Carbaryl Review- Frequently Asked Questions

What is carbaryl?

Carbaryl is a broad spectrum, general purpose carbamate insecticide.

How does it work?

Carbaryl works by poisoning the nervous system in the insects. Carbaryl inhibits the enzyme acetylcholinesterase, interrupting the transmission of nerve impulses.

What is it used for?

Carbaryl is registered for use on cereal crops and is applied during the growing stages for control of certain insect pests such as caterpillars, armyworm and plague locusts. It is also registered for use as a grain protectant chemical used during grain storage and for treatment of structures where grain is stored.

Carbaryl products are also used for the control of insect pests in fruit and vegetable crop as well as in non-crop situations.

There are a number of veterinary uses for carbaryl the majority of these uses are for control of ectoparasites on domestic animals, including birds. The pests controlled include fleas, mites and ticks. The products available for control of these pests are in the form of shampoos, ear drops and dusting powders.

Why is carbaryl being reviewed?

Carbaryl products are being reviewed as part of the APVMA chemical review program, because of possible public health and food safety concerns.

How is the review being conducted?

In undertaking the review the APVMA received information from a number of sources including scientific data packages submitted by registrants, submissions received from the public, published literature and international reports.

In evaluating the information and preparing the recommendations of the review, the APVMA received advice from the Office of Chemical Safety in the Department of Health and Ageing. Advice was also received from state government agencies. The review has been split into two parts. Part 1 of the review is looking at products that are used in the home garden, home veterinary, poultry and domestic situations. Part 2 of the review is looking at the products used in agriculture.

The review has been split into two parts, because the assessment of carbaryl agricultural products required further assessments to be undertaken. The APVMA has been able to program the review for products used in home garden, home veterinary, poultry and domestic situations and ahead of completing the assessment of agricultural products.

What reports are available?

A scope document for the review outlines the key concerns that are the basis of the APVMA’s review.

A first draft report, published in 2004, details the initial findings for all carbaryl products included in the review.

A Review Findings Report for Part 1, released in April 2006, provides details on the review findings and proposed regulatory approach for this part of the review.

A Preliminary Review Findings report for Part 2, released in July 2006, provided the initial findings for the agricultural products and includes a modified proposed outcomes for this part of the review.

What did the APVMA find in its review?

Part 1: Products used in home garden, home veterinary, poultry and domestic situations

The key preliminary findings of the review for Part 1 that have led to the APVMA’s proposed recommendations were that:

carbaryl residues in fruit, vegetables and poultry may pose a potential risk to consumers;
the use of some more concentrated products in the home garden may pose a potential risk to product users and bystanders;
the application of carbaryl dust products in the home, home garden and domestic situations may pose a potential risk to human health.

Part 2: Products used in agricultural situations

The key preliminary findings of the review for Part 2 that have led to the APVMA’s proposed recommendations were that:

carbaryl residues in some fruit and vegetables may pose a potential risk to consumers;
the mixing, loading and application of some products may pose a potential risk to users of the products.

What are we proposing to do about it?

Part 1: Products used in home garden, home veterinary, poultry and domestic situations

As an outcome of the toxicological assessment it was identified that the use of home veterinary dust formulations for the control of fleas and ticks etc on domestic animals and birds and on animal bedding and carpets poses an unacceptable risk to householders applying these products. These uses are to be cancelled.

It was also found that the concentration of some home garden products exceeds the safety threshold for these types of products for use in the home garden and these products are to be cancelled.

The residues assessment identified an unacceptable short term expose risk to residues of carbaryl on some fruit, vegetables and oil seed crops. As a result of these concerns uses on fruit and vegetables that are grown in the home garden will be cancelled.

One carbaryl product is registered for use on poultry, insufficient data was submitted to the review to assess residues in poultry produce from direct animal treatment. As a result of data being unavailable to support this use it is to be cancelled.

Some product labels do not contain adequate first aid and safety directions or personal protective equipment to allow safe use, however labels can be updated to contain adequate safety information.

As a result of the above concerns the following variations to approved labels are proposed:
a. Delete use on fruit and vegetable in no commercial situations
b. Delete use on poultry
c. Delete use of veterinary dusts for the treatment of animals and birds
d. Delete use of dust formulations for indoor use on domestic premises
e. Delete use of dust formulations for treatment of carpets, rugs and animal bedding
f. Retain use of products (other than dust products) for the treatment of lawn and turf
g. Retain use of products (other than dust products) for domestic use
h. Retain use of products (other than dust products) for use on ornamental plants

Part 2: Products used in agricultural situations

At this stage the APVMA is seeking comment on the preliminary findings and proposed actions in the report. It is now the opportunity for interested parties to comment on the proposed review outcomes and provide any additional information that they consider relevant to the review. Once the public comment period is completed, all submission will be considered prior to finalising the review and implementation of the final recommendations.

The proposed recommendations for the continued use of products used in agricultural situations are:

Delete instructions of use for berry fruits (except raspberries), fruit general, citrus (except oranges and lemons), cherries, kiwi fruit, grapes (except butt treatment), sunflower and linseed crops and vegetable crops (except, potatoes, sugarbeets, beetroot and turnip (swede), and limited uses on cucurbits).
Limit the uses for avocados, cucurbits, feijoa, guavas, grapes, jaboticaba, jackfruit, loquats, lychees, mangoes and rambutans to non-flowering/non-fruiting trees/plants.
Retain uses for macadamias, pecans, pome fruit (apples & pears) stone fruit (except cherries), citrus (oranges & lemons), potatoes, raspberries, beetroot, turnips (Swede), sugarbeet, cereal crops & storage, cotton, dubosia, kenaf, lucerne, maize, pastures, pasture seed crops, rice, rosella, sorghum, elm trees, ornamentals, roses, commercial, industrial and domestic areas, tobacco storage sheds and rights of way and in non-crop areas in general.
Retain uses for horses, ponies and dogs.
Delete use of wettable powder formulations by handheld application to garden beds, compost heaps and treatment around buildings.
Change the delivery method for wettable powder formulations.
Delete use by hand-held spray equipment for pest control activities in domestic, commercial and industrial settings, except for the eradication of insect nests.
Operators applying carbaryl by orchard airblast must be protected by appropriate engineering controls.
Use of enclosed transfer/mixing systems for preparation of carbaryl suspension concentrate products is required to reduce the exposure of operators mixing and loading for aerial, boomspray and orchard airblast application to acceptable levels.
Withholding Periods are to be amended.
Re-entry periods to be established.
Directions table for use on pigs to be changed to appear as a separate table.
Warning Statements and Safety Directions are to be updated.

Why has the APVMA made these recommendations?

The APVMA has made these recommendations to ensure that the continuing use of products containing carbaryl do not present an undue risk to public health and safety.

What this will mean for users of carbaryl products?

The outcome of Part 1 of the review, has the following impacts:

Home garden, home veterinary, domestic and poultry– the registration of some currently available products for use in the home garden as well as home veterinary dust treatments have been cancelled and are being phased out. Products for use on domestic and commercial poultry have been cancelled and are being phased out. For the householder, the outcomes of the review will mean that all uses of carbaryl on food-producing plants in the home garden has been deleted from labels; this includes all carbaryl tomato and vegetable dusts and liquid sprays applied to fruit trees and vegetables. A number of concerns were raised about the continuing availability of carbaryl products for the control of black Portuguese millipede, the outcome of the review was that carbaryl products can still continue to be used for control of these millipedes.
Agricultural situations – The use of carbaryl products in most agricultural situations will be retained. For some products there will be restrictions on the way the chemical can be used and supplied. Labels will also contain more detailed instructions relating to the use of the products.

What is happening overseas?

The use of carbaryl in the United States

In October 1996, the United States Environmental Protection Agency (USEPA) imposed exposure mitigation measures on carbaryl based products. Pending the submission of user exposure studies to the agency, approval was suspended for use of dust formulations on trees and ornamental plants where application was intended to be higher than chest height, and some applications to pets. The conditions of use of household liquid and dust products were amended to prohibit use more than once per week, and to mandate that gloves be worn during application.

In June 2003 the USEPA released an Interim Re-registration Eligibility Decision (IRED) for carbaryl. The report stated that ‘although all uses of carbaryl may not meet current safety standards and some uses may pose unreasonable risks to human health and the environment these effects could be mitigated’. The report supported the continued registration of carbaryl products.

The use of carbaryl in the United Kingdom

An initial review conducted in 1996 by the UK identified toxicological concerns about worker exposure to carbaryl. At this time regulatory actions taken included:

revocation of use in poultry houses
prohibition of application via hand-held or similar equipment
revocation of home garden uses of carbaryl
modification to application equipment
strengthening of label protective equipment requirements.

In 1998 the UK commenced a review of anticholinesterase compounds, which included examination of carbaryl. Registrants did not support the continued registration of carbaryl through such a review and therefore all carbaryl products were phased out.

The use of carbaryl in the European Union

The European Union is currently reviewing carbaryl as part of its re-evaluation program under Council Directive (91/414/EEC). Carbaryl is at stage 2 of the process where Data Evaluation Records (DER’s) were completed in 2005 and are currently being reviewed by the member states.

How can the public Comment?

The public comment period has closed ro all reports.

If you require further information email the APVMA Chemical Review Team or phone (02) 6210 4700

A copy of the Preliminary Review Findings report Part 2 can be found on the APVMA web site.

BACKGROUND

What is the Australian Pesticides and Veterinary Medicines Authority (APVMA)?
The APVMA is the Australian Government statutory authority responsible for the regulation of pesticides and veterinary medicines up to the point of retail sale. All pesticides and veterinary medicines must be registered by the APVMA prior to being supplied, sold or used throughout Australia. Pesticides include products that are used around the home garden and those used for commercial or agricultural purposes.

What is product registration?
Registration means that the pesticide or veterinary medicine has been rigorously assessed to ensure that it works, is safe for people, animals and the environment, has been manufactured to appropriate standards and does not pose an unacceptable risk to Australia’s trade with other countries.

All registered products have an approved label that includes instructions for correct use and relevant safety information. Registered products must have a distinguishing number on the label APVMA Approval no. xxxxx/ or NRA Approval No. xxxxx/. This number can be checked for authenticity on the APVMA’s website using the product search facility.

What is a chemical review?
The APVMA has a program for reconsidering (reviewing) the registration of older chemicals that are currently on the market. Reviews are undertaken when there is new information that raises potential concerns about a chemicals ongoing use, suggesting that its registration should be reassessed. This is the process undertaken for products containing carbaryl.

Reviews can be triggered by new research or other evidence that has raised concerns about one or more of the following:

the safety of people using the chemical or the product;
an effect that is harmful to public health;
an unintended effect that is harmful to animals, plants or to the environment;
a prejudice to trade or commerce between Australia and places outside Australia;
whether the product is effective when used as instructed by the label; and
adequacy of label instructions for the safe and effective use of the product.

When the APVMA decides to reconsider the registration of a chemical it will call for any relevant new information from registrants and the public, it may also require registrants to conduct new studies. The APVMA then assesses all of the available information and publishes a review report that details its findings. The assessment also forms the basis for decisions about the future availability of the chemical or how it is used.

There are three possible outcomes from a review:

The APVMA is satisfied that products are safe and effective and the chemical use can continue based on existing instructions;
The APVMA has identified that some aspects of the chemical or its use may not be safe and therefore makes changes to the conditions of registration and/or the label instructions; or
The APVMA is not satisfied that continued use of the chemicals will be safe and effective and suspends or cancels the chemical.

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