Hazardous Substances (Minimum Degrees of Hazard Regulations 2001
(SR 2001/112(br />
1 Title
These regulations are the Hazardous Substances (Minimum Degrees of Hazard
Regulations 2001.
2 Commencement
These regulations come into force on 2 July 2001.
3 Interpretation
In these regulations, unless the context otherwise requires,
Act means the Hazardous Substances and New Organisms Act 1996
ASTM, when followed by letters and numbers, means the document identified by
those letters and numbers that is published by the American Society for Testing and
Materials
data includes values that are directly measured, calculated, or estimated for
any of the measures given
deflagrate, in relation to a substance that is initiated or ignited, means
the production in that substance of a chemical reaction that proceeds through, or
along the surface of, the substance at subsonic velocity, where that chemical
reaction,
(a results in the steady production of hot gases at high pressures; and
(b if the substance is sufficiently confined, results in an increase in
pressure, rate of reaction, and temperature that may produce a detonation of the
substance
detonate, in relation to a substance that is initiated, means the production
in that substance of a chemical reaction that proceeds through that substance at
supersonic velocity, resulting in the production of heat and a supersonic shock wave
through the surrounding medium
gas means a substance that
(a is completely gaseous at 20C and at 101.3 kPa absolute pressure; or
(b has a vapour pressure of more than 300 kPa absolute pressure at 50C
ISO means the International Standards Organisation; and
(a ISO 9328 (II): 1991 means the ISO Standard called Steel plates and
strips for pressure purposestechnical delivery conditions, Part II; and
(b ISO 10156: 1996 means the ISO Standard called Gases and gas mixtures
determination of fire potential and oxidising ability for the selection of cylinder
valve outlets
liquid means
(a a substance with a melting point of less than or equal to 20C at
101.3 kPa absolute pressure; or
(b a viscous substance, without a defined melting point, if
(i more than the quantity of the substance specified in ASTM D 4359C90,
called Test method for determining whether a material is a liquid or a solid,
collects on a watch glass when tested in the manner specified in that test; or
(ii a penetrometer penetrates into the substance the distance defined in
the test for determining fluidity prescribed in Appendix A.3 of the European
Agreement concerning the International Carriage of Dangerous Goods by Road (ADR),
published in 1994 by the United Nations, when the method specified in that test is
followed
pyrotechnic effect, in relation to a substance that is initiated, means the
production in that substance of a self-sustaining exothermic chemical reaction
resulting in heat, sound, light, gas, smoke, or motion, or a combination of these
solid means a substance that is neither a liquid nor a gas
Test Series, when followed by a letter or number, means 1 or more tests as
prescribed in the UN Manual of Tests and Criteria
UN Manual of Tests and Criteria means the third revised edition of the
Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria,
published in 1999 by the United Nations (New York and Geneva(/p>
UN Model Regulations means the 11th revised edition of the Recommendations on
the Transport of Dangerous Goods Model Regulations, published in 1999 by the United
Nations (New York and Geneva)、/p>
4 Substances not considered hazardous
? A substance is not hazardous for the purposes of the Act unless it
meets the minimum degrees of hazard for at least 1 of the intrinsic hazardous
substance properties specified in regulation 7.
? This regulation is subject to regulations 5 and 6.
5 Medicines
? A medicine is not hazardous for the purposes of the Act unless Parts
13, 14, or 15 of the Act apply.
? Despite subclause ?), a new medicine must be treated as hazardous
if it meets any of the minimum degrees of hazard prescribed in these regulations
and
(a it is a substance to which section 3?)(b of the Medicines Act
1981 applies; or
(b an application is made to register that medicine as a trade name
product under the Agricultural Compounds and Veterinary Medicines Act 1997.
? In this regulation,
medicine has the same meaning as in section 3? of the Medicines Act 1981,
except that it does not include a gas contained at a pressure greater than 170 kPa in
a container larger than 100 mL, at any time after that gas becomes so contained and
before the time the gas is first administered to a person for a therapeutic purpose
new medicine means
(a any medicine that has not been generally available in New Zealand
(i before the commencement of the Medicines Act 1981; or
(ii at any time during the period of 5 years immediately before the date
on which it is proposed to become so available:
(b any medicine that, immediately before the commencement of Part 2 of the
Medicines Act 1981, was a therapeutic drug to which section 12 of the Food and Drug
Act 1969 applied, and in respect of the sale or distribution of which the Minister of
Health had not given his or her consent under that section:
(c any medicine that becomes a medicine for the first time after the
commencement of the Medicines Act 1981:
(d any medicine that is referred to the Minister of Health under section
24? of the Medicines Act 1981.
6 Food
? A food is not hazardous for the purposes of the Act unless Parts 13,
14, or 15 of the Act apply.
? In this regulation,
food has the same meaning as in section 2 of the Food Act 1981, except that
it does not include a food additive if that food additive has not been mixed with or
added to any other food or drink
food additive has the same meaning as in section 2? of the Food
Regulations 1984 (SR 1984/262)、/p>
7 Minimum degrees of hazard
? The minimum degrees of hazard for substances with explosive properties
are the degrees of hazard specified in Schedule 1.
? The minimum degrees of hazard for substances with flammable properties
are the degrees of hazard specified in Schedule 2.
? The minimum degrees of hazard for substances with oxidising properties
are the degrees of hazard specified in Schedule 3.
? The minimum degrees of hazard for substances with toxic properties are
the degrees of hazard specified in Schedule 4.
? The minimum degrees of hazard for substances with corrosive properties
are the degrees of hazard specified in Schedule 5.
? The minimum degrees of hazard for substances with ecotoxic properties
are the degrees of hazard specified in Schedule 6.
Schedule 1
Minimum degrees of hazard for substances with explosive properties
1 Minimum degrees of hazard for substances other than manufactured articles
A substance (other than a manufactured article with explosive properties
is not hazardous for the purpose of the Act unless
(a the substance is listed as class 1 in the Dangerous Goods List in
Chapter 3.2 of the UN Model Regulations; or
(b the substance propagates a detonation in accordance with paragraph
12.4.1.4 of the UN Manual of Tests and Criteria when tested as prescribed by Test
Series 2 type (a in paragraph 12.4 of that manual; or
(c the substance propagates a detonation in accordance with paragraph
12.5.1.4 of the UN Manual of Tests and Criteria when tested as prescribed by Test
Series 2 type (b in paragraph 12.5 of that manual; or
(d the substance produces a pressure rise from 690 to 2070 kPa gauge
pressure or more, as determined in accordance with paragraph 12.6.1.4 of the UN
Manual of Tests and Criteria, when tested as prescribed by Test Series 2 type (c
in paragraph 12.6 of that manual; or
(e the substance is specifically manufactured to detonate, deflagrate, or
produce a pyrotechnic effect.
2 Minimum degrees of hazard for manufactured articles
A manufactured article containing, incorporating, or including a hazardous
substance with explosive properties is not hazardous for the purposes of the Act
unless
(a the article is listed as class 1 in the Dangerous Goods List in Chapter
3.2 of the UN Model Regulations; or
(b the article produces some effect of projection, fire, smoke, heat, or
loud noise external to the article when tested as a stack of articles as prescribed
in Test Series 6 type (c in paragraph 16.6 of the UN Manual of Tests and Criteria.
Schedule 2
Minimum degrees of hazard for substances with flammable properties
1 Interpretation
In this schedule, unless the context otherwise requires,
flammable ingredient means a substance that meets 1 or more of the minimum
degrees of hazard for a flammable gas, a flammable liquid, or a flammable solid, or
any combination of them
flammable range
(a means the range between 2 ratios of gas or vapour to air, the lower of
which contains too much air, and the upper of which contains too little air, to
support combustion; and
(b includes a minimal range effectively equivalent to a single value
flashpoint means the lowest temperature at which a flammable liquid, when
tested in a closed cup flash point test, gives off vapour that ignites
SADT means self-accelerating decomposition temperature, being the lowest
temperature at which self-accelerating decomposition of the substance occurs in the
packaging in which it is tested when tested as prescribed in Test Series H in section
28 of the UN Manual of Tests and Criteria.
2 Minimum degrees of hazard
? A substance with flammable properties is not hazardous for the purposes
of the Act unless
(a the substance is a gas or a gas mixture that is sufficiently flammable
to be capable of ignition when mixed with air in a proportion within a flammable
range at 20C and at a pressure of 101.3 kPa absolute; or
(b the substance
(i is or contains a gas compressed, liquefied, or dissolved under pressure
(with or without a liquid, paste, or powder); and
(ii is packed under pressure in a way that is designed to be released
(A as solid or liquid particles in suspension in a gas; or
(B as a foam, paste, or powder; or
(C in a liquid state; or
(D in a gaseous state; and
(iii comprises 45% or more by mass of flammable ingredients; or
(c the substance is a liquid that has a flash point of less than or equal
to 93C; or
(d the substance
(i is described in paragraph 2.4.2.4 of the UN Model Regulations as being
an explosive substance that has been dissolved or suspended in water or other liquid
substances to form a homogeneous mixture in order to suppress its explosive
properties; or
(ii is listed in paragraph 2.3.1.4 of the UN Model Regulations with one of
the serial numbers UN 1204, UN 2059, UN 3064, or UN 3343; or
(iii is listed in the Dangerous Goods List in Chapter 3.2 of the UN Model
Regulations as having a class, division, or subsidiary risk of liquid desensitised
explosive; or
(e the substance is a solid that meets the criteria specified in paragraph
33.2.1.4.4 of the UN Manual of Tests and Criteria when tested in accordance with the
test method for readily combustible solids as prescribed in Test Series N.1 in
paragraph 33.2.1.4 of that manual; or
(f the substance is a solid that
(i is listed in the Dangerous Goods List in Chapter 3.2 of the UN Model
Regulations; and
(ii has one of the serial numbers UN 1331, UN 1343, UN 1944, UN 1945, or
UN 2254; or
(g the substance
(i has an SADT of less than or equal to 75C in a quantity of 50 kg and a
heat of decomposition greater than 300 joules per gram; or
(ii is listed in paragraph 2.4.2.3.2.3 of the UN Model Regulations as
having a class, division, or subsidiary risk of self-reactive; or
(h the substance
(i meets 1 or more of the minimum degrees of hazard for substances with
explosive properties specified in Schedule 1; and
(ii has been desensitised to the extent that it would, when tested as
prescribed in Test Series 6 type (c in paragraph 16.6 of the UN Manual of Tests
and Criteria, not show a projection, fire, smoke, heat, or noise effect external to
the substance itself; or
(i the substance
(i is described in paragraph 2.4.2.4 of the UN Model Regulations as being
an explosive substance that has been wetted with water or alcohols or diluted with
other substances to form a homogeneous mixture in order to suppress its explosive
properties; or
(ii is listed in paragraph 2.4.2.4 of the UN Model Regulations; or
(iii is listed in the Dangerous Goods List in Chapter 3.2 of the UN Model
Regulations as having a class, division, or subsidiary risk of a solid desensitised
explosive; or
(j the substance
(i is a solid in powder form that, when tested as prescribed in Test
Series N.2 in paragraph 33.3.1.4 of the UN Manual of Tests and Criteria, ignites in
one of the tests; or
(ii is a liquid that, when tested in as prescribed in Test Series N.3 in
paragraph 33.3.1.5 of the UN Manual of Tests and Criteria, ignites in the first part
of the test (paragraph 33.3.1.5.3.1?nbsp;or ignites or chars the filter paper in the
second part of the test (paragraph 33.3.1.5.3.2); or
(iii is a solid that, when tested as prescribed in Test Series N.4 in
paragraph 33.3.1.6 of the UN Manual of Tests and Criteria, gives a positive result in
a test using a 100 mm sample cube at 140C; or
(k the substance, when tested as prescribed in Test Series N.5 in
paragraph 33.4.1.4 of the UN Manual of Tests and Criteria, reacts with water at
ambient temperatures to produce a gas that ignites spontaneously; or
(l the substance, when tested as prescribed in Test Series N.5 in
paragraph 33.4.1.4 of the UN Manual of Tests and Criteria, reacts with water at
ambient temperatures to produce a flammable gas at a rate greater than or equal to 1
litre per kilogram of substance per hour.
? When tested in accordance with any of subclause ?)(e), (g),
(h), (j)(i), (j)(iii), (k), or (l), a substance must be
(a in the finest particle form in which that substance is reasonably
capable of being used or rendered; or
(b if it is likely or known that more than 10% of the mass of the
substance will crumble into a finer particle form, in that finer form.
Schedule 3
Minimum degrees of hazard for substances with oxidising properties
1 Interpretation
In this schedule, unless the context otherwise requires,
organic peroxide means a substance containing 1 or more chemical compounds
that
(a contains the bivalent oxygen [-0-0-] structure; and
(b may be considered as a derivative of hydrogen peroxide where one or
both of the hydrogen atoms has been replaced by an organic radical; and
(c may cause or contribute to combustion by the release of chemical energy
or compounds that may cause or contribute to fire, explosion, or chemical
decomposition
oxidising substance means a substance that, while not necessarily combustible
in itself, may cause or contribute to the combustion of other substances or
materials.
2 Minimum degrees of hazard
? A substance with oxidising properties is not hazardous for the purposes
of the Act unless
(a the substance is listed in the Dangerous Goods List in Chapter 3.2 of
the UN Model Regulations as having a class, division, or subsidiary risk of 5.1
(oxidising substances); or
(b the substance is a solid that
(i is an oxidising substance; and
(ii when mixed with dried cellulose, either spontaneously ignites or shows
a mean burning time equal to or faster than the mean burning time of a 3:7 reference
mixture by mass of potassium bromate and cellulose under the same conditions when the
mixture is tested in accordance with the test method for oxidising solids as
prescribed in Test Series O.1 in paragraph 34.4.1 of the UN Manual of Tests and
Criteria; or
(c the substance is a liquid that
(i is an oxidising substance; and
(ii when mixed with dried cellulose, either spontaneously ignites or shows
a mean pressure rise time that is equal to or faster than the mean pressure rise time
of the reference mixture of 65% aqueous nitric acid solution and cellulose under the
same conditions when that solution is tested in accordance with the test method for
oxidising liquids as prescribed in Test Series O.2 in paragraph 34.4.2 of the UN
Manual of Tests and Criteria; or
(d the substance is a gas that
(i is an oxidising substance; and
(ii will cause or contribute to combustion at a faster rate than air when
tested in accordance with the test method for determining the oxidising power of
gases and gas mixtures as prescribed in ISO 10156:1996; or
(e the substance is listed in
(i paragraph 2.5.3.2.4 of the UN Model Regulations as an organic peroxide;
or
(ii the Dangerous Goods List in Chapter 3.2 of the UN Model Regulations as
having a class or division of 5.2 (organic peroxides); or
(f the substance
(i is an organic peroxide or contains organic peroxides; and
(ii has more than 1% available oxygen from the organic peroxides when
containing not more than 1% hydrogen peroxide by mass; or
(g the substance
(i is an organic peroxide or contains organic peroxides; and
(ii has more than 0.5% available oxygen from the organic peroxides when
containing not less than 1% and not more than 7% hydrogen peroxide by mass.
? If a substance is a mixture and is made up of 1 or more chemical
elements or compounds, any one of which meets 1 or more of the minimum degrees of
hazard specified in subclause ?)(b), (c), (f), or (g), then the
mixture is hazardous for the purposes of the Act unless it can be shown that the
exact mixture itself does not meet any of the minimum degrees of hazard specified in
subclause ?)、/p>
? When tested in accordance with subclause ?)(b), a substance must
be
(a in the finest particle form in which that substance is reasonably
capable of being used or rendered; or
(b if it is likely or known that more than 10% of the mass of the
substance will crumble into a finer particle form, in that finer form.
? For the purposes of subclause ?)(f and (g), the available
oxygen content as a percentage by mass must be determined in accordance with the
following formula:
O% = 16 ni [ ci/mi ](/p>
where
O%is the percentage of available oxygen content to be determined
is the symbol for summation where there is more than 1 organic peroxide
niis the number of peroxygen groups per molecule of each organic peroxide
ciis the percentage concentration by mass of each organic peroxide
miis the molecular mass of each organic peroxide.
Schedule 4
Minimum degrees of hazard for substances with toxic properties
1 Interpretation
In this schedule, unless the context otherwise requires,
developmental effect, in relation to an organism, includes structural
abnormality, altered growth, functional deficiency, or interference with the normal
development of an organism (including the death of a developing organism), that
is
(a manifested at any point in the organism's life span; and
(b caused by
(i the exposure of a parent to the substance before conception; or
(ii the exposure of the developing offspring to the substance during
prenatal development or postnatal development up to the time of sexual maturation
dust and mist, in relation to a substance in the atmosphere, means that 90%
of the substance is in the form of particles with a aerodynamic diameter of less than
10 microns
expert means
(a a member of a scientific committee set up by an international,
national, or professional scientific body to review scientific data; or
(b a person considered by his or her scientific peers to be an expert in
the relevant field of scientific study
genotoxic effect means alterations to the structure, information content, or
segregation of DNA, including
(a DNA damage caused by interference with its normal replication
processes; and
(b temporary non-physiological alterations to its replication
LD50 means the median lethal dose, being a statistically derived single dose
of a substance that can be expected to cause death in 50% of animals
mean Draize score,
(a in relation to acute skin irritation tests, means the mean value in at
least 2 of 3 tested animals
(i from Draize grades measured at intervals of 24 hours, 48 hours, and 72
hours after the patch is removed; or
(ii where reactions are delayed, from Draize grades on 3 consecutive days
after the onset of dermal reactions; and
(b in relation to acute eye irritation tests, means the mean value of at
least 2 of 3 tested animals from Draize grades measured at intervals of 24 hours, 48
hours, and 72 hours after instillation of the substance
mutagenic effect means a permanent change in the amount or structure of the
genetic material in a cell, being a permanent change that is
(a manifested at the phenotypic level; or
(b an underlying DNA modification (including specific base pair changes
and chromosomal translocations(/p>
reliable information means information that is derived from
(a a valid and relevant animal study conducted in accordance with
internationally accepted test guidelines and principles of good laboratory practice;
or
(b an epidemiological study in humans that is statistically sound and has
undergone peer review; or
(c any other study whose relevance and validity can be demonstrated
according to internationally accepted criteria and scientific practice
reproductive effect includes
(a interference with reproductive ability or capacity, including
alteration to the male or female reproductive system; or
(b an effect on the onset of puberty, gamete production and transport,
reproductive cycle normality, sexual behaviour, fertility, parturition, or premature
reproductive senescence; or
(c an effect on or through lactation; or
(d modifications in other functions that are dependent on the integrity of
the reproductive system
sensitisation means an immunologically mediated response where, after
exposure to a substance to which an organism or human being has been previously
exposed, the organism or human being is, or 1 or more organs in an organism or human
being are, more readily and adversely affected by that substance
significant adverse biological effect means a toxicologically significant
change in an organ or in an animal observed during the study where the probability
that the change is different from any recognised background history of change or from
the value in a recognised unexposed control organ or animal group in the test animal
strain is greater than 0.95 (equivalent to P (probability of 0.05 or less(/p>
valid, in relation to a study, means
(a the design of the study methodology accurately reflects the matters the
study seeks to measure; and
(b the study findings can be extrapolated from the sample used in the
study to a broader population.
2 Minimum degrees of hazard
? A substance with toxic properties is not hazardous for the purposes of
the Act unless
(a data for the substance indicates an LD50 of 5 000 milligrams or less of
the substance per kilogram of bodyweight as a result of acute exposure of animals to
the substance by oral or dermal routes; or
(b data for the substance indicate any mortality, as a result of acute
exposure of animals by
(i oral or dermal routes to 2 000 milligrams or less of the substance per
kilogram of bodyweight; or
(ii the inhalation route to
(A 5 000 parts or less of the substance per million in air, if the
substance is a gas; or
(B 20 milligrams or less of the substance per litre of air, if the
substance is a vapour; or
(C 5 milligrams or less of the substance per litre of air, if the substance is
a dust or mist; or
(c clinical signs (other than diarrhoea, piloerection, or an ungroomed
appearance indicate to an expert a significant adverse biological effect as a
result of acute exposure of animals by
(i oral or dermal routes to 2 000 milligrams or less of the substance per
kilogram of bodyweight; or
(ii the inhalation route to
(A 5 000 parts or less of the substance per million in air, if the
substance is a gas; or
(B 20 milligrams or less of the substance per litre of air, if the
substance is a vapour; or
(C 5 milligrams or less of the substance per litre of air, if the
substance is a dust or mist; or
(d reliable information for the substance, including reliable information
from animal studies other than those from which LD50 data was obtained, where
exposure was by a route other than oral, dermal, or inhalation, indicates to an
expert the potential for significant acute toxic effects in humans after exposure to
the substance; or
(e data for the substance, in the opinion of an expert, indicates evidence
in humans of significant acute toxic effects as a result of exposure to the
substance; or
(f data for the substance indicates a mean Draize score of 1.5 or more for
either of the skin irritation effects known as erythema or oedema, as a result of
exposure to the substance; or
(g data for the substance indicates a mean Draize score of 1 or more for
either of the eye irritation effects known as corneal opacity or iritis, as a result
of exposure to the substance; or
(h data for the substance indicates a mean Draize score of 2 or more for
either of the eye irritation effects known as conjunctival redness or chemosis, as a
result of exposure to the substance; or
(i data for the substance indicates positive evidence of respiratory
sensitisation in animals as a result of exposure to the substance; or
(j data for the substance indicates positive evidence of sensitisation by
skin contact in animals as a result of exposure to the substance of either
(i 30% or more sensitisation response in an adjuvant type test method; or
(ii 15% or more sensitisation response in a non-adjuvant type test method;
or
(k data for the substance, in the opinion of an expert, indicates evidence
in humans of specific respiratory hypersensitivity (including asthma, rhinitis, and
alveolitis as a result of exposure to the substance; or
(l data for the substance, in the opinion of an expert, indicates evidence
in humans of sensitisation by skin contact as a result of exposure to the substance;
or
(m data for the substance indicates evidence of mutagenic effects as a
result of mammalian in vivo exposure to the substance; or
(n data for the substance indicates evidence of
(i genotoxic effects as a result of mammalian in vivo exposure to the
substance; and
(ii mutagenic effects as a result of in vitro exposure to the substance;
or
(o data for the substance indicates evidence of mutagenic effects as a
result of in vitro exposure of mammalian cells to the substance and the substance has
a structureCactivity relationship to known germ cell mutagens, where
(i structureCactivity relationship means a significant correlative
relationship between the chemical structure of the substance and the chemical
structure of a known germ cell mutagen; and
(ii the relationship relates to that germ cell mutagen activity; or
(p reliable information for the substance indicates to an expert that
exposure to the substance causes the development of cancer or an increase in the
incidence of benign or malignant tumours in an organ or an organism; or
(q reliable information for the substance indicates to an expert that
exposure to the substance causes an adverse reproductive effect; or
(r reliable information for the substance indicates to an expert that
exposure to the substance causes an adverse developmental effect; or
(s data for the substance indicates, in the opinion of an expert, evidence
of a significant adverse biological effect or a significant toxic effect (other than
an effect referred to in any of paragraphs (a to (r)) on the function or
morphology of an organ, or on the biochemistry or haematology of an organism or human
being as a result of exposure to the substance and, in the case of a significant
adverse biological effect, the change is relevant to human health.
? A substance is not required to be tested in accordance with subclause
?)(a if the substance
(a has been tested in accordance with subclause ?)(b); and
(b does not meet the minimum degree of hazard specified in subclause ?(br />
(b)、/p>
Schedule 5
Minimum degrees of hazard for substances with corrosive properties
1 Interpretation
In this schedule, unless the context otherwise requires, mean Draize score,
in relation to acute eye irritation tests, means the mean value in at least 2 of 3
tested animals from Draize grades measured at intervals of 24 hours, 48 hours, and 72
hours after instillation of the substance.
2 Minimum degrees of hazard
A substance with corrosive properties is not hazardous for the purposes of
the Act unless
(a the substance corrodes, at a rate exceeding 6.25 millimetres per year
at a test temperature of 55C,
(i steel type P235 (ISO 9328 (II):1991); or
(ii steel type SAE 1020 (Society of Automotive Engineers); or
(iii non-clad aluminium types SAE 7075-T6 or AZ5GU-T6; or
(b data for the substance indicates that the substance has a pH level of 2
or less, or 11.5 or more; or
(c data for the substance indicates destruction of dermal tissue, being
visible necrosis through the epidermis and into the dermis, as a result of exposure
to the substance, that has not fully reversed within an observation period of 14
days; or
(d data for the substance indicates destruction of ocular tissue, being
adverse effects on the cornea, iris, or conjunctiva, as a result of exposure to the
substance, that has not fully reversed within an observation period of 21 days; or
(e data for the substance indicates a mean Draize score of 3 or more for
the eye irritation effect known as corneal opacity, as a result of exposure to the
substance; or
(f data for the substance indicates a mean Draize score of 1.5 or more for
the eye irritation effect known as iritis, as a result of exposure to the substance.
Schedule 6
Minimum degrees of hazard for substances with ecotoxic properties
1 Interpretation
In this schedule, unless the context otherwise requires,
BCF means bioconcentration factor, being the steady state concentration of a
substance in an aquatic organism divided by the concentration of the substance in the
surrounding water
bioaccumulative, in relation to a substance, means the substance has a BCF
greater than or equal to 500 or, if BCF data is not available, a log Kow greater than
or equal to 4; and, for the purposes of this definition, measured log Kow values take
precedence over estimated values
biocidal action, in relation to a substance, means the substance causes
mortality, inhibited growth, or inhibited reproduction in an organism
BOD5 means 5-day biochemical oxygen demand, being the mass of oxygen consumed
by micro-organisms during oxidation of the substance in water over a period of 5
days, expressed in units of milligrams of oxygen consumed per milligram of the
substance
COD means chemical oxygen demand, being the equivalent mass of oxygen from an
oxidising agent, of a strength at least equal to the oxidising strength of potassium
permanganate or potassium dichromate, that is consumed during oxidation of the
substance in water, expressed in units of milligrams of oxygen consumed per milligram
of the substance
EC50 means the median effect concentration, being a statistically derived
concentration of a substance that can be expected to cause
(a an adverse effect in 50% of organisms; or
(b a 50% reduction in growth or in the growth rate of organisms
Kow means the steady state ratio of the solubility of a substance in n-
octanol to the solubility of that substance in water
LC50 means the median lethal concentration, being a statistically derived
concentration of a substance that can be expected to cause death in 50% of organisms
exposed for a specified time
LD50 means a median lethal dose, being a statistically derived single dose of
a substance that can be expected to cause death in 50% of organisms
LOEC means the lowest observed effect concentration, being the lowest
concentration of a substance that produces a significant ecotoxic effect in an
organism or in an organism population
MATC means the maximum acceptable toxicant concentration, being the geometric
mean of the NOEC and LOEC where the NOEC and LOEC are derived from the same study
NOEC means the no observed effect concentration, being the highest
concentration of a substance that does not produce a significant ecotoxic effect in
an organism or in an organism population
rapidly degradable, in relation to a substance in water, means that
(a 28 days after a solution containing the substance is inoculated with
micro-organisms, there is at least
(i a 70% reduction in dissolved organic carbon in the solution; or
(ii a 60% depletion of oxygen in the solution, when compared with the
maximum depletion of oxygen that would occur if the substance were completely
degraded; or
(iii a 60% generation of carbon dioxide in the solution, when compared
with the maximum generation of carbon dioxide that would occur if the substance were
completely degraded; or
(b if only COD and BOD5 data is available, the ratio of BOD5 to COD is
greater than or equal to 0.5:1; or
(c at least 70% of the substance can be degraded biotically or
abiotically, in the aquatic environment within 28 days
significant ecotoxic effect means an ecotoxicologically significant change in
an organism or in an organism population observed during the study where the
probability that the change is different from any recognised background history of
change or from the value in a recognised unexposed control organism population is
greater than 0.95 (equivalent to P (probability of 0.05 or less)、/p>
2 Minimum degrees of hazard
? A substance with ecotoxic properties is not hazardous for the purposes
of the Act unless
(a the substance is ecotoxic to aquatic organisms because
(i data for the substance indicates that the fish LC50 is 100 milligrams
or less of the substance per litre of water over a 96-hour exposure period, as a
result of exposure to the substance; or
(ii data for the substance indicates that the crustacean EC50 is 100
milligrams or less of the substance per litre of water over a 48-hour exposure
period, as a result of exposure to the substance; or
(iii data for the substance indicates that the algal or other aquatic
plant EC50 is 100 milligrams or less of the substance per litre of water over a 72-
hour or 96-hour exposure period, as a result of exposure to the substance; or
(iv data for the substance indicates that the chronic fish NOEC, or
chronic crustacean NOEC, or algal or other aquatic plant chronic NOEC, is 1 milligram
or less of the substance per litre of water, as a result of exposure to the
substance; or
(v in the absence of the NOEC data prescribed in subparagraph (iv data
for the substance indicates that it is not rapidly degradable and is bioaccumulative;
or
(b the substance is ecotoxic to soil organisms because
(i data for the substance indicates that a plant or soil invertebrate EC50
is 100 milligrams or less of the substance per kilogram of dry weight of soil over a
14-day exposure period, as a result of exposure to the substance; or
(ii data for the substance indicates a 25% reduction in microbial
respiration or microbial nitrification at 100 milligrams or less of the substance per
kilogram of dry weight of soil after a 28-day exposure period, as a result of
exposure to the substance; or
(c the substance is ecotoxic to terrestrial vertebrates because
(i data for the substance indicates an acute avian or mammalian oral or
dermal LD50 of 2 000 milligrams or less of the substance per kilogram of body weight,
as a result of exposure to the substance; or
(ii data for the substance indicates an acute avian or mammalian LC50 of 5
000 parts or less of the substance per million in the diet, as a result of exposure
to the substance; or
(iii data for the substance indicates a chronic avian or mammalian MATC of
100 parts or less of the substance per million in the diet, as a result of exposure
to the substance; or
(d the substance is ecotoxic to terrestrial invertebrates because data for
the substance indicates an acute oral or contact LD50 of 25 micrograms or less of the
substance per terrestrial invertebrate, as a result of exposure to the substance; or
(e the substance is designed for biocidal action.
? A substance referred to in subclause ?)(e is not hazardous for
the purposes of this schedule if
(a the substance is designed for biocidal action against a virus,
protozoan, bacterium, or an internal organism in humans or in other vertebrates; and
(b the substance does not meet any of the minimum degrees of hazard
specified in subclause ?)(a to (d)、/p>
Explanatory note
This note is not part of the regulations, but is intended to indicate their
general effect.
These regulations, which come into force on 2 July 2001, prescribe, for each
intrinsic hazardous substance property, the minimum degrees of hazard that must be
met before a substance is considered hazardous for the purposes of the Hazardous
Substances and New Organisms Act 1996.
Contents
1 General
2 Status of reprints
3 How reprints are prepared
4 Changes made under section 17C of the Acts and Regulations Publication Act
1989
5List of amendments incorporated in this reprint (most recent first(/p>
Notes
1 General
This is a reprint of the Hazardous Substances (Minimum Degrees of Hazard
Regulations 2001. The reprint incorporates all the amendments to the regulations as
at 1 June 2001, as specified in the list of amendments at the end of these notes.
Relevant provisions of any amending enactments that have yet to come into
force or that contain relevant transitional or savings provisions are also included,
after the principal enactment, in chronological order.
2 Status of reprints
Under section 16D of the Acts and Regulations Publication Act 1989, reprints
are presumed to correctly state, as at the date of the reprint, the law enacted by
the principal enactment and by the amendments to that enactment. This presumption
applies even though editorial changes authorised by section 17C of the Acts and
Regulations Publication Act 1989 have been made in the reprint.
This presumption may be rebutted by producing the official volumes of
statutes or statutory regulations in which the principal enactment and its amendments
are contained.
3 How reprints are prepared
A number of editorial conventions are followed in the preparation of reprints.
For example, the enacting words are not included in Acts, and provisions that are
repealed or revoked are omitted. For a detailed list of the editorial conventions,
seehttp://www.pco.parliament.govt.nz/editorial-conventions/or Part 8 of the Tables
of New Zealand Acts and Ordinances and Statutory Regulations and Deemed Regulations
in Force.
4 Changes made under section 17C of the Acts and Regulations Publication Act
1989
Section 17C of the Acts and Regulations Publication Act 1989 authorises the
making of editorial changes in a reprint as set out in sections 17D and 17E of that
Act so that, to the extent permitted, the format and style of the reprinted enactment
is consistent with current legislative drafting practice. Changes that would alter
the effect of the legislation are not permitted.
A new format of legislation was introduced on 1 January 2000. Changes to
legislative drafting style have also been made since 1997, and are ongoing. To the
extent permitted by section 17C of the Acts and Regulations Publication Act 1989, all
legislation reprinted after 1 January 2000 is in the new format for legislation and
reflects current drafting practice at the time of the reprint.
In outline, the editorial changes made in reprints under the authority of
section 17C of the Acts and Regulations Publication Act 1989 are set out below, and
they have been applied, where relevant, in the preparation of this reprint:
omission of unnecessary referential words (such as of this section and
of this Act(/p>
typeface and type size (Times Roman, generally in 11.5 point(/p>
layout of provisions, including:
indentation
position of section headings (eg, the number and heading now appear above
the section(/p>
format of definitions (eg, the defined term now appears in bold type,
without quotation marks(/p>
format of dates (eg, a date formerly expressed as the 1st day of January
1999 is now expressed as 1 January 1999(/p>
position of the date of assent (it now appears on the front page of each
Act(/p>
punctuation (eg, colons are not used after definitions(/p>
Parts numbered with roman numerals are replaced with arabic numerals, and all
cross-references are changed accordingly
case and appearance of letters and words, including:
format of headings (eg, headings where each word formerly appeared with an
initial capital letter followed by small capital letters are amended so that the
heading appears in bold, with only the first word (and any proper nouns appearing
with an initial capital letter(/p>
small capital letters in section and subsection references are now capital
letters
schedules are renumbered (eg, Schedule 1 replaces First Schedule), and all
cross-references are changed accordingly
running heads (the information that appears at the top of each page(/p>
format of two-column schedules of consequential amendments, and schedules of
repeals (eg, they are rearranged into alphabetical order, rather than
chronological)、/p>
5 List of amendments incorporated in this reprint (most recent first(br />