HAZARD EVALUATION DIVISION
STANDARD EVALUATION PROCEDURE
MAGNITUDE OF THE RESIDUE:
PROCESSED FOOD/FEED STUDIES
Prepared by:
M. J. Nelson, Ph.D.
F. D. Griffith, Jr., M.S,
Project Manager:
Orville E. Paynter, Ph.D.
United States Environmental Protection Agency
Office of Pesticide Programs
Washington, D.C. 20460
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R ORT DOCUMENTATiON 1 -
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2422 09 (AS
4. This .nd $ubtItIs .
VAI. .UATIoN DiVISION: STANDARD EVALUATION PROCEDURE
)1agni u e of t1e Re due: Pro essed Food/Feed Studies .
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This Standard Evaluation Procedure (SEP) is one of a
set of guidance documents to aid EPA chemists in the
evaluation of scientific data submitted pursuant to
establishment of pesticide and food/feed additive
tolerances. Whenever there is a possibility that
residues levels in processed foods/feeds may exceed.
the levels in the raw agricultural commodities from
which they are derived, processing data are required.
[ 40 CFR 158.125 ]. This SEP explains in a detailed,.-
stepwise fashion how EPA data reviewers evaluate pr p
cessed food/feed studies, and what type information?..
is taken into consideration in the review process..N
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STANDARD EVALUATION PROCEDURE
PREAMBLE
This Standard Evaluation Procedure (SEP) is one of a set
of guidance documents which explain the procedures used to
evaluate environmental and human health effects data submitted
to the Office of Pesticide Programs. The SEP-s are designed
to ensure comprehensive and consistent treatment of major
scientific topics in these reviews and to provide interpretive
policy guidance where appropriate. The Standard Evaluation
Procedures will be used in conjunction with the appropriate
Pesticide Assessment Guidelines and other Agency Guidelines.
While the documents were developed to explain specifically
the principles of scientific evaluation within the Office of
Pesticide Programs, they may also be used by other offices in
the Agency in the evaluation of studies and scientific data.
The Standard Evaluation Procedures will also serve as valuable
internal reference documents and will inform the public and
regulated community of important considerations in the
evaluation of test data for determining chemical hazards.. I
believe the SEPs will improve both the quality of science
within EPA and, in conjunction with the Pesticide Assessment
Guidelines, will lead to more effective use of both public
and private resources.
Anne L. Barton, Acting Director
Hazard Evaluation Division
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TABLE OF’ CONTF NTS
Pa a e
I. INTRODUCTION
. PurDose of the Standard Evaluation
Procedure . . ••••••,•• I I.e... 1.
B. Backcjround Information ....... 1
C. Objective of Processed Food/Feed
Study ... .................. .... .... 2
II. I JFoRMATIoNToBEsrjPPLIED....................... 2
III. THE DATA EVALEJATION PROCESS
A . r e D a r e a S u rnna r v • • . • • . • • . . . . . . . . . . . . . . . . . . 3
3 Identify DataGaps • I I• 3
C. Assess the Appropriateness and
Adequacy of the Data 3
D. Determine the Need for Consulta-
tion(s)/Deferral(s) . . • ,••••• •........ 4
E. Conclude if the Requested Action
is Supportable .. . .. .. .. .. 4
IV. REVIEWER AIDS 5
V. APPENDIX
Appendix 1: Major Points to Consider in
Evaluatinq Food/Feed Processinq Studies 6
V I. R PERENCES ..... ......... . ............. ........... 1.2
I’
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MAGNITUDE OF THE RESIDUE: PROCESSED FOOD/FEED STUDIES
I . INTRODUCTION
. Purpose of the Standard Evaluation Procedure
This Standard Evaluation Procedure is designed to aid Resi—
due Chemistry Branch (RCB) data reviewers in their evaluations
of processed food/feed studies uhmitted by petitioners/regis-
trants. This particular Standard Evaluation Procedure document
addresses processed food and feed commodities, and is intended
to be an adjunct to the Standard Evaluation Procedure on Magni-
tude of the Residue: Crop Field Trials.
B. Background Information
Residue chemistry data on the magnitude of the residue
in processed foods/feeds are conditionally required by 40 CFR
158.125 to support the registration of any pesticide intended
for use on a food or feed crop under the amended Federal Insec-
ticide, Fungicide, and Rodenticide Act. Specifically, “data
on the nature and level of residue in processed food and feed
are required when detectable residues could concentrate on
processing and thus require establishment of a food additive
tolerance.”
Residue chemistry data on processed food/feed are used by
the Agency to estimate the exposure of the general population
to pesticide residues in foods (including animal commodities)
and for setting and enforcing food/feed additive tolerances
for pesticide residues in or on processed food/feed under
provisions of Section 409 of the Federal Food, Drug, and
Cosmetic Act. (Note: raw aciricultural foods and feeds are
regulated under Section 408 of the Act.)
Data on the level of residue in food as consuried are con-
ditionally required under 40 CFR 158.125 when the assumption
of tolerance level residues would result in predicted exposure
at an unsafe level. Such data are used by the Agency to obtain
a more precise estimate of potential dietary exposure.
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Residue chemistry data on processed food and feed are also
needed to support the adeguacy of one or more methods for the
enforcement of the food additive tolerance, and to support
practical methods (e. ., washing, trimming/peeling, processing,
cooking, etc.) for removing residues on food prepared for con-
sumption.
C. Objective of a Processed Food/Feed Study
A processed food/feed study should answer the following
question: What is the maximum level of the “total toxic resi-
due” that will likely result in the various processed food/feed
commodities resulting from standard (or simulated) commercial
processing as compared with the residue level in the raw agri-
cultural commodity from which these processed comrriodities were
prepared (i.e., are concentration factors, if any, ascertain-
able, or is the processing adequate for estimations of residues
in ready—to—eat foods?).
These data are needed to determine whether residues concen-
trate or are reduced on nrocessing. If residues concentrate,
food/feed additive tolerances on the processing fractions con-
taining higher residues than the r.a.c. will be required. If
residues are reduced on processing, these data will be used by
the gency as the basis of its estimate of potential dietary
exposure. (The tolerance, however, will still he set on the
r.a.c. as it travels in interstate commerce.)
The term “total toxic residue” is used to describe the sum
of the parent pesticide and its degradation products, metabo—
lites (free or bound), and impurities that are considered to he
of toxicological significance, and therefore warrant regulation.
II. IF FORMATION TO BE SUPPLIEI)
The petitioner/reciistrant’s report on the processing of
a raw agricultural commodity into its various food/feed com-
ponents should include all information necessary to provide
a comolete and accurate description of the raw agricultural
commodity (including treatment history and the nature and
magnitude of the residue therein); the commercial processing
procedure (and, if different, the process used in this study);
sample storage; analytical procedure(s) used for residue de-
terminations (including validation data therefor); reporting
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of the data and statistical analyses; and, quality control
measures/precautions taken to ensure the fidelity of these
operations.
A guideiLne of specific inforr’tation that should he in-
cluded in the petitioner/registrant’s report of a processing
study is provided in the Residue (‘herrtistry Branch Data Report-
ing Guideline on the Magnitude of the Residue: Processed Food!
Feed Studies that complements this Standard Evaluation Pro-
cedure. Related information on Crop Field Trials, Storacje
Stability, and Analytical Method(s), among others, are found
in the Standard Evaluation Procedures and Data Reporting
Guidelines on those subject areas.
III. THE DATA EVALUATION PROCESS
A. Prepare A Summary
The initial step in the evaluation of processing study data
is for the reviewer to carefully examine and summarize the in-
formation supplied by the petitioner/registrant in his submis-
sion to the Agency. Statistical treatments of the data should
be independently verified and the quality control precautions
noted.
B. Identify Data Gaps
Using the Pesticide Assessment Guidelines (Subdivision 0,
Residue Chemistry) Data Reporting Guideline on Magnitude of the
Residue: Processed Food/Feed Studies as a quide (in conjunc-
tion with the related Guidelines on Crop Field Trials, Storage
Stability, and Analytical Method(s), etc.), the reviewer
should then look for data gaps——omissions in the information
supplied by the petitioner/registrant in his report——and decide
which are considered siqnificant enough to adversely affect the
review process. Those so identified should be communicated
back to the petitioner/registrant by the Product Manager for
corrective action.
C. Assess the Appropriateness and AdeQuacy of the Data
The data reviewer then considers the appropriateness (vis—
a—vis the standard commercial processing of the raw agricultural
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commodity) and adequacy of the data/information that have been
supplied. The aforereferenced Data Reporting Guidelines are
a useful guide to the various parameters that need to be con-
sidered. Appendix 1. of this document discusses specific aspects
of those parameters that warrant consideration.
As an adjunct to these, the reviewer should draw upon the
technical guidance in the reviewer aids materials that are
available to him, such as the Residue Chemistry Guidelines
(a.ka. Subdivision 0 of the Pesticide Assessment Guidelines).
A listing of some suggested source materials is located in the
References section of this document.
Any perceived deficiencies in the data/information supplied
should be identified and explained, with a statement as to what
steps should be taken to resolve the deficiencies, so that this
information can he relayed back to the petitioner/registrant by
the Product Manager for appropriate action.
1). Determine the Need for Consultation(s)/Deferrals
In considering the appropriateness and adequacy of the data/
information that have been supplied, the data reviewer must also
determine if consultation(s)/deferral(s) with/to other HED
Branch(es) or Government Agencies (e.g., FDA or USDA) are ger-
mane to reachinq that decision.
If so, the specific nature of the consultation(s)/defer-
ral(s) should be clearly and succinctly stated to the specific
parties whose input is sought.
In the interim period until consultation(s)/deferral(s) are
complete, final judgment on the issue(s) in question should he
withheld.
E. Conclude if the Requested Action is Supportable
As the last step in the data evaluation process, the data
reviewer makes a judgment as to whether the submitted data!
information support the requested action (tolerance/registra-
tion) of the data submitter.
If the data are not supøortive, possible alternative ac-
tion(s) that may be taken by the petitiorier/reqistrant are
suggested.
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If deficiencies/omissions exist in the submitted data base,
the reviewer may have to defer iudq’nent until such time as ap-
propriate corrective action has been rendered by the petitioner!
registrant.
(Note: As stated in CD) above, if consultation(s)/defer-
ral(s) with/to any other liED Branch(es) or Governient Agencies
are pending, final judgment will need to be held in abeyance
until the outcome of such consultation(s)/deferral(s).)
IV. REVIEWER AIDS
There are a large number and variety of source materials
that are available to assist the data reviewer in the evaluation
process. A listing of some of the more useful references that
reside within the Branch is provided in the References section
of this document.
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APPENDIX I
MAJOR POINTS TO CONSIDER IN EVALUATING rOOD/FEED PROCESSING STUDIES
This Appendix is a supplement to Appendix 1 of the Standard
Evaluation Procedure on Magnitude of the Residue: Crop Field
Trials. The following are additional specific points to be
considered when raw agricultural commodities are normally sub-
jected to commercial processing operations for milled byprod-
ucts, oils, pornaces, hulls, etc. that are used as food/feed
items.
A. The Raw Agricultural Commodity (r.a.c.)
— Is it clear what the nature and maqnitude of the residue
were in the r.a.c. samples used in the processing
study?
— Are the treatment histories (pesticide(s) used, rate(s),
number of applications, PHI’s, etc.) of the r.a.c. sam-
ples used in the processing study given?
— Dtd the r.a.c. samples used in the processing study contain
field—incurred residues or were they “sniker3” with pest-
icide? (If the latter, see comment in the Pesticide
Assessment Guidelines, Subdivision 0 [ Residue Chemistry] ,
p. 21 for the condition under which such fortification
may be acceptable.)
— Was the processing study conducted with r.a.c. samples
containing detectable residues? At or near the prooosed
tolerance level? If not, why not? Is the situation
correctable?
— Were r.a.c. samples collected at the proposed PHI, or were
samples harvested early to ensure adequate field—incurred
residues for a processing study?
— Were r.a.c. samples for the processing study field—treated
at the intended use rate? An exaggerated rate? If exag-
gerated, how much so?
— Do exaggerated rate field studies (within the limits of phy—
totoxicity, etc.) result in a detectable residue in the
t-.a.c.? If riot, is the difference between the analyti-
cal limit of detection and the proposed tolerance level
greater than the theoretical concentration factor(s)?
— If no detectable residue was in the r.a.c. sample(s) used
in the processing study (nor can be achieved because of
phytotoxicity considerations), and there is a potential
for high theoretical concentration factor(s), is the
proposed tolerance supportable?
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- Are data provided on theoretical concentration factors? To
allow calculation of them? (e.g., % moisture, oil con-
tent, etc.)
— Have the r.a.c. samples for use in the processing study been
adequately identified?
— Is a corrunercially important variety of the r.a.c. represent—
— Is it clear what specific plant part(s) were harvested?
Processed?
— Have the developmental stage(s) and general condition (e.g.,
immature/mature, green/ripe, fresh/dry, etc.) of the r.a.c.
samples at time of processing been specified?
— Were the r.a.c. samples in any way trimmed, cleaned, or oth-
erwise subjected to a means of residue removal at time of
harvest? If so, were the recommended procedures of P.A.M.
I, §S141—2 followed?
— Are there livestock or poultry feed items associated with the
r.a.c.? Processed commodities? If so, are animal metabo-
lism and feeding studies available?
B. The Processing Procedure
— Has the standard commercial process been identified? de—
quately described? Flow diagram(s) provided?
— Does the processing study for the r.a.c. samples in the peti-
tioner/reqistrant’s submission simulate normal commercial
practice in the USA? If different, are the differences
sufficiently described?
— Are residue data for all processed commodities/byproducts of
the r. .c. provided? (See Table II, Pesticide Assessment
Guidelines, Subdivision 0 [ Residue Chemistry].) Residue
data presented for pertinent processed commodities/byprod-
uicts not identified in Table II?
- If appropriate, are residue data provided on food prepared
for consumption?
- Is supplementary processing information available for the
pesticide in other reports submitted by the petitioner/
registrant on this r.a.c. or botanically related r.a.c.s
that can be translated to support the data base, if
needed?
— Is the “total t xtc residue” altered during processing? If
significantly so, has a radioLabeled study been submitted
characterizing the nature and extent of the alteration(s)?
To validate the enforcement method? (Ref. Pesticide As-
sessment Guidelines, Subdivision 0 [ Residue Chemistry]
p. 21.)
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C. Sample Storage
— Is the storage history (e.g., dates, duration, temperature,
container type and size, sample weights, etc.) of the
r.a.c. samples used for the processing study given?
— How long were processed commodity/byproduct carnples stored
prior to residue analysis? re full details of storage
conditions, including dates, given?
— In what form (e.g., whole, chopped, as an extract, etc.)
were r.a.c. samples stored? Processed commodities/by-
products?
— Are storage stability validation data available for the
r.a.c. samples used in processing? For the processed
co-nrnodities/byproducts prepared therefrom?
— What were the means and conditions of shipping the r.a.c.
samples to the processing c-enter? To the residue anal-
ysis laboratory? Are dates given?
— Has the petitioner provided storage stability data on resi-
dues in food prepared for consumption?
D. nalytical Method(s )
— Are the analytical method(s) used in the residue analysis
of the processed commodities/byproducts samples for the
“total toxic residue” the same as those used to gather
residue data on the r.a.c. field trial samples? If riot,
are differences/modifications identified? Described?
Validated? Non-CBI copy available?
— Was more than one analytical method used in the analysis
of r.a.c. field trial and processed commodity/byproduct
samples for the “total toxic residue” (i.e., a “total”
residue method and perhaps separate method(s) for the
metabolite(s) of concern)? If so, were each of those
method(s) subjected to validation/recovery testing?
Limits of detection and sensitivity given for each
sample matrix?
— Were the analytical method(s) adequately identified (e.g.,
title/designation, date and source)?
— Were all the appropriate plant part(s) and processed com-
modities/byproducts subjected to residue analysis?
Identified? (Ref. Table II, Pesticide Assessment Guide-
lines, Subdivision 0 [ Residue Chemistry].)
— Was any cornpositing or subsampling done on either the r.a.c.
or the processed commodity/byproduct samples at any time?
If so, were details given? Were proper sample code num-
bers maintained?
— Are recovery/validation data available for all the matrices
(raw or processed) of interest?
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— Are the analytical niethod(s) used in gathering the residue
data the same as those proposed for enforcement? If not,
is a paired—test comparison or a method validation needed?
Should these method(s) be recommended for inclusion in
the PAM?
— were all the necessary compounds (i.e., those comprising
the “total toxic residue”) analyzed tor in the processed
commodities/byproducts? If not, why not?
— In studies involving reduction of residues, are the analy-
tical limits of detection in foods prepared for consump-
tion adequately determined? Defined? Are they differ-
ent from the r.a.c.? If so, how do they differ?
- Does processing reduce the level of residue to the analy-
tical limit of detection? If so, is the limit of detec-
tion low enough for safety evaluation purposes?
E. Residue Results
— Do the residue levels in processed food/feed samples exceed
the pesticide residue levels in the r.a.c. samples from
which those processed commodities/byproducts were pre-
pared? If so, is the concentration factor clear? Has
the pet itioner/reqistrartt proDosed appropriate food/feed
additive tolerance(s)?
— Is a residue reduction indicated in the processed commodity!
byproduct samples as compared with those in the r.a.c.
from which they were prepared?
— How do these residue results compare with other processing
data for this pesticide, if available? If any discrep-
ancies, are these explainable?
— Do the processing study data indicate the need for additiona]
information? Additional analyses? Another study?
— If the petitioner/registrant is proposinq food/feed addi-
tive tolerance(s) based upon the processing study infor-
mation suhriitted, do the results of such studies support
the requested action of the petitioner/registrant? If
not, what is needed for corrective action?
— If food/feed additive tolerances are being proposed, are
they based upon actual concentration factors (from resi-
due analysis of appropriate samples) or upon theoretical
(calculated) concentration factors?
— Is there any other unpublished or published information
known to us about this pesticide, r.a.c., or the proces-
sed cornr’ odities/byproducts that must he taken into Con—
s iderat ion?
— Are there Codex/FAO Monograph data available for this r.a.c.,
its processed commodities/byproducts, or botanically re-
lated r.a.c.s treated with this same pesticide? If so,
are such data being used in the evaluation process?
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— re there international residue limits (tRLs) established
for use of this pesticide on this r.a.c.? Its processed
commodities/byproducts? If so, upon what use(s) were the
IRLs established, and what cor’Iponent(s) of the residue
are regulated?
— Can harmonization with arty such IRLs he achieved? If not,
why not?
— Are the riethods of calculating the residue level and per-
cent recovery aclerTuately described (formulae, standard
curves, etc.), and illustrated, and the raw data suffic-
iently detailed so that independent calculations to
verify the reported results can be made?
— Were any correction factors (e.g., extraction efficiency,
field blanks, etc.) applied to the residue values/recov-
ery values reported?
— If statistical analyses were performed and applied to the
results of the residue analysis of the processed coririod—
ities/byproducts and the r.a.c.s from which they were
derived and/or to the analytical rtethod(s) validation!
recovery testing, is sufficient information provided on
this to independently validate such calculations?
— Is there a Registration Standard for this pesticide? If
so, is it being used iii the evaluation of these data?
F. Quality Control
— Are all the raw data reported rather than just average val-
ues?
— What quality assurance measures were taken to ensure the
fidelity of the residue analyses of the processed con—
moclities/byproducts and the r.a.c.’s from which they
were derived? The analytical method(s) validation/
recovery testing? Sample storaqe?
— Are all the significant dates given (e.g., dates of sam-
ples receipt in the processing center a-id Jaboratory;
dates of test substrates oreparation [ i.e., trimrninn,
chopping, extraction, etc.J ; dates of test compounds
preparation [ i.e., standard reference solutions); dates
of residue analysis, including the determinative step)?
— Was the sample/laboratory coding sufficiently clear so that
the history of the r.a.c. sample(s) could he traced fron
the field, through the processing procedure, throu h
storage, and through residue analysis?
— Were the analytical method(s) validation/recovery test(s)
on the processed commodities/byproducts and the r.a.c.s
from which they were derived conducted at the same time
as the residue analyses of those samples or on different
dates? If the latter, what are the resoective dates of
those operations?
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— Is information provided on the equipment/instrumentation
used in processing? Storage? Residue analysis? Were
these properly calibrated and maintained?
— Were the analyst’s worksheets provided? Are they suffic-
iently detailed?
Were the person(s) (supervisor, analyst) responsible for
the storage, processing, and residue analysis of the
residue samples (r.a.c. and the processed commodities!
byproducts derived therefrom), including validation!
recovery testing, identified (name, title, organization,
address, telephone number)?
— Are all the test reports (e.g., storage, processing, resi-
due analyses, validation/recovery testing, etc.) auth-
enticated by appropriate signatures?
rs a contact person for the petitioner/registrant given
with title, address, and telephone number?
— - Were representative chromatoqrams, spectra, etc., as r —
plicable, provided for the residue analyses of the
processed commodities/byproducts? The r.a.c.s from
which they were derived? Analytical method(s) vali-
dation/recovery testinci? Storage stability testing?
— Do the representative chromatograms, spectra, etc. indi-
cate adequate clean—up and determination (i.e., low
background “noise,” adequate signal—to—noise ratio,
well—defined peaks rather than shoulder hands, etc.)
of the “total toxic residue?”
— Jere the storage, residue, and recovery values reasonably
uniform for replicate samples?
— Were tests performed for interference from storage con-
tainers, reagents, plant matrices, plastic labware,
etc.?
— Is information provided on the dates the pesticide reference
standard solutions were prepared? F4ow they were stored?
How their stability was monitored? How often fresh stan-
dard solutions were prepared?
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REFERENCES
Following is a listing of some of the more useful source
iaterials within the Residue Chemistry ranch that could prove
helpful in reviewing processed food/feed studies:
C - i) Foods and Food Production Encyclopedia , D. M. Considine
and G. D. Considine, editors, Van Nostrand Reinhold Corn—
party, N .Y. (1982);
(2) McGraw—Hill Encyclopedia of Food, Agriculture & Nutrition ,
4th ed., D. N. Lapedes, editor—in-chief, McGraw—Hill Book
Co., N.Y. (1977);
(3) Soybeans: Improvement, Production, and tJses , B. E.
Caidwell, editor, American Society of Agronomy, Inc.,
Madison, WI (1973);
(4) Fruit and Vegetable Juice Processing Technology , D. K.
Fressler and 0. 3. Maynard, The Avi Publishing Co., Inc.,
Westport, CT (1961);
(5) Sorghum Production and Utilization , 1. S. Wall and W. 11.
Ross, The Avi Publishing Co., Inc., Westport, CT (1970);
(6) Sweet Potatoes: Production, Processing, Iarketing , .1. B.
Edmond and G. R. Ammerman, The Avi Publishing Co., Inc.,
Westport, CT (1Q71);
(7) Peanuts: Production, Processing, Products , 2d ed., J. G.
Woodroof, The Mi Publishing Co., Inc., Westport, CT
(1973);
(8) F.D.A. Pesticide Analytical Manual , Volumes I and II,
available from the National Technical Information Serv-
ice, Sprinqfield, VA;
(9) Official Methods of Analysis of the Association of Offi-
cial Analytical Chemists , 14th ed., S. Williams, editor,
Association of Official Analytical Chemists, Washington,
T).C. (1984);
(10) Chemistry Laboratory Guidebook , USDA, FSIS, Science,
available from the National Technical Information Service,
Springfield, VA;
Ill) Rasic Gas Chromatography , H. M. McNair and E. 1. Ronelli,
ConsoJidated Printers, Berkeley, CA. (1969);
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(12) Gas Chromatography Principles, Techniques and Applications ,
A. B. Littlewood, Academic Press, N.Y. (1962);
(13) Introduction to Modern Liquid Chromatography , 2nd ed.,
L. R. Snyder and .3. 3. Kirkland, John Wiley and Sons, Inc.,
N.Y. (1979);
(14) practical Liquid Chromatography , R. W. Yost, et al. , per—
kin—Elmer, Norwalk, CT (1980);
(15) Biological Applications of Liquid Scintillation Counting ,
y. Kobayashi and D. V. Maundsley, Academic Press, N.Y.
(1978)
(16) Instrumental Methods of Analysis , 5th ed., H. H. Willard,
et al . , D. Van Nostrand Company, Inc., Princeton, N.J.
(1974);
(17) Interpretation of Mass Spectra , 3rd ed., F. W. McLafferty,
University Science Books, Mill Valley, CA (1980);
(18) Applications of Absorption Spectroscopy of Organic Com-
pounds , 3. P. Dyer, Prentice—Hall, Englewood Cliffs, N.J.
(1965);
(19) Systematic Identification of Organic Compounds , R. L.
Shriner, et al. , John Wiley and Sons, Inc., N.Y. (1965);
(20) Spectrometrlc Identification of Organic Compounds , 4th ed.,
R. P4. Silverstein, et al. , John Wiley and Sons, Inc., N.Y.
(1979);
(21) Organic Structural Analysis , 3. B. Lambert, et al. , Mac—
r’lillan Publishing Company, Inc., N.Y. (1976);
(22) Principles of Radioisotope Methodology , 3rd ed., G. D.
Chase and 3. L. Rabinowitz, Burgess Publishing Company,
Minneapolis, MN (1967);
(23) The Identification of Functional Grou s in flrganophos—
phorou.s Compounds , L. C. Thomas, Academic Press, London,
England (1979);
(24) The Pesticide Manual , 7th ed., C. P. Worthinq, editor,
The British Crop Protection Council, Lavenham Press Lim-
ited, Suffolk, England (1983);
(25) EPA Analytical Reference Standards and Supplemental flata,
available from the National Technical Information Service ,
Springfield, VA;
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(26) FDA Laboratory Information Bulletins , available from the
National Technical Information Service, Springf i 1d, VA;
(27) EPA Manual of Analytical Methods for the Analysis of Pes-
ticides in Humans and Environmental Samples , available
from the National Technical Information Service, Sprinq—
field, VA;
(28) Chemical Separations and Measurements , D. G. Peters, et
al., W. B. Saunders Co., Philadelphia, PA (1974);
(29) Basic Statistics: A Primer for the Biomedical Sciences ,
0. J. Dunn, John Wiley & Sons, Inc., New York, N.Y.
(1q64)
(30) Statistical Manual of the Association of Official Analy-
tical Chemists , W. 3. Vouden and E. H. Steiner, Associ-
ation of Official Analytical Chemists, Arliriqton, VA
(1975);
(31) Statistical Methods Applied to Experiments in Agriculture
and Biology , 7th. ed., G. W. Snedecor, Iowa State College
Press, Ames, IA (1980);
(32) Subdivision 0 (Residue Chemistry) of the Pesticide Asses-
sment Guidelines, §171—3 and §171—4, prepared by OPTS/EPA,
Washington, D.C. (1982);
(33) Code of Federal Regulations (40 CFR 158 and 180; 21 CFR
193 and 561), General Services AdrnlnLstration, Washington,
D.C., updated annually;
(34) Pesticide Chemical News Guide , R. E. Dugqan, editor, Food
Chemical T ews, Inc., Washington, D.C., 1982, updated
monthly;
(35) “Guidelines on Pesticide Residue Trials to Provide Data
for the Registering of Pesticides and the Establishment
of Maximum Residue Limits”, FAO Plant Protection Bulletin,
29:lJ , pp. 12—27 (1981);
(36) “Guidel.ines for Data Acquisition and Data Quality Evalua-
tion in Environmental Chemistry”, Anal. Chem . 52, 22.42—2248
(1980);
(37) Chemistry Ouality Assurance Handbook , slols. I and II, USDA,
FSIS, Science, available from the National Tec’inical Infor-
mation Service, Springfield, VA;
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(38) Analysis of Pesticide Residues in Human and Environmental
Samples , R. Watts, editor, EPA—600/8—80—038, U.S. Environ-
mental Protection Agency (1980);
(39) Manual of Analytical Quality Control for Pesticides and
Related_Compounds in Human and Environmental Samples, 1.
Sherma, editor, EPA—600/2—8l—059, U.S. Environmental
Protection Agency (1981);
(40) Acceptable Common Names and Chemical Names for the Ingre-
dient Statement on Pesticide Labels , 4th ed., C.R. Blalock,
et al. , editors, OPP/EPA, 1979, available from National
Technical Information Service, Springfield, VA;
(41) Farm Chemicals Handbook , Meister Publishing Co., Willoughby,
- OH, updated annually;
(42) Nanogen Index: A Dictionary of Pesticides and Chemical
Pollutants , K. Packer, editor, Nanogens International,
Freedom, CA, 1975 (updated periodically by supplements);
(43) Various reference texts and journal publications of a
scientific or agricultural nature, including FAO/Codex
Monographs; Residue Reviews (assorted volumes); Analy-
tical Chemistry (assorted issues); Journal of Agricul-
tural and Food Chemistry (assorted issues); Journal of
the Association of Official Analytical Chemists (assorted
issues); The Analyst (assorted issues); Journal of High
Performance Chromatography (assorted issues; et al . Phila-
delphia (1974);
(44) Registration Standards on various individual pesticides,
prepared by OPTS/EPA, Washington, D.C. (several issued
each fiscal year);
(45) Residue Chemistry Branch files: petition and registra-
tion files; reviewer aids; policies; subject files; reading
files; et al. ;
(46) The Tolerance Assessment System: Issues, prepared by
S. Saunders and S. Johnson, EPA, Washington, D.C., March 7,
1986;
(47) Methods for Organic Chemical Analysis of Municipal and
Industrial Wastewater , EPA—600/4—82—057, available from
the National Technical Information Service, Springfield,
VA (updated periodically);
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(48) Guidelines Establishing Test Procedures for the Analysis
of Pollutants Under the Clean Water Act: Final Rule and -
Interim Final Rule and Proposed Rule , Federal Register,
Vol. 49, No. 209, Friday, October 26, 1984;
(49) Test Methods for Evaluating Solid Waste , EPA SW 846, 2d
edition, available from the National Technical Informa-
tion Service, Springfield, VA (updated periodically);
(50) Effects of Storage (Storage Stability) on Validity of
Pesticide Residues , August 1987, a position document of
the EPA, available from the National Technical Informa-
tion Service, Springfield, VA.
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