Attachment C - NMSP Optional Data Submission Form

NMSP reporting form -2007-10-30.pdf

Information Collection in Support of EPA's Stewardship Program for Nanoscale Materials

Attachment C - NMSP Optional Data Submission Form

OMB: 2070-0170

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Nanoscale Materials Stewardship Program (NMSP) – Optional Data Submission Form
10/30/2007
Notice to Participants:
Participation in and submission of data to the Program is voluntary
EPA is requesting you provide data to the extent it is known or reasonably ascertainable
Use of this form by Program participants is also voluntary
You do not have to fill out the entire form – you may leave portions blank when data is not
known or reasonably ascertainable
In some instances EPA is requesting that you explain why data is not available
EPA encourages participants to provide as much data as possible including why data is not
available
You may use the form as a guide to determine which data to report to EPA
Participation in and submission of data to the Program does not imply an intent to manufacture
or import for a commercial purpose
Completion and submission of this form to the Program does not satisfy any requirement under
40 CFR part 720 to submit a PMN or under 40 CFR part 721 to submit a Significant New Use
Notification

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 1 of 25

Draft version—NOT AN OFFICIAL FORM

10-30-07 Version. - Form Not Yet Approved.

U.S. ENVIRONMENTAL PROTECTION AGENCY

AGENCY USE ONLY:

Document control number

EPA case number

Date of receipt

number
NANOSCALE MATERIALS STEWARDSHIP PROGRAM ofTotal
pages in the
Form
DATA SUBMISSION FORM
When completed
send this form to

U.S. E.P.A.
DOCUMENT CONTROL OFFICER (7407M)
1200 PENNSYLVANIA AVE. NW
WASHINGTON, D.C. 20460
ATTN: NANOSCALE MATERIALS STEWARDSHIP PROGRAM

This form has been developed for the U.S. EPA’s Nanoscale Materials Stewardship Program. To ease the burden of reporting,
the form is based on the standard Premanufacture Notice (PMN) form (EPA FORM 7710-25, Rev. 5-95); many of the pages in
this form are adapted from those in the PMN form; irrelevant sections have been removed. Additional pages seeking nanoscale
materials-specific information are inserted in the most relevant places.
GENERAL INSTRUCTIONS
• As much of this form is adapted from the PMN form, it may be instructive to read “Instruction Manual for Reporting Under the
TSCA §5 New Chemicals Program” (available from the Toxic Substances Control Act (TSCA) Information Service, 202-5541404, or 202-554-5603(fax) or at http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm).
• Just as in a standard PMN, provide all information requested in this form to the extent it is known or reasonably ascertainable.
Particularly as related to the health and environmental effects of the manufacture, processing, distribution in commerce, use, or
disposal of the substance, all test data in your possession or control and a description of all other known data should be
provided. Reasonable estimates or modeling data may be given in the absence of actual data. Standard literature citations may
be submitted for data in the open scientific literature. Complete test data report (written in English), not summary data, should
be submitted, if they do not appear in the open literature. Clearly identify whether test data is on the substance, on an analog, or
from models.
• Any answer may be left blank or filled with “N/A,” if the information is not available, or the question is not applicable (e.g.,
characterization data for tests that were not run, production volume for materials that are not at the production stage, CAS name
and number for materials not registered with CAS, etc.). IT IS NOT NECESSARY TO DO ADDITIONAL TESTING IN
ORDER TO COMPLETE THIS FORM.
• Attach additional sheets as needed. Label each continuation sheet with the corresponding section heading. List all attachments
including data and optional information on page 15.
• Only one substance should be submitted per form.
• Any information may be claimed as confidential. To assert a claim on the form, mark (X) the confidential box next to the
information claimed as confidential. To assert a claim in an attachment, circle or bracket the information claimed as
confidential. If information is claimed as confidential, a sanitized version (including attachments) should be provided. For
additional instructions on claiming information as confidential, read the Instructions Manual. Submission of confidential
information on this form constitutes consent for disclosure of the information to EPA contractors under the security procedures
used in handling information submitted under TSCA.
NOTICES
• Participation in and submission of data to the Program is voluntary.
• Use of this form by Program participants is also voluntary.
• Participation in and submission of data to the Program does not imply an intent to manufacture or import for a commercial
purpose.
• Completion and submission of this form to the Program does not satisfy any requirement under 40 CFR part 720 to submit a
PMN or under 40 CFR part 721 to submit a Significant New Use Notice. For information on PMN submissions, see
http://www.epa.gov/opptintr/newchems/index.htm
TEST DATA Hazard and exposure test data would be most useful if the physical/chemical properties of the nanoscale material
relevant to assessing test results are obtained at the initiation of testing. Additional relevant information on preparation of the
nanoscale material for administration and storage history of the material between production and administration will assist in
interpretation. When possible, interpret data in the context of accompanying positive and negative nanoscale substance control data
from the same test system. Indicate which of the following data are included in this submission:
Physical / Chemical properties
Structure / activity relationships

Health

Environmental effects

effects

Environmental fate

Test data not in the possession
or control of the submitter
Other

Mark (x) if any information is claimed as confidential.

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 2 of 25

Draft version—NOT AN OFFICIAL FORM

TIME REQUIRED TO COMPLETE THE FORM
EPA estimates that it will take ???? hours to complete this form, including time to review instructions, search
existing data sources, gather and maintain the data needed, and complete and review the collection of information.
Please provide an estimate of the amount of time in work hours it took to complete this form.
COMMENTS
Please provide feedback concerning the Nanoscale Materials Stewardship Program Data Submission Form.

Hours:

Mark (X) this box if you attach a continuation sheet.
CHECK LIST
Please verify that the questions in the following general areas were answered by marking (X) in the boxes. (Answers may include,
for example, “N/A,” “none,” “not known”).
Physical and chemical characterization
Risk management information
STATEMENT
1. All information provided in this form is accurate as of the date of submission.
2.

I understand that this is not an actual PMN, and as such, does not satisfy any requirement under 40 CFR part 720 to submit
a PMN.

3.

Mark X in this box if you are willing to allow EPA to forward this data, including confidential portions, to other
government entities. EPA will contact you before releasing any data.
Confidential

Signature and title of Authorized Official (Original Signature Required)

Date

Signature of agent - (if applicable)

Date

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 3 of 25

Draft version—NOT AN OFFICIAL FORM

Part I -- GENERAL INFORMATION
Confidential

Section A -- SUBMITTER IDENTIFICATION
Mark () the “Confidential” box next to any subsection you claim as confidential
1a. Person
Name of authorized official
Position
Submitting
(in U.S.)
Company

Mailing address (number and street)

City, State, ZIP Code

b. Agent (if
applicable)

Name of authorized official

Position

Company

Mailing address (number and street)

City, State, ZIP Code

c.

Telephone

Area Code

Number

Area Code

Number

Area Code

Number

If you are submitting this as part of a joint submission, mark (X) this box.

Joint Submitter (if
applicable)

Name of authorized official

Position

Company

Mailing address (number and street)

City, State, ZIP Code

2.

Telephone

Technical
Name of authorized official
Contact (in U.S.)

Position

Company

Mailing address (number and street)

City, State, ZIP Code

Telephone

Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 3

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 4 of 25

Draft version—NOT AN OFFICIAL FORM

Part I -- GENERAL INFORMATION -- Continued
Section B -- CHEMICAL IDENTITY INFORMATION: **
Mark (X) the “Confidential” box next to any item you claim as confidential
Complete either item 1 (Class 1 or 2 substances) or 2 (Polymers) as appropriate. Complete all other items.

1.

If another person will submit chemical identity information for you (for either Item 1 or 2), mark (X) the box at the right.
Identify the name, company, and address of that person in a continuation sheet.
Class 1 or 2 chemical substances (for definitions of class 1 and class 2 substances, see the Instructions Manual) **
a.
b.

Class of substance - Mark (X)
1
Class 1
or 2
Class 2
Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar substances. **

c.

Please identify which method you used to develop or obtain the specified chemical identity information: (check one).

d.

Method 1 (CAS Inventory Expert Service
Method 2 (Other Source)
Molecular formula and CAS Registry Number (if a number already exists for the substance) **

Confidential

CAS#

e.

For a class 1 substance, provide a complete and correct chemical structure diagram. For a class 2 substance - (1) List the immediate
precursor substances with their respective CAS Registry Numbers. (2) Describe the nature of the reaction or process. (3) Indicate the
range of composition and the typical composition (where appropriate). (4) Provide a correct representative or partial chemical structure
diagram, as complete as can be known, if one can be reasonably ascertained. **

Mark (X) this box if you attach a continuation sheet.
Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 4

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 5 of 25

Draft version—NOT AN OFFICIAL FORM

Part I -- GENERAL INFORMATION -- Continued
Section B -- CHEMICAL IDENTITY INFORMATION -- Continued
2. Polymers (For a definition of polymer, see the Instructions Manual.)
a.

Confidential

Indicate the number-average weight of the lowest molecular weight composition of the polymer you intend to manufacture.
Indicate maximum weight percent of low molecular weight species (not including residual monomers, reactants, or solvents) below 500 and
below 1,000 absolute molecular weight of that composition.
Describe the methods of measurement or the basis for your estimates:

b.

i)

lowest number average molecular weight:

ii)

maximum weight % below 500 molecular weight:

iii)

maximum weight % below 1000 molecular weight:

GPC

Other

: (Specify)

Mark (X) this box if you attach a continuation sheet.
Make separate confidentiality claims for monomer or other reactant identity, composition information, and residual information. Mark (X) the “Confidential”
box next to any item you claim as confidential
(1) Provide the specific chemical name and CAS Registry Number (if a number exists) of each monomer or other reactant used in the manufacture of
the polymer.
(2) Mark (X) this column if entry in column (1) is confidential.
(3) Indicate the typical weight percent of each monomer or other reactant in the polymer.
(4) Mark (X) the identity column if you want a monomer or other reactant used at two weight percent or less to be listed as part of the polymer
description on the TSCA Chemical Substance Inventory.
(5) Mark (X) this column if entries in columns (3) and (4) are confidential.
(6) Indicate the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as manufactured for
commercial purposes.
(7) Mark (X) this column if entry in column (6) is confidential.
Monomer or other reactant and CAS Registry Number
ConfiTypical
Identity
ConfiMaximum
Confidential
composition
Mark (X) dential
residual
dential
(1)
(2)
(3)
(4)
(5)
(6)
(7)
%
%
%

%

%

%

%

%

%

%

%

%

%

%

Mark (X) this box if you attach a continuation sheet.
c.
Please identify which method you used to develop or obtain the specified chemical identity information (check one).
Method 1 (CAS Inventory Expert Service)

Method 2 (other source)

d.

The currently correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for similar polymers. **

e.

Provide a correct representative or partial chemical structure diagram, as complete as can be known, if one can be reasonably ascertained.

Mark (X) this box if you attach a continuation sheet.

Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 5

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 6 of 25

Draft version—NOT AN OFFICIAL FORM

Part I -- GENERAL INFORMATION -- Continued
Section B -- CHEMICAL IDENTITY INFORMATION -- Continued
3. Impurities
(a) Identify each impurity that may be reasonably anticipated to be present in the chemical substance as manufactured for commercial purpose. Provide the
CAS Registry Number if available. If there are unidentified impurities, enter “unidentified.”
(b) Estimate the maximum weight % of each impurity. If there are unidentified impurities, estimate their total weight %.
Impurity and CAS Registry Number
Maximum
Confipercent
dential
(a)
(b)
%

%

%

%

%

%

%

Mark (X) this box if you attach a continuation sheet.
4. Synonyms - Enter any chemical synonyms for the chemical identified in subsection 1 or 2.

Confidential

Mark (X) this box if you attach a continuation sheet.
5.

Trade identification - List trade names for the chemical substance identified in subsection 1 or 2.

Mark (X) this box if you attach a continuation sheet.
6. Generic chemical name -

If you claim chemical identify as confidential, provide a generic name for your substance that reveals the
specific chemical identity of the chemical substance to the maximum extent possible. Refer to the TSCA
Chemical Substance Inventory, 1985 Edition, Appendix B for guidance on developing generic names.

Mark (X) this box if you attach a continuation sheet.
7. Byproducts Describe any byproducts resulting from the manufacture, processing, use, or disposal of the chemical substance. Provide the CAS Registry
Number if available.
Byproduct
CAS Registry Number
Confi(1)
(2)
dential

Mark (X) this box if you attach a continuation sheet.
Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 6

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 7 of 25

Draft version—NOT AN OFFICIAL FORM

Part I -- GENERAL INFORMATION -- Continued
Section C -- PRODUCTION, IMPORT, AND USE INFORMATION:
Mark (X) the “Confidential” box next to any item you claim as confidential.
1. Production volume -- Estimate the maximum production volume during the first 12 months of production. Also estimate the maximum
production volume for any consecutive 12-month period during the first three years of production. Estimates should be on 100% chemical
substance basis.

Maximum first 12-month production (kg/yr)
(100% chemical substance basis)

Maximum 12-month production (kg/yr)
(100% chemical substance basis)

Confidential

2. Use Information -- Make separate confidentiality claims for the description of the category of use, the percent of production volume devoted to
each category, the formulation of the substance, and other use information. Mark (X) the “Confidential” Box next to any item you claim as
confidential.
a. (1) -- Describe each intended category of use of the chemical substance by function and application..
(2) -- Mark (X) this column if entry column (1) is confidential business information (CBI).
(3) -- Estimate the percent of total production for the first three years devoted to each category of use.
(4) -- Mark (X) this column if entry in column (4) is confidential business information (CBI).
(5) -- Estimate the percent of the substance as formulated in mixtures, suspensions, emulsions, solutions, or gels as manufactured for
commercial purposes at sites under your control associated with each category of use.
(6) -- Mark (X) this column if entry in column (6) is confidential business information (CBI).
(7) -- Indicate % of product volume expected for the listed “use” sectors. Mark more than one box if appropriate.
(8) -- Mark (X) this column if entry(ies) in column (8) is (are) confidential business information (CBI).
Category of use (1)

CBI

Production %

CBI

%

% in
Formulation
(5)
%

(by function and application i.e. a dispersive dye
for finishing polyester fibers)

(2)

(3)

(4)

%

%

%

%

%

%

%

%

%

%

%

%

CBI

(6)

Sitelimited

% of substance expected per use
(7)
Con-*
IndusComsumer
trial
mercial

CBI

(8)

* If you have identified a “consumer” use, please provide on a continuation sheet a detailed description of the use(s) of this chemical substance in consumer products.
In addition include estimates of the concentration of the chemical substance as expected in consumer products and describe the chemical reactions by which this
substance loses its identity in the consumer product.
Mark (X) this box if you attach a continuation sheet.
If you claim any category of use description in subsection 2a as confidential, enter a generic description of that category. Read the
Instructions Manual for examples of generic use descriptions.

b. Generic
use description

Mark (X) this box if you attach a continuation sheet.
3. Hazard Information -- Include a copy of reasonable facsimile of any hazard warning statement, label, material safety data sheet, or other information
which will be provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices for the safe
handing, transport, use, or disposal of the substance. List in part III hazard information you include.
Mark (X) this box if you attach hazard information.
Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 7

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 8 of 25

Draft version—NOT AN OFFICIAL FORM

Part I -- GENERAL INFORMATION – Continued
Section C –-Continued
Mark (X) the “CBI” box next to any item you claim as confidential.
4. State of manufacture or importation
Please specify:
a. Substance is at what stage of manufacture (importation)?
currently manufactured
will be manufactured
b. First/planned date of manufacture/import:

5. State of commercial availability
Please specify:
a. Substance is at what stage of commercial availability?
currently available
will be made available
b. First/planned date of commercial availability:

no plan to manufacture

not known

no plan to make commercially available

not known

6. Nanoscale properties. Briefly describe any unique or enhanced properties that arise from the nanoscale features of the material,
particularly in contrast to any non-nanoscale varieties that exist.

Mark (X) this box if you attach a continuation sheet.

7. Briefly explain why this material is designed and/or produced to be a nanoscale material.

Mark (X) this box if you attach a continuation sheet.

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 9 of 25

Draft version—NOT AN OFFICIAL FORM

CBI

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE
Section A – INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER

Mark (X) the “Confidential” box next to any item you
claim as confidential

Complete section A for each type of manufacture, processing, or use operation involving the chemical substance at industrial sites you control.
See instructions manual
1. Operation description
Confia. Identity -- Enter the identity of the site at which the operation will occur.
dential
Name

Site address (number and street)

City, County, State, ZIP code

If the same operation will occur at more than one site, enter the number of sites. Identify the
additional sites on a continuation sheet, and if any of the sites have significantly different
production rates or operations, include all the information requested in this section for those
sites as attachments.
Mark (X) this box if you attach a continuation sheet.

b.
c.

Type -Mark (X)

Manufacturing
Amount and Duration -- Complete 1 or 2 as appropriate

Processing

Maximum kg/batch (100%

chemical
substance)

Use

Hours/batch

Batches/year

Hours/day

Days/year

1. Batch
Maximum kg/day (100%

chemical
substance)

2. Continuous
d. Process description
(1) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify- e.g. 5 gallon pails, 55 gallon
drum, rail car, tank truck, etc.).
(2) Provide the identity, the approximate weight (by kg/day or kg/batch on a 100% chemical substance basis), and entry point of all starting materials and
feedstocks (including reactants, solvents, catalysts, etc.), and of all products, recycle streams, and wastes. Include cleaning chemicals (note frequency if not
used daily or per batch.).
(3) Identify by number the points of release, including small or intermittent releases, to the environment of the chemical substance. If releasing to two media at
the same step, assign a second release number for the second medium.

Mark (X) this box if you attach a continuation sheet.
Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 8

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 10 of 25

Draft version—NOT AN OFFICIAL FORM

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued
Section A – INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER – Continued
2. Occupational Exposure -- Make separate confidentiality claims for the description of worker activity, physical form of the chemical substance, number of workers
exposed, and duration of activity. Mark (X) the “Confidential” box next to any item you claim as confidential.
(1) -- Describe the activities (i.e. bag dumping, tote filling, unloading drums, sampling, cleaning, etc.) in which workers may be exposed to the substance.
(2) -- Mark (X) this column if entry in column (1) is confidential business information (CBI).
(3) -- Describe any protective equipment and engineering controls used to protect workers.
(4) -- Indicate the physical form(s) of the chemical substance (e.g., solid: crystal, granule, powder, or dust) and % chemical substance (if part of a mixture) at the
time of exposure.
(5) -- Mark (X) this column if entry in column (4) is confidential business information (CBI).
(6) -- Estimate the maximum number of workers involved in each activity for all sites combined.
(7) -- Mark (X) this column if entry in column (6) is confidential business information (CBI).
(8) and (9) -- Estimate the maximum duration of the activity for any worker in hours per day and days per year.
(10) -- Mark (X) this column if entries in columns (8) and (9) are confidential business information (CBI).
CBI
Physical forms(s)
CBI
CBI
Maximu
duration CBI
Worker activity
Protective Equipment/
# of
(i.e., bag dumping, filling drums)
(2)

(1)

and % substance
(4)

Engineering Controls

(5)

(3)

Workers
Expose
d
(6)

(7)

m
Hrs/day

Days/yr

(8)

(9)

(10)

Mark (X) this box if you attach a continuation sheet.
3. Environmental Release and Disposal -- Make separate confidentiality claims for the release number and the amount of the chemical substance released and other
release and disposal information. Mark (X) the “Confidential” box next to each item you claim as confidential.
(1) -- Enter the number of each release point identified in the process description, part II, section A, subsection 1d(3).
(2) -- Estimate the amount of the substance released (a) directly to the environment or (b) into control technology (in kg/day or kg/batch).
(3) -- Mark (X) this column if entries in columns (1) and (2) are confidential business information (CBI).
(4) -- Identify the media (stack air, fugitive air (optional-see Instruction Manual), surface water, on-site or off-site land or incineration, POTW, or other (specify)) to
which the substance will be released from that release point.
(5) -- a. Describe control technology, if any, and control efficiency that will be used to limit the release of the substance to the environment. For releases disposed
of on land, characterize the disposal method and state whether it is approved for disposal of RCRA hazardous waste. On a continuation sheet, for each site
describe any additional disposal methods that will be used and whether the waste is subject to secondary or tertiary on-site treatment. b. Estimate the amount
released to the environment after control technology (in kg/day).
(6) -- Mark (X) this column if entries in columns (4) and (5) are confidential business information (CBI).
(7) -- Identify the destination(s) of releases to water. Please supply NPDES (National Pollutant Discharge Elimination System) numbers for direct discharges or
NPDES numbers of the POTW (Publicly Owned Treatment Works). Mark (X) if the POTW name or NPDES # is confidential business information (CBI).
CBI
Release Amount of substance released CBI Media of
Control technology and efficiency (you may wish to optionally attach efficiency data)
release
Number
e.g. stack air
(1)
(2a)
(2b)
(4)
(3)
(5a)
(5b)
(6)

(7) Mark (X) the

POTW provide name(s) below:

destination(s) of
releases to water.

CBI

Navigable
waterway

Other - Specify

provide NPDES #

CBI

Mark (X) this box if you attach a continuation sheet.
Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 9

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 11 of 25

Draft version—NOT AN OFFICIAL FORM

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued
Section B – INDUSTRIAL SITES CONTROLLED BY OTHERS
Complete section B for typical processing or use operations involving the chemical substance at sites you do not control. See the Instructions Manual. Complete a
separate section B for each type of processing, or use operation involving the chemical substance. If the same operation is performed at more than one site describe the
typical operation common to these sites. Identify additional sites on a continuation sheet.

1. Operation Description -- To claim information in this section as confidential, circle or bracket the specific information that you claim as confidential.
(1) -- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers (specify - e.g. 5 gallon pails, 55 gallon
drums, rail cars, tank trucks, etc). On the diagram, identify by letter and briefly describe each worker activity. (2) -- Provide the identity, the approximate weight
(by kg/day or kg/batch, on a 100% chemical substance basis), and entry point of all feedstocks (including reactants, solvents and catalysts, etc) and all products,
recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) -- Identify by number the points of release, including
small or intermittent releases, to the environment of the chemical substance. (4) Please enter the # of sites (remember to identify the locations of these sites on a
continuation sheet):

# of sites

Mark (X) this box if you attach a continuation sheet.
2. Worker Exposure/Environmental Release
(1) -- From the diagram above, provide the letter for each worker activity. Complete 2-8 for each worker activity described.
(2) -- Estimate the number of workers exposed for all sites combined.
(4) -- Estimate the typical duration of exposure per worker in (a) hours per day and (b) days per year.
(6) -- Describe physical form of exposure and % chemical substance (if in mixture), and any protective equipment and engineering controls, if any, used
to protect workers.
(7) -- Estimate the percent of the substance as formulated when packaged or used as a final product.
(9) -- From the process diagram above, enter the number of each release point. Complete 9-13 for each release point identified.
(10) -- Estimate the amount of the substance released (a) directly to the environment or (b) into control technology to the environment (in kg/day or
kg/batch).
(12) -- Describe media of release i.e. stack air, fugitive air (optional-see Instructions Manual), surface water, on-site or off-site land or incineration,
POTW, or other (specify) and control technology, if any, that will be used to limit the release of the substance to the environment.
(14) -- Identify byproducts which may result from the operation.
(3), (5), (8), (11), (13) and (15) -- Mark (X) this column if any of the proceeding entries are confidential business information (CBI).
Letter
of
Activity

# of
Workers
Exposed

CBI

(1)

(2)

(3)

Duration
of
Exposure
(4a)

(4b)

CBI

Protective Equip. /
Engineering Controls/
Physical Form and %
substance
(6)

(5)

% in
Formulation

CBI

Release
Number

(7)

(8)

(9)

(14) -- Byproducts:

Amount of
Substance
Released
(10a)

(10b)

CBI

Media of Release
& Control
Technology

CBI

(11)

(12)

(13)

(15)

Mark (X) this box if you attach a continuation sheet,
Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 10

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 12 of 25

Draft version—NOT AN OFFICIAL FORM

Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued
Section A / B, Subsection 2. Occupational Exposure – Continued. b. Details of protective equipment / engineering controls.
(Use this form both for sites controlled by submitter and by others. Make copies as necessary.)
Please provide the following information:
(1) –The worker activities listed in Section A.2 or B.1 for which protective equipment/engineering controls are in use.
(2) – A brief description of the rationale for selecting the protective equipment/engineering controls, including internal exposure
control limits, data and the methods used to generate the data that informed the decision.
(3) – A brief description of the cleaning, reuse, and/or disposal of the protective equipment
(4) – A brief description of any data (personal and/or area), units (e.g., mass conc., surface area, or particle number conc.) and
any exposure monitoring methods used.
Mark (X) in the “CBI” column next to any item you claim as confidential.

CBI

(1) Worker activity / Protective equipment / Engineering Control
(2) Rationale for selecting equipment / controls, associated internal exposure control limit / data / methods

Mark (X) this box if you attach a continuation sheet.

(3) Cleaning, reuse, and/or disposal of protective equipment

Mark (X) this box if you attach a continuation sheet.

(4) Exposure monitoring data (personal and/ or area), units (e.g., mass conc., surface area, or particle number conc.), and
methods used

Mark (X) this box if you attach a continuation sheet.
Mark (X) this box if you attach a continuation sheet.

Section A.3 / Section B, subsection 2. Environmental Release and Disposal – Continued. Details of control technology.
(Use this form both for sites controlled by submitter and by others. Make copies as necessary)
To assist EPA in gaining a better understanding of the need for and the types of control technology used at the release points in the manufacture and
handling of engineered nanoscale materials, please provide the following information for each release point for which control technology is used:
(1) – The Release Number, as identified in the process description, part II, section A, subsection 1d(3) (page 8).
(2) – A brief description of the rationale for selecting the control technology.
(3) – Data and measurement methods of waste treatment efficiency studies.

Release
Number (1)
(2) Rationale for selecting control technology

Mark (X) in the “CBI” column next to any item you claim as confidential.

CBI

Mark (X) this box if you attach a continuation sheet.

(3) Data and measurement methods of waste treatment or purification studies

Mark (X) this box if you attach a continuation sheet.
Mark (X) this box if you attach a continuation sheet.

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 13 of 25

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Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued
Section C – Lifecycle
Mark (X) the “CBI” box next to any item you claim as confidential.
1. In addition to the information already given, provide a brief overview of the lifecycle of the material, including all workplaces that
manufacture, process, or use the material, methods of packaging and transporting the material, all expected general population,
environmental, and consumer uses, and the expected manufacturing and processing methods of the material or any consumer products
containing the material. If not included in Sections A or B above, include a description of the end of life disposal or disposition of products
containing the nanoscale material.

CBI

Mark (X) this box if you attach a continuation sheet.

Section D – Misc. Health, Exposure, Hazard Information
Mark (X) the “CBI” box next to any item you claim as confidential.
1. Describe any training, hazard communication (e.g. MSDS), etc. specific to the nanoscale material that is provided to workers.

CBI

Mark (X) this box if you attach a continuation sheet.

2. Estimate the total number of individuals—other than previously described workers—(e.g. general public, consumers) who may be
exposed to the material and the duration of the exposure.

Mark (X) this box if you attach a continuation sheet.

3. Describe any other procedure, equipment, etc. being used to mitigate exposure to the material.

Mark (X) this box if you attach a continuation sheet.

4. Describe product labeling and any customer training specific to the nanoscale material.

Mark (X) this box if you attach a continuation sheet.

5. Describe other risk management practices specific to the nanoscale material.

Mark (X) this box if you attach a continuation sheet.

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 14 of 25

Draft version—NOT AN OFFICIAL FORM

POLLUTION PREVENTION INFORMATION
To claim information in this section as confidential circle or bracket the specific information that you claim as confidential.

In this section you may provide information not reported elsewhere in this form regarding your efforts to reduce
or minimize potential risks associated with activities surrounding manufacturing, processing, use and disposal
of the substance. Please include new information pertinent to pollution prevention, including source reduction,
recycling activities and safer processes or products available due to the chemical substance. Source reduction
includes the reduction in the amount or toxicity of chemical wastes by technological modification, process and
procedure modification, product reformulation, raw materials substitution, and/or inventory control. Recycling
refers to the reclamation of useful chemical components from wastes that would otherwise be treated or
released as air emissions or water discharges, or land disposal. Descriptions of pollution prevention, source
reduction and recycling should emphasize potential risk reduction subsequent to compliance with existing
regulatory requirements and can be either quantitative or qualitative. EPA is interested in the information to
assess overall net reductions in toxicity or environmental releases and exposures, not the shifting of risks to
other environmental media or non-environmental areas (e.g., occupational or consumer exposure). In addition,
information on the relative cost or performance characteristics of the substance to potential alternatives may be
provided.
See Instructions Manual and Pollution Prevention Guidance manual for guidance and examples.
Describe the expected net benefits, such as (1) an overall reduction in risk to human health or the environment; (2) a reduction in the
volume manufactured; (3) a reduction in the generation of waste materials through recycling, source reduction or other means; (4) a
reduction in potential toxicity or human exposure and/or environmental release; (5) an increase in product performance, a decrease in
the cost of production and/or improved operation efficiency of the chemical substance in comparison to existing chemical substances
used in similar application; or (6) the extent to which the chemical substance may be a substitute for an existing substance that poses a
greater overall risk to human health or the environment.

Mark (X) this box if you attach a continuation sheet.
Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 11

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 15 of 25

Draft version—NOT AN OFFICIAL FORM

Part III -- LIST OF ATTACHMENTS
Attach continuation sheets for sections of the form and test data and other data (including physical/chemical properties and
structure/activity information), and optional information after this page. Clearly identify the attachment and the section of the form to
which it relates, if appropriate. Number consecutively the pages of the attachments. In the column below, enter the inclusive page
numbers of each attachment.
Mark (X) the “Confidential” box next to any attachment name you claim as confidential. Read the Instructions Manual for guidance on
how to claim any information in an attachment as confidential. Include with the sanitized copy of the form a sanitized version of any
attachment in which you claim information as confidential.
Attachment name

Attachment
page number(s)

Confidential

Material Safety Data Sheet (MSDS)

Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number.
Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 12

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 16 of 25

Draft version—NOT AN OFFICIAL FORM

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET **
To assist EPA’s review of physical and chemical properties data, please complete the following worksheet for data you provide and include it in the form. Identify the
property measured, the page of the form on which the property appears, the value of the property, the units in which the property is measured (as necessary), and whether
or not the property is claimed as confidential. The physical state of the neat substance should be provided. These measured properties should be for the neat (100% pure)
chemical substance. Properties that are measured for mixtures or formulations should be so noted (% substance in __).
Mark
Measured ConfiProperty
Page
Value
(X) if number
or Estimate dential
Mark (X)
provided (b)
(a)
(c)
(d)
(M or E)

(s)

Physical state of neat substance
Vapor pressure
@ Temperature

°C

(g)

Torr

Density/relative density
Solubility
@ Temperature

(l)

g/cm3

°C

Solvent
Solubility in water @ Temperature

g/L
°C

g/L

Melting temperature
Boiling / sublimation temperature@

°C
torr pressure

°C

Spectra
Dissociation constant

Octanol / water partition coefficient
Henry’s Law constant
Volatilization from water
Volatilization from soil
pH

@ concentration

Flammability
Explodability
Adsorption / coefficient

Based on PMN Form EPA 7710-25 (Rev. 5-95) Page 13

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 17 of 25

Draft version—NOT AN OFFICIAL FORM

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET II
To assist EPA in understanding the types of characterization data typically available for engineered nanoscale materials and the cost of obtaining that
data, for each of the physical and chemical properties submitted on page 16, provide: the approximate cost of obtaining data, the method used to obtain
the data, and, if a particular piece of data was not collected, a brief reason why. If non-standard methods were used in the collection of data, briefly
describe them.
Property

Mark
(X) if
provided

Confidential
Mark (X)

Method used

Approx. Cost

Confidential
Mark (X)

Physical state of neat substance
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Vapor pressure
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Density/relative density
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Solubility in solvent
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Solubility in water
Mark (X) if description of method attached

If not provided, why?:

Too much test material required

No known method

Other (specify):

Melting temperature
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Boiling / sublimation temperature
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Spectra
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Dissociation constant
Mark (X) if description of method attached

If not provided, why?:

Too much test material required

No known method

Other (specify):

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 18 of 25

Draft version—NOT AN OFFICIAL FORM

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET II – Continued
Mark
(X) if
provided

Property

Confidential
Mark (X)

Method used

Approx. Cost

Confidential
Mark (X)

Octanol / water partition coefficient
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Henry’s Law constant
Mark (X) if description of method attached

If not provided, why?:

Too much test material required

No known method

Other (specify):

Volatilization from water
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Volatilization from soil
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

pH
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Flammability
Mark (X) if description of method attached

If not provided, why?:

Too much test material required

No known method

Other (specify):

Explodability
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Adsorption / coefficient
Mark (X) if description of method attached

If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 19 of 25

Draft version—NOT AN OFFICIAL FORM

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET III – Nanoscale Materials Specific Data
Please provide the additional chemical and physical characterization data listed below. Additional pages may be attached to provide more
information.
Property

Mark (X) Mark (X)
if
if page
provided attached

Value

Measured / CBI
Estimated Mark
(M or E) (X)

General Characteristics
Crystal structure
Agglomeration state
Particle Characteristics
Particle size distribution

Provide graph with percentage of particles in each diameter
class. For elongated particles, provide length distribution
graph showing the percentage of particles in each length class.

Mean particle size (diameter and/or length)

nm

Standard deviation from mean
Largest particle size (diameter and/or length)

nm

Smallest particle size (diameter and/or length)

nm

Aspect ratio
Average aerodynamic diameter

nm

Average particle mass

g

Particle shape
Surface Characteristics
Surface area

m2/g

Average particle surface area

m2

Surface charge (Zeta potential)

mV

Porosity
Surface chemical composition
Surface / volume ratio
Other
Other

Mark (X) this box if you attach a continuation sheet.

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 20 of 25

Draft version—NOT AN OFFICIAL FORM

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET III cont– Nanoscale Materials Specific Data
Please provide the additional chemical and physical characterization data listed below. Additional pages may be attached to provide more
information.
Property

Mark (X) Mark (X)
if
if page
provided attached

Value

Measured / CBI
Estimated Mark
(M or E) (X)

Fate and Transport
Diffusion rate
Gravitational settling rate
Sorption rate
Deposition rate
Wet and dry transport
Biodegradation rate
Bioaccumulation
Biotransformation
Influence of redox/photochemical reaction
Other
Other
Mark (X) this box if you attach a continuation sheet.

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 21 of 25

Draft version—NOT AN OFFICIAL FORM

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET IV
To assist EPA in understanding the types of characterization data typically available for engineered nanoscale materials and the cost of obtaining that data, for each of
the physical and chemical properties submitted on page 19, provide: the approximate cost of obtaining data, the method used to obtain the data, and, if a particular
piece of data was not collected, a brief reason why. If non-standard methods were used in the collection of data, briefly describe them.
Confi- Approx. Cost ConfiMark
Property
Method used
dential
Mark (X)

(X) if
provided

dential
Mark (X)

Crystal structure
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Agglomeration state
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Particle size distribution
Mark (X) if description of method attached
If not provided, why?:

Too much test material required

No known method

Other (specify):

Mean particle size and standard deviation
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Largest particle size
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Smallest particle size
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Aspect ratio
Mark (X) if description of method attached
If not provided, why?:

Too much test material required

No known method

Other (specify):

Average aerodynamic diameter
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Average particle mass
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 22 of 25

Draft version—NOT AN OFFICIAL FORM

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET IV continued
Property

Mark
(X) if
provided

Method used

Confi- Approx. Cost Confidential
dential
Mark (X)
Mark (X)

Particle shape
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Surface area
Mark (X) if description of method attached
If not provided, why?:

Too much test material required

No known method

Other (specify):

Average particle surface area
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Surface charge
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Porosity
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Surface chemical composition
Mark (X) if description of method attached
If not provided, why?:

Too much test material required

No known method

Other (specify):

Surface / volume ratio
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Diffusion rate
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Gravitational settling rate
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 23 of 25

Draft version—NOT AN OFFICIAL FORM

PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET IV continued
Mark
(X) if
provided

Property

Method used

Confi- Approx. Cost Confidential
dential
Mark (X)
Mark (X)

Sorption rate
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Deposition rate
Mark (X) if description of method attached
If not provided, why?:

Too much test material required

No known method

Other (specify):

Wet and dry transport
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Biodegradation rate
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Bioaccumulation
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Biotransformation
Mark (X) if description of method attached
If not provided, why?:

Too much test material required

No known method

Other (specify):

Influence of redox / photochemical reaction
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Other
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Other
Mark (X) if description of method attached
If not provided, why?:

Not applicable

Too expensive

Too much test material required

No known method

Other (specify):

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 24 of 25

Draft version—NOT AN OFFICIAL FORM

** Notes
Part I
1. Section B: It is recognized that systematic nomenclature has not been fully developed for nanoscale materials,
therefore it is not necessary to provide the “correct Chemical Abstract name” nor the “CAS Registry Number,”
if it does not exist. Please fill out these sections to the best of your ability in light of the limitations.
a. B.1.a: It is noted that a nanoscale material may or may not be accurately described as a Class 1 or Class
2 substance. If the choice is not obvious, this section may be left blank. In addition, a brief explanation
may be given for why a particularly classification is or is not appropriate.
b. B.1.b / B.2.d: If a Chemical Abstracts Name is not available, please use a name that is most in
agreement with CA nomenclature.
c. B.1.d may be read as:
d. Molecular formula (including molecular shape / physical form) and CAS Registry Number (if a
number already exists for the substance).
d. B.1.e: For the nanoscale material, please provide the information requested for Class 2 substances,
regardless of whether the material is Class 1 or Class 2 or cannot be determined.
e. B.2.e may be read as:
"Provide a correct representative or partial chemical structure diagram, as complete as can be
known, if one can be reasonably ascertained. Alternatively, if applicable, provide a correct
representative structure for the polymer as part of a composite."
i. [Note: the components of a composite are separate chemical identities. For example in a
composite of starch molecules between layers of clay treated with surfactants, the starch, clay,
and surfactants might be on the TSCA Inventory, but since the interactions between the
components are weak electrical interactions, there is no chemical substance.]

Physical and Chemical Properties Worksheet
1. It is noted that, for nanoscale materials, protocols and methods may not exist or be standardized for
measurement of the physical and chemical properties listed in this worksheet.

Based on EPA FORM 7710-25 (Rev. 5-95).

Page 25 of 25


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File TitleMicrosoft Word - NMSP reporting form -2007-10-30.doc
Authorahofmann
File Modified2007-10-30
File Created2007-10-30

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