To provide specific and practical advice to Designated National Authorities (DNAs), based on questions that have been raised in the course of implementation of the Rotterdam Convention.
Q1. The Convention requires that governments provide Designated National Authorities (DNAs) with sufficient resources to perform their tasks effectively. What does this mean?
A. In order to ensure the implementation of the Convention, DNAs need to have powers to undertake or to have access to those areas of government responsible for the following:
- regulatory decisions for the use of pesticides and industry chemicals and to notify the Secretariat of these decisions;
- controls on the import and export of chemicals;
- a mechanism to communicate the import responses contained in the PIC Circular to potential exporters;
- access to information on human and environmental poisoning incidents involving pesticides;
- making decisions on the future import of chemicals listed in Annex III of the Convention and to report these decisions to the Secretariat on behalf of the government;
- to have serve as contact point for matters related to the Rotterdam Convention with the Secretariat, other DNAs and national stakeholders.
Q2. During the processing of an application by industry for the use of a chemical in our country, concerns about impacts on health (or the environment) were raised. Industry withdrew its application before this matter could be resolved. Should this be notified?
A. Possibly, yes. The Convention defines a ban or a severe restriction to include the situation where industry withdraws its application (or part of its application) because of health or environmental reasons. However, there is likely to be additional information required and a level of judgement made before a decision could be made to submit a notification to the Secretariat.
The DNA should be certain that the action taken by industry was because of health and/or environmental concerns and not for commercial reasons.
It should also be recognized that in many countries there is a level of negotiation between industry in applying for certain uses and the regulatory agency in setting an approved use that does not pose unacceptable risks. As a result of this negotiation the number of uses approved may be fewer than those originally requested or the way in which the pesticide is to be applied or the formulation type are changed. Where a large number of the uses originally sought are either withdrawn (or not approved) for health or environmental reasons then this might qualify as a severe restriction.
Q3. 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?
A. 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 banned or severely restricted, then this may be a sufficient basis on which to notify the Secretariat.
Q4. 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 reapproved the original uses of the chemical until effective alternatives are found. Should we notify this change to the Secretariat?
A. Yes. This constitutes a change in the final regulatory action and should be conveyed to the Secretariat. Such a change could impact on the listing or possible listing of the chemical in Annex III of the Convention. If the chemical has not yet been included in Annex III then it would affect the obligations of your country with respect to the provision of export notifications.
Q5. Our country has failed to notify the Secretariat of certain valid final regulatory actions that it has taken. What are the consequences of this?
A. 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 to be discussed at the first meeting of the Conference of the Parties. 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.
Q6. 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 severe restriction?
A. A ban is where all uses of the chemical have been prohibited. A severe restriction is where virtually all use of the chemical has been prohibited.
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:
- There may be final regulatory actions that impact on the use of the chemical but which do not significantly change its use. For instance, the restriction of the use of a pesticide or an industrial chemical to certain qualified 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.
- 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 a severe restriction.
- 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 a severe restriction.
Q7. 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?
A. Yes. The Convention includes final regulatory actions (bans or severe restrictions) where the action was taken for human health OR environmental reasons.
Q8. Industry has failed to pay registration (or other) fees and the chemical has therefore been banned. Should this action be notified to the Secretariat?
A. 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.
Q9. 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 no Maximum Residue Limits (MRLs) or MRLs that were much lower than our national MRLs. Should this ban be notified to the Secretariat?
A. No. Actions must be based upon health or environmental concerns. Concerns about impacts on trade are not a basis for notification of a final regulatory action. 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).
Q10. 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?
A. No. The treaty did not establish parameters for what constitutes major or minor uses, although the overall quantity of product still being used is a helpful indicator. In this case, even if the remaining uses are small in number they also constitute a major proportion of the amount of chemical used.
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 governments may be that they do not have quantitative information on the level of chemical used in each use and cannot therefore easily identify what is a major use or a minor use. In such situations governments may need to rely on qualitative opinion from experts in the various fields of use.
Q11. 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?
A. No. Such a restriction does not limit the uses of the chemical.
Q12. 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?
A. 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 in Annex I of the Convention in relation to the hazards and risks from the use of the chemical, the outcome of their national evaluation and their regulatory action.
Q13. 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?
A. 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.
Q14. 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?
A. Yes. Once a final regulatory action to ban or severely restrict a chemical has been adopted, the DNA is 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 in ongoing international trade.
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.
This information would be considered by the Chemical Review Committee in evaluating the chemical.
Q15. The Secretariat has notified that a chemical has been included in Annex III of the Convention. Are we required to ban all uses of this chemical in our country?
A. No. The inclusion of chemicals in Annex III is not an invitation for countries to ban their use. The purpose of the prior informed consent procedures is to allow countries to make their own informed decisions on future imports of the chemical. They should do this in the context of their own needs, circumstances and uses of the chemical.
If a country, however, decides to not allow any future import of the chemical under the Convention then they must also ensure that there is no domestic manufacture of the chemical for domestic use and that no imports of the chemical are accepted from any country including those that are not Parties to the Convention.
Q16. Many of the suicides in our country are the result of people ingesting pesticides. Based on such incidents, are such severely hazardous pesticides eligible for inclusion in Annex III of the Convention?
A. No. The Convention contains criteria which must be considered in evaluating the merits of listing a chemical in Annex III. One of these criteria specifies that intentional misuse is not an adequate basis on which to list a chemical in Annex III.
Q17 How do I know if a poisoning (or wildlife) incident has been caused by a particular hazardous pesticide formulation?
A. There needs to be sufficient evidence to demonstrate that the human health or environmental damage can be linked to the use of the chemical.
Systems need to be in place so that any incidents of human poisonings or damage to the environment are reliably recorded together with information that may establish whether there is a link or not to chemical exposure.
Poison Control Centres and environmental monitoring networks enable countries to identify candidate chemicals for proposal as severely hazardous pesticide formulations.
There are often difficulties encountered in such incidents. These include that:
- the labelling of the containers does not identify what was the active ingredient or the formulation;
- farmers often mix two or more chemicals together in the one application making it difficult to identify which chemical is causing the problem;
- it is difficult to establish exactly what was the use pattern for the chemical;
- lines of reporting are not well known so that it is unknown as to where the information on the incidents should be sent; and
- there is a lack of technical expertise and other resources to enable a proper investigation to be carried out.
Countries should endeavour to establish systems and obtain information to overcome these difficulties.
Q18. A chemical included in Annex III of the Convention has never been used in our country and so has never been banned in our country. Is there any need to do anything in this case?
A. Yes. The fact that there has never been any registration or final regulatory action taken against a chemical in a particular country does not mean that an Importing Country Response does not have to be completed for that chemical.
In many countries there are general provisions that do not allow the use or importation of any chemical that is not registered or approved for that use. This could be the basis for an import response for all unregistered/approved chemicals in Annex III along the lines of no consent to import.
Q19. When our country becomes a Party to the Convention can we be assured that no chemicals listed in Annex III of the Convention will ever be exported to our country?
A. No. The act of becoming a Party to the Convention does not in itself obligate other Parties to ensure that there are no exports of the chemicals listed in Annex III to your country. It is necessary for you to provide an Importing Country Response for each of the chemicals listed.
Q20. If our country indicates “no consent” in its importing country response regarding a chemical listed in Annex III of the Convention, can we expect that there will be no imports of this chemical into our country.
A. No. The obligations of the Convention only fall on those exporting countries that are Parties to the Convention. Although Parties to the Convention should not be exporting the chemical to your country, other non-Parties may continue to export the chemical to your country.
The Convention does require countries to strengthen their own chemicals management infrastructure and countries should therefore put in place mechanisms to ensure that there are no imports from countries that are not Parties to the Convention.
Q21. Our country does not manufacture any chemicals. Do we need to do anything more than provide importing country responses.
A. The obligations of the Convention fall on all Parties irrespective of the nature of their industries and trade in chemicals. This includes the requirement to nominate a designated national authority, notify final regulatory actions and ensure any exports from your country comply with the requirements offset out in the Convention.
Q22. What is the maximum quantity of a chemical listed in Annex III that can be imported for research purposes, under the Convention?
A. There is no amount specified in the Convention. Some countries in implementing the Convention have set a level of 10 kilograms whereas others have set lower amounts than this. What ever amount countries elect to apply, it is important to recognize that these should be small amounts compared to commercially traded quantities.
Q23. Our country does not allow the use of any chemicals included in Annex III of the Convention, therefore do we need to put in place an export notification scheme.
A. Export notifications apply to chemicals that have been banned or severely restricted in the exporting country. The obligation for export notification ceases when the chemical is included in Annex III, the importing party has provided an import response on this chemical to the Secretariat and the response has been published in the PIC Circular. If there are no exports from the country, the export notification scheme may be very simple.
Q24. Our national chemicals management legislation has provisions to ban or severely restrict a chemical but it has no provisions related to the export of a chemical. How do we control exports of chemical?
A. Different governments may elect to control the export of chemicals in different ways. Some may amend their existing legislative mechanisms for customs control, or chemicals registration legislation. Others may chose to develop separate legislation that will cover all of the obligations of the Convention.
A government will also need to make industry aware of the need to comply with importing country responses regarding exports of chemicals and encourage them to comply. In such a circumstance, a government would need to undertake efforts to monitor the situation and to have a mechanism to bring industry into line if exports were occurring contrary to the wishes of importing countries.
If the decision is that different provisions such as export controls relevant to the implementation of the Convention are placed in a different department, agency or office of the government to that of the DNA, then there will need to be liaison between these departments, agencies or offices. It may be appropriate that this be done through an inter-departmental committee.
Q25. An export of a chemical that is included in Annex III of the Convention as a pesticide is about to occur but the chemical also has a dual use as an industrial chemical. How do I know that it is being exported for use as a pesticide or an industrial chemical in the importing country?
A. This will usually require information from the importing country. This might be in the form of a declaration from the importing agent or the DNA of the importing country as to the intended use.
In the absence of the above declaration, information on whether the chemical is already formulated and labeled for pesticide use or for a specific industrial use may be available. At times the name and nature of business of the importer may also be helpful. If the importer is an agricultural supply company or a cooperative farming group then it is likely that it is to be imported as a pesticide.
If the importer is a general trader and the chemical is being shipped as a non-formulated concentrate then it may not be possible to determine the likely use category. In such circumstances the DNA should require confirmation of the intended use from the importing country.
Q26. Our country has just received an export notification for a chemical. What am I to do now?
A. You are required to acknowledge receipt of the export notification by sending a return message to that effect to the DNA of the exporting country.
The export notification advises that an export is about to occur of a chemical that has been banned or severely restricted in the country of export. Dependent upon the circumstances regarding the use of this chemical in your territory and the reasons for the regulatory action taken in the exporting country, there may be sufficient concern for your country to consider reviewing the regulatory status of this chemical.
Q27. I have been notified that an export of a chemical included in Annex III is about to occur from our territory to a country that has not yet provided an importing country response. What am I required to do?
A. The Convention requires that the exporting country ensure that no export of a chemical listed in Annex III is sent to an importing country even if it has failed to send an importing country response. This obligation begins 6 months after the Secretariat has notified countries that this failure has occurred and lasts for a period of 12 months after this date.
The exporting country is able to export the chemical to the importing country during this 12 month period, if it is known that the chemical: is registered in the importing country at the time of import; has been imported into the country of import and that no regulatory action has been taken against this action; or that the importing country has explicitly agreed to the import of the chemical.
Q28. In our country the manufacture and trade of chemicals involves numerous medium and small scale businesses rather than a limited number of large companies. How do we inform all these businesses of their responsibilities and the operation of the Rotterdam Convention ?
A. A large number of small enterprises can make it difficult to contact all such members of industry. This can be exacerbated if many of the industries are transient traders in chemicals and involved in trading other commodities and products as demands and opportunities arise and disappear.
Ideally, contact should be made through a single or small number of points of contact. This might be done through industry associations or trade journals. If such mechanisms do not exist, or where they only provide contact with a relatively low proportion of industry members, governments may need to develop their own list of contacts. Such lists might be compiled from registration records, customs records or other trading activities.
Q29. The Decision Guidance Document (DGD) for a chemical listed in Annex III provides information on alternatives for that chemical. Can I be assured that these alternatives will work in my country?
A. No, not necessarily. Although every effort is made to collect comprehensive information on alternatives, the information in the DGD may be incomplete. A significant proportion of the information may come from the notifying countries and other information provided to the Secretariat by other countries. The alternatives identified have been reported to work effectively in the conditions of those countries. Particularly for pesticides, the uses and conditions in other countries may be quite different and the chemicals may be applied using different techniques and under different cultural practices. Likewise, information regarding alternatives may change over time as new information becomes available.
Ideally countries should seek to obtain supporting data demonstrating that the use of the proposed alternative is effective and that it poses no undue risks to human health and the environment. Governments should also consider non–chemical alternatives where they are applicable.
A clearinghouse mechanism, containing information provided by governments on alternatives to chemicals that are included in Annex III, is available through the Rotterdam Convention Web site (www.pic.int).
