Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell and Lisa R. Burchi

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.”

Background

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.

Discussion

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. 

 


 

By Lynn L. Bergeson, James V. Aidala, and Lisa R. Burchi

On March 20, 2015, the United Nations World Health Organization’s International Agency for Research on Cancer (IARC) announced it had completed evaluations assessing the carcinogenicity of five organophosphate pesticides. Specifically, IARC classified the herbicide glyphosate and the insecticides malathion and diazinon as probably carcinogenic to humans (Group 2A), and classified the insecticides tetrachlorvinphos and parathion as possibly carcinogenic to humans (Group 2B). IARC also found there is “limited evidence” that glyphosate can cause non-Hodgkin’s lymphoma and lung cancer in humans.

A summary of the final evaluations, together with a brief rationale, is published online in The Lancet Oncology; the detailed assessments will be published as Volume 112 of the IARC Monographs. IARC’s press release announcing its evaluation is available at http://www.iarc.fr/en/media-centre/iarcnews/pdf/MonographVolume112.pdf.

Monsanto, on behalf of glyphosate task forces in the U.S. and the European Union (EU), immediately voiced its vigorous disagreement with IARC’s conclusions, noting various scientific issues with IARC’s evaluation that resulted in a conclusion that has not been reached following review by the U.S. Environmental Protection Agency (EPA) and in the EU. Monsanto’s statement is available at http://news.monsanto.com/news/monsanto-disagrees-iarc-classification-glyphosate.

The IARC announcement with regard to glyphosate will further energize both sides of the debate about genetically modified organism (GMO) crops, since there are several crops that have been genetically engineered to be resistant to glyphosate. If some occupational risks are identified as needing possible further mitigation, the distinction between food safety issues and occupational risks may be lost in the rhetoric. Opponents of GMO crops and those who support GMO food product labels can be expected to cite the IARC designation regardless of any further clarification or nuance that the scientific debate over the data might provide. Defenders of the technology will insist that not only is the IARC designation wrong and misleading, but it is clearly at odds with numerous other conclusions reached by multiple competent governmental authorities concerning the safety of using glyphosate and especially consuming GMO crops.

Regardless of Monsanto’s rapid and detailed response, “dueling science” views are not helpful towards enhancing public confidence in the safety of the food supply, which is ultimately where this headline will be most influential. That will only add pressure on the review process and conclusions contained in the expected EPA registration review of glyphosate data scheduled for completion in 2015.