Follow-up/Supplemental FYI Submissions

Notification of Substantial Risk of Injury to Health and the Environment under TSCA Section 8(e)

TDD 9 21 OPPT MTS eReporting FYI Screenshots 091113

Follow-up/Supplemental FYI Submissions

OMB: 2070-0046

Document [pdf]
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For Your Information (FYI) Screenshots
Environmental Protection Agency
Office of Pollution Prevention and Toxics
Manage Toxic Substances

Delivery Order # GS00Q09BGD0022
Task Order # EP-G11H-00154
Project # TDD 9.21
September 11, 2013

Table of Contents
Table of Contents ..........................................................................................................................iii 
Table of Exhibits .......................................................................................................................... iv 
1 

2 

For Your Information (FYI) Screenshots .............................................................................. 1 
1.1 

Overview ........................................................................................................................ 1 

1.2 

FYI Screenshots ............................................................................................................. 1 
Appendix A ......................................................................................................................... 17 

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Table of Exhibits
Exhibit 1-1: Mock-Up of Chemical Information Submission System Screen ................................. 1 
Exhibit 1-2: Mock-Up of Home Screen .......................................................................................... 2 
Exhibit 1-3: Mock-Up of FYI Submissions Screen ........................................................................ 3 
Exhibit 1-4: Mock-Up of Create Passphrase Screen .................................................................... 4 
Exhibit 1-5: Mock-Up of Technical Contact Information Screen ................................................... 5 
Exhibit 1-6: Mock-Up of Submitting on Behalf of Consortium Screen ........................................... 6 
Exhibit 1-7: Mock-Up of Submitting on Behalf of Company Screen .............................................. 7 
Exhibit 1-8: Mock-Up of Chemical Identification Screen – No Mixture (Able to claim chemical as
CBI) ...................................................................................................................................... 8 
Exhibit 1-9: Mock-Up of Chemical Identification – No Mixture (Not able to claim chemical as
CBI) ...................................................................................................................................... 9 
Exhibit 1-10: Mock-Up of Chemical Identification Screen – Mixture ........................................... 10 
Exhibit 1-11: Mock-Up of the Search Substance Registry (SRS) Search Pop-Up Window ........ 11 
Exhibit 1-12: Mock-Up of the Chemical Not Found in Substance Registry Services Pop-Up
Window .............................................................................................................................. 12 
Exhibit 1-13: Mock-Up of Document Management Screen ......................................................... 13 
Exhibit 1-14: Mock-Up of Document Management Pop-up Window (Display Submission Type) 14 
Exhibit 1-15: Mock-Up of Document Management Pop-up Window (Display Effects) ................ 15 
Exhibit 1-16: Mock-Up of Document Management Pop-Up Window (Display Endpoints) .......... 16 

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1

For Your Information (FYI) Screenshots

1.1

Overview

FYI submissions are from a classification system established by the Environmental Protection
Agency (EPA) to distinguish voluntary submissions from substantial risk notices, also known as
Section 8(e) Notices, which are formally submitted to EPA under TSCA Section 8(e). The FYI
classification was created by EPA to capture submissions by people and organizations not
subject to the reporting requirements, but who desire to inform EPA of potential toxic substances
that may pose a risk to human health or to the environment.
EPA has received FYI submissions covering a wide variety of chemical substances and mixtures
from chemical companies, trade associations, unions, public interest groups, civic associations,
private citizens, academic institutions, state and other federal agencies, as well as similar
organizations and agencies in foreign countries. These submissions contain information on
human exposure, epidemiology, toxicity test results, monitoring studies, environmental fate, and
other information that may be important to risk assessment.
Sometimes FYIs are submitted when a manufacturer, importer, or processor is not sure the
information they have gathered supports a conclusion of substantial risk. FYI submissions are
often submitted to the Agency when a person or company that is not required to submit would
like to bring a chemical’s risk information to EPA’s attention. Chemical companies, trade
associations, public interest groups, and academic institutions are among those who submit FYIs.
The FYI application is an electronic, web-based tool provided by EPA for the submission of FYI
data. As a Primary AO, you can create or modify an FYI submission as well as submit to EPA
via the Central Data Exchange (CDX). You can also create FYI amendments and download the
Copy of Record (CoR).
This electronic application is optional for the production and submission of these filings.
Potential users may find that the use of this application saves time, burden and, because it is in an
electronic format, provides easy access to reporting forms. Potential users are reminded to
carefully read and follow application instructions. Persons who wish to use this application must
address all provisions in the application including those relating to indexing information (i.e.,
company name, address, chemical name, etc.) and those related to Confidential Business
Information (CBI) submissions, including the requirement for the submission of sanitized or
redacted filings.
If data is claimed as CBI, it will not be made available to the public unless EPA determines that
the information is not entitled to confidential treatment in accordance with the Agency
confidentiality regulations at 40 Code of Federal Regulations (CFR) part 2, subpart B.
This TSCA FYI Submission electronic application is optional for the production and submission
of these filings. The paper option for filing will continue to be allowed.
Potential users may find that the use of this application saves time, burden and, because it is in an
electronic format, provides easy access to reporting forms. Potential users are reminded to
carefully read and follow application instructions. Persons who wish to use this application must
address all provisions in the application, including those relating to indexing information (i.e.,

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company name, address, chemical name etc.) and those related to CBI submissions, including the
requirement for the submission of sanitized or redacted filings.
Please note that certain CBI claims will not be accepted if you choose to use this electronic
application for TSCA FYI Submission. For example, chemical name and/or chemical identity, if
the chemical is listed on the public portion of the TSCA Inventory, may not be claimed as CBI in
a submission using this application. Similarly, the user must enter a non-confidential study title,
because it may not be claimed as CBI. EPA does not expect that such information, if evaluated
under procedures at 40 CFR part 2, subpart B, would generally be found entitled to confidential
treatment.
If the user believes that these or other data elements should be treated as CBI, then the user may
use the paper option to file the FYI Submission and assert CBI claims.
If the user claims an uploaded document as CBI, a sanitized document must be provided.
The following fields can be claimed as CBI within the ‘FYI Submission’ application:
 Technical Contact Information
 Submitting on Behalf of Company information
 Submitting on Behalf of Consortium information
 A single chemical substance that is not on the public TSCA Inventory
 The chemical substances comprising a mixture
 The percent concentrations of individual chemical substances in a mixture
 Any document uploaded within the ‘Document Management’ pop-up window
 Submitting Official Information

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1.2

FYI Screenshots
Exhibit 1-1: Mock-Up of Chemical Information Submission System Screen

TDD 9.21 OPPT MTS eReporting FYI Screenshots

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Exhibit 1-2: Mock-Up of Home Screen

TDD 9.21 OPPT MTS eReporting FYI Screenshots

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Exhibit 1-3: Mock-Up of FYI Submissions Screen

TDD 9.21 OPPT MTS eReporting FYI Screenshots

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Exhibit 1-4: Mock-Up of Create Passphrase Screen

TDD 9.21 OPPT MTS eReporting FYI Screenshots

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Exhibit 1-5: Mock-Up of Technical Contact Information Screen

TDD 9.21 OPPT MTS eReporting FYI Screenshots

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Exhibit 1-6: Mock-Up of Submitting on Behalf of Consortium Screen

TDD 9.21 OPPT MTS eReporting FYI Screenshots

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Exhibit 1-7: Mock-Up of Submitting on Behalf of Company Screen

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Exhibit 1-8: Mock-Up of Chemical Identification Screen – No Mixture (Able to
claim chemical as CBI)

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Exhibit 1-9: Mock-Up of Chemical Identification – No Mixture (Not able to claim
chemical as CBI)

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Exhibit 1-10: Mock-Up of Chemical Identification Screen – Mixture

TDD 9.21 OPPT MTS eReporting FYI Screenshots

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Exhibit 1-11: Mock-Up of the Search Substance Registry (SRS) Search Pop-Up
Window

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Exhibit 1-12: Mock-Up of the Chemical Not Found in Substance Registry Services
Pop-Up Window

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Exhibit 1-13: Mock-Up of Document Management Screen

TDD 9.21 OPPT MTS eReporting FYI Screenshots

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Exhibit 1-14: Mock-Up of Document Management Pop-up Window (Display
Submission Type)

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Exhibit 1-15: Mock-Up of Document Management Pop-up Window (Display
Effects)

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Exhibit 1-16: Mock-Up of Document Management Pop-Up Window (Display
Endpoints)

**Note: Please find all the possible drop-down options in Appendix A.

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2

Appendix A

The following appendix displays all possible options within each drop-down menu on the ‘Document
Manamgement’ pop-up window.
First Dropdown:
 Title: Submission Type
 Contains the following values
o Initial Submission
o Follow-Up Submission
o Final Submission
Second Dropdown
 Title: Summary/Abstract Submission
 Contains the following values
o Yes
o No
Third Dropdown
 Title: Effects
 Contains the following values
o Health Effect
o Ecotoxicity
o Environmental Fate
o Physical-Chemical Properties
Fourth Dropdown
 Title: Endpoints
 Contains the following values
o For Health Effect (shows when Health Effect is selected from third dropdown)
 Basic Toxic kinetics
 Dermal Absorption
 Acute Toxicity: oral
 Acute Toxicity: inhalation
 Acute Toxicity: dermal
 Acute Toxicity: other routes
 Skin irritation/corrosion
 Eye irritation
 Skin sensitization
 Respiratory sensitization
 Repeated Dose toxicity: oral
 Repeated Dose toxicity: inhalation
 Repeated Dose Toxicity: dermal
 Repeated Dose Toxicity: other routes
 Genetic Toxicity in vitro

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o

o

 Genetic Toxicity in vivo
 Carcinogenicity
 Toxicity to Reproduction
 Developmental Toxicity/teratogenicity
 Toxicity to reproduction: other studies
 Neurotoxicity
 Immunotoxicity
 Specific investigations: other studies
 Health surveillance data
 Epidemiological data
 Direct observations: clinical cases, poisoning incidents and other
 Sensitization data (humans)
 Exposure related observations in humans: other data
 Toxic effects on livestock and pets
 Additional toxicological information
 Other
For Ecotoxicity (shows when Ecotoxicity is selected from third dropdown)
 Short-term toxicity to fish
 Long-term toxicity to fish
 Short-term toxicity to aquatic invertebrates
 Long-term toxicity to aquatic invertebrates
 Toxicity to aquatic algae and cyanobacteria
 Toxicity to aquatic plants other than algae
 Toxicity to microorganisms
 Toxicity to other aquatic organisms
 Sediment toxicity
 Toxicity to soil macroorganisms except arthropods
 Toxicity to terrestrial arthropods
 Toxicity to terrestrial plants
 Toxicity to soil microorganisms
 Toxicity to birds
 Toxicity to other above-ground organisms
 Biological effects monitoring
 Biotransformation and kinetics
 Additional ecotoxicological information
 Other
For Environmental Fate (shows when Environmental Fate is selected from third
dropdown)
 Photo transformation in air
 Hydrolysis
 Photo transformation in water
 Photo transformation in soil
 Biodegradation in water: screening test
 Biodegradation in water and sediment: simulation tests

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o

 Biodegradation in soil
 Mode of degradation in actual use
 Bioaccumulation: aquatic/sediment
 Bioaccumulation: terrestrial
 Adsorption/desorption
 Henry's Law constant
 Distribution Modeling
 Other Distribution Data
 Monitoring Data
 Field Studies
 Additional Information on Environmental Fate and Behavior
 Other
For Physical-Chemical Properties (shows when Physical-Chemical Properties is selected
from third dropdown)
 Appearance/Physical
 Melting Point
 Boiling Point
 Density
 Particle size distribution
 Vapor Pressure
 Partition Coefficient
 Water Solubility
 Solubility in Organic Solvent
 Surface Tension
 Flash Point
 Auto Flammability
 Flammability
 Explosiveness
 Oxidizing Properties
 Oxidation Reduction Potential
 Stability in organic solvents and identity of relevant degradation products
 Storage stability and reactivity towards container material
 Stability: thermal, sunlight, metals
 pH
 Dissociation constant
 Viscosity
 Additional physic-chemical information
 Other

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