Fenthion Chemical Review

The active constituent fenthion, all products containing fenthion and their associated labels were placed under review as part of the third cycle of the Existing Chemicals Review Program (now the Chemical Review Program) because of concerns over toxicological, occupational health and safety, environmental and residue issues.

Fenthion was nominated for review in 1994 because of concerns about public health, occupational health and safety, the environment and food residues.

Part 1 of the review considered the non-food producing uses of fenthion. In December 2005 the APVMA published the toxicology, occupational health and safety and the environmental risk assessment for Non-food uses assessments as Volume 2 of the Preliminary Review Findings. The APVMA has since received new dermal absorption data indicating that fenthion is more readily absorbed than previously understood. This data may lead to further regulatory action for Part 1 of the review.

Part 2 of the review considered food-producing uses of fenthion. All the technical assessments for the review have been completed (see table below).

In September 2012, the APVMA published the revised toxicology assessment for fenthion.

In September 2012, the APVMA also published the Fenthion residues and dietary risk assessment report (which assessed all residues data provided by the registrant and by industry groups). Our assessment found that use of fenthion on certain crops could lead to consumers being exposed to levels of fenthion above the public health standard (the acute reference dose). Therefore we proposed that the use instructions for two fenthion products be modified to reduce dietary exposure risks. In October 2012 the APVMA suspended two horticultural products and imposed modified instructions for use during the suspension that restricted the use of fenthion on certain crops and mitigated the acute dietary exposure risks identified in the residues and dietary exposure assessment of September 2012.

In October 2013, the APVMA published a supplementary dietary risk assessment, including residues data submitted since October 2012. Due to the findings of this report, we continued the suspension of fenthion to 30 October 2014, with further changes to its use to remove uses of fenthion on peaches and apricots. The withholding period for use on nectarines and plums was changed to 14 days.

These changes to the approved uses of fenthion may have significantly affected previously used fruit-fly control methods and interstate trade arrangements for produce that may be a fruit-fly host. The Subcommittee on Domestic Quarantine and Market Access (a state and federal government committee) has developed a national response plan to deal with the outcomes of both the fenthion and the dimethoate reviews (dimethoate is also used for fruit fly control).

In May 2014, the APVMA published the occupational health and safety (all fenthion products), veterinary residues and dietary exposure and environmental assessments for fenthion. These reports are available as links below.

In December 2005, the APVMA released the Fenthion preliminary review findings report: Part 1. This report dealt with products used in non-food producing situations. Since this report was published one (more concentrated) home garden product has been discontinued, labels have been voluntarily amended and the pest bird control products have been declared to be restricted chemicals (restricted to use by authorised and trained personnel only).

The APVMA had since received new dermal absorption data indicating that fenthion is more readily absorbed than previously understood. This data led to revised OHS findings for products included in Part 1 of the review that also recommended that the bird control products be cancelled. These revised findings were included in the Preliminary Review Findings (PRF), published 22 May 2014.

The preliminary review findings for food production uses of fenthion were released 22 May 2014, for a period of public comment. Submissions closed 22 August 2014.

The key findings of the PRF were that use of products containing fenthion may, in a number of situations, pose undue risks to the environment and to human health (via dietary and occupational exposure). The APVMA proposed the following regulatory actions to manage these risks:

• cancellation of the cattle lice control product
• cancellation of all pest control and home garden products except fenthion 1% dust
• variation of the label of the fenthion 1% dust product to delete use in ceilings, wall spaces and crawl spaces and to update the safety directions
• variation of the label of the horticultural product to delete all horticultural uses except post-harvest dipping of tropical and subtropical inedible peel fruits and to update the safety directions and warnings.

Submissions received during the three-month public comment period (ending 22 August 2014) were considered by the APVMA prior to finalising the review.

Responses to the preliminary review findings on the reconsideration of fenthion

The APVMA invited comment on the fenthion Preliminary Review Findings Report from 22 May 2014 to 22 August 2014.

Assessment of available data concluded that the use of products containing fenthion could have, in most situations, posed undue risks to human health (via dietary and occupational exposure) and the environment. The APVMA proposed the following regulatory actions to manage these risks:

• cancellation of the cattle lice control product
• cancellation of all pest control and home garden products except fenthion 1% dust
• variation of the label of the fenthion 1% dust product to update the safety directions and to delete use in ceilings, wall spaces and crawl spaces
• variation of the label of the horticultural product to update the safety directions and warnings and to delete all horticultural uses except post-harvest dipping of tropical and subtropical inedible peel fruits.

Comments on this report were assessed by the APVMA (and partner agencies where required) prior to finalisation of the review.

The fenthion Preliminary Review Findings Report summarised the findings of the technical assessments of the toxicology, occupational health and safety, residues and dietary (both horticultural uses and veterinary uses) and environmental risks arising from the use of fenthion. These technical assessments are available in full from resources section of the assessments tab.

Submissions

The APVMA invited written submissions on the preliminary review findings from industry and other interested parties with a closing date of 22 August 2014.

Fifteen submissions were received in response to the preliminary review findings. These are available from the consultation page.

Final review findings and regulatory decision for the reconsideration of fenthion

The APVMA has reconsidered the approvals, registrations and product labels associated with the insecticide fenthion. The scope of this review was to assess the toxicological, occupational health and safety, residues and dietary exposure and environmental risks associated with the approvals and registrations for fenthion.

Assessment of available data concluded that the use of products containing fenthion may, in most situations, pose undue risks to human health (via dietary and occupational exposure) and the environment. In October 2014 the APVMA took the following regulatory actions to manage these risks:

• cancellation of the cattle lice control product
• cancellation of all pest control and home garden products except fenthion 1% dust
• variation of the label of the fenthion 1% dust product to update the safety directions and to delete use in ceilings, wall spaces and crawl spaces
• variation of the label of the horticultural product to update the safety directions and warnings and to delete all horticultural uses except post-harvest dipping of tropical and subtropical inedible peel fruits.

These decisions took into consideration:

• the technical assessments of the toxicology, occupational health and safety, residues and dietary (both horticultural uses and veterinary uses) and environmental risks arising from the use of fenthion are available from the publications archive.
• the fifteen submissions to the APVMA received in response to the Preliminary Review Findings of 22 May 2014. Available from the consultation page
• the final report of the Federal Government Senate Standing Committees on Rural and Regional Affairs and Transport conducted an inquiry into the implications of the restriction on the use of Fenthion on Australia’s horticultural industry (the Senate Inquiry).The final report and all associated documents, submissions and transcripts of hearings are available from the Inquiry webpage.

Cancellation of the active constituent fenthion

Following the finalisation of the fenthion review, the active constituent 44383–fenthion was cancelled at the request of the holder on 3 November 2014. Consequently, the registrations of the products 32996; Lebaycid Insecticide Spray and 41138; Amalgamated Pest Control 1% Fenthion Dust were also cancelled.

Phase out period has ended: cancelled products must not be supplied or used

The following products have been cancelled and may not be used or supplied after the below cease use and supply dates:

Cease use poster

Download the cease use poster (PDF, 108kb).