EN
SANCO/11843/2010 Rev. 00 (POOL/E3/2010/11843/11843R00-EN.doc)
ENEN
/ EUROPEAN COMMISSIONBrussels, (SANCO 11843/2010)
C(20..) yyy final (rev. July 2010)
SANCO E3 WORKING DOCUMENT DOES NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION SERVICES
Draft
Commission Communication in the framework of the implementation of Commission Regulation (EU) No [SANCO 11803/2010]/2010 laying down the requirements for the dossier to be submitted for the authorisation of plant protection products
ENEN
SANCO E3 WORKING DOCUMENT DOES NOT NECESSARILY REPRESENT THE VIEWS OF THE COMMISSION SERVICES
Draft
Commission Communication in the framework of the implementation of Commission Regulation (EU) No [SANCO 11803/2010]/2010 laying down the requirements for the dossier to be submitted for the authorisation of plant protection products
(Text with EEA relevance)
(Publication of test methods and guidance documents under the Regulation)
[…]
Reference to Part A of theAnnex to Regulation (EU) No [SANCO 11803/2010]/2010 / Test methods / Guidance documents1.IDENTITY OF THE PLANT PROTECTION PRODUCT / - / -
1.1.Applicant
1.2.Manufacturer of the preparation and the active substance(s) / Equivalence of technical materials: SANCO/10597/2003
1.3.Trade name or proposed trade name and manufacturer’s development code number of the preparation if appropriate
1.4.Detailed quantitative and qualitative information on the composition of the preparation (active substance(s) and formulants)
1.5.Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution etc)
1.6.Function
1.5.Melting point and boiling point
1.1.Melting point and boiling point
2.PHYSICAL AND CHEMICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT / - / -
2.1.Appearance / -
2.2.Explosive and oxidising properties / Method A.14 Explosive properties (Annex ofRegulation (EC) No 440/2008).
Solids: MethodA.17 Oxidising properties (solids) (Annex of Regulation (EC) No 440/2008)
Liquids: MethodA.21 Oxidising properties (liquids) (Annex of Regulation (EC) No 440/2008)
2.3.Flammability / Liquids:
MethodA.9 Flash-point (Annex ofRegulation (EC) No 440/2008)
Solids and gases:
Methods A.10 Flammability (solids), A.11 Flammability (gases), A.12 Flammability (contact with water) (Annex ofRegulation (EC) No 440/2008), as appropriate.
2.4.Acidity/alkalinity and pH value / CIPAC Method MT 75.3: Determination of pH values (revised method), CIPAC Handbook J
Acidic or alkaline preparations:
CIPAC Method MT 31: Free acidity or alkalinity, CIPAC Handbook F
CIPAC Method 191: Acidity or alkalinity of formulations, CIPAC Handbook L / -
2.5.Viscosity / Newtonian liquids:
OECD Test Guideline No 114
Non Newtonian liquids:
OECD Test Guideline No 114 or
CIPAC method MT 192: Viscosity of liquids by rotational viscosimetry, CIPAC Handbook L[af1]
Surface tension:
MethodA.5 Surface tension (Annex ofRegulation (EC) No 440/2008)
Method A.5 is written only for solutions in water however the principles contained in it can be used for other formulation types e.g. EC / -
2.5.Relative density and bulk density / Relative density:
MethodA.3 Relative density (Annex ofRegulation (EC) No 440/2008).
Bulk density:
CIPAC method MT 186: Bulk density, CIPAC Handbook H
2.7.Storage stability and shelf-life: effects of temperature and humidity on technical characteristics of the plant protection product / Stability:
CIPAC MT 46.3: Accelerated storage procedure (combined method), CIPAC Handbook J
Effect of low temperature on liquid preparations:
CIPAC Method MT 39.3: Low temperature stability of liquid formulations, CIPAC Handbook J
2.8Technical characteristics of the plant protection productn
2.8.1Wettability / CIPAC Method MT 53.3: Evaluation of wettability, wetting of dispersible powders, CIPAC Handbook F
2.8.2Persistent foaming / CIPAC Method MT 47.2 Foaming of suspension concentrates, CIPAC Handbook F
2.8.3Suspensibility, spontaneity and dispersion stability / Suspensibility:
CIPAC Method MT 184: Suspensibility of formulations forming suspensions on
dilution with water, CIPAC Handbook K
Spontaneity of dispersion
CIPAC Method MT 160:
Spontaneity of dispersion of suspension concentrates, CIPAC Handbook F
or
CIPAC Method MT 174: Spontaneity of dispersion of water dispersible granules, CIPAC Handbook F
Dispersion stability
CIPAC Method MT 180: Suspo-emulsions, dispersion stability, CIPAC Handbook H
2.8.4.Degree of dissolution and dilution stability / CIPAC Method MT 41: Dilution stability, CIPAC Handbook F
or
CIPAC Method MT 179: Water soluble granules, degree of dissolution and solution stability, CIPAC Handbook H
2.8.5.Particle size distribution (powders, granules), content of dust/fines (granules), attrition (granules, tablets) and friability (tablets)
2.8.5.1Particle size distribution / Size distribution:
CIPAC Method MT 187:
Particle size analysis by laser diffraction, CIPAC Handbook K
or
CIPAC Method MT 59.1: Sieve analysis, dry sieving-dusts, CIPAC Handbook F
Nominal size range of granules for direct application:
CIPAC Method MT 58.3: Dust content and apparent density of granular formulations, apparent density after compaction without pressure, CIPAC Handbook F
or
CIPAC Method MT 187: Particle size analysis by laser diffraction, CIPAC Handbook K
Nominal size range of other granules type:
CIPAC Method MT 170: Sieve analysis, dry sieving-water dispersible granules, CIPAC Handbook F
or
CIPAC Method MT 187: Particle size analysis by laser diffraction, CIPAC Handbook K
2.8.5.2Dust content / Dust content:
CIPAC Method MT 171: Dustiness of granular products, CIPAC Handbook F
Particle size:
CIPAC Method MT 187: Particle size analysis by laser diffraction, CIPAC Handbook K
2.8.5.3.Granules / Granules for direct application (GR)
CIPAC Method MT 41: Dilution stability, CIPAC Handbook F
or
CIPAC Method MT 179: Water soluble granules, degree of dissolution and solution stability, CIPAC Handbook H
Dispersible, emulsifiable and soluble granules:
CIPAC Method MT 178.2: Attrition resistance of dispersible granules, CIPAC Handbook K
2.8.5.3.Tablets / CIPAC Method MT 193: Friability of tablets, CIPAC Handbook L
2.8.6Emulsifiability, re-emulsifiability, emulsion stability / CIPAC Method MT 36.3: Emulsion characteristics of emulsifiable concentrates, emulsion characteristics and re-emulsification properties, CIPAC Handbook K
or
CIPAC Method MT 183: Emulsion characteristics of emulsifiable concentrates, dilute, agrochemical emulsion tester, CIPAC Handbook J
2.8.6Flowability, pourability and dustability / Flowability:
CIPAC Method MT 172: Flowability of water dispersible granules, CIPAC Handbook F
Pourability:
CIPAC Method MT 148.1: Pourability of suspension concentrates, revised method, CIPAC Handbook J
2.9.Physical compatibility with other products including plant protection products with which its use is to be authorized / ASTM E1518 – 05: Standard Practice for Evaluation of Physical Compatibility of Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method
2.10.Adherence and distribution to seeds / Distribution:
CIPAC Method MT 175: Seed treatment formulations, liquid, determination of seed-seed uniformity of distribution, CIPAC Handbook F
Adhesion:
CIPAC Method MT 194[206/2]: Adhesion to Treated Seed
2.11.Summary and evaluation of data presented under points 2.1. to 2.10
2.12.Packaging (type materials, size etc), compatibility of the preparation with proposedpackaging materials. / Resistance of the packaging material to its contents:
Crop Life Technical Monograph No 17
3.DATA ON APPLICATION / - / -
4.FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT / - / -
5.ANALYTICAL METHODS / -
6EFFICACY DATA
6.1Preliminary tests
6.2Testing effectiveness / EPPO standards PP1/152, PP 1/181 and PP 1/226[1]
6.3Information on the occurrence or possible occurrence of the development of resistance / EPPO standard PP 1/213
6.4Phytotoxicity to target plants (including different cultivars), or to target plant products / EPPO standard PP1/135
6.5Effects on the yield
6.5.1Effects on the yield of treated plants or plant products
6.5.2Effects on the quality of plants or plant product / EPPO Standard PP 1/242 Taint tests
6.5.3Effects on transformation processes / EPPO Standard PP 1/243 Effects of plant protection products on transformation processes
6.5.4Impact on treated plants or plant products to be used for propagation / Seeds harvested from treated plants :
ISTA Methods- International Rules for Seed Testing – Edition 2010[2]
6.6Observations on undesirable or unintended side-effects
6.6.1Impact on succeeding crops
6.6.2Impact on other plants, including adjacent crops
6.6.3Effects on beneficial and other non-target organisms
6.7Summary and evaluation of data presented under 6.1 to 6.6
7TOXICOLOGICAL STUDIES
7.1Acute toxicity
7.1.1Oral toxicity / MethodB.1 bis Acute oral toxicity - fixed dose procedure (Annex of Regulation (EC) No 440/2008).
MethodB.1 tris Acute oral toxicity - Acute toxic class method (Annex of Regulation (EC) No 440/2008).
OECD Test Guideline N° 420 - Acute oral toxicity: fixed dose procedure
OECD Test Guideline N° 423 - Acute oral toxicity: acute toxic class method
OECD Test Guideline N° 425 - Acute oral toxicity: up-and-down procedure
7.1.2Dermal toxicity / MethodB.3 Acute toxicity (dermal) (Annex ofRegulation (EC) No 440/2008)
OECD Test Guideline N° 402 Acute Dermal Toxicity
7.1.3Inhalation toxicity / MethodB.2 Acute toxicity (inhalation) (Annex ofRegulation (EC) No 440/2008).
OECD Test Guideline N° 403 Acute Inhalation Toxicity
OECD Test Guideline N° 436 Acute Inhalation Toxicity – Acute Toxic Class Method
7.1.4Skin irritation / MethodB.4 Acute toxicity: dermal irritation/corrosion (Annex ofRegulation (EC) No 440/2008).
MethodB.40 In vitro skin corrosion: transcutaneous alectrical resistance test (TER) (Annex ofRegulation (EC) No 440/2008).
MethodB.40 bis In vitro skin corrosion: human skin model test (Annex ofRegulation (EC) No 440/2008).
OECD Test Guideline N° 404 Acute Dermal Irritation/Corrosion
OECD Test Guideline N° 431 In Vitro Skin Corrosion: Human Skin Model Test
OECD Test Guideline N° 430 In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test
OECD Test Guideline N° 435 In Vitro Membrane Barrier Test Method for Skin Corrosion
7.1.5Eye irritation / MethodB.5 Acute toxicity: eye irritation/corrosion (Annex ofRegulation (EC) No 440/2008).
MethodB.40 In vitro skin corrosion: transcutaneous alectrical resistance test (TER) (Annex ofRegulation (EC) No 440/2008).
MethodB.40 bis In vitro skin corrosion: human skin model test (Annex ofRegulation (EC) No 440/2008).
OECD Test Guideline N° 405 Acute eye irritation/corrosion
OECD Test Guideline N° 437 Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants
OECD Test Guideline N° 438 Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants
7.1.6Skin sensitisation / MethodB.42 Skin sensitisation: Local lymph node assay (Annex ofRegulation (EC) No 440/2008).
MethodB.6 Skin sensitisation (Annex ofRegulation (EC) No 440/2008).
OECD Test Guideline N° 429 Skin Sensitisation – Local Lymph Node Assay
OECD Test Guideline N° 406 Skin sensitisation
7.1.7Supplementary studies on the plant protection product
7.1.8Supplementary studies for combinations of plant protection products
7.2Data on exposure
7.2.1Operator exposure
7.2.1.1Estimation of operator exposure
7.2.1.2Measurement of operator exposure / Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application, OECD Series on Testing and Assessment No. 9, OCDE/GD(97) 148 (OECD, 1997).
7.2.2Bystander and resident exposure
7.2.2.1Estimation of bystander exposure
7.2.2.2Estimation of resident exposure
7.2.3Worker exposure
7.2.3.1Estimation of worker exposure
7.2.3.2Measurement of operator exposure / Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application, OECD Series on Testing and Assessment No. 9, OCDE/GD(97)148. (OECD, 1997).
7.3Dermal adsorption / OECD Test Guideline N° 428 - Skin absorption: in vitro method
OECD Test Guideline N° 427 - Skin absorption: in vivo method
7.4Available toxicological data relating to non-active substances
8RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED
9FATE AND BEHAVIOUR IN THE ENVIRONMENT
9.1.Fate and behaviour in soil / OECD Test Guideline N° 307 – Aerobic and anaerobic transformation in soil.
ISO 10381-6:2009 Soil quality. Sampling. Guidance on the collection, handling and storage of soil under aerobic conditions for the assessment of microbiological processes, biomass and diversity in the laboratory
9.1 Fate and behaviour in soil
9.1.1 Rate of degradation in soil
9.1.1.1 Laboratory studies / OECD Test Guideline N° 307: Aerobic and anaerobic transformation in soil. / FOCUS Ground Water [3]
FOCUS Degradation Kinetics3
9.1.1.1.2 Field studies / US EPA OPPTS 835.6100: Terrestrial field dissipation / NAFTA Guidance Document for Conducting Terrestrial Field Dissipation Studies (DIR2006-01)
FOCUS Ground Water
FOCUS Degradation Kinetics
9.1.2 Mobility in the soil
9.1.2.1 Laboratory studies / OECD Test Guideline N° 106: Adsorption - Desorption Using a Batch Equilibrium Method
OECD Test Guideline N° 121: Estimation of the Adsorption Coefficient (Koc ) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC)
OECD Test Guideline N° 312: Leaching in Soil Columns
9.1.2.2 Lysimeter studies / OECD Guidance Document 22: Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies
FOCUS Ground Water
9.1.2.3 Field leaching studies / FOCUS Surface Water3
9.1.3Estimation of concentrations in soil / Guidance on PEC calculation:
Guidance document on persistence in soil
FOCUS soil modelling workgroup
Guidance on degradation parameters:
FOCUS Ground Water
FOCUS Degradation Kinetics
9.2Fate and behaviour in water and sediment
9.2.1Aerobic mineralisation in Surface Water / OECD Test Guideline N° 309: Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test
9.2.2Water/sediment study / OECD Test Guideline N° 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems / FOCUS Surface Water
FOCUS Degradation Kinetics
9.2.3Irradiated water/sediment study / OECD Test Guideline N° 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems
9.2.4Estimation of concentrations in groundwater / FOCUS Ground Water
FOCUS Degradation Kinetics
9.2.4.1Additional field tests.
9.2.5Estimation of concentrations in surface water and sediment. / Guidance on degradation parameters:
FOCUS Ground Water
FOCUS Degradation Kinetics
Guidance for higher tier assessment on landscape level:
FOCUS Landscape and Mitigation3
9.3Fate and behaviour in air
9.3.1Route and rate of degradation in air and transport via air / Guidance on volatilisation, transport, degradation and deposition parameters:
FOCUS Air3
9.4 Estimation of concentrations for other routes of exposure
10ECOTOXICOLOGICAL STUDIES
10.1 Effects on birds and other terrestrial vertebrates
10.1.1 Effects on birds
10.1.1.1 Acute oral toxicity / OECD Test Guideline No. 223:[af3]Avian Acute oral toxicity study
or
US EPA OPPTS 850.2100: Avian Acute Oral Toxicity Test
10.1.1.2 Higher tier data on birds / Guidance of EFSA - Risk assessment for birds and mammals[4].
10.1.2 Effects on terrestrial vertebrates other than birds
10.1.2.1 Acute oral toxicity
10.1.2.2 Higher tier data on mammals / Guidance of EFSA - Risk assessment for birds and mammals
10.2 Effects on aquatic organisms
10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae, macrophytes and amphibians. / OECD Test Guideline No. 203: Fish, Acute Toxicity Test[5]
OECD Test Guideline No. 202: Daphnia sp. Acute Immobilisation Test
US EPA OPPTS 850.1035 Mysid Acute Toxicity Test
OECD Test Guideline No. 202: Daphnia sp. Acute Immobilisation Tes
OECD Test Guideline No. 221: Lemna sp. Growth Inhabition Test
OECD Test Guideline No. 221: Lemna sp. Growth Inhabition Test
ASTM E1913-04: Standard Guide for Conducting Static, Axenic, 14-Day Phytotoxicity Tests in Test Tubes with the Submersed Aquatic Macrophyte, Myriophyllum sibiricum Komarov
OECD Test Guideline No.231: Amphibian Metamorphosis Assay
10.2.2 Additional long-term and chronic toxicity studies on fish and aquatic invertebrates / OECD Test Guideline No. 229: Fish Short Term Reproduction Assay
OECD Test Guideline No. 230: 21-day Fish Assay: A Short-Term Screening for Oestrogenic and Androgenic Activity, and Aromatase Inhibition
OECD Test Guideline No. 210: Fish, Early-Life Stage Toxicity Test
US EPA protocol OPPTS 850.1500 Fish life cycle toxicity
OECD Test Guideline No. 211: Daphnia magna Reproduction Test
US EPA OPPTS 850.1350 Mysid Chronic Toxicity Test
OECD Test Guideline No. 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment
OECD Test Guideline No. 219: Sediment-Water Chironomid Toxicity Using Spiked Water
In general a water-spiked system (i.e. OECD 219) better covers the exposure routes typical for plant protection products
10.2.3 Further testing on aquatic organisms / EU Guidance Document on Aquatic Ecotoxicology(SANCO/3268/2001 rev.4)[6]
10.3 Effects on arthropods
10.3.1 Effects on honeybees / EPP/EPPO (2003), EPPO Standard PP 3/10 Environmental Risk Assessment Scheme for Plant Protection Products - Chapter 10: Honeybees, Bulletin OEPP/EPPO Bulletin 33, 99–101[7]
10.3.1.1 Acute toxicity to honeybees
10.3.1.2 Acute oral toxicity to honeybees / OECD Test Guideline No. 213: Honeybees, Acute Oral Toxicity Test
10.3.1.3 Acute contact toxicity to honeybees / OECD Test Guideline No. 214: Honeybees, Acute Contact Toxicity Test
10.3.1.4 Cage and tunnel tests / EPP/EPPO (2003), EPPO Standard PP 3/10 Environmental Risk Assessment Scheme for Plant Protection Products - Chapter 10: Honeybees, Bulletin OEPP/EPPO Bulletin 33, 99–101
and
OEPP/EPPO (2001) EPPO Standards PP1/170(3) Test methods for evaluating the side-effects of plant protection products on honeybees.Bulletin OEPP/EPPO Bulletin31, 323–330.
10.3.1.5 Field tests with honeybees / EPP/EPPO (2003), EPPO Standard PP 3/10 Environmental Risk Assessment Scheme for Plant Protection Products - Chapter 10: Honeybees, Bulletin OEPP/EPPO Bulletin 33, 99–101
and
OEPP/EPPO (2001) EPPO Standards PP1/170(3) Test methods for evaluating the side-effects of plant protection products on honeybees. Bulletin OEPP/EPPO Bulletin 31 , 323–330.
10.3.2 Effects on non-target arthropods other than honeybees / EU guidance document on terrestrial ecoloxicology(SANCO/10329/2002 rev 2)6
10.3.2.1 Standard laboratory testing for non-target arthropods / Testing should be carried out in accordance with guidelines that satisfy at least the requirements for testing specified in the:
Guidance Document on Regulatory Testing and Risk Assessment Procedures for Plant Protection Products With Non-Target Arthropods: From the Escort 2 Workshop (European Standard Characteristics of Non-Target Arthropod Regulatory Testing) ISBN 1-880611-52-x.
10.3.2.2 Extended laboratory testing, aged residue studies with non-target arthropods / Aged residue studies:
Testing should be carried out in accordance with guidelines that satisfy at least the requirements for testing specified in the:
Guidance Document on Regulatory Testing and Risk Assessment Procedures for Plant Protection Products With Non-Target Arthropods: From the Escort 2 Workshop (European Standard Characteristics of Non-Target Arthropod Regulatory Testing) ISBN 1-880611-52-x.
10.3.2.3 Semi-field studies with non-target arthropods / Testing should be carried out in accordance with guidelines that satisfy at least the requirements for testing specified in the:
Guidance Document on Regulatory Testing and Risk Assessment Procedures for Plant Protection Products With Non-Target Arthropods: From the Escort 2 Workshop (European Standard Characteristics of Non-Target Arthropod Regulatory Testing) ISBN 1-880611-52-x.
10.3.2.4 Field studies with non-target arthropods / Testing should be carried out in accordance with guidelines that satisfy at least the requirements for testing specified in the:
Guidance Document on Regulatory Testing and Risk Assessment Procedures for Plant Protection Products With Non-Target Arthropods: From the Escort 2 Workshop (European Standard Characteristics of Non-Target Arthropod Regulatory Testing) ISBN 1-880611-52-x.
10.3.2.5 Other routes of exposure for non-target arthropods
10.4 Effects on non-target soil mesofauna
10.4.1 Effects on earthworms
10.4.1.1 Tests for sub-lethal effects on earthworms / OECD Test Guideline No. 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)
or
ISO 11268-3:1999:Soil quality -- Effects of pollutants on earthworms -- Part 3: Guidance on the determination of effects in field situations
10.4.1.2 Field studies on earthworms / ISO 11268-3:1999:Soil quality -- Effects of pollutants on earthworms -- Part 3: Guidance on the determination of effects in field situations
10.4.2 Effects on non-target soil mesofauna (other than earthworms)
10.4.2.1 Species level testing / For Collembola:
ISO 11267:1999: Soil quality – Inhibition of reproduction of Collembola (Folsomia candida) by soil pollutants.
For the predatory mite:
OECD Test Guideline No. 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil
or
Bakker, F.M., Feije, R., Grove, A. J., Hoogendorn, G., Jacobs, G., Loose, E.D., van Stratum, P. (2003). A laboratory test protocol to evaluate effects of plant protection products on mortality and reproduction of the predatory mite Hypoaspis aculeifer Canestrini (Acari: Laelapidae) in standard soil. JSS – Journal of Soils and Sediments 3, 73-77, or
Krogh, P.H., Axelsen, J.A. (1998). Test on the predatory mite Hypoaspis aculeifer preying on the collembolan Folsomia fimetaria. In: Lokke, H., van Gestel, C.A.M.: Handbook of soil invertebrate toxicity tests. John Wiley Sons, Chichester, p 239-251
10.4.2.2 Higher tier testing for non-target soil mesofauna (other than earthworms)
10.5 Effects on soil nitrogen transformation / OECD Test Guideline No. 216: Soil Microorganisms: Nitrogen Transformation Test
10.6 Effects on terrestrial non-target higher plants
10.6.1 Summary of screening data
10.6.2 Testing on non-target plants / Seedling emergence and seedling growth:
OECD Test Guideline No. 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test
Terrestrial plant vegetative vigour testing:
OECD Test Guideline No. 227: Terrestrial Plant Test: Vegetative Vigour Test
10.6.3 Extended laboratory studies on non-target plants
10.6.4 Semi-field and field tests on non-target plants
10.7 Effects on other terrestrial organisms (flora and fauna)
10.8 Monitoring studies
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