Document ID: EPA-HQ-OPPT-2009-0105-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-10-07T04:00Z

ATTACHMENT 1

TSCA Health & Safety Study Cover Sheet and Instructions

(EPA Form 7710-58)

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) submssions 

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 8(e): optional for (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________________

   

FOR ENVIRONMENTAL EFFECT (EE) STUDIES ONLY	

FOR ENVIRONMENTAL FATE (EF) STUDIES ONLY

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 __________________________

	

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 ________________________

	

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 ____________________________