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Vertebrate Toxic Agents: Summary of the 2008 ‘Slice of Life’ Review

Introduction

The Approvals and ACVM Group Director commissioned the Compliance and Investigation Group of NZFSA to carry out a ‘slice of life’ review of all stakeholders involved in the vertebrate toxic agent (VTA) manufacture, sale, distribution and use chain. The review, which was to determine the level of compliance with the standards and use conditions imposed upon this class of products, placed special emphasis on assessing the compliance of the distributors, sellers and end users of VTAs. The review also considered (where appropriate) the Memorandum of Understanding (MoU) that exists between NZFSA and the Environmental Risk Management Authority (ERMA NZ) (see Background section below).

The review was conducted in March-April 2008. It included interviews, examination of records and procedures, storage, labelling and signage plus disposal and site clearance at all points in the importation, manufacture, distribution, sale and end use of VTAs.

Legislation/Standards

The review considered requirements laid down in the relevant ACVM legislation, specifications and standards, including:

• Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM Act)

• ACVM Standard for Vertebrate Toxic Agents

• ACVM Registration Standard and Guideline for the Chemistry of Vertebrate Toxic Agents

• ACVM New Zealand Labelling and Advertising Guide for Vertebrate Toxic Agents Requiring Registration

• ACVM Labelling Guide for Hazardous Substances and Agricultural Compounds.

Background

The importation, manufacture, sale, distribution and use of VTAs is jointly controlled by the ACVM Act under the jurisdiction of NZFSA and the Hazardous Substances and New Organisms Act 1996 (HSNO Act) under the jurisdiction of ERMA NZ.

There is a MoU between NZFSA and ERMA NZ. NZFSA’s responsibilities are to ensure that VTAs are manufactured, assigned ‘trade names’, traded and used in accordance with the requirements of the ACVM Act. NZFSA is also tasked with ensuring that VTA use does not compromise food safety and/or market access. ERMA’s responsibilities centre on environmental and immediate personal safety attendant with the manufacture, distribution and use of VTAs.

Because there is some inevitable crossover between the two Acts as they impinge upon this industry sector, some secondary consideration (where necessary) was given to the HSNO Act during this review, but only in circumstances where the issues identified by the reviewer were deemed to be initially and principally raised under the ACVM Act.

Review

This review is the first time that NZFSA has looked at compliance across the VTA industry sector. Thirteen locations, ranging from VTA importers and manufacturers to distributors, retailers and end users were visited. The physical activities of importation and manufacture of VTAs were not examined. However, because manufacturers and importers sell VTAs, their compliance to the ACVM sale requirements was examined along with domestic wholesale, distribution, retail and end use at all relevant locations.

Topics

Conditions of Registration

NZFSA’s ACVM Group registers trade name VTAs and assigns Conditions of Registration to each. (The ACVM Standard for Vertebrate Toxic Agents explains how the Group assesses an individual VTA and assigns various conditions.)

Website and labels

The NZFSA public website (ACVM Registers and Lists) lists the various conditions (by condition number) assigned to each VTA. The physical label for a particular VTA does not necessarily indicate which Conditions of Registration (by condition number) apply, nor does this label explain all of the conditions that relate to that particular VTA.

A distributor, wholesaler, retailer, or a user of a VTA must go to the NZFSA public website and search the conditions imposed upon a particular VTA in order to obtain all of the relevant Conditions of Registration.

The review found that, while manufacturers and registrants of VTAs were conversant with the NZFSA public website, few distributors, wholesalers, or users were aware of, or could access the website in order to obtain the Conditions of Registration. This failure to access the necessary data may have resulted in a breakdown in compliance.

There are 71 VTAs currently listed on the NZFSA public website (ACVM Registers and Lists). The website has provision to display copies of the NZFSA approved label content for each VTA. Of the 71 registered VTAs on this website, 24 VTAs stated "Label content not yet available" at the time of the review. This means a significant percentage of VTA NZFSA approved labels are not accessible.

Upgrades in the NZFSA public website, ACVM Registers and Lists VTA section, may greatly assist the interpretation and understanding of compliance obligations in this industry sector. Compliance may also be enhanced by the provision of labels referencing ACVM VTA Conditions of Registration.

NZFSA response:

The 24 VTAs identified as having no labels available on the NZFSA public website at the time of the review are now available.

It is not practical to place all conditions of registration on the label due to space constraints. There is an expectation that all traders are aware of their obligations when they apply and are approved as a trader. All registered products do have a statement on the label referring to the website for conditions of registration. As it is unlikely for the end user to check the public register prior to use, NZFSA does require labels to contain the relevant conditions that are applicable to the end user, with the expectation that they will read the label and use the product correctly.

Inconsistencies

There may be some inconsistencies in assigning Conditions of Registration to VTAs. For example, two trade name fumigant products containing the same active ingredient are registered with different conditions.

The breakdown in compliance by stakeholders in the VTA industry sector may be alleviated by some refinements and reassesments of how some VTAs have individual Conditions of Registration assigned to them by NZFSA.

NZFSA response:

The conditions placed on a registered product are determined by a number of factors and not just by the active ingredient. Consideration is also given to how the product is used, the inherent safety or danger of the formulation; simplicity or complexity of use instructions etc.

Conditions relating to sale

Must be sold only by approved persons (Condition 43)

Many of the 71 VTAs listed on the website have restrictions on who may sell them.

Condition 43 of the ACVM Conditions of Registration states: "The product must be sold only by a person who has been approved by the ACVM Group". Condition 43 applies to 44 of the 71 VTAs listed on the ACVM website.

NZFSA maintains a list of persons approved by them to trade VTAs under Condition 43. This list was compiled upon the voluntary submission of information from traders or intending traders of VTAs. Traders appearing on this list are either small single site traders or larger (possibly multiple store location) trading entities.

Because some VTA traders are nationwide retail chains with multiple store location trading entities, NZFSA has permitted a ‘Single Trader Approval’ for these retailers. Here, under a Quality System, one nominated senior staff member of a retail chain is approved by NZFSA on the express understanding that this member is responsible for the training and other relevant procedures of all individual members of the VTA trader’s staff. This permission has been well documented and the expectation of a Quality System has been communicated to nationwide retail chains by NZFSA.

The review found there are variable Quality Systems employed by the retail chains. In several cases the Quality Systems employed failed to provide sufficient evidence that ACVM Act VTA trading requirements were being met. This has resulted in the sale of VTA trade name products not in compliance with Condition 43 of the ACVM Conditions of Registration.

NZFSA response:

With changes to the ACVM Act, traders will require an approved operating plan (Quality System) which defines what procedures and processes a particular trader has in place to meet ACVM expectations when selling VTAs. NZFSA will provide guidance of what is required: training of staff, records to address any suspicions or allegations of non-compliance, records of sale, approvals and/or licensing to handle, store and trade in VTAs.

Must be sold only to persons with controlled substances licences (Condition 44)

Of the 71 VTAs listed on the website, 23 are registered pursuant to Condition 44 which states: "If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then: This product must be sold only to a person holding a controlled substances licence issued by a test certifier who has been approved by the ACVM Group".

Controlled substance licences (CSLs) are issued by ERMA NZ, and require a person to have police clearance and appropriate training evidenced by the holding of an approved handler certificate issued by an approved test certifier. The training and ERMA NZ approvals on the CSLs are for specific chemical substances and specific lifecycles, such as storage, use and disposal.

Traders

The national register of CSL holders is held by ERMA NZ, and it is not directly accessible by VTA traders. VTA traders must therefore rely on faxed copies of CSLs from purchasers whenever a sale of a VTA registered pursuant to Conditon 44 is sold to a party geographically isolated from the point of sale. The reviewer noted that many CSL faxed copies held by traders were old copies obtained some time previously. Condition 44 uses the words holding which infers present tense. Arguably, a CSL must be presented (either in an original form or at the very least in a faxed form) each and every time a VTA registered pursuant to Condition 44 is obtained.

Observed non-compliances relating to the sale of VTAs registered pursuant to Condition 44 would be minimised if VTA traders could have ongoing access to the national register of CSL holders, which is currently accessible to ERMA NZ and nominated NZFSA staff.

Registrants, manufacturers or distributors

At five locations the reviewer noted that registrants, manufacturers or distributors were selling VTAs registered pursuant to Condition 44. In all cases the labels on these VTAs did indicate that the VTAs were to be sold only to and/or used by a person holding a controlled substance licence.

• In two of these locations the purchaser of the VTAs did not have a controlled substance licence.

• At a third location the registrant was the purchaser who was accepting VTAs manufactured elsewhere under contract. The manufacturer’s organisation was making and selling these VTAs without checking that any member of the purchasing organisation had a CSL.

• At a fourth location another registrant/manufacturer was found to sell a VTA, registered pursuant to Condition 44, on the verbal instructions of an approved test certifier who had reportedly stated that, while the purchaser had not yet obtained his CSL, it was OK to sell to this individual.

• At the final location, a registrant/manufacturer of VTAs, with labels quoting condition 44, was selling these VTAs to a national retailer knowing that the product would be stored at depots or stores for undetermined times by people who did not have CSLs. In this instance, the registrant/manufacturer was, in some instances, placing the name of the end user who may have had a CSL on the sales documents. Where a CSL licence number could not be quoted on documents, in this finding, the registrant manufacturer deferred to quoting the lesser approved handler certificate numbers.

The findings at these five locations constitute serious non-compliances.

NZFSA response:

All manufacturers of VTA products registered pursuant to condition 44, have been contacted by the NZFSA and reminded of their obligations to ensure that these products are sold only to a person holding a current CSL.

Finding Outside the Terms of Reference – Sales to ‘Authorised Persons’

VTA fumigants are registered under conditions assigned by the ACVM Group. Six of the seven fumigant labels accessible on the website state "Dangerous Poison available to authorised persons only".

The term ‘authorised person’ is not referred to in the ACVM Act, but is referred to in the HSNO Act. The review found that VTA fumigants such as Magtoxin are being sold to persons not authorised by ERMA NZ.

At two nationwide corporate retail chains, the reviewer noted that sales people who were Approved Handlers with Test Certificates (approved to handle agrichemicals but not certified to handle VTAs) were vending VTA products.

NZFSA response:

The label claims determine the conditions of registration. Where a fumigant has a claim to control a vertebrate pest, the conditions are tighter. While fumigants are highly toxic to humans, this is managed by ERMA NZ under the HSNO Act and not the ACVM Act.

Conditions relating to advertising

If product can be sold to and/or used only by person with a CSL, advertisements must clearly state that restriction (Condition 45 Pursuant to Condition 44)

Condition 45 of the ACVM Conditions of Registration states:

"If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then: Any advertisement or promotion for this product must clearly state that it can only be sold to a person who holds a controlled substances licence".

A VTA rabbit poison that was registered pursuant to Condition 44 had two different labels approved for the same poison. Neither label was available on the NZFSA public website. The reviewer sought clarification and approved label copies on this issue from the ACVM Group.

One label did quote Condition 44, and therefore that product was to be sold only to persons who held a CSL. In this situation, the VTA use instructions allowed for distribution of the agent directly onto the ground. The second label stated that the VTA was to "be used only in bait stations", and the use approval was only for this method of application. This second label did not quote Condition 44.

The registrant in this instance of dual label approval was advertising the VTA in the farming press as "No licence required to use bait", and not making any reference to the two labels that required different use approvals and CSL requirements.

This advertisement misleads the public, and is a non-compliance.

NZFSA response:

NZFSA undertakes to discuss the advertising requirements with the registrant of this product to define the limitations clearly because of the use of a dual label.

Conditions relating to record keeping

Containers must be marked for trace back and registers of sales must be kept (pursuant to Conditions 46, 53, and 56 plus sales pursuant to Condition 55)

Condition 46 of the Conditions of Registration states:

"If the label indicates the product can only be sold to and/or used by a person holding a controlled substances licence then: The product must not be displayed for the general public to see. It must be kept secure from unauthorised persons and individual containers marked for trace back purposes." Many VTAs are registered by the ACVM Group on the proviso that registers of sales are kept in order to afford traceability and recall.

Conditions 46, 53, 55 and 56 are all Conditions of Registration imposed across various classes and pack sizes of VTAs. Some of the more stringently controlled VTAs also have requirements spelt out in these conditions for container serial identity registers to be kept at points of sale.

As a generalisation, most registrant/manufacturers and wholesale distributors who only sell VTAs on account held acceptable registers of sales. Retailers, however, who might sell some VTAs to registered account holders and some VTAs to cash buyers, were notably non-compliant with the requirements of Condition 46, 53, 55 and 56. The reviewer notes that partial sales registers were possibly retrievable from computerised electronic card transactions, but that cash sales to individual members of the public and serial number recording (where stipulated in the Conditions) was seriously non-compliant.

At one location where a quantity of cyanide product was sold in breach of Condition 44, a person (not approved by the ACVM Group under condition 37) then proceeded to sell the cyanide product, incorrectly recording the weight quantity and omitting to record container serial identity. Here 5 X 250g cyanide product had been sold by a registrant party and received into the store where nobody held a CSL licence. The cyanide product was on-sold on a traceable invoice to a person who did have a CSL, and this CSL number was recorded on the docket. However, the docket did not appear to have identified the serial identity, and it also stated that 5 X 500 gm containers were sold -- not 5X 250 gm containers as indicated in the original traceable invoice into that store.

Condition 53 of the Conditions of Registration states:

"A register of sales must be kept (minimum of 3 years), recording who the product was sold to, and the quantity sold."

There are 23 VTAs registered pursuant to Condition 53. These VTAs are considered less highly toxic, and in need of less rigorous and precise traceability than required in those VTA registered pursuant to Condition 46, where container serial numbers are required to be kept. However, Condition 53 currently appears to be the only traceability condition imposed upon the seven fumigant VTAs already mentioned as requiring further consideration.

The review identified several retail locations where no registers of sales of VTA registered pursuant to Condition 53 were being kept.

Condition 56 of the Conditions of Registration states:

"For pack sizes greater than 3kg, a register of sales must be kept (minimum of 3 years), recording who the product was sold to and the quantity sold."

There are 13 VTAs registered pursuant to condition 56.

The review identified one retail location where no register of sales of pack sizes greater than 3kg of VTAs registered pursuant to Condition 56 was being kept.

Condition 55 of the Conditions of Registration states:

"For pack sizes greater than 3kg, the product must be sold only by a person who has been approved by the ACVM Group."

The same location that was non-compliant with Condition 56 also failed to comply with Condition 55.

VTA retailers’ failure to comply with registers of sales requirements is a serious non-compliance.

NZFSA response:

NZFSA undertakes to contact the registrants of VTA products and remind them of their obligations to ensure the conditions of registration for their products must be advised to both traders and end users.

Conditions relating to manufacture and use

Product must be manufactured according to GMP standard and used as specified in label content (Conditions 2 and 31)

Condition 2 of the Conditions of Registration of VTAs states:

“The product must be manufactured in accordance with the ACVM Standard for Good Manufacturing Practice and to the chemistry and manufacturing specifications provided by the registrant and approved as part of the registration."

Condition 31 states:

“This product must only be used as specified in the label content.”

At one location, a VTA base active ingredient product used by councils for bird control was being further manufactured by reconstitution into melted petrolatum jelly, and then repackaged into construction type caulking gun cartridges. This activity was not subject to the ACVM Standard of Good Manufacturing Practice. These cartridges were then being distributed nationally to regional councils, with inadequate and non-approved labelling. The reconstitution and end use was not compliant to the use directions approved by the ACVM Group on the original labelling

These activities are a non-compliance.

NZFSA response:

The registrant has applied for an additional claim for this use.

Conditions relating to ongoing obligations

Adverse events must be reported (Condition 37)

All the 71 listed VTAs on the website are registered pursuant to Condition 37, which states ongoing obligations:

"The registrant must provide an annual summary of adverse events to the ACVM Group."

"Adverse events which have serious implications for the continued use of the product must be notified immediately."

"The registrant must also advise the ACVM Group of any new studies or data that contradict information previously supplied."

Four manufacturers/registrants of VTAs were visited during the course of this review and all four were unsure of what constituted an ‘adverse event’. One registrant recalled that he had contacted NZFSA when a transporter carrying several tonnes of a green dyed VTA crashed into the sea. Other registrants reported telephone conversations and enquiries from members of the public and veterinarians (that were not infrequent) when non target poisonings occurred.

The review considers that VTA intoxication in a non-target species is an adverse event. However, the registrants did not consider that these occurrences were adverse events and therefore did not report them. The manufacturers/registrants could not provide the review with copies of an annual summary of adverse events that they provided to the ACVM Group as required in Condition 37.

Failure by registrants to provide the ACVM Group with an annual summary of adverse events is a non-compliance.

NZFSA response:

Registrants will be contacted and advised of their obligations to provide an annual summary of adverse events.

Conclusion

There were serious non-compliances with the ACVM legislation identified across this range of locations. These serious non-compliances should not be considered solely as a lack of good intent amongst reviewees and organisations visited. The reviewer notes that, while some non-compliances could be attributed to commercial expediency by operators, in many cases genuine lack of awareness and ignorance of the requirements by a sector not previously reviewed has resulted in the findings tabled.

Where deficiencies were found the reviewer notes that prompt corrective actions were proposed by all reviewees.

Despite the significant number of non-compliances and serious non-compliances uncovered in this review, there is evidence that the Conditions of Registration of VTAs have been elegantly designed and, in most circumstances, very adequately cover the practical scenarios of VTA trade and use. However, the compliance by stakeholders in the VTA industry sector may be assisted by some refinements and reassessments of how individual VTAs have Conditions of Registration assigned to them by the ACVM Group.

The findings highlight the need for the Authorities to provide urgent ongoing education, followed by timely in depth re-audit, across all participants operating in the VTA industry sector. The review shows that only a low level of regulatory confidence can be taken from these findings.