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
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Table of Contents

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
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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
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Introduction

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

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.
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Phase I: Literature Acceptance Criteria for Effects Data

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

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

For the ECOTOX database, literature is identified through comprehensive and welldocumented 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

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. 
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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

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

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

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 
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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

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

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 
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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)
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· 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

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

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 
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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.)
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Phase II: Categorization of Studies and Determination 

of Use in Risk Assessment

`

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

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.
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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
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· Create an amphibian table

· Create a reptile table

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: 

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 registrantsubmitted 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 
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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 

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

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.
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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 registrantsubmitted 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

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). 
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· 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

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 
18

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

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.
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· 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

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 
20

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, 2

nd

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. 
21

Roles and Responsibilities

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

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

The risk assessor is responsible for the following tasks:
22

· 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.
23

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.
24

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 
25

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 
26

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 nonchemical 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).
27

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 
28

(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 Concentratio

n 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 Concentratio

n, 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.
29

Example Data Summary Table

CAS 

#

Chemic

al Name

Phylum Class Order Family Genus Species Common

name

Effect Meas Endp Media pH O.

C.

Hard

ness

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 nigromaculi

s

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 Cyprinodontiform

es

Poecillidae Gambusia affinis Western 

mosquitofish

BEH THML NR FW 48 h A 5 ug/L 5149

298000 Methyl 

parathion

Chordata Actinoptergyii Cyprinodontiform

es

Poecillidae Gambusia affinis Western 

mosquitofish

MOR MORT NR FW 24 h F 5000 ug/L 7762
30

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.
31

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
32

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
33

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 
34

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.
35

Regulatory Context, if any:

Regulatory Context justifying existence of the Application goes here.

Process for archiving and documentation:
36

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.
37

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 nontoxicity information. These studies would 

include incident, fate, in vitro, mixture, 

review, and modeling studies.

R6 Paper not ordered - deemed not pertinent
38

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
39

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: