The Prior Informed Consent or PIC procedure is the central core around which the Rotterdam Convention has been developed. This section of the document includes a brief overview of the PIC procedure as well as detailed information on how the process works, the relevant documents, the importance of import decisions and the roles and responsibilities of Parties with respect to the import and export of chemicals included in Annex III of the Convention.
For each chemical included in Annex III of the Convention, a DGD is prepared and sent to all Parties with a request that they take a decision as to whether they will allow future import of the chemical. The resulting import decisions are published by the Secretariat and made available to all other Parties through the PIC Circular (see Section 1.4.3 and Annex 7.2 to this guide).
The PIC procedure provides all Parties with an opportunity to make an informed decision as to whether they will consent to future imports of the chemicals listed in Annex III of the Convention. All Parties are required to ensure that their exports do not take place contrary to an importing Party’s import decision.
The PIC Circular is compiled by the Secretariat and sent to DNAs every six months, in June and December. The key sections relevant to the PIC procedure are Appendices III and IV. Appendix III contains a current list of the chemicals subject to the Convention. Appendix IV contains all the import decisions for chemicals subject to the Convention that have been submitted by Parties as well as a list of those Parties that have failed to provide import responses.
The compilation of import decisions in Appendix IV represents the official reference for countries that are looking to export chemicals subject to the Convention.
A summary of information found in the PIC Circular is shown in Annex 7.2 to this guide.
A decision guidance document has been developed for each chemical included in Annex III of the Convention. The DGD sets out the scope of the individual chemicals subject to the PIC procedure, provides basic information about the chemicals’ characteristics and a summary of the reasons why the chemicals were either banned or severely restricted or, in the case of a SHPF, the problems found under the conditions of use.
A DGD is not intended to be a scientific treatise on a given chemical but rather to assist governments in making an informed decision regarding future importation of the chemical. Governments may wish to seek further information, if they consider it necessary, before making an import decision.
A summary of information found in a DGD is shown in Annex 7.1 of this guide.
Chemicals included in Annex III of the Convention are those that Parties have determined pose unacceptable risks for all or some uses as used in their territories. These decisions and the underlying circumstances may have been specific to the proposing countries’ conditions of use and may or may not be related to the way in which the chemical is used in other countries or regions.
This means countries should consider the relevance of their national conditions with regard to the use of the chemical and taking into account the information in the DGD, including the reported regulatory actions for BSR chemicals or the conditions under which SHPFs were used.
Some of the factors to consider in consulting a DGD include:
whether the chemical is used in your country and, if so,
- explain how it is used;
- estimate the likely exposure of the chemical to workers, the public and non-target plants or animals; and
- assess whether this is similar to the conditions reported as the basis for the actions of the notifying or proposing Parties.
whether the climatic, environmental and other conditions are similar between your country and the notifying country(ies);
whether the level of chemicals management in your country is comparable to that of the notifying countries; and
if the notification was from a developed country, whether that country already had safety directions and precautions that are either not available in your country or impractical to use in your circumstances.
A further important consideration may be whether there are safer alternative chemicals or techniques available that can replace the chemical in question. Particularly for pesticides, countries should be aware that an alternative chemical identified by a notifying Party may not be an effective alternative under the conditions of use in another Party. It would be prudent to require confirmatory data to demonstrate that the proposed alternative is effective and has no unacceptable effects on human health and the environment under the conditions of use in your country.
Countries should not limit their consideration to chemical alternatives. For instance, the practice of integrated pest management (IPM) may include any combination of physical treatments, changes in management and cultural practices while minimizing the use of chemical treatments.
Information provided by Parties on alternatives (chemical and non-chemical) and additional national evaluations of chemicals in Annex III are available on the Rotterdam Convention web site (www.pic.int).
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Obligations relating to the Import of chemicals Included in Annex III and subject to the PIC procedure Under Article 10 of the Convention, Parties have the following obligations with respect to imports of chemicals listed in Annex III of the Convention and subject to the PIC procedure:
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Types of response
The import response shall consist of either a final decision based on national legislative or administrative measures or an interim response.
A final decision may include:
consent to future importation of the chemical; or
not consent to future importation of the chemical; or
consent to future importation of the chemical but subject to certain specified conditions.
An interim response may include:
an interim decision either consenting to import with or without specified conditions, or not consenting to import during the interim period until a final decision is reached; or
a statement that a final decision is under active consideration; or
a request to the Secretariat, or to the Party that notified the final regulatory action, for further information; or
a request to the Secretariat for assistance in evaluating the chemical.
An import response form has been developed to facilitate the transmission of the import decisions to the Secretariat. Copies of this form and instructions on how to complete the form may be found in Annex 7.5.2 to this guide or downloaded from the Rotterdam Convention web site at (www.pic.int).
Points to consider in making an import response
Countries need to be aware of related provisions of the Convention in making an import response.
1. Category under which the chemical is included in the Convention
An import response shall relate to the category specified in Annex III of the Convention and in the DGD for the chemical. For example:
aldrin, is listed under the category “pesticide” that includes all existing formulations subject to the PIC procedure;
- import decisions apply to all forms of aldrin used as a pesticide
phosphamidon is listed under the category SHPF;
- specifically soluble liquid formulations of phosphamidon that exceed 1000g active ingredient/l
- import decisions would only apply to the specific formulations identified
dinoseb is listed under the category “pesticide”, even though it also has uses as an industrial chemical;
- import decisions would only apply to use of dinoseb as a pesticide; imports for industrial chemical uses would not be included
- however, an importing country may extend coverage to the other category; the difference is that the exporting country is not obligated in every instance to enforce it
2. Statement on legislation or administration measures for a final decision
A final decision on import should be accompanied by a description of any legislative or administrative measures upon which it is based. It could be any official document that further explains or implements the regulatory or import status of this chemical in the country or an official document that deals with chemical regulation generally. This does not necessarily require legislative or administrative measures specifically to address chemicals subject to the Rotterdam Convention. For example, chemicals that have never been registered or approved for use in a country may be subject to a general regulation that does not allow their use or importation.
3. The need to specify conditions
As noted above, a final decision on import shall consist of one of three options: consent to import; not consent to import; or consent only subject to specified conditions. If the third option is selected, then the conditions need to be “specified”. In other words, this suggests the need to state specifically the conditions under which export is allowed. It might be considered insufficient, for example, simply to note that general conditions apply, or to fail to identify the relevant conditions.
4. Registration under national laws
Many countries require that pesticides are not imported/used unless registered or authorized under national law. Some countries describe this as a “no consent” situation, while others describe it as a “consent subject to conditions” situation. These different response patterns could create unintended confusion. Subject to any further guidance by Parties, and consistent with 2) and 3) above, references to national registration systems in import responses should be accompanied by sufficient information to clarify how the system applies to the chemical under consideration. One approach used by some countries in this situation is to transmit a “no consent” response for chemicals that are not registered. It is then further explained (as applicable) that in the absence of official registration, a chemical may not be used or imported, and that registration may only be granted if a chemical complies with strict norms and a thorough regulatory review process. Where applicable, some countries have also identified relevant exemptions, e.g. for purposes of research subject to specific conditions. Also where applicable, some countries have indicated that a particular chemical has been specifically banned.
5. Trade neutrality
If the decision is not to consent to import or to consent to import only under specified conditions, this decision must apply equally to import of the chemical from any source and to domestic production of the chemical for domestic use. It is important to note that any source applies to both Parties and non-Parties.
Under the PIC procedure, exporting Parties must ensure that their exports of chemicals included in Annex III of the Convention are in line with the import decision of the importing Party. However, it should be noted that export of the chemicals subject to the Convention from exporting countries that are not Parties to the Convention may still take place contrary to the import decision of a country, as such countries are not bound by the Convention. Importing Parties should endeavour to strengthen their own regulatory infrastructure as called upon by the Convention in Article 4, paragraph 2 and Article 15, paragraph 1.
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How to reach to an import decision The inclusion of a chemical in Annex III of the Convention has been because one or more Parties have determined that continued use of the chemical in their country poses unacceptable risks and that use should cease (or be severely restricted). In the case of a SHPF, it has been shown that the pesticide formulation has caused a human health or environmental problem in a developing country or a country with an economy in transition under conditions of use. The decision guidance document (DGD) provides basic information about the chemical and the reasons for its listing in Annex III. It is intended to initiate an informed decision making process regarding future imports of the chemical in question. The DGD can serve as a starting point for countries in making a decision about a particular chemical, taking into account their national circumstances (see Figure 2). In addition, it is important that there be appropriate consultation at the national level with others involved within and outside the government, e.g. customs authority, trade authority and industry association. Countries need to assess whether the continued importation and use of the chemical poses an unacceptable risk to human health or the environment that cannot reasonably be managed through their chemical management infrastructure and schemes. In addition to the DGD, countries may request further information from the Secretariat and notifying countries. If additional technical information is requested, it should be clearly identified (e.g. more detailed information on ecotoxicity, characteristics of the chemical, etc.). Countries may also seek assistance from the Secretariat in reaching a decision. Where such assistance is requested, the specific areas of difficulty and the nature of the assistance needed should be clearly indicated. An important element of reaching an import decision is whether or not there is domestic production of the chemical for domestic use. In order to do so, the DNA needs to have some level of information about producers, products and usage. |
FIGURE 2. THE PIC PROCEDURE – A NATIONAL DECISION MAKING PROCESS
Obligations and procedures related to exports of chemicals included in Annex III
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Obligations under Article 11 of the Convention Article 11 sets out the obligations of Parties in relation to exports of chemicals included in Annex III of the Convention. These obligations can be implemented in a variety of ways. It is important to note that the Convention does not prescribe how countries implement these obligations. Rather, governments must individually decide how they will ensure that exports do not occur contrary to importing country decisions. A further obligation for exporting countries is to put in place legislative and/or administrative mechanisms that ensure that exporters do not export chemicals to importing countries contrary to their import decisions. This mechanism is to be applied no later than six months after the Secretariat informs Parties of the Party’s importing country decision in the relevant PIC Circular. The mechanism that governments choose to implement this obligation will depend upon their own legislative and administrative arrangements and available resources. Countries are required to inform those concerned within their own territories of the decisions of importing countries with respect to future importation of chemicals included in Annex III the Convention. This is to ensure that those involved with exports, or controls on exports, have the necessary information to ensure that exports do not take place contrary to decisions of importing countries. Depending upon arrangements within the exporting Party those concerned are likely to be chemical manufacturers, formulators and exporters and may include other government agencies involved in the regulation of chemicals, such as customs or other border control agencies. |
Process for the implementation of export responsibilities
The mechanism that governments choose to relay this information to relevant stakeholders may include direct correspondence, the use of government publications such as gazettes or websites, the holding of seminars and workshops and advertisements or notices within the electronic or print media.
A possible mechanism could be to pass laws that make it an offence to export chemicals listed in Annex III of the Convention unless issued with a permit to do so. This would allow permits to be issued for countries that have consented to further imports. This mechanism would require some level of border control for it to be effective, either through a specific service designed for such exports (and possibly the imports of chemicals) or through the utilization of existing systems such as a country’s customs or phytosanitary/quarantine controls.
Alternatively, countries may elect to inform their industries of their responsibilities and require industry to self-regulate in compliance with this requirement. For this mechanism to be effective, it is likely that governments would still need to audit exportation and have some means of enforcing obligations where industry has been found not to have complied.
An important aspect of obligations regarding chemicals listed in Annex III of the Convention is that the exporting country obligations only apply to exports of the chemical where it is destined for use in the category of chemical for which it was included in the Convention (i.e. pesticide, industrial chemical or SHPF).
Column 3 of Annex III of the Convention indicates the category for which a chemical has been listed. Most chemicals clearly fall into one category or the other (i.e. most pesticides do not have an industrial chemical use and most industrial chemicals are not used as pesticides). However, there are a small number of chemicals with uses as both a pesticide and an industrial chemical, or so-called “dual use” chemicals. Where such chemicals are included in the Convention under a single category, then there are no obligations on the exporting country if the chemical is being exported for use in the importing country in the other category.
The difficulty for DNAs in exporting Parties is in knowing, at the point of export, what the intended use is to be in the importing country. For example:
if the chemical being exported is already pre-formulated and labelled for pesticide use, then this would provide a very strong indication of its intended use. However, most trade in international chemicals occurs in bulk form and this would not, in general, enable a determination to be made as to its intended use (or in the case of an active ingredient for a SHPF, what type and concentration of formulation it might become). Exporting country DNAs might consider some means to ensure import is compliant. One way of doing this is by requiring a documented declaration from the importing agent, through the exporter, as to its intended use before deciding whether to allow the export.
Responsibility of an Exporting Party when there is no Importing Country Response or interim response without a decision
On occasion, a Party will fail to send an import response to the Secretariat or will send an interim response that does not address future importation. These failures to respond are listed in Appendix IV of the PIC Circular. In such circumstances an exporting Party must still ensure that exportation does not occur unless:
the chemical is registered in the importing country at the time of export;
the exporting country has evidence/information that the chemical has been previously imported or used in the importing country and that there has been no consequent prohibition of that use or importation; or
the DNA of the importing Party has provided explicit consent to the exporter.
The obligation of exporting Parties not to export a chemical in these circumstances commences six months after the date when the Secretariat informed Parties that the country had not sent an import response or had sent an interim response that did not contain a decision regarding importation. This obligation only applies, however, for one year and therefore ceases 18 months after the date when the Secretariat informed Parties of the failure to provide a decision.
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Information to Accompany Exports Article 13 outlines the information to accompany exports of chemicals included in Annex III of the Convention as well as chemicals that are banned or severely restricted in the exporting Party. Such exports should have labelling that provides adequate information on the hazards and risks posed by the chemical to human health and the environment. The Convention also requires that for such exports a copy of an up-to-date Safety Data Sheet (SDS), in an internationally recognized format, be sent to the importer. Furthermore, the information on the label and the SDS should be in the official language of the importing country, as far as is practicable. The Convention requires that shipping documents for exports of chemicals listed in Annex III should bear any harmonized system customs code assigned by the World Customs Organization (WCO) to chemicals listed in Annex III of the Convention. The purpose of these requirements is to ensure that for certain hazardous chemicals there is sufficient information provided on labels and the SDS to minimize risks to workers, others and the environment. |
Benefits to Parties include:
Early warning / Information Exchange
Parties are made aware of national bans or severe restrictions of hazardous chemicals in participating countries through publication of the summaries of notifications of final regulatory action in Appendix IV of the PIC Circular. This early warning of potentially hazardous chemicals is a source of information on why countries have taken domestic regulatory actions and may provide impetus for other countries, particularly countries that import such chemicals, to review the regulatory status of these chemicals. In addition, the PIC Circular also contains summary reports on human poisonings and environmental damage associated with the use of SHPFs. This information may alert countries to possible problems that may be occurring in their own territory.
Informed decision–making
Parties receive decision guidance documents (DGDs) for each of the chemicals included in Annex III the Convention. The information contained in the DGD provides the basis for initiating a process for making informed decisions regarding future imports of these chemicals.
Shared responsibility
The PIC procedure helps countries to better manage chemicals by promoting a shared responsibility among exporting countries, importing countries and industry. Importing countries have a responsibility to make informed decisions regarding future import in a timely manner, while exporting countries have a responsibility to ensure that exports do not occur contrary to the importing decisions of participating countries. In participating in the PIC procedure, countries should recognize that non-Parties to the Convention may still export chemicals listed in Annex III of the Convention.
Networks among participating countries
Participation in the Rotterdam Convention helps a country’s officials build networks with officials in other countries. This could facilitate an exchange of ideas and create opportunities for cooperative efforts to resolve issues that could not be easily resolved by one country alone.
