Summary of Submissions: NZFSA Public Discussion Paper No 13/07 Proposed Bee Product Residue Regulated Control Scheme (RCS)

• APA

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Animal Products Act 1999

• CE

=

Chief Executive

• EU

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European Union

• MPL

=

Maximum Permissible Level

• MRL

=

Maximum Residue Limit

• Notice

=

Draft Animal Products (Contaminated Regulated Control Scheme for Exported Products) Notice 2007

• NZ

=

New Zealand

• NZFSA

=

New Zealand Food Safety Authority

• RCS

=

Regulated Control Scheme

• RMP

=

Risk Management Programme

• Sub. No.

=

Submitter Number (indicates from which are drawn)submission comments

Sub.

No.

Submitters’ comments

NZFSA Response

2

Could not recall any problems with residues in NZ honey, other than for a chemical used to control wax moths. With audits being carried out to satisfy the requirements of both RMPs and organic assurances, could not see how impurities could still be present in honey.

The RCS needs to be established to meet the access requirements of overseas trading partners. Overseas trading partners consider that the RCS will provide continuous validation that New Zealand’s overall system of control for residues and contaminants in bee products is robust.

Audits of RMPs and audits for organic assurance purposes relate to the process followed by a specific supplier of bee products at a single point in time, rather than to New Zealand’s overall system of control.

4

Recognised the need for export market access assurances to demonstrate that NZ bee products are free of residues above maximum permissible levels.

Noted.

6

Supported the establishment of the RCS because an overarching New Zealand designed programme will be most effective in the long term.

Noted.

Sub.

No

Submitters’ comments

NZFSA response

3, 5 & 6

Supported the NZFSA recommendation that the RCS for bee products be made under specifications under Section 38(2)(b) of the APA.

Noted.

Sub.

No.

Submitters’ comments

NZFSA response

2

Concerned that the industry may be charged for someone independently visiting [i.e. outside of regular verifications] to take samples and that this will involve travel costs and wages and cause potential delay to exports. Suggested that samples could instead be taken from each batch extracted by beekeepers and kept for NZFSA.

The intent is that, where possible, verifiers will take the samples required for the RCS, or supervise the collection of these samples, at the same time as they make their regular RMP verification visits. This will prevent additional travel/wage costs from being incurred. The purpose of testing is not to certify the absence of residues on an export “lot” basis so the issue of delays to exports is not relevant and would only occur if an export “lot” was found to not comply with market access requirements.

If those who extract bee products were to themselves take samples for the RCS without independent supervision, then such a collection system could be open to claims that it is not independent. It would be unlikely to withstand scrutiny from overseas trading partners and hence would not provide the assurances that are required about the overall system.

2

Did not know how comb honey and packed honey could be sampled.

Sampling of comb honey and packed honey will need to be done, where these products are intended for export. However NZFSA would expect those collecting samples of comb honey or packed honey to exercise due care to limit, as far as practical, the impact which the sampling will have on the subsequent ability to market the products being sampled.

3

Samples should be taken from exporters’ premises/packing facilities, as beekeepers do not necessarily know where their product will be sold, until such time as it is delivered to these facilities. Beekeepers also do not have any control over their product once it is sold to a packer.

Agreed. However, samples for the RCS need to be taken at sites or premises where bee products are primary processed i.e. extracted – not just at exporters’ facilities (where product from several beekeepers is often combined)..

5

Noted that “producers of bee products intended for export” will be covered by the RCS. Asked that the term “producer” be defined and whether it includes apiarists. Queried who it is that audits apiarists to ensure they comply with their harvester declarations and suggested that harvest declarations be extended to include a listing of all chemicals used by apiarists.

Definitions of the terms “primary producer or producer” and “produce” are given in the interpretation section (Section 4) of the APA. Whilst samples for the RCS will be taken at sites or premises where bee products are primary processed or extracted, the RCS will have the scope to cover any apiarist who harvests products that may be, or are intended, for export. For example, any suppliers of non-compliant product could be subject to surveillance under the RCS, and to related regulatory penalties. To ensure traceability back to apiarists, RMP holders are required to keep full records relating to the supply of product. Given the widespread and scattered distribution of bee hives in NZ, it would however be very costly and logistically impractical to sample product from the hives of every apiarist who could potentially supply product for export.

With regard to the comment about harvester declarations, consideration is being given to ways of ensuring that apiarists comply with regulatory requirements and do not introduce risks.

6

Supported regulatory penalties associated with non-compliance with the RCS being applied to whoever is the source of the non-compliant product (for example, the beekeeper or farmer). Submitted that this would provide an important incentive for producers to ensure that their product is compliant.

Any regulatory penalties associated with non-compliance under the RCS will not necessarily be applied to the RMP holder. In general the intent of the APA is to apply penalties to the person who is the source of the non-compliance, rather than the person having custody of the product when it is sampled.

Sub.

No.

Submitters’ comments

NZFSA Response

1

Noted that some beekeepers have registered RMPs regardless of whether the honey is intended for export, for example for their storage facilities. This is because most, if not all honey packers, will only accept honey extracted in an RMP registered premises. This means that, if the costs of the RCS are recovered from all holders of RMPs for bee products, some businesses who do not export will be charged for the RCS, even though they do not export.

Operators who have RMPs solely for the purposes of freight forwarding and/or storage of bee products will not be charged for the RCS (please refer to Section 7.2, page 12 of the public discussion paper).

As has been submitted, at the time when product is supplied to processing, packing and/or export facilities, beekeepers do not necessarily know where this product will be sold. In such cases, product may be subsequently exported.

2

Submitted that, as the bee products industry contributes to the greater good of the community and to the economy, some of the costs of the RCS should be shared by Government.

NZFSA cost recovery policy is consistent with Government guidelines.

3

Submitted that it is inequitable to make producers of bee products pay for EU residue testing, as producers do not necessarily know if their product will be exported and, if it is exported, to which market/s it will be sent. Submitted that the cost of the RCS should fall on exporters only. Suggested that a simple computer system be developed to separate out those RMP holders who have exported honey.

Those that have RMPs solely for the purposes of freight forwarding or storage of bee products will be excluded from meeting the costs of the RCS.

The submitter refers to inequity. In Section 113 of the APA, equity is only one of the four criteria which need to be taken into account, as far as is reasonably practicable when establishing cost recovery mechanisms. The other criteria are efficiency, justifiability and transparency.

With regard to limiting cost recovery for the RCS just to those processing or exporting products destined for the EU, the final market destination of products is not always known at the time of extraction and/or the time of processing (as submitters have noted). It would be logistically difficult to limit the costs of the RCS just to those producing, processing and exporting bee products to the EU.

It should also be noted that overseas markets other than the EU are asking for information about the residue free status of NZ bee products. NZFSA considers the RCS will make an important contribution to facilitating and protecting access to these overseas markets in the future. This would make it inequitable to bill the RCS costs only to those sending products to the EU.

3

Considered that, if the costs of the RCS are distributed amongst all RMP holders, this could result in beekeepers deciding to swap to selling their honey locally, rather than exporting.

Noted. Any such actions would flow from commercial decisions made by the beekeepers concerned.

4

Wished to see minimal cost impact on industry members with cost recovery spread widely and equitably.

Noted.

5

Supported the cost of the RCS being levied from all holders of RMPs. But would like all apiarists/beekeepers to be required to have an RMP, as the largest risk to exports is posed by the management of hives. Appreciated the transparency of the proposed RCS cost recovery mechanism.

Noted. Apiarists were made exempt from the requirement to have an RMP for their harvesting operations in the Animal Products (Exemptions and Inclusions) Order 2000. Reconsideration of whether apiarists/ beekeepers should be required to have an RMP, and whether the management of hives poses the greatest risk to exports, is outside the scope of the public discussion document or the proposed RCS.

5

Suggested that all within the industry benefit from exporting, because without active marketing of New Zealand bee products, the demand and hence return on honey would decrease markedly.

Noted. However, at this stage linking cost recovery for the RCS to RMP holders offers the most efficient means of cost recovery. It is also important to trace costs back to the direct beneficiaries of the RCS.

6

Supported NZFSA being required to consult with the industry prior to any future enhancement being made to the monitoring programme or any new survey being proposed.

NZFSA will consult with industry, wherever practical, about any future enhancements or surveys.

6

Supported the cost of the RCS being recovered through an increase in the annual fee which NZFSA levies from all bee product processing premises or places with RMPs. Would like the cost recovery scheme to commence in early 2008.

Noted.

6

Queried the details of the cost recovery for surveillance activities (section 7.3 of the public discussion paper). Asked for details of the overall cost of the surveillance programme, the maximum charge per beekeeper and, if the surveillance programme was to find nothing, who would then pay?

The surveillance activities which will be carried out will be specifically determined by what is required to manage each instance of non-compliance. It is therefore not possible to predict in advance the overall costs, or maximum charges per RMP holder. If the surveillance activities reveal no issues with residues or contaminants, then the bee products industry will benefit from the renewed confidence that such a positive circumstance could generate. However, unfavourable results revealed by a surveillance investigation could affect the overall monitoring programme under the RCS.

Sub.

No.

Submitters’ comments

NZFSA Response

5

Noted that the Notice does not contain any default Maximum Permissible Level (MPL), or list compounds which can be legally used by the industry. Also noted that MPLs are not given for the compounds itemised in Schedule 1.

These matters will be covered in a separate Notice to be issued.

5 & 6

Supported the establishment of a password protected “Surveillance List” (Part 5 section 17(3) refers).

Noted.

5

Suggested a thorough risk analysis be done when deciding the fate of the identified risk product (Part 5 Section 23(2) refers).

Agreed.

5

Queried why testing is only to be done for honey rather than for all bee products.

The RCS is being established in direct response to overseas market access requirements. At this stage, both the EU and the other overseas markets to which the RCS will be relevant only require that residue and contaminant testing is undertaken for honey and comb honey and not for other bee products. The RCS therefore mirrors these market requirements. Additional costs would be involved in extending the product scope of the RCS; however NZFSA would be open to doing this if in future there is evidence that such an extension is required by overseas markets

5

Surprised at the range of tests listed in Schedule 1 and asked if testing could be targeted towards compounds of specific risk to the bee industry. Regarding Schedule 2, asked how decisions will be made on the scope of the substances to be monitored and whether the results of the monitoring will be made publicly available, perhaps as per surveillance, from a password protected area.

The sampling regime listed in Schedule 1 is based on what is required to satisfy overseas market access requirements. Likewise the monitored substances indicated in Schedule 2 will mirror the requirements of overseas markets.

Consideration is being given to whether the results of the monitoring will be made publicly available.

6

Regarding Section 8(4), asked if the reference to “3 days” actually refers to “3 working days”?

The reference does relate to 3 working days, and this will be clarified in the finalised Notice.

6

Regarding Section 14(2) asked for a definition of the term “container”.

A definition for the term “container” will be added to the “interpretation” section of the finalised Notice.

6

In Section 14(4), recommended that each sample should be labelled to identify: (1) the registration number of the RMP premise, (2) the batch extraction reference, (3) the apiarist registration number, and (4) the harvest declaration reference.

The information that will be attached to each sample will be the minimum that required to uniquely identify the sample and to enable trace-back. Additional requirements beyond what is needed for these purposes could impose unnecessary costs. Information that fully supports trace-back of samples should be held by RMP holders. All sample information will be entered onto a secure NZFSA database and the sample itself will be identified by a database allocated number and a number code for the tests required.

6

Regarding section 15(2), asked for definitions for the terms “risk source” and “risk source operators”.

These terms are defined in the Animal Products (Regulated Control Scheme – Contaminant Monitoring and Surveillance) Regulations 2004. Where specifications are made under Regulations or an Act, any terms used, but not defined, in the specifications have the same meaning as in the Act or Regulations.

6

Asked that specific timelines be given for: (1) the time taken for the Chief Executive (CE) to revoke or amend an entry on the surveillance list (Section 19(1) of the Notice refers); (2) the time taken for the CE to provide a surveillance notice in writing to the affected risk source operator (Section 20(1) refers); and (3) the time taken for the CE to revoke or amend surveillance conditions (Section 21(1-3) refers).

Agreed that timelines should be known. However, such timelines are normally notified in operational guidance material/manuals etc, rather than set out in tertiary legislation. For further information on these timelines, RMP holders should talk to verifiers. In practical terms these times will be short as they will in effect involve amending entries on the web based database.

Sub

No.

Submitters’ comments

NZFSA Response

2 & 3

Submitted that beekeepers are very busy at this time of year and that discussion papers should be released during winter months to maximise the number of detailed submissions received.

Noted. NZFSA appreciates this is a busy time of year for beekeepers. However, the date of the release of the discussion paper reflects the importance of having the RCS in place for the 2008 production season. Sampling for residues in bee products generally occurs from February to April each year, following the harvest cycle. NZFSA is therefore concerned to ensure that the scheme is in place by early 2008, so as to facilitate and protect access to overseas markets for exports of bee products harvested during the 2008 season. NZFSA has been in communication with representative groups and individuals from the honey/bee sector about the proposed RCS for over a year.

6

Concerned at the lack of apparent consultation with industry on the production of documents related to the proposed RCS. Requested that in future industry groups should be consulted prior to the release of any document affecting the bee industry.

Prior to releasing the discussion paper and Notice, NZFSA attended a number of industry meetings and working groups to explain the need for the RCS and the likely form that it would take. The subsequent release of the paper and Notice builds on these earlier discussions and is designed to give industry groups, as well as concerned individuals, an opportunity to make formal comment.

Sub.

No.

Submitters' comments

NZFSA response

2

Submitted that, instead of introducing the RCS, NZFSA should negotiate with importing countries to manage access without introducing more regulations.

NZFSA is committed to undertaking negotiations with trading partners to minimise any requirements which overseas markets may impose, over and above those necessary to meet NZ domestic requirements. However in some cases, in order to facilitate and protect access to overseas markets, regulatory measures are required.

2

Submitted that NZFSA is more concerned about residues in exports, than about proposed honey imports from Australia and China which could include bee diseases, pesticides and antibiotics.

The control of bee diseases in imports is the responsibility of Biosecurity New Zealand.

In regard to the safety of imported food products, NZFSA has developed a new programme. The NZFSA website provides information on this programme at:

http://www.nzfsa.govt.nz/imported-food/imports-portfolio/index.htm

2

Asked if it would be timely to reinstate the Apiaries Act instead of “squeezing” the industry into an Act that suits bigger agricultural exporters.

Noted. However, no matter what legislative or regulatory regime applies, New Zealand would still be required to impose an RCS (or national monitoring scheme) to meet overseas market access requirements.

2

Suggested tutu honey is a problem that needs to be addressed.

Harvester declarations contain a requirement that apiarists ensure their bees do not forage in tutu.

3

Noted that whilst Codex Alimentarius does not have MRL residue limits, the EC does under EU directive 2001/110EC.

Noted.

5

Requested clarification as to what notices and specifications would be linked to, or made redundant by, the proposed Notice on the RCS.

The Notice will not render other tertiary legislation redundant as the RCS that it sets out is a new requirement. However, a new MPL (Maximum Permissible Level) Notice will be issued that outlines acceptable levels for exported honey to supplement those set in existing OMARS (Overseas Market Access Requirements)