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					         HONEYBEES
Guidance Document on Terrestrial Ecotoxicology
     Under Council Directive 91/414/EEC
            (SANCO/10329/2002)




            Domenica Auteri
DATA REQUIREMENTS AND TESTING

             ACTIVE SUBSTANCE
                               Acute oral e contact
Acute toxicity                  LD50 (g a.s./bee)

Always, except where preparations containing the
a.s. are for exclusive use in situations where bees
are not likely to be exposed


Bee brood feeding test
Always, when the a.s. may acts as an insect growth
regulator, except when it is not likely that bee
brood would be exposed to it
DATA REQUIREMENTS AND TESTING

                  PREPARATIONS
                                 Acute oral e contact
Acute toxicity                    LD50 (g a.s./bee)

Testing is requiring if:
• the product contains more than one a.s.
• the toxicity of a new preparation cannot be reliably
predicted


Residue test                   Median Letal Time LT50


Where HQ  50 expert judgement is required to decide
whether the effect of residues must be determined
  DATA REQUIREMENTS AND TESTING
                       PREPARATIONS
Higher tier tests
                                    no clearly defined endpoints
• Cage test:                             for higher tier tests
where HQ (oral and contact) > 50 or
significant effects are observed in the bee brood feeding test or
if there are indications for indirect effects

• Field test:
where HQ (oral and contact) > 50 or
significant effects are observed in the bee brood feeding test or
if there are indications for indirect effects or
Significant effect are observed in cage testing

• Tunnel test:
Where it is not possible to investigate certain effects in cage or
field trials
DATA REQUIREMENTS AND TESTING

                    METABOLITES

Standard lab test are normally not required for met.


Exceptions may be cases where for example the met. is
the pesticidal active molecule


If higher tier studies are conducted with the PPP under
realistic exposure conditions, potential risks from met.
should be covered
         EXPOSURE ASSESSMENT

For products applied as sprays (HQ approach):

                        Exposure
                            =
    max single application rate of the product (g/ha)

For systemic plant protection products:

                        Exposure
                            =
      a.s. (or metabolite) present in the respective
        plant parts (e.g. nectar, pollen) to which
               honeybees could be exposed
RISK ASSESSMENT: Hazard Quotient

                     appl. rate  g a.s. ha 
           HQoral 
                    oral LD50 g a.s. bee

                      appl. rate  g a.s. ha 
        HQcontact 
                    contact LD50 g a.s. bee

HQ < 50  low risk to bees, no further testing is
          required

HQ > 50  further higher tier testing is required to
          evaluate the risk to bees

 NB: maximum single application rate should be used to
       calculate the oral and contact HQ-values
  RISK ASSESSMENT: Higher tier

no clearly defined endpoints for higher tier studies




  expert judgement is required to interpret both
         semi-field and field study results



 It is important to consider any effects observed
                 in relation to the
   overall survival and productivity of the hive
    RISK ASSESSMENT: Higher tier

Key parameters which may be considered in a field test:

• mortality  assessed via the use of dead bee traps

• behaviour  including foraging behaviour in the crop
                     and around the hive

• honey crop  assessed via weighing the hive at
               appropriate intervals

• state of colony  including an assessment of brood

In the initial risk assessment it may be appropriate to
use pollen traps as well as appropriate analysis of dead
bees. Analysis of honey and wax may be useful in
determining exposure.
   RISK ASSESSMENT: Higher tier

The use of a toxic standard in both semi-field and
field trials along with an untreated control can aid
interpretation of the results.


    For insect growth regulators and other active
            substances which may cause
      long-term adverse effects on hive health




    evidence confirming a lack of effects on hive
     health over a long time period is required
        RISK MITIGATION OPTIONS

In order to mitigate the predicted risk the following
aspects may be considered :

• application rate

• timing of application (e.g. apply in the evening after
honeybee flight, do not apply during honeybee flight)

• GAP adaptation (e.g. do not apply during crop flowering)

•agronomic practice (e.g. mulch ground cover before
application of the plant protection products)

      These measures will require consideration at a
                     national level
           and implementation will depend on
         local agronomic practice and conditions

				
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