Directorate-General Environment
Directorate-general Environment
Unit B-4
Office Bu-9
6-163
B-1049 Brussels
Bergen 5/6 2006
Comments to Directive 98/8/EC of the European Parliament and of the Council, and the use of the biocides rotenone and piperonyl in Norway.
The Norwegian Environment Protection Association (NMF) is an Norwegian environmental organization (NGO) which was founded in 1993. NMF want to emphasize on the biocides rotenone and piperonyl butoxide which have serious environmental impacts. We have for many years wanted a ban on these active substances.
According to Commission Regulation (EC) No 2032/2003 Rotenone is placed on Annex l, that is existing active substances which have been identified in accordance with the requirements of Article 3 and 5 of Regulation (EC) No 1896/2000. It is also listed under Annex III which contains the list of existing active substances that have been identified but in respect of which there has been neither an accepted notification nor an expression of interest by Member State.
According to the regulations rotenone products are therefore banned and not allowed for use after august 2006.
Piperonyl butoxide is listed under Annex ll which specify the product type in respect of which notification has been accepted or a Member State has expressed an interest.
NMF is kjent med at The Norwegian govenement tries to get permission for using the rotenone products in the future, claiming that rotenone is not a biocide but a veterinary medical product and that there are no alternative substances that can be used to eradicate the parasite Gyrodactylus salaris from Norwegian river systems.
Dette medfører ikke riktighet. Det er nå utviklet gode alternativ til bruk av rotenon.
Nye norsk studie viser lovende resultater med å bruke kontrollerte mengder av utvalgte metallsalter mot lakseparasitten Gyrodactylus salaris.
Poleo AB et.al. (The effect of various metals on Gyrodactylus salaris (Platyhelminthes, Monogenea) infections in Atlantic salmon (Salmo salar. Parasitology. 2004 Feb;128(Pt 2):169-77.) viste at G. salaris ble fullstendig eliminert ved en blanding av aluminium i testvannet på 100 og 200 mikrogram/l, mens 50 mikrogram/l reduserte parasitten uten å fjerne den helt. Det ble dokumentert at vannløselige salter av aluminium med pH lavere enn 6.0 har negativ effekt på atlanterhavslaks.
Atlantic salmon (Salmo salar) parr (age 0+), infected by the ectoparasite Gyrodactylus salaris, were exposed to aqueous aluminium (Al), copper (Cu), zinc (Zn), iron (Fe) and manganese (Mn), at 4 different concentrations. There was a negative correlation between G. salaris infections and metal concentrations in both Zn- and Al-exposed salmon. In the Zn-experiment, all 4 concentrations tested caused a decrease in the G. salaris infections, while in the Al-experiment the G. salaris infection did not decline at the lowest concentration. The number of G. salaris increased continuously during the experiments in all control groups, and in all groups exposed to Cu, Fe and Mn. At the highest concentration, however, copper seemed to impair the growth of G. salaris infection. The results show that aqueous Al and Zn are environmental factors of importance controlling the distribution and abundance of the pathogen G. salaris. Other pollutants might also have an influence on the occurrence of G. salaris. Finally, the results demonstrate that aqueous Al and Zn have a stronger effect on the parasite than on the salmonid host, suggesting that both metals may be used as a pesticide to control ectoparasites such as G. salaris.
Et fullskalaforsøk som inkluderer denne metoden er utført i Batnfjordselva i Møre og Romsdal med godt resultat.
We will emphasize that, according to Article 2 in the Directive, biological products are active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.
A veterinary medical product is defined in European legislation (Article 2 of Directive 2001/82/EC) as: “Any substance or combination of substances presented for treating or preventing disease in animals”.
Any substance or combination of substances which may be administered to animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in animals is likewise considered a veterinary medical product”.
A chemical substance that kills the patient (host) before it kills the infection (parasite) can not be defined as a veterinary medical product in accordance with this definition.
According to U.S. EPA Health assessment information rotenone is a none-specific botanical insecticide with some acaricidal properties. Rotenone is used in home gardens for insect control, for lice and tick control on pests, and for fish eradications as part of water body management.
Both IPMRC (Integrated Pest Management Resource Centre), North Carolina Agricultural Chemical Manual, Agrochemical Control Option (Australia) and The UK Pesticide Guide mentions rotenone as a botanical Insecticide.
According to notes from the winter scientific meeting held at the Royal College of Veterinary Surgeond, London on 28.november 1997, Tony Owen, Head of Fisheries in England and Wales, stated that “the parasite (G. salaris) is now found extensively in France were Rotenone – a piscicide - has been used to kill all fish in a river.”
Rotenone is here defined as a piscicide.
Up to now Norwegian authorities have defined rotenone-products in a similar way.
The Norwegian Directorate for Nature Management last year ordered a report from Centre for Veterinary Contract research and Commercial Services in Oslo entitled “ Therapeutic substances against the salmon parasite Gyrodactylus salaris”
This report states that “rotenone is a piscicide, i.e. a substance which kill fish. Therefore it need to be replaced with a substance that kill the parasite without killing the host (a pure parasiticide).”
Clearly, the Norwegian authorities themselves distinguish between a biocide/piscicide (like rotenone) and a therapeutic substance (veterinary medical product).
Gyrodactylus salaris is a monogenean ectoparasite of fish that occurs in a number of European countries, and that has had devastating effects on Atlantic salmon stocks in rivers, most notably in Norway. The usual method of control in Norway is treatment of the affected rivers with a product called CFT-Legumin where rotenone is the active substance and piperonyl butoxide is used as a synergist. This is a very severe treatment, resulting in the death of all vertebrates and most insects and other invertebrates breathing with gills in the river (not only the target species).
Fish death is a result of rotenone inhibiting mitochondrial NADH-ubiquine reductase, which makes oxygen unavailable for respiration.
Most of these consequences of rotenone use are rejected by the Norwegian authorities which is contradictory to a great amount of scientific papers.
Mangum,F.A. and Madrigal,J.L.(Rotenone effects on Aquatic Macroinvertebrates of the Strawberry River, Utah: A Five-years Summery; in Journal of Freshwater Ecology, Volume 14, Number 1, 1999) found (for example) that statistical analysis of the data indicated that the application of rotenone had a significant impact on sixty- six percent of the benthic invertebrate taxa. 21 % of the taxa were still missing after five years.
After the treatment with rotenone-product in the famous salmon-river Lærdalselven in western Norway in 1997, the population of trout was totally eradicated, and the parasite was back in the river shortly after the treatment.
Pekka Tuunainen investigated the effect of rotenone-use in Julkujervi, Finland and found that the poison did not disappear from the river the following winter, and that the brown trout and rainbow trout released the following spring had all died. The toxic effect of rotenone on the zooplankton lasted for about eight to nine months before it was inactivated with KMnO4. Rotenone decomposes in water to at least 20 degradation products, of which one is toxic.
According to U.S. EPA rotenone has local effects on the body include conjunctivitis, dermatitis, sore throat, and congestion. Ingestion produces effects ranging from mild irritation to vomiting. Inhalation of high doses can cause increased respiration followed by depression and convulsions.
The carcinogenicity of rotenone is a controversial issue. It has been suggested that rotenone may cause tumours in vitamin-deficient animals (Gozalvez,M. 1983. Carcinogenesis with the insecticide rotenone. Life Science 32: 809-816).
It has serious reproductive effects. Pregnant rats fed 10 mg/kg/day on days 6 through 15 of gestation experienced decreased fecundity, increased fetal resorption, and lower birth-weight.
Fetotoxity and failure of offspring are reported in guinea pigs. Several epidemiological studies have hinted at a role for pesticides in the development of Parkinson´s disease. Studies have found that farmers, people who live in rural areas, and people who drink well water are more likely to have Parkinson disease than people who do not.
According to the results of a Emory University study, recently published in Nature Neuroscience, the disease has been linked to rotenone.
Rotenone was found to produce all the symptoms of Parkinson´s disease in a study on rats. When exposed to (low dosages) of the chemical for long periods of time, the rats grew stiff, hunched over and developed tremors – the kind of symptoms that develop in Parkinson´s disease.
Other studies as well have shown teratogenic effects: Pregnant rats fed 5 mg/kg/day produced a significant number of young with skeletal deformities.
In a teratogenicity study on rotenone (Khera,K.S. et.al., 1982: Teratogenicity study on pyrethrum and rotenone (natural origin) and ronnel in pregnant rats, J Toxicol Environ Health; 10(1): 111-9 jul82)
rotenone was associated with an increased number of nonpregnant rats, reduction in maternal body weight gain, fetal weight, and skeletal ossification.
Pesticide exposure seems to contribute to the epidemic of attention deficit hyperactivity disorder (ADHD), and rotenone is now linked to the disease (Dr.med. Terje Sagvolden in Behavioral and Brain Science 2004).
According to Article 10 in Directive 98/8/EC an active substance cannot be included in Annex l A if it is classified as (among others) toxic for reproduction. It is obvious in light of the information above that rotenone has serious impacts on reproduction, and should be classified as extremely toxic for reproduction. The probability that rotenone, if there had been a notification, had been included in Annex l is therefore extraordinary low.
It is also obvious that the killing of not only the parasite, but also the hosts and non-target species and organisms give rise to great concern.
According to Article 10 (5 i) an entry of an active substance in Annex l (Directive 98/8/EC) may be refused if “risk to health or the environment still give rise to concern” and “if there is another active substance on Annex l for the same product type which, in the light of scientific or technical knowledge, presents significantly less risk to health or to the environment”.
NMF want to emphasize that there are better environmental alternatives to rotenone-products in regard to the problem with the parasite Gyrodactylus salaris.
Gyrodactylus salaris is particularly sensitive to aluminium in acidified water, and use of metal ions to kill the parasite is showing promising results in tests. Norwegian scientists found that aqueous aluminium eliminate parasites after only 4 days, without killing the hosts.
Results suggest that aluminium treatment could form an effective disinfection method against ectoparasites in hatcheries, as well as an alternative to the controversial rotenone treatments used against natural populations of G.salaris.
Results of challenge experiments using G. salaris have shown that salmon stocks from the Baltic area appear to be resistant to the parasite, while Atlantic salmon stocks are highly susceptible. This difference in resistance have a genetic basis. The present scientific results provide evidence that: (1) Norwegian salmon stocks are variable in their susceptibility/resistance, with some fish able to control S. salaris infections; (2) trout stocks are innately resistant to G. salaris; (3) susceptibility/resistance traits to gyrodactylids are genetically controlled and resistance can be transferred as a dominant trait through interspecific crosses between different salmonids; (4) resistance to gyrodactylids may be controlled by relatively few genes in salmonids.
That the ability to tolerate infections is related to parr size and that some fish, irrespective of size, can obviously control the infection, has important evolutionary consequences for this parasite-host association and is of practical importance because it provides a basis for genetic selection and manipulation. Selective salmon breeding from survivors able to control the infection in experiments, and stocking of infected rivers with their progeny, could enhance the effects of natural selection in restoring rivers to their former status. This method can then be used as an alternative to rotenone-treatment.
The Norwegian authorities claims that this method can not be used, since Norway is under obligation to eradicate alian species (according to the Rio-Convention).
Therefore NMF want to emphasize that, according to Article 8g and h in the Rio-Convention, “each Contracting Party shall, as far as possible and as appropriate, in particular for the purposes of Article 8 to 10: Prevent introduction of, control or eradicate those alian species which threaten ecosystems, habitats or species”.
In document UNEP/CBD/SBTTA/3/inf.18 from the 3.th Meeting in the Susidiary body for Scientific, technical, and Technological Advice (SBSTTA) in 1997 (consult Convention on Biological Diversity article 25) it is emphasised that: “We know of no cases in which programs to eradicate an introduced species have been successful.
We should, therefore, accept that most introductions are irreversible events, and emphasise mitigation rather than eradication.
We believe in most cases it will be a waste of money to try to eradicate an introduced species.” The document refers to rotenone-treatment in Norwegian rivers, stating that “rotenone treatment causes political and cultural conflicts in society, as well as negative ecological effects”.
Furthermore, NMF want to emphasize that rotenone is a poison which give rise to concern in regard to human health, and should therefore not be listed on Annex l.
According to U.S. EPA 26 cases of pesticide-related illness attributable to
occupational use of flea-control products were reported in California during 1989 – 1997. Responsible active ingredients were pyrethrin/piperonyl butoxide (five cases) and rotenone/pyrethrin (five cases) (MMWR Weekly, June 04, 1999 / 48(21); 443-447).
We can conclude that rotenone is a biocide substance of concern which have great unacceptable effects on both target and non-target species (they are killed), as well as having unacceptable effect on both human and animal health and has great unacceptable effect on the environment (killing none-target organisms).
There are acceptable alternatives that are more environmental preferable.
Due to these facts the Norwegian authorities should not get any exceptions to the rules in Directive 98/8/EC.
dr.scient. Åge Simonsen
Executive officer
Kurt Oddekalv
Leader of NMF