Evaluation of Pesticide Incident Report 2011-5299

Background

Pest control products are only registered by Health Canada's Pest Management Regulatory Agency (PMRA) for use if there is reasonable certainty that no harm to human health or the environment will result from exposure to, or use of the product as directed on the label. Health Canada collects incident reporting data under the authority of the Pest Control Products Act. If a pesticide manufacturer receives information about an incident involving one of their products, they are required by law to submit that information to Health Canada. Members of the public may also submit information about an incident directly to Health Canada. It is important to note that the information presented in incident reports reflects the observations and opinion of the person reporting it, and does not include any assessment by Health Canada, nor does it confirm an association between the pesticide and the effects reported.

Health Canada considers the reported information to determine if there are potential health or environmental risks associated with a pesticide and, if necessary, takes corrective action. Such action could range from minor label changes to discontinuation of the product.

Incident Report 2011-5299

An incident report containing a scientific study was received by the PMRA from S.C. Johnson and Son Ltd. in November, 2011. The incident report described an issue that was noted during a quality assurance audit of products stored in warehouses. The potential for some containers of insect repellent to a have higher concentration of active ingredient than what was registered was identified due to a packaging issue.

Samples of the product (as well as a second product that was packaged in a similar container) were collected and analyzed to determine the concentration of DEET.

In addition to the investigation, the registrant immediately implemented several measures to prevent these products from reaching consumers. This included a quarantine of the affected products remaining in their warehouses (which represented approximately 75% of all product stock), a request that any stock remaining with distributors and retailers be returned, and a halt to manufacturing of these products until the problem has been identified and corrected.

This incident report is available through the PMRA electronic Public Registry on the Health Canada Web site.

Health Canada Evaluation

The two products identified in this investigation were OFF! FAMILY CARE SPRAY INSECT REPELLENT FAMILY UNSCENTED (PCP Reg. No. 29934) containing DEET at 7%, and OFF! DEEP WOODS SPRAY INSECT REPELLENT 5 (PCP Reg. No. 29931) containing DEET at 25%.

As a result of the 2002 re-evaluation of personal insect repellents containing DEET conducted by Health Canada, insect repellents applied to children younger than 12 years of age cannot contain more than 10% DEET, and products containing DEET at concentrations above 30% are not be permitted in Canada. The label for OFF! FAMILY CARE SPRAY INSECT REPELLENT FAMILY UNSCENTED allows for application to children younger than 12 years of age; as such, the level of DEET in that product must not exceed 10%. Furthermore, the level of DEET in OFF! DEEP WOODS SPRAY INSECT REPELLENT 5 must not exceed 30%.

The concentration of DEET in the samples of product collected, which had been stored in the warehouse up to 9 months, did not exceed these cut-off values. It was estimated that concentrations of DEET would not increase significantly with longer storage times.

Health Canada Conclusion

The two products affected by this issue are sold in small, personal size (15 mL) applicators; as such, it is assumed that each container of product will be used up within one season. It is therefore unlikely that any significant amount of product will remain in the possession of consumers long enough for the concentration of DEET to reach levels of concern.

Therefore, in light of the small volume of these products and the measures that the registrant has taken to collect unsold product, the packaging issue with the containers of these two insect repellents does not pose a significant health risk to consumers.

More information about the Pesticide Incident Reporting Program is available on the Health Canada Web site. Should you require further information please contact the Pesticide Incident Reporting Program.