STAFF ASSESSMENT REPORT - epa.govt.nz

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STAFF ASSESSMENT REPORT

Application APP204205

Applicant Malaghan Institute of Medical Research

To HSNO Decision Making Committee

From Senior Advisor, New Organisms

Date 6 October 2021

Purpose of report Information to support the consideration of application APP204205

1. Purpose of this document1. This report provides information to support your consideration of application APP204205 and

guidance around the proposed controls for the approval. This document is intended to be read in

conjunction with the draft Decision.

2. The decision path for this application can be found in Appendix 1 of this report.

2. Application summary and background3. On 9 September 2021, the EPA formally received an application from the Malaghan Institute of

Medical Research (MIMR, the applicant) under section 40 of the Hazardous Substances and New

Organisms (HSNO) Act 1996 (the Act). This application seeks approval to import into containment

two new animal species, for research and teaching purposes.

4. The controls sought under the present application are outcome-based, rather than prescriptive.

Such controls specify outcomes that must be achieved (eg, containment of the organisms), rather

than prescribing a set method by which the containment must be achieved. Such an outcome-

based approval would provide the applicant with the flexibility to adapt their containment methods

and measures (eg, design, construction, and management of the facility) to reflect best practice.

5. The Department of Conservation (DOC) and the Ministry for Primary Industries (MPI) were

provided with the application and given the opportunity to comment.

3. Description of the new organisms6. The applicant intends to import two new organisms, Mesocricetus auratus (Syrian golden

hamster) and Ancylostoma ceylanicum (human hookworm) into containment for research

purposes.

Mesocricetus auratus (Syrian golden hamster) 7. The Golden hamster (hereinafter referred to as “hamster”) belongs to the Cricetidae family, with a

very narrow geographical distribution range comprising arid regions of northern Syria and

southern Turkey. Compounding the fact that they are very territorial and intolerant of other

members of their species, loss of habitat from agriculture and deliberate elimination has

profoundly reduced their numbers. According to the International Union for Conservation of

Nature, they are now considered vulnerable (Yigit 2008).

8. The hamster gestation period is 16 days with average number of offspring being nine. The young

are sexually mature at approximately 1 month of age. The lifespan of hamsters is up to 2 years.

9. Captive breeding programs for hamsters have been well established. The species is considered

to be a useful model organism for biomedical purposes such as inflammation, and antiviral drug

evaluation and development. It enables the rapid evaluation of medicine candidates at relatively

low cost compared to other animal models such as ferrets and non-human primates.

10. The lack of a certain cell receptors in mice necessitates the use of hamster as an additional

infection model. In contrast to mice, the hamster’s immune response is similar to humans and its

naïve cell receptors are capable of binding various bacterial and viral proteins. In addition to this,

for some infections hamsters are capable of producing age-related differences, including weight

loss and developing lung pathology (Imai et al. 2020).

11. The applicant notes that hamsters had been present previously in NZ as a laboratory animal. To

support this, they submitted a published manuscript (Hamster Potency Test for the Lepto

Components of a Bovine Multivalent Vaccine Containing Lepto hardjo and Lepto pomona, 1998)

including experimental procedures (Massey University, Small Animal Production Unit, SAPU) that

describes the use of hamsters for the testing of the Leptospyra vaccine. Our search through the

journal databases revealed at least one more publication from New Zealand in which hamsters

were used for scientific purposes (Heath et al. 1984).

12. To clarify this, we contacted the Director of the Intensive Animal Research Unit (IARU), previously

the Small Animal Production Unit (SAPU) facility, to elucidate Massey University’s involvement in

the testing involving hamster. She confirmed that the Massey University SAPU unit was indeed

the last facility in NZ to house hamster colonies. The colony was terminated on 27 April 2005 with

the confirmation letter sent to MAF (Hamilton). The Director was not able to provide the

documentation related to the approval or importation of hamsters into the country.

13. It is highly likely the approval for the hamster importation and maintenance was obtained under

the legislation pertaining to the Hamster Importation and Control Regulations Act 1972 (revision

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by Order-in-Council) pursuant to the Animal Act 1967. The regulation allowed importations of

hamsters for the purpose of approved experiments, research, and testing by:

a) laboratories under the control of the Animal Health and Research Divisions of theDepartment of Agriculture,

b) laboratories under the control of the Health Department,

c) such vaccine manufacturers as may be approved from time to time.

14. The applicant proposes to use hamsters in conjunction with Ancylostoma ceylanicum (human

hookworm) to develop a model of hookworm infection to study antigenic challenge, and immune

response and modulation.

15. In addition to this, MIMR is the host institution for Vaccine Alliance Aotearoa New Zealand

(VAANZ), tasked with running a national COVID-19 vaccine development and clinical trial. If

needed, the hamster model might be used for infection studies with SARS-CoV-2 and in models

with other infectious agents in the future.

Ancylostoma ceylanicum (hookworm) 16. Hookworms are members of Ancylostomatidae family and they can parasitise a wide range of

mammalian hosts. The majority of human infections are caused by Ancylostoma duodenale and

Necator americanus. Hookworm Ancylostoma ceylanicum is a zoonotic (capable of parasitising

both humans and animals) parasite of domestic dogs, cats and humans throughout Asia and

northern Australia.

17. Until recently, A. ceylanicum was considered to be of local importance throughout south east Asia

and therefore largely ignored, but more recent molecular-based surveys have revealed that it is

likely to be second most prevalent hookworm species infecting humans in Asia (Traub 2013). A.

ceylanicum thrives in warm and moist conditions and it can infect and parasitise humans through

percutaneous1 penetration along with the faecal-oral route.

18. The lifecycle of A. ceylanicum is similar to other human hookworm species (Figure 1). Larvae

hatch in one to two days after eggs are passed in the stool. As long as the soil temperature is

maintained above 21°C, the larvae will grow and develop into infective larval stage within nine

days. In moist and warm environment infective larvae can survive for up to six weeks. The hands

and feet represent the major sites of larval entry into a human host, thereby causing a rash known

as ”ground itch”. Upon the host infection, larvae migrate via the blood stream to the lungs, and

finally to the small intestine of the gut. Eggs laid by mature females are then passed into the

faeces, completing the life cycle.

19. Allergies and autoimmune disorders are on the rise in the developed world. Many theories exist

trying to explain this phenomenon. One of them has linked increased hygiene and lack of

exposure to pathogens with increased incidences of chronic inflammatory conditions. Hookworm

1 Passing through the skin

infections have been often associated with the parasite’s ability to condition the immune system in

a way that prevents autoimmune disorders such as allergic asthma and inflammatory bowel

disease (Navarro et al. 2013).

20. MIMR has previously requested advice on the new organism status of the related species of

hookworms Necator americanus and Ancylostoma caninum (advice documents PNZ1000146 and

PNZ1000180 respectively). Both species were deemed to be present in NZ for the purpose of the

HSNO Act before and after 29 July 1998

21. In its earlier work, the applicant used the hookworm N. americanus with variable results and

inconsistent infections, including the lack of adult hookworm development. In contrast to this,

A. ceylanicum has been noted for its ability to infect hamsters and mice, and mimic clinical

features seen in human infections (Liu et al. 2014).

Fig 1. The hookworm life cycle. Eggs are passed in the stool 1, and under favourable conditions (moisture,warmth, shade), larvae hatch in 1 to 2 days and become free-living in contaminated soil. These released rhabditiform larvae grow in the faeces and/or the soil 2, and after 5 to 10 days (and two moults) they becomefilariform (third stage) larvae that are infective 3. These infective larvae can survive 3 to 4 weeks infavourable environmental conditions. On contact with the human host, typically bare feet, the larvae penetrate the skin and are carried through the blood vessels to the heart and then to the lungs. They penetrate into the pulmonary alveoli, ascend the bronchial tree to the pharynx, and are swallowed 4. Thelarvae reach the jejunum of the small intestine, where they reside and mature into adults. Adult worms live in the lumen of the small intestine, typically the distal jejunum, where they attach to the intestinal wall with resultant blood loss by the host 5. Most adult worms are eliminated in 1 to 2 years, but the longevity mayreach several years (CDC 2019).

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22. The applicant proposes to use A. ceylanicum hookworms to investigate the gut and systemic

immune responses as a preclinical infection model in mice and hamsters. The ultimate goal of this

research is to determine if hookworms could be used for therapy of human inflammatory

diseases.

4. Containment of the organismsApplicant’s proposed containment regime

Mesocricetus auratus (Golden hamster)

23. The applicant intends to import into containment and work with the proposed unmodified new

organisms within MPI-approved containment facilities to contain the organisms in accordance with

their Containment Manuals. The applicant already houses rats and mice within its containment

facility.

24. The applicant proposes to maintain the hamster colony in the Biomedical Research Unit

transitional and containment facility within MIMR. If the applicant decides to transfer the hamsters

to other approved facilities the transfer will be carried out within the MPI approved guidelines and

procedures and with the prior reporting of the hamster movements to the MPI.

25. The applicant proposes specific controls for keeping hamsters in the approved PC2 conditions.

These controls include provisions related to the staff, personal protection equipment (PPE),

training, treatment of waste material, tracking, transportation and building quality of the

containment facility.

Ancylostoma ceylanicum

26. Ancylostoma ceylanicum will be securely held within MIMR’s PC2-approved transitional and

containment facility.

27. The applicant states that in appropriate caging systems, hookworms cannot be transmitted

between animals or to staff involved in animal care since animal bedding rapidly desiccates

hookworm eggs and leads to rapid loss of viability. Many peer reviewed publications have clearly

made connection between the desiccation and the loss of egg viability eg, (Udonsi et al. 1987). In

the event of infection de-worming treatment bought over the counter is effective in eradicating A.

ceylanicum.

28. In the event of accidental human exposure in the laboratory, Mebendazole is an effective de-

worming treatment measure and available over- the-counter sold as Vermox® or Combantrin®.

29. Based on the information on the proposed level of containment provided by the applicant, we are

satisfied that the imported new organisms will be adequately contained.

EPA proposed controls 30. MIMR has a long history of housing and breeding genetically modified mice and rats with no

breach of containment having ever occurred. The applicant’s experience with the handling and

containment of non-GMO and GMO strains of mice and rats, and the proposed containment

regime will be sufficient to ensure that the escape of any hamsters is highly improbable.

31. Hamsters are not very sociable animals, especially when it comes to the other hamsters. Female

hamsters are generally more aggressive than males. This aggression can be extended to the staff

handling the hamsters in their enclosures. The proposed Control 20 requires additional training

related to the hamster handling, to account for their behavioural characteristics.

32. Section 45(2) of the HSNO Act specifies that an approval must include controls that provide for

each of the applicable matters specified in Schedule 3, and may include controls that provide for

any other matters that give effect to the purpose of the Act.

33. The proposed controls are primarily outcome-focused, specifying outcomes that must be

achieved, rather than prescribing a set method by which the outcome must be achieved. This

enables the approval user to update their containment measures (design, construction and

management of the facility) to reflect best practice and any new information about the biology of

the organisms being contained.

34. In addition to those controls addressing the matters in Schedule 3 (Part 2) of the HSNO Act, it is

proposed that controls 3 and 4 be imposed. Control 3 requires that the approval user document

the technical and operational policies and procedures that they will implement to meet the controls

and the quality control measures they will use to ensure those policies and procedures are

effective in achieving the outcomes set out in the controls. Control 4 requires that the

containment facility where the new organisms are held be operated in compliance with the

documentation specified in control 3.

35. Although MIMR is using its PC2 containment facility for housing other hookworm species, they are

currently not approved to MPI/EPA Standard 154.02.08: (Transitional and containment facilities

for invertebrates).

36. Therefore, control 25 requiring the MIMR to apply for the approval to contain invertebrates is

proposed. The applicant’s ability to use this approval, if granted, is conditional on the approval

holder providing a containment facility that is suitable for the specific containment requirements of

invertebrates, which is approved for use by MPI. Proposed control 26 requires that MIMR must

notify EPA that its facility is approved, and to notify both MPI and EPA before the first importation

of A. ceylanicum into the facility.

Escape routes and potential for forming undesirable self-sustaining populations 37. In considering the adverse effects of having the organisms in containment, it is noted that the

organisms will be imported into and maintained in containment, and are therefore isolated from

the external environment with structures and procedures in place to ensure the organisms do not

gain access to the external environment

38. The potential for these organisms to escape from containment and form undesirable self-

sustaining populations is limited by the stringent containment regime and the proposed additional

controls 25 and 26 imposed on the applicant.

39. Hamsters are adapted to arid and dry regions of northern Syria and southern Turkey. All

laboratory hamsters originate from a sibling pairing dating to 1930. Imported animals are further

bred and acclimatised to laboratory conditions, imposing significant constraints on their fitness,

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movements and ability to survive and breed in the wild (Weinert et al. 2001; Fritzsche et al. 2006).

Considering the MIMR imposed controls within the existing containment facilities alongside the

EPA proposed controls and the specific characteristics of the laboratory hamsters it is highly improbable that they will be able to survive in the New Zealand environment and cause any long-

term adverse effect. Considering this, the risk of hamsters forming a self-sustaining population is

deemed to be very low.

40. In the event that hamsters did escape, contingency plans are in place for the retrieval of these

organisms. The applicant proposed specific contingency plans including search of the facility and

vicinity, and live traps set up in strategic places within and around the facility.

41. Despite the anecdotal evidence of NZ travellers with overseas acquired hookworm infection, the

consequence of which is production of hookworm eggs in our environment, there has never been

a recorded case of hookworm infection transmitted and acquired in NZ (Leng et al. 1974; Andrews

1976). To our knowledge, there have been no recorded cases since these publications. However,

we were unable to find any more recent publications attesting to this point.

42. Although it is remotely possible that A. ceylanicum could survive and infect new hosts in some

parts of New Zealand, modern sanitation and waste control, in conjunction with the distinctiveness

of the New Zealand climate and environment, would present a considerable barrier for such

events to happen (Andrews 1976).

43. Escape from containment via the pathways identified in the draft decision is highly improbabletaking into account the applicant’s containment management plan and the EPA staff-proposed

containment regime. After considering the biological characteristics of the organisms under

consideration, the potential pathways of escape and the proposed containment regime, we

concluded that the organisms under consideration can be adequately contained with the

possibility of the establishment of self-sustaining population being very low.

44. According to control 22, the contingency plan must be implemented immediately if there is any

reason to believe that an approved organism has escaped or been released from the containment

facility, or any other breach of containment has occurred.

5. Potential benefits of the organisms in containment45. The applicant states that “much of the research will have beneficial implications for the health and

well-being of New Zealanders. It will have both economic and social benefits for the country

through, for example, improved medical practices and gains in scientific knowledge. The applicant

also notes that the approval is required for the Institute to maintain world-class research, teaching,

and recruitment in a wide range of biological and medical sciences.

46. We consider it highly improbable that any potential adverse effects on the environment, human

health, the relationship of Māori and their culture and traditions with their ancestral lands, water,

sites, wāhi tapu, valued flora and fauna, and other taonga, the market economy, society or

communities will occur if our recommended controls are adopted and the applicant’s importation

restrictions and good laboratory practices are enforced. Therefore, the potential adverse effects of

having the organisms in containment are negligible.

6. Consultation with Māori47. The applicant undertook a consultation regarding this application with the Te Urungi Māori

advisory group that provides support and guidance to the VAANZ programme and the Malaghan

Institute. Te Urungi felt there were no issues or concerns with this application as long as the

procedures and processes described in the application for containment of the organisms in

question were in place and maintained.

48. Kaupapa Kura Taiao, the Authority’s Māori advisory group, carried out a cultural risk assessment

on this application. They noted that this research is not likely to adversely affect the economic,

social, and cultural well-being of Māori. Moreover, they stated that it could benefit hau / mauri

(vital essence) and manawaroa (resilience) of individuals as well as oranga pai me te toiora -

quality of life and enjoyment of healthy lifestyles, and the potential to participate fully in life, at

work, at home, or in society.

49. We consider that this approval (if granted) would not adversely affect Māori interests. This

includes potential risk to Māori communities, culturally significant species and materials, and

cultural values and practices associated with these.

7. Summary of information from other agencies50. In accordance with section 58(1)(c) of the Act, and clauses 2(2)(e) and 5 of the Methodology, the

Department of Conservation (DOC) and the Ministry for Primary Industries (MPI) were notified

and provided with the opportunity to comment on this application.

51. In line with our analysis, DOC noted that no records could be found of hamsters establishing wild

populations anywhere in the world outside their native range. They are to be imported into

containment in an institution with considerable experience with similar laboratory rodents.

Therefore, they consider that the risks are well managed, and do not oppose permitting this

importation.

52. While MPI supports the applicant’s proposal to import Syrian golden hamster and human

hookworm they made several comments:

• Although A. ceylanicum is unable to survive in the temperate NZ environment, it is still

animal and human pathogen and able to survive within these hosts. If transmitted to

humans, it would be able to escape containment facility and subsequently be transmitted

to humans and susceptible animal species.

• A. ceylanicum must be imported and held within a containment facility approved to

MPI/EPA Standard 154.02.08. (Transitional and containment facilities for invertebrates).

Currently, the Malaghan transitional and containment facility is not approved to this

standard and the application makes no mention of an intention to apply for approval.

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• MPI notes that Syrian hamsters are active chewers, skilful at escaping and can be

aggressive towards handlers. They advise additional controls to manage the above risks,

considering the behavioural characteristics of Syrian hamsters.

53. In response to the MPI comments we note that in order for the hookworm to be transmitted it

would first have to be established in the soil considering that there is no direct human to human or

human to animal transmission. Our proposed controls 25 and 26 approval is conditional on the

MPI being satisfied that the facility meets MPI’s requirements for the containment of the new

organisms. Our proposed control 20 addresses training for animal handlers in dealing with the

specific behavioural characteristics of hamsters.

8. Legislative criteria to be consideredPublic notification 54. Under section 53(2) of the HSNO Act, the EPA has discretion to publicly notify an application to

import into containment or develop in containment any new organism if it is considered that there

is likely to be significant public interest in the application.

55. The Chief Executive was delegated by the EPA Board to decide whether to publicly notify an

application to import into containment or develop in containment any new organism under section

19(1) of the HSNO Act. This power was sub-delegated to the General Manager of Hazardous

Substances and New Organisms (HSNO) under an instrument of delegation effective 06 March

2020.

56. Application APP204205 was not publicly notified because the GM HSNO did not identify any

exceptional circumstances warranting public notification, and significant public interest in this

application was not anticipated.

Assessment of the risk of application APP204205 against legislative criteria 57. Application APP204205 was lodged pursuant to section 40(1) of the Act. The application must be

determined in accordance with section 45, taking into account the matters specified in sections

37, 39, and 44 and other matters relevant to the purpose of the Act, as specified in Part 2 of the

Act, and relevant provisions of the HSNO (Methodology) Order 1998 (the Methodology).

58. Section 45(1)(a)(i) of the Act requires that the application be for one of the purposes specified in

section 39(1) in order to be approved. The purpose of application APP204205 fits within section

39(1)(h) such other purposes as the Authority thinks fit, that being research and teaching.

International obligations 59. We are not aware of any international obligations that may be impacted by the approval of this

application.

9. Staff assessment60. We prepared this Staff Assessment associated for this application although we evaluated the risks

related with this application as being low and straightforward.

61. We believe that the applicant’s experience with the handling and containment of the new

organisms and the proposed containment regime will be sufficient to prevent the highly

improbable escape of the new organisms.

62. Please note that the attached Decision document is a draft, and you may deem that changes to its

content may be required following your consideration of the application, as you see fit.

10. Conclusion and recommendation63. Based on the information available and taking into account the biological characteristics of the

unmodified new organisms, the potential pathways of escape and the proposed containment

regime, we consider that the organisms can be adequately contained.

64. Therefore, we recommend that the Committee approves application APP204205 under section

45(1)(a) of the HSNO Act, subject to the proposed controls (Appendix 2) of the draft Decision

document).

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11. ReferencesAndrews JRH 1976. The parasites of man in New Zealand: A review. New Zealand Journal of Zoology

3: 59-67.

Fritzsche P, Neumann K, Nasdal K, Gattermann R 2006. Differences in Reproductive Success between Laboratory and Wild-Derived Golden Hamsters (Mesocricetus auratus) as a Consequence of Inbreeding. Behavioral Ecology and Sociobiology 60: 220-226.

Heath AC, Bishop DM 1984. Treatment of mange in guinea pigs, hamsters and hedgehogs. N Z Vet J 32: 120.

Imai M, Iwatsuki-Horimoto K, Hatta Met al. 2020. Syrian hamsters as a small animal model for SARS-CoV-2 infection and countermeasure development. Proc Natl Acad Sci U S A 117: 16587-16595.

Leng RA, Cornere BM 1974. A review of the isolation of intestinal parasites at Green Lane Hospital 1971-1972. N Z Med J 79: 620-2.

Liu Y, Zheng G, Alsarakibi Met al. 2014. The zoonotic risk of Ancylostoma ceylanicum isolated from stray dogs and cats in Guangzhou, South China. Biomed Res Int 2014: 208759.

Navarro S, Ferreira I, Loukas A 2013. The hookworm pharmacopoeia for inflammatory diseases. Int J Parasitol 43: 225-31.

Traub RJ 2013. Ancylostoma ceylanicum, a re-emerging but neglected parasitic zoonosis. Int J Parasitol 43: 1009-15.

Udonsi JK, Atata G 1987. Necator americanus: temperature, pH, light, and larval development, longevity, and desiccation tolerance. Exp Parasitol 63: 136-42.

Weinert D, Fritzsche P, Gattermann R 2001. Activity rhythms of wild and laboratory golden hamsters (Mesocricetus auratus) under entrained and free-running conditions. Chronobiol Int 18: 921-32.

Yigit NK, B. 2008. Mesocricetus auratus. The IUCN Red List of Threatened Species 2008. .

Appendix 1: Decision path for applications to import into containment any NO (non GMO) Context

This decision path describes the decision-making process for applications to import into containment any new organism that is not a GMO. These applications are made under section 40 of the HSNO Act, and determined under section 45 of the Act. Applications to import a new organism into containment require consideration of section 44 (section 37 and ability to escape: section 37 refers to the ability of the organism to form an undesirable self-sustaining population and ease of eradication).

Introduction

The purpose of the decision path is to provide the HSNO decision maker with guidance so that all relevant matters in the HSNO Act and the Methodology have been addressed. It does not attempt to direct the weighting that the HSNO decision maker may decide to make on individual aspects of an application.

In this document ‘section’ refers to sections of the HSNO Act, and ‘clause’ refers to clauses of the Methodology.

The decision path has two parts –

o Flowchart (a logic diagram showing the process prescribed in the Methodology and theHSNO Act to be followed in making a decision), and

o Explanatory notes (discussion of each step of the process).

Of necessity the words in the boxes in the flowchart are brief, and key words are used to summarise the activity required. The explanatory notes provide a comprehensive description of each of the numbered items in the flowchart and describe the processes that should be followed to achieve the described outcome.

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Flowchart: Decision path for applications to import into containment any NO (non-GMO) (application made under section 40 of the Act and determined under section 45 of the Act) For proper interpretation of the decision path it is important to work through the flowchart in conjunction with the explanatory notes.

1Review the content of the

application and all relevant information

2Is this information sufficient

to proceed?

6Identify scope of organism description

9Assess each risk assuming controls in place.

10Undertake combined consideration of all risks

and costs, cognisant of proposed controls

11Are all risks with controls in place

negligible?

12Is it evident that benefits outweigh

costs?

16Confirm scope of organism description

Confirm and set controls

Approve(section 45(1)(a))

3Seek additional

information

4Sufficient?

Decline (section 45(1)(b)

13Establish position on risk averseness

and appropriate level of caution

14Assess benefits

15Taking into account controls,

do positive effects outweigh adverse effects?

Decline(section 45(1)(b))

Clause 27

Clause 26

No

No

No

No

Yes

Yes

YesYes

No5

Is the application for a proper purpose?

Yes

No

7Identify all risks, costs and benefits that are

potentially non-negligible

8Consider extent and impact of mandatory and

additional controls under section 45(2) and whether the organism(s) can be adequately

contained

Yes

Explanatory Notes

An application may be for a single new organism, or for a variety or range of new organisms where the boundaries of the extent of modifications envisaged are well defined. In both of these cases organisms having similar risk profiles should be grouped into categories. Each category should be considered separately via the path below.

Item 1:

Review the content of the application and all relevant information

Review the application, the E&R Report (or draft decision and EPA staff advice), and information received from experts and that provided in submissions (where relevant) in terms of section 40(2) of the Act and clauses 8, 15, 16 and 20 of the Methodology.

Item 2: Is this information sufficient to proceed?

Review the information and determine whether or not there is sufficient information available to make a decision.

The Methodology (clause 8) states that the information used by the HSNO decision maker in evaluating applications shall be that which is appropriate and relevant to the application. While the HSNO decision maker will consider all relevant information, its principal interest is in information which is significant to the proper consideration of the application; ie information which is “necessary and sufficient” for decision-making.

Item 3: (if no) Seek additional information

If there is not sufficient information then additional information may need to be sought from the applicant, the EPA staff or other parties/experts under section 58 of the Act (clause 23 of the Methodology).

Item 4: Sufficient?

When additional information has been sought, has this been provided, and is there now sufficient information available to make a decision?

If the HSNO decision maker is not satisfied that it has sufficient information for consideration, then the application must be declined under section 45(1)(b).

Under section 40(4) of the Act the applicant may choose to withdraw the application at any time.

Item 5: (If ‘yes’ from item 2 or from item 4) Is the application for a proper purpose?

Section 39(1) of the Act specifies the purposes for which the HSNO decision maker may approve the importation, development or field testing of a new organism. Specifically section 39(1)(a) refers to the development of any new organism, and 39(1)(b) to the field testing of any new organism.

If the application is not for one of these purposes then it must be declined.

Item 6: Identify scope of organism description

Clearly identify the scope of the organism. Particular attention should be paid to whether the application is for a single new organism or a variety of new organisms as referenced in the Introduction to these notes. Exclusions may be used to sets bounds on the scope of the organism description where a range or variety of new organisms is being considered.

Item 7: Identify all risks, costs and benefits that are potentially non-negligible2

2 Relevant effects are marginal effects, or the changes that will occur as a result of the organism(s) being available. Financial costs associated with preparing and submitting an application are not marginal effects and are not effects of the organism(s) and are therefore not taken into account in weighing up adverse and positive effects. These latter types of costs are sometimes called ‘sunk’ costs since they are incurred whether or not the application is successful.

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Costs and benefits are defined in the Methodology as the value of particular effects (clause 2). However, in most cases these ‘values’ are not certain and have a likelihood attached to them. Thus costs and risks are generally linked and may be addressed together. If not, they will be addressed separately. Examples of costs that might not be obviously linked to risks are direct financial costs that cannot be considered as ‘sunk’ costs (see footnote 1). Where such costs arise and they have a market economic effect they will be assessed in the same way as risks, but their likelihood of occurrence will be more certain (see also item 12).

Identification is a two steps process that scopes the range of possible effects (risks, costs and benefits).

Step 1: Identify all risks and costs (adverse effects) and benefits (beneficial effects) associated with the approval of the organism(s), and based on the range of areas of impact described in clauses 9 and 10 of the Methodology and sections 5 and 6 of the Act3.

Relevant costs and benefits are those that relate to New Zealand and those that would arise as a consequence of approving the application (clause 14).

Consider short term and long term effects.

Identify situations where risks and costs occur in one area of impact or affect one sector and benefits accrue to another area or sector; that is, situations where risks and costs do not have corresponding benefits.

Step 2: Document those risks, costs and benefits that can be readily concluded to be negligible4, having regard to the characteristics of the organism and the circumstances of the application, and eliminate them from further consideration.

Note that where there are costs that are not associated with risks some of them may be eliminated at this scoping stage on the basis that the financial cost represented is very small and there is no overall effect on the market economy.

Item 8: Consider extent and impact of mandatory and additional controls under sections 45(2) and whether the organism(s) can be adequately contained

Section 45(2) requires the application of controls for all applicable matters specified in the 3rd Schedule (Part II). The HSNO decision maker may consider other controls to give effect to the purpose of the Act. The impact of these controls also needs to be considered.

Section 45(1)(a)(iii) requires the HSNO decision maker to be satisfied that the organism can be “adequately contained”. The concept of adequate containment includes the satisfactory biological and/or physical containment of the organism and also the ability of the applicant to apply and maintain all the controls satisfactorily.

Item 9: Assess each risk assuming controls in place

The assessment of potentially non-negligible risks and costs should be carried out in accordance with clauses 12, 13, 15, 22, 24, 25, and 29 to 32 of the Methodology. Most of these risks and costs will relate to matters in sections 5 and 6 of the Act. In undertaking this assessment the HSNO decision maker must take into account the principles of the Treaty of Waitangi (section 8, and clause 9(c)(iv)).

The assessment is carried out with the controls in place. It should consider the following three matters that have particular relevance for this type of application.

1. The ability of the organism to escape from containment (section 44)

Although strictly speaking, this requirement applies only to field test applications and not to development applications (see section 45(1)(a)(ii)), it is prudent and good practice to consider it

3 Effects on the natural environment, effects on human health and safety, effects on Māori culture and traditions, effects on society and community, effects on the market economy. 4 Negligible effects are defined in the Annotated Methodology as “Risks which are of such little significance in terms of their likelihood and effect that they do not require active management and/or after the application of risk management can be justified by very small levels of benefits”.

anyway. This element must be considered in an integrated way in the assessment process because the ability to escape depends on the containment controls set.

2. Self-sustaining population (section 37).

Section 37 of the Act requires the consideration to have regard to the ability of the organism to establish an undesirable self sustaining population and the ease of eradication if it were to establish such a population. Undesirable means (in effect) able to create significant risks.

3. Additional matters

Other matters to be considered in the assessment are:

• the extent to which the risk will be mitigated by the setting of containment and other controls, including the mandatory controls in the Act; and

• the extent to which the risk will be mitigated by the ability to eradicate the organism if it becomes established.

Assess each potentially non-negligible risk and cost estimating the magnitude of the effect if it should occur and the likelihood of it occurring considering also the level of risk if containment or other controls fail, as well as the probability of such a failure. In estimating the magnitude of the adverse effect take into account the extent to which the risk might be mitigated by how or whether it might be possible to eradicate the organism if a significant adverse effect eventuated (section 37). When estimating the likelihood of the effect occurring, consider the full pathway, that is, all the possible steps that must occur before the final identified effect is realised. Estimating the likelihood requires combining (multiplying) all of the individual likelihoods for each link in the chain of events.

Where there are non-negligible financial costs that are not associated with risks then the probability of occurrence (likelihood) may be close to 1. Relevant information provided in submissions should be taken into account.

The distribution of risks and costs should be considered, including geographical distribution and distribution over groups in the community, as well as distribution over time. This information should be retained with the assessed level of risk/cost.

Approach to risk and approach to uncertainty

Consider the HSNO decision maker’s approach to risk (clause 33 of the Methodology) or how risk averse the HSNO decision maker should be in giving weight to the residual risk, where residual risk is the risk remaining after the imposition of controls.

The risk characteristics set out in clause 33 are:

a. Exposure to the risk is involuntary:

b. The risk will persist over time:

c. The risk is subject to uncontrollable spread and is likely to extend its effects beyond the immediate location of incidence:

d. The potential adverse effects are irreversible:

e. The risk is not known or understood by the general public and there is little experience or understanding of possible measures for managing the potential adverse effects.

Consider each non-negligible risk in terms of the factors listed and decide whether to be risk averse by giving additional weight to that risk. This may be done as part of estimating the magnitude of the effect or where this is not relevant, it may be done separately.

Where the HSNO decision maker chooses to be risk averse, and there is uncertainty as well, the approach to risk may be consolidated with the approach to uncertainty by adopting a conservative approach such as the worst feasible case scenario.

See the EPA report ‘Approach to Risk’ for further guidance.

The assessment includes consideration of how cautious the HSNO decision maker will be in the face of uncertainty (section 7 and clauses 29-32). Where there is uncertainty, it may be necessary to

17

estimate scenarios for lower and upper bounds for the adverse effect as a means of identifying the range of uncertainty (clause 32). It is also important to bear in mind the materiality of the uncertainty and how significant the uncertainty is for the decision (clause 29(a)).

For each component (magnitude and likelihood) consider the degree of uncertainty associated with the estimation of each component. In some cases it may be clear that the uncertainty could be reduced by gathering further information (undertaking more scientific tests, or extending the literature search). Before requesting or seeking further information it is important to consider how important the uncertainty is in terms of the decision (clause 29(a) – materiality), and to essentially consider the cost-effectiveness of gathering further information.

Another approach to addressing uncertainty is to look at a range of scenarios and consider a best feasible-worst feasible scenario range. However, where there is a large degree of uncertainty, this may not be particularly meaningful for calculating the level of risk. In other cases, calculating the level of risk for each end of the range may result in a fairly similar level of risk. Where this does not occur, rather than presenting a wide range in the level of risk it may be better to concentrate on analysing why the uncertainty occurs and whether or not there is any obvious way of resolving it.

Additional controls

Controls additional to those mandated in section 45(2) of the Act (see item 8) may need to be considered, in order to mitigate risks to whatever level is considered to be appropriate, and to provide adequate containment.

Item 10: Undertake combined consideration of all risks and costs, cognisant of proposed controls

Once the risks and costs have been assessed individually, if appropriate consider all risks and costs together as a ‘basket’ of risks/costs. This may involve combining groups of risks and costs as indicated in clause 34(a) of the Methodology where this is feasible and appropriate, or using other techniques as indicated in clause 34(b). The purpose of this step is to consider the interactions between different effects and determine whether these may change the level of individual risks.

Item 11: Are all risks with controls in place negligible?

At this point the decision path branches. Looking at individual risks in the context of the ‘basket’ of risks, consider whether all of the residual risks are negligible. Consider also the cumulative effect of the assessed risks.

Where all risks are negligible, and the cumulative effect of the risks is considered to be negligible then take the clause 26 option and move to item 12. If one or more of the risks is considered to be non-negligible, or the cumulative sum of the risks is non-negligible, then take the clause 27 option and move to item 13.

Item 12:

(from item 11 - if ‘yes’) Is it evident that benefits outweigh costs?

Risks have already been determined to be negligible (item 11), therefore the decision must be made under clause 26 of the Methodology. In the unusual circumstance where there are non-negligible costs that are not associated with risks they have been assessed in item 9.

Costs are made up of two components: internal costs or those that accrue to the applicant, and external costs or those that accrue to the wider community.

Consider whether there are any non-negligible external costs that are not associated with risks.

If there are no external non-negligible costs then external benefits outweigh external costs. The fact that the application has been submitted is deemed to demonstrate existence of internal or private net


negligible?

Clause 26 Yes

benefit, and therefore total benefits outweigh total costs5. As indicated above, where risks are deemed to be negligible, and the only identifiable costs resulting from approving an application are shown to accrue to the applicant, then a cost-benefit analysis will not be required. The act of an application being lodged will be deemed by the HSNO decision maker to indicate that the applicant believes the benefits to be greater than the costs.

However, if this is not the case and there are external non-negligible costs then all benefits need to be assessed (via item 14).

Item 13:

(from item 11 - if ‘no’) Establish position on risk averseness and appropriate level of caution

Although ‘risk averseness’ (approach to risk, clause 33) is considered as a part of the assessment of individual risks, it is good practice to consolidate the view on this if several risks are non-negligible. This consolidation also applies to the consideration of the approach to uncertainty (section 7).

Item 14: Assess benefits

Assess benefits or positive effects in terms of clause 13 of the Methodology.

Since benefits are not certain, they are assessed in the same way as risks. Thus the assessment involves estimating the magnitude of the effect if it should occur and the likelihood of it occurring. This assessment also includes consideration of the HSNO decision maker’s approach to uncertainty or how cautious the HSNO decision maker will be in the face of uncertainty (section 7). Where there is uncertainty, it may be necessary to estimate scenarios for lower and upper bounds for the positive effect.

An understanding of the distributional implications of a proposal is an important part of any consideration of costs and benefits, and the distribution of benefits should be considered in the same way as for the distribution of risks and costs.

The HSNO decision maker will in particular look to identify those situations where the beneficiaries of an application are different from those who bear the costs6. This is important not only for reasons related to fairness but also in forming a view of just how robust any claim of an overall net benefit might be. It is much more difficult to sustain a claim of an overall net benefit if those who enjoy the benefits are different to those who will bear the costs. Thus where benefits accrue to one area or sector and risks and costs are borne by another area or sector then the HSNO decision maker may choose to be more risk averse and to place a higher weight on the risks and costs.

As for risks and costs, the assessment is carried out with the default controls in place.

Item 15: Taking into account controls, do positive effects outweigh adverse effects?

In weighing up positive and adverse effects, consider clause 34 of the Methodology. Where possible combine groups of risks, costs and benefits or use other techniques such as dominant risks and ranking of risks. The weighing up process takes into account controls proposed in items 8 and 9.

Where this item is taken in sequence from items 13 and 14 (i.e. risks are not negligible) it constitutes a decision made under clause 27 of the Methodology.

Where this item is taken in sequence from items 12 and 14 (i.e. risks are negligible, and there are external non-negligible costs) it constitutes a decision made under clause 26 of the Methodology.

5Technical Guide ‘Decision making’ section 4.9.3. Where risks are negligible and the costs accrue only to the applicant, no explicit cost benefit analysis is required. In effect, the HSNO decision maker takes the act of making an application as evidence that the benefits outweigh the costs. 6 Clause 13 of the Methodology


negligible?

Clause 27No

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Item 16: Confirm scope or organism description

Confirm and set controls

At this step the scope of the organism description for generic applications should be reviewed. If changes are made to the organism description, items 7-15 above should be repeated for the revised organism description. Then the weighing up process in this item for the revised organism description should also be repeated.

The scope of the organism description has been identified in item 6. This step in the decision-making process confirms the scope of the organism description in such a way that the risk boundaries are defined. Controls have been considered at the earlier stages of the process (items 8, 9 and 16). The final step in the decision-making process brings together all the proposed controls, and reviews them for overlaps, gaps and inconsistencies.

Once these have been resolved the controls are confirmed.

Appendix 2: Proposed controls that addresses the matters specified in Part 2 of Schedule 3

Schedule 3 (Part 2) Matters to be addressed

by containment controls for new organisms

(excluding GMOs)

Addressed by control:

1 To limit the likelihood of any accidental release of any organism or any viable genetic material, the controls imposed by an approval shall specify—

1(a) Requirements for treatment and decontamination to prevent escape by way of expelled air, discharge of water or liquid waste, removal of solid waste, or breaches in facility boundary:

6 The containment area(s) must be designed, constructed and maintained to prevent the approved organism(s) from escaping.

7 Persons entering and exiting the containment facility must do so in a way that does adversely affect containment of the approved organism(s).

14 Unauthorised persons must be excluded from the containment facility.

17 Any waste (including biological material) that may harbour the approved organism(s), or heritable material from the approved organism, must be treated to ensure that the approved organism or any heritable material is killed prior to disposal.

18 Any equipment, that may harbour the approved organism(s) or heritable material from the approved organism, must be treated to ensure that the approved organism or any heritable material is killed prior to the equipment being used for another purpose or being removed from the containment facility.

1(b) Equipment and requirements for facility construction to enable the




(excluding GMOs)


requirements for treatment and decontamination to be readily met:



1(c) Requirements to be complied with for the access of persons to the facility:

7 Persons entering and exiting the containment facility must do so in a way that does not adversely affect containment of the approved organism(s).


20 Any person (including contractors, staff, students, visitors, and volunteers) entering the containment facility must have received sufficient instruction on the containment regime to enable the person to meet their responsibilities in relation to containment.

1(d) Procedures and requirements for transport, identification, and packaging for all biological material to and from the facility and within the facility:

5 The containment facility where the approved organisms will be held must be clearly defined, described, and documented, including the location and boundaries.

8 The approved organism(s) must be identifiable as a new organism and able to be linked to the relevant HSNO Act approval.

9 Notification must be given to MPI of any intended movement of approved organisms outside of the facility, or any proposed modification to the containment regime which may affect the integrity of containment of the approved organism(s), before the actions are undertaken

10 The EPA and MPI must be notified in writing before this HSNO Act approval is used for the first time.

12 The approved organism(s) must be contained during movement within, to, or from the containment facility.

13 When being moved outside of a containment facility, within New Zealand, the approved organism must accompanied by documentation stating the: a) identity of the approved organism b) containment requirements c) details of the sender d) details of the receiving facility.

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(excluding GMOs)


1(e) Requirements for the disposal of any biological material:



1(f)

Requirements for facility construction:

1 The approved organism(s) must be contained.


9 Notification must be given to MPI of any intended movement of approved organisms outside of the facility, or any proposed modification to the containment regime which may affect the integrity of containment of the approved organism(s), before the actions are undertaken.

24 Any remedial requirements identified under control 23, or by any other means, must be actioned as soon as possible.

1(g) Requirements to secure the facility and openings, including securing against failure in the event of foreseeable hazards.



19 The containment facility must be secured and monitored to ensure the exclusion of undesirable organisms that might compromise the containment of the approved organism(s).

23 To ensure containment is being achieved, containment measures must be: a) inspected, monitored and reviewed as appropriate b) inspected as soon as possible after any event that

could compromise the containment regime such as an Act of God (such as flood, earthquake) or any unauthorised attempt to enter the containment facility.

2 To exclude unauthorised people from the facility, the controls imposed by an approval shall specify—

2(a) Means of identification of all entrances to the facility:

5 The containment facility where the approved organisms may be held must be clearly defined, described, and documented, including their location and boundaries.

15 All containment facility entrances must be clearly identified including specifying who has the right of access



(excluding GMOs)


16 The number and location of entrances to the containment facility where the approved organism(s) are held must be identified and documented.

2(b) The numbers of entrances and access to the facility:

5 The containment facility where the approved organisms may be held must be clearly defined, described, and documented, including their location and boundaries.


2(c) Security requirements for the entrances and the facility.


15 All containment facility entrances must be clearly identified including specifying who has the right of access.


3 To control the effects of any accidental release or escape of an organism—

3(a) Controls imposed by an approval shall specify an eradication plan for escaped organisms:

21 The containment facility must have a documented contingency plan for each approved organism held in that containment facility.

3(b) Controls imposed by an approval may specify requirements to limit the likelihood of an escaped organism spreading, surviving, and breeding, including, but not limited to,—

(i) Exclusion zones (spatial or temporal):

(ii) Location of the facility outside the usual habitat range of the organism.

11 MPI must be notified as soon as possible, and within 24 hours, of any escape and/or breach of containment and the actions taken in response to that incident

21 The containment facility must have a documented contingency plan for each approved organism held in that containment facility.

22 The contingency plan must be implemented immediately if there is any reason to believe that an approved organism has escaped or been released from a containment area or the containment facility, or any other breach of containment has occurred.

4 Controls imposed by an approval shall specify inspection and monitoring requirements for containment facilities.

19 The containment facility must be secured and monitored to ensure the exclusion of undesirable organisms that might compromise the containment of the approved organism(s).

23 To ensure containment is being achieved, containment measures must be: a) inspected, monitored and reviewed as appropriate b) inspected as soon as possible after any event that

could compromise the containment regime such as an Act of God (such as flood, earthquake) or any unauthorised attempt to enter the containment facility.

23



(excluding GMOs)


5 Controls imposed by an approval may specify the qualifications required of the person responsible for implementing those controls.

2 The organisation, entity or person(s) responsible for the ownership, control and management of the containment facility where the approved organisms are held (including Board members and/or directors) must ensure compliance with the controls of this approval.

20 Any person (including contractors, staff, students, visitors, and volunteers) entering the containment facility and/or containment areas must have received sufficient instruction on the containment regime to enable the person to meet their responsibilities in relation to containment.

Documents

STAFF ASSESSMENT REPORT - epa.govt.nz