Toelatingsnummer 10568 N

Agrichem Ethofumesaat (2)  

 

10568 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 WIJZIGING TOELATING

 

Gelet op het verzoek d.d. 19 juli 2007 (20070661 WGGAG) van

 

Agrichem B.V.

Koopvaardijweg 9

4906 CV  OOSTERHOUT NB

 

 

tot wijziging van de toelating als bedoeld in artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden (Staatsblad 2007, 125)  van het gewasbeschermingsmiddel, op basis van de werkzame stof ethofumesaat

 

Agrichem Ethofumesaat (2)

 

gelet op artikel 41, tweede lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

§ I  Wijziging toelating

De toelating van het middel Agrichem Ethofumesaat (2) is laatstelijk bij besluit d.d.
27 februari 2007
verlengd tot 28 februari 2013. De toelating van het middel Agrichem Ethofumesaat (2) wordt gewijzigd en is met ingang van datum dezes toegelaten voor de in bijlage I genoemde toepassingen.Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

 

§ II  Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

 

§ III  Gebruik

Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I onder A bij dit besluit is voorgeschreven.

 


§ IV Classificatie en etikettering

 

Gelet op artikel 29, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden,

 

1.    De aanduidingen, welke ingevolge artikel 36 van de Wet milieugevaarlijke stoffen en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

aard van het preparaat: vloeistof

 

werkzame stof:

gehalte:

ethofumesaat

200 g/l

 

 

 

op verpakkingen die (mede)  bestemd zijn voor huishoudelijk gebruik: het kca-logo

(het kca-logo is het logo voor klein chemisch afval bestaande uit een afvalbak met een kruis erdoor als opgenomen in bijlage III bij de genoemde Nadere regels)         

 

letterlijk en zonder enige aanvulling:

 

andere zeer giftige, giftige, bijtende of schadelijke stof: xyleen

 

 

gevaarsymbool:

aanduiding:

Xn

Schadelijk

 

 

Waarschuwingszinnen: 

 

Ontvlambaar.

Irriterend voor de huid.

Schadelijk voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

Schadelijk: kan longschade veroorzaken na verslikken.

 

 

Veiligheidsaanbevelingen:

 

Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart.

Bij inslikken niet het braken opwekken, direct een arts raadplegen en de verpakking of het etiket tonen.

 

Specifieke vermeldingen:

 

Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen.

 

2.    Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten voorge­schreven aanduidingen en vermeldingen moeten op de verpakking voorkomen:

 

a.       letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.

 

b.      hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn
.

 

c.      bij het toelatingsnummer een cirkel met daarin de aanduiding W.2.

 

2 DETAILS VAN HET VERZOEK EN DE TOELATING

 

2.1 Verzoek

Het betreft een verzoek tot wijziging van de toelating van het middel Agrichem Ethofumesaat (2)  (10568 N), een middel op basis van de werkzame stof ethofumesaat. Het middel is toegelaten als als onkruidbestrijdingsmiddel in de teelt van suiker- en voederbieten.

 

De gevraagde wijziging betreft:

Het verwijderen van de restrictiezin van het Wettelijk Gebruiksvoorschrift: “Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden.”

 

2.2 Informatie met betrekking tot de stof

Ethofumesaat is een bestaande werkzame stof, geplaatst op Bijlage I van Richtlijn 91/414/EEG (Publikatieblad van de Europese Gemeenschappen, richtlijn 2002/37/EG van 3 mei 2002). Ethofumesaat is geplaatst tot en met 28 februari 2013.

Er zijn in Nederland andere middelen op basis van de werkzame stof ethofumesaat toegelaten.

 

2.3 Karakterisering van het middel

Agrichem Ethofumesaat Flowable is een herbicide met als werkzame stof ethofumesaat die in middelen als enige werkzame stof is toegelaten, maar ook in diverse combinaties zoals met desmedifam, fenmedifam en metamitron. Ethofumesaat behoort tot de groep van benzofuran. Het werkingsmechanisme is gebaseerd op de remming van de vetzuursynthese, waardoor onder meer de vorming van een celmembraan wordt belemmerd. De groei van de meristemen wordt geremd en de celdeling vertraagt. Deze stof heeft een systemische werking in de plant en wordt opgenomen door het blad. De opname door het blad (incl. opnamesnelheid) neemt af naarmate de onkruiden groter zijn. Ethofumesaat werkt op éénjarige grassen en éénjarige tweezaadlobbige onkruiden.

 

2.4 Voorgeschiedenis

De aanvraag is op 19 juli 2007 ontvangen; op 24 juli 2007 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 11 januari 2008 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

 

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is de Regeling gewasbescherming en biociden (Rgb) H2.

 

3.1  Fysische en chemische eigenschappen

Niet van toepassing gezien de aard van de aanvraag.

 

3.2  Analysemethoden

Niet van toepassing gezien de aard van de aanvraag.

 

3.3  Risico volksgezondheid

Niet van toepassing gezien de aard van de aanvraag.

 

3.4  Risico voor het milieu

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met de volgende aspecten:

-          de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat betreft besmetting van het water, waaronder drinkwater en grondwater,

-          de gevolgen voor niet-doelsoorten.

(artikel 28, eerste lid, sub b, onderdeel 5, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.

Het profiel gedrag en lotgevallen staat beschreven in Hoofdstuk 6 in Bijlage II bij dit besluit. Het profiel Ecotoxicology staat beschreven in Hoofdstuk 7 in Bijlage II bij dit besluit.

 

3.5  Werkzaamheid

Niet van toepassing gezien de aard van de aanvraag.

 

3.6  Eindconclusie

Bij gebruik volgens het gewijzigde Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Agrichem Ethofumesaat (2) op basis van de werkzame stof ethofumesaat voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, Wet gewasbeschermingsmiddelen en biociden).

 

4 AFLEVER- EN/OF OPGEBRUIKTERMIJN 

 

Niet van toepassing gezien de aard van de aanvraag.

 

 

 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

 

Wageningen, 7 maart 2008

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





(voorzitter)

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 7 maart 2008 tot wijziging van de toelating van het middel Agrichem Ethofumesaat (2), toelatingnummer 10568 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als onkruidbestrijdingsmiddel in de teelt van suiker- en voederbieten.

 

Ethofumesaat mag slechts om de 3  jaar worden toegepast.

De totale dosering in één seizoen mag niet groter zijn dan 1,0 kg ethofumesaat per hectare.

 

Toepassing met een luchtvaartuig is niet toegestaan.

 

Dit middel is schadelijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

B.

GEBRUIKSAANWIJZING

 

Algemeen

Agrichem Ethofumesaat (2) is een bodemherbicide met systemische werking via de ondergrondse delen van de onkruiden. Vochtige grond op het moment van toepassen en enige neerslag nadien bevorderen de werking. De gewassen moeten echter bij behandeling droog zijn. Met uitzondering van kamille bestrijdt Agrichem Ethofumesaat (2) een breed spectrum éénjarige onkruiden waaronder kleefkruid. Waterhoeveelheid: 200-300 liter per ha.

 

Toepassingen

Agrichem Ethofumesaat (2) is na-opkomst alleen werkzaam in combinatie met fenmedifam (157 g/l). Deze tankmenging geeft een goede bestrijding tot in het 4-6 bladstadium van de meeste tweezaadlobbige zaadonkruiden.

 

Deze combinatie komt vooral in aanmerking voor toepassing op zand- en dalgronden en specifiek voor de bestrijding van veelknopigen en kleefkruid op alle grondsoorten.

 

Dosering:

-        Vanaf het 2 bladstadium (BBCH 12) van de biet:
1,5 liter Agrichem Ethofumesaat (2) + 3,5 liter fenmedifam (157 g/l

Zonodig na 10-14 dagen een tweede bespuiting uitvoeren met 1,5 liter Agrichem Ethofumesaat (2) + 3,5 liter fenmedifam (157 g/l). Tijdelijk kan enige gewasbeschadiging optreden, vooral van kleine bietenplantjes. De eerste 2 echte blaadjes moeten daarom bij alle bieten min. 1 cm groot zijn alvorens een behandeling wordt uitgevoerd en de onderstaande restricties dienen opgevolgd te worden.


 

-        Vanaf het 4 bladstadium (BBCH 14) van de biet:
2,5 liter Agrichem Ethofumesaat (2) + 5 liter fenmedifam (157 g/l) als enkelvoudige behandeling.

 

Mengvoorschriften

Agrichem Ethofumesaat (2) toegepast in combinatie met fenmedifam (157 g/l):

-           Giet 20-50 liter water in de tank

-           Voeg fenmedifam toe en zet het roersysteem in werking

-           Voeg water toe tot de helft van de benodigde hoeveelheid

-           Voeg Agrichem Ethofumesaat (2) toe

-           Vul verder aan met water

 

Laat de roerinrichting in werking, zowel bij het vullen van de tank als tijdens het spuiten.

 

Restricties:

-        Spuit alleen op een afgehard en gezond bietengewas, dat niet verzwakt is door insecten,
stuifschade, nachtvorst of herbiciden.

-        Spuit niet bij maximale dagtemperatuur boven 18°C en niet bij scherp zonnig weer. In deze gevallen bij voorkeur ‘s avonds spuiten.

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 7 maart 2008 tot wijziging van de toelating van het middel Agrichem Ethofumesaat (2), toelatingnummer 10568 N

 

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product            2

 

2.   Physical and chemical properties                      2

 

3.   Methods of analysis                                             2

 

4.   Mammalian toxicology                                         2

 

5.   Residues                                                               2

 

6.   Environmental fate and behaviour                    2

 

7.   Ecotoxicology                                                     14

 

8.   Efficacy                                                                14

 

9.   Conclusion                                                          14

 

10. Classification and labelling                              15

 


1.         Identity of the plant protection product

 

1.1       Applicant

Agrichem b.v.

Koopvaardijweg 9

4906 CV Oosterhout

The Netherlands

 

1.2       Identity of the active substance

The identity of the active substance remains unchanged.

 

1.3       Identity of the plant protection product

The identity of the plant protection product remains unchanged.

 

1.4       Function

Agrichem Ethofumesaat (2) is an herbicide.

 

1.5       Uses applied for

The uses applied for remain unchanged.

 

1.6       Background to the application

The registration holder applied for the removal of the following restriction sentence: “Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden. ” from the label for use.

 

1.7       Packaging details

The packaging details remain unchanged.

 

 

2.      Physical and chemical properties

The physical and chemical properties remain unchanged.

 

 

3.      Methods of analysis

The methods of analysis remain unchanged.

 

 

4.      Mammalian toxicology

The chapter mammalian toxicology remains unchanged.

 

 

5.      Residues

The chapter residues remains unchanged.

 

 

6.      Environmental fate and behaviour

 

The following assessment was carried out for re-registration of the plant protection product Agrichem ethofumesaat (2) (based on ethofumesate, 500 g/L SC) (February 23rd , 2007) as an herbicide, in the uses listed in Table M.1.

 


Table M.1 Overview of intended use

Use

Application rate a.s.

[kg/ha]

Frequency

Interval

[days]

Time of application

Beets* (1)

0.3

2

10-14

Spring, after emergence

(2)

0.5

1

-

Spring, after emergence

* Only in combination with phenmedipham (157 g/L):

(1): + 3.5 L/ha phenmedipham = 0.550 kg a.s./ha

(2): + 5 L/ha phenmedipham = 0.785 kg a.s./ha

 

The use in grasslands and grass seeds has been withdrawn.

 

In the monograph the following passage is included:

 

“The maximum amount of active substance per season per hectare must not exceed 1.0 kg every 3 years.

 

Extension of the use pattern beyond those described above will require an evaluation at Member State level in order to establish whether the proposed extensions of use can satisfy the requirements of Article 4(1) and of the uniform principles laid down in Annex VI of Directive 91/414/EEC. “

 

List of Endpoints Fate/behaviour (May 15, 2002)

Only the endpoints of the studies relevant to the application are given.

 

 

Fate and Behaviour in the Environment

 


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Mineralization after 100 days

Range 6 - 13%; median 8.7%; n=5

Non-extractable residues after 100 days

Range 16 - 34%; median 31%; n=5

Relevant metabolites - name and/or code, % of applied (range and maximum)

All less than 6%

 

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Anaerobic degradation

Not relevant because of very slow transformation

Soil photolysis

In one study: maximum conc. of NC8493 30%

 

           

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Method of calculation

9 of 10 calculated according to 1st order kinetics,

1 of 10 calculated according to 1.5 order kinetics

Laboratory studies (range or median, with n value,

with r2 value)

DT50lab (20°C, aerobic, 40 - 75% WHC):

Range 47 – 211 days; mean 97 days;

median 84 d n=10

 

DT90lab (20°C, aerobic, 40 - 75% WHC):

Range 210 – 701 days; median 331 days; n=10

 

DT50lab (10°C, aerobic): No study

Calculation of DT50 at 10°C carried out on eight DT50 laboratory tests (20-21°C, aerobic) using Q10=2.2.

Results: DT50, (10°C, aerobic): 198 days.

 

DT50lab (20°C, anaerobic):

Very slow transformation: 90-100% unaltered after 60d.

 

Degradation in the saturated zone: No study

Soil photolysis

DT50, two studies:

14 d; ³290 nm, 24 h light 1.5 kg as/ha.

 65 days; 300-800 nm, light 12 h per day, 15 mg as/kg.

Field studies (state location, range or median with

n value)

DT50f:

Germany: One dose range 0.8 - 6.5 kg as/ha: range 15 - 250 days; median 65 days; n=10. Not dose related

 

UK:  One dose 1.5 kg as/ha: 36 and 56 days; mean 46 days; n=2

 

California, USA: 2.1 kg as/ha: 75 days; n=1

Calculated mean of all = 77 d; median = 56 d; n=13

 

DT90f:

Germany: One dose range 0.8 - 6.5 kg as/ha: range 3 months - >3 years; median ca.11 months; n=11

 

UK:  One dose 1.5 kg as/ha: 4 and 4.6 months, mean 4.3 months; n=2

Soil accumulation and plateau concentration

No relevant data.

Accumulation calculated based on a field DT50 = 119 days assuming 5.0 cm incorporation

a)      Application of 1.0 kg as/ha and year, a plateau concentration of 114% of maximum PECsoil reached after 3 years. Plateau concentration 1.5 mg as/kg soil.

 

Application 1.0 kg as/ha each third year new GAP dec. 1999). There was no significant accumulation. Three years after applic. 0.1% of dose remained.

 


Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf /Koc

Kd

pH dependence (yes / no) (if yes type of

dependence)

Koc = range 97 - 245; mean = 147; median 132; n=11

 

Kd = range 0.73 – 6.2; mean = 2.7; median 2.3; n=11

Not pH dependent

Koc sediment

Koc = 267 and 449; mean 358, n=2

Kd  = 6.1 and 19.4; mean 12.8, n=2

 

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching

 

According to BBA Guideline: 200 mm over 2 days: n.d.-2.9% as; n=9

Other method, 508 mm over 15-20 d.: 4.2-67% of applied radioactivity; n=4

Aged residues leaching

 

Three different methods: n.d.-4.2% of applied initial radioactivity; n=5

Lysimeter/ field leaching studies

 

Two studies according to BBA guideline:

 

Two lysimeters per study:

1.      Three lysimeters with loamy sand soil. Lysimeter surface area 0.5 m2 and 1.0 m depth. One dose of 1.25 kg as/ha applied pre-emergence to sugar beet in April 1992. Rainfall of ca. 857 mm/year. Terminated after 2 years.
LOD = 0.1 µg/L

 

2.      Two lysimeters with a sandy soil.Lysimeter surface area 1.0 m2 and 1.2m depth. One dose of 1.5 kg as/ha applied to fodder beet on both lysimeters in May year 1 and additionally to one lysimeter in May year 2. Total rainfall (4 years) 3280 mm. Terminated after 3 years. LOD = 0.01 µg/L

 

Results: No detectable amount active substance or metabolite in leachate in any of the lysimeters.

 

 

6.1.2    Leaching to shallow groundwater

The leaching potential of the a.s. (and metabolites) is calculated in the first tier according to the RUUBG, using Pearl 2.2.2. and the FOCUS Kremsmünster scenario. The methodology as described in the report "The new decision tree for the evaluation of pesticide leaching from soils", A.M.A van der Linden, J.J.T.I. Boesten, A.A. Cornelese, R. Kruijne, M. Leistra, J.B.H.J Linders, J.W. Pol, A. Tiktak and A.J Verschoor, RIVM report 601450019/2004, RIVM, Bilthoven (2004) has to be used. Input variables are the actual worst-case application rate [1.5 kg/ha], the crop [crop, sugarbeets] and an interception value appropriate to the crop of [0.8]. For metabolites all available data concerning substance properties are regarded. Metabolites are modelled as parent. The application rate is corrected for formation rate and molecular weight relative to the parent substance. The following input data are used for the calculation:

 

PEARL:

 

Active substance:

Mean DT50 for degradation in soil (20°C):  84 days

Mean Kom (pH-independent): 78 L/kg .

 

Saturated vapour pressure: 6.5 x 10-4 Pa (25 ŗC)

Solubility in water: 0.05 g/L (25 ŗC)

Molecular weight: 286.3 g/mol

 

Other parameters: standard settings of PEARL 2.2.2

 

The following concentrations are predicted for the a.s. ethofumesate following spring applications, see Table M.2.

 

Table M.2(a) Leaching of a.s. ethofumesate as predicted by PEARL 2.2.2

Use

Substance

Rate substance

Frequency

Interval

Fraction

intercepted

PEC

groundwater

 

 

[kg/ha]

 

 [days]

 

spring

[mg/L]

Beets

Ethofumesate

0.3

2

10

0.8

1.56

 

 

0.5

1

-

0.8

1.25

 

Results of Pearl 2.2.2. using the Kremsmünster scenario are examined against the standard of 0.01 µg/L. This is the standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

 

From Table M.2(a) it reads that the expected leaching based on the PEARL-model calculations for the a.s. ethofumesate larger than 0.1 µg/L. Therefore, further study into the leaching behaviour is necessary.

 

In the second tier, leaching in the area of potential application is evaluated using the spatial distribution model GeoPEARL 1.1.1.

 

GeoPEARL

The leaching potential of substances to the shallow groundwater in the area of potential application within The Netherlands is calculated using the GeoPEARL model. The same input data as used in the first tier with Pearl 2.2.2. is employed. Additional input is the crop and the number of runs (plots). For results see Table M.2b.

 

Table M.2b Leaching of a.s. ethofumesate as predicted by GeoPEARL 1.1.1.

Use

Substance

Rate a.s.

Frequency

Interval

Fraction

intercepted

PEC

groundwater

 

 

[kg/ha]

 

 [days]

 

spring

[mg/L]

Beets (1)

Ethofumesate

0.3

2

10

0.8

1.29

(2)

 

0.5

1

-

0.8

0.99

 

GeoPEARL calculations show that the predicted leachate concentrations for ethofumesate are larger than 0.1 µg/L. Therefore, the proposed use of the active substance is not permissible. Monitoring data or a lysimeter study is required.

 

Lysimeter/field leaching studies

Agrichem has submitted a lyimeter study. In this study ethofumesate was not found in the leached water. An assessment to the vulnerability of the soil, according to Verschoor et al., (2001), the soil profile was more vulnerable than the Dutch standard soil. The amount of precipitation and irrigation was comparable. However, due to a higher soil temperature, the lysimeters were less vulnerable. Also the amount of water leached, was lower.

The lysimeter study was standardised according to Verschoor (2001). The standardisation resulted in a simulation error of 2 x 10-12. This error is irrelevant for risk assessment. Results for the PEARL calculation can therefore not be corrected for the simulation error.

 

It can be concluded that the lysimeter was not vulnerable enough for the Dutch situation. Therefore, the proposed use of the active substance is not permissible. Monitoring data or a lysimeter study comparable to the Dutch situation is required.

 

A second lysimeter study has been submitted together with a standardisation according to Verschoor (2001). Also in this lysimeter no ethofumesate was found in the leachate. However the same argumentation with regard to vulnerability as above is true. Furthermore, according to the report by Verschoor a quantitative vulnerability assessment can only be sufficient if a lysimeter study was triggered by a slight exceedance of the trigger concentration by the model calculations.

Standardisation of the lysimeters on the basis of the standard dossier data according to Verschoor revealed a simulation error of 0.75.

For the lysimeter soil a preliminary sorption test was performed that resulted in a Kom value of 106 L/kg. This value can be used for the standardisation calculation. If the value is used together with the worst case DT50 value of 47 days a simulation error of  262 is calculated. If the simulation error is used as correction factor on the model results the estimated concentration in the groundwater is <0.01 mg/L.

In the lysimeters during the experiment the concentration ethofumesate was measured in the top layers of the soil. There are 3 timepoints available. From these measurements a half-life in the lysimeter topsoil can be estimated.

From these calculations a lysimeter half-life of 29.4 days was derived. Standardisation using the lysimeter specific DT50 and Kom value revealed a simulation error of 14.5.

As a result the adjusted estimate for the concentration in groundwater is as reported in table M.3.

 

Table M.3 Adjusted estimate leaching of a.s. ethofumesate

Use

Substance

Rate a.s.

Frequency

Interval

PEC

groundwater

 

 

[kg/ha]

 

 [days]

spring

[mg/L]

Beets (1)

Ethofumesate

0.3

2

10

0.092

(2)

 

0.5

1

-

0.07

 

The adjusted estimates show that the predicted leachate concentrations for ethofumesate are smaller than 0.1 µg/L. Hence, the active substance meets the standards for the proposed applications. However, as the predicted concentration is larger than 0.01 µg/L, a restriction on the use in groundwater protection areas should be placed on the label.

 

Monitoring data

The notifier submitted monitoring data from groundwater monitoring from five locations in Denmark and from a regional survey in the Netherlands. Notifier submitted statements that at greater depths in none of the samples ethofumesate was detected. The original reports were not submitted. In the Danish study for most of the locations the filter depth is missing. For the Dutch survey also essential information is missing to be able to use the monitoring data in the assessment. Therefore, these are considered supplemental information.

 

Conclusions

The proposed application of the product complies with the requirements concerning leaching to shallow groundwater. However, as the predicted concentration for ethofumesate is larger than 0.01 µg/L, a restriction on the use in groundwater protection areas should be placed on the label.

 

(End of assessment for re-registration of Agrichem Ethofumesaat (2) d.d. February 23rd , 2007)

 

By letter of July 19 2007 Agrichem provided some new reports in order to delete the restriction sentence “Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden. ”. 

1.  Ethofumesate Calibration of lysimeter study 836695, Dr. H.J.M. Verhaar, Environ
Document: 77AC-LYS2-20070002, 12 July 2007

2.             Degradation of '4C- Ethofumesate in one soil incubated under aerobic conditions, Dr. J. Hellstern, RCC Study No.: B01901, 4 July 2007

3.             Adsorption/desorption of I4C- Ethofumesate on soil - advanced test, Dr. J. Hellstern, RCC Study No.: B01912, 4 July 2007.

 

Recently an extra lysimeter study has become available. This study is summarized and evaluated in RIVM report 11495A00.

 

1.      Diehl M. 2005. Ethofumesate: mobility and degradation in soil in outdoor lysimeters. Itingen, Switzerland: RCC Ltd. Report no. 836706. 118 pp. Data provided by AgriChem B.V. Confidential: Y.

2.      Verhaar HJM.  2007. Ethofumesate - Calibration of lysimeter study 836706. Zeist, the Netherlands: Environ Netherlands B.V. Report no. 77AC-GRAS-20070048. 34 pp. Data provided by AgriChem B.V. Confidential: Yes.

 

Reaction of Ctgb:

Study 1.

Ethofumesate Calibration of lysimeter study 836695, Dr. H.J.M. Verhaar, Environ
Document: 77AC-LYS2-20070002, 12 July 2007

 

Environ Document 77AC-LYS2-20070002 shows based on the parallel studies with the lysimeter soil of ethofumesaat (respectively 60.5 days and 108 L/kg at 20 °C) (RCC study no. 836695), a real SE of > 4513.

 

The study is considered complete and adequate. A calculation of the adjustment factor according to Van der Linden et al. based on the available SE values is lacking.

 

Study 2.

Degradation of '4C- Ethofumesate in one soil incubated under aerobic conditions, Dr. J. Hellstern, RCC Study No.: B01901, 4 July 2007

 

GLP: Y Guide line: SETAC en OECD 307

1 soil: lysimeter soil, loamy sand

DT50 value of 60,5 days.

 

DT50 value is recalculated according to Guidance Document on Estimating Persistence and Degradation Kinetics FOCUS (2005)[1].

DT50: 58.8 d (c2: 5.9)

 

The study is considered complete and adequate.

 

Study 3.

Adsorption/desorption of I4C- Ethofumesate on soil - advanced test, Dr. J. Hellstern, RCC Study No.: B01912, 4 July 2007.

 

GLP: Y  Guideline: OECD 106

Number of soils: 1 lysimeter soil, loamy sand

 

ethofumesaat

 

 

 

 

 

 

 

 

 

 

 

 

soil

type

rep

pH(CaCl2)

%OC

SLratio

KF

1/n

Pcrit

Koc-calc

Koc-dos

Kom-calc

kom-dos

lysimeter

loamy sand

1

6.67

1.41

0.33

2.634

0.93

0.86922

186.81

187

108.36

108.00

arithmetic mean

 

 

 

 

 

 

0.93

0.87

186.81

187.00

108.36

108.00

 

The soil used fulfills the p criterium (p > 0,1) and the same values are calculated.

The Kom value of the lysimeter soil is 108.4 L/kg.

 

The study is considered complete and adequate.

 

Study 4.

Third lysimeter study (Diehl)

 

Substance

Soil type1

Location

Dose

 

[kg as/ha]

Month of

application

OM1

 

[%]

pH1

 

[KCl]

Leached

 

[%]

Ri

ethofumesate, 200 g/L EC

loamy sand

Itingen, Switzerland

2

October 10, 2001

3.0

5.6

0%

1

ethofumesate, 200 g/L EC

loamy sand

Itingen, Switzerland

2

October 10, 2001

3.0

5.6

0%

1

1in top 30 cm soil layer

 

Test substance

Ethofumesate 200 g/L EC, containing 14C-ethofumesate, purity 98.12%.

Soil

Undisturbed soil monoliths from agricultural land in Borstel/Neustadt a. R., Lower Saxony/Germany. For characteristics, see Table below.

2.       Characteristics of lysimeter soil

Parameter

Horizon

Horizon

Horizon

Horizon

0-30 cm

30-60 cm

60-90 cm

90-120 cm

Soil type (USDA)

loamy sand

sand

sand

sand

pH (KCl)

5.60

5.36

4.95

5.09

OC (%)

1.77

0.30

0.08

0.00

CEC (meq/ 100g dry soil)

7.12

3.16

0.93

0.68

 

Planting details

Crop: Grass, sown on September 7, 2001, sowing density 33 g/m2, cutting of grass on March 20, May 22, July 17, August 15, September 27 in 2002 and on June 6, 2003.

 

Results

Application

Application losses amounted to about 2 and 3%.

Environmental conditions

Precipitation

In the first year (days 0-384), the natural precipitation amounted to 1055.6 mm. In May, July and October 2002, the monthly amounts of precipitation were clearly much higher compared to the long-term average (147 to 218%). Additional irrigation was not performed.

In the second year (days 385-737), the precipitation amounted to 853 mm. In November 2002 and October 2003, 221 and 145% of the long-term average precipitation was recorded. Additional irrigation was performed in June and July 2003 to assure proper plant growth.

Temperature

The annual average temperatures were slightly higher than the long-term average (1961-1990) of 9.7 °C and reached values of 10.3 °C in 2001 and 11.0 °C in 2002.

Leachate collected

During the first year the quantity of leachate amounted to 588 and 604 L for lysimeter 1 and 2, respectively. These values represent about 56-57% of the precipitation within this period.

During the second year the quantity of leachate amounted to 422 and 442 L, respectively. These values represent about 46 and 48% of the precipitation and irrigation within this time period.

Distribution of radioactivity

Leachates

radioactivity collected in the lachates is given in the table below

3.       Radioactivity in the leachates

 

Lysimeter 1

 

Lysimeter 2

 

Year 1

Year 2

 

Year 1

Year 2

radioactivity (% applied)

1.7

0.7

 

1.5

0.6

mean concentration (µg parent equiv./L)

5.51

3.26

 

4.45

2.34

 

In the leachates, 14CO2 amounted to 0.09 and 0.08% of AR, corresponding to 3.8% of the radioactivity in the leachates. This indicates that degradation and mineralisation of the test compound occurred in the monolith. Upon characterisation of non-volatile radioactivity in the leachates, the first TLC chromatograms showed polar radioactivity that was smearing over the plate or not moving at all i.e. remaining at the origin of the plate or smearing through the HPLC column. Consequently, part of the radioactivity in the leachates was bound to water dissolved organic matter and a good chromatography was not possible. Several HPLC methods were tested in order to obtain well separated peaks, but peak separation was impossible. It could be shown, however, that none of the available reference items, i.e. ethofumesate nor 2-ketoethofumesate, were present in the leachates. In order to confirm this, an additional analysis was performed for determination of the parent. Aliquots of yearly pool leachates were pooled and radioactivity was determined by LSC. The whole aliquot was partitioned into dichloromethane, but no radioactivity was determined in the organic phase. In a procedural recovery with spiked control leachate (0.07 and 0.65 µg/L), recovery in the organic phase was 105 and 107%.

Soil

Radioactivity in soil layers approximately 2 years after last application is reported in the following table.

4.       Distribution of radioactivity in lysimeter soil

Layer no.

Soil layer

depth

Total radioactive residue (parent equivalents)

 

 

Lysimeter 1

 

Lysimeter 2

 

 

[cm]

[mg/kg]

[mg]

[% of AR]

 

[mg/kg]

[mg]

[% of AR]

1

0-15

0.214

37.58

20.03

 

0.257

50.51

27.18

2

15-24

0.042

4.11

2.19

 

0.032

3.98

2.14

3

25-34

0.026

3.16

1.69

 

0.021

3.01

1.62

4

35-44

0.024

3.25

1.73

 

0.018

2.67

1.44

5

45-54

0.018

2.71

1.44

 

0.015

2.18

1.17

6

55-64

0.012

1.90

1.02

 

0.010

1.60

0.86

7

65-74

0.008

1.24

0.66

 

0.008

1.27

0.68

8

75-84

0.006

0.96

0.51

 

0.006

0.96

0.52

9

85-94

0.007

1.09

0.58

 

0.004

0.72

0.39

10

94-104

0.006

1.00

0.53

 

0.005

0.90

0.49

11

105-114

0.005

0.77

0.41

 

0.005

0.80

0.43

12

115-125

0.007

1.21

0.64

 

0.005

0.79

0.42

Total

 

 

58.97

31.43

 

 

69.38

37.33

Total >65 cm

 

 

3.33

3.3

 

 

2.92

2.9

 

Radioactivity released by extraction of the upper most layer amounted to 5.6 and 6.7% of the radioactivity in that layer, indicating that about 95% of the radioactivity was present as bound residues.

Organic matter fractionation of the non-extractable residues in layer 1 indicated that the majority of the radioactivity present in the layer (about 64%) was bound to the immobile humic acids and humin fraction of the soil. The major part of the non-extractable radioactivity was bound to the immobile humic acids and humin fraction amounting to 66.9 and 67.8% of the non-extractable radioactivity present in layer 1 of lysimeters 1 and 2, respectively. The corresponding radioactivity associated with the more mobile fulvic acids was 33.1% and 32.2% of the non-extractable radioactivity in lysimeters 1 and 2, respectively.

Crops

Radioactive residues in the crop are given in the table below.

5.       Radioactive residues in crops

Crop

Radioactivity (% applied)

 

Lysimeter 1

Lysimeter 2

grass

0.01

0.02

 

The mass balance at the end of the experimental period showed that about 3 and 39% of AR was recovered in lysimeter 1 and 2, respectively. Apparently, 66% and 61% were lost to the atmosphere by volatilisation for lysimeters 1 and 2, respectively.

Remarks

It is reported that irrigation was performed in June and July 2003 to assure proper plant growth. No daily irrigation values were available. Irrigation was pooled per month. However, according to Verschoor et al. (2001), irrigation should not exceed 20 mm/day. By reporting the monthly irrigation it can not be verified if irrigation at exceeded 20 mm/day at one point in time. However, since the maximum irrigation per month did not exceed 45 mm, this is considered unlikely. The results of the study, that none of the available reference items (i.e. ethofumesate nor 2-ketoethofumesate), were present in the leachates, can be used for risk assessment.

 

Study 5.

Calibration of field lysimeter (836706)

Results

After a first SWAP simulation was run, using the lysimeter characteristics as described above, the estimated leaching for this run showed a leaching profile that was in good agreement with the recorded leaching from the two lysimeters, but with a significantly lower percolation during most of the simulation period than actually measured. Adjustment of the soil water retention parameters did not appreciably influence the simulated leaching pattern, or the cumulative amout leached. Therefore, the crop factor for the lysimeter crops was decreased to simulate lower evapotranspiration. The crop factor for grass was set to 0.8. No adjustment was made to the crop factor for bare soil, since there was a continuous crop during the entire study period. With this crop factor, the simulated leaching follows the actual leaching very well, with only a slight deviation during the final month, which is not particularly relevant for the evaluation of the leaching behaviour considering the DT50 value of ethofumesate. The author states that the areic mass leached from the two lysimeters in the lysimeter study can be derived form the concentration of ethofumesate in the individual leachate fractions, and the size of these fractions. However, since the concentration of ethofumesate in the leachate fractions was below the LOD at all times, it is only possible to give an upper limit on the amount that may have leached. The upper limit concentration was set to 15.33 pg/L (LOD of the TLC phospor-imager is 20 dpm, which equals 92 pg 14C-ethofumesate. A total of 3 L of the pooled percolate was submitted to the ultrafiltration/TLC analysis approach. No parent compound was detected in the percolate in this analysis, setting the maximum amount present to half of the LOD, or 46 pg in 3 L). Combined with the average amount of leachate recovered form the two lysimeters of 1027.7 L, the upper limit on the amount of leached ethofumesate can be set to < 15.8 ng. The areic mass leached from the lysimeters therefore is < 15.8 ng/m2 or < 158*10-9 kg/ha. The author states that the total accumulated areic mass leached from the PEARL lysimeter simulation, performed with the default lysimeter calibration settings, expressed in the variable AmaLea, for the soil profile is 6.68 x 10-3 kg/ha. This leads to a simulation error of > 42280. It can be concluded that PEARL greatly overestimates the leaching potential of ethofumesate. With this simulation error applied to default (Kremsmuenster scenario) PEARL calculations, all foreseen applications of ethofumesate in grass fulfil the requirements for leaching to the upper groundwater.

Remarks

Conclusion: Using the soil-specific, parallel Kom and DT50 values for ethofumesate for the lysimeter soil, PEARL estimates the leaching and the results (simulation error > 42280) can be used for risk assessment.

 

Based on this second lysimeter (grass), including calibration, a second SE has become available. This SE has a value of > 42280.

 

If these studies are taken into account in the risk assessment the result is as follows:

 

6.1.2    Leaching to shallow groundwater

The leaching potential of the active substance (and metabolites) is calculated in the first tier using Pearl 2.2.2. and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate, the crop [sugar beets] and an interception value appropriate to the crop of [0.2]. First date of yearly application is 01/04/1901. For metabolites all available data concerning substance properties are regarded. The following input data are used for the calculation:

 

PEARL:

 

Active substance:

Median DT50 for degradation in soil (20°C):  84 days

Median Kom (pH-independent): 78 L/kg

1/n: 0.9

 

Saturated vapour pressure: 6,5 x 10-4 Pa (25 °C)

Solubility in water: 0.05 g/L (25 °C)

Molecular weight: 286.3 g/mol

 

Other parameters: standard settings of PEARL 2.2.2

 

The following concentrations are predicted for ethofumesaat following the realistic worst case GAP, see Table M.4 a.

 

Table M.4a Leaching of ethofumesaat as predicted by PEARL 2.2.2

No./ Use

Substance

Rate substance [kg/ha]

Frequency

Interval [days]

Fraction

intercepted

PEC

groundwater [mg/L]

 

 

 

 

 

 

spring

autumn

Beets

ethofumesaat

0.5

1

-

0.2

1.71

n.a.

Beets

ethofumesaat

0.3

2

7

0.2

2.19

n.a.

 

Results of Pearl 2.2.2. using the Kremsmünster scenario are examined against the standard of 0.01 µg/L. This is the standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

 

From Table M.2a it reads that the expected leaching based on the PEARL-model calculations for ethofumesaat equal to or larger than 0.1 µg/L. Therefore, further study into the leaching behaviour is necessary.

 

Lysimeter/field leaching studies

A lysimeter study in sugar beets has been submitted. In this lysimeter no ethofumesate was found in the leachate.

A vulnerability assessment according to the report by Verschoor et al. 2001 showed a more vulnerable soil profile compared with the Dutch standard scenario. The precipitation and irrigation is comparable. The soil temperature is higher and by that less vulnerable. No parallel studies on DT50 and Kom with the lysimeter soil are available. Nevertheless standardisation according to Verschoor was carried out. The result was a simulation error (SE) of 2 x 10-12. This value is not relevant for risk assessment because this value is too low.

 

A second lysimeter study has been submitted together with a standardisation according to Verschoor (2001). Also in this lysimeter no ethofumesate was found in the leachate. However the same argumentation with regard to vulnerability as above is true. Furthermore, according to the report by Verschoor a quantitative vulnerability assessment can only be sufficient if a lysimeter study was triggered by a slight exceedance of the trigger concentration by the model calculations.

Standardisation of the lysimeters on the basis of the standard dossier data according to Verschoor revealed a simulation error of 0.75.

For the lysimeter soil a preliminary sorption test was performed that resulted in a Kom value of 106 L/kg. This value can be used for the standardisation calculation. If the value is used together with the worst case DT50 value of 47 days a simulation error of  262 is calculated. If the simulation error is used as correction factor on the model results the estimated concentration in the groundwater is <0.01 mg/L.

In the lysimeters during the experiment the concentration ethofumesate was measured in the top layers of the soil. There are 3 timepoints available. From these measurements a half-life in the lysimeter topsoil can be estimated.

From these calculations a lysimeter half-life of 29.4 days was derived. Standardisation using the lysimeter specific DT50 and Kom value revealed a simulation error of 14.5.

 

From the final degradation and sorption studies with the lysimetersoil a lysimeter half-life of 58.8 days and a Kom value 108.4 L/kg were derived. Standardisation using the lysimeter specific DT50 and Kom value revealed a simulation error of 4513.

 

Standardisation using the third lysimeter (grass) specific DT50 and Kom value revealed a simulation error of > 42280.

 

Simulation errors for ethofumesaat were calculated for the two soil types of the three lysimeter soils. In principle the simulation errors of all lysimeters can be used for the risk assessment for deriving the adjustment factor. Nevertheless the very low simulation error is excluded because this value is not relevant for risk assessment.

Calculated values and conclusions for leaching including lysimeter data are given in Table M.4b. According to Van der Linden et al., the adjustment factor for leaching estimations in the authorisation procedure is 4513 (2 experiment2, 1 number of lysimeter soils).

 

Table M.4b Expected leaching for ethofumesaat including correction based on lysimeter studies

Use

Substance

Computed target [mg/L]

Simulation Error (mean)

No. of lysimeter soils

fadjustment

Adjusted PEC

groundwater

spring (modelled target conc./fadj.) [mg/L]

 

 

spring

autumn

 

 

 

spring

autumn

Beets

ethofumesaat

1.71

n.a.

23396.5

1

4513

< 0.001

n.a.

Beets

ethofumesaat

2.19

n.a.

23396.5

1

4513

< 0.001

n.a.

Beets

ethofumesaat

2.17

n.a.

23396.5

1

4513

< 0.001

n.a.

 

Results of Pearl 2.2.2. using the Kremsmünster scenario are examined against the standard of 0.01 µg/L. This is the standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

 

From Table M.2b it reads that the expected leaching based on the PEARL-model calculations for the a.s. ethofumesaat is smaller than 0.01 µg/L for all proposed applications. Hence, the applications meet the standards for leaching and the restriction on the use in groundwater protection areas on the label is no longer necessary.

 

Conclusions

The proposed application(s) of the product complies with the requirements concerning persistence and leaching in soil.

 

 

7.                  Ecotoxicology

The chapter Ecotoxicology remains unchanged.

 

 

8.                  Efficacy

The chapter Efficacy remains unchanged.

 

 

9.      Conclusion

 

The product complies with the Uniform Principles.

 

The evaluation is in accordance with the Uniform Principles laid down in appendix VI of Directive 91/414/EEC. The evaluation has been carried out on basis of a dossier that meets the criteria of appendix III of the Directive.

 

 

10.      Classification and labelling

The classification and labelling remains unchanged.

 

The restriction sentence “Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden. ” is removed from the label of use.

 



[1] FOCUS (2005) “Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration” Report of the FOCUS Work Group on Degradation Kinetics, EC Document Reference Sanco/10058/2005 version 1.0, 431 pp.