The Final Regulatory Action Evaluation Toolkit (FRAE Toolkit) is aimed at assisting and enhancing the efforts by Designated National Authorities (DNAs), especially from developing countries, to take scientifically sound final regulatory decisions on hazardous chemicals. But even more so, the toolkit should lead DNAs toward a chemical that has already been notified by a DNA from another region and where that notification already satisfies the requirements of Annex I of the Convention. That notification would then be awaiting another notification on the chemical from another region that also satisfies Annex I requirements for both notifications to then go forward for consideration by the Chemical Review Committee (CRC) of the Rotterdam Convention.
The contents of the FRA Evaluation Toolkit are shown in the figure below. The figure is interactive for easy access, click on the section you wish to obtain. For a quick overview you can download the FRA Evaluation Toolkit pamphlet (Ar, En).
Rotterdam/CRC Requirements
A summary of the purpose of the Rotterdam Convention regarding the sharing of information on certain hazardous chemicals in international trade is presented. A short introduction to both Annex I and Annex II criteria is provided along with how these parameters are used by the CRC in their evaluation of a chemical.
Mention is made of the obligations of DNAs to report decisions taken to regulate each chemical using the process of notification to the Secretariat; a hyperlink to the notification form is available.
An explanation of the requirement for two notifications that satisfy Annex I information requirements from two different PIC regions is tendered; chemicals that have one satisfactory notification should be considered priority for decision-making within the context of the national need to make such a final regulatory decision. The role of the CRC and how it conducts its business are explained. The make-up of the committee, the consideration of risk evaluations and the emphasis on scientific soundness are presented.
The need to fulfill the information requirements of Annex I is stressed in order to ensure that all DNAs understand that it is important to be conscious of these pieces of information and that these pieces of information should be available and used as part of the decision-making process for each chemical considered nationally for final regulation.
Notifications that satisfy Annex I
Many notifications are on hand that satisfy Annex I requirements from a single region. Each chemical from this batch now requires another notification from a different PIC region so as to trigger the chemical being forwarded to the CRC for consideration.
A hyperlink is provided that leads the DNA to the database where these chemicals may be viewed by the region of origin and by common name, alphabetically.
Selecting and clicking on a particular chemical leads to the notification on that chemical with the requisite background information on risk evaluation, etc., available for download.
Risk Evaluations that satisfy Annex II
A hyperlink leading to the risk evaluations from all the chemicals listed in Annex III along with final regulatory actions are available. Also, the risk evaluation of a chemical found acceptable from one of the two notifications presented to the CRC is presented for review. Such chemicals are also presented in the section immediately above in an attempt to encourage new notifications for these chemicals that satisfy Annex I.
References for making a Risk Evaluation
This section contains a non-exhaustive compilation of tools for risk evaluation developed by various agencies. DNAs should seek to contact other DNAs, both from developing countries and developed countries, especially in their region, to share information.
The term “Risk Evaluation” is used by the Rotterdam Convention in relation to an evaluation of intrinsic toxicological and ecotoxicological properties and actual or expected relevant exposure, which may include information on actual incidents. One of the key criteria in Annex II of the Convention for listing chemicals under the Convention is to establish that the final regulatory action has been taken as a consequence of a risk evaluation.
To further support DNAs in their decision-making, scientific documentation is referenced and the hyperlink to such documentation is available. The documentation is sourced from reputable organizations, including World Health Organization (WHO), Food and Agriculture Organization (FAO), accredited institutions and universities, and regulatory agencies of developed and developing countries.
Bridging Information
Bridging information provides an opportunity for a developing country with limited resources to use a risk evaluation from another country with similar local conditions when taking a decision on a chemical for a final regulatory action.
The background to and explanation of this vital process, which was approved by the CRC, is presented. Reference is made to the CRC Working Paper on bridging with a hyperlink to the paper itself. A mapping is presented showing the countries in each region, which have already carried out accepted risk evaluations.
DNAs may contact the DNAs from these countries, where applicable, to obtain risk evaluations to be used in their decision-making for final regulatory action. An effort is made to characterize the local conditions of these countries with approved risk evaluations; in addition, a list of possible developing countries with similar local conditions that align to each of these developed countries is available.
Chemical Information Assessment (CIA) Tool
The CIA tool is designed to assist DNAs from developing countries toward making a scientifically sound risk evaluation on whether to take a final regulatory action on a hazardous chemical. This tool offers only examples of some areas that DNAs should consider when undertaking a scientifically sound risk evaluation. It should not be used to take a final regulatory action as it does not offer a complete process for a risk evaluation. Tools to undertake a scientifically sound risk evaluation are available in the References for making a Risk Evaluation section of the toolkit.
Developing countries have varied methods of making decisions in order to arrive at a final regulatory action on any chemical. Sometimes, such a decision may involve political and economic reasons with limited scientific basis being used. The CIA is introduced as a means by which DNAs from developing countries can consider available information for certain endpoints of a chemical to use as a guide and an example toward taking a more scientifically sound basis in decision making for a final regulatory action on the chemical. The CIA tool is not designed to carry out a scientific risk evaluation. The section in the toolkit on References for making a Risk Evaluation provides access to such tools that will support the DNA in taking a final regulatory action on a chemical.
The CIA tool provides comments on responses to particular questions or statements aligned to certain endpoints for a chemical and to its use. A DNA should further investigate a chemical before taking a decision on a final regulatory action. Consideration is given in the CIA tool that many pieces of useful information are not available. As such, the user is directed to sources of information for each given point.
The limitations of the CIA tool means that the DNA is obliged to consider other areas of the chemical such as: other hazardous properties, its use, alternatives, its social and environmental impact, before making a decision on a final regulatory action.
DNA Contact Information
Currently, the contact information for all DNAs is available on the website of the Convention. This information is available by country. By way of a hyperlink in the toolkit, the information is also made available by region. Additionally, the contact information of DNAs that have already presented approved risk evaluations to the CRC is presented.
The toolkit encourages DNAs to contact each other and also offers the services of the Secretariat to act as a conduit for sharing information.
Sponsorship
The Final Regulatory Action Evaluation Toolkit is being developed with financial support from The European Commission.