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Dogs are among the more than 100,00 animals consumed each year by toxicity tests of pesticides in the EU. © istock.com |
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What substances are considered pesticides?
A pesticide is any substance or mixture of substances intended for use in preventing, destroying, repelling or mitigating living organisms considered to be “pests.” Common examples include weed-killers (herbicides), bug spray (insecticides), rat poison (rodenticides), bird poison (avicides), fumigants (nematocides), and even “germ-killing” soaps and cleaning products (antimicrobials). EU law makes a general distinction between pesticides intended for use on food crops (plant protection products) and those not intended primarily for agricultural use (biocides).
Who are the major pesticide manufacturers in Europe?
Among the largest EU pesticide manufacturers are BASF, Bayer CropScience, Dow AgroSciences, DuPont, Monsanto and Syngenta. Many of these companies are members of the EU-level lobby group, European Crop Protection Association.
Why test pesticides?
Most pesticides are designer poisons—tailor-made to be toxic to living creatures. Many are applied to foods we eat, to household lawns and gardens, to our pets or to our own bodies. In addition, residues from agricultural and other outdoor applications can linger in soil and groundwater, sometimes building up in plants and wildlife. Given their inherent toxicity and the potential for significant human and environmental exposure, pesticides are subject to stringent testing (mainly in animals) to determine the nature and severity of adverse effects, as well as the levels of exposure at which such effects do not occur.
How are pesticides regulated in the EU?
Plant protection products are authorised at EU-level on behalf of all Member States according to the provisions of Directive 91/414/EEC [PDF]. This legislation is administered by the European Commission Directorate General for Health and Consumer Protection, with scientific input from the European Food Safety Authority Panel on Plant Protection Products and their Residues (EFSA PPR Panel) and applies to manufactured chemical (e.g., organophosphate), bio-chemical (e.g., pheromones), and biological (e.g., micro-organisms) pesticides, as well as to the non-pesticidal ingredients within a formulated product, that are intended for agricultural use.
Biocides are subject to a separate regulatory regime administered by the Commission’s DG Environment pursuant to Directive 98/8/EC [PDF]. This Directive currently recognises 23 different classes of biocidal products, including antibacterial disinfectants, preservatives, antifouling agents, and wild animal repellants/lethal control measures such as rodenticides.
What animal tests are carried out on pesticides?
EU regulations prescribe extensive animal testing for every “active substance” (i.e., the toxic component) in plant protection and biocidal products. Most or all of the following animal tests may be required:
- Acute lethality via oral and inhalation routes in rodents and skin route in rabbits
- Eye and skin irritation in rabbits
- Skin allergy in mice or guinea pigs
- 1-3 month repeated-dose general toxicity studies via the skin route in rabbits
- 3 month repeated-dose general toxicity studies via the oral route in rodents and dogs
- 12-24 month repeated-dose general toxicity studies in rodents and dogs via the oral route
- Lifetime (18-24 month) cancer studies in rats and mice
- Genetic toxicity studies of at least 2 varieties in rodents (if the results of non-animal gene mutation tests are positive)
- Reproductive toxicity in at least 2 generations of rodents
- Prenatal developmental toxicity in rodents and rabbits
- Absorption, distribution, metabolism and elimination studies in rodents
- Acute lethality to fish of two or more species
- Partial or full life-cycle toxicity to fish of two or more species
- Acute and/or dietary toxicity to birds of two or more species
- Reproductive toxicity to birds
- And many more
In addition to the testing required for the active substance, other ingredients in a pesticide product (e.g., safeners, synergists and co-formulants) are also individually subject to some or all of the above tests. Moreover, each finished product is also required to undergo separate acute lethality testing via the oral, skin and inhalation routes, as well as testing for skin and eye irritation and skin allergy (known as the acute toxicity “six-pack”) for labelling purposes.
How many animals are used in pesticide toxicity testing?
Some of the tests above consume hundreds or thousands of animals per study. In 2005, pesticide testing in the EU consumed 102,629 animals, or approximately 9.5 percent of all animals used in toxicological and other safety evaluations, according to European Commission statistics [PDF].
Are animal tests accurate predictors of pesticide risks to people?
Not necessarily. Animal tests may under- or over-estimate the hazards of pesticides to people who eat foods treated with the chemicals; to pesticide applicators and families who live in agricultural zones; and to countless species of wild animals.
What are the alternatives?
A number of in vitro and other alternative methods germane to pesticide safety assessment have been endorsed as scientifically valid by the European Centre for the Validation of Alternative Methods (ECVAM) and its counterparts worldwide for toxic effects including skin and eye irritation, acute lethality studies in mammals and fish, skin allergy, genetic toxicity, toxicity to the developing embryo, and 12-month general toxicity.
In addition, an independent scientific expert group has recommended the deletion of certain longstanding testing requirements (e.g., 1-year dog studies and 18-month mouse cancer studies, which would save more than 400 animals per pesticide), and the significant scaling back of other standard tests (e.g., evaluating reproductive toxicity using one, rather than two, generations of offspring, which would save an additional 1,200 or more animals per test). These recommendations have been endorsed by the EFSA PPR Panel, and it is hoped that these and other important changes will be reflected in revised EU plant protection legislation.
Are there other developments that could impact pesticide testing on animals?
Some environmental and consumer protection organisations, unhappy with the continued widespread use of pesticide chemicals, have been lobbying the EU and member states to increase the amount of animal testing that is required before a pesticide can be brought to market. These demands cite concerns regarding potential adverse effects of pesticides on the body’s hormone system (“endocrine disruption”) and on the developing nervous and immune systems of human foetuses, infants and children (“developmental neuro- and immunotoxicity,” respectively). The EU has already adopted a community strategy for endocrine disrupters, as well as a broad environment and health initiative known as SCALE (Science, Children, Awareness, Legal instrument, Evaluation), to further evaluate these emerging health concerns.
Another development with the potential to further increase animal testing is the emerging use of nanomaterials in pesticide products. The ultra-tiny nature of these substances raises unique toxicological questions and concerns, which some stakeholders have claimed can only be answered through long-term animal testing.
What is Humane Society International (HSI) Europe doing to help animals used in pesticides testing?
HSI Europe has been at the forefront of lobbying efforts to ensure that all available, validated non-animal methods and testing strategies achieve expeditious regulatory acceptance in the EU. Additionally, HSI Europe and affiliate organisations The Humane Society of the United States (HSUS) and Humane Society Legislative Fund have assumed a leading role in supporting implementation of the vision of “twenty-first century toxicology” articulated by the U.S. National Research Council, which would see animal tests that are decades old, costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and human-relevant non-animal methods. HSI Europe is calling for a “big biology” project to meet this challenge, akin to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder consortium make this landmark vision a reality as quickly as possible.
How can I help?
Pesticide exposure can be reduced by purchasing organic produce and avoiding meat, dairy and other animal products, which are often contaminated with pesticide and other unappetizing residues. There are also a many alternatives to pesticides for safe and effective lawn and garden care. Also, remember that any product that claims to “kill germs” is regarded as a pesticide, and is subject to substantially more animal testing than equivalent soaps and cleaning products that simply don’t advertise their antibacterial properties. For assistance in identifying cruelty-free soaps and cleaning products, visit LeapingBunny.org.
Updated March 25, 2009