Carbaryl review history and regulatory outcomes

Nomination for review

In 1995 the APVMA (formerly the NRA) began a review of carbaryl because of concerns that residues in treated cereals may exceed the Maximum Residue Limits (MRLs) and concern over the lack of MRLs for animals fed on treated cereal products.

In 1999 the scope of the review was extended to assess whether the use of products containing carbaryl in the home garden or as home veterinary applications would be harmful to people. This action was based on advice from the Office of Chemical Safety (OCS) following studies which identified a potential health risk to people from the use of carbaryl in the home garden.

In June 2003 the scope of the review was extended a second time following the establishment of a new acute reference dose (ARfD) for carbaryl. This action was based on concerns over the possible dietary intake risks from residues of carbaryl in food.

The review of carbaryl was split into two parts:

• Part 1 looked at products that are used in home garden, home veterinary, poultry and domestic situations
• Part 2 looked at the products used in agriculture.

Currently only Part 1 of the review has been finalised. A Preliminary Review Findings (PRF) report for Part 2 of the carbaryl review has been released and a final review report will be published after the assessment is completed.

Draft Review Report (PRF)

In June 2004 the APVMA released the Carbaryl Draft Review Report (PRF) (Part 1). The APVMA found that possible domestic and home garden uses of carbaryl posed a potential risk to human health from exposure during use and from residues in produce.

The APVMA proposed that many of the uses of carbaryl on fruit and vegetables be cancelled. The use of the chemical in its dust form including products for animals was also proposed for cancellation. However, it was recommended that uses of carbaryl products on pastures, cropping and grain storage, in commercial or industrial areas as well as in domestic animal shampoos and ear drops continue.

Registrants of pet shampoos, 1% ready-to-use liquid sprays and home veterinary ear drop products containing carbaryl elected to voluntarily cancel their products before the completion of the review; therefore these products were not considered as part of the review.

Part 1—uses of carbaryl in home garden, home veterinary, poultry and domestic situations

Final Review Report and outcomes

In January 2007 the APVMA released the Carbaryl Final Review Report and Regulatory Decision (Part 1). Part 1 of the review considers the active constituent carbaryl and products containing carbaryl that are used in home garden, home veterinary, poultry and domestic situations.

The APVMA’s key findings for Part 1 of the review were:

• there were insufficient data to assess the potential risk to users from household (dusting treatments) and home garden (fruit and vegetables) uses of products containing carbaryl
• the use of carbaryl home veterinary dust preparations and the use of carbaryl products on fruit and vegetable crops may pose a potential risk to the safety of people
• domestic/home garden products with a maximum carbaryl concentration of greater than 160 g/kg (or g/L) may pose a risk to the safety of people.

As an outcome of Part 1 of the review, the APVMA:

• cancelled home veterinary (companion animal dusting treatments) and home garden uses of carbaryl on fruit and vegetables
• cancelled product registrations and label approvals for:
  - carbaryl based home veterinary dusts registered for the treatment of animals and birds
  - a carbaryl based treatment for poultry
  - carbaryl dusts for treatment of carpets, rugs and animal bedding
  - products containing 800 g/kg wettable powder and liquids containing 400 and 500 g/L carbaryl for use in domestic/home garden situations
  - the use of carbaryl (all forms) for indoor use on domestic premises.
• restricted the concentration of domestic/home garden products to a maximum carbaryl concentration of 160 g/kg (or g/L).
• amended product labels to:
  - delete uses for home garden food crops (fruit and vegetables) and home veterinary dusting preparations, where unacceptable risks were identified
  - update warning statements and safety directions
  - add new stronger label statements to home garden products.

Part 2—uses of carbaryl in agricultural situations

Preliminary Review Findings Report (Part 2)

In July 2006 the APVMA release the Carbaryl Preliminary Review Findings (PRF) Report (Part 2). Part 2 of the review considers products containing carbaryl that are used in agriculture.

The APVMA’s key findings for Part 2 were:

• some methods of application (wettable powder, hand-held spray equipment for pest control, orchard airblast) posed a potential risk to the safety of people
• the risk associated with the application of carbaryl by orchard airblast can be reduced if operators are protected by appropriate engineering controls
• the mixing and loading of carbaryl 800 g/kg wettable powder poses an unacceptable risk to the safety of people. However, if carbaryl as an 800 g/kg wettable powder formulation can be provided in water soluble packaging it would not pose an unacceptable risk to the safety of people
• the mixing and loading of carbaryl suspension concentrate (SC) products for aerial, boomspray and orchard airblast application poses an unacceptable risk to people. However, mixing and loading of SC products via an enclosed transfer/mixing system would reduce the risk to people
• the use of carbaryl on 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 on cucurbits), may pose potential risk to people from consumption of carbaryl residues
• restricting the use of carbaryl to non-flowering/non-fruiting trees/plants due to insufficient residues data.

In the preliminary report for Part 2 the APVMA proposed:

• amending product labels to:
  - delete the handheld spray application of wettable powder formulations to garden beds, compost heaps and treatment around buildings
  - delete the handheld spray application method for pest control activities in domestic, commercial and industrial settings, except for the eradication of insect nests
  - include a requirement for workers applying carbaryl by orchard airblast to be protected by appropriate engineering controls, such as closed cab tractors
  - include a requirement for carbaryl SC products to be handled using enclosed transfer/mixing systems to reduce the exposure of operators
  - delete instructions for use on 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 on avocados, cucurbits, feijoa, guavas, grapes, jaboticaba, jackfruit, loquats, lychees, mangoes and rambutans to non-flowering/non-fruiting trees/plants.
  - amend withholding periods and re-entry periods
  - include stronger and updated warning statements and safety directions.
• modifying the product delivery method for 800 g/kg wettable powder formulations by providing the product in water soluble packaging.

The APVMA will issue a final report once the assessment of all available data is completed.

For more information please contact the Chemical Review Program on (02) 6210 4749 or by email to chemrev@apvma.gov.au