Follow-up/Supplemental TSCA Sec. 8(e) Submissions

Section 8(e) Notice 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 
1 

Table of Exhibits.................................................................................................................. iv 

2 

Section 8(e) Notice Screenshots .......................................................................................... 1 

3 

2.1 

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

2.2 

Section 8(e) Notice Screenshots .................................................................................... 3 
Appendix A ......................................................................................................................... 22 

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1

Table of Exhibits

Exhibit 2-1: Mock-Up of Chemical Information Submission System Screen ................................. 3 
Exhibit 2-2: Mock-Up of Home Screen .......................................................................................... 4 
Exhibit 2-3: Mock-Up of Section 8(e) Notice Submissions Screen ............................................... 5 
Exhibit 2-4: Mock-Up of Create Passphrase Screen .................................................................... 6 
Exhibit 2-5: Mock-Up of Technical Contact Information Screen ................................................... 7 
Exhibit 2-6: Mock-Up of Submitting on Behalf of Consortium Screen ........................................... 8 
Exhibit 2-7: Mock-Up of Submitting on Behalf of Company Screen .............................................. 9 
Exhibit 2-8: Mock-Up of Chemical Identification Screen – No Mixture (Able to claim chemical as
CBI) .................................................................................................................................... 10 
Exhibit 2-9: Mock-Up of Chemical Identification – No Mixture (Not able to claim chemical as
CBI) .................................................................................................................................... 11 
Exhibit 2-10: Mock-Up of Chemical Identification Screen – Mixture ........................................... 12 
Exhibit 2-11: Mock-Up of the Search Substance Registry (SRS) Search Pop-Up Window ........ 13 
Exhibit 2-12: Mock-Up of the Chemical Not Found in Substance Registry Services Pop-Up
Window .............................................................................................................................. 14 
Exhibit 2-13: Mock-Up of Document Management Screen ......................................................... 15 
Exhibit 2-14: Mock-Up of Document Management Pop-Up Window (Display Submission Type)16 
Exhibit 2-15: Mock-Up of Document Management Pop-up Window (Display Effects) ................ 17 
Exhibit 2-16: Mock-Up of Document Management Pop-Up Window (Display Endpoints) .......... 18 
Exhibit 2-17: Mock-Up of Substantiation Screen ........................................................................ 19 
Exhibit 2-18: Mock-Up of Substantiation (continued) .................................................................. 20 
Exhibit 2-19: Mock-Up of Substantiation (continued) .................................................................. 21 

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Section 8(e) Notice Screenshots

2.1

Overview

Toxic Substances Control Act (TSCA) regulations require industry to provide the Environmental
Protection Agency (EPA) with documentation regarding chemical production, manufacture,
distribution, use, disposal, import, and export. As a result, the implementation of TSCA has
generated a large volume of documents submitted to the Agency by the regulated community.
TSCA Section 8(e) requires all United States chemical manufacturers, importers, processors, and
distributors to notify EPA after obtaining information on any of their chemical substances or
mixtures that reasonably supports the conclusion that these substances or mixtures present a
substantial risk of injury to health or to the environment.
Anyone subject to the TSCA Section 8(e) reporting requirement should submit a report to EPA
within thirty calendar days of obtaining said information. This information may be toxicity or
exposure data, full reports, summarized results, limited studies (e.g., range-finding studies),
preliminary results, and draft reports that constitute sufficient evidence for Section 8(e)
reporting.
General information on TSCA Section 8(e) “notice of substantial risk” is available at
http://www.epa.gov/oppt/tsca8e/
This document presents screenshots for the ‘Section 8(e) Notice’ electronic application as if you
were logged in as the Primary AO. As the Primary AO you are able to create, modify, delete, and
submit an 8(e) notice. The user may claim certain information as Confidential Business
Information (CBI). If the data is claimed as CBI, it will be treated in accordance with Agency
confidentiality regulations at 40 CFR part 2, subpart B.
This TSCA Section 8(e) Notice 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.,
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 Section 8(e). 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 Section 8(e) Notice and assert CBI claims.

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If the user claims the ‘Mixture Percent’ or an uploaded document as CBI, they are required to
complete the appropriate substantiation questions prior to submitting their Notice to EPA. 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 ‘Section 8(e) Notice’ 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
 All responses to substantiation questions
 Submitting Official Information

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2.2

Section 8(e) Notice Screenshots
Exhibit 2-1: Mock-Up of Chemical Information Submission System Screen

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Exhibit 2-2: Mock-Up of Home Screen

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Exhibit 2-3: Mock-Up of Section 8(e) Notice Submissions Screen

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Exhibit 2-4: Mock-Up of Create Passphrase Screen

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Exhibit 2-5: Mock-Up of Technical Contact Information Screen

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Exhibit 2-6: Mock-Up of Submitting on Behalf of Consortium Screen

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Exhibit 2-7: Mock-Up of Submitting on Behalf of Company Screen

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Exhibit 2-8: Mock-Up of Chemical Identification Screen – No Mixture (Able to
claim chemical as CBI)

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Exhibit 2-9: Mock-Up of Chemical Identification – No Mixture (Not able to claim
chemical as CBI)

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Exhibit 2-10: Mock-Up of Chemical Identification Screen – Mixture

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Exhibit 2-11: Mock-Up of the Search Substance Registry (SRS) Search Pop-Up
Window

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Exhibit 2-12: Mock-Up of the Chemical Not Found in Substance Registry Services
Pop-Up Window

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Exhibit 2-13: Mock-Up of Document Management Screen

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Exhibit 2-14: Mock-Up of Document Management Pop-Up Window (Display
Submission Type)

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Exhibit 2-15: Mock-Up of Document Management Pop-up Window (Display
Effects)

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Exhibit 2-16: 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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Exhibit 2-17: Mock-Up of Substantiation Screen

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Exhibit 2-18: Mock-Up of Substantiation (continued)

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Exhibit 2-19: Mock-Up of Substantiation (continued)

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3

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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