Deliverable 28: Specification of low risk products REBECA ...

cannot afford the high costs for a successful registration of their biological control
agents (BCAs), which are in most cases niche products.
Microbial pesticides are generally regarded as posing lower risks to human health
and the environment than chemical pesticides (OECD, 2007). Many governments
have responded to growing public demands for safer means of plant protection and
have recognized that the obstacles for safer biological pesticides need to be
addressed. In the European Union, the multidisciplinary REBECA (acronym;
Regulation of Biological Control Agents) consortium sought to find more appropriate
protocols to address data requirements for biological pesticides and thereby facilitate
access to lower risk biological controls (REBECA, 2007).
In Canada, the pesticide regulatory authority, Health Canada’s Pest Management
Regulatory Agency (PMRA) has waived all registration review fees for microbial
pesticides. To complement this measure, the federal department of Agriculture and
Agri-food Canada has set up a regulatory support program for biopesticides needed
by the grower community. The new Canadian pesticide legislation explicitly requires
that the registration to lower risk products will be facilitated by the regulator
(Government of Canada, 2002). Both in Canada and in the United States the
respective regulatory agencies have established data requirements that reflect the
current scientific knowledge about the risks posed by microbial pest control agents
(Pest Management Regulatory Agency, 2001; Environmental Protection Agency,
2006).
Unlike chemical pesticides, microbial agents may infect other living organisms
causing diseases. Potential adverse effects of microbial pesticides include the
displacement of non-target micro-organisms and allergenic, toxic, and pathogenic
effects on humans or other non-target organisms (Cook et al., 1996; OECD, 2003).
The key challenge in risk assessment method development is to establish protocols
and guidelines that enable an efficient yet responsible risk assessment.
In the area of exotic natural enemies van Lenteren et al. (2003) proposed the use of
a risk indicator developed in the ERBIC project (Hokkanen et al., 2003) as an
objective approach to a comparative risk assessment of “classical biocontrol agents”
(definition as in Eilenberg et al., 2001). This approach has been implemented in a
guideline for the risk assessment of arthropods as part of the OECD Plant Protection
Programme (OECD, 2004a).
Legislators in Canada (Government of Canada, 2002) and US EPA (US EPA, 2000)
have recognized the value of objectively comparing the risks of different pesticides
for the same pattern of use and allowing regulators to consider the risks of other
pesticides when registering a new product. A similar approach has been suggested
by the European Parliament (European Parliament, 2003).
Several authors have suggested concepts to compare the health or environmental
risks or hazards of conventional pesticides, but, unfortunately, the applicability of
these tools to biological control agents is limited. The availability of a tool to
objectively compare the environmental impact of biological and conventional
pesticides is desirable in light for the promotion of safe biological control options and
the measurement of resulting risk reduction in agricultural use.
In this paper we propose such a tool for microbial BCAs by using data gathered in
the EU funded BIPESCO (FAIR6-CT-98-4105) and RAFBCA (QLK1-CT-2001-01391)
research projects, as well as data from public regulatory documents and scientific
literature. Selected microbial pest control agents were used to critically review the
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