United States Prevention, Pesticides EPA712-C-96-182
Environmental Protection and Toxic Substances August 1996
Agency (7101)
&EPA Residue Chemistry
Test Guidelines
OPPTS 860.1480
Meat/Milk/Poultry/Eggs
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INTRODUCTION
This guideline is one of a series of test guidelines that have been
developed by the Office of Prevention, Pesticides and Toxic Substances,
United States Environmental Protection Agency for use in the testing of
pesticides and toxic substances, and the development of test data that must
be submitted to the Agency for review under Federal regulations.
The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has developed this guideline through a process of harmonization that
blended the testing guidance and requirements that existed in the Office
of Pollution Prevention and Toxics (OPPT) and appeared in Title 40,
Chapter I, Subchapter R of the Code of Federal Regulations (CFR), the
Office of Pesticide Programs (OPP) which appeared in publications of the
National Technical Information Service (NTIS) and the guidelines pub-
lished by the Organization for Economic Cooperation and Development
(OECD).
The purpose of harmonizing these guidelines into a single set of
OPPTS guidelines is to minimize variations among the testing procedures
that must be performed to meet the data requirements of the U. S. Environ-
mental Protection Agency under the Toxic Substances Control Act (15
U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act
(7U.S.C. I36,etseq.).
Final Guideline Release: This guideline is available from the U.S.
Government Printing Office, Washington, DC 20402 on The Federal Bul-
letin Board. By modem dial 202-512-1387, telnet and ftp:
fedbbs.access.gpo.gov (IP 162.140.64.19), internet: http://
fedbbs.access.gpo.gov, or call 202-512-0132 for disks or paper copies.
This guideline is also available electronically in ASCII and PDF (portable
document format) from the EPA Public Access Gopher (gopher.epa.gov)
under the heading "Environmental Test Methods and Guidelines."
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OPPTS 860.1480 Meat/milk/poultry/eggs.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing requirements of both the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.} and the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301, et seq.}.
(2) Background. The source material used in developing this har-
monized OPPTS test guideline is OPP 171-4 Results of Tests on the
Amount of Residue Remaining, Including A Description of the Analytical
Methods Used (Pesticide Assessment Guidelines, Subdivision O: Residue
Chemistry, EPA Report 540/09-82-023, October 1982) and Addendum No.
8 on Data Reporting, Residues in Meat, Milk, Poultry, and Eggs: Livestock
Feeding Studies (Pesticide Assessment Guidelines, Subdivision O: Residue
Chemistry, EPA Report 540/09-89-010, 1989). This guideline should be
used in conjunction with OPPTS 860.1000, Background.
(b) Purpose. Whenever pesticide residues are detected in feed items,
data on the transfer of residues to meat, milk, poultry, and eggs are re-
quired. These studies are also required if a pesticide is to be applied di-
rectly to animals. Data from these studies are used to determine which
components of the total toxic residue (TTR) are present and at what con-
centrations secondary residues could appear in meat, milk, poultry, and
eggs in order to set appropriate tolerances.
(c) Data requirements. Data must be submitted to show the level
of residues that will result in ruminant meat (muscle), meat byproducts
(liver, kidney) and fat, poultry (muscle, fat, liver), eggs, or milk. These
data are needed whenever a pesticide is to be applied directly to livestock
or residues occur on a livestock feed. Based upon the residue level in
the feed item and the residue resulting in meat, milk, poultry, and eggs
in these feeding studies, the use must be classified as specified in
40 CFR 180.6(a). Category 1 of § 180.6(a) applies to cases where it is
shown that residues will occur in animal products, Category 2 applies if
there is a reasonable expectation of residues in animal products, and Cat-
egory 3 applies if there is no reasonable expectation of residues. Since
tolerances for residues in animal products are required when the use is
judged to be Category 1 or 2, the animal feeding studies must not only
show whether residues transfer, but may also need to serve as a basis
for setting appropriate tolerance levels for the animal products.
(d) Conduct of studies—(1) Feeding studies, (i) In most cases only
the parent pesticide should be fed to livestock. However, in those cases
where the parent compound comprises only a minor proportion of the resi-
due of concern, it may be acceptable to feed a mixture of parent and plant
metabolites. In cases where a unique plant metabolite exists (i.e. one that
is not formed in livestock), a separate feeding study may be required dos-
ing with that metabolite. Registrants considering dosing with a mixture
or a unique plant metabolite should contact the Agency prior to initiation
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of such a study. The feeding study should include the level of intake ex-
pected (Ix) (see next paragraph), plus two exaggerated levels of 3x and
lOx. The Ix level should represent the worst case estimate of the potential
livestock exposure based on the assumption of all components of the feed
having tolerance level residues. The exaggerated levels are especially im-
portant in judging a Category 3 use, as well as to cover possible future
tolerances for the pesticide on additional feed items and allow estimation
of whether residue levels in tissues vary linearly with the level in the feed.
The dosage levels should be expressed in terms of concentration (in parts
per million) in the total ration (dry weight basis for ruminant studies),
so that the Agency can relate the dosage to that expected from the pro-
posed use. It is also desirable to express the feeding level in terms of
milligrams per kilogram body weight.
(ii) In selecting the dosage levels based on total rations, the petitioner
should take into account the proportion in the diet of the feed item bearing
the residue and, in the case of ruminants, the percentage of dry matter
in the feed. Table 1 of OPPTS 860.1000 should be used as a guide in
determining the proportion of the diet of the various food items. The cor-
rection for percentage of dry matter is explained in more detail in para-
graph (e) of this guideline. For example, dried citrus pulp (91 percent dry
matter content) may in some circumstances comprise up to 20 percent of
the total ration (dry weight basis) of dairy cattle. If a tolerance of 5 ppm
of a given pesticide were proposed on dried citrus pulp, the total diet (dry
weight basis) should be fortified at the 1.10 ppm level, i.e.:
(5.0 ppm/0.91)x 0.20
to reflect the expected level of intake (Ix). If other feed items with toler-
ances could also be fed in combination with citrus pulp, the contribution
from these feed items should also be added in. As noted, two dosages
at exaggerated levels are also required, preferably threefold and tenfold
or higher where not precluded by toxicity of the pesticide.
(iii) Separate feeding studies are required for a ruminant and poultry
whenever residues occur on the feeds of these classes of livestock, or di-
rect animal treatment is proposed. The species of choice for these feeding
studies are the cow and chicken. In most cases the results of the cattle
feeding study will be used to establish tolerances on goats, hogs, horses,
and sheep. Data will not be translated from other meat animals to poultry.
However, within the poultry group, data on chickens will usually be ac-
cepted in lieu of data on turkeys. Data on residues in milk from dairy
cows will usually apply as well to dairy goats. Data on tissue storage in
rats, dogs, or other small animals used in toxicology studies will not be
accepted in lieu of residue data on livestock.
(iv) In addition to establishing a baseline or blank in a predosing
period, control animals should be carried through the experiment with
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treated animals. This is highly desirable, since values for control animals
have been observed to change during feeding studies. The number of ani-
mals carried at each treatment level, and as controls, will vary with the
circumstances but as a general rule a minimum of three animals should
comprise a group in a cattle feeding study. For chicken feeding studies,
a minimum of 10 birds per group should be used. It is often advisable
to have additional animals on test that can be used to determine the rate
of decline of residues on the cessation of dosing, so that if residues above
tolerance are found, data on the time necessary for residues to fall to the
tolerance level are available.
(v) Animals should be dosed daily for a minimum of 28 days or until
residues plateau in milk or eggs if they have not done so in 28 days.
(vi) If a feed-through formulation is specifically designed to change
absorption characteristics within the digestive system, this formulation
should be employed in the feeding study.
(2) Direct animal treatment, (i) When a pesticide is proposed for
direct use on food animals, data are required to show the extent of residues
incurred by the use. The experimental treatment should reflect as closely
as possible the conditions under which the pesticide will be used commer-
cially. Control animals should be carried along with treated animals. Fac-
tors such as whether sheep passing through a dip tank were freshly shorn
or unshorn should be considered. Generally, separate studies should be
carried out for each species of livestock to be treated.
(ii) When a pesticide may be applied in more than one type of formu-
lation or by more than one mode of treatment, separate studies reflecting
the usage or combination of usages proposed are required. However, data
from dips or high pressure wetting sprays on cattle may be accepted in
lieu of data from dust treatments but not vice versa. When the use of
devices which permit unlimited access (e.g. backrubbers) is proposed, the
experiment should be designed to assure the maximum exposure of the
animal to the pesticide. Data reflecting exaggerated treatments are desir-
able.
(iii) If livestock are exposed to the pesticide both in feed and as a
direct treatment, the magnitude of the residue study should reflect the level
of residues to be expected from the combined exposure scenarios. If sepa-
rate feeding and direct treatment studies have been conducted, it is nor-
mally acceptable to add the residues from these studies to determine the
appropriate tolerances. However, this may result in higher than necessary
tolerances for animal commodities.
(3) Agricultural premise use studies. When the use of pesticides
in agricultural buildings is such that restrictions cannot preclude the possi-
bility of residues in meat, milk, poultry or eggs, residue studies should
be carried out reflecting the maximum conditions of exposure. Separate
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studies are required for ruminants (catties), nonruminants (swine), and
poultry (chickens). The studies should reflect all possible residue transfer
routes such as:
(i) Direct absorption (dermal or inhalation) from sprays, mists, or
fogs.
(ii) Direct consumption (e.g. by the animal licking surfaces treated
with sugar base baits, pick up of bait granules by poultry, or contamination
of feed, feed troughs, or water troughs).
(iii) Direct contamination of milk from deposition on milking equip-
ment, treatment of milk rooms, etc.
(4) Meat, milk, poultry, and egg sampling, (i) Milk and egg samples
should be taken twice daily. Eggs from birds within a dosage group may
be pooled if necessary so that adequate sample weight is available for
analysis and retained samples. Milk from animals within a dosage group
should not be pooled in order that data for individual animals are available.
However, compositing the a.m. and p.m. milk from each individual cow
in the ratio of production is acceptable. Enough of the pooled daily milk
and egg samples should be analyzed (preferably at least twice weekly)
to allow for a determination of trends in storage of residues with time.
Three unique samples of milk and eggs should be analyzed at each time
point for each feeding level. Petitioners are advised to analyze the samples
from the highest feeding level first. If no quantifiable residues are observed
in any of these samples, samples from the lower feeding levels do not
need to be analyzed.
(ii) If detectable residues occur in whole milk at any dosing level,
analyses of a few samples of milk fat is advisable at some point to show
how residues partition into that commodity. This information can be used
to determine if a specific tolerance value should be specified for milk fat
and to calculate dietary risk more accurately.
(iii) Analysis of eggs should be conducted on the egg yolk and white
combined in one sample. The yolks and eggs may also be analyzed sepa-
rately provided the weights of each are known so that the residue can
be calculated on a whole egg basis.
(iv) Animals should be slaughtered within 24 hours of the last dosing
and tissue samples taken and frozen as soon as possible. Tissue residue
level results from animals slaughtered long after cessation of dosing cannot
be used in estimating tolerances, and thus if only such samples are ana-
lyzed, the feeding study will have to be repeated. The commodities to
be analyzed in a feeding study include the following tissues that are used
as human food: Muscle, fat, liver, and, in the case of cattle only, kidney.
For dermal uses on poultry or swine, skin should also be analyzed. As
noted above for milk and eggs, three unique samples of edible tissues
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should be analyzed at each dose level to show the variability of residues
among different animals. In the case of cattle, this usually means one sam-
ple per animal as three cows are generally dosed at each level. For poultry,
tissue samples from three to four birds may be composited to generate
the three unique samples for each dosage group. If no quantifiable residues
of a pesticide are observed in a tissue at the highest dose level, no further
analyses of that tissue at lower feeding levels are required.
(v) Dermal treatment of livestock. Animals should be sacrificed with-
in the preslaughter interval (PSI) prescribed on the product label. However,
PSIs longer than 3 days are not considered to be practical by the Agency
in most cases. Since it has been observed that residues may not peak in
tissues until a week or so after application, additional data reflecting longer
PSIs should be obtained to establish the maximum residue levels for toler-
ances.
(vi) The components of the residue to be analyzed in tissues, milk
and eggs should be those found to constitute the TTR in the animal prod-
ucts as determined in the livestock metabolism study described in OPPTS
860.1360. The analytical method should be described in detail or ref-
erenced. Fortified samples should be run concurrently with those from the
feeding study to validate the method. The required limit of quantitation
for the animal products will be related to the toxicity of the compound
but should generally be on the order of 0.01-0.05 ppm or less. Require-
ments for analytical methods are spelled out in detail in OPPTS 860.1340.
(5) Storage stability data. Appropriate storage stability data are re-
quired on representative livestock commodities as outlined in OPPTS
guideline 860.1380.
(6) Waiver of livestock feeding studies. When the level of residues
in feed items is found to be low, registrants should refer to OPPTS guide-
line 860.1300 for a possible waiver of conventional livestock feeding stud-
ies. In some cases, livestock metabolism studies will indicate that feeding
studies and meat and milk tolerances are not necessary.
(e) Guidance procedure for calculating livestock dietary exposure.
(1) While feed percentages listed for ruminants (i.e. beef and dairy cattle)
in Table 1 of OPPTS 860.1000 and in the Harris Guide (see paragraph
(g)(6) of this guideline) and the ANI Report (see paragraph (g)(7) of this
guideline) are listed on a dry matter basis, tolerances for these feed items
are established on an as-fed basis. Hence, the correct calculation of rumi-
nant dietary burden includes the conversion of the feed to a dry-matter
basis in the diet.
(2) Percentages of the diet for poultry and swine feeds in the Harris
Guide are on a dry matter basis. Poultry and swine listings Table 1 of
OPPTS 860.1000 and the ANI Report are on an as-fed basis but since
almost all feeds for poultry and swine are in the dry category, the dietary
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burden calculation for poultry and swine using Table 1 of OPPTS
860.1000 does not require conversion of the feed to a dry-matter basis.
(3) The dietary burden calculation must also handle the situation that
arises when the feed items on which there are tolerances for a given chemi-
cal do not comprise a complete diet for the animal. For example, pesticide
A has tolerances on alfalfa forage (50 percent of beef cattle diet) and al-
falfa hay (25 percent), but on no other feed items. In this case, there is
no information on the feed items 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.
(4) These problems can be avoided 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. The following equation, Equation A, has been
derived for such calculations. For ruminants, where feed percentages are
expressed on a dry matter basis, equation A should be used to calculate
the total dietary burden.
f dietary \ (%diet [DM]) ( mg}
[DM] \(ppm) = \ ¥L x (tolerance). — (^)
.burden I (%DM) { kg }
v y / v / / V ° /
where
(dietary burden [DM]) = estimation of total exposure of a pesticide
through feeds on a dry-matter basis, expressed in ppm (mg pesticide per
kg feed)
(% diet [DM])i = percentage in the animal diet of commodity / ex-
pressed on a dry-matter basis
(%[DM])i = dry-matter percentage in feed commodity /
(tolerance)i = proposed or existing tolerance expressed in mg/kg
(ppm)
(5) The burden thus calculated is on a dry-matter basis, and 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.
(6) The feed percentages for poultry and swine in Table 1 of OPPTS
860.1000 are on an as-fed basis. Therefore, no correction will have to
be made for percent moisture; the dietary burden for poultry and swine
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will be simply calculated by Equation B as follows and the dietary burden
in this case will be on an as-fed basis:
(dietary}
J(ppm) = N (%diet)i x {tolerance^
\ ke
I burden
V r j \
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(B) Without correcting for moisture, the same 2.1 ppm burden would
be calculated using Equation B. However, correcting for moisture, the bur-
den calculated by Equation A would be:
(0.80) (.20)
x (0.1 ppm} -\ x (10.0 ppm} = 8.1 ppm
(0.88) (0.25)
(C) Thus, using only Equation B, the dietary burden for beef cattle
would be seriously underestimated.
(iii) Scenario 3 exists when not all feed items in the selected diet
have established tolerances.
(A) Similar underestimation of an animal's dietary burden can occur
if the available feed items do not comprise a complete diet. Using the
example of Pesticide A for beef cattle,
alfalfa forage
alfalfa hay
50 percent of diet
25 percent of diet
35 percent DM
89 percent DM
2.0 ppm tolerance
8.0 ppm tolerance
(B) The dietary burden, if calculated using Equation B without con-
version to a dry matter basis, is:
[(0.50) x (2.0 ppm)] + [(0.25) x (8.0 ppm)] = 3.0 ppm
(C) Using Equation A, the dietary burden is calculated as follows:
(0.50) (0.25)
x (2.0 ppm) -\ x (8.0 ppm) = 5.1 ppm
(0.35) (0.89)
(D) This latter number represents a worst-case scenario; thus, the bur-
den cannot be more than 5.1 ppm.
(f) Data reporting format. The following describes a suggested order
and format for a report item by item. Other formats are acceptable pro-
vided that the information described in this paragraph is included.
(1) Cover page. Title page and additional documentation requirements
(i.e., requirements for data submission and statement of data confidentiality
claims) if relevant to the study report, should precede the content of the
study formatted below. These current requirements are described in PR
Notice 86-5 published by the Office of Pesticide Programs on July 29,
1986 (see reference in paragraph (g)(5).
(2) Table of contents. The table of contents should provide page num-
bers on which are found the essential elements of the study.
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(3) Introduction and summary, (i) This section should provide back-
ground and historical perspective for the study. It should include:
(A) Registration history.
(B) Proposed use of the pesticide.
(C) Purpose of the study.
(D) Summary of the results.
(ii) The summary of the experiment should include:
(A) A discussion of any unusual problems encountered and how these
were resolved.
(B) A discussion of any deviation from the experiment's protocol and
the effect this may have had on the results.
(C) A brief description of the study's findings addressing such ques-
tions as: Residues transfer, preferential accumulation in certain organs,
highest residues, and occurrence of a plateau in residue concentration in
milk or eggs.
(iii) A comparison of the results to those of the animal metabolism
studies would also be useful. Such comparisons can also be presented in
a separate overview document.
(4) Materials—(i) Test substance. (A) The pesticidal active ingredient
and/or its metabolites which are fed should be identified by:
(7) Chemical name.
(2) Common or trivial name (American National Standard Institute
(ANSI), British Standards Institution (BSI), International Standards Orga-
nization (ISO)).
(3) Company developmental name/number.
(4) Chemical Abstracts Service (CAS) number.
(B) The source and purity of each compound should be specified.
(C) Chemical structure graphics of these compounds are also desired.
(D) Rationale for feeding compounds other than parent pesticide.
(ii) Test facilities. The animal housing should be described. Factors
to consider include: Sizes of enclosures, individual versus group housing,
food and water containers, temperature, lighting, and waste handling.
(iii) Test animals. (A) A description of the test animals should in-
clude: Species, breed, age, weight, and health status.
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(B) The number of animals per feeding level must be specified.
(C) The mode of identification should be noted (e.g. ear tags).
(D) Body weights and egg/milk production should be reported for
both the acclimation and dosing periods.
(E) Any health problems, abnormal behavior, or unusual treatment
of animals should be reported and the effect of these on study results dis-
cussed.
(iv) Feed. (A) Diet of the animals during acclimation and the dosing
period should be described as to both:
(7) The types of feed (e.g., corn grain, layers mash, alfalfa pellets)
and liquids.
(2) The quantities provided (i.e., specific amounts or ad libitum).
(B) Feed consumption (dry weight for ruminants) should be reported
on an individual or treatment group basis throughout the study.
(5) Methods—(i) Dosing. (A) The preparation of the dose should be
described (mixing with feed or concentrate ration, gelatin capsule, bolus,
etc.). The level of the test material in the total diet in parts per million
(mg/kg feed) (dry weight basis for ruminants) is needed. The rec-
ommended doses are Ix, 3x and lOx the anticipated dietary intakes from
proposed usages of the pesticide. The calculation of these dietary burdens
based on Table 1 of OPPTS guideline 860.1000 and the procedure in para-
graph (e) of this guideline should be explained. The petitioner should con-
sider possible future uses of the pesticide when determining the dosages
to be fed. Dosing schemes other than Ix, 3x, and lOx are acceptable pro-
vided a satisfactory rationale is given.
(B) The date of dose preparation should be specified along with the
storage conditions prior to its administration.
(C) A brief description of the method used to analyze spiked feeds
and the results of such analyses should be presented. These analyses
should demonstrate that the pesticide was stable in the feed or dosing ma-
terial throughout its entire storage period.
(D) The frequency of dosing should be reported if the test material
is not incorporated into the total diet or feed.
(E) The dates of the initial and final doses (or the total length of
the dosing period) should be indicated.
(ii) Sample collection. (A) The collection of milk and eggs should
be described with any differences from normal practice explained. Any
compositing or pooling of samples should to be noted, although milk from
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animals within a dosage group should not be pooled. Compositing the a.m.
and p.m. milk from each individual cow in the ratio of production is ac-
ceptable.
(B) The collection dates for those samples which are analyzed for
the residue of concern should be reported.
(C) The mode of sacrifice and the time interval in hours between
the latter and the administration of the last dose should be specified. An
explanation of intervals longer than 24 hours should be presented along
with a discussion of their effect on residues.
(D) The tissues taken after sacrifice, their type (e.g., thigh muscle,
omental fat, etc.), and their weights should be listed. Combining of sam-
ples from different animals should be noted (usually acceptable for poultry,
but not for ruminants).
(iii) Sample handling and storage stability. (A) The storage and han-
dling of tissues, eggs, and milk between sample collection and analysis
should be described. Factors to consider are:
(7) Sample preparation (e.g., chopping) prior to storage.
(2) Containers.
(3) How quickly the samples are put into storage.
(4) Storage temperature.
(5) Length of storage (dates of collection, shipping, analysis, etc.).
(6) Mode of shipping, if applicable.
(B) Evidence should be presented showing that the storage did not
affect the results of the study. Preferably, this is obtained by concurrently
spiking control samples and storing them under the same conditions as
samples from treated animals. For guidance in this area refer to OPPTS
860.1380. If such information is provided in another section of the overall
data report, the study may be referenced.
(iv) Analysis of samples. (A) A detailed description of the analytical
method employed to measure residues should be provided along with a
statement as to which chemical species were measured (parent pesticide,
metabolites). When the method has been submitted as a separate report
in the total data report (as is often the case), it may simply be referenced.
See OPPTS 860.1340 for assistance on how to describe methodology.
(B) Recovery data should be obtained concurrently with the residue
analyses to validate the method and establish its sensitivity (lowest reliable
quantitation limit). The experimental design of these validation studies
should be described, including:
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(7) Identity of the test compounds and substrates (tissues, milk, and
eggs).
(2) Magnitudes of fortification levels.
(3) Number of replicates per test compound per level.
(C) Dates of sample fortification, extraction, and analysis of extracts
should be listed. If extracts are not analyzed on the day of preparation,
storage conditions should be described.
(D) Raw data such as sample weights, final volumes of extracts, and
peak heights/areas should be furnished for control, fortified (including
those for storage stability data), and treated samples to support reported
residue values and recoveries. Analytical responses of standards (xero-
graphic copies of calibration curves) are also needed. See also OPPTS
860.1000 for more guidance on presentation of raw data.
(E) Xerographic copies of representative chromatograms should be
supplied for control, fortified, and treated samples of each matrix (milk,
eggs, each edible tissue, etc.) along with a few sample calculations of resi-
due levels and percent recoveries using the raw data.
(6) Results and discussion, (i) Recovery percentages (all values, not
just averages or ranges) for the pesticide and/or its metabolites should be
reported for tissues, milk, and eggs fortified with these compounds.
(ii) Storage stability data showing the behavior of residues as a func-
tion of time in tissues, milk, and eggs should be submitted or referenced.
Storage duration and temperature of these samples should be specified in
the table.
(iii) Levels of the TTR should be reported for each tissue for each
feeding level (including control (untreated) samples). The tissues rec-
ommended for analysis include muscle, fat, liver, and kidney (latter not
required for poultry). The individual values should be listed for all samples
(not merely averages or ranges). It should be clearly indicated whether
or not residues have been corrected for recoveries. If the parent pesticide
and its metabolites are measured separately, the residues of each should
be reported.
(iv) Residues in milk and eggs should be listed for each feeding level
including controls along with the dates of sample collection. As with tissue
residues, the values for each sample should be reported (not just ranges
or means).
(v) Discussion should be presented as to whether the data indicate
that residues of the pesticide transfer to tissues, milk, and eggs, and if
so, when did residues plateau in milk and eggs? Do they preferentially
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accumulate in certain tissues? Are the results consistent with the 14C me-
tabolism studies?
(7) Conclusions. A conclusion must be reached as to whether residues
of the pesticide transfer from feed items to meat, milk, poultry, and eggs.
If so, the extent of transfer should be discussed. The results can be summa-
rized in a table (the preferable format) showing either the ranges or maxi-
mum residues in type each of sample for each feeding level. Such a table
can then be used to determine appropriate tolerances each time additional
feed items are registered.
(9) Certification. A certification of authenticity must be provided by
the study director (including signature, typed name, title, affiliation, ad-
dress, telephone number and date).
(10) References. Any references cited in the report should be included
here.
(11) Appendices. Reproductions of published reports that support the
submitted study may also be included here if, in the registrant's opinion,
it will increase the efficiency of its review by the Agency.
(g) References. The following references should be consulted for ad-
ditional background material on this test guideline.
(1) Environmental Protection Agency. Pesticide Reregistration Rejec-
tion Rate Analysis—Residue Chemistry; Follow-up Guidance for: Generat-
ing Storage Stability Data; Submission of Raw Data; Maximum Theoreti-
cal Concentration Factors; Flowchart Diagrams. EPA Report 737-R-93-
001, February 1993.
(2) Environmental Protection Agency. Pesticide Reregistration Rejec-
tion Rate Analysis—Residue Chemistry; Follow-up Guidance for: Updated
Livestock Feeds Tables; Aspirated Grain Fractions (Grain Dust); A Toler-
ance Perspective; Calculating Livestock Dietary Exposure; Number and
Location of Domestic Crop Field Trials. EPA Report No. 737-K-94-001,
June 1994.
(3) Environmental Protection Agency. Pesticide Reregistration Rejec-
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