PESTICIDE ASSESSMENT GUIDELINES
SUBDIVISION O
RESIDUE CHEMISTRY
Series 171-4
Magnitude of the Residue; Processed Food/Feed Study
ADDENDUM 4 ON DATA REPORTING
Prepared ty:
M. J. Nelson, PhD and F. D. Griffith, Jr., MS
Residue Chemistry Branch
Hazard Evaluation Division
Edited by:
Anne Bradford
Hazard Evaluation Division
Project Manager:
Elizabeth M. K. Leovey, PhD
Hazard Evaluation Division
Office of Pesticide Programs
US Environmental Protection Agency
-------
Subdivision O - Magnitude of the Residue: Processed Food/Feed Study
Table of Contents of A3dendum
Discussion Page
Introduction 2
Response to Public Ccmmsnts 3
Guideline
Title/Cover Page 4
Table of Contents 4
I. Summary/Introduction 4
II. Materials 4
III. Mettods 5
IV. Results/Discussion 5
V. Conclusions 6
VI. Certification 6
VII. Tables/Figures 6
VIII. References 6
DC. Appendix(es) 6
End Notes 7
-1-
-------
PESTICIEE ASSESSMENT GUIDELINES
RESIDLE CHEMISTRY
Magnitude of the Residue; Processed Food/Feed Study_l/2/
Subdivision 0, Series 171-4
DATA REPORTING
INTROEUCTICN
A. Purpose
Residue chemistry data on the magnitude of the residue in processed
food/feed 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 Insecticide, Fungicide, and Rodenticide
Act. Specifically, data on the identity and magnitude of the residue
in processed food/feed are required whenever there is a possibility of
residue levels in processed food/feed exceeding the level in the raw
agricultural commodity [r.a.c.] from vAiich it is processed, thereby
requiring 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 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 agricultural foods and feeds are
regulated under Section 408 of the Act.]
Data on the level of residue in food as consumed are conditionally
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. 3f
Residue chemistry data on processed food/feed are also needed to support
the adequacy of one or more methods for the enforcement of the food
additive tolerance, and to support practical methods (e.g., washing,
trimming/peeling, etc.) for removing residues on food prior to
processing.
This particular Data Reporting Guideline document addresses processed
food and feed commodities, and is intended to be an adjunct to the
Data Reporting Guideline on Magnitude of the Residue: Crop Field
Trials. 4_/
B. Objective
A processed food/feed study should answer the following question:
What is the maximum level of the "total toxic residue" that will
-2-
-------
-3-
likely result in the various processed food/feed cxmnoditles resulting
from standard (or simulated) ccrnraercial processing as compared with
the residue level in the raw agricultural catmodity from which these
processed cannDdities were prepared [i.e., are concentration factors,
if any, ascertainable, or is the processing adequate for estimation
of residues in ready-to-eat food?].
The term "total toxic residue" is used to describe the sum of the
parent pesticide and its degradation products, metabolites (free
or bound), and impurities that are considered to be of toxicological
significance, and therefore warrant regulation.
An effort should be made to achieve harmonization with applicable
International Residue Limits (Codex) residues in processed food/feed.
Processing studies must simulate commercial practices as closely as
possible. Raw agricultural commodity (r.a.c.) samples used in processing
studies must contain field-treated detectable residues, preferably
at or near the proposed tolerance level, so that concentration
factors for the various by-products can be determined. This may
require field treatment at exaggerated application rates to obtain
sufficient residue levels for processing studies. Processing
studies utilizing spiked samples are not acceptable unless it can
be demonstrated that the r.a.c. residue consists entirely of a
surface residue.
This Data Reporting Guideline is designed to aid the petitioner/
registrant in generating reports which are compatible with the
Agency's review process. Data submitters are encouraged to submit
complete reports which can be efficiently reviewed by the Agency. 5/
This guidance pertains to the substance of the data report.
PR Notice 86-5, effective November 1, 1986 (available from the
Registration Support and Emergency Response Branch, Office of
Pesticide Programs, US EPA), pertains to the physical formatting of
reports (which are referred to as "studies") and submittal packages.
Seme of the requirements in PR Notice 86-5 are mandatory.
RESPONSE TO PUBLIC COMMENTS
The purpose of this section is to acknowledge and address the concerns
expressed in the letters of comment received by the Agency in response to
the public notice in FEDERAL REGISTER Volume 51, No. 199, p. 36753,
October 15, 1986.
This addendum to the Pesticide Assessment Guidelines (Subdivision 0) is
to be considered an all-encompassing document. EPA recognizes there are
sections in the addendum which do not apply in all cases. Therefore, regis-
trants should exercise scientific judgment in deciding which portions are
germane to a specific data submission.
This Data Reporting Guideline is not intended to introduce new data
-------
requirements or revisions into the Pesticide Assessment Guidelines (Subdivision
O); nor is it intended for use by Agency data reviewers as a mere checklist.
It is intended to clarify ambiguities in interpretation of those existing
Guidelines/ and to organize the submission of data to facilitate the review
process.
For conments relating to Good Laboratory Practices (GLPs), the Agency has
revised its requirement in this document in recognition that there is currently
no regulatory GLP Guideline for chemistry data.
GUIDELINE
TITLE/COVER PAGE
Title page and additional documentation requirements (i.e., requirements
for data submission and procedures for claims of confidentiality of data
if relevant to the study report should precede the content of the study
formatted below. These requirements are described in PR Notice 86-5.
TABLE CF CONTENTS
I.
Purpose
Results [include Suimary Tables of Processing Study Data; Method
Recovery Data; and Storage Stability Validation Data (if any)];
Discussion [including explanations for apparently aberrant or
atypical values; need for food/ feed additive tolerances; etc.]
II. MATERIALS
A. Test Substance
1. Identification of the pesticide formulated product used in the
field trial from which the r.a.c. used in the processing study was
derived, including the active ingredient therein;
2. Identification and amount of residue(s) in experimentally treated
r.a.c. samples at the time of harvest (i.e., weathered) or of
fortification (if applicable), and also at the time the processing
study is initiated;
3. If fortified r.a.c. samples were used in the processing study,
identify the nature and amount of the fortifying substance (s);
4. Other [any and all additional information the petitioner considers
appropriate and relevant to provide a complete and thorough
description and identification of the test substance(s) used in
the processing study.]
-------
-5-
B. Test Cannodity
1. Identification of the r.a.c.(s) (crop/type/variety) and the
specific crop part(s) used in the processing study;
2. Sample identification [source of sanple(s); field trial
identification number; control or weathered residue sample; coding
and labeling information (should be the same as—or cross-referenced
to—the sample coding/labeling assigned at harvest)];
3. Treatment histories [pesticide(s) used, rate(s), number of
applications, FHIs, etc.] of the r.a.c. samples used in the
processing study. [Note: r.a.c. samples with detectable residue
levels, preferably at or near the proposed tolerance level, should
be used in the processing study.];
4. The developmental stage(s), general condition [immature/mature,
green/ripe, fresh/dry, etc.] and size(s) of the r.a.c. samples
used in the processing study;
5. Other [any and all additional information the petitioner considers
appropriate and relevant to provide a complete and thorough description
of the r.a.c.(s) used in the processing study].
III. METHODS
A. Experimental Design [e.g., number of test/control samples; number of
replicates; residue levels in the r.a.c.s to be used; representativeness
of test commodities to the matrices of concern; etc.]
B. Test Procedures
1. Fortification ("spiking") procedure, if used [detail the manner in
which the test conpound(s) were introduced to the r.a.c.s];
2. A description of the processing procedure used and how closely it
simulates conmercial practice;
3. A description of the method(s) of residue analysis; 6/
4. A description of the means of validating the method(s) of residue
analysis; 7/
4. A description of any storage stability validation studies that may
have been done. 8/
IV. RESULTS/DISCUSSION
A. Residue Results [raw data; correction factor(s) applied, if any;
recovery levels; storage stability levels, if applicable; direct
conparison of residues in the r.a.c. with those in each processed
product or processing fraction derived from that sample, etc.];
-------
-6-
B. Statistical Treatment(s) [describe test(s) applied to the raw data];
C. Quality Control [if not covered elsewhere: control measures/precautions
followed to ensure the fidelity of the processing study]; and
D. Other [any and all additional information the petitioner considers appro-
priate and relevant to provide a complete and thorough description of the
processing study (studies).]
V. CONCLUSIONS
Discuss conclusions that may be drawn re the concentration/reduction of the
test compound (s) in the test matrices as a function of the standard ccnmercial
processing procedure, and the need of food/feed food additive tolerances.
VI. CERTIFICATION
Certification of authenticity by the Study Director (including signature,
typed name, title, affiliation, address, telephone number, date).
VII. TABLES/FIGURES
A. Tablet s) of raw data frcm the processing study; method recovery data;
storage stability recovery data (if applicable); etc.; and
B. Graphs, Figures, Flowcharts, etc. (as relevant; include the processing
procedure).
VIII. REFERENCES
IX. APPENDIX(ES)
A. Representative chromatograms, spectra, etc. (as applicable);
B. Reprints of methods and other studies [unless physically located
elsewhere in the overall data sutmission, in which case cross-referencing
will suffice] which will support the registrant's conclusions; and
C. Other [any relevant material not fitting in any of the other sections to
this report.]
-------
-7-
EM) NOTES
I/ Other aspects of the Magnitude of the Residue [see 40 CFR 158.125:
crop field trials; meat/milk/poultry/eggs; fumigation uses; dermal
uses; post-harvest treatments, etc.] will be addressed in separate
Data Reporting Guideline documents.
2/ See Table II of the Pesticide Assessment Guidelines, Subdivision 0,
Residue Chemistry, for a listing of the processed canmodities and
feed items derived fron crops.
3/ For further details, see the Pesticide Assessment Guidelines,
Subdivision 0, Residue Chemistry, §171-4(c)(2)(iv) (b) and the
Tolerance Assessment System Issue Paper No. 4, "The Use of
Post-Processing Residue Data to Estimate Residues in Poods
'As Eaten1 and to Calculate Dietary Exposure to Pesticides."
4/ EPA Document #540/9-86-151. Available fron the National
Technical Information Service, Springfield, VA, as NTIS Document
#PB86-24S192.
5/ All of the data/information necessary to independently verify
the results and conclusions drawn from the data results, etc.,
should be included.
Separate reports using the following guidance should be prepared
for each study performed.
A processed food/feed study on a different r.a.c. will be
considered relevant only if that r.a.c. is a related crop and if
the experimental design is appropriate to current considerations.
6/ Refer to the Data Reporting Guideline on Analytical Methods for
guidance in this area. Contained within EPA Document #540/9-86-151;
from the National Technical Information Service, Springfield, VA,
as NTIS Document #PB86-248192.
7/ Refer to the Data Reporting Guideline on Magnitude of the Residue:
Crop Field Trials for guidance in this area. Contained within EPA
Document #540/9-86-151; available frcm the National Technical
Information Service, Springfield, VA, as NTIS Document #PB86-248192.
8/ Refer to the Data Reporting Guideline on Storage Stability testing for
guidance in this area. Contained within EPA Document #540/9-86-151;
available from the National Technical Information Service, Springfield,
VA, as NTIS Document #PB-86-248192.
------- |