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EPA’s Approach for Considering Other Scientifically Relevant Information (OSRI) 

under the Endocrine Disruptor Screening Program 

March 26, 2009 

 This paper was developed by EPA to provide guidance to EPA staff and managers who 

will be reviewing the responses to Tier 1 Orders issued under the Endocrine Disruptor Screening 

Program (EDSP), and may also be of interest to parties considering whether to submit other 

scientifically relevant information to EPA. This paper provides general guidance and is not 

binding on either EPA or any outside parties, and the use of language such as "will," "is," "may," 

"can" or "should" in this paper does not connote any requirement for either EPA or any outside 

parties. As such, EPA may depart from the guidance where circumstances warrant and without 

prior notice, and this guidance is not otherwise intended to limit anyone’s submission of or citation 

to other scientifically relevant information. Anyone may provide other scientifically relevant 

information and the Agency will assess the information on a case-by-case basis to determine 

whether the information can be used to satisfy part or all of the Tier 1 Order, and/or otherwise 

inform the Tier 1 determination. EPA will respond to the submitter in writing and will make its 

determination publicly available. 

General EPA understanding of what OSRI is: 

“Other scientifically relevant information” is information that informs the 

determination as to whether the substance may have an effect that is similar to 

an effect produced by a substance that interacts with the estrogen, androgen, 

and/or thyroid hormonal systems (e.g., information that identifies substances as 

having the potential to interact with the estrogen, androgen, and/or thyroid 

system(s); information demonstrating whether substances have an effect on the 

functioning of the endocrine system). OSRI may either be functionally equivalent 

to information obtained from the Tier 1 assays—that is, data from assays that 

perform the same function as EDSP Tier 1 assays—or may include data that 

provide information on a potential consequence or effect that could be due to 

effects on the estrogen, androgen or thyroid systems. 

Discussion of OSRI in general: 

• Anyone may submit OSRI, not just Test Order recipients. 

• Rather than simply describing the other scientifically relevant information the 

submitter wishes EPA to consider, EPA encourages submitters to provide the 

information itself or to cite the publication or a reference number for information 

previously submitted to EPA, as these will make the greatest amount of information 

available for the Agency to consider, in the shortest time frame. 

• Information may receive different weights in a weight of evidence judgment that 

evaluates the totality of the evidence. 

• The quality of the information will weigh heavily in EPA’s evaluation. For examples 

of some of the factors EPA may consider when evaluating the quality of 

information, please see the Guidelines for Ensuring and Maximizing the Quality, 

Objectivity, Utility, and Integrity of Information Disseminated by the Environmental 

Protection Agency (available at: 

http://epa.gov/quality/informationguidelines/documents/EPA_InfoQualityGuidelines.pdf) and the 
 

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EPA Assessment Factors Guidance (available at: 

http://www.epa.gov/OSA/spc/pdfs/assess2.pdf).

• Factors that EPA may consider include sensitivity, specificity, confidence in the 

conclusions, and applicability of conclusions across taxa. 

• Judgments will be made considering all factors, not just apparent similarity of 

endpoints and effects. Such factors may include route of administration, duration 

of dosing, rationale for the dose levels chosen, frequency of dosing, age at 

exposure, species, test system, vehicle used, number of test units, variability of 

data, other factors, and whether the final data set available to the Agency provides 

a basis for conclusions about the potential for interaction with the endocrine 

system in both mammalian and non-mammalian systems. 

• As a general matter, EPA thinks that the following types of studies may contain 

information that the EPA would be likely to regard as scientifically relevant 

information: studies that correspond to the assays in Tier 1 or Tier 2; metabolism 

studies; or other vertebrate or invertebrate toxicity studies, including, but not limited 

to, developmental toxicity tests, carcinogenicity tests, toxicogenomic data, and 

reproductive toxicity tests. Other types of studies may also be considered 

scientifically relevant. For instance, testing conducted under 40 CFR Part 158 data 

requirements to support a pesticide registration may be considered by EPA. The 

weight any study carries in a weight of evidence judgment may depend on whether 

the protocol meets information quality and scientific standards, and evaluates 

relevant and necessary endocrine related endpoints. 

Relationship to the Tier 1 Orders: 

• The Agency’s consideration of OSRI is initiated when someone submits the OSRI. 

• EPA will evaluate the OSRI, in combination with any other available information, 

and determine the extent to which the OSRI satisfies the Tier 1 Order. 

• Some OSRI may be sufficient to satisfy part or all of the Tier 1 Order. For 

example, the OSRI may have been submitted to only address a particular part of 

the Tier 1 Order. 

• EPA encourages submitters to provide a cogent and complete rationale for why 

they believe the OSRI is sufficient to satisfy part or all of the Tier 1 Order. 

• Decisions about whether the OSRI satisfies part or all of the Tier 1 Order will be 

based on the weight of evidence from all relevant information available. 

• Judgments about whether the OSRI satisfies part or all of the Tier 1 Order will 

generally consider the dataset as a whole for the subject chemical. In general, it 

may in some cases be possible to determine that a particular chemical has the 

potential to interact with the endocrine system and therefore could proceed to Tier 

2 even if Tier 1 data are limited. However, if only some of the Tier 1 data are 

available, there may not be sufficient information to determine that some of the Tier 

2 data are not necessary. For example, if, based on the weight of available 

information, EPA were able to determine that it has sufficient data to know that Tier 

2 testing is needed due to estrogen-related effects, EPA may be able to determine 

that additional Tier 1 data on androgen and thyroid systems is not needed to 

satisfy the Tier 1 Order. However, depending on the results, more complete Tier 1 

data might allow EPA to determine that not all of the Tier 2 testing is necessary.