Q. What is a final regulatory action (FRA)?
The Convention defines “Final regulatory action” (FRA) to mean an action taken by a Party that does not need subsequent regulatory action, the purpose of which is to ban or severely restrict a chemical. A ban means all uses of the chemical within one or more of the categories (pesticide, including severely hazardous pesticide formulations, and industrial) have been prohibited. A severe restriction means virtually all use of the chemical within one or more of the categories has been prohibited. The Party decides, on a case by case basis, whether the action it has taken amounts to a chemical being severely restricted in line with the Convention.
Q. What should our country be notifying to the Secretariat to fulfil its obligations?
The procedures under the Convention require that FRAs need to have been taken to protect human health or the environment as one of the criteria for listing the chemical in Annex III to the Convention after receipt of FRAs (See below and Article 5).
Once a final regulatory action to ban or severely restrict a chemical has been adopted, the Party 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 final regulatory action is independent of whether the chemical is still being traded internationally or not.
Below are some examples of what Parties have defined as:
Banned chemicals
- Ban of a chemical following concerns for workers’ health, leading to a decision that the chemical could not be used in a way to guarantee workers’ safety due to information on hazards involved and on exposure;
- Ban of the use of a pesticide because it was seen that this might cause problems with export trade in agricultural commodities due to residues for which trading partners either had very low or no Maximum Residue Limits (MRLs).
Parties did not consider it necessary to notify as an FRA if an original chemical formulation and application technique had been removed from the market but industry had taken action to reformulate the product and change the application methodology to address concerns about possible health (or environmental) impacts. The Party may however wish to advise other Parties of such changes as part of the Convention’s information exchange provisions.
Severely restricted chemicals
- A ban of all major uses of a chemical, even if only 1 or 2 minor uses remain approved, 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;
- 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 were not considered to constitute severe restrictions;
- 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;
- Restriction of the use of a pesticide or an industrial chemical to certain qualified users/operators to limit the number of persons who can use the chemical but with all approved uses for the chemical remaining unchanged has not been considered a severe restriction.
In the past, data deficiencies (e.g. phase out of chemicals if an evaluation concludes there is not enough information to support the continued use of a chemical) have not been notified by Parties as they did not consider them to constitute FRAs. Actions based upon failure to pay fees (e.g. Ban resulting from unpaid registration fees), not taken for health or environmental reasons, could be unlikely to meet the criteria in Annexes I and II and therefore not be eligible for consideration for inclusion of the chemical concerned in Annex III to the Convention.
It is important to remember that the list of chemicals and pesticides that are subject to the legally binding PIC procedure are not a “Black list” but rather a “watch list” based on decisions taken by individual Parties to ban or severely restrict a chemical.
Further information, guidance and examples are available in the FRA Evaluation Toolkit, which is available at https://www.pic.int/Implementation/FinalRegulatoryActions/FRAEvaluationToolkit/Introduction/tabid/4976/language/en-US/Default.aspx
Q. When should our country send a notification of FRA or notify of changes to a previous FRA notification?
A. It is important to notify so that all stakeholders can be informed of the measures and decisions that your country has taken. This is turn improves compliance with those national measures and decisions. Please note that any Party has the right to change its previous notifications of FRAs, as well as any previous decisions on the import of Annex III chemicals. Any such changes should be immediately transmitted to the Secretariat so that they can be communicated as soon as possible on the Convention website as well as in the next PIC Circular.
Q. What would be the consequences of not transmitting a notification of FRA?
- For chemicals already listed in Annex III, changes to previous notifications could lead to changes in import responses;
- For chemicals not listed in Annex III, if there is no longer a ban or severe restriction in place it could mean the chemical is no longer a candidate chemical for listing. Failure to notify may mean the chemical is not included in Annex III when it may otherwise have been listed and the country may not be able to rely on an international mechanism to strengthen and enforce a national decision not to accept imports of a hazardous chemical;
- For chemicals not listed in Annex III, if the chemical is no longer banned or severely restricted, it may mean that your country no longer has obligations to transmit export notifications when exporting the chemical from your territory.
Information exchange through the notifications under the Convention also ensures that a country does not receive imports of chemicals that it either does not want to receive or cannot manage, leading to a threat to human health and the environment.
Q. Should we notify the Secretariat of the incidents related to pesticides poisoning?
A. Notification of final regulatory action should only be made when the Party has adopted a regulatory final action. As for the listing of chemicals into Annex III, the Convention contains criteria which should also 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 relevant criteria for listing a chemical in Annex III are contained in Annexes I and II of the Convention.
However, Parties may wish to report on pesticide incidents that are not intentional misuse. Reporting on pesticide incidents to the Rotterdam Convention has the advantage of making those incidents known to the world through the PIC Circular. This can help other countries be informed about specific pesticide formulations causing problems in other countries, allowing them to see if risk management measures are needed. This can help prevent further incidences of poisoning. More information on the procedures for reporting pesticide incidents is available here.