Chemical name: Oxirane

Final regulatory action has been taken for the category: Pesticide

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

All formulations for agricultural use, except those for sterilization uses considered appropriated by the General Direction of Public Health.

Pesticide use or uses that remain allowed:

None.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

Agricultural Development Ministry Decree no. 074 of 18 September 1997 establishing prohibited pesticides and listing prohibited pesticides in agriculture. Ethylene oxide is also included in this list.

Law no. 12 of 14 June 2000 approved the Rotterdam Convention for the application of the Prior Informed Consent Procedure for certain hazardous pesticides and chemicals in the international trade, signed in Rotterdam on 10 September 1998.

Law no.1 of 10 January 2001 on medicines and other hazardous products for human health.

Technical Regulatory DGNTI-COPANIP 43-2001 refers to Industrial Safety and Public Health for atmospheric pollution control on working areas produced by chemical substances, regulated by

Resolution no. 124 of 20 March 2001 based on Law no. 23 of 15 July 1997.

Resolution no. 195, of 4 October 2001 giving dispositions for the use of Ethylene oxide and revokes:

Resolution no. 165, of 25 July 2001.

Executive Decree no. 305 of 9 September 2002 establishing the automatic cancellation in order to regulate the import of certain potentially hazardous chemical substances (such as substances or controlled hazardous materials), and determining other provisions.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

The inherent risks to human health and environment are higher than the benefits obtained with the use, there are no measures to reduce risks to acceptable level, and better alternatives can be found.

Reducing exposure to risk factor will reduce the effects on the population directly exposed (occupational) and on the population indirectly exposed (accidental, environmental or acquired) to this product.

Expected effect of the final regulatory action in relation to human health:

The product is subject to the Prior Informed Consent (PIC) procedure that requires that hazardous substances and pesticides that are banned or severely restricted must not be exported, unless the importing country provide explicit consent. Those countries that do not consent such substances are obliged to prohibit national production of the substance for domestic uses. It is declared restricted by the Government of Panama until June 2002.

Summary of known hazards and risks to the environment:

Fish is the more susceptible aquatic organism. The reported 24-hour LC50 value is 90mg/l (Bridie et al., 1979) in gold fish; the reported 48-hour LC50 is 212 mg/l in Daphnia magna (Conway et al., 1983).

Expected effect of the final regulatory action in relation to the environment:

Formulations of Ethylene oxide for agricultural use are not registered in Panama. It is considered dangerous waste subject to control and specialized treatment after the due date. There are still around 1000 obsolete ampoules under the Basel Convention.

Date of entry into force of the final regulatory action: 05/10/2001

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