INSIGHTS | PERSPECTIVES
ing, pesticide sales statistics are used as a
less accurate proxy. Reporting systems for
incidents involving spills, livestock or wild
animal deaths, or other effects of pesticide
use are also lacking in many countries (12,
13). Regulation in the European Union and
the United States requires that pesticide
authorization holders submit new information on potentially dangerous effects
of a pesticide on human or animal health,
ground water, or the environment, but it is
often not clear what they should be measuring and reporting; the onus is on the
user to make a judgment about what is
worth reporting, and compliance is rarely
In some countries, such as the United
Kingdom, other European Union member
states, and the United States, all reported
pesticide incidents involving people, wildlife, or the environment are investigated,
but there is no equivalent to the Yellow
Card, EudraVigilance, or VigiBase systems
to monitor the environmental effects of
pesticides during normal use. There is also
no estimate of the number of incidents
that go unreported and that are therefore
not investigated. Monitoring and preventing misuse, accidents, and unintended effects of pesticides requires investment in
organizational design for information collection and processing, which is absent in
THE UK EXAMPLE
The United Kingdom has one of the most
developed regulatory and monitoring sys-
tems for pesticides. Yet, it has no system-
atic monitoring of pesticide residues in
the environment, and no equivalent to
MRL in foods exists for the environment.
There is no consideration of safe pesticide
limits at landscape scales. For example,
statistics about the use of neonicotinoids
in the United Kingdom suggest that the
landscape-scale dose increased by a factor
of four between 2000 and 2014 (14). With-
out knowledge of safe environmental limits,
the total pesticides used—and therefore the
total environmental dose—is governed by
market demand rather than by a limit on
what the environment can endure. There is
little information about where, when, and
why pesticides have been used, making it
very difficult to quantify potential environ-
An essential step for pesticide regulation
in the future is to develop an equivalent
to pharmacovigilance—perhaps called pes-
ticidovigilance. Such a system would place
responsibility for monitoring the use and
effects of these chemicals on manufactur-
ers and growers by applying preregistered
designs for how data should be collected.
It would improve decisions concerning ap-
proved use and would avoid sole reliance
on ad hoc studies and sparse data. New
methods of precision farming provide op-
portunities for new data flows. This would
also address issues of environmental jus-
tice by placing the responsibility for active
management of pesticide dosing on those
who benefit directly and who have the
capacity to adapt and innovate. It would
be a foundation for defining best practice,
allowing the level of precaution applied
in regulation to be scaled to the level of
knowledge about the effects of the pesti-
cides. Such a system would promote genu-
inely risk-based pesticide use that would
make the trade-offs between the environ-
mental costs and food production more
explicit. In specific circumstances where
there are strong reasons for protecting a
vital crop, a risk-based system could even
allow some chemicals currently banned
under the present systems of regulation to
The better alignment of pesticide use
with this kind of best practice is in everybody’s interest. It has the potential to
increase trust and to sustain the use of
important chemical technologies. The current assumption underlying pesticide regulation—that chemicals that pass a battery
of tests in the laboratory or in field trials
are environmentally benign when they are
used at industrial scales—is false. Future
regulation to deal with this issue may have
to vary regionally because of differing cost-benefit analyses, but the effects of dosing
whole landscapes with chemicals have been
largely ignored by regulatory systems. This
can and should be changed. j
REFERENCES AND NOTES
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2. J. P. Myers et al ., Environ. Health 15, 19 (2016).
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5. B. Borel, Nature 543, 302 (2017).
6. Phillips McDougall, “The cost of new agrochemical
product discovery, development and registration in 1995,
2000, 2005-8 and 2010 to 2014” (Crop Life International,
CropLife America and European Crop Protection
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8. C. E. Handford, C. T. Elliott, K. Campbell, Integr. Environ.
Assess. Manag. 11, 525 (2015).
9. United Nations Human Rights Council, “Report of the
Special Rapporteur on the right to food” A/HRC/34/48
10. Food and Agriculture Organization of the United Nations
and World Health Organization (FAO and WHO), “The
International Code of Conduct on Pesticide Management”
11. L. V. Dicks et al. , Science 354, 975 (2016).
12. G. Matthews et al. , Environ. Health Perspect.119, 1517
13. European Commission, “A common methodology for the
collection of pesticide usage statistics within agriculture
and horticulture” (Eurostat Methodologies and Working
Papers, European Communities, 2008); http://ec.europa.
14. Fera. PUS STAT: Pesticide Usage Surveys (2015); https://
A.M.M. acknowledges funding from the Natural Environment
Research Council (NERC) and UK Government Department for
Environment, Food, and Rural Affairs (Defra) for a secondment
to Defra (NE/L008599/2). I.L.B. is chief scientific adviser at UK
Defra. The views in this paper are the authors’ own.
How pharmaceuticals and pesticides are regulated
During early stages of discovery and testing, pharmaceuticals and pesticides are regulated in a similar way,
but in the later stages and after approval, pharmaceuticals are monitored far more effectively.
Search for and synthesize molecules; perform biological tests and screening to determine
biological activity; determine commercial prospects (e.g., potential for patents).
Conduct safety, efficacy, and toxicological tests using in vitro and in vivo laboratory trials
and computer modeling.
Clinical and field
Test effectiveness, determine safety, and
identify side effects using three levels of
trials [phase 1 (first in human), 2, and 3]
with increasing patient numbers.
Test effectiveness, toxicology, fate, and
behavior in the environment using laboratory
and field trials. No equivalent to the phased
trials used in pharmaceutical testing.
Submit development study results on efficacy, effectiveness, safety, toxicology, fate, and
behavior to regulatory body for license approval.
marketing, use, and
Once licensed, the substance can be used in
accordance with the product label. Long-term
monitoring starts (phase 4) to determine
unexpected effects in different categories of
people and the population more generally
(using national and global reporting systems
and pharmacovigilance regulations).
Once licensed, the substance can be used
in accordance with the product label (MRL
monitoring checks compliance with product
label to protect human health). Ad hoc
reporting of incidents or effects. No postapproval or long-term monitoring of effects
and no equivalent to pharmacovigilance.