Approved Under OMB Control # 2070-0156
Expiration Date: xx/xx/xxxx
TSCA HEALTH & SAFETY STUDY COVER SHEET
Use of this form is voluntary, but recommended by EPA as a cover sheet for TSCA section 4, 8(d), and 8(e) submissions
to expedite and improve the management, processing, quality, review, and public availability of data in TSCATS
TSCA CBI STATUS:
CHECK IF THIS PAGE CONTAINS CONFIDENTIAL BUSINESS INFORMATION (CBI)
Clearly mark the confidential information with bracketing and check the box in the appropriate section ( Contains CBI).
Submit a sanitized cover sheet with CBI deleted. Mark the sanitized copy, "Public Display Copy" in the heading.
1.0 SUBMISSION TYPE Contains CBI 8(d) 8(e) FYI 4 OTHER: Specify____________________ Initial Submission Follow-up Submission Final Report Submission Previous EPA Submission Number or Title if update or follow-up: ____________________ Docket Number, if any: # ________________ ITC Submission Yes No continuation sheet attached |
2.1 SUMMARY/ABSTRACT ATTACHED (may be required for Sec. 8(e); optional for Secs. 4, 8(d) & FYI) Yes No |
2.2 SUBMITTER TRACKING NUMBER OR INTERNAL ID |
2.3 FOR EPA USE ONLY |
2.4 Study ___ of ____ |
3.0 CHEMICAL/TEST SUBSTANCE IDENTITY Contains CBI Reported Chemical Name (specify nomenclature if other than CAS name): __________________________________________________ CAS#__________-_____-___ Purity _______% Single Ingredient Commercial/Tech Grade Mixture Trade Name: ________________________ Common Name: __________________________ |
CAS Number NAME % WEIGHT Other chemical(s) present in tested mixture continuation sheet attached |
4.0 REPORT/STUDY TITLE Contains CBI
continuation sheet attached |
5.1 STUDY/TSCATS INDEXING TERMS [CHECK ONE] HEALTH EFFECTS (HE): ENVIRONMENTAL EFFECTS (EE): ENVIRONMENTAL FATE (EF):_____ |
5.2 STUDY/TSCATS INDEXING TERMS (see instructions for 4 digit codes) STUDY SUBJECT ROUTE OF VEHICLE OF TYPE: ___________ ORGANISM (HE, EE only): EXPOSURE (HE only): EXPOSURE (HE only)_____ Other:____________ Other:_________________________ Other: ____________________ Other:__________________ |
6.0 REPORT/STUDY INFORMATION Contains CBI Study is GLP Laboratory ____________________________________________________________ Report/Study Date_______ Source of Data/Study Sponsor (if different than submitter) Number of pages _________ continuation sheet attached |
7.0 SUBMITTER INFORMATION Contains CBI Submitter: _____________________________________ Title: ________________________ Phone: ( )______________ Company Name: _________________________________Company Address:_____________________________________ _____________________________________________ ________________________________________ _______________________________________________Submitter Address (if different): _____________________________________ Technical Contact: ________________ ______________ Phone: ( )______________ continuation sheet attached e-mail address__________________________________________________________ |
8.0 ADDITIONAL COMMENTS Contains CBI
continuation sheet attached Submitter Signature: Date:___________________ |
EPA Form No. 7710-58 (Revised 6/25/96) Page____of____
Approved Under OMB Control # 2070-0156
TSCA HEALTH & SAFETY STUDY COVER SHEET
9.0 CONTINUATION SHEET
TSCA CBI STATUS:
CHECK IF THIS PAGE CONTAINS CONFIDENTIAL BUSINESS INFORMATION (CBI)
Clearly mark the confidential information with bracketing and check the box in the appropriate section ( Contains CBI). Submit a sanitized cover sheet with CBI deleted. Mark the sanitized copy, "Public Display Copy" in the heading.
Submitter Tracking Number/Internal ID
|
CONTINUED FROM COVER SHEET SECTION # _______________
Contains CBI
|
EPA Form No. 7710-58 (Revised 6/25/96) Page____of____
Approved under OMB Control # 2070-0156
TSCA HEALTH & SAFETY STUDY COVER SHEET - INSTRUCTIONS
(Note: Do not mail these instructions with your submission)
Paperwork Reduction Act Notice
The annual public burden for this collection of information is estimated to average 30 minutes per response, including the time needed for reading the instructions and completing the necessary information contained in this form. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, Collection Strategies Division, Environmental Protection Agency (2822T), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. Include OMB number 2070-0156 in any correspondence. Do not send the completed form to this address. The actual information or form should be submitted in accordance with the instructions specified in the corresponding regulations
General Instructions
This voluntary cover sheet was designed to serve as a tool for industry and EPA in the preparation, processing, review, and availability of TSCA information, and as an alternative for cover letters to TSCA submissions.
As with all EPA submissions, follow applicable EPA regulations and guidance in submitting the information.
A check box at the top has been provided to indicate if there is confidential business information (CBI). Check this box if the page contains information that is confidential. For information what can be claimed confidential under TSCA refer to TSCA section 14, 40 CFR Part 2 Sub-Part B and other applicable EPA and TSCA guidance. If the page contains CBI, clearly mark the information with bracketing. Check the box "Contains CBI" in the appropriate section. Submit another cover sheet with the CBI deleted and mark "Public Display Copy" in the heading.
Under TSCA reporting requirements, a submission may contain multiple studies. A cover sheet should be completed for each study in the submission and go to box 2.4 and add Study 1 of 1 for a submission having a single study, Study 1 of x, Study 2 of x, etc. (for a submission having multiple or x number of studies).
A cover sheet is unnecessary for submissions containing no health and safety data. Examples of submissions with no health and safety data include: section 4-related correspondence on issues of different test protocols; section 8(e) or FYI voluntary actions of submitters to reduce exposures; information on chemical use or commercial status; substantiation for submitting FYI vs. 8(e). If a submission is related to a previous submission, please reference the EPA assigned Document ID for PMN, 8(e) and FYI submissions (PMN, 8EHQ and FYI numbers). For other submissions, please reference the EPA Document Control Number (DCN) or Study title with submission date. The EPA will provide the Document ID as well as the DCN when acknowledging PMNs, 8(e)s and FYIs.
If additional space is needed in any of the sections of the Cover Sheet, please check the "continuation sheet attached" box in the appropriate section and attach a Continuation Sheet (a standardized continuation sheet has been provided; it is titled 9.0 Continuation Sheet).
INSTRUCTIONS - continued page 2
It is important to indicate if a study/submission is initial, follow-up or final. An initial submission is for a given chemical/case identified or initiated by a company. A follow-up or a supplement is a submission which contains information specifically requested by EPA (Follow-up) or information related to a previous submission but not specifically requested by EPA (Supplement).
Please attach to the cover sheet package an abstract or summary for each study prepared by or for the submitter, if available, and check the box "YES" under section 2.1. Otherwise check the box "NO". [Note: a summary/abstract is required under 8(e).]
Space is provided in section 8.0 for the submitter to provide any additional study interpretation, comments, etc which could immediately assist in EPA’s screening and review of the study/submission. A continuation sheet may be attached.
If any information in the cover sheet is unknown, write "unknown." If it is not applicable write "N.A." Provide written explanation if appropriate.
Detailed Instructions For Completing Cover Sheet
TSCA CBI (Confidential Business Information) Status - Check this box if the page contains information that is confidential. For information what can be claimed confidential under TSCA refer to TSCA section 14, 40 CFR Part 2 Sub-Part B and other applicable EPA and TSCA guidance. If the page contains CBI, clearly mark the information with bracketing. Check the box "Contains CBI" in the appropriate section. Submit another cover sheet with the CBI deleted and mark "Public Display Copy" in the heading.
1.0 Submission Type - Check one of the boxes for the TSCA section that the submission is being made under- 8(d), 8(e), FYI, 4 or OTHER. Check the appropriate box to indicate if a study/submission is initial, follow-up or final. An initial submission is for a given chemical/case identified or initiated by a company. A follow-up or a supplement is a submission which contains information specifically requested by EPA (Follow-up) or information related to a previous submission but not specifically requested by EPA (Supplement).
2.1 Summary/Abstract Attached - Please attach to the cover sheet package an abstract or summary for each study prepared by or for the submitter, if available, and check the box "YES" under section 2.1. Otherwise check the box "NO". [Note: a summary/abstract may be required under 8(e).]
2.2 Submitter Tracking Number or Internal ID - Enter an internal company id number; also, write this ID on the complete submission for easy linkage to and retrieval of the entire study/submission for EPA processing, review, and public availability.
2.3 For EPA Use Only - Please leave this section blank. This is for EPA purposes such as assignment of submission tracking numbers.
2.4 Study of -
INSTRUCTIONS - continued page 3
3.0 Chemical/Test Substance Identity - If additional space is required for any chemical identity data element, check the continuation box and attach a continuation sheet appropriately identifying the relevant specific data element and referencing the study/submission. Enter the CAS# of the chemical for the specific study of the cover sheet. Enter the chemical name; specify nomenclature if other than CAS name. Enter the % purity if impurities are present, leave blank if unknown. Check one of three boxes indicating if the chemical is a single ingredient (e.g., 100% NaCl), technical grade product (e.g., 50% NaOH solution), or mixture (e.g., perfume formula with many ingredients). Enter the trade names and common names for the material if applicable. If the test substance contains more than one chemical, list the components by CAS number, name, and % weight in the mixture. Submitters are requested to provide informative generic chemical names for substances whose chemical identity has been claimed TSCA confidential business information.
4.0 Report/Study Title - Provide the title of the entire submission, not the title of any specific study subsection; if insufficient space, check the continuation box and attach a continuation sheet with the complete title.
5.1 Study/TSCATS Indexing Terms - Check either Health Effects, Environmental Effects, or Environmental Fate - check only one.
5.2 Study/TSCATS Indexing Terms - See the attached Study Indexing Terms Sheet. Find appropriate (checked) Study Type and select relevant, detailed Study Type (for HE, EE, EF), Subject Organism (HE, EE only), Route of Exposure (HE only), and Vehicle (HE only, if applicable); transfer the 4-letter TSCATS code to the cover sheet. If an appropriate indexing term is not available, check other box and clearly print description.
6.0 Report/Study Information - If additional space is required for any study information data, check the continuation box and attach a continuation sheet identifying the relevant specific data element and referencing the study/submission. Enter the complete name of the contractor or laboratory which conducted the study. Include the source of data or study sponsor, if different than the submitter. Enter the actual completion date of the study/submission as dd/mm/yy. Check GLP box if existing Good Laboratory Practices were used in the conduct of the study.
7.0 Submitter Information - If additional space is required for any submitter information, check the continuation box and attach a continuation sheet identifying this data element and referencing the study/submission (e.g. submitter tracking number). Enter submitter name, title, and phone. Enter company name and address. Enter the address of the submitter if the submitters address is different than the company address. Please provide a key technical contact name and telephone number of an individual who can discuss the content/substance of the study/submission during the EPA scientific review process.
8.0 Additional Comments - This space is provided for the submitter to provide any additional study interpretation, comments, etc., which could immediately assist in EPA’s screening and review of the study/submission. A continuation sheet may be attached. For TSCA section 8(e) and FYI submissions state rationale for submitting information as 8(e) versus FYI and voluntary actions taken by the submitter in response to the new information.
Submitter Signature/Date - TSCA section 8(e) submissions must be signed by the submitter and dated. All submissions should be submitted by certified mail with return receipt to demonstrate submission receipt by the EPA.
9.0 Continuation Sheet - If additional space is needed in any of the sections of the cover sheet, please check the "continuation sheet attached" box in the appropriate section and attach a Continuation Sheet, Section 9.0.
INSTRUCTIONS - continued page 4
STUDY INDEXING TERMS
FOR HEALTH EFFECT (HE) STUDIES ONLY |
Study Type ___ Acute Toxicity (ATOX) ___ Subchronic Toxicity (STOX) ___ Chronic Toxicity (CTOX) ___ Carcinogenicity (CARC) ___ Combined Chronic Toxicity/ Carcinogenicity (CTCA) ___ Cell Transformation (TRFM) ___ Biochemical Interactions and/or Mechanism of Toxic Effects (BCHM) ___ Absorption, Distribution, Metabolism Excretion (ADME) ___ Primary Dermal Sensitization (DSEN) ___ Primary Dermal irritation (DIRR) ___ Primary Eye irritation (EIRR) ___ Reproduction/Fertility Effects (RTOX) Teratology (TERA) ___ Combined Teratology/Reproductive Effects (TERE) ___ Epidemiology Study (EPID) ___ Case Report (CASE) ___ Genotoxicity (GTOX) ___ Gene Mutation (MUTA) ___ Chromosomal Effects (CHRM) ___ DNA Effects (DNAF) ___ Tissue Determination Concentration (TCON) ___ Industrial Hygiene (HYGN) ___ Neurotoxicity (NEUR) ___ Immunotoxicity (ITOX) ___ Target Organ Toxicity: specify____ ___ Other: specify_________________ |
Subject Organism/Test System ___ Mammals (MAMM) ___ Rats (RATS) ___ Mice (MICE) ___ Hamsters (HAMS) ___ Guinea Pigs (GUIN) ___ Rabbits (RABB) ___ Dogs (DOGS) ___ Cats (CATS) ___ Monkeys (MNKY) ___ Pigs (PIGS) ___ Cattle (COWS) ___ Sheep (SHEP) ___ Goats (GOAT) ___ Humans (HUMN) ___ Other Mammals (OTMA) ___ Bacteria (BACT) ___ Algae (ALGA) ___ Fungi (FUNG) ___ Yeast (YEST) ___ Plant (PLNT) ___ Insect (INSE) ___ Bird (BIRD) |
Route of Exposure ___ Oral (ORAL) ___ Gavage (GAVG) ___ Dermal (DERM) ___ Inhalation (INHL) ___ Intratracheal Instillation (INTR) ___ Parenteral (PARN) ___ Intravenous (INTV) ___ Intraperitoneal (INTP) ___ Intramuscular (INTM) ___ Subcutaneous (SUBC) ___ Implant (IMPL) ___ Transplacental (TRPL) ___ In Vitro (INVR)
----------------------------------------------------- Vehicle of Exposure (check only if applicable)
___ Water ___ Corn Oil ___ Food ___ Other: specify________________
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FOR ENVIRONMENTAL EFFECT (EE) STUDIES ONLY |
FOR ENVIRONMENTAL FATE (EF) STUDIES ONLY |
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Study Type ___ Acute Toxicity (ATOX) ___ Subchronic Toxicity (STOX) ___ Chronic Toxicity (CTOX) ___ Critical Life Stage Test (CLIF) ___ Seed Germination Test (SEED) ___ Plant Growth or Damage Test (PGRD) ___ Microbiological Function Test (MICR) ___ Ecosystem Modeling (ECOS) ___ Reproduction/Fertilization Test (RTOX) ___ Absorption, Distribution, Metabolism Excretion (ADME) ___ Tissue Concentration (TCON) ___ Other Environmental Effects (OTEE) specify __________________________
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Subject Organism ___ Bacteria (BACT) ___ Algae (ALGA) ___ Fungi (FUNG) ___ Yeast (YEST) ___ Plant (PLNT) ___ Amphibians (AMPH) ___ Mollusks (MOLL) ___ Fish - Freshwater (FFRE) ___ Fish - Marine (FMAR) ___ Reptiles (REPT) ___ Bird (BIRD) ___ Insect (INSE) ___ Invertebrates (INVE) ___ Other Wildlife (WILD) specify ________________________
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Study Type ___ Physical / Chemical Properties (PCHE) ___ Water Solubility (WSOL) ___ Vapor Pressure (VPRE) ___ Partition Coefficient (PART) ___ Dissociation Constant (DISS) ___ Henry's Law Constant (HLAW) ___ Transport Processes (TSPT) ___ Biodegradation (BDEG) ___ Bioconcentration / Bioaccumulation (BIOC) ___ Photolysis (PHOT) ___ Hydrolysis (HYDR) ___ Monitoring Information (MONT) ___ Production and Process Info (PROD) ___ Other Studies (OTHR) specify ____________________________
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| File Type | application/msword |
| File Title | Approved Under OMB Control # 2070-0156 |
| Author | ctsuser |
| Last Modified By | ctsuser |
| File Modified | 2010-05-20 |
| File Created | 2010-05-19 |