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 animal feeds.  However, recently because of dumping restrictions in
 many communities,  disposal via animal  feeds  is much' more widely
 used.

 The  grain and the animal  feed  industries commonly refer to this
 material  as  "aspirated grain  fractions" and this  is the preferred
 term when discussing  elevator grain dust.

 Various pesticides are applied either preharvest to growing grains
 (and oil  seeds)  or postharvest to stored grains  (and oil seeds),
 and  the harvested/stored grains (oil seeds) could potentially have
 high surface residues of pesticides that  could  concentrate in  the
 aspirated dust due to the large absorbent-surface areas of the dust
 particles.   Thus incorporation  of this aspirated  dust into animal
 feeds  can  cause  increased  exposure  of  pesticide   residues   to
 animals,  and possibly result in the transfer of  pesticide residues
 into the  human food chain  through meat, milk, and eggs.

 The  incorporation of "aspirated grain fractions" into animal feeds
 falls under  the auspices of the Federal Food, Drugs, and Cosmetic
 Act  (Amended January 1980), and a tolerance is needed to cover  any
 pesticide residues in cereal grains and oil seeds.  A discussion of
 this feed use for  "aspirated grain fractions"  from  a tolerance
 perspective  follows in the attached report and  includes a summary
 of the total volume of aspirated dust that might be available from
 export elevators for  animal feeds, a discussion how the aspirated
 dust is  used in  animal   feeds  and to  what the extent in   the
 livestock meat-producing  industries,  and guidance in  regards   to
 residue chemistry  data requirements  for  this  aspirated  dust   in
 registration and tolerance actions of pesticides used  on cereal
 grains and oil seeds.
Attachment:
ASPIRATED GRAIN FRACTIONS (GRAIN DUST)
A TOLERANCE PERSPECTIVE (JUNE 1194)
cc: RBP, Margie Feherenbach (FOD)
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ASPIRATED GRAIN FRACTIONS (GRAIN DUST):






       A TOLERANCE PERSPECTIVE






              (JUNE 1994)
-------
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                 ASPIRATED GRAIN FRACTIONS (GRAIN DUST):

                           A TOLERANCE PERSPECTIVE
BACKGROUND

Every time cereal grains or oilseeds (e.g., corn, wheat, sorghum, barley, oats, rye, and rice,
and soybeans) are moved into, transferred within, or shipped from US grain handling facilities,
dust is generated as the grain moves through a transfer point, e.g., bucket elevator, one belt
to another, etc..  This dust escapes as an air pollutant and is potentially damaging to workers
if inhaled, and because of its flammability when it becomes airborne, it is also a highly
explosive dust which creates a hazardous work environment.  The Occupational Safety and
Health Administration  (OSHA, US Department  of Labor) regulations require dust control
systems in grain elevators to remove this dust both for environmental and safety reasons. The
grain elevator industry  has  designed dust control systems to capture dust at each of these
transfer points in compliance with OSHA standards.  OSHA commonly refers to the elevator
dust as "fugitive dust", and defines this dust as combustible particles  <425 microns ifjm)
which escape in the handling of grain.   Particles sizes  <425 //m are a factor in worker
inhalation, while from an explosion safety point, dust particles below 100//m cause the major
explosion hazard;  even larger particles  250 to 500 //m can  also be made to explode in
sufficient concentrations.  OSHA standards also require that grain elevators implement a
housekeeping program to  reduce  accumulations of  "fugitive dust" on ledges,  floors,
equipment, and other exposed surfaces.  Thus, the elevator dust is collected by the dust
control system solely to achieve worker safety and to produce good air quality at the elevator
facilities, and not for grain  cleaning.  Of course, some cleaning of the grain is accomplished
in the process.  The grain elevator industry refer to this elevator dust as "grain dust".
However, the livestock feed manufactures for aesthetical reasons commonly refer to  this
material as "aspirated grain fractions".   Since  our  interest is related to livestock feeding
"aspirated grain fractions" is the preferred term in this discussion of elevator "grain dust".


Dust captured by above systems is divided  into three types: I) dust removed from the grain
stream and collected into  dust bins, 2)  dust sweepings gathered  from the elevator floors,
equipment and  other  elevator  areas, and  3) dust removed from grain  stream by a dust
 recirculation/recombination (R/R) system.  Many facilities disposed of this aspirated dust either
 by recombining with the grain as it is moved through the elevators, or by dumping into landfills
 or the waterways, or by processing into animal feeds. Since many landfills or waterways will
 no longer accept aspirated dust, other disposal methods have been investigated, i.e., burning
 at elevator sites to provide heat energy, using in building materials and roadways, etc., but
 not with great success.  Thus disposal via animal feeds may become more important since it
 is  a nutritious livestock feed somewhat comparable to the whole grain, and therefore an
 acceptable disposal method.

 Changes in the grain standards by the Grain Quality Improvement Act of 1986 (GQIA) prohibit
 the recombination or addition of previously collected "aspirated grain fractions" once it has
 been removed  at the export  facilities and  have consequently increased the volume  of
 "aspirated grain fractions" available for disposal. This includes all three types of dust that are
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 generated at elevators: bin dust, dust sweepings, and recirculation/ recombination dust.  The
 Federal Grain Inspection Service (FGIS), after public comments on the GQIA, adopted the final
 rules (Federal Register, Vol. 52, No. 125, June 30,1987, pp. 24414-24441 )that prohibit the
 addition of dust from bins and sweepings to grain at export facilities.  However, based on
 public comments, FGIS has not yet implemented the prohibition of recombining recirculation
 (R/R) dust to the grain stream, and has deleted this proposal from the final rule-making until
 additional data are gathered for the recirculation/recombination dust. In addition, although not
 prohibited by law, FGIS has recommended that operators of non-export elevators (i.e., country
 and inland terminals) refrain from the recombination or addition practices of bin dust and dust
 sweepings, but not including the R/R dust.  If the addition of R/R dust back into grain is also
 prohibited, then the volume of dust that  must be disposed will increase, and more dust will
 possibly be available for use in animal feeds.  The current market value of "aspirated grain
 fractions" averages $20/ton, while in some cases, in busy seasons, operators of the export
 elevators will even pay the shipping freight for disposal of the dust.

 Since various pesticides are  applied either preharvest to growing grains or postharvest to
 stored grains, the harvested/stored grains could have pesticide surface residues which could
 concentrate in the aspirated dust. This concentration occurs from postharvest treatment
 because pesticide residues are absorbed onto the large surface areas of the dust particles on
 the grain. The particle sizes of the dust can range from < 1 //m to  2500 jwm, with a much as
 50% being < 100//m.  Incorporation of this fine dust into animal feeds can cause increased
 exposure of pesticide residues to animals, and these residues could be transferred into the
 human food chain through livestock meat,  milk,  or  eggs.   Concentration of residues in
 aspirated dust can also potentially occur if measurable surface residues of pesticides are found
 on harvested grain/oilseeds even from preharvest treatment.

 The incorporation of "aspirated grain fractions" into animal feeds would fall under the auspices
 of the Federal Food, Drugs, and Cosmetic Act (Amended January 1980) if a tolerance for
 pesticide residues is  needed  as  a result of moving  cereal grains and oil seeds through
 commerce.  A discussion of this  feed use for "aspirated grain fractions" from a tolerance
 perspective follows in this report.  Included is a  summary of the estimated total volume of
 aspirated dust that might be available yearly from export elevators for animal  feeds.  Since
 these estimates are based upon the total US grain export volumes, the R/R dust would also
 be included in the estimated dust volumes and these estimated volumes will not be affected
 even if the FGIS  prohibits the recombination of  the recirculation  dust.  Also  included is a
 discussion how the aspirated  dust is used in animal feeds, the extent of its use in the cattle,
 swine, and poultry producing industries,  and conclusions about residue data needs for this
 aspirated dust.

 DEFINITIONS/CHARACTERISTICS

The 1993 Official Publication of the Association of American Feed Control Officials  (AAFCO)
defines "grain dust" (Section 60.43) as "aspirated grain fractions". [(IFN 4-12-208) Cereals-oil
seeds grain and seed fractions aspirated.]: "'Aspirated grain fractions' are obtained during the
normal aspiration of cereal grains and/or oil seeds for the purpose of environmental control and
safety within a grain handling facility. It shall consist primarily of seed parts and may  not
contain more than 15% ash.  It shall not contain aspirations from medicated feeds."  (Note:
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Medicated feeds refer to those treated with animal drugs; Ash is defined as the mineral residue
remaining after combustion in air.).   [International  Feed Numbers and Names (IFN) were
developed and provided by the Feed Composition Data  Bank,  USDA National Agricultural
Library, Beltsville, MD.].

A related grain byproduct is called "chaff and/or dust".  This material is  collected in grain
processing plants solely to clean the grain, whereas "aspirated grain fractions" are collected
at grain elevators for environmental and safety reasons. The AAFCO defines "chaff and/or
dust" [IFN 4-02-149  Cereals-legumes chaff and/or dust  (Section 81.3, Screenings)]  as
follows:  "Chaff and/or dust is material that is separated from grains or seeds in the usual
commercial  cleaning processes.  It may include hulls,  joints, straw, mill or elevator dust,
sweepings, sand, dirt, grains, seeds.  It must be labelled, 'chaff and/or dust'. If it contains
more than 15% ash the words 'sand' and 'dirt' must appear on the label."  "Chaff and/or
dust" is normally recombined with unprocessed broken grain pieces and/or bran before being
used in animal feeds. Any pesticide residues in regard to tolerance needs would be considered
in grain byproducts from the grain processing.

Therefore, only the residue data requirements of the tolerance setting process for "aspirated
grain fractions" will be considered in this discussion.

Although "aspirated grain fractions" can be defined in general by IFN 4-12-208,more specific
characteristics for this dust are not as easily defined. First, the dust collection systems are
designed to achieve safety and air quality, and not to  isolate the dust by particle size or
content, i.e., dust, and/or chaff, bran, other light materials.  There are no specific guidelines
or industrial standards of dust collection equipment for grain handling facilities.  Second, the
large variability of the dust composition is governed by the location, time of year, and crop
condition at harvest, as most elevators handle grains on a seasonal basis, e.g., wheat in the
summer, and  corn, sorghum, and soybeans in early fall.  Third, the dust is not normally
segregated  by an individual grain or seed commodity as it is collected, but is trapped in a
common container or bin.  Normally this dust will be recombined with other transient grain at
the elevator site.  Thus, a composite of this aspirated dust will probably be found at inland and
export terminal elevators. In general, aspirated  dust from one commodity will only be found
at country elevators.

Various physical properties, e.g., particle size, density, and surface area, are basic parameters
that can be measured aspirated dust.  Figures 1  through 5 (Appendix A) show the dry-sieved
fractions of corn, rice, soybean, wheat, and wheat-sorghum dust, respectively, from terminal
elevators located  along the Gulf  coast.  These samples were analyzed for the purposes of
elevator explosion studies, and showed that all  five dusts had the greatest mass percentage
in the 45 to 106//m range.  The level of large particles greater than 1000^m varied from 25%
for both wheat and wheat/sorghum samples to  only 1 % for rice. Wet-sieved measurements
in Figure 6 (Appendix A) shows a similar pattern, i.e., greater mass percentage below 400//m.
Figure 7 (Appendix A) reveals large differences between the dry- and wet-sieved measurement
methods for the 100 //m particle  size, but these differences are explained by entrapment of
the  irregularly shaped particles  on the  top of the filter  media in  wet sieving, while  the
mechanical shaking in the dry sieving causes the particles to reorient so these  pass through
the  sieve openings. Dry sieving may also cause addition mechanical breakdown of the dust
-------
and subsequent generation of smaller size dust particles. In either case, results show that the
dust consists of very fine particles, particles which probably contain highly absorbent surface
areas.

Other workers have investigated particle size distribution and found similar results.  These
samples, however, were analyzed only for the purposes of investigating dust explosions (dust
particles below 100//m): wet sieving of the soybean, rice, corn, wheat, and sorghum dusts
showed 51 %, 44%, 54%, 34%, and 34% (% by wgt), respectively, of dust particles below
100//m.

Additional particle size data were reported for wheat and wheat/oats aspirated dust samples
that were collected from three Texas Gulf export terminals in the Houston/Corpus Christi area.
These samples were dry-sieved through the following four screen sizes: 2030,1190, 841,
and 420//m.  The size distribution patterns are shown in Figures 8 through 10 (Appendix A).
The two wheat samples showed approximately 79% and 68% (% by wgt) of the particles
<420jt/m.  The remaining 11 % and 5% (% by wgt) of the particles were greater than 1190
jum, and ca. 21 % and 32 % of the particles greater than 420//m, respectively.  In comparison,
the wheat  sample  in Figure 4 (Appendix A)  showed ca. 25% of the particles greater than
1000/ym, and 34% greater than 500 //m, thus underlining the point about the variability of
particle size distribution based on the factor discussed above. However, the data indicate that
a large portion of the "aspirated grain fractions" can be defined as very small particle sizes,
usually <420//m,  and a very useful characteristic to more adequately define the elevator
aspirated dust.

The ash  content of samples in  Figures 1  through  5 (Appendix A) showed considerable
variation.   The corn dust sample was the  lowest in ash with only  1.8%, the wheat and
wheat/sorghum samples had  12% and 7.7%, respectively. Rice showed 32%, and soybeans
showed 33% ash.  The high ash content in rice is a result of soil particles and husk parts
which concentrate  in the aspirated dust. The high ash content in soybeans is a consequence
of soil contamination in the harvested soybeans which eventually concentrates in the aspirated
dust.  As stated above the ash content of "aspirated  grains fractions" is defined at less than
15%. Ash content, of course, based on seasonal  and harvesting differences can  also vary,
and is probably a more general term to be used in defining "aspirated grain fractions".

VOLUMES  OF EXPORTED GRAINS AND ESTIMATED  VOLUMES OF  ASPIRATED GRAIN
FRACTIONS.

In order to estimate the volume of "aspirated grain fractions" produced annually in the US, and
the subsequent incorporation into animal feeds, the US volumes of grains harvested and
moved into and out of grain elevators must be considered.

Based on Agricultural Statistics (1992), the US has produced up to 347 million metric tons of
grains/oilseeds (i.e., corn, wheat, soybeans, grain sorghum, barley, oats, rye, and rice) in one
year.   The percentage breakdown for the specific grains are corn, 40%,  wheat, 28%,
soybeans, 14%, grain sorghum, 6%, barley, 4%, oats, 4%, and other (including rye and rice),
ca. 4%.
-------
Based upon FGIS grain export data, an average of 4.1 billion bushels (Bbu) of inspected U.S.
grains/oilseeds  (i.e.,  corn, wheat, soybeans, sorghum,  oats, barley, and  rye) have been
exported each year from 1987 to 1992.  FGIS no longer measures rice exports because of
minute volumes.  Exported grains may pass through three types of elevators, i.e., country,
inland,  and  export  terminals.   There are over  7000 country elevators in  the U.S.,
approximately 400 inland terminals, and 63 export facilities (Grain Guide, 1990) which handle
US grain storage/commerce. Aspirated dust is handled at each type of elevator, but several
factors must be considered in the estimation of the volumes of this aspirated dust produced
in the US per year. These factors are:  1) according to a  grain industry representative, grain
can be moved up to 10 times before it is exported or processed;  2) dependent on the grain
harvest, the US can export as much as 1/3 of the total harvested and stored grain in a year;
3) every time grain is  moved in an elevator, the amount.of  dust collected can reportedly range
from 0.06 %  to 0.7% of the total weight of grain moved; the best industrial estimation, to
include all grains, since some are dustier that others, is 0.2%; 4) since the country and inland
elevators normally recombine the collected dust to the transient grain, then presently the
disposal of dust is only  a problem at the export facilities;  less dust from the grain may be
available at the country elevator since this is normally the first storage location after harvest
where most of  the grain drying  occurs; 5) in addition, at no point in the movement of grain
from the farm to the export terminal is there any economic incentive to separate the aspirated
dust from grain; the economic incentive is to transport all grain products (including the dust)
forward from the country elevator to the inland terminal, and subsequently to the  export
terminal; any products that are separated and not returned to the grain stream are losses
referred to as "shrinkage", and mean  a financial difference in the total payment for the grain
with the dust vs. without the dust.

If the problem of estimation is approached in consideration of these factors, then  any best
estimate of the  total volume of "aspirated grain fractions" available for livestock feeds should
be based upon the U.S. export grain/oilseed volumes, and not the U.S. yearly production
volumes. Corn averages 46%,  wheat, 30%, soybeans, 16%, and sorghum, 6% of this 4.1
Bbu export volume and these crops make up 98% of the total U.S. grain exports each year.
Oats, barley and rye  make up the remaining 2% of the total exports. FGIS no longer records
rice exports.

Table 1  (Appendix B) gives FGIS data for grain volumes shipped from U.S. export elevators
for corn, wheat, sorghum, soybeans,  barley, oats, and rye.

Based upon the grain volumes listed in Table 1, and using the  industry estimate of 0.2 % for
"aspirated grain fractions" usually collected from transient grain. Table 2 (Appendix B) gives
estimations of the total volumes of "aspirated grain fractions" that could be available at export
terminals, per move,  within a storage/export facility.

Recently in a report  prepared for FGIS by Texas A & M researchers volumes of bin dust
collected by aspiration were reported from seven US export facilities (See Table A).
-------
TABLE A. Volumes of Grain Handled Yearly and Amounts of Bin Dust
Generated at Seven Export Elevators.
Elevator
1
2
3
4
5
6
7
Million Bu/Yr
Grain
360
129
400
430
40
100
470
Amount of Bin
Dust
(tons/yr)
5000
7150
0
12,600
1300
1300
13,000
Pounds of Bin
Dust/ton of
Grain
1.0
3.9
0
2.1
2.3
0.75
2.0
Average % of
Bin Dust in
Grain
0.05
0.2
0
0.1
0.11
0.04
0.1
The volumes of grain handled per year for the seven facilities ranged from 40 Mbu to 470
Mbu.  These seven elevators not only span the range from the small public elevator to the
large corporate elevator, but also accounted for 47% of the U.S. annual average grain exports
of 4.1 billion bushels.

The above table also gives the amount of dust collected per ton of grain handled by the bin
dust systems in operation at seven export elevators and the average weight percentage of bin
dust collected vs. grain weight.  If these elevators handle 47% of the total US grain exports,
then a rough estimate of the total bin  dust collected at the 63 export terminals is 86,000
tons/yr (1.7 million Ib./yr). This of course does not include the R/R dust which  at the present
time is added back to the grain stream. If FGIS decides that R/R dust must be collected and
not returned to the grain stream, then the volume of dust could double, i.e., 172,000 tons/yr
(3.4 million Ib./yr). Table A also shows the large variability between elevators of the amounts
of dust produced because of the varying degrees of moisture in the transient grains/oil seeds,
differences in the aspiration equipment at the elevator sites, and the type of grain/oil seed
passing through a facility.  This 172,000 tons/yr value is approximately 2/3's the total
estimated in Table 2 using the 0.2% (by weight) value for the amount of dust generated each
time the  grain is moved.  Judging from this fact, it appears that the 0.2% value will provide
a good estimate of the total amount of "aspirated grain fractions" that could be available in
one year for inclusion in animal feeds.

According to the authors of the above report, the data presented in Table A are affected by
the following:  Elevator  2 collected  more dust per ton  of grain than  the others because
approximately 85% of this elevator's dust control systems were the bin dust type.  Elevator
3 uses 100% recirculation/recombination systems, therefore it had 0% bin dust. All the other
elevator's dust control systems were approximately 50% bin dust except elevator 5. A high
percentage of elevator 5's export was sorghum, and since sorghum tends to have higher dust
-------
levels than corn or soybeans, this elevator uses mineral oil for dust suppression. Elevator 1
had a pelleting system for their dust and data on the amount of dust collected per year was
not as reliable as some other elevators.  Elevator 6 exported predominantly hard wheat which
tends to contain significantly less dust than corn or soybeans.

However, even with these variations between elevators, the 172,000 tons/year value is still
a good estimation of the total volume of "aspirated grain fractions" that can be funneled into
the US animal feedstuff market on an annual basis.

UTILIZATION IN ANIMAL FEEDSTUFFS

"Grain dust appears to be a suitable feedstuff for swine and poultry, replacing part of the grain
in the ration. Use in feeds could provide a market for dust, making efficient dust collection
more feasible, improving elevator safety and providing cleaner commodities." (Behnke, Clark,
and Helman, 1979).  (Note:  As explained below, "aspirated grain fractions" is not being fed
to poultry.)

"Our preliminary studies indicate that cereal grain dust has nutritive values similar to the grain
itself.  If  we can process it on site (in elevators and  mills), it will be much more readily
acceptable for use in the feed industries."...." In studies  conducted  with cattle, crumblized
dust replaced 70 percent of the cereal grain fraction of the ration with no apparent rejection
or reluctance to consume demonstrated by the animals."  {Behnke, 1978)

These comments of fifteen years ago, still hold today.

The  feed  industry has always been an outlet  or dumping ground  for waste materials  or
byproducts from other industries.  A high percentage of the modern feeds are composed of
materials  which were formally considered waste, e.g., byproducts from the cereal milling,
meat packing waste, vegetable and fruit processing waste, brewers' and distillers' grains, and
livestock waste.  These materials have high feed value  in today's feedstuff market.

Studies have indicated that "aspirated grain fractions" from cereal grains and soybeans have
nutritive values similar to the grain or seed itself.  The technology to remove the dust from
grain has  been available for almost 50 years, thus "aspirated grain fractions" is not a recent
or new feedstuff, but has  been an acceptable ingredient  in feed  for years.  However,
government regulations and potential environmental hazards from the presence of pesticides,
have narrowed the  avenues  for disposal of this aspirated dust.  There is  an economic
resistance to removing this material because removing it is expensive, i.e., the dust is paid for
at the price of the grain.  When it is removed, it reduces the weight of the grain and the profits
from the grain, and the dust  is worth a lot less in this form. Therefore, the animal feedstuffs
market is a viable alternative for disposal of "aspirated grain fractions".

However, several factors affect the "aspirated grain fractions" composition: 1) type of dust
collecting system, 2) type of grain, 3)  season of the year, and 4) supply point  in  the grain
handling system. The closer a grain facility is to the point of harvest, the greater the effect
of seasonal harvest  on  the  "aspirated  grain fractions" quality. A port terminal sees  little
difference in product mix throughout the market year; consequently, the dust would be quite
similar in mix throughout the year. A country elevator  in western Kansas in June would
-------
                                                                                   8

expect to handle very little grain sorghum, while an eastern Kansas elevator in November
would likely handle mostly corn, sorghum, soybeans, and some wheat. In addition, inland and
country elevators also show variability during the year, i.e., dust from a country elevator
would be expected to be somewhat lower in quality than dust from a port or large inland
terminal  due  to soil contamination from the harvest.  Then as grain is handled at each
subsequent location, the  proportion of fines generated from the moving grain would increase
relative to the dirt from the harvest.

Several problems face the feed industry in utilizing "aspirated grain fractions":  1) the product
is hazardous  to handle in its normal state, both from a  human risk exposure and from a
potential explosive nature, 2) the quality is somewhat variable and the supply is sometimes
erratic, and 3) the dust provides an ideal growth media for germination  of mold spores if the
moisture  content is high enough.   However, one restriction  placed  on  the utilization of
"aspirated grain fractions" is simply its name "dust". To overcome this problem, the grain and
animal feed industry commonly refer to this dust product as "aspirated grain fractions".

Based upon the feed industry uses  of "aspirated grain fractions", the initial estimate of 20%
of the diet was used for all livestock, although some research had shown that the  dust can
be fed up to  50% to cattle and swine.  "Aspirated grain fractions" is  normally mixed with
other feedstuffs (e.g., molasses as a binding agent), or it can be pelleted  by mixing with alfalfa
meal at 50%  to produce "range cubes" which are fed possibly at 20-30% in addition to other
feedstuffs, e.g., grasses, hay, etc.  Dairy farmers and processors of dairy feeds also tend not
to use "aspirated grain fractions" in  feeds because of the possibility of pesticide contamination
of milk.   Leading US poultry  producers have stated that the current poultry production
practices prevent the use of "aspirated grain fractions" in their feed mixes  because of the
possible  presence of high pesticide concentrations in the feed which can result in a lower
weight gain for broiler and/or a drop in egg production with laying hens. Thus, the  inclusion
of "aspirated grain fractions" in poultry diets should not be considered.  It also appears that
much more of the dust may be used for beef cattle, than for other livestock.

SIGNIFICANCE  OF  ASPIRATED GRAIN  FRACTIONS  TO RESIDUE  CHEMISTRY  DATA
REQUIREMENTS.  QUESTION and ANSWERS.

Should "aspirated grain fractions" be considered an animal feedstuff?

"Aspirated grain fractions" is used  in animal feeds, although it appears that this feed may be
restricted largely to the beef  producing industry.   Data to support that "aspirated grain
fractions" are not being fed to dairy cattle are not presently available, and thus, it must be
considered a  feed item for both beef and dairy cattle. "Aspirated grain fractions" should also
be considered a feedstuff for swine. However, comments from the leading poultry producers
clearly show  that "aspirated grain fractions" are not used  in the poultry industry, and should
not be considered a poultry feed item. "Aspirated grain fractions" should not be considered
for the remaining livestock, i.e., horses, sheep, and goats, or for catfish.
-------
                                                                                   9

What are the maximum levels of "aspirated grain fractions" that could be in animal diets?

Based upon available data, a maximum anticipated use level of 20% in animal feeds, to include
poultry had previously been established. Currently, data in this report still support this 20%
value, thus the use of this level in cattle and swine diets only should be considered.

What grains/oil seeds should be considered contributors to the "aspirated grain fractions" used
in animal feeds?

Based upon the US export volumes it appears that corn, wheat, sorghum, and soybeans are
the major grains/oil seed that will generate the estimated elevator dust volumes shown in the
above tables.  Barley, oats, rye, and rice are either exported at very low volumes or not at all,
and any dust collected from these grains would make up a very small percentage «2%) of
the total "aspirated grain fractions" available for animal feeds.  In addition,  rice grain  dust is
not used in animal feeds  because of a high silica  content of >30%.

Can the "aspirated grain  fractions" residue data from one crop be translated to support the
required residue data on one of the other three grains?

Because  of  different growing patterns, i.e.,  difference in the grain exposure because of
protective glumes around the kernels  in several crops, and possibly different application
patterns  of the pesticide, individual  data  will be required for  corn,  wheat, sorghum, and
soybeans, and should  not be translated from one to the other  to support  a  proposed or
registered use.

Should "aspirated grain fractions" be considered  a rac or a processed commodity?

Presently the grains of corn, wheat, and sorghum, and the seed of soybeans,are considered
rac's. When the grain is harvested and stored some dust is present on the grain. "Aspirated
grain  fractions" from these crops are removed by aspiration methods for environmental and
safety reasons as the grain and seed are moved through commerce. This dust is normally
added back to the whole grain/seed as it travels through country and inland elevators, with
final removal, in many cases, occurring at the export elevators.  Removal and/or addition of
this aspirated dust does  not change  the rac.  There is no processing per se involved in its
removal or its addition. Therefore, for consistency,  "aspirated grain fractions", which is only
a portion of the whole grain or seed at harvest and storage, should also be considered a rac.

Should tolerances be established for each of the four crops listed above?

According to the  grain  elevator industry, "aspirated grain fractions" is normally  a composite
of more than one grain. The collected dust from the grain being moved through the elevator
is added to a common dust bin, meaning that the dust from corn can be added to dust from
wheat, the  dust  from sorghum can be added to corn, etc.  Therefore, a tolerance for
"aspirated grain fractions" should be established  for the pesticide, and this  tolerance should
consider the use of a pesticide on corn, wheat, sorghum, and/or soybeans.   For example, if
the pesticide  is used only on one grain/oil seed, then the tolerance  should  be established
assuming this crop will represent 100% of the dust. If the pesticide is used on several crops,
then the rac with the highest residues in the dust will be used to establish the tolerance.
-------
                                                                                   10
Are residue data needed for both preharvest and postharvest uses?
Presently residues  data for  "aspirated grain fractions" are required for all postharvest
applications of pesticides for corn, wheat, sorghum, soybeans, barley, oats, rye, and rice, and
on some preharvest applications for these crops with a zero day or short PHI whose seed
heads are formed at the time of application. However, based upon the  above discussion,
"aspirated grain fractions" data is needed only for corn, wheat, sorghum, and soybeans.
Residue data should be submitted in support of all postharvest uses.
preharvest use follow the discussions on postharvest uses.
Data needs for a
How are residue data for "aspirated grain fractions" to be collected for a postharvest use?

For a postharvest use the following can be used as a reference to help design a laboratory
experiment to measure residue levels in "aspirated grain fractions" from transient grains in
elevator operations.

If the  pesticide is currently  registered  for a  postharvest use, then treated grain  from  a
commercial operation can be  used. The treated grain should be analyzed for residues of the
pesticide under investigation, then cleaned by an aspirated method identical or similar to a
commercial elevator operation to trap the dust.  For each 100 Ib of grain, the amount of dust
should be approximately 200 g.  Depending upon the pesticide residue levels, this may or may
not be a sufficient amount for fractionation and analyses;  larger quantities of grain may be
utilized.  Next, the cleaned grain and the dust should be analyzed for the pesticide residues,
and the level of pesticide residue concentration determined. However, before analysis of the
dust, it should be fractionated into 4 or 5 different ranges, e.g, under 400/vm, 400 to 800fjm,
800 to 1200//m, 1200 to 2000//m, and 2000 to 2500//m, or any other similar sieve sizes
to determine the particle size distribution. The purpose of this distribution data is to show that
the aspirated dust sample typifies a sample of commercial elevator "aspirated grain fractions";
normally, at least 50% of the elevator "aspirated grain fractions" have a particle size of < 400
/jm.  But, for purposes of residue analysis, the pesticide treated dust should  be recombined
since this reconstituted dust sample would  be  more representative of  "aspirated grain
fractions" used in commercial feed production and/or feeding  practices.  In  addition, since
"aspirated grain fractions" are defined according to the American Feed Control Association to
contain ash at less than 15%, the ash content of the combined dust fractions should also be
determined. The elevator dust sample should be analyzed using methodology for the pesticide
under  investigation which does not exhibit interference problems from residues of other
registered cereal/oilseed pesticides  that might be  present from prior applications.  It is
recommended that triplicate samples be taken. Duplicate analyses of pesticide residue levels
should be performed on all samples.

An alternative procedure for either a currently registered postharvest pesticide, or a proposed
registration of a newly developed postharvest  pesticide could be as follows.

First, "aspirated grain fractions" that has been collected by a commercial elevator aspiration
system should be acquired.  A particle size  distribution  of the  aspirated dust should be
measured from 2500 (or 2000) fjm to under 400 //m (using 4 or 5 sieve sizes  to cover this
range as described above), and the ash content determined. Analysis of the untreated dust
-------
                                                                                   11

as the control will indicate any problems if other pesticides are present from prior applications.
A sample of the grain should be cleaned by aspiration, using a method identical or similar to
commercial operations.  Next, using the unfractionated aspirated dust sample that was
acquired as described above from a commercial grain elevator, apply the dust to the cleaned
grain at a rate of 0.2% (by weight), and mix to distribute the dust evenly over the grain.
Apply the pesticide at its maximum  allowable label rate, and after the solvent has dried, a
portion of the  grain, which is now covered with the aspirated dust and the pesticide, should
be sampled for analysis. Remove the treated dust from the grain by an aspirated method, and
analyze this cleaned grain and the treated dust for pesticide residues. It is recommended that
triplicate samples be taken.  Duplicate analyses of pesticide residue levels should also be
performed on all samples. The level of concentration should be determined for the pesticide
using average results.

Will separate storage stability data be required for  "aspirated grain fractions"?

Storage stability data  on the whole grain will adequately support storage of "aspirated grain
fractions".

Are any additional data needed for postharvest pesticides normally used on stored grains?

According to an industry representative, in commercial practices, grain can be moved as many
as 10 times before utilized,  processed, or exported.  However, a new pesticide application
may not always accompany the grain transport every time.  Previously,  however, for the
purposes of residue studies, in regard to possible multiple postharvest applications of some
grain pesticides, CBTS required "grain dust" data to reflect a minimum  of four applications
over a minimum one-year period, with the collection, particle size distribution, and residue
analysis of the treated grain and.the dust only at the end of the one-year trial.

However, on  reconsideration of these four applications due to, 1) vast  variability  of the
"aspirated grain fractions" composition (composite mixture in grain dust collection bins), 2)
variability of volume of "aspirated grain fractions" collected from transient grains (0.05 to 0.7
% by weight), 3) possible partial removal of pesticide residues when the aspirated dust is
collected from transient grain, and 4) residue data showing low levels of pesticide residues in
support of the several postharvest pesticide from samplings of commercial elevator "aspirated
grain fractions", it appears that four application are not needed. Therefore, one application
at the maximum allowable  label rate, followed by the collection and  the analysis  of the
"aspirated  grain fractions" for the  pesticide immediately after application, should provide
sufficient data to adequately determine the expected level of a pesticide in commercial elevator
"aspirated grain fractions".  The collection and analysis of this dust should follow the above
suggestions for the gathering of "aspirated grain fractions" data from a postharvest pesticide
use. The Agency reserves the right to change this data requirement if actual commercial
practices change to require additional applications.
-------
                                                                                   12

When and how are residue data for "aspirated grain fractions" to be collected for a preharvest
use?

For a preharvest use, residue data for "aspirated grain fractions" will not normally be needed
if the pesticide is applied during the vegetative stage and before the reproduction stage begins
and seed heads are formed, unless the plant metabolism and /or processing study shows a
concentration of residues  of  regulatory  concern in  outer seed  coat.  If there are higher
pesticide residues in the outer seed coat, data needs for preharvest uses are determined
according to the following flowchart:
                             Analysis of Harvested
                             Grain, Free of Field
                             Trash
 Measurable Residues on
 Grain a: Limit of
 Quantitation
 Aspiration of Grain &
 Analysis of Dust
  Measurable Residues
  in Dust > Level
  in Grain Above
            Residues
             < Limit of
            Quantitation
            No "Aspirated Grain
            Fractions" Data or
            Tolerance Required
No, Tolerance Not
Required for
"Aspirated Grain
Fractions"
 Yes, Tolerance Must Be
 Proposed to Cover
 Maximum Expected Levels
 of Residues in "Aspirated
 Grain Fractions"
       Note: Additional guidance for data requirements for aspirated grain fractions can be obtained
            from the Chemistry Branches, HED, OPP, OPPTS, EPA.
-------
                                                                                        13

REFERENCES

American Feed Control Officials, .Inc. Official Publication 1993.

Anderson, S. L. and Foley, K. M.  Current Utilization of Grain Dust. National Grain & Feed Assoc.
Research Report.  March 13,  1981.

Behnke, K. C., Grain bust May Be a Quality Ingredient. Feed Industry Review. 54 (20): 20-21. 1978.

Behnke, K. C.  Grain Dust Utilization, A Literature Survey.  National Grain & Feed Assoc. Research
Report.  December, 1979.

Behnke, K. C., Clark, III, H. M., and Helman, L.  Grain Dust Utilization in Animal Feeds. FEEDSTUFFS.
51(11):  31-32.  March 12,  1979.

Clark, III, H.  M.   The Incorporation of Grain Dust in Livestock Diets.  M. S. Thesis. Kansas State
University.  Manhattan, KS. 1979.

Gerngross, M. Food Protein and Development Center, Texas A & M University. Letter to the author,
July 5, 1990.

Grain Guide/North American Grain Yearbook.  Milling & Baking News (Pub.),  Shawnee, KS. 1990.

Martin, C. R. Characterization of Grain Dust Properties.  Transactions of the ASAE. 24 (3): 738-742.
1981.

Miller, B. S. and Pomeranz, Y.  Proceedings of the International Symposium on Grain Dust, pp 219-
240. October 1979.

Parnell, Jr. C. B., Jones, D. D., Rutherford, R. D., and Goforth, K. J. Physical Properties of Five Grain
Dust Types.  Environmental Health Perspectives. 66: 183-188.  1986.

Parnell,  Jr., C. B., Spillman,  D. D., and Whitelock, D.  P.   Impact Study of Prohibiting Recombinina
Recirculation Dust At Export  Elevators. Contract report from Texas A & M University to FGIS, USDA.
February 1992.

OSHA.  Grain Handling Facilities: Final Rule.  Federal Register. Vol. 52, No. 251, December 31, 1987, .
pp. 49624-49631.

Schnake, L. D.  Grain Dust: Problem and Utilization. USDA, ESS-6, April 1981.

USDA.  Agricultural Statistics 1993.  U. S. GPO. Washington, D. C.  1993.

USDA.  Grain Standards: Official U. S. Standards, Handling Practices and Insect Infestation: Final
Rules. Federal Register. Vol. 52, No. 125, June 30, 1987,  pp. 24414-24441.

USDA.  Task Force Report: Prevention of Dust Explosions In Grain Elevators - An Achievable Goal. U.
S. GPO, 0-310-945/FGIS-24. 1980.
-------
-------
APPENDIX A
-------
-------
                                        Appendix A
        Dry sieved fractions of corn dust
                                                   Fraction size
                                                  >100°
                                                  <1000>500
                                                  <500>250
                                                  <250 >106
                                                  <106>45
    Percentage
                    Partlde size, microns
         Dry sieved fractions of rice dust
        100 n
        90
        80
        70-
        60
        50
        40
        30
        20
        10
               o>
               o
 Fraction size
>1000
<1000 >500
<500 >250
<250 >106
<106 >45
     Percentage
                    Particle size, microns
Figure 1. (top) and Figure 2. (bottom)
-------
                                         Appendix A
      Dry sieved fractions of soybean dust
100
 90
 80
 70
 60
 50
 40
 30-
 20-
 10-
     Percentage
                                                   Fraction size
                                                  >1000
                                                  <1000>500
                                                  <500>250
                                                  <250 >108
                                                  <106>45
                                                  <45
                                        CO
                    Particle size, microns
        Dry sieved fractions of wheat dust
        100
         90
         80
         70
         60
         60
         40
         30
         20-
         10-
     Percentage
                          «.
            0>
Ol
CO
                               in
                               1000
                        <1000 >500
                        <500 >250
                        <250 >108
                        <106 >45
                        <45
                    Particle size, microns
Figure 3. (top) and Figure 4. (bottom)
-------
                                      Appendix A
Dry sieved fractions of wheat/sorghum dust
                                               Fraction size
                                              >1000
                                              <1000 >500
                                              <500 >250
                                              <250 >106
                                              <106 >45
                                              <45
    Percentage
                   Particle size, microns
    Wet sieve analyses of five grain dusts
     Percentage
            Com
Rice   Soybean  Wheat Wheat/Sorghum
Grain
                                               Size opening
                                              <390 microns
                                              <100 microns
                                              <48 microns
 Figure 5. (top) and Figure 6. (bottom)
-------
                                      Appendix A
   Comparison of wet and dry sieving methods
       Percentage Com
                                                Size, method
                                               <100 microns, wet
                                               <106 microns, dry
Rice   Soybean   Wheat Wheat/Sorghum
Grain
Figure 7.
-------
                                        Appendix A
      Dry sieved fractions of wheat dust
      100-,
       90-
       80
       70-
       60
       50
       40-I
       30
       20
       10
(Corpus Christ!)
                           in
                           04
                           Fraction size
                          >2030
                          <2030 >1190
                          <1190 >841
                          <841 >420
                         I <420
    Percentage
                    Particle size, microns
       Dry sieved fractions of wheat dust
       100-1
        90
        80-
        70
        60
        50-
        40
        30
        20
        10
   (Houston)
              8
                     CM
   2030
<2030 >1190
<1190 >841
<841 >420
<420
     Percentage
                    Particle size, microns
Figure 8. (top) and Figure 9. (bottom)
-------
                                   Appendix A
    Dry sieved fractions of wheat/oats dust
100-
90-
80-
70-
60-
50-
40-
30-
20-
10-
0-
Percentagt







04 m

' Pnrtlola »l-r
                                           Fraction size
                                          >2030
                                          <2030 >1190
                                          <1190 >841
                                          <841 >420
                                          <420
Figure 10.
-------
APPENDIX B
-------
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-------
Guidance Procedures for Calculating
Livestock Dietary Exposure
-------
-------
              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                         WASHINGTON, D.C. 20460
                            JUN   2 1994
MEMORANDUM

SUBJECT:



FROM:
                                                            OFFICE OF
                                                       PREVENTION, PESTICIDES AND
                                                         TOXIC SUBSTANCES
           Guidance  Procedure  for Calculating  Livestock  Dietary
           Exposure
           Esther Saito, Chief   ct^
           Chemistry Branch I: Tolerance Support
           Health Effects Division  (7509C)
                         and

           Ed Zager, Chief      /
           Chemistry Branch II: Reregistr
           Health Effects Division  (7509C)
                                                Support
TO
THRU:
          Peter Caulkins, Deputy Director
          Special Review and Reregistration Division (7508W)

                         and

          Steven L.  Johnson, Acting Director
          Registration Division (7505C)
            i&yUiMr/b  Ct  .3v^z^?i^H -  
-------
-------
   GUIDANCE PROCEDURE






     FOR CALCULATING






LIVESTOCK DIETARY EXPOSURE






        (JUNE 1994)
-------
-------
         Guidance Procedure for Calculating Livestock Dietary Exposure


As a guidance to registrants and petitioners the Chemistry Branches have outlined a
procedure for the correction of feed moisture in the calculation of livestock pesticide
dietary burdens. The discussion herein does not represent any change from normal
past procedure.  The  updated Table  II  {June 1994) of the  Residue Chemistry
Guidelines is currently  being  used by reviewers of the Chemistry Branches as the
source of percentage dry matter and percentage of the diet for such calculations.

The feed percentages listed for ruminants (i.e., beef and dairy cattle) in the updated
Table II are on a dry matter basis, while tolerances for these feed items are established
on an as-fed basis. Percentages  for ruminants in the "Guide For Estimating Toxic
Residues in Animal Feeds or Diets" (authored by Dr. L. Harris, 1975, and commonly
known as the Harris Guide), and the "Update of Livestock Feed  Consumption" [Animal
Nutrition, Inc.,  1993, referred to in this document as the ANI Report) are also listed
on a dry matter basis.  Therefore, the correct calculation of ruminant dietary burden
includes the conversion of the feed to a dry-matter basis in the diet.

Percentages  of the diet for  poultry and  swine feeds in the Harris Guide  and the
previous Table  II are also on a dry matter basis. However, poultry and  swine listings
in the updated  Table II and the ANI Report are on  an as-fed basis since almost all
feeds for poultry and swine are in the dry category.  Therefore, the dietary burden
calculation for poultry and  swine  using the updated  Table II  does not require
conversion of the feed  to a dry-matter basis.

The dietary burden calculation must also handle the situation that arises when the feed
item(s)  on which there is (are) tolerance(s)  for a  given chemical do not comprise a
complete diet for the animal.  For example, at the time of this  document, hexazinone
has tolerances  on alfalfa forage (50% of beef cattle diet) and alfalfa hay (25%), but
on no other feed items. In this case, there is  no information on the feed item(s) which
would be used  to round out the animal's diet.  If those additional feed items are wet,
the residues on an  as-fed basis will  be diluted more than they would  be if the feed
items were dry. Errors in the estimate of the dietary burden to the animal could result.

These problems can be avoided,  however, if the burden is calculated in terms of the
weight (as opposed to  concentration) of the pesticide consumed by the animal, and
that amount compared with a standard amount of feed consumed by  the animal.
Thus using this approach  an equation  is  derived for  such calculations  and the
derivation scheme of such an equation, Equation A, is discussed  in Appendix A.
-------
 For ruminants, where feed percentages are expressed on a dry matter basis, equation
 A should be used.
(dietary r nKf^
(burden ^J
                                                                         (A)
       (dietary burden  [DM]) (ppm) =  estimation of total exposure of a pesticide
                                    through feeds on a dry-matter basis, expressed
                                          in ppm (mg pesticide per kg feed)

       (%diet [DM]); =  percentage in the animal diet of commodity i expressed on a
                        dry-matter basis

       (%[DM])i = dry-matter percentage in feed commodity i

       (tolerance)j (mg/kg) = proposed  or existing tolerance expressed
                                    in mg/kg  (i.e., parts per million, ppm)
The burden thus calculated is on a dry-matter basis. Therefore, ruminant feeding and
metabolism studies submitted to the Agency must have their feeding levels calculated
on a dry-matter basis. For feeding studies in which the pesticide has been introduced
via capsule, the petitioner should.report the feed items and intake of each animal so
that dietary  burden can be calculated on a dry-matter basis.

Also note that Equation A could have been used for poultry and swine in the previous
Table II.  However, as noted above the feed percentages for poultry and swine in the
updated Table II are on an as-fed basis.  In that case, no correction will have to be
made for percent moisture; the dietary burden will be simply calculated by Equation
B as follows:
               ,      -
                burden
                                                                         (B)
The dietary burden in this case will be on an as-fed basis.
-------
The following sample calculations using both Equations A and B show how dry matter
correction(s) can alter the estimated dietary burden.

Scenario I. All feed items in the selected diet have proposed or established tolerances,
and all feed items have low moisture content.

For example, consider the burden for beef cattle to chlorpyrifos fed the following diet
(Updated Table II percentages).  The dietary burdens are calculated with and without
correcting for moisture content using  the feed items chosen for the  animal's diet
which have relatively low moisture contents.
corn grain
corn fodder
80% of diet
20% of diet
88% DM
83% DM
0.1 ppm tolerance
10.0 ppm tolerance
Calculation of the burden by Equation B (i .e., without conversion to a dry matter basis)
would give the following:

              (0.80) x (0.1 ppm}  +  (0.20) x (10.0 ppm) = 2.1 ppm
 When the adjustment for moisture  content is made, a difference of 0.4 ppm is
 observed using Equation A:
                                                             ppm
 Scenario 2. All feed items in the selected diet have established tolerances, and some,
 or all feed items have a high moisture content.

 If wet items are included in the diet (e.g., forages), substantial errors in the estimated
 ruminant dietary burden  could result if the calculations are not corrected for the
 moisture content. For example, if corn fodder in the above diet is replaced with corn
 forage,
corn
forage
20%
of
diet
25 °/
o DM
1
0
.0
ppm
tolerance I
 without correcting for moisture, the same 2.1  ppm burden would be calculated by
 Equation B.  However, correcting for moisture, the burden calculated by Equation A
-------
 would be:
               (0.80)
               (0.88)
 (.20)
(0.25)
x (0.1 ppm)  +  -£=£? x (10.0 ppm) = 8.1 ppm
 Thus, using only Equation B,  the dietary burden for beef cattle would be seriously
 underestimated.

 Scenario 3. Not all feed items in the selected diet have established tolerances.

 Similar underestimation of an animal's dietary burden can occur if the available feed
 items do not comprise a complete diet.  Using the above example of hexazinone for
 beef cattle,
I alfalfa forage
alfalfa hay
50% of diet
25% of diet
35% DM
89% DM
2.0 ppm tolerance
8.0 ppm tolerance
the dietary burden, if calculated using Equation B without conversion to a dry matter
basis, follows:
               (0.50) x (2.0 ppm)  +  (0.25) x (8.0 ppm) = 3.0 ppm
Using Equation A, the dietary burden is calculated as follows:
                     x (2.0 ppm)  +  ||| X (8.0 ppm)  = 5.1 ppm
This latter number represents a worst-case scenario; thus, the burden cannot be more
than 5.1 ppm.
      NOTE: Dry-matter percentages for feed items in the updated Table II are listed in Appendix B.
      For unlisted feed items, consult the above ANI Report, or contact the Chemistry Branches, HED
      OPP, OPPTS, EPA.
-------
Appendix A:  Derivation of Equations A and B
-------
-------
           Appendix A
                                                                         1
Based on  the  principles discussed  in the preceeding text, i.e.,  if the  burden is
calculated in terms  of the weight as opposed  to  concentration  of the pesticide
consumed by the animal, and that amount compared with a standard amount of feed
consumed by the animal, Equations A and B are  derived.

First, imagine a diet comprised of a number of feed items where / represents each
individual feed  item. For each ingredient /, the amount of that item consumed by the
animal can be calculated from the assumed total weight of the animal's daily intake
expressed on a dry-matter basis, as indicated by the symbol "[DM]"):
                       total
                                               amount
                                                   (1)
Note that both {% diet [DM]); and (% dry matter) in Equations 1 and 2 should be
expressed as fractions, e.g. 87%  = 0.87. The amount of each ingredient is still
expressed on a dry-matter basis at this point. In order to convert this value to an as-
fed basis, one corrects for the amount of moisture in the item:
           (amount consumed [DM]), (kg)   ( amount
                                       = (consumed
                                                   (2)
 If the amount of feedstuff and the tolerance are expressed on the same basis (i.e. as-
 fed), the amount of pesticide contributed from each feed item can be calculated:
        (pesticide}  (mg) = (  amount  [as_fecfl] (kg} x(tolerance),
        (consumed) ,v y)   {consumed1      V/
                                                   (3)
 After substituting Equations 1 and 2 into Equation 3, the total pesticide burden in mg
 is found by adding up the contributions of each feed item.
total (mg)
pesticide   =  £
consumed     i
(%diet[OM]}'
   (%DM),
                                 x (tolerance),
                                                                        (4)
 The burden can be calculated in terms of a concentration by dividing the sum total of
 pesticide consumed by the total amount of feed consumed by the animal. If the total
 amount consumed is expressed on a dry-matter basis, the result is Equation 5:
                           tort x (tote/    [DM1
                           (kg)   \consumea
                         (%DM),
                                                                         (5)
-------
            Appendix A                                                     2

Since the total amount is expressed on a dry-matter basis for this to occur, the total
amount consumed by the animal divides out in this equation.    Therefore, it is not
necessary to make any assumptions about the total amount of feed that the animal
eats.  Equation 5 thus simplifies to the final Equation A, and Equation A is used in the
dietary burden calculations for ruminants (i.e., beef and dairy cattle in the updated
TAble II):
_  (%diet [DM]),
£     ^»ij%    x (tolerance),
                                                                         (A)
In the case that no correction will have to be made for percent moisture (i.e., poultry
and swine), the dietary burden will be simply calculated by Equation B.
                                                                         (B)
-------
Appendix B: %DM for Feedstuffs in Table II Update (June 1994)
-------
-------
Appendix B
CROP
Alfalfa





Almond
Apple
Barley





Bean


Beet, sugar



Buckwheat





Canola
Carrot
Citrus


Clover


Corn, field




Corn, pop

Corn, sweet



FEEDSTUFF
forage
seed
seed screenings
hay
meal
silage
hulls
pomace, wet
grain
bran
forage
hay
straw
flour
seed
forage
straw/hay
tops (leaves)
molasses
pulp, wet
pulp, dried
grain
forage
hay
straw
milled bypdts
flour
meal
culls
pulp, wet
pulp, dried
molasses
forage
hay
silage
grain
forage
fodder (stover)
milled bypdts
aspirated grain fractions
grain
fodder (stover)
forage
cannery waste
grain
fodder (stover)
% DM
35
88
88
89
89
40
90
40
88
88
30
88
89
88
30
35
89
23
25
30
88
87
30
83
88
89
89
88
12
21
91
68
30
89
30
88
40
83
85
85
88
85
48
30
88
83
-------
Appendix B
CROP
Cotton



Cowpea


Crown vetch

Flax


Grape

•

Grass (pasture
& rangeland)


Hops
Lentil

Lespedeza


Lupine



Mangel beet

Millet



Oats



Pea



Peanut


Pineapple
FEEDSTUFF
meal
undelinted seed
hulls
cotton gin bypdts
seed
hay
forage
forage
hay
meal
straw
seed
raisin, culls
pomace, wet
pomace, dried
raisin waste
forage (fresh)
hay
silage
seed screenings
spent hops
seed
forage
forage
hay
meal
seed
forage
hay
straw
root
tops (leaves)
forage
grain
hay
straw
grain
forage
hay
straw
seed
vines
hay
silage
meal
hay
hulls (shells)
process residue
% DM
89
88
90
90
88
86
30
30
90
88
89
88
85
15
89
79
25
88
40
88
86
88
85
22
88
89
88
30
85
90
11
23
30
88
85
90
89
30
90
90
90
25
88
40
85
85
95
25
-------
Appendix B



CROP         FEEDSTUFF
% DM
Potato

Rape

Rice


Rye




Safflower


Sainfoin

Sorghum, grain



culls
processed potato waste
meal
forage
grain
hulls
straw
grain
forage
straw
hulls
milled bypdts
seed
forage
meal
forage
hay
grain
forage
fodder (stover)
aspirated grain fractions
Sorghum forages, sudangrass (See Grass)
Soybean






Sugarcane
Sunflower



Sweet potato
Tomato

Trefoil

Turnip

Vetch

Wheat





seed
meal
hulls
forage
hay
silage
aspirated grain fractions
molasses
meal
hulls
seed
forage
root
pomace, wet
pomace, dried
forage
hay
root
tops (leaves)
forage
hay
grain
forage
hay
straw
milled bypdts
aspirated grain fractions
20
12
88
30
88
90
90
88
30
88
88
85
94
23
91
30
89
86
35
88
85

89
92
90
' 35
85
30
85
75
92
89
90
23
32
15
92
30
85
15
30
30
85
89
25
88
88
88
88
-------
-------
EPA Guidance on Number and Location
of Domestic Crop Field Trials for
Establishment of Pesticide Residue
Tolerances
-------
-------
              UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

                         WASHINGTON, D.C. 20460
                            JUN   2 1994
                                                            OFFICE OF
                                                       PREVENTION, PESTICIDES AND
                                                         TOXIC SUBSTANCES
MEMORANDUM
SUBJECT!
FROM:
EPA Guidance on  Number and Location of Domestic Crop
Field Trials for Establishment of Pesticide Residue
Tolerances
Esther Saito,  Chief
Chemistry Branch I: Tolerance Support
Health Effects Division (7509C)
                         and

           Ed Zager,  Chief
           Chemistry Branch II: Reregistfation
           Health Effects Division  (7509C)
                                     Support
TO:
THRU:
Peter Caulkins,  Deputy Director
Special Review and Reregistration Division  (7508W)

               and

Steven L. Johnson,  Acting Director
Registration Division (7505C)
                              6
                              , 'D£re/ctor
Health Effects Division (7509C)
      As  part of the Rejection Rate Project,  the Chemistry
Branches  in the Health Effects Division have  prepared the
attached  guidance document on crop field  trials.  The document
was prepared by the Senior Scientists Advisory Council (SSAC) of
the Chemistry Branches following submission of a proposal by
NACA, IR-4,  and USDA.  That proposal proved to be a useful
starting  point, but the SSAC concluded that additional field
trials  would be needed for many fruits and vegetables.
Therefore,  a scheme was developed whereby the number of trials
required  for a crop takes into account not only its production
acreage,  but also its dietary significance.  The senior
scientists  also believed the proposal needed  to be expanded to
address collection of samples and other considerations such as
formulations.
                                                      Recycled/Recyclable
                                                      Printed with Soy/Canola Ink on paper that
                                                      contains at least 50% recycled fiber
-------
      As stated in the document,  we expect crop field trial
 programs initiated in 1995 or later to adhere to this guidance.
 For studies initiated prior to 1995,  implementation of this
 guidance will be handled as follows:

      Registrationt  Issuance of  this document should not impede
      registration actions in which crop field trials are
      initiated prior to 1995.  We will be flexible regarding
      whether such studies which  do not meet the guidance in this
      document are adequate to support tolerances and whether
      additional data will be required to be submitted under our
      data call-in authority.

      Rereaistration;   Issuance of this document should also not
      impede Reregistration Eligibility Decision (RED)  schedules.
      In those cases where the registrant will not initiate
      required crop field trials  until 1995,  the new guidance can
      be referred to and will provide  assurance that the trials
      will be acceptable in terms of number of sites,  site
      locations,  etc.   For field  trials initiated prior to 1995,
      we will be flexible as noted above as to whether additional
      data will need to be called in when the RED is issued.   [For
      those uses registered after 1984 (i.e.,  those not subject to
      the present reregistration  process),  the need for additional
      studies will be  determined  when  the Agency reexamines those
      uses in future reregistration assessments (e.g.,  as  planned
      in the pending legislation).]

      The attached guidance document will be  provided  to
 scientists in both Chemistry Branches and will be  utilized in
 future  Residue Chemistry reviews.   Therefore we recommend that
 this  document be provided as soon as  feasible to all  interested
 parties via SRRD's Rejection Rate Project follow-up document
 publication mechanism.

      Finally,  it should  be noted  that the Office of Pesticide
 Programs  is currently  exploring more  rigorous  statistical
 approaches  to collecting and analyzing residue  data used  to
 establish pesticide tolerances.   As a  result,  additional  guidance
may be  issued in the future on how  and where to  conduct crop
 field trials.
Attachment: EPA GUIDANCE ON NUMBER AND LOCATION OF DOMESTIC CROP
FIELD TRIALS FOR ESTABLISHMENT OF PESTICIDE RESIDUE TOLERANCES
cc: D. Barolo (7501C), A. Lindsay (7501C),  R. Schmitt (7509C),
    D. Edwards (7509C)
-------
EPA GUIDANCE ON NUMBER AND LOCATION

    OF DOMESTIC CROP FIELD TRIALS

         FOR ESTABLISHMENT OF

     PESTICIDE RESIDUE TOLERANCES
         Senior Scientists Advisory Council
              Chemistry Branches
             Health Effects Division

                 June 1994
-------
-------
                        TABLE OF CONTENTS

Page 1     Summary

Page 5     Background

Page 5     Summary of NACA Proposal

Page 6     EPA Analysis of NACA Proposal

Page 7     Definitions

Page 8     Sampling Requirements

Page 9     Number of Trials for Individual Crops

Page 14    Residue Decline Studies

Page 15    Crop Group Tolerances

Page 16    Uses Resulting in No Quantifiable Residues

Page 17    Additional Considerations for Early Season Uses on
           Annual Crops

Page 18    Formulations

Page 20    Spray Volumes-Ground versus Aerial Equipment

Page 22    Amended Registrations

Page 22    Location of Trials  .

Page 24    Requirements for Tolerances with Geographically
           Restricted Registrations and for 24(c) Registrations

Page 25    List of Attachments/Tables
-------
-------
                                                  JUNE 1994

EPA GUIDANCE ON NUMBER AND LOCATION OF DOMESTIC CROP FIELD TRIALS
        FOR ESTABLISHMENT OF PESTICIDE RESIDUE TOLERANCES

Summary

     As a follow-up to the Rejection Rate Analysis of residue
chemistry studies, the Agency has developed more specific
guidance on the number and location of crop field trials.  All
trials initiated in 1995 or later should adhere to this guidance,
which is a modification of a proposal submitted by NACA and IR-4
in Sept. 1992.  That proposal served as a useful starting point,
but the Agency concluded that dietary significance of crops
needed to be factored in to a greater extent, especially for
crops having <300,000 acres.  In addition, the NACA/IR-4 proposal
did not address how crop samples should be collected and the
number of samples per site.

     It should be emphasized that the Agency believes this
guidance formalizes the current requirements for crop field
trials.  Results of FDA monitoring showing <1% violation rates
over the last five years is one indication that adequate data are
currently being submitted to establish tolerances.  Therefore,
significant changes in the number of field trials typically
required are not considered to be necessary.

     Definitions for the terms "pesticide field trial site",
"pesticide field trial", and "sample" were developed in the
process of generating this document (see page 7).

     The actual numbers of field trials that will be required for
a large number of crops are shown in Table 1 or Attachment 7
("REQ #FT" column).  The required numbers of trials range from 1
to 20.  Crops having large acreage and high consumption for the
general population or infants will need up to 20 trials, whereas
crops of <200 total U.S. acres will need only one trial.   In
each case these represent the number of acceptable trials
reflecting the label use pattern (maximum rate, etc.) producing
the highest residue.  Trials which reflect other use patterns or
which for some reason do not generate viable samples (e.g., crop
failure) will not be counted.  For the purposes of standardizing
the number of field trials, it should be emphasized that in most
cases  (see next paragraph) these numbers represent the minimum
that will be accepted to establish a tolerance  (with the
exception of crop group tolerances or uses resulting in no
quantifiable residues).  Additional trials are always welcome and
even encouraged by the Agency.

     EPA has taken into consideration several major factors to
determine the necessary numbers of trials and believes these
numbers will be applicable in most cases.  However, in limited
circumstances the Agency may require additional trials or .accept
-------
fewer trials than specified in Table 1.  Any petitioner believing
that fewer trials are adequate for a given crop will need to
provide a convincing rationale.  In such cases the Agency
strongly advises petitioners to submit a protocol and rationale
before initiating such trials.  Likewise, any residue chemistry
reviews requesting additional trials will include a justification
as to the need for such data.

     This document also gives more specific guidance for current
residue decline requirements.  Residue decline data will be
required for uses where:  (1) the pesticide is applied when the
edible portion of the crop has formed or (2) it is clear that
residues may occur on the food or feed commodities at, or close
to, the earliest harvest time.  The number of decline studies
needed is one for crops requiring 5-12 total trials and two for
crops requiring 16-20 total trials.  These studies are included
in the 5-12 or 16-20 total trials (i.e., not "in addition to"
these numbers of trials).  For a given pesticide additional
decline studies will not be required crop by crop if studies on
representative crops (tree fruit, root crop, leafy vegetable,
grain, and fruiting vegetable) indicate residues do not increase
with longer preharvest intervals.

     Two independently composited samples of treated commodity
should be collected and separately analyzed in each field trial.
These two samples may be taken from the same plot.  An exception
to these guidelines is crops requiring only 1-2 trials; for these
crops four samples  (one each from four separate plots  (2 at Ix
rate, 2 at 2x rate)) will be needed for each trial.  In all cases
Codex guidelines on minimum sample sizes should be followed
 (Attachment 8).  A control crop sample should also be collected
from each crop field trial site for analysis.

     The numbers of trials in Table 1 or Attachment 7 are based
upon each crop being the only one within its crop group for which
a tolerance is requested.  In the case of crop group tolerances
for which there are at least two representative crops, the number
of trials can be reduced by 25% for those representative
commodities that need £8 trials when requested individually
 (i.e., 20 -* 15, 16 -» 12,  12 -» 9, 8 -* 6) .  Table 2 shows the
resulting numbers of trials needed for all crop groups in 40 CFR
180.34(f).

     Since the Agency has recently proposed creation of subgroups
within the existing crop  grouping scheme, guidance on the number
of field trials needed for the representative commodities in
these subgroups is also provided in Table 3.  These numbers of
trials were determined on a case-by-case basis looking at the
acreages and consumption  of the representative commodities and of
the whole subgroup.  Similar principles were applied to crop
"groups" established in 40 CFR 180.l(h) as specified in Table 4.
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     Provided metabolism data (on the crops of interest or
related crops) or field trial data on related crops indicate
quantifiable residues are not likely, a petitioner may elect to
conduct 25% fewer trials for crops normally requiring >8 trials.
However, if all of these trials do not show residues below the
method's limit of quantitation (LOQ), additional trials will
normally be required to bring the total number conducted up to
the standard requirement.  In addition to residues being below
the LOQ, the following two conditions must be met for 25% fewer
trials to be accepted: (1) the method has a sufficiently low LOQ
(usually <0.01-0.05 ppm)  and (2)  the trials still represent all
significant regions of production.

     The application of both 25% reductions discussed above (crop
group and residues 3 total trials, Table 5 shows suggested distributions
of trials among these 13  regions.   These distributions were
developed using the concept that the number of trials per region
should generally correlate with the percentage of the crop grown
in that region.  However, where possible, at least one trial
should be included in each region having >2% of the national
production.
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     The distributions of trials in Table 5 are not intended to
be absolute requirements.  Petitioners may wish to contact EPA
regarding the suitability of alternative distributions of trials.
To aid petitioners in determining distribution of trials, the
production of numerous crops by region is specified in Table 6.

     For crops requiring £3 trials, the data should represent to
the extent possible a balance of the highest production areas,
different geographic/climatic conditions, and/or major
differences in varieties of the crop.  At least one trial should
be conducted in the region of highest production.

     With respect to the distribution of multiple trials within a
region, this should generally follow the relative production in
the individual growing areas (states or counties as appropriate)
of the region.  However, the sites should also be sufficiently
separated to reflect the diversity of the growing region.

     To aid the Agency's review process, petitioners are
requested to include a copy of the map in Attachment 9 showing
the locations of all sites of acceptable trials in the volume of
field trial reports for each crop.

     Finally, separate guidance has been provided in Attachment
11 to address requirements for tolerances with geographically
restricted registrations and for 24(c) registrations.
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DETAILED DISCUSSION

Background

     In 1992 EPA conducted an analysis of residue chemistry
studies that had been submitted in support of the reregistration
of pesticides to determine the factors that led to rejection of
certain studies (i.e., classified as unacceptable).  This
analysis included active participation by representatives of the
pesticide industry (National Agricultural Chemicals Association
or NACA) and the IR-4 program, the two major groups which
generate residue chemistry data.  The results of this analysis
were published in a June 1992 document entitled "Pesticide
Reregistration Rejection Rate Analysis Residue Chemistry".

     For crop field trials a frequent reason for rejection was
insufficient geographical representation.  This could be due to
either an insufficient number of trials being conducted or to the
trials not being conducted in all areas of significant production
for a given crop.   NACA stated that Agency guidance in this area
is vague and proposed that an EPA, USDA, IR-4, and industry
workgroup address this topic to resolve ambiguities for both
petitioners (usually pesticide companies/registrants or IR-4) and
reviewers.  EPA suggested that industry and IR-4 prepare a
package for Agency review that addresses the definition of a
site, the number of sites needed for various crops, the states in
which trials should be conducted, and the percent of national
production to be accounted for.  (See pages 37-39 of the
"Rejection Rate" document.)  EPA also noted (page 46 of same
document) that industry could address the issue of number of
samples per site in its proposal.

     The document entitled "NACA Recommendations for Residue Site
Selection and Number of Field Trials" (hereafter referred to as
the "NACA proposal")  was prepared by members of NACA, USDA and
IR-4 and submitted to EPA in September 1992.

        of NACA Proposal
     NACA/ IR-4 /USDA proposed dividing crops into 3 groups (based
on total acres) for purposes of defining the number and location
of crop field trials:
     Major crops - >2 million acres
     Major-Minor crops - >300,000 acres but <2 million acres
     Minor crops - <300,000 acres

     The number of trials suggested for major crops (20 trials)
and minor crops (3-6 trials) did not take into account factors
such as dietary significance or the geographical distribution of
production.  Such factors were considered for the major-minor
crops (8-12 trials) .  If the data indicate residues below the
level of quantitation (LOQ) , the proposed number of trials was
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reduced significantly for the major and major-minor crops.  No
such reduction was proposed for minor crops.  It was also
proposed that the number of trials needed for label expansions
(new formulations, use rate increases, decreases in PHI) be 10
for major crops and 6-8 for the major-minor crops (i.e., same #
of trials as proposed for establishing the initial tolerance when
residues are below LOQ).  The NACA proposal did not address the
number of samples per site with the exception of minor crops for
which it was specified that a control, Ix and 2x use samples will
be taken from each site.

     With regard to location of trials the NACA proposal divided
the country into 13 regions based on natural geography and
climatic boundaries for the major and major-minor crops.  For
minor crops the same basic regions are used, although four are
subdivided.  For distribution of trials for major and major-minor
crops it was stated that "The number of trials per region should
generally correlate with the percent of the crop grown in that
area.  In order to ensure geographic diversity, however, at least
one trial should be included for each region with 2% or more crop
production."  Multiple test sites within a region should be
spread over the region as much as possible.  "However, running
the residue trial in typical growing regions should take
precedent."

     For the minor crops it was ambiguous as to how the
distribution of trials is to be determined.  Regions were listed
for each crop in Attachment 6 of the proposal and the Overview
stated that there should be at least one trial in each region.
However, there are about 20 crops for which there were more
regions listed than number of sites  (e.g., mustard greens—4
regions, but only 3 sites proposed).  Attachment 6 also had the
following guidelines based on production:
     ">90% in 1 state- all sites in the major producing state
      £75% in 2-3 states- all sites in the major producing states
          with regional representation.
      All others- Obtain sites in regions with the regional
          production accumulating to about 75% of the total
          production for the crop."

EPA Analysis of NACA Proposal

     A team of EPA senior scientists reviewed the NACA proposal
in detail and concluded it was a useful starting point.  However,
there were two major concerns.  First, there was no consideration
of the dietary significance of the crops that NACA had placed in
the "minor" crop category  (3-6 trials).  The Agency scientists
concluded that more trials were necessary for a significant
number of the fruits and vegetables categorized as minor crops.
On the other hand, fewer trials were considered necessary for
those minor crops with very low dietary intake.  The second major
concern was that the NACA proposal did not address the definition
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of a site, how samples should be collected, and the number of
samples per site.  The proposal was revised to take into account
the above concerns.

     Each of the topics such as definitions of site, numbers of
trials, sampling, and distribution of trials is discussed in more
detail below.  Tables are also included to specify the numbers of
trials for many crops, crop groups, and crop subgroups; the
percentages of crop production by region; and suggested
distribution of trials in each region for numerous crops.

     It should be emphasized that the Agency believes this
guidance formalizes the current requirements for crop field
trials.  Results of FDA monitoring showing <1% violation rates
over the last five years is one indication that adequate field
trial data are currently being submitted to establish tolerances.
If insufficient data were being received such that tolerances are
being set too low, the violation rate should be considerably
higher than 1%.  Therefore, significant changes in the number of
field trials typically required are not considered to be
necessary.

Definitions

     A "pesticide field trial site" is a geographically defined
address/location within a country/region/state of a field, space,
water body or other area in or on which a pesticide field trial
is conducted.  (In most cases this definition boils down to a
site being one farm.)  A site typically consists of several plots
(areas of ground with defined boundaries on which a crop is
grown), each of which receives a specified pesticide application
regimen.

     A "pesticide field trial" entails one or more applications
per growing season of a formulated pesticide product to a
specified crop (or the soil) at one site following actual or
simulated cultural practices.  Such applications are usually in
accordance with registered or proposed uses (or a fraction or
multiple thereof in some cases) to provide treated commodity
samples for estimating pesticide tolerances and/or dietary
exposure to pesticides.

     "Sample" is a defined amount of individual agricultural
commodity units  (e.g., specific number of fruits or tubers; a set
weight of grain; etc.) randomly selected from a plot which may be
composited for pesticide analysis.  [NOTE: As discussed in the
next section, tolerances will continue to be based on analyses of
composite samples.  In the future EPA may also require analyses
of individual servings (e.g., one apple, one potato) to assess
the dietary risk from acutely toxic pesticides.  This possible
requirement will not be discussed further in the present
document.]
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                                8

     [The Agency will not address plot size in this document.
     NACA is encouraged to submit a proposal on this issue at a
     later time.]

Sampling Requirements

     With respect to how samples should be collected, the Agency
will continue to base tolerances on composite samples.  As to the
number or weight of agricultural commodity that should be
collected for each composite sample, petitioners should follow
the Codex "Guidelines on Minimum Sample Sizes for Agricultural
Commodities from Supervised Field Trials for Residue Analysis",
ALINORM 87/24A (1987)(Attachment 8).  In each field trial report
the petitioner should indicate whether or not these guidelines
were followed.  If they were not, an explanation should be
provided along with details of how the sampling deviated from the
Codex recommendations.  Petitioners should also include in the
field trial report the number of agricultural commodity units
making a composite as well as the weight of the composite sample.

     With regard to the number of samples per site, the Agency
has decided that more than one treated sample is needed to
provide some estimate of variability, but that three or more
samples are unlikely to result in much additional information
since compositing will tend to mask much of the variability.
Therefore, the Agency has concluded that two independently
composited samples should be collected at each site  (i.e., for
eachAfield trial—with the exception- of crops needing only 1-2
•trials as described later in this section).  The treated samples
may be taken from two separate plots or from the same plot.  In
addition, at least one control (untreated) sample should be
collected and analyzed at each site.

     In those cases where the two treated samples are obtained
from the same plot, it needs to be emphasized that the samples be
collected by two separate runs through the plot following the
aforementioned Codex guidelines.  Splitting one sample from a
plot or conducting two analyses on one sample will not be an
acceptable alternative to separately collecting and analyzing two
samples.  In other words, multiple analyses of a single sample or
of aubsamples constitute the equivalent of only one data point.
(However, as explained below, if such multiple analyses are
conducted, each value should be reported and clearly indicated as
to which sample it represents.)

     For crops which require only 1 or 2 field trials (<200 and
>200-2000 acres, respectively), at least one composite sample
should be collected from each of the four separate treated plots
(plus the control plot) at each site.  It is strongly suggested
that more than one sample be collected from each plot.  Two plots
should be treated at the proposed or registered application rate
(lx) and two plots at a 2x rate.  Furthermore, each plot should
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receive independently prepared applications of the pesticide.  In
other words, the same tank mixture should not be used to treat
more than one plot.  This will allow some assessment of
variability due to factors such as preparation of the tank mix.
[NOTE: As discussed in the next section of this document,
petitioners always have the option of conducting three or more
field trials at the Ix rate (with two treated samples per trial)
instead of the one or two trials with at least four treated
samples per trial and plots reflecting both Ix and 2x rates.]

     With regard to the handling of samples at the residue
analysis stage, petitioners should follow the guidance in Section
142 of FDA's Pesticide Analytical Manual (PAM), Volume I on
sample compositing and comminuting.  Multiple analyses of a
sample are not required, but are advised as a check in those
cases where the residue values from the two composite samples are
significantly different.

     In all field trial reports petitioners need to indicate
clearly whether each reported residue refers to a separate sample
or a second analysis of the same sample.  In either case, all
analyses should be reported—petitioners should not average
multiple analyses of a single sample or the results of multiple
samples in a trial.  The January 1993 EPA document entitled
"Guidance on Submission of Raw Data" should be consulted
concerning this point.

Number of Trials for Individual Crops
                                       *
     The required number of trials for a crop can be found in
either Table 1 or Attachment 7 (column "REQ FT").  Table 1 is an
alphabetical list of crops with the minimum number of trials and
treated samples.  Attachment 7 lists the crops in order of number
of required field trials, but does not specify numbers of
samples.  However, Attachment 7 does include the acreages and
consumptions of crops that were used to determine the number of
trials as discussed below.  Although the list of crops is not all
inclusive, an attempt was made to include all crops for which
acreage and/or consumption information was available.  With
regard to names for crops, the Index to Commodities as published
in the proposed "Pesticide Tolerances; Revision of Crop Groups"
rule  (8/25/93) was used.

     As discussed above, the Agency believed that dietary
significance needed to be a greater factor in determining the
amount of residue data required for each crop.  First, criteria
were developed to assign a base number of field trials dependent
solely on total U.S. acreage of the crop.  Acreage was used
instead of production by weight since the former is more
consistent from year to year.  The primary sources used for
acreage information were USDA's Agricultural Statistics  (1991)
and the 1987 Census of Agriculture  (Dept. of Commerce).  IR-4
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                                10

also provided information on some low acreage crops that are not
included in the aforementioned publications.  When acreage
figures varied between sources, the highest figure was used.
Acreage from Puerto Rico was included for coffee and bananas
since such production was greater than or comparable to that in
the fifty states.  The base numbers of field trials as a function
of acreage are delineated in Attachment 7.  For simplicity the
base numbers of trials are limited to 16, 12, 8, 5, 3, 2 and 1.

     Next, criteria were developed to adjust the number of trials
based on dietary importance of the commodity.  The figures
contained in the Agency's Dietary Risk Evaluation System (DRES)
for the general population were used to make a first cut.  The
diets of non-nursing infants and children aged 1-6 were then
examined to adjust upward the number of trials on any commodities
that had significantly higher consumption by these groups than by
the general population.  The consumption percentages used are
those of the whole diet (i.e., food plus water consumption) and
are shown along with the acreages of crops in Attachment 7.

     For crops having 8-16 base trials (>300,000 acres), it was
decided that the number of trials could be increased or decreased
based on human consumption.  Crops which comprise >0.4% of the
general population diet had the number of trials increased by one
level (e.g., 8 -> 12, 12 -»• 16).  For those crops having 16 base
trials, the number of trials was increased to 20 if they comprise
>0.4% of the diet. In addition, any crop with >300,000 acres and
comprising >l.0% of general population consumption requires at
least 16 field trials.  This particular criterion results in an
increased number of trials for apples, oranges, and tomatoes.  On
the other hand, crops with >300,000 acres accounting for <0.1% of
consumption had their number of trials decreased by one level.
The crops affected by this criterion are primarily or exclusively
animal feeds: alfalfa, clover, cotton, grasses, and sorghum.

     For crops <300,000 acres the Agency has concluded that due
to the small number of base trials (<5)  for such crops, it would
not be appropriate to decrease the number of trials based on low
consumption.  However, any such crops comprising >0.02% of the
general population diet had their number of trials increased by
one level (e.g., 3 -> 5, 5 -»• 8) .  This criterion affected a
significant number of fruits and vegetables such as broccoli,
carrots, grapefruit, lettuce, peaches, pears, and snap beans.

     As noted above and addressing concerns raised in the recent
NAS report entitled "Pesticides in the Diets of Infants and
Children", the Agency also looked at the contribution of crops to
the diets of non-nursing infants and children 1-6 years of age.
In most cases, crops that are significant in these diets are also
important in the diet of the general population.  However,  rice
and oats were found to exceed the 0.4% of the diet criterion for
large acreage crops using the infant diet, but not when using the
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                                11

diet of the general population.  Therefore, the number of trials
for these two crops was increased from 12 to 16.  In addition,
peaches comprise a much higher percentage (1.12%) of the non-
nursing infant diet than of the general population diet (0.366%).
Therefore, the number of trials required for peaches was
increased from 8 (number based on general population) to 12.
[Based on the relatively low acreage of peaches, it was decided
not to increase the number of peach trials to 16, the number of
trials required for crops having >300,000 acres and comprising
>1.0% of the diet.]

     For a number of crops no information could be located as to
total acreage.  The acreage for such crops is "0.00" in Table 7.
While most of these are almost certainly very minor crops, for
such crops a minimum of three field trials will be required
unless documentation of national acreage can be provided to show
fewer trials are an acceptable number.

     In addition to total acreage and percentage of the diet, one
other factor was considered in determining the number of trials
for crops.  The Agency believes that the number of trials can be
reduced if most of a crop is grown in one region.  Therefore, for
most crops which have 5:90% of their production in one region the
number of trials has been reduced one level (e.g., 8 -» 5, 5 -* 3).
Crops subject to this reduction include avocadoes, olives, and
pistachios.  It should be noted, however, that for some crops
having >90% of production in one region the number of trials was
not reduced due to the dietary significance of these commodities.
In the case of crops which only require 3 trials based on total
acreage but have >90% of production in one region, petitioners
will have the option of conducting 3 trials with 2 treated
samples per trial or 2 trials with 4 treated samples each (4
plots per trial—two at Ix rate and two at 2x rate as described
above).  Some of the crops having this option include globe
artichokes, brussels sprouts, figs, mangoes and parsley.  For
crops which require <2 trials based on total acreage, there will
be no reduction based on production being primarily in one
region.

     The effect of the 90% production being in one region can be
ascertained by comparing the "REQ #FT W/O 90%" AND "REQ #FT"
columns in Table 7.  Those crops which have a smaller number of
trials in the "REQ #FT" have received a reduction due to >90% of
production being in one region.  The "REQ #FT" column agrees with
the "Minimum No. of Trials" column in Table 1.

     For the purposes of standardizing the number of required
field trials, it should be emphasized that in most cases  (see
next paragraph) the number of trials based on the above criteria
and listed in Table 1 or Attachment 7. (REQ #FT) represent the
minimum number of trials that will be accepted  (with the
exception of crop group tolerances or uses resulting in no
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                                12

quantifiable residues as described later in this document).
Additional trials are always welcome and, in fact, encouraged in
the sense that more data points provide greater certainty of
expected residue levels.

     As discussed above, EPA has taken into consideration several
major factors to determine the necessary numbers of trials and
believes these numbers will be applicable in most cases.
However, in limited circumstances the Agency may require
additional trials or accept fewer trials than specified in Table
1.  Any petitioner believing that fewer trials are adequate for a
given crop will need to provide a convincing rationale.  In such
cases the Agency strongly advises petitioners to submit a
protocol (outlining number and locations of trials) and rationale
before initiating such trials.  Likewise, any residue chemistry
reviews requesting additional trials will include a justification
as to the need for such data.

     The numbers of trials in Table l or Attachment 7 represent
how many acceptable trials are required reflecting the label use
pattern producing the highest residue.  In most cases such trials
include the maximum rate per application and per season, the
minimum intervals between applications, and the minimum
preharvest interval.  Trials which reflect other use patterns
will not be counted unless the difference in use is insignificant
(e.g., application rate 5% higher; PHI of 23 days versus 21
days).  In those cases where multiple use patterns are desired
and it is not clear which would result in the highest residue
(e.g., different PHI's as a function of application rate), the
full number of trials will be needed for each use unless side-by-
side studies consistently show higher residues from one use
pattern.  [Additional guidance on this subject for early season
uses appears in a later section of this document.]  Petitioners
should also be aware that trials which for some other reason do
not generate viable samples reflecting the proposed use will not
be counted.  Possible causes of the absence of such samples are
crop failure, mislabelling of samples, contamination, and
insufficient documentation of sample integrity from collection to
analysis.  For these reasons it would be prudent for petitioners
to conduct at least the field portions of a greater number of
trials than the minimum listed in Table 1.

     Although the NACA proposal included three trials as a
minimum for any crop, the Agency believes that one or two trials
are adequate for very low acreage crops (<200 and >200-<2000
acres, respectively).  A greater uncertainty in residue levels is
tolerable for these crops based on their extremely low
contribution to the diet.  However, if considerable variability
is encountered between plots or between trials for such crops,
the Agency may set the tolerance noticeably higher than the
highest observed residue.  In such scenarios petitioners have the
option of conducting additional field trials to attempt to show
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                                13

that a lower tolerance level would suffice.  In fact, petitioners
always have the option of conducting three or more field trials
at the ix rate (with two treated samples per trial) instead of
the one or two trials with at least four treated samples per
trial and plots reflecting both Ix and 2x rates.

     Additional points need to be made with regard to the numbers
of trials listed in Table 1 or Attachment 7:
     1.  Residue decline studies are included for many uses on
crops needing >5 trials.  Refer to the next section of this
document for details.
     2.  These numbers are based upon each crop being the only
one within its crop group for which a tolerance is requested.
Refer to the Crop Group Tolerances section for how many trials
are needed for uses on crop groups.
     3.  Fewer trials may be accepted for uses that do not yield
quantifiable residues.  Refer to the appropriate section later in
this document for details.
     4.  The numbers are also predicated upon only one
formulation type being requested for use on each crop.  Refer to
the Formulations section for data requirements for additional
types of formulations.
     5.  The spray volumes specified for certain uses, especially
ultra-low volume (ULV) and orchard uses, can affect the number of
required trials.  This is discussed in more detail later in this
document.
     6.  Fewer trials will be needed for an amended registration
provided the existing tolerance is shown to be adequate.  Refer
to the appropriate section later in this document  for more
details.
     7.  Table 1 addresses only national registration of
terrestrial uses on domestic crops.  Import tolerances are not
covered.  Refer to Attachment 11 for guidance on crop field
trials to support regional and  24(c) registrations.
     8.  The numbers represent  trials required for permanent
tolerances.  With the exception of the small acreage crops, fewer
trials will normally be accepted for temporary tolerances
 (experimental use permits).
     9.  Validated analytical methodology, appropriate storage
stability data, and documentation on sample handling, shipping,
and storage intervals and  conditions from  sampling to analysis
are needed to support all  field trials.
     10.  Sampling and analysis of treated and control samples
for each raw agricultural  commodity of a crop as specified in
Table  II of the Residue Chemistry Guidelines  (e.g.,  corn grain,
forage and fodder) should  be included in all field trials unless
a practical livestock feeding restriction  is placed  on the
pesticide label for a commodity.
     11.  Commercially  important varieties of a crop as well as
seasonal variations  (e.g., winter wheat vs. spring wheat) should
be covered by the field trials.  Data on different varieties are
especially important  if there are  significant differences in size
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                                14

and/or length of growing  season.  Residue data from more than one
year are desirable, but not required for national registration.
[NOTE: Data from more than one year will be required for regional
registration of crops which require £8 trials for national
registration as detailed  in Attachment 11.]
     12.  The numbers of  trials are intended to cover terrestrial
food uses on growing crops.  They do not address postbarvest
applications to commodities such as fruit or stored grain.  These
will continue to be handled on a case-by-case basis.
     13.  Unless radiolabeled data show a seed treatment to be a
non-food use, it will not be treated differently than any other
food use.  However, in many cases such uses may be eligible for
the 25% reduction in the  number of trials due to residues being
below the method's LOQ.

Residue Decline Studies

     Residue decline studies are required by the Pesticide
Assessment Guidelines (Subdivision O, Residue Chemistry).  Such
data will be needed for uses where (1) the pesticide is applied
when the edible portion of the crop has formed or (2) it is clear
that quantifiable residues may occur on the food or feed
commodities at, or close  to, the earliest harvest time.  The
primary purpose of these  studies is to determine if residues are
higher at longer preharvest intervals than requested and the
approximate half-life of  the residues.  In addition, such studies
are frequently of great value for determining an appropriate
tolerance when a use pattern is changed.  The number of decline
studies needed is one for crops requiring 5-12 total trials and
two for crops requiring 16-20 total trials.  These studies are
included in the 5-12 or 16-20 trials (i.e., not "in addition to"
these numbers of trials).  Decline studies will not be required
for crops needing <3 total trials.

     The design of the decline studies should include 3-5
sampling times in addition to the requested preharvest interval
(PHI).  The sampling times should all fall within the crop stage
when harvesting could reasonably be expected to occur.   The time
points should be approximately equally spaced and, where
possible, represent both  shorter and longer PHI's than that
requested.  Of course, shorter PHI's can not be examined in the
case of a use with a zero day PHI.  In addition,  for an at-
plant/pre-plant use, the  PHI is usually predetermined by the
length of the growing season of the crop.   Therefore, for such
uses that result in quantifiable residues,  petitioners should
attempt to stretch the harvest period by sampling immature fruit,
tubers, etc. if necessary.

     Only one composite sample will be required for each time
point in a decline study.  However, petitioners are advised to
take two or more samples to prevent method and sampling
variability from masking or appearing to create residue changes
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                                15
with time.
     For most pesticides it is anticipated that residue decline
studies will not be necessary for all crops.  For a given
pesticide additional decline studies will not be required if
studies on representative crops indicate residues do not increase
with longer preharvest intervals.  This will provide some
assurance that the tolerances represent the maximum residues that
will occur from proposed or registered uses of a pesticide.
The representative crop approach to be used is similar to that
described in the January 1993 document "Guidance on Generating
Storage Stability Data in Support of Pesticide Residue Chemistry
Studies".  If a pesticide is to be applied to all types of crops,
it is recommended that decline data be obtained on the following
five representative commodities: a tree fruit, root crop, leafy
vegetable, grain, and fruiting vegetable.  Some flexibility in
the choice of crops will be permitted.  For example, a legume
vegetable could be substituted for the fruiting vegetable.

Crop Group Tolerances

     As mentioned above, the numbers of trials in Table 1 are
based upon each crop being the only one within its crop group for
which a tolerance is requested.  In the case of crop group
tolerances for which there is more than one representative crop,
the number of trials can be reduced based on the reasonable
assumption that residues in the representative commodities should
reflect residues on all crops in the group.   The reduction in
the number of trials is 25%  (i.e., 20 - 15, 16 -»• 12, 12 ->• 9, 8 -»•
6) for those representative commodities that need >8 trials when
requested individually.  Crops which require <5 field trials will
not receive any reduction when used as a representative
commodity.  Table 2 shows the resulting numbers of trials needed
for all crop groups in 40 CFR 180.34(f).

     As stated in 180.34(f)(5), if maximum residues for the
representative crops vary by more than a factor of 5 from the
maximum value observed for any crop in the group, a group
tolerance will ordinarily not be established.  In this case
individual crop tolerances will normally be established and the
25% reduction in the number of trials will not apply.
Petitioners should keep this in mind when planning crop field
trials for crop group tolerances.

     It should be noted that a similar 25% reduction in the
number of trials may be applied to uses that do not yield
quantifiable residues  (see next section of this document).
However, both of these 25% reductions may not be applied to the
same crop.  In other words, the number of trials can not be
reduced 50% for a representative commodity that does not contain
quantifiable residues.
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                                16

      Since the Agency has recently proposed  creation of  subgroups
within the existing crop grouping scheme  ("Pesticide Tolerances;
Revision of Crop Groups",  Federal Register Vol.  58,  No.  163, pp.
44990-45006,  8/25/93),  guidance on the  number  of field trials
needed for the representative  commodities in these subgroups is
also  provided in Table 3.   These  numbers of  trials were
determined on a case-by-case basis looking at  the acreages and
consumption of the  representative commodities  and the whole
subgroup.   Refer to the footnotes of Table 3 for more details.
It should be noted  that these  subgroups are  only proposed at this
time  and can not be used for establishment of  tolerances until a
final rule is published.

      In effect,  some crop groups  have been established in 40 CFR
180.l(h).   For example,  a tolerance on  "onions"  applies  to "dry
bulb  onions,  green  onions,  and garlic".  To  determine the number
of trials required  for the "groups" in  180.l(h)  refer to Table 4.

Uses  Resulting in No Quantifiable Residues

      Provided metabolism data  or  field  trial data on related
crops indicate quantifiable residues are not likely,  a petitioner
may elect to  conduct 25%  fewer trials for crops  normally
requiring >8  trials.   However, if all of these trials do not show
residues  below the  method's limit of quantitation (LOQ),
additional trials will  normally be required  to bring the total
number conducted up to  the standard requirement.  Thus,  the
petitioner could risk a delay  in  obtaining a tolerance if this
option is  chosen.   In addition to residues being below the LOQ,
two other conditions must  be met  for the 25% fewer trials to be
acceptable.   First,  the method must have a sufficiently  low LOQ
both  from an  analytical chemistry standpoint and for risk
assessment purposes.  This  means  the LOQ will need to be in the
£0.01-0.05  ppm range in most cases.  Second, the  trials  still
need  to represent all significant regions of production.
Distribution  of  trials  across  regions is discussed in more detail
in a  later  section  of this  document.

     As explained earlier  in this  document,   the  25%  reduction in
the number  of  field trials  for residues below the LOQ can not be
applied to  representative  commodities being used to  establish
crop group  tolerances.  The reduction is also not applicable to
crops  that  require  <5 field trials.

     For crops which  have more than one raw agricultural
commodity,  the 25%  reduction for  residues below the LOQ may be
applied to  one commodity even  if the others have quantifiable
residues.   For example, if a pesticide is applied to an early
stage of corn, it is  possible residues are found on forage and
fodder, but not  in the grain.   In this case,  16 trials may be
acceptable  for grain, even though 20 are needed for the forage
and fodder.  This is  not meant to imply that separate trials are
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                                17

to be conducted for different crop parts.  In other words, corn
grain, forage and fodder should be collected from each trial
site.  If no residues are found on grain from a minimum of 16
geographically representative sites, the grain collected at other
sites need not be analyzed.

     To take advantage of this option, petitioners should be
certain to submit adequate recovery data and chromatograms
establishing the limit of quantitation of the method.  If the
method ends up being validated in Agency laboratories, the LOQ
will be included in the fortification levels that are tested.
For a definition of LOQ the Agency suggests the article
"Principles of Environmental Analysis", Analytical Chemistry.
1983, 55, 2210-2218 (L.H. Keith, et al).

Additional Considerations for Earlv Season Uses on Annual Crops

     For pesticide applications made prior to crop emergence,
many labels give options such as allowing the use to be pre-
plant, at-plant, or pre-emergence.  The Agency has concluded that
these three types of application can be grouped for the purposes
of determining the total number of field trials.  In other words,
the trials for a specific crop can be divided among these three
applications at the petitioner's discretion.  For example, the
twelve trials for a particular pesticide on cotton could consist
of 3 pre-plant, 3 at-plant, and 6 pre-emergence applications
(plus the maximum rate and number of any proposed post-emergence
applications—see last paragraph of this section).

     If the label gives a choice for surface application versus
incorporation into the soil, data reflecting both of these modes
of application will be required.  There are two options as to how
to conduct and determine the number of trials in this instance.
The preferred option is for.each trial to include both the
surface and incorporated applications on side-by-side plots.
Only one composite treated sample would be required  for each
plot.  The minimum number of trials should be as designated  in
Table 1.  This means that the total number of samples would be
equivalent to that required for most  other uses on the same crop.
Using cotton again as the  example,  at  least twelve trials would
be needed with each having two  samples  (one for surface applied
and  one  for soil  incorporated).  As described in the previous
paragraph, the 12 trials can be divided  among pre-plant,  at-plant
and  pre-emergence applications  if all  these appear on the  label.

      The alternative option  is  to divide the total number  of
trials  in Table  1  (but note  caveat  below) roughly equally  between
those having only the surface treatment  and those reflecting only
soil incorporation.  Two composite  treated samples will be needed
in  each trial.   Since the  trials  for  each mode  of application
will need to have adequate geographic representation, this option
may result  in  a  greater  number  of trials for those crops  which
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                                18

 have a region(s)  normally needing only one trial.   Using the
 cotton example,  the result would be at least two additional
 trials (14 total)  since regions 6 and 2 (representing 10% and 8%
 of production,  respectively)  would each need to have two trials
 (one for surface and one for incorporation).   If the side-by-side
 option above were chosen,  only one trial would be required in
 each of those regions.

      Particularly in the case of  herbicides,  the label may permit
 pre- and/or post-emergence applications.   If both are allowed,
 aJLl field trials should include both applications.   If the choice
 is limited to one or the other,  the full number of trials as
 specified in Table 1 should be conducted for each type of
 application.  However,  fewer total trials will be accepted if
 some side-by-side studies  show a  consistent  pattern between the
 residues from the pre-  and post-emergence uses.   In this instance
 the full number  of trials  will be needed only for  the mode of
 application consistently resulting in higher residues.   [NOTE:
 The discussion in this  paragraph  refers to before  or after the
 emergence of  the  food/feed crop.   Occasionally,  labels specify
 application timing in terms of before or after weeds emerge.  The
 critical factor  for purposes  of this discussion is  whether or not
 the food/feed crop has  emerged.]

 Formulations

      In the "Number of  Trials for Individual  Crops"  section of
 this document it  is stated that the numbers  are  based upon only
 one formulation type being requested for  use  on  each crop.   The
 number  of trials needed to register additional  formulation types
 or classes will be addressed  on a case-by-case basis.   In  some
 instances the full number  of  trials will  also be needed for a new
 type of formulation,  whereas  other  formulation classes  may be
 registered with a  few bridging studies  or perhaps no  field trials
 at all.   The  decision depends upon  how  similar the  formulations
 are  in  composition and  physical form, the mode of application,
 and  the timing of  the application.  More details are  provided
 below.

      One  type of formulation  which  will normally require a  full
 set  of  field  trials  is  the microencapsulated  or  controlled
release  formulation.  Since these are designed to control the
release rate  of the  active  ingredient, the same number  of field
trials  is  needed as  to  obtain an  original tolerance regardless of
the timing and mode  of  its application and the amount of data
available  on  other formulations classes.

     Most  of  the remaining types of formulations can be divided
into two groups: those which  are diluted with water prior to
application and those which are applied intact.  Granules and
dusts are the most common examples of the latter.  Granular
formulations will generally require the full number of field
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                                19

trials regardless of what data are already available for other
formulation classes.  This is based on several observed cases of
residue uptake being quite different for granules versus other
types of formulations of the same active ingredient.  No residue
data will be required for dusts if data are available at the same
application rate and preharvest interval for a formulation
applied as a wetting spray (e.g., EC, WP).

     The most common formulation types which are diluted in water
prior to application include emulsifiable concentrates (EC),
wettable powders (WP), water dispersible granules (WDG; WG) or
dry flowables (DF), flowable concentrates (F1C), and soluble
concentrates (liquid or solid)(SC; SL).  Residue data may be
translated among these classes of formulations for applications
that are made prior to crop emergence (i.e., pre-plant, at-plant,
and pre-emergence applications)  or just after crop emergence.
Data may also be translated among these formulation classes for
applications directed to the soil (as opposed to foliar
treatments).

     For mid- to late season foliar applications of formulation
types listed in the previous paragraph, two options are
available.  The new type of formulation could be treated
similarly to an amended registration  (see later section): 25%
fewer trials would be required than were required for the
formulation class used to obtain the original tolerance.
Alternatively, side-by-side studies  (often referred to as
bridging data) could be conducted.  These involve applications of
the registered formulation (the type used to obtain the
tolerance) and the new type of formulation to side-by-side plots
using the same rates and pre-harvest intervals.  If residues from
the new formulation are comparable to or less than those from the
registered formulation, the new formulation can be registered.
However, if residues are higher from the new formulation in the
side-by-side comparison, the full number of trials specified in
Table 1 will be required for that formulation to determine the
higher tolerance level needed to cover its registration.

     The exact number of side-by-side studies required will be
decided on a case-by-case basis.  A  "representative crops"
approach may be used if the new formulation is requested for use
on numerous crops.  Submission of protocols outlining the crops
and sites to be used in these bridging studies is encouraged.
The most common questions from petitioners in this area have
involved use of EC data to support registrations of wettable
powders.  It is EPA's understanding  that NACA is compiling data
from its members that compare residues from EC's and WP's.  If a
sufficient number of such studies are available, it is possible a
conclusion could be made in the future that no additional crop
field trials are required to register a WP if data for an EC
reflecting the same use pattern are  available.
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                                20

     The previous two paragraphs  address the data requirements
for a new type of formulation when a registered one already
exists.  If a petitioner wishes to register two or more
formulation classes when obtaining the initial tolerance and
registration, the same basic concepts would apply.  That is, a
complete set of trials as specified in Table 1 should be
conducted on one type of formulation and the additional
formulation classes handled like  an amended registration (25%
fewer trials than the primary formulation) or compared to the
primary type of formulation using side-by-side studies.

     A few other statements can be made concerning data
requirements for formulations.  Dry flowable or water dispersible
granular formulations are sufficiently similar to wettable
powders to allow translation of residue data between them.
Placing a formulation (typically  WP) in a water soluble bag does
not require additional residue data provided adequate data are
available for the unbagged product.

     Some pesticides (e.g., phenoxy herbicides) can be applied as
one or more salts and/or esters.  Generally, different salts or
esters of an active ingredient can be treated as new formulations
of that active ingredient for purposes of determining the number
of crop field trials.  Thus, a new salt could be treated like an
amended registration (25% fewer trials than the original salt or
form of the active ingredient) or compared to the registered form
of the active ingredient using side-by-side studies.

8prav Volumes—Ground versus Aerial Equipment

     The subjects of spray volumes and aerial versus ground
equipment are often interconnected and were addressed in PR
Notice 93-2 (Feb. 11, 1993).  This notice stated the following:
"Provided that the pesticide product label specifies that aerial
applications are to be made in a  minimum of 2 gallons water per
acre (or 10 gallons per acre in the case of tree or orchard
crops), crop,, field trials reflecting aerial application will be
waived in those cases where adequate data are available from use
of ground equipment reflecting the same application rate, number
of applications, and preharvest interval.  This data waiver does
not apply to aerial applications  using diluents other than water
(e.g.,  vegetable oils).   In addition, the Agency reserves the
right to require aerial data if special circumstances warrant
it."

     Based on the above, there are only a few instances where the
number of field trials will be affected by the spray volumes or
type of equipment (at least for aerial versus ground)  specified
on the label.   However,  the following two exceptions should be
kept in mind:
     (1)  Ultra-low volume uses (<2 gallons spray per acre;  <10
gallons per acre for orchards)  in mid- to late season will be
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                                21

treated as separate use patterns regardless of the nature of the
diluent (water, vegetable oil, etc.).  If the ULV application is
the first use on the crop (i.e., no tolerance established), the
minimum number of field trials specified in Table 1 or Attachment
7 is required.  If data are already available reflecting higher
spray volumes, the ULV application can be handled similarly to an
amended registration (i.e., 25% fewer trials than specified in
Table 1 providing these trials show the existing tolerance is
adequate—see Amended Registrations below).  Alternatively, it
would acceptable for petitioners to demonstrate using side-by-
side studies that residues from the ULV applications are
comparable to or lower than those from higher spray volumes.
However, if residues are higher from the ULV application in these
side-by-side studies, the full number of trials specified in
Table 1 will be required for this use.

     (2)  For treatment of orchards, dilute sprays (typically
100-400 gallons per acre) and concentrate sprays  (typically 20-
100 GPA) will be treated as separate uses.  The number of trials
will depend upon which of two options is chosen, analogous to the
discussion earlier in this document for surface applied versus
soil incorporation (see Additional Considerations for Early
Season Uses on Annual Crops).   If side-by-side plots  (dilute vs.
concentrate) are included at all sites  (the preferred option),
the numbers of trials in Table  1 will apply and one treated
sample from each plot  (instead  of the normally required two) will
be acceptable.  Alternatively,  the trials could be divided
roughly equally between dilute  and concentrate sprays with
adequate geographic representation required for each type of
spray.  In this case, two treated samples are needed at each site
and the total  number of required trials may exceed that in Table
1 if one or more regions require only one study.  Refer to the
example for cotton in the section on Early Season Uses.

     If either dilute or concentrate sprays are already approved
for use on an  orchard crop, the request to add the other type of
spray to the  label will be treated as an  amended  registration
requiring 25%  fewer trials than specified in Table 1  (see Amended
Registrations  below) or a number of  side-by-side  studies
establishing  that residues from the  requested type of spray are
not higher than those  from the  registered one.  The exact  number
of side-by-side studies required will be  determined on a case-by-
case basis.   Submission of protocols outlining the locations and
numbers of sites  is  encouraged.

     One  final comment on  spray volumes concerns  chemigation—the
application  of pesticides  by  injection  into  irrigation water.
The Agency views  this  as a type of  ground application using very
 large  spray  volumes.   Provided  that data are  available for
typical ground spray volumes, data  reflecting chemigation  are not
required.
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                                22
Amended  Registrations
      For amended registration requests  that  involve  a  significant
 change  in application rate  (either  individual  or  seasonal),
 interval between applications,  or preharvest interval,  the number
 of field trials  required will normally  be  25%  less than that
 needed  to establish  an original tolerance, provided  that the
 latter  is shown  by the reduced number of trials to be  adequate to
 cover the new use.   However,  if the reduced  number of  trials
 indicates that the original tolerance is inadequate, or if the
 original number  of trials was ^5 or already  included a 25%
 reduction (crop  group or residues 3 trials.   These distributions are delineated in Table
5 and were developed using the following general criteria
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                                23

proposed by NACA.  The number of trials per region should
generally correlate with the percentage of the crop grown in that
region.  However, where possible, at least one trial should be
included in each region having >2% of the national production.
The latter criterion can be met in most, if not all, cases for
crops requiring £12 trials.  However, for some crops needing 5-8
trials, trying to satisfy this criterion would result in regions
with a high percentage of the production having too few trials.
For example, in the case of sweet cherries the Agency has not
suggested that trials be conducted in Regions 1 and 9 (3% each of
national production) since this would leave too few trials in the
major regions of production (5, 10, 11).

     The distributions of trials in Table 5 are not intended to
be absolute requirements, but "suggested" designs for these
studies.  There are likely to be several acceptable alternatives
for most crops.  Petitioners may wish to contact EPA regarding
the suitability of alternative  distributions of trials.

     For crops requiring <,3 trials, it  is more difficult to
develop guidance on distribution of trials since the number of
growing regions  is often comparable to  or even greater than the
total number of trials.  In these cases the data should represent
to the extent possible a balance of the highest production areas,
different geographic/climatic conditions, and/or major
differences in varieties of the crop.   At least one trial should
be conducted in  the region of highest production.

     To aid petitioners in determining  distribution of trials  for
crops not listed in Table  5 or  alternative distributions of
trials for crops that are  in that table, the production of
numerous crops by region is specified in Table 6.  Most of these
figures were provided by NACA  (crops >300,000 acres) and IR-4
 (crops <300,000  acres) using acreage information from USDA's
Agricultural Statistics  (1991)  and the  1987 Census  of Agriculture
 (Dept. of Commerce).  These publications  list production by state
instead of  region.   Since  numerous states fall into more than one
region, NACA/IR-4 had to estimate the distribution  of acreage
Within these states  to calculate regional production.  Numerous
crops  (primarily minor crops  such  as spices, herbs, and unusual
berries)  are not listed  at all in  this  table since  the IR-4
report contained no regional  production figures  for them.  As can
also be  seen  in Table  6, the  total accountability  of production
 is <100%  for  a considerable number of  crops.  However, the Agency
believes  sufficient percentages of production  (most are  >85%)  are
 accounted for  to determine the distribution of trials.

     A special comment needs  to be made concerning distribution
 of trials for crop group or (proposed)  crop subgroup  tolerances
 for legume vegetables.   The regulation and proposed rule specify
 that the representative commodities  include one  variety of
 succulent bean,  one variety of dried bean,  one variety of dried
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                                24

 pea,  etc.  depending upon the crop group or subgroup.   If
 possible,  the variety chosen should be one that is grown in all
 significant areas of production for that class of bean or pea.
 If this can not be done,  then a combination of varieties may be
 used  to encompass all regions of production.   As an example,  it
 will  not be acceptable to provide data from only one  region for  a
 certain variety of dried bean even if that dried bean is grown
 only  in that region.   The data need to reflect all significant
 regions of production for all dried beans if a crop group or
 subgroup tolerance is desired.

      The above discussion focuses on the distribution of trials
      regions.   With respect to the distribution of multiple
trials within  a  region, this  should generally follow the relative
production  in  the  individual  growing areas  (states or counties as
appropriate) of  the region.   However, the sites should also be
sufficiently separated to reflect the diversity of the growing
region including soil types.  In other words, if production is
scattered throughout much of  a region, the trials should not be
clustered in one small portion of that region.

     To aid the  Agency's review process with regard to the
distribution of  trials among  and within regions, petitioners are
requested to include a copy of the map in Attachment 9 showing
the locations  of all sites of acceptable trials (i.e., those
reflecting  the proposed use and generating viable samples) in the
volume of field  trial reports for each crop.

Requirements for Tolerances with Geographically Restricted
- Registrations and for 24 fc) Registrations _

     The preceding discussion in this document on determining the
number of crop field trials addresses national registration of
pesticides.  Since regional registration is accepted by the
Agency under certain circumstances, separate guidance has been
developed as detailed in Attachment 11.  This attachment also
addresses field  trial requirements for 24 (c) or Special Local
Needs registrations.  In summary, the basic concept described in
Attachment  11 is that the number of trials for a regional
registration should be determined by multiplying the number of
field trials required for national registration by the proportion
of the crop (on  an acreage basis) grown in the region in which
registration is  sought.
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                                25
List of Attachments/Tables

Table 1-Minimum Numbers of Crop Field Trials and Treated Samples
     for Tolerances in Individual Crops
Table 2-Required Numbers of Field Trials for Crop Groups in
     180.34(f)
Table 3-Required Numbers of Field Trials for Proposed Crop
     Subgroups in 180.34(f)
Table 4-Required Numbers of Field Trials for Crop "Groups" in
     180.l(h)
Table 5-Suggested Distribution of Field Trials by Region for
     Crops Requiring >3 Trials
Table 6-Regional Distribution of Crop Production
Attachment 7: Methodology for Determining Number of Field Trials
Attachment 8: Codex "Guidelines on Minimum Sample Sizes for
     Agricultural Commodities from Supervised Field Trials for
     Residue Analysis"
Attachment 9: Map of Growing Regions for Trial Distribution
Attachment 10: Border Definitions of Regions
Attachment 11: Number of Field Trials Required for Tolerances
     with Geographically Restricted Registration and for 24(c)
     Special Local Needs Registrations
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TABLE 1: MINIMUM NUMBERS OF CROP FIELD TRIALS AND TREATED SAMPLES
FOR TOLERANCES ON INDIVIDUAL CROPS

     Following the procedure explained in the body of this document
     and in Attachment 7,  this table specifies the minimum numbers
     of  field  trials  and  treated  samples required  to  obtain
     tolerances on individual crops.  For those crops requiring >8
     trials in this  table, a 25% reduction in the number of trials
     is acceptable for uses resulting in no quantifiable residues
     providing certain criteria are met (see  document for details).
     The   same  reduction  is   acceptable  for   representative
     commodities  that  are  being  used  to  obtain  crop  group
     tolerances  (see  Table  2)  and some crop  subgroup  tolerances
     (see  Table  3) .    [NOTE: Application  of both  25%  reductions
     (residues 3  trials.   For crops requiring <3
     trials,   a  minimum  of  four  treated  samples   from  four
     independently treated plots is required for each trial - two
     samples reflecting the  maximum proposed application rate (ix)
     and two reflecting a 2x rate.  As  discussed in the  Sampling
     Requirements section of this document,  each composite sample
     should be collected by  a separate run through a treated plot.
     Splitting one sample  from a plot or conducting two analyses on
     one sample will not be an acceptable alternative to separately
     collecting and  analyzing two samples.   Multiple analyses of a
     single sample or of  subsamples constitute  the equivalent of
     only one data point.
Table 1: Minimum Numbers of Crop Field Trials and
Treated Samples for Tolerances on Individual Crops
Crop
Acerola
Alfalfa
Minimum No.
of Trials
1
12
Minimum No. of
Treated Samples
4
24
                           PAGE 1 OF 9
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Table 1: Minimum Numbers of Crop Field Trials and
Treated Samples for Tolerances on Individual Crops
Crop
Almonds
Apple, Sugar
Apples
Apricots
Arracacha
Artichokes,' Globe
Artichokes , Jerusalem
Asparagus
Ateraoya
Avocado
Bananas
Barley
Beans, Dried1
Beans, Edible Podded1
Beans, Lima, Dried
Beans , Lima ,
Succulent
Beans, Mung
Beans , Snap
Beans , succulent shelled1
Beets , Garden
Blackberries
Blueberries
Bok choi
Boysenberries
Broccoli
Broccoli, Chinese (gai
Ion)
Minimum No.
of Trials
* £
2
3.6
5
2
3 or 2*
3
8
1
5
5
12
12
8
3
8
3 or 2*
8
8
5
3*
8
2
2
. 8
2
Minimum No. of
Treated samples
" * 10
8
32
10
" - 8
6 or 8*
6
16
4
10
10
24
24
16
6
16
6 or 8*
16
16
10
62
16
» '
8
16 ' ' 'fr
8
PAGE 2 OF 9
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Table 1: Minimum Numbers of Crop Field Trials and
Treated Samples for Tolerances on Individual Crops
Crop
Brussels sprouts
Buckwheat
Cabbage
Cabbage , Chinese
cacao Bean (cocoa)
Calabaza
calaiaondin
Canola
Cantaloupe
Carambola
carob
Carrots
Cassava, bitter or sweet
Cauliflower
celery
Cherries, Sour
Cherries r sweet
Chestnuts
chickpea (garbanzo bean)
Chicory
Clover
Coconut
Coffee
Col lards
Corn, Field
Corn, Pop
corn, Sweet
Minimum No.
of Trials
a or 2*
5
8
3
3
2
1
8
8
2
3
8
2
8
8
8
8
3
3
2
^2
5
5
5
20
3
3.2
Minimum No. of
Treated Samples
6 or 8*
10
16
6
6
8
4
16
16
8
6
16
8
16
16
16
16
6
6
8
24
10
10
10
40
6
24
PAGE   3  OF   9
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Table 1: Minimum Numbers of Crop Field Trials and
Treated Samples for Tolerances on Individual Crops
Crop
Cotton
Crabapples
Cranberries
cress, Upland
Cucumbers
currants
Dandelion
Dates
Dill (dill seed,
dillweed)
Eggplant
Elderberries
Endive (escarole)
Figs
Filberts (hazelnuts)
Flax
Garlic
Genip
Ginger
Ginseng
Gooseberries
Grapefruit
Grapes
Grasses (crop group)
(also see Table 2)
Guar
Guava
Hops
Minimum No.
of Trials
12
3
5
1
8
2
1
3 or 2*
2
3
3
3
3 or 2*
3 or 2*
5
3
1
2
1
3
8
12
12
3 or 2*
2
3 '
Minimum No. of
Treated Samples
24
6
10
4
16
8
4
6 QV 8*
8
6
6
6
6 or 8*
6 or 8*
10
6
4
S
4
6
16
24
24
6 or 8*
8
6
PAGE 4 OF 9
-------
Table 1: Minimum Numbers of Crop Field Trials and
Treated Samples for Tolerances on Individual Crops
Crop
Horseradish
Huckleberries
Kale
Kiwi fruits
Kohlrabi
KumxjuatS
Leeks
Lemons
Lentils
Lettuce, Head
Lettuce , Leaf
Limes
Loganberries
Longan Fruit
Lotus Root
Lyehee
Macadamia Nuts
Mamey sapote
Mandarins (tangerines)
Mangoes
Melons , Casaba
Melons t Crenshaw
Melons, Honeydew
Millet, proso
Mint3
Mulberry
Mushrooms
Minimum No.
of Trials
3
3
3
3 or 2*
3
^
3
5
3
8
8
3
2
1
1
, 1
3 or 2*
2
5
3 or 2*
3
3
'5
5
5
3
3
Minimum No . of
Treated Samples
6
6
6
6 or 8*
6
4
6
10
6
16
16
, ,6
8
4
4
4
6 or 8*
8
10
6 or 8*
6
6
10
10
10
6
6
PAGE 5 OF 9
-------
Table is Minimum Numbers of Crop Field Trials and
Treated samples for Tolerances on Individual Crops
Crop
Muskmelons4
Mustard, Chinese
Mustard Greens
Nectarines
Oats
Okra
Olives
Onions, Dry Bulb
Onions, Green
Oranges, Sour and Sweet
Papaya
Parsley
Parsnips
Passion Fruit
Pawpaws
Peaches
Peanuts
Peanuts, Perennial
Pears
Peas, Austrian Winter
Peas, Chinese
Peas, Dried1
Peas, Edible Podded1
Peas, Garden, Dried
Peas, Garden, succulent
Peas, Succulent Shelled1
Pecans ,
Minimum No.
of Trials
8
2
5s
8
16
5
3
8
3
16
3 or 2*
3
3
2
3 or 2*
12
12
3
8
3
- 1
5
3
3
8
8
5
Minimum No. of
Treated Samples
16
8
10*
16
32
10
6
16
6
32
6 or £*
6
6
8
6 or 8*
24
, 24
6
16
6
4
10
6 	 "
6
16
16
10
PAGE 6 OF 9
-------
Table it Minimum Numbers of Crop Field Trials and
Treated Samples for Tolerances on Individual Crops
Crop
Peppers, Bell
Peppers, non-bell
Persimmons
Pimentos
Pineapples
Pistachios
Plantains
Plums
Pomegranates
Potatoes
Pumpkins
Quinces
Radish, Japanese
(da ikon)
Radishes
Raspberries, Black and
Red
Rhubarb
.Rice
'Rice, wild
Rutabagas
Rye
Saf flower
sainfoin
Salsify
sesame
Shallots
Sorghum, Qrain (milo)
Minimum No.
of Trials
8
3
3 or 2*
2
8
3
3 or 2*
8
3 or 2*
16
5
3 or 2*
2
S
32
2
16
5
3
5
5
3
3
3
1
3.2
Minimum No . of
Treated Samples
16
6
6 or 8*
8
16
6
6 or 8*
16
6 or 8*
32
10
6 or 8*
8
10
62
8
32
3.0
6
10
10
6
6
6
4
24
PAGE 7 OF 9
-------
Table l: Minimum Numbers of crop Field Trials and
Treated Samples for Tolerances on Individual Crops
Crop
Soybeans (dried)
Spinach
Squash , Summer
Squash, winter
Strawberries
Sugar Beets
Sugarcane
Sunflowers
Sweet Potatoes
Swiss Chard
Tangelos
Tanier
Taro (dasheen)
Tobacco
Tomatoes
Turnip roots
Turnip tops
Walnuts , Black and
English
Watercress
Watermelons
Wheat
Yam, True
Minimum No.
of Trials
20
f S s frS*'<'f
8
5
.„&_,/;<
8
12"" '
8
8
8
3
3
2
2
3
16
5
5
3
2
8
20
3
Minimum No. of
Treated Samples
40
, ™ ' 16
10
10
16
24
16
16
16
6
6
8
8
5 ,
32
10
10
6
8
16
40
6.
* For  these crops  petitioners  have the  option of  doing 3
trials with two treated  samples (Ix rate)  per trial  or 2
trials with four treated  samples (two at  Ix rate,  two at 2x
rate) per trial.

1.  These bean/pea commodities include more than one type of
bean/pea.  The specific commodities  included in each of these
                      PAGE 8 OF 9
-------
 groups are shown below. The specific representative commodity
 for which field trials should be run in each  case are those
 representative commodities  provided  in  the  proposed  crop
 subgroup Federal  Register notice.

      beans,  dried: include those  commodities  listed  in  the
      proposed crop subgroup  6-C  as Lupinus spp.,  Phaseolus
      spp., Vigna  spp.,  guar and lablab  beans.

      peas.  dried;  include those  commodities  listed  in  the
      proposed crop subgroup  6-C as Pisum spp., lentils  and
      pigeon  peas.

      beans,  edible podded; include those commodities listed in
      the proposed  crop subgroup 6-A as  Phaseolus spp., Vigna
      SPP-/   jackbeans,  soybeans   (immature  seed)  and  sword
      beans.

      peas, edible podded: include those commodities listed in
      the proposed  crop subgroup 6-A as  Pisum spp.  and  pigeon
      peas.

      beans,  succulent  shelled;   include  those commodities
      listed  in the proposed  crop  subgroup  6-B as  Phaseolus
      spp., Vigna spp.  and broad beans.

      peasf succulent shelled;  include those commodities  listed
      in  the  proposed crop subgroup  6-B as Pisum spp.

 2.  A minimum  of five trials  (and 10 samples)  is required  on
 any  one  blackberry or  any one raspberry if a tolerance  is
 sought on "caneberries" (see  Table  3 or Table  4).   A minimum
 of three trials (and six  samples)  is required  if a  tolerance
 is sought only on blackberries or only on raspberries.

 3.  A tolerance for mint  may  be  obtained using residue data
 for spearmint and/or peppermint.  If a tolerance is  sought for
 either spearmint  or peppermint separately,  five  trials are
 still required.

 4.  A tolerance for muskmelons may be obtained using residue
 data for  cantaloupes.

 5.  A minimum of eight trials  (and 16 samples)  is required on
mustard greens if a tolerance is sought on the crop subgroup
 leafy Brassica greens  (see Table 3).
                      PAGE 9 OF 9
-------
-------
TABLE 2: REQUIRED NUMBERS OF FIELD TRIALS FOR CROP GROUPS
                       [180.34(f)]
Crop Group
t) Hoot and Tuber Vegetables.
2) Leaves of Root and Tuber Vegetables
(Human Food or Animal Feed)
3} Bulb Vegetables fAllhun spp.)
4) Leafy Vegetables (Except Brassica
Vegetables)
5) Brassica (Cote) Leafy Vegetables
f
6) Legume Vegetables (Succulent or
Dried)

Representative Commodities
carrot
potato
radish
sugar beet

turnip
sugar beet1

green onion
bulb onion
one other commodity In group2
-
leaf lettuce
head lettuce
celery
spinach

laroceoli3
cabbage
mustard greens

bean (Phaseolus spp.), succulent
bean (Phaseolus spp.), dried
pea (Pisum spp.), succulent
Number of Field
Trials for
Commodity if Not
Part of Crop
Group
g
16
5
12

5
12

3
8
3

8
8
8
8

8
8
5

NA
12
NA
Number of Field Trials
for » Commodity as Part
of Crop Group
6
12
5
9
Total - 32
5
9
Total = 14
3
6
3
Total = 12
6
6
6
6
Total = 24
6
6
5
Total - 17
124
9
95
                       PAGE 1 OF 4
-------
TABLE 2: REQUIRED NUMBERS OP FIELD TRIALS FOR CROP GROUPS
                       [180.34(f)]
Crop Group


7) Foliage of Legume Vegetables
8) Fruiting Vegetables (Except Cucurbits)
9) Cucurbit Vegetables
10) Citrus Fruits (Cjtrus spp.. Fortunella
spp.)
11) Pome Fruits
12) Stone Fruits
f f i tyfy v*
Representative Commodities
..
pea (Pisum spp.), dried
soybean

bean (any variety)
field pea9 - , , , -,-Ck
soybean
„ -^
tomato
pepper

cucumber ,„, TV
melon (cantaloupe or muskmelon)
summer squash
-<'*, re
orange, sweet
lemon
grapefruit

apple
pear
V ,^
sweet or sour cherry
peach
plum (or fresh prune)

Number of Field
Trials for
Commodity if Not
Part of Crop
Group
5
20

8
5
20

16
8

8
8
5

16
5
8

16
8

8
12
8

, , !' -
Number of Field Trials
for A Commodity a$ Part
of Crop Group
5
15
Total = 50
6 s - ", , ,
5
J £ •V/ •"
15 , - '-
Total - 26
12
6
Total = 18
6
6 * ' ;Tf*
5
Total "17 -• - ;
12
5
6
Total = 23
12 ' ' /. " ' <. K
6
Total = 18
6
9
6
Total = 21
                        PAGE 2 OF 4
-------
TABLE 2: REQUIRED NUMBERS OF FIELD TRIALS FOR CROP GROUPS
                       [180.34(f)3
Crop Group
13) Small Fruits and Berries
14) Tree Nuts
15) Cereal Grains
16) Forage, Fodder and Straw of Cereal
I Grains


17) Grass Forage, Fodder, and Hay
18) Non-Grass Animal Feeds (Forage,
rodder, straw, and Hay)

Representative Commodities
blackberry {or raspberry)
blueberry, highbush
cranberry*
grape*
strawberry6

almond
pecan
English walnut7

sweet corn
field com
rice
sorghum
wheat

com
wheat
any other cereal grain

Bermuda grass, bluegrass, and
bromegrass or fescue
alfalfa
clover

Number of Field
Trials for
Commodity if Not
Part Of Crop
Group
3
8
5
12
8

5
5
3

12
20
16
12
20

20
20
16

12 (4 trials for
each variety)
12
12

Number of Field Trials
for * CoawnodiJy a$ Part
of Crop Group
3
6
5
9
6
Total *P 29
5
5
3
Total = 13
9
15
12
9
15
Total =-60
15
15
12
Total = 42
Total = 12
9
9
Total = 18
                       PAGE 3  OF 4
-------
           TABLE 21  REQUIRED NUMBERS OP FIELD TRIALS FOR CROP GROUPS
                                  [180.34(f)]
Crop Group
•U 	 ,-•,, 	 i 1 	
19) Herbs and Spices*
, , s , " ' % ' " '^sytfw
ff ' '*•&* -• ,.
Vs* '• '"' ' ' '
- Representative Commodities
," "''':•' " '"" ',", ",
bas'tl .-'..'
.,.„ c>;« <"
chive , ,, „,,,," "
dill , - '
marjoram (or other Origanum
*PP*>
Wgef"
I
-, ' -"X/ %^k ^'Ift^
Number of Field
Trials for
Commodity if Not
FtttofCrop
Group
3 """ -
3
2
3
3
[ ,, ,
Number of Field Trials
Jo* * Commodity as Fart
of Crop Group J
3 - . - "*-'
3
3 ' ' 1
• , : ; r. 1
3 	
towl-JS „ :",,^,,\
1.   The Proposed  Revision of  Crop Groups  (OPP-300269; FRL-4170-6;  publishec
8/25/93) allows a  choice  between sugar beet or garden beet  as  a representative
commodity.   The same number of field trials would be required for each.
2.  The Proposed Revision of Crop Groups  includes only green and bulb onions as
representative commodities for this crop group.
3.   The Proposed Revision of  Crop Groups allows a choice  between  broccoli 01
cauliflower as a representative commodity.  The same number of field trials woulc
be required for each.                                 .           "
4.  Twelve  total field trials are required; 6 for an  edible podded bean, and 6 foi
a succulent shelled bean.
5.  Nine total  field  trials are  required,  3  for  an  edible podded pea, and 6
a succulent shelled pea.
6.   The  Proposed  Revision  of  Crop  Groups  includes  "blueberry  and any  one
blackberry or any one raspberry"  as  representative commodities for the crop groui
"berries".   Cranberries,  grapes,  and  strawberries will no longer be included u
any crop group.
7.   The Proposed Revision of  Crop Groups includes only almonds and pecans as
representative  commodities for this crop group.
8.   The Proposed  Revision of Crop  Groups  (a)  deletes  marjoram and sage,  (b)
changes "dill"  to  "dill seed",  (c)  provides an  option to obtain data on celery
seed or dill  seed,  (d)  adds black pepper  as  a representative commodity, and (e]
specifies that  data are required on both fresh and dried basil.  Since a minimui
of 3 field trials is required  for any  representative commodity,  each  of the above
will require  3  field  trials for  a crop group tolerance.
9.   The required number  of field trials  for field peas  takes  into account the
total acreage of various  types of peas and lentils.
                                   PAGE 4 OF 4
-------
                   TABLE 3: REQUIRED NUMBERS OF FIELD TRIALS
                    FOR PROPOSED CROP SUBGROUPS [ISO.34(f)]
The number of field trials required for crop groups is provided in Table 2.
For crop groups.  the required number of field trials shown in Table l should be
done for each representative commodity, except that 25% fewer trials are
required for representative commodities normally requiring 8 or more trials.
This procedure does not necessarily apply to the proposed crop subgroups shown
in the Table below since there are fewer representative commodities in many
cases (see Pesticide Tolerances; Revision of Crop Groups; OPP-300269; FRL-4170-
6, published 8/25/93).  The table Joelow and the corresponding footnotes
describe the required numbers of field trials for crop subgroups.
Crop Group
1A. Root Vegetables3
IB. Root Vegetables
Except Sugar Beets3
1C. Tuberous and Conn
Vegetables4
ID. Tuberous and
Conn Vegetables
Except Potato4
4A. Leafy Greens3
Representative
Commodities
carrot
radish
sugarbeet

carrot
radish



potato


sweet potato8
lettuce, head
lettuce, leaf
spinach

Other
Commodities1



Total


beet, garden
turnip
Total

sweet potato8
Total


•

Total
Production
Acres*
(xioooy
98
46
1350
1494
98
46
13
20
177
1310
90.5
1400
90.5
240
51
36
327
% ' "
Consumption
0.322
0.003
0.617
0.942
0.322
0.003
0.042
0.043
0.410
2.091
0.072
2.163
0.072
0.394
0.025
0.081
0.500
# s
Field
Trials*
6
5
9
20
6
5


11
16

16
8
6
6
6
18
                                  PAGE 1 OF 4
-------
TABLE 3: REQUIRED NUMBERS OF FIELD TRIALS
 FOR PROPOSED CROP SUBGROUPS [180.34(f)]
Crop Group
4B. Leaf Petioles4
5A. Head and Stem3
Brassica

SB. Leafy Brassica
Greens7



6A. Edible Podded
Legume Vegetables3

6B. Succulent, Shelled
Pea and Bean3

6C. Dried, Shelled Pea
and Bean, Except
Soybean3

7A. Foliage of Legume
Vegetables Except
Soybeans3

9A. Melons4


Representative
Commodities
celery8
cabbage8
cauliflower (or broccoli)

mustard greens

.


one bean
one pea

one bean
one pea

one bean
one pea

one bean
field pea

cantaloupe


Other /"
Commodities1



Total

cabbage, Chinese (napa)
collards
kale
Total


Total


Total


Total


Total

watermelon
melon, honeydew
Production
Acres*
(xlOOO)
36
98.7
65 (115)
278.7
•^•••^•••i
9.7
8.7
15
6.2
39.6
289
unknown
289
•••^••I^H
51
314
365
1750
395
2145
2090
709
2799
130
193
29
, J* ' ' ""
Consumption
0.114
0.182
0.029 (0.091)
0.302
•HIHHMHMHMB
0.027
0.007
0.035
0.003
0.072
0.372
unknown
0.372
••••^^•••••M
0.048
0.319
0.367
MMMMB^^HM^Bi
0.267
0.005
0.272
•^••IMMIMH^M
0
0
0
0.083
0.142
0.034
* 11
Fteld II
Trials1 (I
8 	 II
6 1
6 1
12 I
S7 II



87 ||
6 ||
3 |
1
9 1
•i— "J
6 |[
6
12 I
9
5 	 [I
14 	
6 ||
5. I
11 ||
8


                PAGE 2 OF 4
-------
                   TABLE 3:  REQUIRED NUMBERS OF FIELD TRIALS
                    FOR PROPOSED CROP SUBGROUPS [180.34(f)]
Crop Group
<

9B. Squash /
Cucumber3
13A. Caneberry
(Blackberry and
Raspberry)5
13B. Bushberry4
19A. Herbs6
19B. Spices6
Representative
Commodities

one variety summer
squash
cucumber



any one blackberry8 (or
raspberry)

blueberry, high bush
basil, fresh and dried
chive

black pepper
celery or dill seed

Other
Coramoditiesi'
Total


pumpkin
winter squash
Total

Total
•


Total


Total
Production
Acres*
(xiOOO)
352
29
130
41
29
229
7.9 (15)
22.9
59


2.75


2.75
%
Consumption
0.259
0.059
0.134
0.008
0.060
0.261
0.018 (0.006)
0.024
0.017 (consumption
for non-nursing
infants = 0.043%)


0.014


0.014
#
Held
Trials*
8
5
fi-


ll
3(3)
5
8
3
3
6
3
3 .
6
1.   The column "other commodities" only includes commodities which account for
>5% of the acreage estimates for the representative commodities.
!.   A minimum of 3 field trials is required for any representative commodity.
3.   The number of required field trials for these crops was determined in the
same manner as for crop groups.
4.   For each of these crop subgroups, the normal number of field trials
required for the representative commodity is required for the crop subgroup.
5.   The required number (five)  of field trials for Caneberries was determined
using the total acreage and consumption estimates for blackberries and
raspberries, and then applying the same criteria as used for determining the
                                  PAGE 3 OF. 4
-------
                   TABLE 3: REQUIRED NUMBERS OF FIELD TRIALS
                    FOR PROPOSED CROP SUBGROUPS [180.34(f)]

number of required field trials for individual commodities.  A minimum of three
field trials is required if a tolerance is sought for either blackberries or
raspberries separately.
6.  For the subgroups "Herbs" and "Spices", the minimum number of required
field trials (3) was required for each representative commodity.
7.  The required number of field trials for Leafy Brassica Greens was
determined using the total acreage and consumption estimates for the major
commodities in the subgroup (since mustard greens represents a relatively smal]
fraction of this total), and then applying the same criteria as used for
determining the number of required field trials for individual commodities.
Therefore, a minimum of eight trials is required if a tolerance is sought on
Leafy Brassica Greens.  If a tolerance on only "mustard greens" is desired, a
minimum of five trials is required (see Table 1).
8.  Acreage information (given in thousands of acres) and consumption for the
following commodities include values for both the commodity itself, and the
acreages and consumptions of other commodities for which the tolerance would
apply as defined in 40 CFR 180.l(h):

     blackberries;   blackberries (6.7), boysenberries (1.2)
     cabbage;        cabbage (90), Chinese cabbage (napa)  (8.7)
     celery;         celery (36), fennel (only consumption data available)
     sweet potatoes; sweet potatoes (87), yams (3.5)
                                  PAGE 4 OF 4
-------
   TABLE  4: REQUIRED NUMBERS  OF  FIELD  TRIALS  FOR CROP  "GROUPS"
                            IN 180.l(h)

The Code  of Federal  Regulations  (40  CFR 180.l(h))  states  the
following:

      "Tolerances  and exemptions  established for  pesticide
      chemicals  in or on the general  category  of  raw
      agricultural commodities listed in column A apply to
      the  corresponding specific  raw  agricultural commodities
      listed in  column B.  However, a tolerance or exemption
      for  a specific  commodity in column B does not apply  to
      the  general  category in  Column  A."

This  section of the  CFR addresses  two  distinct situations.   In
the first situation, a specific  commodity is  included  in  both
columns A and B.   Residue data for that commodity support a
registration or tolerance for itself as well  as  for the
additional items  listed in  column  B.   These include the following
column A  commodities: alfalfa, bananas,  blackberries,  broccoli,
cabbage,  celery,  endive, lettuce (head), lettuce (leaf),
marjoram, muskmelons, onions  (dry  bulb only), onions (green),
peaches,  sugar  apple, summer  squash, sweet potatoes, tangerines,
tomatoes, turnip  tops or turnip  greens,  and wheat.  The required
number and distribution of  field trials for items  in column  A
support items in  column B for this situation.  The minimum
numbers of field  trials for these  commodities are  specified  in
Table 1 or Attachment 7.  [Note: Although "muskmelons11  and
"summer squash" do not appear by name  in column  B  next  to their
entry in  column A, for practical purposes these  entries are
treated as falling under the  situation  described above  with  the
numbers of field  trials specified  in Table 1.]

The second situation occurs in cases where the item in  column A
is a term identifying a group of commodities  in  column  B.  These
include the following column  A commodities: beans,  beans  (dry),
beans (succulent), caneberries,  cherries, citrus fruits,  lettuce,
melons, onions, peas, peas  (dry), peas  (succulent), peppers, and
squash.   Since  these column A commodities are in essence  crop
"groups", the number of field trials required for  these
"commodities" will be determined in  a similar manner as for  crop
subgroups (or crop groups in  the case of citrus).   Listed in
Table 4 below are the field trial requirements to  support a
tolerance for these column  A  commodities.  In each case, one or
more representative commodities  from column B are  shown for  which
field trial data are required  to support the "commodity"  in
column A.  The required number of field trials for  each
representative  cpmmodity is also provided.   Since  these are
treated similar to crop groups and/or subgroups,  a  25%  reduction
in the required number of field  trials  for commodities  typically
requiring 8 or more field trials was employed in those  cases
where there is more than one representative commodity.

                            PAGE  l OF 3
-------
TABLE 4: REQUIRED NUMBERS OF FIELD TRIALS FOR CROP "GROUPS"
                        IN 180.l(h)
Column A
Commodities
Beans



Scant, dry
Beans,
succulent


Caneberrie*
Cherries


Ckru* fruit*
Lettuce


Melon*
Onions


Representative Column B
Commodities
one edible podded bean
one succulent shelled bean
one dried shelled bean

one dried shelled bean
one succulent edible podded
bean
one succulent shelled bean

any one blackberry or
raspberry
sour cherries
sweet cherries

See Table 2
lettuce, head
lettuce, leaf

cantaloupe
dry bulb onions
green onions

Acres
(xlOOO)
289
51
1750

1750
289
51

23 '"
68.4
60.5

,
240
51

130
246
18.1

Consumption
0.372
0.048
0.267

0.267 -
0.372
0.048

0.024
0.035
0.031


0.394
0.025

0,083
0.199
0.004

Number at
Field Trials if
Not in Crop
Group
8
8
12

12' xv"'''
8
8

5
8
8

„#*»»
8
8

8
8
3

Dumber of Field
Trials if Part of ,
Crfcp "Ortrtip* ift
'Column A
6
6
9

12
6
6

5 '
6
6

•cxr " "' "
6
6

8
6
3

Total Number at
Required Field trials
for Tolerance on Croj
"Croup" in Coforow A



21
12


12
s s' ' "


12
23


12
8 ' ''"''"':,


9
                         PAGE 2 OF 3
-------
          TABLE 4:  REQUIRED NUMBERS OF FIELD TRIALS FOR CROP "GROUPS"
                                  IN 180.1(11)
Column A
Commodities
Peas
Peas (dry)
Peas
(succulent)
Peppers
Squash1
Representative Column B
Commodities
one edible podded pea
one succulent shelled pea
one dried shelled pea
Acres
(xlOOO)
unknown
314
395
%
Consumption
unknown
0.319
0.005
Number of
Field Trials if
Not in Crop
Group
3
8
5
Number of Field
Trials if Pat* of
Crop "Group* in
Column A
3
6
5

one dried shelled pea
one edible podded pea
one succulent shelled pea
395
unknown
314
0,005
unknown
0.319
S
3
8
5
3
6

peppers, bell
peppers, non-bell
70,6
27.7
0,040
0.016
8
5
6
3

one variety summer squash
29.0
0.055
5
8
Total Number at
Required Field Trials
for Tolerance on Crop
"Group1* in Column A
14
5
9
9
8
   To be  consistent with the proposed squash/cucumber subgroup (see Table 3),
>ne variety  of  summer squash was chosen as representative of all squash and
Dumpkins.  However,  since the combined acreage  and consumption for all these
commodities  far exceeds that for the representative commodity, summer squash
 combined  acreage  =  99,000 including 58,000 for summer and winter squash, and
:1,000 for pumpkins; combined consumptions are  0.118% and 0.2% for the general
copulation arid  non-nursing infants,  respectively), the required number of field
:rials for the  latter was increased one level from 5 to 8.  Alternatively, five
:rials each  could  be conducted on summer squash and winter squash to obtain a
tolerance  on "squash".
                                  PAGE 3 OF 3
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-------
-------
                           ATTACHMENT 7

        METHODOLOGY FOR DETERMINING NUMBER OF FIELD TRIALS
Methodology:

(1) Assign a base number of field trials to each commodity based
on acreage as follows:
     Number of Acres
    >10,000,000
     >1,000,000
       >300,000
        >30,000
          >2000
           >200
           <200
<10,000,000
 <1,000,000
   <300,000
    00,000
     <2000
Number of Field Trials

     16
     12
      8
      5
      3
      2
      1
(2) For commodities with acreage > 300,000 A, increase the number
of required field trials one level (e.g. 5 to 8, or 8 to 12) if
consumption X).4% of total consumption  (general population,
children 1-6, or non-nursing infants).

(3) For commodities with acreage > 300,000 A, decrease the number
of required field trials one level if consumption < 0.1% of total
consumption.

(4) For commodities with acreage < 300,000 A, increase the number
of required field trials one level ,if consumption > 0.02% of
total consumption.

(5) For the column "REQ #FT", the number of required field trials
was decreased one level for commodities with greater than 90%
production in one region unless indicated otherwise by a
footnote.

(6) A minimum of 16 field trials is required for commodities with
production greater than 300,000 acres and comprising greater than
1% of dietary consumption for the U.S. general population, non-
nursing infants, or children 1-6 (except sugarcane, see footnote
3).

(7) A minimum of 12 field trials is required for commodities with
production less than 300,000 acres and comprising greater than 1%
of dietary consumption for the U.S. general population, non-
nursing infants, or children 1-6.
-------
-------
                                          PERCENT CONSUMPTION
IOMMODITY

:ORN,  FIELD
SOYBEANS (DRIED)
7HEAT
LPPLES
)ATS
 RANGES (SOUR AND SWEET)
 OTATOES
IICE
 'OMATOES
ALFALFA
JARLEY
JEANS, DRIED
JLOVER
X>RN,  SWEET
COTTON
JRAPES
JRASSES (CROP GROUP 18 0.3 4(f))
BEACHES
'EANUTS
SORGHUM, GRAIN  (MILO)
3UGARBEETS
ASPARAGUS
JEANS, EDIBLE PODDED
JEANS, LIMA, SUCCULENT
JEANS, SNAP
JEANS, SUCCULENT SHELLED
JLUEBERRIES
JROCCOLI
:ABBAGE
:ANOLA
CANTALOUPES
:ARROTS
:AULIFLOWER
:ELERY
:HERRIES, SOUR
CHERRIES, SWEET
:UCUMBERS
GRAPEFRUIT
LETTUCE, HEAD
LETTUCE, LEAF
MUSKMELONS
NECTARINES
ONIONS, DRY BULB
PEARS
PEAS, GARDEN, SUCCULENT
PEAS, SUCCULENT SHELLED
PEPPERS, BELL
PINEAPPLES
PLUMS
SPINACH
BEST REQ
ACREAGE NON- #FTs
ESTIMATE GENERAL NURSING W/O REQ
(XlOOO) POPULATION INFANTS 90% #FTs
63300.00
59200.00
61700.00
601.00
6120.00
791.00
1310.00
2800.00
455.00
26000.00
9180.00
1750.00
37300.00
671.00
11000.00
833.00
475000.00
273.00
1690.00
11200.00
1350.00
97.00
289.00
51.00
289.00
51.00
59.00
115.00
98.70
278.00
130.00
98.00
65.00
36.00
68.40
60.50
130.00
189.00
240.00
51.00
159.00
33.00
246.00
84.00
314.00
314.00
70.60
36.00
151.00
36.00
0.530
0.631
2.620
1.260
0.153
2.313
2.091
0.294
1.484
0.000
0.106
0.267
0.000
0.440
0.038
0.437
0.000
0.424
0.139
0.044
0.617
0.024
0.372
0.048
0.372
0.048
0.017
0.091
0.182
0.000
0.083
0.322
0.029
0.114
0.035
0.031
0.134
0.271
0.394
0.025
0.118
0.024
0.199
0.228
0.319
0.319
0.040
0.126
0.083
0.081
0.402
0.875
0.554
3.391
0.402
1.439
0.601
0.710
0.318
0.000
0.075
0.054
0.000
0.219
0.003
0.127
0.000
1.120
0.016
0.000
0.207
0.002
0.440
0.022
0.440
0.022
0.043
0.014
0.010
0.000
0.004
0.786
0.001
0.013
0.027
0.024
0.014
0.059
0.000
0.002
0.007
0.000
0.022
0.848
0.288
0.288
0.007
0.175
0.251
0.099
20
20
20
16
16
16
16
16
16
12
12
12
12
12
12
12
12
12
12
12
12
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
20
20
20
16
16
16
16
16
16
12
12
12
12
12
12
12
12
12
12
12
12
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
8
FOOT
NOTES


11

2


2



15





11


3

15


15

9,11
11
7



11
4
4



16
11,18

11


15

9
9

-------
 COMMODITY

 STRAWBERRIES
 SUGARCANE
 SUNFLOWERS
 SWEET POTATOES
 WATERMELONS
 ALMONDS
 APRICOTS
 AVOCADOS
 BANANAS
 BEETS, GARDEN
 BUCKWHEAT
 COCONUT
 COFFEE
 COLLARDS
 CRANBERRIES
 FLAX
 LEMONS
 MANDARINS (TANGERINES)
 MELONS, HONEYDEW
 MILLET, PROSO
 MINT
 MUSTARD GREENS
 OKRA
 PEAS,  DRIED
 PECANS
 PUMPKINS
 RADISHES
 RICE,  WILD
 RYE
 SAFFLOWER
 SQUASH, SUMMER
 SQUASH, WINTER
 TURNIPS
 ARTICHOKES,  JERUSALEM
 BEANS, LIMA,  DRIED
 BLACKBERRIES
 CABBAGE,  CHINESE
 CACAO  BEAN (COCOA)
 CAROB
 CHESTNUTS
 CHICKPEA  (GARBANZO)
 CORN,  POP
 CRABAPPLES
 EGGPLANT
 ELDERBERRIES
 ENDIVE (ESCAROLE)
 GARLIC
 GOOSEBERRIES
HOPS
HORSERADISH
BEST
ACREAGE
ESTIMATE
(xlOOO)
PERCENT CONSUMPTION

            NON-
 GENERAL    N
 POPULATION INFANTS
      53.00
     830.00
    1980.00
      90.50
     193.00
     428.00
      24.00
      88.00
      24.20
      13.00
      81.00
       0.00
      75.00
      15.00
      27.00
     430.00
      69.00
      28.00
      29.00
     292.00
     122.00
       9.70
       5.70
     394.00
     453.00
      41.00
      46.00
      31.40
     546.00
     211.00
      29.00
      29.00
      20.00
       0.00
      44.40
       7.90
       8.70
       0.00
       0.00
       2.32
       4.00
     268.00
       0.00
       5.30
       0.00
       6.00
      14.80
       0.00
      34.00
       0.00
      0.064
      1.386
      0.008
      0.072
      0.142
      0.005
      0.063
      0.023
      0.426
      0.042
      0.002
      0.050
      0.086
      0.035
      0.060
      0.000
      0.040
      0.021
      0.034
      0.000
      0.001
      0.027
      0.027
      0.005
      0.010
      0.008
      0.003
      0.000
      0.008
      0.003
      0.059
      0.060
      0.043
      0.000
      0.015
      0.018
      0.007
      0.077
      0.000
      0.000
      0.001
      0.013
      0.001
      0.011
      0.000
      0.002
      0.001
      0.001
      0.007
      0.000
REQ
#FTs
3 ING W/0 REQ FOOT
\NTS 90% #FTs NOTEl
0.015
0.463
0.000
0.154
0.008
0.001
0.207
0.001
0.555
0.102
0.000
0.660
0.000
0.009
0.008
0.000
0.002
0.001
0.003
0.000
0.000
0.000
0.000
0.016
0.000
0.000
0.000
0.000
0.000
0.000
0.003
0.198
0.000
0.000
0.000
0.000
0.000
0.008
0.000
0.000
0.000
0.001
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
8
8
8
8
8
5
5
8
5
5
5
5
8
5
5
5
8
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
5
3
5
3
3
5
3
3
3
5
3
3
3
3
3
3
5
3
8
8 3
8
8 11
8
5 10
5
5
5 5,11
5
5
5
5
5
5
5
5
5 11
5
5
5 19
5 12
5
5 9,15
5
5
5
5
5
5
5 13
5 13
5
3
3
3 11
3 17
3
3
3
3
3
3
3
3
3
3
3
3
3
-------
COMMODITY

IUCKLEBERRIES
CALE
KOHLRABI
lEEKS
LENTILS
IMES
MELONS, CASABA
MELONS, CRENSHAW
MULBERRIES
MUSHROOMS
DLIVES
3NIONS, GREEN
PARSLEY
PARSNIPS
PEANUTS, PERENNIAL
PEAS, AUSTRIAN WINTER
PEAS, EDIBLE PODDED
PEAS, GARDEN, DRIED
PEPPERS, NON-BELL
PISTACHIOS
RASPBERRIES, BLACK AND RED
RUTABAGAS
SAINFOIN
SALSIFY
SESAME
SWISS CHARD
TANGELOS
TOBACCO
WALNUTS, BLACK AND ENGLISH
YAM, TRUE
APPLE, SUGAR
ARRACACHA
ARTICHOKES, GLOBE
BEANS, MUNG
BOK CHOI
BOYSENBERRIES
BROCCOLI, CHINESE  (GAI LON)
BRUSSELS SPROUTS
CALABAZA
CARAMBOLA
CASSAVA, BITTER OR SWEET
CHICORY
CURRANTS
DATES
DILL  (DILL SEED, DILLWEED)
FIGS
FILBERTS/HAZELNUTS
GINGER
GUAR
GUAVAS
BEST
ACREAGE
ESTIMATE
(X1000)
PERCENT CONSUMPTION

            NON-
 GENERAL    NT
 POPULATION INFANTS
       0.00
       6.20
       0-. 00
       0.00
     162.00
       6.60
       0.00
       0.00
       0.00
       3.00
      33.30
      18.10
       5.10
       0.00
       6.00
      36.40
       0.00
     232.00
      27.70
      52. 00
      15.00
       0.00
       0.00
       0.00
       0.00
       0.00
      20.00
     681.00
     214.00
       3.50
       0.30
       0.30
      12.00
      15.00
       1.70
       1.20
       0.60
       4.40
       2.00
       0.50
       0.50
       0.42
       0.34
       6.80
       0.30
      17.00
      28.70
       0.30
       6.70
       1.20
      0.000
      0.003
      0.000
      0.000
      0.002
      0.006
      0.001
      0.000
      0.000
      0.040
      0.017
      0.004
      0.007
      0.001
      0.000
      0.000
      0.000
      0.003
      0.016
      0.000
      0.006
      0.005
      0.000
      0.000
      0.001
      0.003
      0.005
      0.000
      0.009
      0.003
      0.000
      0.000
      0.006
      0.012
      0.001
      0.001
      0.000
      0.013
      0.000
      0.000
      0.000
      0.001
      0.001
      0.001
      0.000
      0.005
      0.001
      0.002
      0.000
      0.000


;ING
.NTS
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.002
0.003
0.000
0.001
0.000
0.000
0.000
0.000
0.016
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.005
0.006
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.007
0.000
0.000
0.000
0.000
0.000
0.000
0,000
0.001
0.000
0.000
0.000
0.000
REQ
#FTs
w/o
90%
3
3
3
3
5
3
3
3
3
3
5
3
3
3
3
5
3
5
3
5
3
3
3
3
3
3
3
3
5
3
2
2
3
3
2
2
2
3
2
2'
2
2
2
3
2
3
3
2
3
2


REQ FOOT
#FTs NOTES
3
3
3
3
3
3
3
3
3
3 6
3
3 11
3
3
3
3
3 15
3
3
3
3
3
3
3
3
3
3
3 8
3
3
2 11
2
2
2
2 17
2
2
2
2
2
2
2 , ,
' 2 /
2 /'
2 /
2 /
2 /
2/-'"
2
/2
-------
COMMODITY

KIWIFRUITS
LOGANBERRIES
MACADAMIA NUTS
MAMEY SAPOTE
MANGOES
MUSTARD, CHINESE
PAPAYAS
PASSION FRUIT
PAWPAWS
PERSIMMONS
PIMENTOS
PLANTAINS
POMEGRANATES
QUINCES
RADISH, JAPANESE  (DAIKON)
RHUBARB
TANIER
TARO (DASHEEN)
WATERCRESS
ACEROLA
ATEMOYA
CALAMONDIN
CRESS, UPLAND
DANDELION
GENIP
GINSENG
KUMQUATS
LONGAN FRUIT
LOTUS ROOT
LYCHEE
PEAS, CHINESE
SHALLOTS
BEST
ACREAGE
ESTIMATE
(XlOOO)
   PERCENT CONSUMPTION

               NON-
    GENERAL    N1
    POPULATION INFANTS
       9.00
       0.24
      24.00
       0.30
       3.16
       0.40
       3.90
       0.27
       0.00
       2.60
       1.80
      12.50
       3.50
       0.00
       0.30
       0.90
        ,00
         70
       0.46
       0.05
       0.10
       O.Ol
       0.10
       0.20
       0.05
       0.20
       0.10
       0.08
       0.03
       0.20
       0.10
       0.10
2.
1.
0.000
0.000
0.000
0.000
0.001
0.000
0.010
0.000
0.000
0.001
0.004
0.003
0.000
0.000
0.000
0.007
0.000
0.000
0.001
0.000
0.000
0.000
0.000
0.001
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.001

;ING
iNTS
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
o.obo
0.000
0.000
0.000
0.000
0.000
0.000
o.ooo
0.000
0.000
0.000
0.000
0.000
0.000
0.000
0.000
REQ
#FTS
w/o
90%
3
2
3
2
3
2
3
2
3
3
2
3
3
3
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1

REQ FOOT
#FTs NOTE;
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
-------
FOOTNOTES


1) Acreage values in this table are presented to three
significant figures.

2) The number of field trials required for these commodities
(oats and rice) was increased 1 level from 12 to 16 due to high
consumption by non-nursing infants.

3) The numbers of field trials required for sugar beets and
sugarcane were not increased one level based on comprising >0.4%
consumption for the general population (or increased based on >1%
consumption as discussed in criterion (6) under "methodology")
because  (a) the major human food -derived from these two
commodities (sugar) is highly refined, and (b) neither are major
national animal feeds.

4)  Individual consumption estimates for sweet and sour cherries
were obtained by weighting the total consumption of cherries by
the production (acreage) of each.

5) Limited geographical production was not used as a criterion to
reduce the number of field trials for bananas because of the
small number of trials required and the large consumption of this
commodity by infants and children.

6) The number of field trials required for mushrooms was
decreased since mushrooms are generally grown indoors under
relatively constant growing conditions likely leading to little
residue  variability.

7) Due to the expanding production and consumption of canola
products, eight field trials will be required for this commodity.

8) The number of field trials for tobacco was reduced because of
the limited importance of this commodity for dietary exposure
assessment.

9) Limited geographical production was not used as a criterion to
reduce the number of field trials for broccoli, pineapples, and
plums because of the widespread high consumption of these
commodities, and was not used to reduce the number of field
trials required for peas, dry because of the high acreage and the
large variety of peas represented by this commodity.

10) Since the number of field trials for almonds was already
reduced  based on low dietary consumption, a further reduction due
to >90%  production  being in one region was not made.

11) Acreage information  (given in thousands of acres) and
consumption for the following commodities include values for both
-------
 the commodity itself,  and the acreages and consumptions of other
 commodities for which  the tolerance would apply as defined in 40
 CFR 180.l(h):

      apples.  sugar;  apple,  sugar (0.2),  atemoya (0.1)
      bananas;  bananas  (11.7),  plantains (12.5)
      blackberries: blackberries  (6.7),  boysenberries (1.2)
      broccoli;  broccoli  (114), broccoli,  Chinese (gai  Ion,  0.6)
      cabbage:  cabbage  (90),  Chinese cabbage (8.7)        ;<
      celery;  celery  (36),  fennel (only consumption data
      available)
      mandarins (tangerines);  tangerines (15), tangelos (13)
      muskmelons; cantaloupe  (130),  honeydew (29);  consumption
      information is  also  available  for casaba,  crenshaw and
      Persian melons
      onions, drv bulb: onions, dry  bulb (231),  garlic  (14.6)
      onions. green;  green onions (18),  shallots (0.1)
      peaches;  peaches  (240),  nectarines  (33)
      sweet  potatoes; sweet potatoes (87),  yams  (3.5)
      wheat; wheat  (61577), triticale (152)

 12) Eight field trials are needed if mustard greens  are used  as  a
 representative  commodity  of the  Brassica  Leafy  Greens  crop
 subgroup (see Table  3).

 13)^Acreage estimates for all squash were  divided  by 2  to
 estimate acreage for summer and  winter squash separately.

 14) Acreage estimates are given  as  0.000 when acreage  information
 is not available for a commodity.

 15) These bean/pea commodities include more than one type of
bean/pea.   The  specific commodities  included in each of  these
groups are  shown below.  The specific representative commodity
for which field trials should be run in each case  are those
representative  commodities provided  in the proposed  crop subgroup
Federal Register notice.

     beans, dried;  include those commodities listed in the
     proposed crop subgroup 6-C as Lupinus spp., Phaseolus spp.,
     Vigna  spp., guar and lablab beans.

     peas,  dried;  include those commodities listed  in the
     proposed crop subgroup 6-C as Pisum spp.,  lentils and pigeon
     peas.

     beans,  edible podded;  include those commodities listed in
     the proposed crop subgroup 6-A as Phaseolus spp.,  Vigna
     SPP-i  jackbeans, immature soybean seeds,  and swordbeans.

     peas,  edible podded:   include those commodities listed in
     the proposed crop subgroup 6-A as Pisum spp.,  and pigeon
     peas.
-------
     beans,  succulent shelled;  include those commodities listed
     in the proposed crop subgroup 6-B as Phaseolus spp., Vigna
     spp. and broad beans.

     peas, succulent shelled;  include those commodities listed
     in the proposed crop subgroup 6-B as Pisum spp.

16) Consumption estimates for leaf lettuce include "lettuce-leafy
varieties" and "lettuce-unspecified".

17) Individual consumption estimates for Chinese cabbage and bok
choi were obtained by weighting the total consumption of the two
commodities by the relative production  (acreage) of each.

18) A tolerance for muskmelons may be obtained using residue data
for cantaloupes.

19) If a tolerance is sought  for either spearmint or peppermint
separately, five field trials are still required.
-------
-------
                                   .-Hi
                                                       ALINORM 87/24A
                                                       APPENDIX IV
                                                       ANNEX X
           ON MINIMUM SAMgLI_SlZ5§-IO«-AGSlCintTURAL,i COMMODITIES FROM
           FfilTTilALS fOB_RBSHqiS_ANA^YS15
The "Guidelines on pesticide residue trials to provide data for the
registTTtion of pesticides and the establishment of maximum residues
limits" include a section entitled "Guide  to Sampling" in which
minimum sample size* are recommended for a number of  crops, selected
as examples. Practical experience in sampling in recent years has
indicated the need to reconsider the recommendations  in the
Guidelines for the sample sizes and the ad hoc Working Group on the
Development of Residues Data and Sampling  recommends  that the ANNEX
II which follows this ANNEX I replaces the relevant section in the
Trials Guidelines.
The major changes are the results of adopting a general principle
that, with certain exceptions, such as very small items like berries,
nuts, grain and immature vegetables, it is more appropriate to
recommend taking a number of crop units rather than a minimum
weight. In many cases, the recommendation  is to take  12 units for
large  items or 24 units for smaller items. The choice of  12 units
permits easier planning of composite samples, for example, 3 units
from each of 4 replicates (6 units for smaller items). It is useful
too  in sampling tree fruits, where 6 fruits from each of 4 trees  is
recommended. The principle of taking 12 units is readily  extended  to
crops  such as cereals, fodders or grain where a minimum sample weight
is proposed with sampling from 12 areas of the plot.
A  number of crops can be harvested mechanically and  in these cases  12
primary samples from the harvester as it proceeds through the treated
plot is recommended.
Although  it  is not normally recommended  it may sometimes  be necessary
to subsample bulky or heavy items before shipment to  the  residue
laboratory. This practice must be limited  to  special  sampling
problems  identified  in ANNEX  II  always  bearing  in mind  the  importance
of maintaining  a fully representative sub-sample  and  avoiding  any
possible  contamination or deterioration  of the material.  It  is
essential  that  it  should only  be  done  if  a clean  area is  available
and  if  the  personnel involved  have  received  specific  instruction  or
training  in  this  respect.
The  ad hoc  Working Party emphasised  that  the  recommendations  for
minium lizes  are  for  samples  of  crops  at  the  stage of  growth  at
whichthey  would  be  harvested  for consumption when  taken from
suoervised  trials, which  frequently  involve relatively small  plots.
It may be  necessary  to  take  larger  samples in certain circumstances,
especially  if  larger plots  or fields are being sampled.  !••'••'
samples of  some  crops  may  also be needed if particularly low limits
of determination are involved (thus possibly requiring larger
 analytical  samples)  or for multi-residue determinations (requiring
 larger, or multiple, analytical samples).  The small  sample size
 required  by most analytical methods is not the major factor in
deciding  the size of field samples - obtaining represent***™
material  must be_the_o.r.ior.itv,..in .the f^e^d...
 AlII7ninvI~onTidTrTtions may apply when deciding on the quantities
 of immature crops required from residue dissipation  trials.
                                                 8
-------
                                                        ALINORM 87/24A
                                                        APPENDIX IV
                                                        ANNEX II
                                                        Page  1
Sample Type
Fodder_and sugar
&A1&1
Codex
Code No.
VR 0596
AM 1051
Previous
Recommendat ion
5 kg
(rain. 5 plants)
New
Recommendat ion
12 plants
 eg.  carrots, red beet,
 Jerusalem artichoke,
 sweet potato,  celeriac,
 turnip,  swede,  parsnip,
 horseradish, salsify,
 chicory,  radish,
 scorzonera
    aK .onions
                         VR 0589
                           Group
                            016
                         VA 0384

                         VA 0389
Srea,lil~j.e8£j,3aj.ad_crQB^ ,
e.g.. cress, dandelion,
corn salad
                         VA 0381
                         VA 0388
                           Group
                            013
£2JLS.I£i!» chicory  leaves  VL 0469
                         •VL 0502
                         VL 0503
                         VL  0482
                         VL  0483
Kale
                        VL 0476

                        AV 0480
                        VL 0480
                                           5  kg  or
                                           5  items
5 kg (large)
2 kg (small
     items)
      2 kg

      2 kg




      2 kg



      2 kg




      2 kg



      2 kg
                                          2 kg

                                          5 kg
 24  tubers  or
 12  if  very
 large  from at
 least  6  plants

 12  large roots
 or  24  (or  more)
 small  for
 minimum  sample
 weight of  2 leg
12 plants

24 plants (or
more) for a
minimum sample
weight of 2 kg

24 bulbs from
at least 12
plants

0.5 kg from at
least 12
plants (or
sites in plot)

1  kg from at
least 12
plants

12 plants or 1
kg from at
least 12
plants if
individual
leaves are
collected

12 plants

2  kg from at
Least 12
plants sampled
from at least
2  levels on
the plant
-------
 eg .  fodder crops
 rape mustard,
 gretn oil poppy
  Group
   023
                           Group
 eg.  cauliflower,  cabbage   010
  Group
   010
 broccoli
 Kohlrabi
Rhubarb
VB 0405

VS 0624

VS 0627
                         VS  0621
Pea§J._ghaaeglua_beans
(French, Kidney,
Runner etc) ,
broad, ^beafls, ,
field beans
HS.S.S.S.SLS.
                         VS  0620

                         VS  0541
  Group
   014

  Group
   015

  Group
   012
 5  kg  or
 5  items

 2  kg
5 kg or
5 items
2 kg

2 kg
                                          2 kg
2 kg


2 kg


2 kg
 ALINORM 87/24A
 APPENDIX IV
 ANNEX II
 Page  2

 2 kg from at
 least 12
 separate areas
 of plot(b)

 12 plants
 1  kg  from at
 least  12
 plants  and  for
 Brussels
 sprouts
 sampled from
 at  least  2
 levels  on  the
 plant

 12  plants

 12  plants

 12  sticks
 (or more) from
 at  least  12
 separate
 plants for
minimum sample
weight of 2 kg

 24 sticks
 (or more) from
 at least 24
separate plants
for minimum
sample weight
of 2 kg

 12 heads

 1 kg from at
 least 12
 separate areas
of plot

 1 kg (fresh
green or dry
 seed as
 appropriate)
24 fruits or
12 from large-
fruiting
varieties from
at least 12
plants (more
fruit if
necessary for
a minimum
sample we ight
of 2 kg)
-------
Aubf Sf,i.n«ST
7«ff plants)
Cucumbers
                         VO 0440
                         VO 0424
                           Group
gater rations
Sweet corn
                           Group
                            OH
                        VO 0447
                                          5 kg or
                                          5 items
                                          S kg or
                                          5 Items
                                          2  kg
5 kg or
S items
2 kg
 AUNORM 87/24A
 APPENDIX IV
 ANNEX II
 Page   3

 12  fruits  from
 12  separate
 plants

 12  fruits  from
 12  separate
 plants

 24  fruits  from
 at  least 12
 plants  (more
 if  necessary
 to  make  a
 minimum weight
 of  2  kg)

 12  fruits  from
 12  separate
 plants

 12  ears  (more
 if  necessary
 to  make a
minimum weight
 of  2  kg)
FRUIT
£A££H£ fruit eg.           Group
orange, lem'on, Clementine,  001
mandarin, pomelo,
grapefruit,
tangelo, tangerine
                          Group
                           002
                          Group
eg. apricots, nectarines,  003
peaches, plums
eg. apples, pears,
quinces, medlars
                                         5 kg
                                          5  kg
                                         5 kg
                                   (2 kg for plums)
             24 fruit from
             several places
             on at least 4
             individual
             trees (more if
             necessary for
             a minimum
             sample weight
             of 2 kg)
      s tone ^1 fruit , .
eg. cherries
Grapes
                          Group
                           003
                        FB 0269
2 kg
2  kg
and o'ther small berries
                          Group
                           004
                                          2  kg
1 kg from
several places
on at least 4
trees

12 bunches, or
parts of 12
bunches from
separate vines
to give at
least 1 kg

0.5 kg from at
least 12
separate areas
or bushes
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S.trawbe.rr.ie^.,.
                        FB 0268
                        FB 0275
                        FB 0276
      2 kg
ALINORM 67/24A
APPENDIX IV
ANNEX II
Page  4

1 leg from at
least 12
separate areas
or bushes
 golives, dates,
figs

Banjinajj.
                           Group
                            005
                        Fl 0327
                                          2  kg
5 kg or 4 fruits
from each of
5 bunches
1 kg from
several places
on at least 4
trees

24 fruits from
at least 6
bunches from
separate trees
and from
several places
of each of the
bunches
eg, avocados,  guavas
mangoes, pawpaws,
pomegranates ,
pers iraraons ,
kiwi fruit,  litchi
                           Group
                            006
                                          5  kg
GraJ,n of wheat,
b"arle"y oats, rye,
triticale and other
small grain cereals;
maize (off the cob),
rice, sorghum
 Straw  of  the  above crops
                         Fl °353
                           Group
                            020
                                          5  kg or
                                          5  items
(2 kg maize)
                           Group
                            051
                            °645
 lodde.£ (mature plants
 excluding cobs)

 Green or. silage m^i_ z e,
 crops o  alfafa,
 clover, fodder peas and
 beans,  'vetch, sainfoin,
 lotus,  fodder soybeans,
 ryegrass,  fodder cereals,
 so rghum
                           Group
                            050
       I kg
                                          5 plants
                                          5 plants

                                    1 kg (smaller
                                          leaves)
                                    2 kg (larger
                                          leaves)
                   24 fruit  from
                   at least  4
                   separate  trees
                   or plants
                   (more  fruit  if
                   necessary for
                   a minimus
                   sample weight
                   of 2 kg)

                   12 fruit
1 kg from at
least 12
separate areas
of a plot or
treatment lot
(applies to
both field and
post-harvest
trials)

0.5 kg  from  at
least 12
separate areas
of a plot, (b)

12 plants  (a)
                    12 plants (a)

                    1 kg from at
                    least 12
                    separate
                    areas of a
                    plot
-------
Dry hag of the above
crop*
Peanuts
         etc
eg. parsley, thyme

T«« (dry leaves)

Mushrooms
H££jL
          cones)
l«££J._wj. ne j._c j,d e r ,
                          Group
                           050
                         SO  0697
                           Group
                            022
1-2 kg
                                    1  kg  (2  kg  with
                                          fibre)
                                          1  kg
Rapeseed, flax and
wild mustard
Sunflower, safflower
                        SO 0702
SO 0691


  Group
   024

Group 027
Group 028
Group 057

Group 066

VO 0450
1 kg
                                    1 kg  (1  delinted)
                                    2 kg  (with  fibre)

                                          2  kg
                                          1  kg
                         GS  0659
                                    5  kg  (20  em of
                                          stem)
                         DH  1100

                         Group  070
                              ALINORM 87/24A
                              APPENDIX  IV
                              ANNEX  II
                              Page   5

                              0.5 kg from at
                              least  12
                              separate  areas
                              of a plot (b)

                              1  kg from at
                              least  24
                              plants

                              1  kg (with or
                              without
                              shells)
TN 0665
Group
023
5 kg or
5 items
1 Kg
12 nuts
0.5 kg
least 1
separate areas
of a plot (b)

12 heads or 1
kg from 12
separate areas
of a plot (b)

1 kg with or
without fibre

1 kg (fresh or
dry)

0.5 kg fresh
0.2 kg dry
             0.2 kg

             12 items or
             more with a
             minimum sample
             weight of 0.5
             kg

             12x20 cms
             lengths of
             stem from 12
             areas of the
             plot (a)

             0.5 kg

             1 litre
(a) Divide each  stem  with  leaves  attached into 3 equal lengths. Take
    top, middle  and bottom portions  respectively from each of three
    groups of  four stems ensuring that  parts of all 12 stems are
    included  in  the sample.
(b) Crops which  are harvested  mechanically can be sampled from the
    harvester  as  it proceeds  through the crop.
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                                                     10
                REGIONAL MAP FOR TRIAL DISTRIBUTION:

                           BORDER DEFINITIONS
I.
H.
m.

IV.



V.
VI.
VH.
            ME, NH, VT, MA, RI, CT, NY, PA,
            NJ-NofRt. 1,
            MD-NWofI-95,
            VA - N of 1-64 and W of 1-81,
            WV - N of 1-64 and E of 1-77,
            OH -E of 1-77.

            NC, SC, GA, DE,
            VA - E of 1-81 or S of 1-64,
            MD-SEofI-95,
            NJ-SofRt. 1,
            WV-SofI-64,
            KY - S of 1-64 and S of BGP and E of 1-65,
            TN-EofI-65,
            AL - Except Mobile and Baldwin Co.'s.

            FL, AL - Mobile and Baldwin Co.'s.

            LA,  AR, MS,
            TN-WofI-65,
            MO - E of Rt. 67 and S. of Rt. 60.

            MI, IN, IL, WI, MN, IA,
            OH -W of 1-77,
            WV - N of 1-64 and W of 1-77,
            KY - N of 1-64 or N of BGP or W of 1-65,
            MO - W of Rt.  67 or N of Rt. 60,
            KS, NE, SD, ND - all E of Rt. 281.

            OK -E of Rt. 281/183,
            TX - E of Rt. 283 or SE of Rt. 377.

            MT - E of Rt.  87 or E of 1-15,
            WY - E of 1-25 or N of 1-90,
            ND, SD, NE - all W of Rt. 281,

            KS-WofRt. 281,
            CO -E of 1-25,
            NM-EofI-25,
            TX - W of Rt. 283 and NW of Rt. 377,
            OK -W of Rt. 281/183.
SJKl/eh/D476
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                                   -2-
                       BORDER DEFINITIONS (cont'd)
      K.  UT, NV,
           NM - W of 1-25 and N of MO,
           CO-W of 1-25,
           WY - W of 1-25 and S of 1-90,
           MT - W of Rt. 87 and W of 1-15,
           AZ - NE of Rt. 89/93 and N of HO.

      X.   CA - Except Mendocino, Humboldt, Trinity,
                 Del Norte, and Siskiyou Co.'s,
           AZ - SW of Rt. 89/93 or S. of 1-10,
           NM-SofI-10.

     XI.   ID,
           OR & WA - E of Cascades.

     Xn.  CA - Counties excluded from Reg. X,
           OR & WA - Wof Cascades

     xm.  ffl, PR
SJKl/eh/D476/2
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                           ATTACHMENT 11

        Number of Field Trials Required for Tolerances with
          Geographically Restricted Registration,  and for
              24(C)  Special Local Needs Registrations


Throughout this document, additional guidance has been provided
regarding field trial data requirements for tolerances with
national  registrations.  This attachment provides guidance
concerning the number of field trials required  for tolerances
with geographically restricted registrations, and 24(C)  Special
Local Needs (SLN)  registrations.  Sampling requirements and other
criteria  presented elsewhere in this document also apply to the
data requirements discussed in this attachment.   A flow chart
follows the text below to facilitate determination of field trial
data requirements.

Tolerances with geographically restricted registrations may be
established for minor agricultural uses (1990 Farm Bill).
Specifically (see 7/7/93 memorandum, Victor J.  Kimm,  Acting
Assistant Administrator, OPPTS, to Honorable Bob  Graham,  U.S.
Senate),

     The Administrator shall not require a person to submit, in relation to registration or
     reregistration of a pesticide for minor agricultural use under this Act, any field residue
     data from a geographic area where the pesticide will not be registered for such use.

Comments  below address the data requirements for  both tolerances
with geographically restricted registration,  and  the additional
state-specific data required for 24(C)  SLN registrations.   When
discussing the number of required field trials  below,  the  term
"geographically restricted region" will apply to  either of these
situations.

The number of  field trials required for a tolerance  with
geographically restricted registration is equal to the number  of
field trials required for the  commodity for a national tolerance
or registration, multiplied by the proportion (by acres) of the
crop grown in  that  region.   However,  regardless of the acreage in
the specific region for which  the regional registration is
requested,  at  least 2  field trials will be required  (except in
the case  of very minor crops as specified elsewhere  in this
document  which require only 1  field trial for national
registration).   Two composite  samples per field trial  are
generally required.   However,  when 3 or fewer field  trials  are
required  for any registration,  the registrant may choose to (a)
obtain  samples from IX and 2X  application rates from separate
plots in  each  of 2  field trials (i.e.,  one composite  sample taken
from each of two IX and two 2X separately treated plots,
resulting in 4 total samples per field trial), or  (b)  perform  3
field trials in different locations at the IX rate  (2  composite
samples obtained from each plot).
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Field trial locations must be representative of growing
conditions throughout the region covered by the regional
registration.

For 24(C) SLN registrations requested for two neighboring states,
data from one state will be accepted for a 24(C) use in a
neighboring state only if (1) the states, or pertinent parts
thereof, are in the same geographical region as defined in this
document, (2) a sufficient number of field trials are available
from the state to fulfill the requirements of the paragraph above
for the acreage of commodity grown in both states, and (3) field
trials are performed in sufficiently diverse areas such that
conditions likely to be found in both states are represented in
the field trials.

For crops requiring 8 or more field trials nationally, regional
and 24(C) registrations will require multiple year field trial
data.  Multiple year data are required to account for variability
due to varying climatic conditions and other factors which would
normally be expected to be seen by obtaining field trial data
from more diverse regions, but would not be seen for regional
registrations since field trial data are obtained from more
limited geographical areas.  The total required number of field
trials must be performed over at least 2 different years  (e.g.,
if 4 total field trials are required, 2 would be performed in one
year, and 2 in the next year).  Multiple year data will not be
required if sufficient nationally representative or multiple year
data are available for other pesticide formulations of the same
active ingredient or similar uses from which the Agency can
estimate likely variability.

For crops normally requiring 5 or more field trials for a
national registration, and uses requiring a decline study
 (discussed elsewhere in this guidance), one or more decline
studies will be required for a 24(C) or regional registration.
The number of decline studies required for a use will not exceed
the number required for a national tolerance/registration for
that commodity.  See the flow chart for further details.
-------
                                EXAMPLES

Example 1:  A 24(C) SLN is desired for use of a pesticide on apples in
Washington (WA).  Since WA accounts for approximately 27% of national
apple production, and since 16 field trials are required for apples nationally, 5
field trials will be required from WA for this use (0.27 x 16  = 4.3 or 5 field
trials).  Since greater than 8 field trials are required nationally (16), multiple
year data will be required (3 field trials the first year, 2 the second year).
Finally, if the use were one requiring a decline study, 1 decline study would
also be required for this 24(C) use.

Example 2:  A 24(C) SLN is desired for use of a pesticide on alfalfa in Iowa
(IA).  Since IA accounts for approximately 8% of alfalfa grown nationally,
and since 12 field trials are required for alfalfa nationally, 2 field trials will  be
required from IA to support this registration (0.08 x 12  = 0.96, however,
except for  crops requiring only  1 field trial nationally, at least 2 trials are
required for any regional registration; therefore, 2 field trials are required).
Since greater than 8 field trials are required nationally (12), the two required
field trials  would have to be distributed over two years  (one field trial in each
of two years).  Since alfalfa requires greater than 5 field trials for a national
registration (12), one of these studies would have to be a decline study if the
use pattern requires a decline study.  For the other study, one sample from
each of 4 separately treated plots (two at IX and two at 2X rates) would be
required.

Example 3:  A tolerance with regional registration is requested for application  of a
pesticide to peanuts in the Southeastern  U.S. (GA, 42%, AL, 14%, NC, 9%, FL,
5%, SC, 1%, total 71% of U.S. peanut production).  Since 12 field trial are required
for peanuts nationally, 9 field trials would  be required for this use (0.71 x 12 = 8.5
or 9 field trials required).  Since 12  field trials are required nationally (>8), the
required field trials would have to be distributed over at least two years (preferably 5
the first year, four  the second).  If the use pattern was one requiring a  decline study a
single decline study would be required.
-------
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                      24 (C) OR TOLERANCE
                         WITH REGIONAL
                         REGISTRATION
                              (1) Estimate the percentage of national production
                                (acres) of the state or region
                              (2) Determine the number of field trials required
                                for national registration
                              (3) Multiply these two values
           Result < 3
 2 FIELD TRIALS
 REQUIRED WITH
 PLOTS FOR BOTH 1X
 AND 2X RATES*
      -OR
                                                       Result >3
                             NUMBER OF
                             REQUIRED HELD
                             TRIALS EQUALS
                             RESULT ROUNDED
                             TO NEXT HIGHEST
                             INTEGER
3 HELD TRIALS
REQUIRED AT-1X
RATE
      < 8 FIELD TRIALS REQUIRED
      NATIONALLY
               8 OR MORE FIELD TRIALS
                REQUIRED NATIONALLY
         MULTIPLE YEAR DATA
         NOT REQUIRED
                  MULTIPLE YEAR DATA
                  REQUIRED
     NO
DECLINE STUDY
  REQUIRED
DOES THE CROP REQUIRE 5 OR MORE HELD
TRIALS NATIONALLY, AND DOES THE USE
REQUIRE A DECLINE STUDY FOR A NATIONAL
REGISTRATION?
                               YES
IF 16 OR MORE FIELD TRIALS REQUIRED FOR REGIONAL REGISTRATION, 2 DECLINE
STUDIES REQUIRED; OTHERWISE, 1 DECLINE STUDY REQUIRED
  TbrcropSTOptfng-onfcrf teW trial rationally; only 1 fioWtrterwBHwneqolredior*
  regional registration.
                                 * U.S. GOVERNMENT PRINTING OFFICE:1994-521 -539/81161
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