Annex 2 JMPR 1975
GLOSSARYa
Pesticide
A pesticide is any substance or mixture of substances intended for
preventing or controlling any unwanted species of plants and animals
and also includes any substances or mixture of substances intended for
use as a plant-growth regulator, defoliant or dessicant.
Explanatory note. The term "pesticide" includes any substance
used for the control of pests during the production, storage,
transport, marketing or processing of food for man or animals or which
may be administered to animals for the control of insects or arachnids
in or on their bodies. It does not apply to antibiotics or other
chemicals administered to animals for other purposes, such as to
stimulate their growth or to modify their reproductive behaviour; nor
does it apply to fertilizers.
Pesticide residue
A pesticide residue is any substance or mixture of substances in
food for man or animals resulting from the use of a pesticide and
includes any specified derivatives, such as degradation and conversion
products, metabolites, reaction products and impurities which are
considered to be of toxicological significance.
Explanatory note. The term "pesticide residue" includes residues
from unknown sources (i.e., background residues) as well as those from
known uses or the chemical in question.
Good agricultural practice in the use of pesticides
Good agricultural practice in the use of pesticides is the
officially recommended or authorized usage of pesticides under
practical conditions at any stage of production, storage, transport,
distribution and processing of food and other agricultural
commodities, bearing in mind the variations in requirements within and
between regions and taking into account the minimum quantities
necessary to achieve adequate control, the pesticides being applied in
such a manner as to leave residues that are the smallest amounts
practicable and that are toxicologically acceptable.
a The definitions given in this glossary am those adopted for use in
Joint FAO/ WHO Meetings on Pesticide Residues and are not necessarily
of universal validity.
Explanatory note. The "officially recommended or authorized" usage
is that which complies with the procedures, including formulation,
dosage rates, frequency of application and pre-harvest intervals,
approved by the relevant authorities.
Acceptable daily intake
The acceptable daily intake of a chemical is the daily intake
which, during an entire lifetime, appears to be without appreciable
risk on the basis of all the known facts at the time. It is expressed
in milligrams of the chemical per kilogram of body weight.
Explanatory note. For this purpose "without appreciable risk" is
taken to mean the practical certainty that injury will not result even
after a lifetime of exposure. Furthermore, for a pesticide residue,
the acceptable daily intake is intended to give a guide to the maximum
amount that can be taken daily in the food "without appreciable risk"
to the consumer. Accordingly, the figure is derived as far as possible
from feeding studies in animals and/or man. The studies are usually
conducted with the pesticide chemical itself. However, if the residues
of a pesticide are known to consist of more than one chemical that may
influence the toxicology of the residue (see definition of "pesticide
residue"), information on the toxicology of the residual chemicals
and, where appropriate, their acceptable daily intakes have to be
taken into account when assessing the risks (see section 2.3 of the
report of the 1969 Joint Meeting for further information concerning
the inclusion of metabolites). Acceptable daily intakes are always
subject to revision at any time in the light of new information.
Temporary acceptable daily intake
A temporary acceptable daily intake is an acceptable daily intake
established for a specified, limited period.
Explanatory note. A specified period is provided to enable
additional biochemical, toxicological or other data to be obtained, as
may be required for establishing an acceptable daily intake (see
definition of "further work required"). In such cases any
recommendation will normally involve the application of a safety
factor, the size of which will depend on the nature of the toxicity of
the compound but which will be larger than that normally used in
estimating acceptable daily intakes. In all cases the position will be
reviewed not later than the first meeting following the specified
date.
Conditional acceptable daily intake
A conditional acceptable daily intake is one that is established
for a pesticide in order to limit its use to those situations where no
satisfactory substitutes are available.
Potential daily intake
The potential daily intake of a pesticide is the theoretical
intake calculated on the basis of the maximum residue limits and/or
extraneous residue limits and the per caput consumption of the
relevant food commodities per day.
Maximum residue limit
A maximum residue limit is the maximum concentration of a
pesticide residue resulting from the use of a pesticide according to
good agricultural practice directly or indirectly for the production
and/or protection of the commodity for which the limit is recommended.
The maximum residue limit should be legally recognized. It is
expressed in milligrams of the residue per kilogram of the commodity.
Explanatory note. The expression "maximum residue limit" replaces
the formerly used "tolerance" in accordance with the practice
initiated by the 1972 Joint Meeting.
Temporary maximum residue limit
A temporary maximum residue limit is a maximum residue limit
established for a specified, limited period.
Explanatory note. The expression "temporary maximum residue limit"
replaces the formerly used "temporary tolerance" in accordance with
the practice initiated by the 1972 Joint Meeting.
A temporary maximum residue limit is proposed under either of the
following conditions:
(i) when only a temporary or conditional acceptable daily intake has
been established for the pesticide concerned; or
(ii) when, although, an acceptable daily intake has been established,
the residue data are inadequate for firm maximum residue
recommendations.
Residues for which data are inadequate include those for which
information on losses of residue during storage, handling and
preparation is inadequate and for which calculations based on the
inadequate figures indicate that the potential daily intake could be
exceeded. In cases of this kind temporary maximum residue limits are
recommended only after the Joint Meeting has considered information on
the actual occurrence of residues in food, obtained front total diet
and similar studies, and after it is satisfied that the potential
daily intake is not likely to be exceeded. The information considered
includes the results from subjective and/or objective sampling,
including total diet studies, in various countries and particularly in
places where pesticides are most widely used. Temporary maximum
residue limits will be reviewed no later than the first meeting
following the specified date.
Extraneous residue limit
An extraneous residue limit is, for a particular commodity, the
maximum toxicologically acceptable concentration of a residue
unavoidably arising from sources other than the use of a pesticide
directly or indirectly for the production of that commodity. The
extraneous residue limit should be legally recognized.
Explanatory note. Residues in food of animal origin arising from
residues in animal feed derived from activities that are controllable
by farming practices are covered by "maximum residue limits". The term
"practical residue limits" which has lead to much confusion has been
abandoned.
Guideline level
A guideline level is the maximum concentration of a pesticide
residue that might occur after the officially recommended or
authorized use of a pesticide for which no acceptable daily intake or
temporary acceptable daily intake is established and that need not be
exceeded if good practices are followed. It is expressed in milligrams
of the residue per kilogram of the food.
Total diet study
A total diet study is a study designed to establish the pattern
of pesticide residue intake by a person consuming a defined diet.
Explanatory note. To make total diet studies, random samples of food
are usually purchased in representative population centres in the
country or district concerned and weighed out in the proportions in
which they are consumed in the total diet. The weighed portions are
then washed, cooked or otherwise prepared in the normal way for table
presentation and then mixed to give a number of predetermined food
group samples comprising, for example, cereals, green vegetables, root
crops, fruits and preserves, fats, meats and milk. These groups are
chosen with the intention of minimizing the subsequent analytical
problems; they also serve to identify the areas of the diet which
contribute most to total residues present. The foods are purchased and
prepared under expert supervision with the requirements of the studies
in mind, but otherwise they resemble as far as possible the normal
character of the total diet. Water and beverages are included. Each
food group sample, prepared as above, is analysed for various
residues. This may involve several different analyses for each group.
The exact analytical procedure may vary from group to group. In
addition, from experience, it may become possible to omit certain
analyses for some groups. Thus, the different groups will not
necessarily be subject to exactly the same analytical procedure.
Similar studies have also been described as "market basket" studies.
Subjective sample
A subjective sample is a sample of a food or other agricultural
commodity taken after a known or suspected use of a pesticide thereon.
Explanatory note. Subjective samples include those taken during the
early stages of the introduction of a pesticide into practical
application, when it is desirable to ascertain the residues occurring
after known methods of application in the field, as well as those
taken in circumstances where there are reasons to suspect that good
agricultural practices have not been followed. Such samples may relate
to, crops from specific sites or from districts or countries where the
use of particular pesticides is known or suspected. Subjective
sampling, rather than total diet studies, is sometimes used to assess
the actual danger to consumers, particularly where the sampling and
analytical facilities are limited; it enables the facilities to be
concentrated on those categories of food intake considered to offer
the greatest risks. Subjective sampling also enables certain of the
analytical difficulties encountered in total diet studies to be
avoided.
Objective sample
An objective sample is a sample of a food or other agricultural
commodity taken at random.
Explanatory note. The samples taken during total diet intake studies
fall into this category.
Regulatory method of analysis
A regulatory method of analysis is a method suitable for the
determination of a pesticide residue in connexion with the enforcement
of legislation.
Explanatory note. For this purpose, it is often necessary to
identify the nature of the residue as well as to determine its
concentration. Subject to any expression of requirements in the
particular legislation, the accuracy, precision and limit of
determination of a regulatory method need be sufficient only to
demonstrate clearly whether or not a maximum residue limit has been
exceeded. Usually, regulatory methods are not specified in pesticide
residues legislation, and at any given time there may be a number of
methods suitable for a particular purpose.
Further work required
Further work required is work that must be done, properly
reported and made available to the Joint Meeting within a specified
period before acceptable daily intakes and/or maximum residue limits
can be recommended or confirmed.
Explanatory note. In certain instances, although acceptable daily
intakes have been established, further work has been considered to be
essential to remove doubts about the toxicological significance of
some experimental observations. Results of the further work required
should be made available not later than the specified date, after
which the compound will be re-evaluated. The re-evaluation may be done
at an earlier Meeting if relevant information should become available.
Further work desirable
Further work desirable is work which, when properly reported and
made available to the Joint Meeting, would be expected to provide
additional assurance that acceptable daily intakes and recommended
maximum residue limits are adequate for the protection of the health
of the consumer.
Limit of determination
The limit of determination of a method of analysis is the lowest
concentration of a pesticide residue that can be quantitatively
measured in the specified commodity with an acceptable degree of
certainty.
Limit of detection
The limit of detection of a method of analysis is the lowest
concentration of a pesticide residue that can be qualitatively
detected in a specified commodity.
ANNEX 3
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