FAQ on Notifications of Final Regulatory Action
This is a list of frequently asked questions about how Parties can meet their obligations in the implementation of the Rotterdam Convention
During the processing of an application by industry for the use of a chemical in our country, concerns about its impacts on health (or the environment) were raised and, in the end, industry withdrew its application. Should this be notified?
No! Since this chemical was only being considered for use in the country but was never allowed for use shows that there was no final regulatory action against it. That is, it was neither severely restricted nor banned.
Our country has undertaken a reevaluation of the regulatory status of a chemical and found that there was insufficient data to support its continued use. As a consequence its use has been phased out. Should this be notified to the Secretariat?
No. Data deficiencies in themselves do not constitute an identifiable health or environmental concern. However, if the data deficiencies are such that continued use of the substance was considered to pose unacceptable health or environmental risks, and therefore the substance was then banned or severely restricted, then this will be sufficient basis on which to notify the Secretariat.
Our country had previously notified a ban of a hazardous chemical to the Secretariat. Subsequently, we have discovered that possible alternatives are ineffective and because of needs in our country, we have re-approved the original uses of the chemical until effective alternatives are found. Should we notify this change to the Secretariat?
Yes. This constitutes a change in the final regulatory action and should be communicated to the Secretariat. Please note that any Party has the right to change its previous decisions on the list of Annex III chemicals. Any such changes should be immediately communicated to the Secretariat so that the change will also be reflected in the next PIC Circular. If this change in decision was for a non-Annex III chemical, the secretariat must still be informed so that the chemical is removed as a potential candidate for listing in Annex III of the Convention and the obligations of your country with respect to the provision of export notifications will no longer be valid.
Our country has failed to notify the Secretariat of certain valid final regulatory actions that it has taken. What are the consequences of this?
At this stage, there are no direct penalties in the Convention to be imposed upon countries in this situation. The issue of non-compliance is still being discussed by the Conference of the Parties and a mechanism has not been finalized.. However, the country will have lost an opportunity to alert other countries of concerns regarding a particular chemical.If the failure to notify has meant that the chemical is not included in Annex III when it may otherwise have been listed, then the country will not be able to ensure that the chemical is not exported to it by Parties to the Convention.
There are many types of controls that countries can impose on the possession and use of chemicals. Which of these actually constitutes a ban or a severe restriction?
A ban is where all uses of the chemical have been prohibited. A severe restriction is where virtually all uses of the chemical have been prohibited but there remains a few limited uses. The determination of whether a chemical has been severely restricted in line with the Convention will need to be determined on a case by case basis. For example:
a) The restriction of the use of a pesticide or an industrial chemical to certain qualified users/operators will limit the number of persons who can use the chemical but all of the uses that are approved for the chemical will remain unchanged. Therefore, this is not a severe restriction.
b) Similarly, the imposition of standards such as stringent environmental exposure limits, maximum residue limits (MRLs) or occupational exposure limits such as Threshold Limit Values (TLVs), do not by themselves modify the uses of the chemical and do not constitute severe restrictions.
c) Regulatory controls requiring the use of protective clothing or safety equipment to minimize exposure also do not limit the uses and again would not be considered as severe restrictions.
In our country a chemical was banned (or severely restricted) because its use caused wildlife kills but did not affect human health. Should this be notified to the Secretariat?
Yes. The Convention includes final regulatory actions (bans or severe restrictions) where the action was taken for the purposes of human health OR environmental reasons.
Industry has failed to pay registration (or other) fees and the chemical has therefore been banned. Should this action be notified to the Secretariat?
No. Notifications of bans or severe restrictions must be made where the final regulatory action was taken for health and/or environmental reasons. A regulatory action based upon failure to pay fees does not relate to health or environmental concerns and is therefore not eligible for consideration under the Convention.
The use of a pesticide was banned in our country because it was seen that this might cause problems with our export trade in agricultural commodities due to residues for which our trading partners either had very low or no Maximum Residue Limits (MRLs). Should this ban be notified to the Secretariat?
Yes. However, since actions must be based upon health or environmental concerns, this type of notification would not have enough data to support it being a candidate chemical for inclusion in the PIC list. If there are concerns about the impacts of pesticide residues occurring in commodities in international trade then the country concerned should consider making a proposal for consideration of the relevant MRLs to the Codex Alimentarius Commission through its sub-ordinate committee the Codex Committee on Pesticide Residues (CCPR).
Several minor uses of a chemical have been banned in our country while 2 or 3 major uses remain permitted. Is this a severe restriction that should be notified to the Secretariat?
No. The Convention does not establish parameters for what constitutes major or minor uses, although the overall quantity of product still being used is a helpful indicator. However, if the situation were that all major uses were banned and only 1 or 2 minor uses remain as approved uses then this action could be notified as a severe restriction. The difficulty for some Parties may be the lack of quantitative data on the level of usage of chemicals for them to determine what is a major or minor use.
Because of the high toxicity of a chemical to fish, it is not approved for use within 30 metres of waterways. Is this a severe restriction?
No. This is a precaution and does not limit the use of the chemical.
Recent information on the hazards of a chemical and information on the exposure of workers to the chemical raised concerns for their health. Although several protective measures were proposed and investigated it was decided that the chemical could not be used in a way to guarantee the safety of the workers and consequently under our national legislation the chemical was banned. Should this be notified to the Secretariat?
Yes. This action contains the necessary elements for a valid final regulatory action. In making a notification the DNA should provide all the necessary information collected at the national level that contributed to the making of the decision to ban the chemical.
Concern was raised about possible health (or environmental) impacts regarding a chemical which led to industry reformulating the product and changing the application methodology for the chemical to reduce the risks. The new product replaced the original product and application technique. Should the removal of the original formulation and application technique be notified to the Secretariat as a ban?
No. The chemical marketed in a different product would still be available for all its uses. However, the DNA may wish to advise other governments of these changes through the Secretariat as part of the information exchange provisions of the Convention.
Our country has banned a chemical because of health concerns. Current stocks are being allowed to be used until exhausted. Manufacture of the chemical in our country in recent years was solely for domestic consumption. This manufacture has now ceased and there appears to be no international trade in the Chemical. Should this chemical be notified?
Yes. Once a final regulatory action to ban or severely restrict a chemical has been adopted, the DNA is obliged to notify the Secretariat. The notification should be made as soon as possible and no later than 90 days after the regulatory action has taken effect. The obligation to notify the Secretariat regarding a final regulatory action is independent of whether the chemical is still being traded internationally or not.
If there were a notification from a second PIC region then the Secretariat would gather information including any indication of ongoing international trade in the chemical for consideration by the Chemical Review Committee.
Many of the suicides in our country are the result of people ingesting pesticides and severely hazardous pesticide formulations. Are these pesticides and severely hazardous formulations eligible for notification to the Secretariat?
No. Notification should only be made when the Party has decided on a regulatory final action. As for the listing of chemicals into Annex III, the Convention contains criteria which must be considered in the evaluation process. One of these criteria specifies that intentional misuse is not an adequate basis on which to list a chemical in Annex III. The criteria for listing a chemical in Annex III are contained in Annex II of the Convention.
How do I know if a human (or wildlife) poisoning incident has been caused by a particular hazardous pesticide formulation?
There needs to be specific and characteristic symptoms of poisoning typical for most hazardous pesticide formulations and sufficient clinical evidence to link the chemical to the poisoning. Similar characteristic symptoms may also be used for wildlife.