- Print Friendly - Help

Pesticides ‘Slice of Life’ Review

To ensure that all stakeholders involved in the importation, manufacture, distribution and use chain of pesticides¹ comply with the conditions of registration in New Zealand, NZFSA’s Approvals and ACVM Group contracted the Compliance and Investigation Group (CIG) to conduct a ‘slice of life’ review. This type of review provides NZFSA with a preliminary overview of relevant activities in an industry sector not previously subject to a compliance or monitoring programme. The following is a summary of the final CIG report, which was completed in February 2009. (A glossary at the end provides definitions of some terms relevant to this report. Please note that the term ‘plant compound’, which appears in some document titles and quotations, has been replaced by the term ‘agricultural chemical’.)

Scope of review

Sample

A sample of importers, manufacturers, distributors and users of agricultural chemical pesticides were surveyed in order to ascertain compliance with ACVM requirements. Selected registrants were chosen for review on the basis that they were deemed to provide a cross-section from multinational companies to smaller domestic companies more involved in generic pesticides.

Pesticides under consideration were fungicides, herbicides, insecticides, miticides, molluscicides and nematicides.

Relevant legislation

• The Food Act 1981

• The Food Hygiene Regulations 1974

• The Animal Products Act 1999

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

• The ACVM Regulations 2001

Focus

The review focused on the following areas:

1. Pesticide use was assessed to ensure that products are registered and that approved label claim directions and records of application by growers comply with legislation and approved codes of practice.

2. For imported pesticides, documentation was examined to ascertain if certificates of analysis (CoA) are being routinely provided from the manufacturing source.

3. For pesticides manufactured in New Zealand, documentation was examined to ascertain compliance with the chemistry and manufacturing information supplied (Registration and Product Datasheet) by registrants to NZFSA.

4. Packaging and labelling of pesticides was viewed in the marketplace to assess compliance with NZFSA approvals.

5. End user spray records were checked to confirm pesticide withholding period compliance.

6. End user pesticide storage sheds were examined.

Registrants interviewed

Large registrant organisations

Three of the six registrants interviewed were classed as large registrant organisations. These are large multinational corporations involved in research and development (R&D) of novel new patented pesticides. Such organisations also often manufacture their own active ingredients (AI) and formulated product (FP), either offshore or within New Zealand. These large organisations tend to have integrated ‘in house’ control of the full lifecycle of their pesticides from R&D, to manufacture, to importation and distribution. They also provide regional technical field support to end users.

Small registrant organisations

The other three registrants interviewed were classed as small registrant organisations. These are New Zealand-based organisations involved in sourcing AI/FP from various chemical companies throughout the world. Such organisations may then manufacture (or have manufactured by toll process operators) ‘generic type’ AI/FP pesticides that may or may not be out of patent cover.

Some registrants in this class are merely marketing organisations having all manufacture, warehousing and distribution carried out by third parties either in New Zealand or offshore. As such, these small registrant organisations might be considered to be in less immediate ‘in house’ control of the full lifecycle of their pesticides prior to end use.

Review findings: Registrants

All registrants had a good understanding of the registration process. However, some aspects related to compliance with conditions imposed on registration and ongoing obligations could be improved.

Registrant compliance to ACVM conditions of registration

All pesticides reviewed were registered by NZFSA subject to conditions of registration 2, 3, 8 and 37. Some of the pesticides chosen for the review were also registered subject to condition 4. The following table provides the conditions and a summary of the reviewer’s findings about compliance to each condition.

Number	Condition	Reviewer’s Comments
2	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.	High manufacturing standards appear to be being applied by some large registrant organisations. Where manufacturing is being carried out by third parties batch CoA may not always be supplied for each and every batch. There was no evidence of audits being undertaken by NZFSA or third party agencies to ascertain that the industry as a whole meets ACVM GMP standards as referred to in this condition.
3	Agricultural chemical: In addition to any labelling, advertising or promotion requirements specified in the current registration, labelling, advertising or promotion of the product must comply with the current ACVM New Zealand Labelling and Advertising Guide for Plant Compounds Requiring Registration.	All registrants interviewed complied with this condition.
4	The product must only be sold or imported according to the current registration.	This condition only appears to apply to some of the pesticides reviewed. The Approvals and ACVM Group reports that condition 4 is redundant and that it is being removed from registrations as they undergo triennial re-registration.
8	If the product is used on any food-producing plant or on or around any plant not used to produce food: • other than those specified on the current registration; or • in a manner not specified in the current registration, the user must ensure that residues of any substance in the product that may occur in plant material produced from the plants treated, or in animal material produced from grazing or direct feeding of the plants treated to food-producing animals, do not exceed the lesser of either: • the specified residue limit in the current New Zealand (Maximum Residue of Agricultural Compounds) Food Standard and any subsequent amendments; or • the default maximum residue limit in the current New Zealand (Maximum Residue of Agricultural Compounds) Food Standard and any subsequent amendments, when a maximum residue limit for that substance has not been specified.	Registrants in general are not end users of the products they register and therefore the responsibilities of this condition are not necessarily applicable to them. Compliance to condition 8 is covered in the End User section of this report.
37	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. (This requirement is explained in detail in the NZFSA publication, ACVM Registration Information Requirements for Plant Compounds in New Zealand.)	Several registrants interviewed were not clearly aware of what constituted an adverse event. For example, some registrants asked if a pesticide product failure due to user non compliance with label directions might constitute an adverse event. Regardless of this lack of consistent awareness of what constitutes an adverse event, no annual summary reports are furnished (by registrants interviewed) to NZFSA.

Registrant ongoing production compliance to the ACVM Registration and Product Datasheet submissions

Prior to approval, each potential pesticide registrant must submit a Registration and Product Datasheet (PDS) that details sources of manufacture (AI and FP) and formulation details (including impurities).

The reviewer had copies of each relevant PDS at each interview location to assess production compliance. Registrants were asked to provide a certificate of analysis (CoA) from ongoing production at the time of the interview.

There was a wide range in both the ready availability and the quality of CoAs supplied to the reviewer. This range may be explained by the following factors:

• absence of a set ACVM standard for CoAs to be produced for AI and FP products

• AI and FP CoA being generated by parties other than the registrant and not immediately available (more notable where CoAs are generated offshore)

• reluctance (commercially sensitive information) by principal manufacturing parties to divulge CoAs, especially for FP to registrants not involved in the manufacture of the FP.

CoAs derived from ongoing batch production should, at the very least, measure all of the parameters described by the registrant in their original PDS submissions as approved by NZFSA.

One multinational manufacturer was not interviewed but was formally requested to supply a CoA for specified batches of FP. This FP was manufactured and supplied by this company to a small domestic-based registrant for decanting and labelling prior to retail sale by this same registrant. The company could not or would not provide a CoA for these batches of FP, despite repeated requests from the reviewer.

Absence of CoAs for batches of agricultural chemical pesticides does not provide assurances that such products meet registration requirements.

Change of supplier

One registrant was unable to demonstrate compliance to the PDS submissions. In this case the registrant claimed that because of recent increased international demands for agricultural chemical pesticides caused by a surge in biofuels crop plantings there was now a worldwide shortage of pesticide manufacturing capacity. In this instance the registrant had changed their AI supplier.

The same registrant stated that such alternative sources can be accessed by attending Chemical Trade Fairs held regularly in Australasia and that such fairs provide supply and purchasing advantages. This registrant also indicated that such use of alternative supply sources was not uncommon within the industry. A CoA supplied by this registrant for the AI sourced from the new supplier showed that it did not comply with approved registration data held on NZFSA files.

Compliance to standard

The ACVM Standard and Guideline for Chemistry of Plant Compounds states:

"Registrants must apply for approval of any variation to the registration of a plant compound. Such variations may relate to changes to formulation, current use patterns or claims". "Even minor changes must be approved." (Clause B1.3)

"These are applications for:

• change in the method of manufacture (Note: where the formulation details change, an application for a type C1 will also be required)

• change in site of the manufacturer of the formulated product or the technical active ingredient

• new or additional manufacturer of the formulated product

• •new or additional manufacturer of the active ingredient.

These are variations to conditions of registration." (Clause C2)

Non compliance

The sourcing of such AI and or FP from suppliers other than those indicated on the current approved PDS without NZFSA approval is a non compliance with the conditions of registration and the requirements of the ACVM Standard and Guideline for Chemistry of Plant Compounds.

Registrant and vendor compliance with the ACVM New Zealand Labelling and Advertising Guide for Plant Compounds Requiring Registration

Labelling

All six registrants interviewed provided copies of labels currently being applied to containers of pesticides selected for the review. Further; where possible, warehoused product and outer cartons held by or on behalf of these registrants were examined for label and container size compliance. At retail farm supply stores and at chemical stores at each farm site visited selected pesticide labels and container sizes were also examined.

At one registrant’s manufacturing premises a pesticide was being produced and packed in a 10 litre container when NZFSA datasheets indicated that this product was supplied in 20 litre containers. The registrant indicated that this discrepancy would be corrected.

At no other stage during the review did examination of labels or containers from manufacture through to end use storage indicate any significant non compliance with the requirements of the PDS and the ACVM New Zealand Labelling and Advertising Guide for Plant Compounds Requiring Registration.

Advertising

The farming industry publications Straight Furrow and Rural News were examined by the reviewer over the months August to November 2008 for agricultural chemical pesticide advertisements. There were no advertising compliance issues identified in these publications.

End users interviewed

An end user of agricultural chemical pesticides is identified for the purposes of this review as the person growing the plant or plant product and/or the person responsible for the application of the pesticide prior to direct use or sale of that plant or plant product for human or animal consumption.

A total of 14 location interviews were held with end users of pesticides. Selection of end users was made after obtaining sales data on selected pesticides from registrants and then tracing this data to retailers for eventual sale to end users.

Commercial spray contractor

One commercial spray contractor was interviewed. He was principal of a large organisation employing 8 staff (5 were ERMA Approved Handlers and 3 were also Growsafe approved pesticide applicators). This contractor operated throughout the lower North Island applying pesticides to both industrial and agricultural land.

Farmers

Thirteen farmers (from Hawke's Bay, Horowhenua/Kapiti, Manawatu, and Mid and South Canterbury) producing food for animal and human consumption were interviewed.

The table below shows the range of crops grown by the farmers interviewed.

Crops for Seed Production	Crops for Animal Consumption	Crops for Human Consumption
wheat	wheat	apples, asparagus, barley, beans, beetroot
barley	barley	blueberries, broccoli, cabbage, capsicum, carrots
white clover	maize	celery, fennel, grapes, leeks, lettuce
ryegrass	sweet corn	nectarines, peaches, peas, pears, plums,
brassicas (Asian kale and round red radish)	lucerne	potatoes, pumpkin, red onion, rye corn, shallots
oats	grass (hay/silage)	silver beet, spinach, spring onion, squash, stone fruit,
rapeseed oil for biofuel (trial)	brassicas	sweet corn, tomatoes, wheat, zucchini
	oats

Seven farms were large operations where more than one staff member was responsible for decision making with regards to pesticide selection and application plus harvesting. At some of these large operations pesticide spray or application was undertaken by a third party commercial contractor. At the six smaller operations only one person held responsibility for all decision making relating to pesticide selection and application plus harvesting.

Review findings: End users

There was sufficient evidence gained from interviewing end users of pesticides to conclude that there was an acceptable level of compliance within this sector. This evidence is based principally upon interview outcomes and also from the fact that agricultural chemical pesticide purchases and applications are a cost to end users. Interviewees consistently emphasised the financial incentives of only paying for and applying necessary pesticides at optimally recommended rates. Most end users also indicated that large scale purchasers of their produce routinely had significant input into pesticide use decisions and that it was not uncommon for multi-residue analysis to be part of a produce supply contract between grower (pesticide end user) and large scale produce purchasers.

All interviewed farm operators involved in direct end use of pesticides had good awareness of spray withholding periods, pre-harvest intervals, spray drift and risks from residue violation.

All interviewees or persons responsible for pesticide application were either Approved Handlers (where their pesticide use profiles necessitated such ERMA qualifications) or Growsafe registered.

Records

Pesticide application record keeping procedures varied from diary hardcopy to computer recording. Some larger operations controlled pesticide application rates and frequency recording using the Muddy BootsTM software application. Many arable farms belonged to agronomy groups that were supported by regular technical input from a tertiary qualified agronomist.

Off-label use of pesticides

Where off-label use of pesticides was necessitated in less common crops such as blueberries, evidence of residue profile testing was provided to support such use. One large farm involved in off-label use in crops selectively used off-label pesticides to promote beneficial insects. This location employed a full time agronomist and the off-label use was said to be utilised on the principle that sprays lethal to pests but harmless to beneficial insects were employed where possible. This selective pesticide use was facilitated by information derived from a Netherlands- based website (www.koppert.com).

Review outcome

The review outcome is that the agricultural chemical pesticides industry is substantially compliant with NZFSA ACVM requirements.

The large multinational manufacturers who are also New Zealand registrants of these products have stringent operational controls for procedures relating to quality of production, storage, distribution, end user technical support and disposal.

The large multinational manufacturer/registrants interviewed mostly comply with NZFSA ACVM requirements examined. However, one such large manufacturer of pesticides failed to provide the reviewer with CoA documentation sought for review purposes.

Some smaller domestic manufacturers or importers who are also New Zealand registrants of these products are less resourced to ensure compliance with ACVM requirements. Compliance issues found relate principally to obtaining active ingredients from sources other than those approved during the registration process.

The review identified issues relating to quality of and immediate availability of CoA for production batches of active ingredients and formulated product from third party manufacturers, either based in New Zealand or offshore.

The review identified that the current condition (condition 2) relating to compliance to the NZFSA Standard of GMP is not applicable to this industry sector. (GMP is internationally applied only to veterinary medicines). During the implementation of the ACVM Act amendments, the conditions of registration will be reviewed and this inaccurate general condition will be replaced with a specific manufacturing condition relating to agricultural chemicals.

Finally, the review identified that end users of registered agricultural chemical pesticides interviewed showed an acceptable level of compliance to label instructions and conditions of registration.

One non-compliance is cited and four recommendations are made in this ‘slice of life’ review.

Non Compliance

Non compliance against agricultural chemical pesticide registrant: Failure to comply with the ACVM Standard and Guideline for Chemistry of Plant Compounds

It is a non compliance with Clauses B1.3 and C2 of the ACVM Standard and Guideline for Chemistry of Plant Compounds for registrants to source AI and FP from sites/manufacturers not applied for by the registrant and from sites/manufacturers not subsequently approved as a variation to the conditions of registration by NZFSA.

NZFSA response

The registrant has updated the relevant information relating to the registered trade name products.

Recommendations to NZFSA

Mandatory CoA receipt by registrants for all batches of agricultural chemical pesticides

This review recommends that consideration be given to making it mandatory for registrants of agricultural chemical pesticides to hold batch CoA (that are fully compliant with all relevant NZFSA approved parameters) prior to the sale of each batch of agricultural chemical pesticides.

NZFSA response

This will be considered during the development of the Registration Information Requirements relating to agricultural chemicals, which are currently being developed as part of the implementation of the ACVM Act amendments.

Targeted GMP audits in the pesticides sector

This review recommends that consideration be given for targeted ACVM Standard GMP audits in the agricultural chemical pesticides manufacturing sector.

NZFSA response

The ACVM Standard for GMP is not applicable to agricultural chemicals. NZFSA manufacturing compliance programme will be developed in line with international requirements for this industry sector.

‘Adverse event’ definition and audit of registrant reporting responsibilities

This review recommends that the term ‘adverse event’ as outlined in Condition of Registration (number 37) be clearly defined to registrants of agricultural chemical pesticides and that such reporting of adverse events mandated by Condition of Registration (number 37) be subject to audit.

NZFSA response

The adverse event reporting scheme for agricultural chemicals is currently under review and some limited consultation has been initiated. NZFSA is currently awaiting the results of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA’s) review of the Australian adverse event reporting scheme for agricultural chemicals as part of our alignment.

CoA of production batches to test for all parameters approved by NZFSA

This review recommends that consideration be given for CoA of production batches of all AI or FP to test for and report on all parameters identified in Registration and Product Datasheet submissions approved by NZFSA for such registered agricultural chemical pesticides.

NZFSA response

This will be considered during the development of the Registration Information Requirements relating to agricultural chemicals, which are currently being developed as part of the implementation of the ACVM Act amendments.

Glossary

Some definitions of relevant terms are supplied as background information.

A pest: (a) Includes any unwanted living organism including micro-organisms, pest agents, and any genetic structure that is capable of replicating itself (whether that structure comprises all or only part of an entity, and whether it comprises all or only part of the total genetic structure of an entity) that may affect plants, animals, or raw primary produce; and

(b) Includes any entity declared to be a pest for the purposes of this ACVM Act by Order in Council made under subsection (2):

(c) Does not include-

(i) Any human being or living organism which affects only human beings; and

(ii) Any living organism declared not to be a pest for the purposes of this Act by Order in Council made under subsection (2).

In general terms, plant compounds include, but are not limited to:

• bactericides

• fungicides

• herbicides

• insecticides

• miticides (acaricides)

• molluscicides

• nematicides

• piscicides

• plant growth regulators

• antisapstains

• viricides.

Registrant: Means, in relation to a registered trade name product, the person who applied to register that product or the person to whom a registration is transferred. (For the purposes of this review a registrant can mean the above and can also mean the representative of the registrant interviewed on that registrant’s behalf during this review).

Active ingredient: (AI) The substance(s) in a trade name product, which is primarily responsible for the biological or other effects that make the product an agricultural chemical.

Batch: A specific quantity of an active ingredient or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

Formulated product: (FP) Final trade name product containing all ingredients (listed and approved by the Approvals and ACVM Group) with their concentrations added together. This will contain one or more active ingredient(s) and possibly excipient(s) (non-active ingredient[s]).

Certificate of analysis: (CoA) A physicochemical analytical report based upon laboratory analysis of either active ingredient(s) of formulated product(s) of a defined batch of an agricultural chemical that measures the parameters defined in the relevant NZFSA Registration and Product Datasheet.

¹ Pesticides, for the purposes of this review, are defined as any registered agricultural chemical

trade name product as defined under the registration requirements. An agricultural chemical means

any substance, mixture of substances, or biological compound, used or intended for use, in the

direct management of a plant in an agricultural context. It also includes compounds used in

post-harvest pest control or disinfection of raw primary produce.