General comments
Manufacture
Comment - In reading this document it is unclear whether a general release application to EPA for a
new hazardous substance/formulation has to include “manufacture” i.e. can an applicant just apply
for use in New Zealand?
This is an important point to clarify as it will affect the risk assessment; if a substance is not
manufactured in New Zealand then the exposure to production plant workers can be excluded from
the risk assessment.
Proposed outcome: EPA to clarify in this document whether manufacture is always included in the
risk assessment, even though there is no intention of the applicant ever manufacturing the
substance in New Zealand.
Section 2.2.1, Classification using data from scientific studies
Experimental studies on formulated product
Comment - The statement in the first paragraph of this section needs clarification, as it appears to
be at “odds” with international approaches to testing of chemicals and animal usage. It is commonly
accepted international practice that when safety testing involves animals it is only the “6-pack”
acute-type set of studies (acute oral, dermal and inhalation, skin and eye irritation and skin
sensitisation studies) which use the final formulation as the test article. The remaining repeat dose
toxicity studies are performed on the active ingredient and not individual formulations.
Proposed outcome - amend the wording to clarify the situation i.e to indicate that for repeat
dose/chronic toxicity testing studies EPA expect the studies to be performed on the active ingredient
and not the individual formulations.
Use of study data from peer-reviewed journals and other international regulatory reviews
Comment – is the EPA approach, as detailed in this document, consistent with approaches of other
NZ regulatory organisations e.g ACVM, MOH.
Proposed outcome – EPA to investigate approaches taken by other similar NZ government
regulatory bodies so that there is a consistent approach across NZ government. EPA could also
explore how other international regulators approach to this issue, with an aim of being consistent,
as possible, with other worldwide regulators.
Section 3 – Assessing the risk
Comment – The introductory paragraphs make no specific mention of fauna i.e potential effects on
native birds etc.
Proposed outcome – EPA to provide clarity as to what “environment” includes; people are currently
explicitly mentioned but animals/fauna are not. By adding clarity may go someway to address the
common confusion stakeholders have over the difference in what EPA cover and what MPI/ACVM
cover with respect to animals in the environment.
3.2 Qualitative assessment
Comment - Third paragraph, “In addition to the scientific assessment and
unique to New Zealand….”
The use of “unique” is not clear….perhaps “and” should be deleted????
Proposed outcome – EPA to review wording and amend accordingly
Comment – I found this section quite confusing because it is titled “Qualitative assessment” but uses
numerical values to explain levels of risk/benefit. A better title would be “Semi-qualitative
assessment”. I understand the reason for taking the approach explained in this section but strongly
feel that for ease of reader understanding the title should more accurately address the procedure
being described.
Proposed outcome - EPA to amend the title of the section to more accurately reflect the process
being described.
Comment – final paragraph of section 3.2, it is unclear why this paragraph is here. The role of the
HSNO Act should be in the first introductory section of this document, rather than tucked away in
what appears to be an “add-on” paragraph at the end of a section dealing with more detailed issues
than the overall objective of the HSNO Act. In addition, in the first sentence, “reduce” is redundant;
the overall objective of the HSNO Act is to adequately managing risks from hazardous substances,
which might be achieved by reducing risk.
The possibility of using qualitative risk assessment to consider residual risk should be in the
introductory paragraph for this section. The fact that using such an approach may be of value to the
decision makers could remain at the end of this qualitative section, although I would question
whether such a statement is even needed. I also question the value of the statement “…assuming
that these controls are appropriate and are practical for compliance”; it should be a given that any
mention of controls means they are appropriate and practical for compliance.
Proposed outcome - remove the redundant word “reduce” from the first sentence. Consider moving
reference to objective of the HSNO Act to the document introductory section. Consider deleting the
wording around practical controls.
3.2.1 Qualitative descriptors
Comment - Table 1 – rather than just reproduce the 2009 table, this would be a good opportunity to
review and update the table. It appears inappropriate to use quantitate descriptors in a section
focused on qualitative (non-numerical) assessment e.g. use of “less than ten” in the Minimal
examples of Table 1.
It should be up to the applicant/author to justify the level/time period for each category. If you put
numbers in that’s what people will focus on and it will become at least a semi-qualitative
assessment.
N.B. the above comments become redundant if the title of the section is amended to “Semi-
qualitative”.
Proposed outcome - Remove quantitative descriptors e.g. “less than ten” from Tables 1 and 2. If
not removed, then a similar approach should be taken for all levels of risk.
Comment – Table 1 - Example for “Moderate”; for social disruption it is unclear what is meant by
“people delayed”?
Proposed outcome - EPA to include some more context to this example.
3.3.1 Quantitative models used by the EPA
Comment – second paragraph, “….and have been validated or used by other regulators”, this could
be read that EPA will use models which are used by other regulators but which haven’t necessarily
been validated.
Proposed outcome - revise sentence to reflect that EPA only use models used by other regulators
which have been adequately validated i.e. models used by other regulators are subject to the same
overall validation procedures as required for other publicly available models.
Comment - Fourth paragraph, Table 6 – error message. Following sentence “is” should be are, as it
refers to “details”.
Proposed outcome - EPA to fix the error message so the link to Table 6 is functional. Correct
grammatical error.
Comment – sixth paragraph, it would be helpful if EPA provided brief details on how an
applicant/interested party could check whether new models have been “approved” for use by EPA.
Will this be done by amending this document or some other method? Currently paragraph 6 seems
to be of little value to this document.
Proposed outcome - either remove the sixth paragraph or amend it so it provides the reader a
mechanism of checking for updates.
3.3.2 Selecting inputs for quantitative models
Comment – Fourth paragraph wording implies that this document is only for Applicants.
Proposed outcome – Revise the paragraph so it is clear that the requirements relate to an
application/applicant.
3.3.3 Understanding uncertainty in quantitative models
Comment – first paragraph, last sentence, it isn’t definitive that “all the steps help to improve the
assessments made”; rather it is the “aim” of the steps to improve the assessment.
Proposed outcome – amend sentence to reflect the aim rather than a definitive outcome.
Comment – second paragraph, last sentence “This is known as “knowledge uncertainty” – or gaps in
knowledge…….” This sentence seems to be in the wrong place, as it is not clear what “This” refers to.
Proposed outcome – EPA to review positioning of sentence within the second paragraph or
rewording of the sentence so it makes sense to the reader.
Comment – paragraph 5, my understanding is before the most conservative toxicology value is
selected the study with the “highest value of confidence” is selected i.e. there may be a very
conservative toxicity value but if the data are not reliable then a less conservative toxicity value may
be chosen from a more reliable study/data source.
Propose outcome - The first sentence of paragraph 5 should be re-written to put the emphasis
where it belongs i.e. on the data quality/confidence.
Comment - paragraph 6, “type and quality of studies….” are important for both human health and
ecotoxicity studies.
Proposed outcome - amend section to reflect the above.
Comment – paragraph 6, “at risk” species have been omitted, to be consistent with Section 3.3.4 “at
risk” should be included.
Proposed outcome - include “at risk” along with “threatened”
3.3.4 Threatened and “at risk” species
Comment –there is no guidance provided as to when the applicant needs to consider doing addition
risk assessment for endangered/threatened species. Due to the diversity of New Zealand and the
use of hazardous substances/pesticides is not region/location specific it is likely that for some
application sites there is a threat to endangered/threatened species, whereas at other application
sites there is no such risk. It isn’t clear how EPA expect this type of scenario to be addressed.
Proposed outcome: EPA to provide guidance on when risks to specific endangered/threatened
species should be undertaken.
3.3.5 Standardising terminology and using quantitative model outputs
Comment – paragraph 2, after introducing risk quotients it would be helpful to include its’
abbreviation “RQ”
Proposed outcome – include RQ after “risk quotients”
Comment - paragraph 4, to make it clear to the reader that this paragraph is no longer about human
health the paragraph should start out with such an indicator.
Proposed outcome – start the paragraph with a statement such as “For environmental assessments
the models and equations…..”
Comment – paragraph 7, to ease understanding suggest an example of a toxicology value which is
being referred to is given.
Proposed outcome – include an example
Comment – paragraph 7, error message for Table 6
Proposed outcome – address error message
Comment – Table 9 no explanation of “LOC”
Proposed outcome - provide an explanation for the abbreviation “LOC”
4. Controls
4.1. The purpose of controls
Comment – first paragraph, third line, “safe” is inappropriate and misleading. The aim of HSNO is to
manage risk to an acceptable level, not to necessarily make them safe for all, sometimes the risk to
vulnerable cohorts is outweighed by the benefits to the majority. Using terms such as safe can give a
false sense of “security” to those cohorts which lie outside the general population.
Proposed outcome – remove the comment with regard to a product being safe for all.
Comment – paragraph 3, last sentence, it is unclear who the “you” refers to as this document isn’t
just aimed at Applicants. In addition, the sentence doesn’t seem to add value to the paragraph; it is
unclear of the purpose of the sentence in the context of the whole paragraph.
Proposed outcome – amend the sentence to clarify who is “you” or delete the sentence completely.
5. Benefit assessment
5.3 What to include in a benefits assessment
Comment – first paragraph, third sentence, use of “your”
Proposed outcome - remove “your” and merely indicate the information needs to be in the
application.
Appendix A Glossary
Comment – Active ingredient, this should also be in the plural form as there may be more than one
active ingredient in a formulated product
Proposed outcome – amend entry to reflect that there may be more than one active ingredient
Comment – Evaluate, the explanation contains “evaluation” which is basically using “evaluate” to
explain “Evaluate”
Proposed outcome – improve the explanation by not using “evaluation” e.g. summing up or bringing
together the combined assessments of the risks, costs etc
Comment - exposure assessment explanation includes water but not air or soil, this seems
inconsistent.
Proposed outcome – consider including air and soil for completeness
Comment – risk quotient, explanation does not mention human health although RQ’s are used in
human health risk assessment.
Proposed outcome – include human health in the explanation.
Comment – it would be of value to also include such terms as “AOEL”, “PDE”, “ADE”, “TER”, “TV” for
completeness and value; having these terms in one place makes it easier for the reader to check
their meanings, and also it would it would help the reader to appreciate the differences in the
values. For a “non-expert” it is difficult to grasp the difference in the terms AOEL vs ADE vs PDE etc.
Another approach would be for the document to contain a separate appendix explaining the terms
and their associations (or not). This comment also applies to acronyms used for
environmental/ecotoxicity parameters.
Proposed outcome - add terms as suggested above
Comment – it would be of value to include a definition of “environment” in the glossary
Proposed outcome – include “environment” in the glossary.
B.1 Introduction to human health modelling
Comment – paragraph 2, it would be of value to include RQ and AOEL after mention of these terms,
or just use the acronyms.
Proposed outcome - add acronyms
B.2 Acceptable Operator Exposure Level
Comment – it would be of value to explain the derivation of the “100” assessment factor (AF), as
well as to give an example as to when such a value may need varying.
Proposed outcome – consider including above suggestions
B.3 Dermal absorption
Comment - paragraph 2, third sentence, “physco” needs to be spelt correctly
Proposed outcome – correct spelling “physico”
B.4 Commercial pesticide operators
B.4.1. Exposure linkage assessed
Comment - is “assessed” correct here?
Proposed outcome – amend “assessed” to “assessment”
B.4.2 Model used
Comment – the third bullet point doesn’t make sense
Prosed outcome – review wording and amend as appropriate
Bodyweight default values
Comment - Table B.2 gives a bodyweight default value of 70kg, whilst Table B.10 gives a default
value of 60Kg. It would be of value to have an explanation as to the reasons for the differences in
these default values. It would also be of value to have a default bodyweight for toddlers, and an
associated explanation.
Proposed outcome – Inclusion of the above-mentioned explanations and values.