Draft – 12/27/16

08-29-2016 Version. - Form Not Yet Approved. 

U.S. ENVIRONMENTAL PROTECTION AGENCY

AGENCY USE ONLY:	Document control number	EPA case  number	Date of
receipt

When completed 

send this form to

U.S. E.P.A. 

DOCUMENT CONTROL OFFICER (7407M)

1200 PENNSYLVANIA AVE. NW

WASHINGTON, D.C. 20460

ATTN: 8(a) Reporting for Chemical Substances Manufactured or Processed
as Nanoscale Materials

	

	

GENERAL INSTRUCTIONS

This form is to be used for reporting as prescribed in 40 CFR 704.20. 
As indicated in that regulation, definitions in TSCA and 40 CFR part 704
apply.

You must provide information requested in this form to the extent it is
known to or reasonably ascertainable by you. “Known to or reasonably
ascertainable by” is defined in 40 CFR §704.3. Make reasonable
estimates if you do not have actual data.  

You must provide the currently correct Chemical Abstracts (CA) name of
the chemical substance and material characterization data described in
Part I, section C4 when it is known or reasonably ascertainable. 

As much of this form is adapted from the Premanufacture Notice (PMN)
form (EPA Form No. 7710-25), 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, 202-554-1404, or 202-554-5603(fax) or at
https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-contr
ol-act-tsca/instruction-manual-reporting-under.

If there are several manufacture, processing, or use operations to be
described in Part II, sections A and B of this form, reproduce the
sections as needed.

Attach additional sheets if there is not enough space to answer a
question fully.  Label each continuation sheet with the corresponding
section heading.  In Part III of this Form, list all attachments,
including any continuation sheets, any test data reports or other data
and any optional information provided.  

Only one chemical substance may be submitted per form unless you have
consulted with EPA to submit a consolidated notice.

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) must be
provided with your submission and should be labeled as such.   

You are required to submit all existing data concerning the
environmental and health effects of the substance known to or reasonably
ascertainable by you.  Standard literature citations may be submitted
for data in the open scientific literature.  Submit a complete test data
report (written in English, if available), not summary data, unless the
test data report appears in the open literature.  Clearly identify
whether test data is on the chemical substance, on an analog, or from
models.  Characterize the chemical composition of the tested material.

You may want to consult with your customers or suppliers about the
confidentiality of any information you report about them on this form. 



TEST DATA   

Data must be submitted according to the requirements of 40 CFR §704.20.
 In addition, hazard and exposure test data are 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 is not required but can assist in
interpretation.  Indicate which of the following data are included in
this submission:

  FORMCHECKBOX   Physical / Chemical properties

  FORMCHECKBOX   Structure / activity relationships	    FORMCHECKBOX  
Health effects

    FORMCHECKBOX   Exposure	      FORMCHECKBOX   Environmental effects

      FORMCHECKBOX   Environmental fate



    FORMCHECKBOX  	Mark (x) if any information in your submission
package is claimed as confidential.



TIME REQUIRED TO COMPLETE THE FORM

EPA estimates that it may take, up to 175 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. More details about the EPA estimate are
provided in the Information Collection Request identified as EPA ICR No.
2517.01, approved under OMB Control No. 2070-[tbd], a copy of which is
available here [insert url when finalized]. To help us refine that
estimate, please provide an estimate of the amount of time in work hours
that it took you to complete this form.	Hours:

        

       FORMCHECKBOX    I authorize sharing of all confidential business
information with Environment and Climate Change Canada and Health
Canada. 

             Any shared confidential information would be subject to the
confidential business information protection laws and policies of 

             those agencies.



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”).

	  FORMCHECKBOX   Physical and chemical characterization

	  FORMCHECKBOX   Risk management information

CERTIFICATION

 

   I certify that to the best of my knowledge and belief that all
information entered on this form is complete and accurate. 

The company named in Part I, section A, subsection 1a of this form
manufactures, imports, or processes or intends to manufacture, import,
or process for a commercial purpose (as those terms are defined in TSCA
and 40 CFR Part 704), the chemical substance identified in Part I
section B.  

I am submitting with this form all existing data concerning the
environmental and health effects and all other required data known to or
reasonably ascertainable by me as required by 40 CFR §704.20. 

   I further certify that, pursuant to 15 U.S.C. § 2613(c), for all
claims for protection for any confidential information made with this 

   submission, all information submitted to substantiate such claims is
true and correct, and that it is true and correct that the person

   submitting the claim has: 

taken reasonable measures to protect the confidentiality of the
information;

determined that the information is not required to be disclosed or
otherwise made available to the public under any other 

Federal law.  

   (iii) a reasonable basis to conclude that disclosure of the
information is likely to cause substantial harm to the competitive
position     

    of the person; and  

(iv) a reasonable basis to conclude that disclosure of the information
is not readily discoverable through reverse engineering.

 

 Mark (X) the “Confidential” box on the right if you claim the
signature and title as confidential.	Confidential

Signature and title of Authorized Official (Original Signature Required)

 	Date

	

  FORMCHECKBOX  



Part I -- GENERAL INFORMATION

Section A -- SUBMITTER IDENTIFICATION	Confi-

Mark (X) the “Confidential” box in the right column next to any
subsection you claim as confidential	Dential

1a.	Person Submitting 

       (in U.S.)	Name of authorized official

   FORMTEXT   	Position

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	Company

 

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Mailing address (number and street)

   FORMTEXT   	     FORMCHECKBOX  	

	City, State, ZIP Code

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 b.	Other Person Submitting     (in U.S.)	Name of authorized official

  FORMTEXT   	Position

  FORMTEXT   	

  FORMTEXT   

	Company

  FORMTEXT   



Mailing address (number and street)

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

	  FORMCHECKBOX  

	Joint Submitter (if applicable)	Name of authorized official

  FORMTEXT   	Position

  FORMTEXT   	

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	Company

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Mailing address (number and street)

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	City, State, ZIP Code	Telephone	Area Code	Number



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

   FORMTEXT   	Position

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	Company

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Mailing address (number and street)

   FORMTEXT   	  FORMCHECKBOX  

	City, State, ZIP Code	Telephone	Area Code	Number



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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, 2, or unknown substances) or 2
(Polymers) as appropriate.  Complete all other items.

	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.	  FORMCHECKBOX  	Confi-

	dential

1.	Class 1, 2, or unknown chemical substances (for definitions of class
1 and class 2 substances, see the Instructions Manual) 

	a.	Class of substance - Mark (X)	1	  FORMCHECKBOX  	Class 1         2  
 FORMCHECKBOX     Class  2    or    3     FORMCHECKBOX     Unknown

		b.	Chemical name (Currently correct Chemical Abstracts (CA) Name that
is consistent with TSCA Inventory listings for similar substances.  **

		 



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

		  FORMCHECKBOX  	Method 1 (CAS Inventory Expert Service 	 
FORMCHECKBOX  	Method 2 (Other Source)

		d.	Molecular formula and CAS Registry Number (if a number already
exists for the substance)  

	  FORMTEXT   	CAS#

		  FORMTEXT   

		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.   (5)
Note: the components of a composite can be 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 single chemical substance
representing the composite as a whole.  

	

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



Part I -- GENERAL INFORMATION – Continued

Section B -- CHEMICAL IDENTITY INFORMATION – Continued

2.	Polymers (For a definition of polymer, see the Instructions Manual.)
Confi-

dential

	a.	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:
GPC	  FORMCHECKBOX  		Other      FORMCHECKBOX  :	(Specify)		  FORMTEXT  
		

		i)	lowest number average molecular weight:		  FORMTEXT   	

		ii)	maximum weight % below 500 molecular weight:		  FORMTEXT   	

		iii)	maximum weight % below 1000 molecular weight:		  FORMTEXT   	



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

	b.	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

(1)	Confi-

dential

(2)	Typical

composition

(3)	Identity

(4)	Confi-

dential

(5)	Maximum

residual

(6)	Confi-dential

(7)

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		c.	Identify which method you used to develop or obtain the specified
chemical identity information (check one).   

	  FORMCHECKBOX  	Method 1	(CAS Inventory Expert Service)	  FORMCHECKBOX
 	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. 

	



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

 (a)	Maximum

percent

(b)	Confi-

dential

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	  FORMCHECKBOX  		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.	Confi-

dential

  FORMTEXT   

	  FORMCHECKBOX  		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.

	

  FORMTEXT   

	  FORMCHECKBOX  		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.

			  FORMTEXT   

  FORMCHECKBOX  		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

(1)	CAS Registry Number

(2)	Confi-



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 – Report the production volume during calendar
year 20XX.  Also estimate the maximum production volume for any
consecutive 12-month period during the next three years of production. 
Make estimates on a 100% chemical substance basis.  

 Production volume for 20XX (kg/yr)

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

(100% chemical substance basis)	Confi-dential

	

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	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 category of use of the chemical substance by
function and application.

		(2) --	Mark (X) this column if entry column (1) is claimed as
confidential business information (CBI).

		(3) --	Estimate the percent of total production volume devoted to each
category of use.

		(4) --	Mark (X) this column if entry in column (4) is claimed as 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 claimed as 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)
claimed as CBI.

Category of use (1)	CBI

Produc-tion %	CBI	% in

Form-	CBI	% of substance expected per use

(7)	CBI

(by function and application i.e. a coating for automobile body parts)	

(2)



(3)	

(4)	ulation

(5)	

(6)	Site-

limited	Con-*

sumer	Indus-trial	Com-mercial



(8)

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*	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.

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

	b.	Generic

		use description	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.

			  FORMTEXT   



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

3.	Hazard Information -- Include a copy or reasonable facsimile of any
hazard warning statement, label, material safety data sheet, or other
information which is 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.

	



Part I – GENERAL INFORMATION – Continued

Section C –-Continued

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

  4. Material characterization – Describe characteristics of the
nanoscale material used to distinguish it from other discrete forms

      of the nanoscale material, as described in 40 CFR 704.20,
including but not limited to the particle size, morphology,
encapsulation,

      and formulation.

   

 

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

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

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

   FORMCHECKBOX  

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

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

   FORMCHECKBOX  



Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE

Section A – INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER	Mark (X) the
CBI 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

		a.	Identity -- Enter the identity of the site at which the operation
occurs.	   CBI

	Name

   FORMTEXT   	  FORMCHECKBOX    FORMTEXT   

	Site address (number and street)

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City, County, State, ZIP code

	If the same operation occurs 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.

  FORMTEXT   	

  FORMCHECKBOX    FORMTEXT   

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

			b.	Type --

			Mark (X)	

  FORMCHECKBOX  	Manufacturing	

  FORMCHECKBOX  	Processing	

  FORMCHECKBOX  	Use

		c.	Amount and Duration -- Complete 1 or 2 as appropriate





1.	Batch	Maximum kg/batch (100%  chemical substance)

   FORMTEXT    	Hours/batch

  FORMTEXT    	Batches/year

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2.	Continuous	Maximum kg/day (100%  chemical substance)

  FORMTEXT     	Hours/day

  FORMTEXT    	Days/year

  FORMTEXT    	  FORMCHECKBOX  

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.





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) in the
“CBI” column 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 claimed 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 claimed 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 claimed 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 claimed CBI.

Worker activity	CBI	Protective Equipment/

Physical forms(s)

CBI	# of	CBI	Maximum	  Duration	  CBI

(i.e., bag dumping, filling drums)

(1)	

(2)	Engineering Controls

(3)

and %  substance

(4)



(5)	Workers Exposed

(6)	

(7)	Hrs/day

(8)	  Days/yr

(9)	

(10)

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  FORMCHECKBOX  	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) in the
CBI column 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) in this column if entries in columns (1) and (2) are
claimed as 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 is
released from that release point.

	(5) --	a.  Describe control technology, if any, and control efficiency
that is 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 is 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) in this column if entries in columns (4) and (5) are
claimed as 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 claimed as CBI.

Release

Number	Amount of substance released	CBI	Media of

release	Control technology and efficiency (you may wish to optionally
attach efficiency data)	CBI

(1)	(2a)	(2b)	

(3)	e.g. stack air

(4)	

(5a)



(5b)	

destination(s) of releases to water.

	

  FORMTEXT   	  FORMTEXT   		waterway

  FORMTEXT   	

  FORMTEXT   	

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



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):

	  FORMTEXT   			

# of sites				

  FORMCHECKBOX  	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
that is used to limit the release of the substance to the environment. 

	(14)	--     Identify byproducts which result from the operation.

	(3), (5), (8), (11), (13) and (15) -- Mark (X) in these columns if any
of the proceeding entries are claimed as CBI.

Letter

of

Act-ivity	# of

Workers

Exposed	CBI	Duration 

of

Exposure	CBI	Protective Equip. /

Engineering Controls/

Physical Form and %

Substance	% in

Form-

ulation	CBI	Release

Number	Amount of

Substance

Released	CBI	Media of Release

& Control

Technology	CBI

(1)	(2)	(3)	(4a)	(4b)	(5)	(6)	(7)	(8)	(9)	(10a)	(10b)	(11)	(12)	(13)

  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	 
FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	 
FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   

  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	 
FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	 
FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   

  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	 
FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	 
FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   

  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	 
FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	 
FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   	  FORMTEXT   

(14) -- Byproducts:

  FORMTEXT   	(15)



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.)

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	 
FORMCHECKBOX  

	 (2) Rationale for selecting equipment / controls, associated internal
exposure control limit / data / methods

	  FORMCHECKBOX  



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



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

	  FORMCHECKBOX  



	  FORMCHECKBOX  	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

	  FORMCHECKBOX  



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

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

	(2) Rationale for selecting control technology

	  FORMCHECKBOX  







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



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

	  FORMCHECKBOX  



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

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



Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE – Continued



Section C – Misc. Health, Exposure, Hazard Information

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

1. Describe any training, hazard communication (e.g. MSDS), etc.
specific to the nanoscale material that is provided to workers.	 
FORMCHECKBOX  





  FORMCHECKBOX  	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.	  FORMCHECKBOX  





  FORMCHECKBOX  	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.	  FORMCHECKBOX  





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

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





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

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





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



Part III - OPTIONAL 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 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.

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



Part IV -- LIST OF ATTACHMENTS



List and then attach continuation sheets for sections of the form; test
data and other data (including physical/chemical properties and
structure/activity information), and optional information you are
providing.  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) in the “Confidential” column 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)	Confi-dential





PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET

1.     To assist EPA’s review of physical and chemical properties
data, summarize data you have already provided or used to complete the
reporting 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), the physical state of the
neat substance, and whether or not the property is claimed as
confidential.  If properties are not measured for the neat (100% pure)
chemical substance then the measured mixtures or formulations can be
noted (% substance in __).    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.

 	Mark (X) if provided	Page number 	Value

	Measured or Estimate

(M or E)	Confi-dential Mark (X)



	

	Physical state of neat substance

	

		 (s)		 (l)		 (g)





	Vapor pressure

		@ Temperature				°C

	

						Torr		

	

	Density/relative density

	

						g/cm3

	



	Solubility

		@	Temperature 			°C

		Solvent				

	

						g/L





	Solubility in water @ Temperature			°C

	

						g/L			

	

	Melting temperature

	

						°C			

	

	Boiling / sublimation temperature@		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





	







	







	



PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET Cont – Nanoscale Materials
Specific Data

2.      To assist EPA’s review of physical and chemical properties
data, summarize data you have already provided or used to complete the
reporting 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), the physical state of the
neat substance, and whether or not the property is claimed as
confidential.  If properties are not measured for the neat (100% pure)
chemical substance then the measured mixtures or formulations can be
noted (% substance in __).    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. 

Property	Mark (X)  

if provided	Page number	Value	Measured / Estimated

(M or E)	CBI

 Mark (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



















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



PHYSICAL AND CHEMICAL PROPERTIES WORKSHEET Cont– Nanoscale Materials
Specific Data

3.     To assist EPA’s review of physical and chemical properties
data, summarize data you have already provided or used to complete the
reporting 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), the physical state of the
neat substance, and whether or not the property is claimed as
confidential.  If properties are not measured for the neat (100% pure)
chemical substance then the measured mixtures or formulations can be
noted (% substance in __).    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. 

  	Mark (X)  

if provided	Page   

number	Value	Measured / Estimated

(M or E)	CBI

Based on EPA FORM 7710-25  						Page   PAGE  1  of   NUMPAGES  18 		   
                  

ATTACHMENT

PAGE    PAGE  14 

Page 10-NMSP-2

Identical to PMN Form EPA 7710-25 (Rev. 5-95) Page 3

