Chapter 3Performance management report

Strategy 3: Review registered chemicals to ensure they meet contemporary standards

The APVMA’s Chemical Review Program re-examines registered pesticides and veterinary medicines if potential risks to safety and performance have been identified. Review decisions can include:

  • assessing a nomination for review and publishing the nomination
  • deciding to commence a review and publishing the notice for review
  • deciding whether approval or registration should continue, be varied, suspended or cancelled.

The activities underpinning reviews of registered chemicals include making regulatory decisions, informing stakeholders, monitoring for new information, initiating reviews and staff training. The process, scope and reasons for chemical reviews are outlined on the APVMA’s website http://www.apvma.gov.au.

Chemicals under review

At 30 June 2011, the Chemical Review Program had 29 chemicals or chemical groups under review, of which two (azinphos-methyl and molinate) have had interim regulatory actions applied to help deal with the risks originally identified (see Table 12). These reviews cover more than 170 active approvals and 1000 product registrations and associated labels.

Table 12: Chemicals under review

2,4-D (c)

Diuron

Methiocarb (c)

2,4-D (spray drift)

Fenamiphos (c)

Molinate

Azinphos-methyl (spray drift)

Fenitrothion

Neomycin

Carbaryl – Part 2

Fenthion (c)

Omethoate

Carbendazim

Fipronil

Paraquat (c)

Chlorfenvinphos (c)

Macrolide antibiotics

Parathion-methyl (c)

Chlorpyrifos

Maldison (Malathion)

Polihexanide

Diazinon (c)

MCPA (spray drift)

Procymidone

Dimethoate

Methamidophos

Sheep ectoparasiticides

Diquat (c)

Methidathion

(c) covering all aspects of the active constituent, product and labels

The APVMA Operational Plan 2010–2011 specified a target of five review decisions in relation to the targeting selected registered chemicals for review. By 30 June 2011, the following major review decisions were made:

  • publication of the thiophanate-methyl Preliminary Review Findings in August 2010 and the Final Review Report and Regulatory Decision in November 2010; one active constituent approval was affirmed, labels for three product labels were varied, and previous label approvals were cancelled
  • publication of the technical reports and subsequent cancellation of the registration of all products containing endosulfan in October 2010; three active constituent approvals were cancelled, five registered products were cancelled, and use will be phased out over the next two years
  • publication of the dichlorvos Final Review Report and Regulatory Decision in March 2011; four active constituent approvals were affirmed, one product registration was cancelled, nine product labels were varied, and previous label approvals were cancelled
  • publication of the carbendazim Preliminary Review Findings in May 2011; eight active constituent approvals and 17 products were affected
  • publication of the fipronil (human and animal safety) Preliminary Review Findings in June 2011; 13 active constituent approvals and 51 products were affected.

The APVMA also published the following technical assessment reports relating to existing chemicals:

  • the Carcinogeniticy Hazard Assessment Report for polihexanide in June 2011
  • the toxicological component of the human health risk assessment of dimethoate in January 2010
  • the preliminary human health assessment (toxicology) and two Residues Evaluation reports for nicarbazin in December 2010.

Voluntary label amendments and publication of the current Review Findings for azinphos-methyl was completed on 6 July 2011. The reviews for carbaryl, diuron, dimethoate and parathion-methyl are also progressing well, and publication is expected in the first half of the 2011–12 year.

Other review activities included:

  • progressing spray drift reviews for 2,4-D and MCPA under the spray drift review program
  • re-suspending active constituents and products containing quintozene for a further 12 months
  • re-examining the existing chemicals listed in Table 13 because of new information.

Fourteen existing chemical-related regulatory decisions were made during 2010–11.[2]

Table 13: Other chemicals being re-examined in 2010–11 because of new information

Chemical

Risk area assessed

Copper chrome arsenate

Control of use — declaration as restricted chemical product

Molinate

Label instructions — limit use to closed systems

Naphthalene

Packaging and warning statement to protect sensitive people
and children

Nicarbazin

Revised MRL and voluntary label changes

Quintozene

Toxic impurities (dioxins) in active constituents and products

Sodium dichromate

Label instructions — exclude domestic use

Triallate

Residue definition change

Chemical review outcomes and review related activities

Thiophanate-methyl

A Preliminary Review Findings document was published for thiophanate-methyl in August 2010. Following consideration of public responses, the review was finalised and the Review Findings document was published in November 2010. This review affected one active constituent approval and three product registrations.

Endosulfan

The APVMA published the technical reports for endosulfan in September 2010 and subsequently cancelled the registration of endosulfan on 11 October 2010.

The decision to cancel approvals and registrations was based on an assessment of new information by DSEWPaC, which concluded that the prolonged use of endosulfan is likely to lead to adverse environmental effects from spray drift and run-off. These long-term risks could not be mitigated through restrictions on use or variations to label instructions. Some of the new environmental data on which the APVMA’s decision is based emerged following the recent nomination of endosulfan to the Stockholm Convention on Persistent Organic Pollutants. This nomination increased the level of attention on endosulfan and produced a large volume of new information on its environmental fate and effects.

The three current approvals for endosulfan have been cancelled and five products have been cancelled and will be phased out over the next two years.

Risks to human health were not a factor in the APVMA decision. While recent and emerging toxicological data were assessed by the OCSEH, it determined that the current regulatory regime has been effective in managing these risks.

Dichlorvos

The Final Review Report and Regulatory Decision for dichlorvos was published in March 2011. The outcomes of the review include the cancellation of the registration of one home garden product, deletion of some specific uses and the revision of product labels to include new safety instructions.

The proposed cancellation of use as a grain fumigant was based on the review finding that there is a likelihood of toxicologically unacceptable levels of operator exposure with respect to use patterns involving application to grain. Registrants of dichlorvos products for grain fumigation are on notice to submit to the APVMA interim risk reduction measures to allow use while data are generated to support continued use or to show why use as a grain fumigant should not be discontinued.

Four active constituent approvals and nine products are affected by the review of dichlorvos.

Carbendazim

The Preliminary Review Findings for the review of carbendazim were published in May 2011. Eight active constituent approvals and fifteen products are affected by the carbendazim review.

Fipronil

The APVMA initiated the review of fipronil due to concerns over toxicity. The main concerns were related to skin irritation and induction of skin sensitisation, but there were also some concerns about the adequacy of label instructions and the potential of fipronil to form toxic photodegradation products, leading to occupational health and safety issues and animal safety. The Preliminary Review Findings report for fipronil was published on 21 June 2011.

The APVMA has recommended that there should be no change to the approval status of fipronil or to the ongoing registration of existing fipronil products in Australia.  However, some amendments are recommended to the first aid instructions and safety directions for most agricultural and veterinary chemical products.  New or revised re-entry intervals are also recommended for many agricultural uses, and a rehandling statement is recommended for veterinary spray products. Additional warnings are recommended when fipronil products are used on dogs and cats.  This includes warnings about the possibility of skin reactions in dogs and cats treated with the spot-on formulations, avoiding applying fipronil products to ‘non-healthy’ skin, and for the spray, treating animals in open areas, and ensuring they are not placed in confined spaces until the spray has dried. Fipronil is not recommended for use on non-target animals, especially rabbits.  Additional label warnings concerning off-label use on rabbits are recommended due to the severity of reactions (including death) in this species.

The APVMA will consider finalising the review of fipronil following consideration of public comments. Thirteen active constituent approvals and 51 products are affected by the fipronil review.

Polihexanide

Polihexanide is under review because of human health concerns, primarily concerns about potential carcinogenicity. The APVMA published the Carcinogeniticy Hazard Assessment Report for polihexanide in June 2011. The report identified polihexanide as a potential carcinogen in rodents but only at high exposure levels which are unlikely to be encountered in occupation or public settings. A number of other toxicological and occupational exposure matters remain to be addressed for polihexanide. Nine products are affected by the polihexanide review.

Dimethoate

Dimethoate is under review due to human health and trade concerns. The APVMA published the toxicological component of the human health risk assessment in January 2011 and the residue assessments are expected to be completed early in 2011–12. One active constituent approval and 24 products are affected by the review of dimethoate.

Nicarbazin

Nicarbazin is a coccidiostat used in poultry. Nicarbazin is being re-examined due to concerns over the residue definition and the dietary risk for humans who eat treated chickens. As an outcome of the human health assessment, the acceptable daily intake was amended to a five-fold lower value and the APVMA re-assessed the resulting dietary risk to humans. The residue definition was amended, new MRLs set, and some associated withholding periods were amended. The APVMA published its findings in December 2010. All registrants updated their labels with the new withholding periods and safety directions and voluntarily cancelled previously approved labels. Therefore, the APVMA has also removed nicarbazin from the review nomination list. This work has affected one active constituent approval and ten products.

2,4-dichlorophenoxyacetic acid (2,4-D), ethyl, butyl and isobutyl esters

The APVMA is continuing the suspension until 31 January 2012 of 2,4-D ethyl, butyl and isobutyl esters due to concerns that the volatile components of these high volatile esters may cause harm to non-target vegetation. The registrants and active approval holders of these 2,4-D esters are required to generate data relating to environmental effects. The data requirements of the 2,4-D esters review have been applied to all registered products that contain 2,4-D high volatile esters, affecting the registrants of 24 products.

A permit was issued to allow the use of 2,4-D high volatile exters in Western Australia during the 2010–11 summer and autumn seasons.

Quintozene

Quintozene was re-suspended for a further period of 12 months in April 2011 to allow affected active constituent approval holders and product registrants additional time to address the identified concerns. This suspension affects two active constituent approvals and ten product registrations.

Copper chrome arsenate

The review of copper chrome arsenate was completed in 2006. The APVMA has been working with DAFF and the states and territories to complete the task of declaring products containing copper chrome arsenate as Restricted Chemical Products. This declaration is anticipated to occur in early 2012. Five products would be affected by the declaration.

Molinate

Molinate, a thiocarbamate herbicide used exclusively in rice growing is under review due to toxicological, occupational health and safety and environmental concerns. The APVMA has been working collaboratively with the registrants of products containing molinate to reduce identified worker exposure risks associated with some methods of application. Registrants voluntarily amended product labels in June 2011 to ensure molinate is used in closed delivery and supply systems only. Three active constituent approvals and two products are affected by the review of molinate.

Naphthalene

The APVMA took action in June 2011 to stop supply of naphthalene loose flake products in retail outlets. This action followed advice from the Department of Health and Ageing that the packaging and warning statements on naphthalene loose flake products may not be adequate to protect sensitive people and children from inhalation and ingestion risks if they are exposed to treated fabrics. Four registered products have been required to stop supply.

Sodium dichromate

Products containing sodium dichromate, a timber preservative, are not suitable for domestic use: the chemical is corrosive and has the potential to cause severe skin, eye and lung irritation. Two products containing sodium dichromate were previously approved with label instructions that could imply suitability for use by householders. Registrants voluntary cancelled the two products affected by this situation in March 2011 after they were contacted by the APVMA.

Triallate

A change in residue definition was considered for triallate, resulting in necessary changes to label withholding period statements. The APVMA wrote to registrants in February 2011, and work is underway to ensure labels are amended accordingly.

Other review activities

The following activities align with the operational plan objectives of informing stakeholders of regulatory activities, monitoring the regulatory science environment for emerging issues and improving the understanding of staff of primary production industries.

Endocrine disrupting chemicals

A member of the review team attended a two-day symposium on ‘What’s in Our Water’, the 3rd Australian Symposium on Ecological Risk Assessment of Endocrine Disrupting Chemicals (EDCs) and Pharmaceuticals and Personal Care Products (PPCPs) in the Australasian environment in November 2010, followed by a meeting of relevant regulatory agencies.

Stakeholder communication

The APVMA’s review section provided comprehensive written information on existing chemicals related to the APVMA’s website Chemical review page, as ‘Regulatory news’, ‘Our view’, media releases or responses to ‘Community questions’.

Education and training

Review staff took part in external meetings on a number of issues, including spray drift and the possible withdrawal of approvals for dimethoate and fenthion as post-harvest dips. Review staff participated in a field trip in May 2011, visiting a range of agricultural primary production enterprises and a second field trip in June 2011, visiting veterinary manufacturing sites.

Prioritisation of chemicals on APVMA’s ‘Priority Candidate Review List’ and on the ‘Priority List for Spray Drift Label Reviews’

Agricultural and veterinary medicines nominated for review are given a priority according to the level of concern that led to the chemical being nominated. Prioritisation is based on advice received from the APVMA’s residue chemists and from the APVMA’s external advisory agencies, the OCSEH and DSEWPaC.

The Priority Candidate Review List is located at http://www.apvma.gov.au/products/review/a_z_reviews.php.

A priority list of chemicals to be reviewed for spray drift risk is at http://www.apvma.gov.au/use_safely/spray_drift/priority_list.php. The APVMA has invited people to nominate agricultural pesticides for spray drift review.

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