- MAF uses a risk management approach to regulation
- MAF's risk management approach to biosecurity
- MAF's risk management approach to food
- Managing food safety
- MAF interface with other food regulatory regimes
- Managing biosecurity risks at the border
- Managing GM organisms in New Zealand
- Managing agricultural and veterinary products
- Managing animal welfare
3 - Existing Regulation - MAF's Regulatory Roles
MAF uses a risk management approach to regulation
- The government uses a 'managed risk' approach in many areas of activity, which means
using the most cost-effective ways of reducing risks rather than trying to eliminate all
risks. The Biosecurity Act prescribes this approach for biosecurity risks from imported
goods that might damage New Zealand's fauna or flora.
- Biosecurity agencies (MAF, the Ministries of Health and Fisheries, and the Department of
Conservation) as well as other relevant agencies (the Ministries of Economic Development,
Foreign Affairs and Trade, and Research, Science and Technology, and Te Puni Kokiri) are
working through the Biosecurity Technical Forum to develop an interdepartmental statement
on the application of precaution in managing biosecurity risks under the Biosecurity Act.
This work is still in progress.
- Legislation administered by MAF has the facility for post-release controls and conditions for agricultural material and products, including GM products.
MAF's risk management approach to biosecurity
- New Zealand's isolation gives it a high level of natural biosecurity protection.
Together with active border control, this
gives New Zealand one of the highest levels of biosecurity protection available anywhere
in the world. But it is impossible for any country to completely insulate itself against
biosecurity risks. Even if New Zealand prevented all imports, zero risk could not be
assured. For instance, organisms could be brought in illegally or by natural movements
such as migratory birds or windblown insects. Each country must decide on factors that
will contribute to an appropriate level of protection from risks to biosecurity. MAF
Biosecurity adopts a level of precaution when deciding if the available scientific
evidence for a risk analysis is sufficient to recommend action.
- Consistency in risk management is required to provide natural justice. It is also important in an international context for demonstrating that trade restrictions are not arbitrary. MAF aims for consistency in biosecurity risk management through the consistency of its processes, which has these elements:
- using a systematic risk analysis process;
- applying biosecurity measures that are firmly based on the supporting risk analysis;
- comparing proposed risk management decisions with those taken previously for similar risks or similar products; and
- having this whole process well-documented and transparent.
- MAF is working to enhance consistency in biosecurity by:
- Working with the New Zealand Customs Service to improve risk management decision-making at the border. This joint project is the result of a recommendation arising from a recent review of New Zealand's border activities.
- Finalising a biosecurity policy statement on conducting and applying import risk analyses, which has been subject to extensive public consultation. This policy statement will apply to all biosecurity groups within MAF, and will be proposed as the basis for a Biosecurity Council policy statement on risk analysis (to apply to all biosecurity departments).
- Developing, in conjunction with other biosecurity departments, a policy statement on the use of `precaution' in managing biosecurity risks.
- Leading an interdepartmental team on further developing a statement on New Zealand's overall appropriate levels of protection against biosecurity risks.
- Preparing a handbook on animal biosecurity risk analyses that will be completed shortly. It will greatly help to achieve consistency and rigour in animal health risk analyses, and will be considered for application to plant health and forest health risk analyses.
MAF's risk management approach to food
- Food safety risk management involves evaluating the likely impact of different risk
management options on reducing the risks to human health. In most cases, it will also
consider other factors that are legitimately part of the decision-making process such as
technological feasibility and economic concerns.
- In June 2000, the MAF Food Assurance Authority and the Ministry of Health jointly adopted this generic approach to food safety and published Food Administration in New Zealand: a risk management approach for food safety. This framework comprises four steps:
- risk evaluation - identification of a food safety problem, a need to develop a food safety standard, development of food safety policy that achieves broad food safety goals, and the development of sanitary measures that are necessary to achieve specified food safety goals;
- risk management option assessment - identifies available risk management options in light of qualitative and quantitative information on risks;
- implementation of the risk management decision - possibly involving the setting of regulatory standards, establishment of performance and/or process parameters, and verification of the system; and
- monitoring and review - gathering and analysing data from appropriate points so as to service ongoing risk assessment and risk management activities.
- This framework specifically acknowledges developments outside New Zealand, particularly policy and scientific decisions made under the World Trade Organisation Agreement on the Application of Sanitary and Phytosanitary Measures SPS Agreement) and Australia New Zealand Food Authority (ANZFA) decisions on food labelling and composition. A domestic risk management framework that reflects internationally agreed principles and practices ensures that our obligations under multilateral and bilateral agreements are, and are seen to be, transparent and consistent. This facilitates the equivalence of sanitary measures for food in international trade.
Managing food safety
- MAF is responsible for food safety in the animal products and dairy sectors. Food
processors that are licensed or registered under legislation administered by MAF are
exempt from the hygiene requirements under the Food Act. To facilitate exports, MAF
sometimes provides official assurances to foreign governments verifying that certain
requirements or standards have been met.
- MAF is the New Zealand contact point for the Committee on Sanitary and Phytosanitary Measures and the Codex Alimentarius Commission, which sets international food standards recognised by the World Trade Organisation. There are more details about Codex in the background paper on international 8. MAF leads the New Zealand delegation on the Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology, which is mainly concerned with risk assessment, safety issues, and testing methodologies. MAF and Ministry of Health jointly represent New Zealand on the Codex Committee on Food Labelling, which is considering labelling of GM foods.
MAF interface with other food regulatory regimes
- MAF is closely involved in food safety and labelling issues that affect the agriculture
and horticulture industries, although statutory responsibility mainly rests with the
Ministry of Health through the Food Act. For details relating to GM foods, see the
Ministry of Health submission. MAF played a significant role in developing the labelling
regime for GM foods, mainly from a scientific perspective.
- Cost of compliance considerations has been a key driver in recent reviews of regulatory
regimes administered by MAF. To this end, it has been important to remove duplication
across regimes and improve the interface where necessary.
- For example, to date there has been no requirement to apply the generic risk management
approach to GM foods in primary processing. This is because primary processing almost
always involves live genetic material and to date no live GM organisms have been approved
by the Environmental Risk Management Authority (ERMA).
- In relation to secondary processing, MAF supports the Ministry of Health view that, once
a GM food has passed safety assessments by competent authorities such as ANZFA, it is as
safe as its conventional counterparts. Therefore, as a compositional attribute of
processed foods, MAF considers that ANZFA's pre-market assessments of GM foods satisfy the
food safety risk assessment of secondary processing.
- This primary/secondary food-processing interface is also reflected in the regulatory regimes for food administered by MAF. The most recent risk-based food legislative regime implemented by MAF is the Animal Products Act 1999. It provides a mechanism for secondary processors to switch between risk-based management systems under the Food Act and the Animal Products Act. It also provides for setting standards for genetically modified animal material or products or ingredients or additives (section 44(2)(e)) should it be necessary to complement ANZFA provisions or requirements of other New Zealand regulatory regimes in the future.
Managing risks from pests, unwanted organisms and new organisms
- The Biosecurity Act 1993 is the principal statute for the exclusion, eradication and
effective management of pests and unwanted organisms. It is the legislative basis for the
biosecurity activities of MAF, Department of Conservation, Ministry of Fisheries and
Ministry of Health. The act prescribes a risk management approach, rather than assuming
that risks can be eliminated entirely. MAF is responsible for enforcing the Biosecurity
Act at New Zealand's borders, i.e. for preventing unauthorised organisms and goods that
may pose a biosecurity risk from entering the country.
- There is a close relationship between the Biosecurity Act and the Hazardous Substances
and New Organisms (HSNO) Act 1996 for managing the risks associated with new organisms.
Under the HSNO Act, new organisms cannot enter New Zealand unless they are approved by
ERMA. `New organisms' means organisms of a type not already at large in New Zealand and
also includes GM organisms, whether they are imported into New Zealand or developed here.
MAF enforces the controls set by ERMA for importation, development, or field-testing in
containment. A memorandum of understanding between ERMA and MAF Biosecurity Authority
clarifies their respective roles and responsibilities.
- When a new organism is detected in New Zealand, the government decides whether to attempt eradication based on the technical feasibility and an analysis of the costs and benefits. Government priorities for the long-term control of established organisms are also guided by cost-benefit analysis.
Managing biosecurity risks at the border
- All goods that could be harmful or that could harbour harmful organisms, including
imported GM organisms, are biosecurity 'risk goods' and must meet the conditions set out
in import health standards. MAF inspects the goods and/or any accompanying documents when
they arrive. Commercial consignments must generally have documents certifying that
specified conditions have been met. This may include freedom from specific pests and
diseases in the exporting country, or that certain treatments have been carried out, or
that other biosecurity measures have been applied.
- Passengers bringing in potentially harmful goods do not usually carry such
certification. MAF inspects goods that are declared or detected on arrival, to ensure they
meet the entry requirements. In some cases treatments may be required, in other situations
the goods would be confiscated and destroyed or returned to their country of origin (at
the importer's expense). Similar options also apply to commercial consignments.
- X-ray machines are installed at Auckland, Wellington, Christchurch and Hamilton
international airports and the International Mail Centre in Auckland to improve MAF's
ability to detect potentially harmful goods. Detection rates vary depending on the type of
goods. For example, since X-ray machines were installed MAF estimates that between 85
percent to 95 percent of material that can harbour fruit flies is detected, depending on
the product type. Before the X-ray machines were installed, the detection rate of
agricultural risk goods was approximately 55 percent. Even with X-ray machines, some risk
goods are difficult to detect. For example, seeds are often brought in with passengers or
sent through the mail, but are not easy to detect because of their size and composition.
- These examples show the difficulty in locating agricultural risk goods, let alone any goods that are also GM. An inspector cannot tell by sight that particular goods either contain GM material or are non-GM. Testing is expensive and time consuming and only possible where a test has been developed. Currently there are tests that can identify specific genetic modifications or categories of modifications that use common techniques (e.g. the same marker genes). There is no generic test for genetic modification. Currently, MAF relies on importers obtaining the appropriate approvals from ERMA before importing GM organisms. Border control is likely to continue to rely on documentation to determine the GM status of incoming goods.
Managing GM organisms in New Zealand
- No GM organisms have been approved for release in New Zealand. So far, the only
approvals for GM organisms under the HSNO Act have been for containment, according to
controls set by ERMA.
- The containment controls are based primarily on standards approved by ERMA in accordance
with the HSNO Act. MAF and ERMA have developed a range of standards for different classes
of organisms based on the Australia/New Zealand Standard, Safety in Laboratories, Part 3
Microbiology (AS/NZS 2243.3:1995). Containment facilities are approved under the
Biosecurity Act according to these standards. The operators are also approved under the
Act.
- Inspectors appointed by MAF under the Biosecurity Act ensure that the controls set by
ERMA are being met. Facilities are inspected according to the requirements of the MAF
standard and any additional controls required by ERMA. The frequency of inspection is
specified in the standard or by ERMA if they require a different frequency.
- Inspectors assess a number of factors, including the following as appropriate:
- that the identity of the organisms held in the facility correlates with the species specified on the permit to import, the export certification is in order and any post-arrival requirements of the import health standard have been, or are being complied with;
- that the procedures as required in the containment manual are practised (including procedures for meeting the containment controls);
- that the structural requirements as set out in this Standard are being maintained; and
- that the organisms in containment correlate with the register.
- As well as meeting an import health standard, imported GM organisms cannot obtain a
biosecurity clearance or proceed beyond border controls without some type of approval
under the HSNO Act. In most instances, they will have ERMA approval for importation into
containment and are directed to a containment facility on arrival. Depending on the health
status of the exporting country, they will sometimes be held in containment in a
transitional facility (e.g. a quarantine facility) to ensure they are not carrying pests
and diseases.
- GM organisms undergoing field tests must also be contained. Field test sites are places
where organisms are held under conditions similar to those into which the organisms are
likely to be released. The area in which the field tests are conducted is approved as a
containment facility under the Biosecurity Act and must meet the standard for that type of
facility.
- GM organisms that have been approved for containment are considered to be `restricted organisms' under the Biosecurity Act. If any such organisms escaped from a containment facility, they would become `unauthorised goods' and `unwanted organisms' as defined in the Act, enabling MAF to take certain actions. The Act provides for surveillance activities, including obtaining information about unwanted organisms. The Act also allows inspectors to seize and dispose of unauthorised goods and to carry out such acts that they consider necessary or expedient for eradicating or managing unwanted organisms.
Managing agricultural and veterinary products
- MAF has a role in approving agricultural and veterinary products through the Pesticides
Act 1979, Animal Remedies Act 1967, Fertilisers Act 1960 and Stock Foods Act 1946. These
acts will be replaced by the Agricultural Compounds and Veterinary Medicines (ACVM) Act
1997, which will commence at the same time as the hazardous substance sections of the HSNO
Act (expected early 2001). Any agricultural compound or stockfeed that contains a new
organism (such as a GM organism) would have to be approved through the HSNO Act process.
- Regulations under the ACVM legislation would not be triggered by the fact that a product is GM, but by the product's characteristics and how it is used. Whether or not they are GM, almost all veterinary medicines undergo a safety assessment while most stockfeeds do not pose any inherent risk to trigger a safety assessment or registration. Regulations will impose an obligation on manufacturers and suppliers to ensure their products are safe to use.
Managing animal welfare
- Under the Animal Welfare Act 1999, research, testing or teaching must not be carried out on a live animal unless the person or organisation involved has a code of ethical conduct. These codes are approved by the Director-General of MAF after consulting the National Animal Ethics Advisory Committee. Every project must be approved and monitored by an Animal Ethics Committee. Regulations specify that records must be kept and returns filed annually on the number of animals used in research.
Contact for Enquiries
Dr Sharon Adamson
Manager,
Innovation Policy
Ministry of Agriculture and Forestry
PO Box 2526
Wellington
NEW ZEALAND
Phone: +64 4 894 0618
Fax: +64 4 4 894 0741
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