Document ID: EPA-HQ-OPP-2006-0801-0036
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-06-30T04:00Z

Interim Guidance of the Evaluation Criteria for

Ecological Toxicity Data in the Open Literature

PHASES I and II 

PROCEDURES FOR IDENTIFYING, SELECTING AND ACQUIRING

TOXICITY DATA PUBLISHED IN THE OPEN LITERATURE 

FOR USE IN ECOLOGICAL RISK ASSESSMENTS

July 16, 2004

Office of Pesticide Programs

U.S. Environmental Protection Agency

	Table of Contents

 tc \l1 "Table of Contents 

 TOC \f 

Table of Contents	2

Introduction	4

Purpose	4

Background	4

Phase I: Literature Acceptance Criteria for Effects Data	5

Background on the ECOTOX Database	5

ECOTOX Eligibility Criteria	5

ECOTOX Literature Identification Procedures	5

Manual Literature Searches	5

Electronic Literature Searches	6

Identification of Relevant Literature	6

Papers Eligible for the ECOTOX Database	6

EFED Acceptability Criteria	7

Data Summary Tables	7

Bibliographic Files	9

Papers Excluded from the ECOTOX Database	9

Phase II: Categorization of Studies and Determination of Use in Risk
Assessment	11

Introduction	11

Studies Identified as Acceptable Based on Phase I Analysis	11

Standardization of Data Summary Table	11

Data Comparison and Summary Tables 	12

Studies with Concentrations/Doses of Concern	13

Identification of Data for Taxonomic Groups not Normally Considered in
RQ Calculations 	14

Identification of Data with Ecologically Relevant Effects not Typically
Addressed in 40 CFR Section 158	14

Studies Excluded from the ECOTOX  Database and EFED Screen	15

Determining the Use of Open Literature in the Risk Assessment	16

Rationale	16

Data Quality Objectives	17

Determining if Study Should be Used Quantitatively vs. Qualitatively	17

Roles and Responsibilities	20

ORD’s Role	20

EISB’s Role	20

Risk Assessor’s Role	20

Appendix I: ECOTOX QA/QC Support Documents	22

Appendix II: Acceptability Criteria For Effects Data	23

Appendix III: Completion of the Data Summary Table	26

Example Data Summary Table	29

Appendix IV.  ECOTOX Exclusion Categories	30

Appendix V.  Example of Summary of Registrant-Submitted Data	32

Appendix VI.  EISB Summary Table QA/QC Procedures	34

Appendix VII.  Rationale for Ordering Papers	37

Appendix VIII.  Rationale for the Use of Open Literature in Risk
Assessment	38

Appendix IX.  Qualitative Study Summary	39

 



	Introduction

 tc \l1 "Introduction 

Purpose

 tc \l2 "Purpose 

This guidance is for use by scientists) in the U.S. Environmental
Protection Agency’s (EPA) Office of Pesticides Program (OPP).  It is
intended to ensure consistent consideration and use of information in
the open literature by OPP risk assessors for ecological risk
assessments of pesticide effects on non-target organisms.  Use of this
guidance will assist OPP risk assessors in screening papers in an
efficient and consistent manner.  This guidance, in final form, will be
applied across the division to ensure consistency and transparency in
the risk assessment process. 

Background

 tc \l2 "Background 

Open literature can provide useful information in assessing the
ecological risk of pesticides.  For most pesticides there is a paucity
of research conducted beyond that required for registration.  An
exhaustive literature search for a lesser-known pesticide will
frequently provide few useful papers for risk assessment.  For certain
older pesticides, several hundred papers describing toxic effects may be
available and many papers may provide similar information and results. 
Replication of results can provide confidence in conclusions.  In
choosing whether or not to review or include a paper in a risk
assessment, the risk assessor should evaluate that paper’s potential
to improve the risk assessment through adding confidence to the
assessment conclusions or helping to reduce uncertainties.  For
pesticides with many papers presenting similar conclusions, it may not
be justified for the risk assessor to address all of the papers, but
instead a significant sampling of them, with the desired result of
presenting sound and confident risk conclusions without using
unnecessary resources.  The intent of this guidance is to provide
consistent and transparent methods for selection of appropriate studies,
but it is also important that risk assessors execute best professional
judgement, with documentation of the rationale,  when choosing to
include or exclude papers in the final risk assessment.

 The method described under the section entitled “Phase I: Literature
Acceptance Criteria for Effects Data,”is intended to provide a coarse
filter for identifying potentially useful ecotoxicology papers for
OPP’s ecological risk assessments, thereby reducing the expenditure of
resources on the review and evaluation of papers with a low likelihood
of usefulness.  For papers that pass this acceptance criteria, a summary
table of selected information from each study will be generated.  Under
the section entitled “Phase II: Categorization of Studies”, the data
provided in the summary table will be compared to OPP’s
registrant-submitted data set with the intent of increasing confidence
and decreasing uncertainties in the risk assessment conclusions.

	Phase I: Literature Acceptance Criteria for Effects Data tc \l1 "Phase
I: Literature Acceptance Criteria for Effects Data 

Background on the ECOTOX Database

 tc \l2 "Background on the ECOTOX Database 

Staff scientists in OPP will consider data from the open literature that
the EPA Office of Research and Development’s (ORD) Mid-Continental
Ecology Division (MED) locate using the search strategy developed for
EPA’s Ecotoxicology database (ECOTOX).  ECOTOX is a publicly available
database summarizing the ecological effects of single chemicals to
aquatic and terrestrial plants and animals (http://www.epa.gov/ecotox).

ECOTOX Eligibility Criteria

 tc \l3 "ECOTOX Eligibility Criteria 

Papers acquired using the ECOTOX literature searching and acquisition
protocols must meet five minimum data requirements to be considered
eligible for inclusion in the database.  The paper is eligible for the
ECOTOX database if it reports (1) toxic effects related to a single
chemical exposure; (2) toxic effects on an aquatic or terrestrial plant
or animal species; (3) a biological effect on live, whole organisms; (4)
a concurrent environmental chemical concentration/dose or application
rate; and (5) an explicit duration of exposure.

ECOTOX Literature Identification Procedures

 tc \l3 "ECOTOX Literature Identification Procedures 

 For the ECOTOX database, literature is identified through comprehensive
and well-documented literature searches (See
http://lester.dul.epa.gov/qa/sop/#DAM for standard operating procedures)
either manually (e.g., skimming of reference sections of review/summary
articles and skimming literature held in ORD/MED’s library) or
electronically  (e.g., searches of electronic abstracting services such
as STN, Cambridge Scientific Abstracts, Toxline).  Quality
Assurance/Quality Control (QA/QC) procedures for the ECOTOX database are
outlined in the document Overview of the Ecological Risk Assessment
Process in the Office of Pesticide Programs, U.S. Environmental
Protection Agency ( January 2004) and the support documents are itemized
in Appendix I.

Manual Literature Searches

 tc \l4 "Manual Literature Searches 

For papers identified using a manual literature search method,
citations for potentially applicable articles are entered into an
electronic bibliographic file.  Abstracts are not available in the
electronic bibliographic file for these papers.  As articles are
received, papers that meet the minimum data requirements for ECOTOX are
assigned an ECOTOX reference number and a copy of the paper is
maintained in the ECOTOX file room.  ORD/MED also maintains copies of
some non-applicable papers that are useful to the ECOTOX database
effort, and these are also assigned an ECOTOX reference number.  These
papers include review or summary articles that are not the primary
source of data but are used in manual literature searches, and papers
that document test method procedures.  All papers that are received and
identified as non-applicable, including any retained in the ECOTOX file
room, have annotations added to the electronic bibliographic entry
documenting the reason the paper was excluded from consideration for the
ECOTOX database effort.  Copies of non-applicable papers, other than
methods and review articles, are discarded.

Electronic Literature Searches

 tc \l4 "Electronic Literature Searches 

For papers identified using an electronic literature search method, the
citation and abstract information are downloaded electronically into a
bibliographic file.  Each citation and abstract are reviewed to
determine if the paper is potentially applicable to the ECOTOX database.
 When a paper is identified as not applicable to ECOTOX, the entry is
annotated with the reason the study was excluded, and a copy of the
paper is not acquired.  The citation and abstract are moved to a
separate electronic bibliographic file that stores citations for all
papers identified via the ECOTOX electronic literature search method,
which were never acquired.  Citations for papers (excluding the
abstract) that are identified as potentially applicable are moved to
another electronic bibliographic file that tracks papers that have been
ordered via the ORD/MED library or other sources, and the paper is
acquired.  As papers are received, the ECOTOX eligibility criteria are
applied, and citations for any papers that are identified as not
applicable to ECOTOX are transferred to another bibliographic file that
tracks papers that were received and subsequently rejected.  All
citations for rejected studies are annotated with the reason for
exclusion, and the paper is not retained.  All papers that are received
and identified as applicable are assigned an ECOTOX reference number and
placed in the ECOTOX file room.

Identification of Relevant Literature

 tc \l2 "Identification of Relevant Literature 

The results that ORD/MED obtains through the ECOTOX literature search
can be divided into two broad categories: 

Papers identified as applicable to the ECOTOX database (i.e., those that
meet the five minimum eligibility criteria); and

Papers located using the ECOTOX search strategy but rejected for entry
into the ECOTOX database

Papers Eligible for the ECOTOX Database

 tc \l3 "Papers Eligible for the ECOTOX Database 

Within the category of papers identified as acceptable to the ECOTOX
database effort, are two sub-categories: (a) papers with data available
in the online version of ECOTOX; and (b) papers that are in the queue
for data abstraction and inclusion in the ECOTOX database.  All papers
identified as applicable to the ECOTOX database, with the exception of
the OPP database (ECOTOX Reference Number 344), will undergo an
acceptability screen by ORD/MED to discriminate between papers that are
potentially applicable to the OPP risk assessment (i.e., papers that
meet all the criteria) from those papers that have a low probability of
usefulness in the OPP risk assessment (i.e., papers that do not meet one
or more of the criteria).

OPP Acceptability Criteria

 tc \l4 "OPP Acceptability Criteria 

The OPP Technical Teams identified criteria that will assist in
eliminating papers that have a low probability of usefulness in the
hazard identification component of a screening level risk assessment. 
See Appendix II for the data form and guidance on determining the
acceptability of an ecotoxicology study.  Papers must meet all of the
following Acceptability Criteria:

The paper reports toxicology information for a chemical of concern to
OPP; 

The article is published in English language;

The study is presented as a full article.  Abstracts will not be
considered;

The paper is a publicly available document; 

The paper is the primary source of the data;

The paper reports that treatment(s) were compared to an acceptable
control;

The paper reports an explicit duration of exposure;

The paper reports a concurrent environmental chemical concentration/dose
or application rate;

The paper reports the location of the study (e.g., laboratory vs.
field);

The paper reports a biological effect on live, whole organisms;

The paper reports the species that was tested; and this species can be
verified in a reliable source;

The paper reports effects associated with exposure to a single chemical.

Data Summary Tables

 tc \l4 "Data Summary Tables 

Once the OPP acceptance criteria have been applied to all the papers
meeting the ECOTOX eligibility requirements, ORD/MED will summarize the
data associated with the potentially acceptable studies for use in the
screening level risk assessment.  For each paper that passes the
Acceptance Criteria, ORD/MED will summarize the parameters listed below
in separate fields within a Data Summary Spreadsheet, and provide the
results in an electronic format to the appropriate staff person within
OPP’s Environmental Information Services Branch (EISB).  See Appendix
III for instructions on the completion of the Data Summary Table and an
example table.



Chemical identification information

Chemical Abstract Services registry number

common name of chemical

Taxonomic information including: 

phylum

class

order

family

genus

species

species common name

Effect information including: 

major effect category (e.g., reproduction)

specific result measurement (e.g. number of viable eggs)

calculated endpoint (e.g., LC50)

Species habitat (aquatic and/or terrestrial)

Test location (laboratory vs. field)

Number of treatment levels

Concentration/dose/application rate associated with the observed effect
response

Concentration units (e.g., ug/l)

Concentration type (e.g., active ingredient vs. formulated)

Percent purity

Media (freshwater vs. marine)

Duration of the study

Duration units (e.g., hours)

For avian and mammalian studies, identify the route of exposure (e.g.,
dietary, oral, etc.)

pH ranges

Hardness

Organic Carbon Concentrations

Remarks

ECOTOX reference number

Bibliographic Files

 tc \l4 "Bibliographic Files 

The following procedures will be followed for all papers identified as
acceptable to the ECOTOX database:

ORD/MED will provide OPP/EISB staff with a ProCite file that includes
citations for all papers identified as acceptable to the ECOTOX database
effort;

Each entry will include an ECOTOX reference number;

Each entry will include complete citation information; 

Studies that pass the acceptance criteria will be marked as acceptable;

Each entry will identify the paper’s coding status at it relates to
the ECOTOX database (i.e., papers that are in the public version of the
ECOTOX database and papers that are in the queue);

Each citation will identify whether the paper presents data for aquatic
and/or terrestrial species;

Each citation will include a code identifying the chemical(s)

For studies that did not pass the acceptance criteria, each entry will
include a code that denotes the specific criterion/criteria that the
paper did not meet.

Papers Excluded from the ECOTOX Database

 tc \l3 "Papers Excluded from the ECOTOX Database 

ORD/MED maintains electronic bibliographic files of all rejected papers
that include codes documenting the reason the paper was rejected.  See
Appendix IV for a list of exclusion criteria used within the scope of
the ECOTOX database.  The following procedures will be followed for
these excluded studies:

ORD/MED will provide OPP with a ProCite database of citations and
abstracts for papers that were rejected, and never acquired.  The
compilation will include the following:

Citations for papers that have been retained in the ECOTOX literature
holdings, but that do not meet the eligibility requirements;

Citation for papers identified as potentially applicable to the ECOTOX
effort, which were rejected once the full article was acquired;

Citation and abstract, when available, for publications excluded based
on information provided in the literature search (i.e., without
acquisition of the paper)

All records will include the following information:

The reason the paper was not considered applicable to the ECOTOX
database;

All available citation information;

Abstracts when available (Note: These will only be available for
electronic search results rejected prior to acquisition of the full
publication.)

	Phase II: Categorization of Studies and Determination of Use in Risk
Assessment

 tc \l1 "Phase II: Categorization of Studies and Determination of Use in
Risk Assessment 

`

Introduction

 tc \l2 "Introduction 

Although registrants are required to submit data on the toxicity of
pesticides, data from the open literature can provide additional
information that may improve the risk assessment through adding
confidence to the assessment conclusions, reducing uncertainties, and
identifying additional effects that will require further data and
analysis.  The purpose of Phase II of this guidance is to provide OPP
risk assessors an efficient and consistent manner in which to screen the
open literature studies that may be used in ecological risk assessments.
 The risk assessor will provide the rationale for the inclusion or
exclusion of literature in their risk assessments. 

Studies Identified as Acceptable Based on Phase I Analysis

 tc \l2 "Studies Identified as Acceptable Based on Phase I Analysis 

The process outlined in this section of the guidance document was
developed to provide OPP scientists an efficient way to locate studies
reporting toxic responses that are more sensitive than those reported in
the registrant submitted data sets, to quickly identify receptors and
ecologically relevant endpoints that are not contained in current EPA
guideline studies, and identify, when possible, studies reporting direct
 toxicity  information on endangered species.  While guidance has been
developed for the selection of appropriate open literature for possible
inclusion in a risk assessment, the exercise of best professional
judgement is also required.  Scientists should use their best
professional judgement on whether to include open literature and if
necessary consult with the appropriate technical team.  It is important 
that the risk assessor document the rationale associated with all
choices made regarding open literature data in the assessment.  This
documentation must follow the Agency “TCCR” rules for Transparency 
in  process followed, and Clarity, Consistency and Reasonableness in its
ecological risk assessments.

Standardization of Data Summary Table

 tc \l3 "Standardization of Data Summary Table 

In order to categorize data effectively, the data summary file must be
in a standardized format.  The following manipulations will be made by
ORD/MED staff to the Data Summary Table:

For studies reporting pesticide concentrations based on formulated
product and/or the chemical was not measured in the test media (i.e.,
nominal concentrations), the values will be converted to a
concentration/dose based on active ingredient

For pesticides not reporting measured chemical concentration/dose, the
percent purity will be used to convert the value to the active
ingredient 

For metals reporting concentrations (or doses) based on the amount of
compound used (e.g., mg/L of copper sulfate), the molecular weight of
the compound will be used to convert to elemental metal (e.g., mg
copper/L)

All effect concentrations/doses will be converted to a standard unit: 

For aquatic studies (fish, invertebrate, algae and plant species)
convert to mg/L for aqueous phases and mg/kg (dry weight) for matrices
such as sediment

For avian, reptilian and mammalian dietary studies convert to ppm

For  avian oral  studies and mammalian oral and intravenous studies,
convert to mg/kg bw

For aquatic phase amphibians, convert to mg/L; for terrestrial phase
amphibian oral studies, convert to mg/kg bw; for terrestrial phase
amphibian dietary studies convert to ppm

For reptilian oral and dietary studies, convert to mg/kg bw

For inhalation studies, report in units presented in the study

For dermal studies, report in units presented in the study

All durations will be converted to days

The following tables will be generated by EISB staff from the Data
Summary Tables received from ORD/MED:

Each Data Summary Table will be separated into taxonomic groups

Create a freshwater fish table

Create a saltwater fish table

Create an algae table

Create a freshwater invertebrate table

Create a saltwater invertebrate table

Create an aquatic plant table

Create a terrestrial plant table

Create a mammal table

Create a bird table

Create an amphibian table

Create a reptile table

Data Comparison and Summary Tables 

 tc \l3 "Data Comparison and Summary Tables  

As needed, the EISB staff will apply the following criteria to develop
comparison tables.   Prior to preparing comparison tables, the EISB team
should have the results from the Data Evaluation Reviews (DER) available
from the Risk Assessor.  It will be the Risk Assessor’s responsibility
to provide the summarized DER results in a formatted table (see example
template table in Appendix V).  EISB staff will provide the risk
assessor with the following three comparison tables and the original
Data Summary Tables received from ORD/MED.  QA/QC procedures for the
development and production of summary tables by EISB are located in
Appendix VI.

Table 1:  Studies with Concentrations/Doses of Concern tc \l4 "Table 1: 
Studies with Concentrations/Doses of Concern : 

The purpose of this procedure is to identify studies associated with a
taxonomic group that report more toxic endpoints than results summarized
in registrant-submitted data (i.e. data submitted in support of
registration or re-registration actions according to 40 CFR Section
158).  

This procedure potentially relates to the following taxonomic groups:
Class Osteichthyes; all plant studies; Class Branchiopoda; Order
Rodentia with oral or dietary routes of exposure; and Class Aves with
oral or dietary routes of exposure.

For each taxonomic category with registrant-submitted test data, the
toxicological endpoint and the exposure duration associated with that
endpoint (acute vs. chronic) will be identified.  See Appendix V for an
example of how to summarize the data;

For each taxonomic category, effects that are not included in the
registrant-submitted data set are removed; 

For birds and mammals, all exposure routes other than dietary or oral
are removed;

For invertebrates, all terrestrial species are removed;

Data removed from Table 1 by this process will be placed in Table 2 or
3.

The Data Summary Table will be sorted in descending order by the
concentration field;

The row in the Data Summary Table will be marked where measurement
endpoint values above the line are greater (less sensitive) than the
values provided in the registrant-submitted studies, and data below the
line are less (more sensitive) than the registrant-submitted data;

The risk assessor will review this table and order all papers below the
line (i.e., more toxic than the registrant-submitted data).  This
information will be communicated to EISB staff and the papers will be
ordered from ORD/MED;

Risk assessors should use best professional judgement when identifying
additional papers above the line for acquisition from ORD/MED;  however,
documentation is required as to the rationale underlying the decision
(see Appendix VII for documentation for rationale for ordering and not
ordering papers).  



Table 2:  Identification of Data for Taxonomic Groups not Normally
Considered in RQ Calculations 

 tc \l4 "Table 2:  Identification of Data for Taxonomic Groups not
Normally Considered in RQ Calculations  

The purpose of this procedure is to identify potentially useful toxicity
data/measurement endpoints on taxonomic groups that are not addressed by
registrant-submitted data (i.e. data submitted in support of
registration or re-registration actions according to 40 CFR Section
158).  

This procedure relates to the following species groups: mammalian data
with the exception of rodent studies and all data on terrestrial
invertebrates, reptiles, and amphibians.

The resulting tables will be sorted by effect and concentration.  OPP
scientists will  review the tables and identify studies of concern. 
Consideration should be given to sensitive species groups and
ecologically relevant effects not typically addressed in an OPP risk
assessment.  Scientists should use best professional judgement to
identify papers of concern; however, documentation is required as to the
rationale supporting the use or exclusion of studies (see Appendix
VIII).  The reprint request will be communicated to EISB staff and the
papers will be ordered from ORD/MED.

Table 3:  Identification of Data with Ecologically Relevant Effects not
Typically Addressed in 40 CFR Section 158

 tc \l4 "Table 3:  Identification of Data with Ecologically Relevant
Effects not Typically Addressed in 40 CFR Section 158 

The purpose of this procedure is to identify test results for
ecologically relevant endpoints that are not addressed by
registrant-submitted data.  

This procedure potentially relates to the following taxonomic groups:
Class Osteichthyes; Class Branchiopoda; all plant studies; Order
Rodentia; and Class Aves.

If there were no registrant-submitted data for the taxonomic group, the
resulting table will be sorted by effect and concentration.  For each
taxonomic category with registrant-submitted test data, the effects that
are included in the registrant-submitted data set will be removed.

OPP risk assessors will review the tables and identify studies of
concern .   Consideration should be given to sensitive species groups
and measurement endpoints not typically addressed identified in
guideline studies.  Scientists should use best professional judgement to
identify papers of interest, however documentation is required as to the
rationale supporting in inclusion or exclusion of open literature
studies (see Appendix VIII); 

Paper requests will be communicated to EISB staff and ordered from
ORD/MED.

Studies Excluded from the ECOTOX  Database and OPP Screen

 tc \l2 "Studies Excluded from the ECOTOX  Database and OPP Screen 

ECOTOX-rejected studies that may be of interest to the OPP risk assessor
will include papers related to modeling, monitoring, mixtures, in vitro
studies, incident reports, fate studies, and review articles. 
Scientists should use best professional judgement to identify papers of
interest, however documentation is required as to the rationale
supporting their use or exclusion.  ECOTOX rejection codes may be cited
to explain exclusion of literature or after review, the risk assessor
may use best professional judgement for exclusion (Appendix VIII).

ORD/MED will provide OPP with a ProCite database of all citations for
papers that were reviewed and subsequently rejected.  Each citation will
be annotated with the reason the paper was excluded from consideration.

These papers are not retained at MED, but as papers are acquired and
rejected, those relevant to chemicals under review will be sent via
surface mail to EISB upon OPP’s request based on criteria discussed
below.

EISB will use ProCite to print a bibliography of the rejected papers
associated with each chemical of concern for the OPP risk assessment
teams.  

The bibliography will contain a field entitled “KEYWORD” which
reports the coded rationale for why the paper was rejected for ECOTOX
(e.g. REVIEW, NON-ENGLISH, PUBL AS, etc.; see Appendix I).  

OPP scientists will use these rejection codes as a guide to filter out
papers that they wish to exclude from further consideration in their
risk assessment.  It is important to remember the five minimum
eligibility criteria that must be met in order to be included in ECOTOX
(chemical, species, effect, concentration/dose, and exposure must be
provided in the paper) since these are also important elements of
reporting for OPP.

OPP staff will review the bibliography of rejected papers to identify
those likely to provide useful information for the risk assessment.  In
evaluating citations and abstracts (which will be provided when
available), the risk assessor will consider the same OPP acceptance
criteria outlined above.  When considering  papers not meeting ECOTOX
inclusion criteria, the risk assessor should consider the following
questions:

Is the paper likely to provide useful information on 

the effects of exposure to other pesticides?

the effects of other environmental stressors in combination with the
pesticide?

information on population-level effects?

exposure or toxicity to pesticide degradates?

If the risk assessor determines that the papers could address
uncertainties or provide other useful information in assessing pesticide
risk, reprints will be requested from ORD/MED through EISB.

Determining the Use of Open Literature in the Risk Assessment

 tc \l2 "Determining the Use of Open Literature in the Risk Assessment 

Rationale

 tc \l3 "Rationale 

Reprints from ORD/MED will be distributed to the risk assessors by EISB
staff.  Based on the selection of requested literature from the summary
tables, the risk assessor may encounter effects data that can provide
additional information on existing measurement endpoints commonly used
in the screening risk assessment, insight on endpoints not routinely
considered in risk quotient calculations, and effects data on
non-guideline receptors (e.g., amphibians, mussels, etc).

It is the risk assessor’s responsibility to closely review the study. 
Professional judgement is used and documented by the risk assessor to
determine whether and how available data on other toxicological
endpoints are included in the risk assessment.  This evaluation may
include reference to data quality objectives (see below)  for specific
types of studies, the degree to which adequate documentation is
available to evaluate the technical merit of the study, and whether the
study’s measurement endpoints are relevant to the assessment endpoints
established for ecological risk assessment.

To decide if data are applicable to assessment endpoints, the risk
assessor uses best professional judgement and available lines of
evidence to determine if the toxicological endpoints can be linked to
assessment endpoints in a reasonable and plausible manner.  There must
be a  determination of whether there are clear, and reasonable links
between the effect and survival or reproductive capacity of organisms in
the field in accordance with the screening assessment endpoints of
survival and reproductive capacity.

It is imperative that the risk assessment process be transparent and, to
that end, that risk assessments themselves be clear, consistent and
reasonable relative to other risk assessments of similar scope.  The
risk assessment must clearly document the criteria used in selecting
additional literature and its potential effects on the confidence of the
overall risk assessment conclusions.



Data Quality Objectives

 tc \l3 "Data Quality Objectives 

Defining Best Scientific and Commercial Data Available

Guidelines were issued by the Office of Management and Budget (OMB) in
response to the Data Quality Act mandated by Congress in Section 515(a)
of the Treasury and General Government Appropriations Act for FY 2001
(Public Law 106-554; H.R. 5658).  The EPA then developed the policy and
procedural guidance Guidelines for Ensuring and Maximizing the Quality,
Objectivity, Utility, and Integrity of Information Disseminated by the
Environmental Protection Agency (EPA/206R-02-008, October 2002).  

The following criteria apply to defining best scientific and commercial
data available:

Quality is a term that encompasses the other criteria below.  The
overall quality of a study must be determined by evaluating these
additional criteria.

Utility refers to the usefulness of the literature to its intended
purpose and use.  The studies, data, information and methods must only
be relied upon to the extent their use is scientifically justified.

Objectivity refers to whether the information in the study is being
presented in an accurate, clear, complete, appropriate and unbiased
manner.

Transparency refers to the clarity of the process. Are the uncertainty
and error sources, assumptions, statistical methods, and justification
identified? A high degree of transparency facilitates reproducibility by
third parties.

Quantity refers to study design. Is the magnitude of the effect, number
of studies, number of replicates, sample size, or power identified?

Consistency refer to the extent similar findings are reported using
similar study design and methods.

Integrity refers to scrutiny to ensure the information is not
compromised through alteration or improper interpretation.

EPA data quality objectives are met by OPP’s current procedure of
evaluating studies through the data evaluation record (DER) process. 
Studies are identified as core, supplemental, or invalid.  Studies
classified as invalid cannot be used for risk assessment purposes.  Open
literature that will be used quantitatively will undergo the same level
of scrutiny as registrant-submitted data.

Determining if Study Should be Used Quantitatively vs. Qualitatively

 tc \l3 "Determining if Study Should be Used Quantitatively vs.
Qualitatively 

To determine if a study should be used quantitatively versus
qualitatively, one question may be posed:

Does the study show clear and reasonable links between the effect and
survival or reproductive capacity? 

Quantitative Use in Calculating Risk Quotients

If the answer to this question is “yes”, decisions are to be made
regarding the quality of the data and their utility in the risk
assessment (e.g., a review of the validity and reliability of study
protocols), relative to the Agency’s risk assessment guidance.  The
extent to which such additional data are either employed or rejected
should be clearly described.  Regardless of the amount of data beyond
the guideline-required toxicity studies, the screening-level risk
assessment relies on selecting the most sensitive species tested from
acceptable studies.

Acceptable studies are determined on the basis of the design and conduct
of the experiment from which the data were derived.  In evaluating the
experimental design, OPP scientists will consider methods generally
recognized as acceptable by the scientific community (e.g. ASTM),
following reasonable statistical design and rigor, and the proper use of
controls in all phases of the experiment. The study is evaluated to
determine whether it conformed to its experimental design. The review of
the study is documented in the contractor-prepared DER.  If the DER
deems the study to core or supplemental and the paper has identified a
more sensitive toxicity value, the study may be used to determine risk
quotients.

Qualitative and Descriptive Use in Risk Characterization

If the answer to the question is “no” and the study is of acceptable
quality and addresses other endpoints of concern to the risk assessment,
the study may be used descriptively (qualitatively) in the risk
characterization.  Additionally a paper not used in quantitative risk
quotient calculations may still be a seminal document for line of
evidence reasons (e.g. endangered species concerns).  Therefore, it may
be beneficial to document the rationale for the study’s use in the
assessment by preparing a qualitative study summary to be archived in
the chemical file (see Appendix IX for a qualitative study summary
template).

The risk assessor will use established guidance documents such as the
Guidelines for Ecological Risk Assessment  (EPA/630/R-95/002F, April
1998),  Risk Characterization Handbook (EPA/100-B-00-002, December
2000), and the Peer Review Handbook, 2nd Edition (EPA/100-B-00-001,
December 2000) to prepare the risk characterization.  In addition, the
risk assessor will follow the process as outlined the document Overview
of the Ecological Risk Assessment Process in the Office of Pesticide
Programs, U.S. Environmental Protection Agency ( January 2004).

Clear, Consistent and Reasonable Rationale for Use of Papers

In accordance with established risk assessment guidance, the risk
assessor will identify in the risk assessment:

The measurement endpoints from the literature that were considered in
the risk assessment;

The rationale for why such data were incorporated in the risk
assessment;

The rationale for not including data obtained from the literature

Appendix VIII provides a list of rationales for the inclusion and
exclusion of literature in the risk assessment.  

	Roles and Responsibilities

 tc \l1 "Roles and Responsibilities 

ORD’s Role

 tc \l2 "ORD’s Role 

In cooperation with OPP, ORD/MED will do the following tasks:

Apply the OPP acceptance criteria outlined above;

Summarize the effects data for acceptable studies in a Data Summary
Table as outlined in this document; 

Convert the Data Summary Table to a standard format; 

For studies that do not meet one or more of the OPP acceptance criteria,
ORD/MED will document in the electronic bibliographic file the specific
criterion/criteria that were not met;

ORD/MED will provide OPP/EISB with reprints as outlined in this
document;

ORD/MED will provide ProCite files including citations for all studies
identified in ECOTOX literature searches including studies that meet the
OPP acceptance criteria, studies that do not meet the OPP acceptance
criteria, and papers that did not meet the ORD/MED ECOTOX database
inclusion criteria.

EISB’s Role

 tc \l2 "EISB’s Role 

OPP’s EISB is responsible for the following tasks:

EISB will serve as the OPP repository for reprints provided by ORD;

EISB will generate tables of different taxonomic groups from the
standardized data summary tables provided by ORD/MED;

EISB will categorize the data presented in the Data Summary Table
following procedures outlined in this document, and EISB will provide to
the risk assessors the following results related to the chemical of
concern: 

Results for taxonomic groups included in the registrant-submitted data

Results for non-target species not addressed in the registrant-submitted
guideline studies; 

Results for observed effects not addressed in registrant-submitted data

EISB will provide summary tables and database to OPP risk assessor;

EISB staff will coordinate all communication with ORD/MED staff related
to the tasks outlined in this document.

Risk Assessor’s Role

 tc \l2 "Risk Assessor’s Role 

The risk assessor is responsible for the following tasks:

Providing EISB with summary of toxicity results from Data Evaluation
Records;

Communicate to EISB staff which papers should be ordered from ORD/MED;

Reviewing the papers and bibliographies in terms of their utility
relative to ecological assessment endpoints;

Using best professional judgement in determining the utility of papers
in strengthening the risk assessment conclusions and reducing
uncertainty;  

Describing the method used to evaluate open literature and the rationale
for either including or excluding it, for use in the risk assessment.

Prepare a summary sheet (Appendix IX) for studies used qualitatively in
the risk assessment.



	Appendix I: ECOTOX QA/QC Support Documents

 tc \l1 "Appendix I: ECOTOX QA/QC Support Documents 

#72 Section 1.  Database and Documentation Overview.  MED ECOTOXICOLOGY
DATABASE SOP’s.  September 1997.

#73 ECOTOX.  ECOTOXicology Database System.  Literature Search and
Citation Identification.  MED ECOTOXICOLOGY DATABASE SOP’s.  April
2001.

#74 ECOTOX.  ECOTOXicology Database System.  AQUIRE Coding Guidelines. 
August 2003.

#75 ECOTOX Data Entry Procedures (AQUIRE).  MED ECOTOXICOLOGY DATABASE. 
June 2000.

#76 ECOTOX.  ECOTOXicology Database System.  Chemical Verification and
Database Entry Procedures (EcoChem).  April 2001.

#77 ECOTOX.  ECOTOXicology Database System.  Taxonomic Name Verification
Procedures (CRITTERS).  September 2001.

	Appendix II: Acceptability Criteria For Effects Data

 tc \l1 "Appendix II: Acceptability Criteria For Effects Data 

ECOTOX Reference No.: ____________

General instructions: If more than one experimental design is used in
the study, multiple Literature Acceptance Criteria Checklist forms may
be required, but the acceptability of the paper is based on at least one
experimental design meeting all the Acceptability Criteria.

No.	

Criteria / Instructions	

Yes / No

1	

The paper reports toxicology information for a chemical of concern to
OPP.	

	

Check chemical list for chemicals tested.  If a chemical in appears on
the list answer Yes.  If the chemical is not on the list answer No.	

2	

The article is published in the English language.	

	

The full article is published in the English language.  Translations
will not be conducted.	

3	

The study is presented as a full article. 	

	

Abstracts from journal publications where the full article is published
in non-English, the abstract is published in English and conference
proceedings published as brief abstracts will not be considered.	

4	

The paper is a publicly available document.	

	

Publications that are not publicly available; i.e., internal memoranda,
government reports that are not available from NTIS or other government
sources will not be considered.	

5	

The paper is the primary source of the data.	

	

A document is considered a primary source if at least one of the
investigators who conducted the toxicity test is an author, and the
authors do not cite another publication as the original source of the
data.  	

6	

The paper reports a calculated endpoint.	

	

For the purposes of this evaluation, an endpoint is defined as the
quantification of an observed effect obtained through statistics or
other means of calculation for the expressed purpose of comparing
equivalent effects (e.g., LC50, BCF, NOAEL).  If within a single
experiment, the authors report the same endpoint at multiple durations,
only code the duration most relevant to the OPP SEPs (see Table below),
and note the other endpoints in the remarks field.  If NOEC/NOEL and
LOEC/LOEL endpoints are not explicitly reported by the authors,
reviewers should interpret endpoints based on levels of significance
reported in the paper.  If more than one measurement (e.g., juveniles
per litter, juveniles per females, etc.) is observed for a particular
effect (e.g., reproduction), then only the most sensitive measurement is
coded, and the remaining measurements are noted in the remarks field.	

7	

The paper reports that treatment(s) were compared to an acceptable
control.	

	

The control treatment must be comparable to the other treatments, and
must be free of the chemical stressor. Appropriate controls include:
baseline or background control - parameters of actual or representative
test species measured before and after administration of test chemical,
though not as part of the same test scenario; negative control -
organisms maintained under conditions identical to exposed organisms
except for the absence of the test substance; positive controls -
organisms maintained under conditions identical to the exposed organisms
except the test substance is replaced with a substance known to elicit a
consistent toxic response; and solvent controls - organisms exposed to
carrier or solvent that is used as a vehicle for administrating the test
substance to exposed organisms. 

The number of treatments (other than controls) should be reported in the
data summary table.	

 

8	

The paper reports an explicit duration of exposure.	

	

Authors must explicitly report the duration of the exposure related to
the observed effect.  

Durations can include qualitative terms (e.g., at hatch, at harvest).	

9	

The paper reports a concurrent environmental chemical concentration/dose
or application rate.	

	

Authors clearly report a concentration/dose or application rate
associated with the observed effect response. If the study results are
only available in a graphical format, add a comment to the remarks
field.	

10	

The paper reports the location of the study (e.g., laboratory vs.
field).	

	

Authors clearly state the locations of the study, either in a controlled
laboratory setting or in the fields.  Field studies can include natural
or artificial settings (e.g., outdoor pen studies; enclosures).	

11	

The paper reports a biological effect on live, whole organisms.	

	

The authors clearly identify an observed effect response related to the
exposure of a live organism to the chemical of concern.  In vitro
studies are not considered. Positive effects will be recorded, with a
note in the remarks field flagging the response as such.	

12	

The paper reports the species that was tested; and this species can be
verified in a reliable source.	

	

The authors clearly identify the test species and the organism’s
scientific name can be verified in a reliable reference.  The preferred
scientific name should be reported.  If a specific genus/species is not
reported, reviewers should code the species information at the lowest
taxonomic level.	

13	

The paper reports effects associated with a single chemical exposure.	

	

Tests concerning synergism, additivity, potentiation, or antagonism,
whether it involves two or more chemical stressors or a combination of
chemical and non-chemical stressors are not acceptable studies under
this criteria. Effluents, leachates, drilling muds, fly ashes,
sediments, and sludges are not considered single chemicals. In addition,
the single chemical cannot be introduced as a component of an effluent,
etc.

Formulated products, such as emulsifiable concentrates and wettable
powders are considered single chemicals.  Also, chemicals that are
mixtures of structurally similar organic chemicals are considered single
chemicals because the mixtures have similar biological, chemical,
physical, and toxicological properties (e.g., toxaphene).	

	Appendix III: Completion of the Data Summary Table

 tc \l1 "Appendix III: Completion of the Data Summary Table 

General Instructions: All entries should be made in an Excel spreadsheet
using version 9.0 (Excel 2000) or higher.  Each sub-category within a
general parameter must be data entered into a separate data field within
the spreadsheet. Entries should be based on information provided by the
authors, unless clarified in the instructions for each parameter.

No.	

Parameter	

Instructions

1	

Chemical Identification	

In separate data fields, enter the Chemical Abstract Services registry
number and the chemical name as listed in Appendix III.

2	

Percent Purity	

Percent purity of compound tested as reported by the authors.

3	

Taxonomic Identification	

In separate data fields, enter the following taxonomic information:

ECOTOX species number, phylum, class, order, family, genus, species, and
the common name of the organism involved in the exposure.

4	

Habitat	

Identify whether the study is an aquatic or terrestrial study.

5	

Test Location	

In a separate data field, enter the test location using codes presented
in Appendix H of the ECOTOX Code Appendix
(www.epa.gov/ecotox/codeappendix.pdf).

6	

Media	

The type of exposure media reported using codes presented in Appendix L
of the ECOTOX Code Appendix (www.epa.gov/ecotox/codeappendix.pdf).

7	

Route of Exposure	

Identify the route of exposure using codes presented in Appendix J of
the ECOTOX Code Appendix (www.epa.gov/ecotox/codeappendix.pdf).

8	

Number of concentrations/

doses	

Enter the number of treatment levels (other than controls) that were
used in the study.

9	

Duration	

The exposure duration associated with the observed effect, as reported
by the authors.

10	

Duration Units	

Units associated with the reported duration.

11	

Observed Effect and Calculated  Endpoint 	

In separate data fields, enter the major group effect, observed effect,
and measurement codes presented in Appendix S of the ECOTOX Code
Appendix (www.epa.gov/ecotox/codeappendix.pdf).

In a separate data field enter the appropriate calculated endpoint using
the codes presented in Appendix T of the ECOTOX Code Appendix
(www.epa.gov/ecotox/codeappendix.pdf).

If more than one measurement (e.g., juveniles per litter, juveniles per
female, etc.) is observed for a particular effect (e.g., reproduction),
then only the most sensitive measurement is coded, and the remaining
measurements are noted in the remarks field.

If within a single experiment, the authors report the same endpoint at
multiple durations, only code the duration most relevant to the OPP SEPs
(see Table below), and note the other endpoints in the remarks field.

12	

Concentration Type	

Report if the chemical concentration is based on active ingredient or
formulation. If chemical concentration is reported as measured, the
concentration type should be coded as active.  If chemical concentration
is reported as nominal, concentration type should be coded as
formulation.  If the authors do not clearly state whether or not the
chemical concentration was measured or whether the reported
concentrations are based on formulated product vs. active ingredient,
code as formulations, but make a comment in the remarks field that
concentration type could not be determined from paper.

13	

Concentration, Dose, or Application Rate	

In a separate data field, enter the chemical concentration, dose, or
application rate associated with the observed effect.  If both a
concentration and application rate are presented, only report the
concentration.  If a dose is presented and a concentration, only present
the dose. 

In separate data fields enter the unit associated with the
concentration/dose/application rate entry, the concentration type (F if
formulated; A if active ingredient); and the percent purity of the
compound as reported by the authors.  If the authors clearly state that
the compound is measured in the test matrix, enter the concentration
type as ‘A’.  

14	

Remarks	

General comments on other endpoint durations, graphical data coding,
concentration type, and positive effects.

15	

Reference Number	

In a separate field, enter the ECOTOX reference number for the paper.



Example Data Summary Table

 tc \l2 "Example Data Summary Table 

CAS #	Chemical Name	Phylum	Class	Order	Family	Genus	Species	Common

name	Effect	Meas	Endp	Media	pH	O.C.	Hardness	Dur	Dur Unit	Conc Type	Conc
Conc Units	Ref #

298000	Methyl parathion	Arthropoda	Maxillopoda	Calanoida	Acartiidae
Acartia	tonsa	Calanoid copepod	BEH	EQUL	EC50	SW

96	h	A	890	ug/L	742

298000	Methyl parathion	Arthropoda	Insecta	Diptera	Culcidae	Aedes
nigromaculis	Mosquito	MOR	MORT	LC50	FW

24	h	A	0.008	ppm	4431

298000	Methyl parathion	Chordata	Actinoptergyii	Siluriformes	Ictaluridae
Ameiurus 	melas	Black bullhead	MOR	MORT	LC50	FW

24	h	F	7910	ug/L	6797

298000	Methyl parathion	Chordata	Actinoptergyii	Siluriformes	Ictaluridae
Ameiurus	melas	Black bullhead	MOR	MORT	LC50	FW

96	h	F	6640	ug/L	6797

298000	Methyl parathion	Chordata	Actinoptergyii	Cyprinodontiformes
Poecillidae	Gambusia	 affinis	Western mosquitofish	BEH	THML	NR	FW

48	h	A	5	ug/L	5149

298000	Methyl parathion	Chordata	Actinoptergyii	Cyprinodontiformes
Poecillidae	Gambusia	 affinis	Western mosquitofish	MOR	MORT	NR	FW

24	h	F	5000	ug/L	7762

	Appendix IV.  ECOTOX Exclusion Categories

 tc \l1 "Appendix IV.  ECOTOX Exclusion Categories 

General Instructions: The following is a list of ECOTOX rejection codes,
exclusion terms and definitions utilized under the ECOTOX database
efforts.  Each citation that is identified as not applicable to the
ECOTOX database (i.e., NON-APPLICABLE entered in field #37 of the
ProCite bibliographic file) will have one or more of these codes entered
in the KEYWORD field (number 45) of the ProCite bibliographic files to
identify the reason the study was excluded.  

Code Used in 

ProCite File	

Description

REVIEW	

All toxicity tests reported elsewhere. If the publication is applicable
to one of the ECOTOX databases, the bibliography is skimmed and any
applicable articles are ordered.

METHODS	

Methods paper with no usable toxicity tests. Reports of methods of
conducting tests, determination or purification of chemicals, etc.
Methods publications are selected to be ordered for the ECOTOX
toxicology methods information file.

PUBL AS	

Author publishes data in multiple formats.  For instance, an author
publishes the same study results in a Ph.D. thesis and in a
peer-reviewed journal.  In order to reduce redundancy of data in the
ECOTOX database, only one document is encoded; with preference given to
peer-reviewed publications..

NON-ENGLISH or FORE	

Paper is published in a foreign language.

Modeling 	

Paper reports models only, no new organism exposure data. Modeling
studies may report original toxicity tests performed as comparisons or
as a basis for extrapolation; order the paper if it is not clear from
the abstract.

Air pollution 	

Air pollution and emissions, no specific chemical.

Other ambient conditions	

Effects on organisms from changes in conditions other than addition of
chemicals, including radioactivity, ultraviolet light (UV), temperature,
pH, salinity, dissolved oxygen (DO), or other water, air, or soil
parameters.

Biological Toxicant	

Biological toxicants; includes venoms, fungal toxins, Bacillus
thuringiensis, other plant, animal, or microbial extracts or toxins.

Drug	

Testing for drug effects and side-effects specific to human health.

Effluent	

Studies reporting effects associated with exposure to effluent, sewage,
or polluted runoff.  

Mixture	

Mixture study without data on single chemical exposures.

Nutrient	

Nutrient studies--in situ chemicals tested as nutrients.

Oil	

Studies with oil and petroleum products as the only test chemical.

No Species	

No organism present or tested,  unable to verify a species, or exposure
of dead organism.

In Vitro 	

In vitro studies, including exposure of cell cultures and excised
tissues.

Bacteria 	

Bacteria as test organism, including Microtox tests, or other microbial
organisms.

Yeast 	

Yeast as the test organism.

No Tox Data	

Publications which are not toxicology studies; no toxicity data are
presented in the paper.

Human Health	

Human health effects; studies with human subjects or with animal
subjects as surrogates for human health risk assessment.

No Conc	

No usable dose or concentration reported; identified after examination
of full paper. Includes lead-shot studies which lack dose information or
give only number of pellets. Also includes papers with concentrations
reported only in log units.

Sediment Conc	

Chemical concentration reported in sediment.  Sediment studies are 
coded  if a water concentration of the added chemical is also reported;
order the publication if unclear from the abstract.

No Duration 	

Duration is not reported, identified after examination of full paper.

Incident 	

Report of incidents--reports of animal deaths by poison, etc. Lacks
usable concentration or duration or both.

Survey 	

Survey studies--measuring amounts of chemical present, but no usable
quantification of exposure. Lacks either usable concentration or
duration or both.

Fate 	

Studies reporting only what happens to the chemical in abiotic matrices

Food Studies 	

Food studies, no chemical and effects information are reported

	Appendix V.  Example of Summary of Registrant-Submitted Data

 tc \l1 "Appendix V.  Example of Summary of Registrant-Submitted Data 

Aquatic Animals

Acute Assessment	

Lowest tested EC50 or LC50 for freshwater fish	

	

Lowest tested EC50 or LC50 for freshwater invertebrates	

	

Lowest tested EC50 or LC50 for estuarine/marine fish	

	

Lowest tested EC50 or LC50 for estuarine/marine invertebrates	

Chronic Assessment	

Lowest NOEC for freshwater fish	

	

Lowest NOEC for freshwater invertebrates	

	

Lowest NOEC for estuarine/marine fish	

	

Lowest NOEC for estuarine/marine invertebrates	

Terrestrial Animals

Acute Avian Assessment	

Lowest LD50 (single oral dose)	

	

Lowest LC50 (subacute dietary)	

Chronic Avian Assessment	

Lowest NOEC for 21-week avian reproduction test	

Acute Mammalian Assessment	

Lowest LD50 from single oral dose test	

Chronic Mammalian Assessment	

Lowest NOEC for two-generation reproduction test	

Plants

Terrestrial non-endangered	

Lowest EC25 values for seedling emergence for monocots	

	

Lowest EC25 values for vegetative vigor for monocots	

	

Lowest EC25 values for seedling emergence for dicots	

	

Lowest EC25 values for vegetative vigor for dicots	

Aquatic vascular and algae	

Lowest EC50 for vascular plants	

	

Lowest EC50 for algae	

Terrestrial Endangered	

Lowest EC5 or NOEC for seedling emergence for monocots	

	

Lowest EC5 or NOEC for vegetative vigor for monocots 	

	

Lowest EC5 or NOEC for seedling emergence for dicots	

	

Lowest EC5 or NOEC for vegetative vigor for dicots 	

	Appendix VI.  EISB Summary Table QA/QC Procedures

 tc \l1 "Appendix VI.  EISB Summary Table QA/QC Procedures 

Application Name Version Number 

QA Summary

Summary Developer: Person or Team Name and Team Member Names

Date: dd/mmm/yyyy

Application Developer: Person or Team Name and Member Names

Phone, Address (e-mail and postal)

Application Contact: Primary Contact Name and Alternate Contact Name

 Phone, Address (e-mail and postal)

Application Type: Empirical, deterministic,stochastic(?), Aquatic,
Ecological, Health Effects, etc.

Historical Insight:

Method of Version Control and Notification: process and names involved
in version control

List of All Prior Application Versions and Dates of their QA Summaries:

Version Number, QA Summary Date: dd/mmm/yyyy

Version Number, QA Summary Date: dd/mmm/yyyy

Application Calibration Reports:

Include a reference to where this information is available.

Application Evaluation Reports:

Include a reference to where this information is available. Summerize
Application evaluation.

Refer to: Guidance for QA Project Plans for Applicationing (QA/G-5M)

EPA/600/R-02/007     http://www.epa.gov/quality/qa_docs.html

                                        

Peer Review Report Summary - Dated: dd/mmm/yyyy 

Include a reference to where this information is available.

Application Access Mechanism or Application Site: Web Site or Access
Location

User Manual Access Mechanism or Site: Web Site or Access Location

Intended Use of Output (risk characterization, support decision, answer
question, etc.):

Intended Use of Output justification goes here.

Regulatory Context, if any:

Regulatory Context justifying existence of the Application goes here.

Process for archiving and documentation:

Application Name Version Number 

QA Summary

Summary Developer: Person or Team Name and Team Member Names

Date: dd/mmm/yyyy

Application Output Description:

Include output description(s) including the format(s).

And/Or include a reference to where this information is available.

Examples of How Application Output is Used:

Include examples of Application output.

And/Or include a reference to where this information is available. 

An appendix in the User’s Manual might be appropriate.

Limitations on Application Use:

Describe any limitations on using the Application.

And/Or include a reference to where this information is available.

An appendix in the User’s Manual might be appropriate.

Description of Application Input including Input Sources:

List the Application Input and Input Sources.

Describe details as necessary and/or include a reference to where this
information is available.

This should refer to a particular portion of the User’s Manual.

 

	Appendix VII.  Rationale for Ordering Papers

 tc \l1 "Appendix VII.  Rationale for Ordering Papers 

Code	

Rationale

R1	

Paper reports a more sensitive endpoint than registrant data

R2	

Paper supports the line of evidence approach

R3	

Paper identifies a species of concern (e.g., endangered species or
sensitive species group) that are not typically addressed in registrant
data

R4	

Paper reports ecologically relevant endpoints not typically addressed by
registrant submitted data

R5	

Although these papers are rejected by ECOTOX as a toxicity study, they
may provide the risk assessor with useful non-toxicity information. 
These studies would include incident, fate, in vitro, mixture, review,
and modeling studies.

R6	

Paper not ordered - deemed not pertinent

	Appendix VIII.  Rationale for the Use of Open Literature in Risk
Assessment

 tc \l1 "Appendix VIII.  Rationale for the Use of Open Literature in
Risk Assessment 

Code	

Rationale

QUANT	

The study has been evaluated by a DER, determined to be supplemental,
and deemed appropriate for use in risk quotient calculations

QUAL	

The paper is not appropriate for quantitative use but is of good
quality, addresses issues of concern to the risk assessment and is used
in the risk characterization discussion

INV	

The study has been deemed inappropriate for use in risk quotient
calculations (quantitatively) and in the risk characterization
(qualitatively) because it does not address endpoints of concern to the
risk assessment and/or is of poor quality

	Appendix IX.  Qualitative Study Summary

 tc \l1 "Appendix IX.  Qualitative Study Summary 

Chemical Name:

ECOTOX Record Number and Citation:

DP Barcode:

Date of Assessment:

Brief Summary of Study Findings:

Description of Use in Document:

Rationale for Use:

Limitations of Study:

Reviewer:

 PAGE  39