On May 10, 2016, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) issued guidelines on highly hazardous pesticides (HHP) (Guidelines) as part of the International Code of Conduct on Pesticide Management (Code of Conduct). HHPs are defined in the Guidelines as “pesticides that are acknowledged to present particularly high levels of acute or chronic hazards to health or environment according to internationally accepted classification systems such as WHO or GHS or their listing in relevant binding international agreements or conventions. In addition, pesticides that appear to cause severe or irreversible harm to health or the environment under conditions of use in a country may be considered to be and treated as highly hazardous.” The Guidelines state that they are “intended to help national or regional pesticide regulators with limited resources to design a process to address HHPs that follows the three steps of identification, assessment and mitigation,” and they aim “to underscore the importance of adequate pesticide legislation, and risk and needs assessment as part of the registration process.”
In 2006, the FAO Council endorsed FAO participation in the Strategic Approach to International Chemicals Management (SAICM) and noted that the International Code of Conduct on the Distribution and Use of Pesticides was to be considered an important element of the SAICM process. The Council “suggested that the activities of FAO could include pesticide risk reduction, including the progressive banning of Highly Hazardous Pesticides (HHPs).” The Joint FAO/WHO Meeting on Pesticide Management (JMPM) developed the criteria that defines HHPs when the Code of Conduct was revised in 2013.
In 2015, SAICM’s International Conference on Chemicals Management adopted a resolution recognizing “HHPs as an issue of concern and called for concerted action to address HHPs, with emphasis on promoting agro-ecologically based alternatives and strengthening national regulatory capacity to conduct risk assessment and risk management.”
2016 HHP Guidelines
The Guidelines include information on:
Identification of HHPs: The Guidelines set forth the following eight criteria for identifying HHPs (i.e., HHPs should be defined as having one or more of the following characteristics):
- Criterion 1: Pesticide formulations that meet the criteria of classes Ia or Ib of the WHO Recommended Classification of Pesticides by Hazard;
- Criterion 2: Pesticide active ingredients and their formulations that meet the criteria of carcinogenicity Categories 1A and 1B of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS);
- Criterion 3: Pesticide active ingredients and their formulations that meet the criteria of mutagenicity Categories 1A and 1B of the GHS;
- Criterion 4: Pesticide active ingredients and their formulations that meet the criteria of reproductive toxicity Categories 1A and 1B of the GHS;
- Criterion 5: Pesticide active ingredients listed by the Stockholm Convention in its Annexes A and B, and those meeting all the criteria in paragraph 1 of Annex D of the Convention;
- Criterion 6: Pesticide active ingredients and formulations listed by the Rotterdam Convention in its Annex III;
- Criterion 7: Pesticides listed under the Montreal Protocol; or
- Criterion 8: Pesticide active ingredients and formulations that have shown a high incidence of severe or irreversible adverse effects on human health or the environment.
Assessment: The Guidelines set forth guidance to assess the risks to human health and the environment under the conditions of use, as well as the needs for the products. FAO developed a Pesticide Registration Toolkit (Toolkit) to assists registrars in the evaluation for authorization of pesticides and review of registered pesticides. The Guidelines state:
- The Toolkit can best be considered as a web-based registration handbook intended for day-to-day use by pesticide registrars. It supports and facilitates informed decision-making by registrars, but is not an automated system that suggests decisions for registrars.
- Registrars can use the Toolkit to support several of their regular tasks. With respect to highly hazardous pesticides (HHPs), the Toolkit can be used as an aid to implement the three steps described in these guidelines: Identification, Assessment and Mitigation.
Mitigation: The Guidelines provide options for mitigating risks of HHPs currently in use, and for possible new HHPs. Specifically, the Guidelines state the “main lines for risk mitigation are ending, restricting or changing formulations or uses. Selection of the most appropriate option will vary from case to case and depend on risk levels and needs, but also on policies and adequacy of institutional infrastructure for pesticide management.”
Planning: The Guidelines set forth steps for designing an action plan to address HHPs. FAO and WHO note the importance of effective communication and involvement with stakeholders in the pesticide supply chain (e.g., growers, food retailers, consumers) in developing an action plan.
Prevention: The Guidelines discuss elements to prevent future problems with HHPs, particularly possible revision of the registration system, strengthened enforcement, extensive training, and the installation of surveillance systems.
Concerns have been raised previously regarding any potential for efforts by WHO and FAO to eliminate HHPs to be based purely on hazard without consideration of risk. The Guidelines include discussions related to the steps to “assess the risks that [HHP] products are posing to human health and the environment under the conditions of use in that country and to review the needs for these products, taking into consideration available alternatives.” Whether this provision sufficiently addresses past concerns should be examined.
Companies will need to review the Guidelines, and the Toolkit, to determine how their products would be identified, assessed, prioritized, and managed under the Guidelines and Toolkit. While some elements of the Guidelines are relatively straight-forward, others may be more subjective and thus much more controversial, such as, for example, the HHP criteria that a pesticide active ingredient or formulation has “shown a high incidence of severe or irreversible adverse effects on human health or the environment.” In addition, the Toolkit is under development, meaning that several modules are not completed and that webpages may not yet be completed. It, thus, will be important to continue to monitor how the Guidelines and Toolkit are developed and applied.