – codes, regulations and variations
Hazardous Substances (Classes 6, 8, and 9 Controls) Regulations 2001
Code
Regulation
Description
Variation
T1
11 – 27
Limiting exposure to toxic
substances through the setting of
TELs
No TELs are set for this substance at this time.
T2
29, 30
Controlling exposure in places of
work through the setting of WESs
No DoL WES values are set for DAPI at this time.
T4
7
Requirements for equipment used
to handle substances
T5
8
Requirements for protective
clothing and equipment
T6
9
Approved handler/security
requirements for certain toxic
substances
The following regulation is inserted immediately
after regulation 9:
9A Exception to approved handler
requirements for the transportation of
packaged DAPI
(1) Regulation 9 is deemed complied with if(a) in the case of DAPI being
transported on land(i)
in the case of DAPI being
transported by rail, the person
who drives the rail vehicle that is
transporting the substance is
fully trained in accordance with
an approved safety system
under section 6D of the
Transport Services Licensing
Act 1989 or a safety system
which is referred to in an
approved safety case under the
Railways Act 2005; and
(ii) in every other case, the person
who drives, loads, and unloads
the vehicle that is transporting
7
The regulations can be found on the New Zealand Legislation website; http://www.legislation.co.nz
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the substance –
A. for hire or reward, or in
quantities which exceed
those set out in Schedule 1
of the Land Transport Rule
45001/1: Dangerous Goods
2005, has a current
dangerous goods
endorsement on his or her
driver’s licence; or
B. in every other case, the
Land Transport Rule
45001/1: Dangerous Goods
2005 is complied with; or
(b) in the case of DAPI being
transported by sea, one of the
following is complied with:
(i)
Maritime Rules: Part 24A –
Carriage of Cargoes –
Dangerous Goods
(MR024A):
(ii) International Maritime
Dangerous Goods Code; or
(c) in the case of DAPI being
transported by air, Part 92 of the
Civil Aviation Rules is complied with.
(2) Subclause (1)(a)—
(a) does not apply to a tank wagon or
transportable container to which the
Hazardous Substances (Tank
Wagons and Transportable
Containers) Regulations 2004
applies; but
(b) despite paragraph (a), does apply to
an intermediate bulk container that
complies with chapter 6.5 of the UN
Model Regulations.
(3)
Subclause (1)(c)—
(a) applies to pilots, aircrew, and airline
ground personnel loading and
managing this substance within an
aerodrome; but
(b) does not apply to—
(i)
the storage and handling of
this substance in any place
that is not within an
aerodrome; or
(ii)
the loading and managing
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Application for approval to import DAPI for release (APP201371)
of this substance for the
purpose of aerial spraying
or dropping.
In this regulation, UN Model Regulations means
the 14th revised edition of the recommendation on
the Transport of Dangerous Goods Model
Regulations, published in 2005 by the United
Nations.
T7
10
Restrictions on the carriage of
toxic or corrosive substances on
passenger service vehicles
E1
32 – 45
Limiting exposure to ecotoxic
substances through the setting of
EELs
E6
7
Requirements for equipment used
to handle substances
E7
9
Approved handler/security
requirements for certain ecotoxic
substances
No EELs are set for this substance at this time
and the default EEL values are deleted.
See variation to regulation 9 above.
Hazardous Substances (Identification) Regulations 2001
Code
Regulation
Description
I1
6, 7, 32 – 35,
36(1) – (7)
Identification requirements, duties
of persons in charge,
accessibility, comprehensibility,
clarity and durability
I3
9
Priority identifiers for ecotoxic
substances
I8
14
Priority identifiers for toxic
substances
I9
18
Secondary identifiers for all
hazardous substances
I11
20
Secondary identifiers for ecotoxic
substances
I16
25
Secondary identifiers for toxic
substances
I17
26
Use of generic names
I18
27
Requirements for using
concentration ranges
I19
29 – 31
Additional information
requirements, including situations
where substances are in multiple
Variation
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packaging
I20
36 (8)
Durability of information for class
6.1 substances
I21
37 – 39, 47 –
50
General documentation
requirements
I23
41
Specific documentation
requirements for ecotoxic
substances
I28
46
Specific documentation
requirements for toxic substances
I29
51, 52
Signage requirements
I30
53
Advertising corrosive and toxic
substances
Hazardous Substances (Packaging) Regulations 2001
Code
Regulation
P1
5, 6, 7(1), 8
Description
Variation
General packaging requirements
P3
9
Criteria that allow substances to
be packaged to a standard not
meeting Packing Group I, II or III
criteria
P13
19
Packaging requirements for toxic
substances
P15
21
Packaging requirements for
ecotoxic substances
PS4
Schedule 4
Packaging requirements as
specified in Schedule 4
PG3
Schedule 3
Packaging requirements
equivalent to UN Packing Group
III
Hazardous Substances (Disposal) Regulations 2001
Code
Regulation
Description
D4
8
Disposal requirements for toxic
and corrosive substances
D5
9
Disposal requirements for
ecotoxic substances
D6
10
Disposal requirements for
Variation
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packages
D7
11, 12
Information requirements for
manufacturers, importers and
suppliers, and persons in charge
D8
13, 14
Documentation requirements for
manufacturers, importers and
suppliers, and persons in charge
Hazardous Substances (Emergency Management) Regulations 2001
Code
Regulation
Description
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
EM11
25 – 34
Level 3 emergency management
requirements: duties of person in
charge, emergency response
plans
EM13
42
Level 3 emergency management
requirements: signage
Variation
Hazardous Substances (Personnel Qualifications) Regulations 2001
Code
Regulation
Description
AH1
4-6
Approved Handler requirements (including test certificate and qualification
requirements)
Hazardous Substances (Tracking) Regulations 2001
Code
Regulation
Description
TR1
4(1), 5, 6
General Tracking Requirements
Hazardous Substances (Tank Wagon and Transportable Containers) Regulations 2004
Code
Regulation
Description
Tank
Wagon
4 to 43 as
applicable
Controls relating to tank wagons and transportable containers.
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Additional controls added under Section 77A of the Act.
Code
Use
Description
1)
Prohibition on use of DAPI
No person may use DAPI for any purpose other than –
(a) for research and development; or
(b) as an ingredient or component in the manufacture of a veterinary medicine.
(2)
Despite subclause (1)(a), research and development using DAPI does not include
investigation or experimentation in which the substance is discharged, laid or applied
in or to the outdoor environment.
Specification of DAPI
(1)
(2)
(1)
(2)
(3)
(4)
Any person who (a) imports into New Zealand DAPI, which that person has not previously
manufactured or imported; or
(b) had previously imported DAPI, but has since changed the source of manufacture
for that hazardous substance,
must provide to the Authority in writing the information required by subclauses (3)
and (4).
The information required by subclause (1) must be provided –
(a) in the case of a substance that is manufactured in New Zealand prior to that
substance being sold to another person or used; or
(b) prior to the substance being imported; and
(c) in the case of DAPI to which subclause (1)(b) applies –
(i) each and every time the source of manufacture is changed; and
(ii) include equivalent information for the substance that was supplied by the
previous source of manufacture, if such information has not previously
been provided to the Authority.
The information to be provided is (a) the name and address of the manufacturer of DAPI (as appropriate);
(b) the specification of DAPI (as appropriate) including –
(i) the full name, including relevant citation, of the national and/or international
standard(s) set by an international scientific or regulatory body recognised
by the Authority with which the substance complies, and evidence to
support this; or
(ii) the manufacturer’s specifications including purity of the hazardous
substance, isomeric ratio where applicable, maximum impurity content
and evidence to support these, including details of analytical methods
used. Where DAPI is produced at more than one manufacturing site, this
information must be provided for each site separately;
(c) the identity of any impurity, its origin, and the nature of its relationship to the
active component when the impurity is present at a concentration of 10 g/kg or
more;
(d) the identity of any impurity that is known to be of toxicological concern, its
origin, and the nature of its relationship to the active component when the
impurity is present at a concentration of less than 10g/kg.
Information on an impurity that is required under subclause (3) must include –
(a) its chemical name;
(b) its Chemical Abstract Service Registry number (if available); and
(c)
its maximum concentration in the substance.
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