TEST DATA AND OTHER DATA

Part I — GENERAL INFORMATION

LVE Modification LOREX Modification Fonn Approved 0.M.B. No. 2070-0012. APpraval Expires 10-31-96 

### U.S. ENVIRONMENTAL PROTECTION AGENCY 

## AGENCY USE ONLY 

# i g v;EPA PREMANUFACTURE NOTICE

CES Date of receipt



# 07 „It

- 

## 81- 

# 11112 , 19ci t j

.tv in the Premanufacture Notice 

### GENERAL INSTRUCTIONS

• You must provide all information requested in this form to the extent that it is known to or reasonably ascertainable by you. Make reasonable estimates if you do not have actual data.

• Before you complete this form, you should read the "Instructions Manual for Premanufacture Notification" (the Instructions Manual is available from the Toxic Substances Control Act (TSCA) Information Service by calling 202-554-1404, or faxing 202-554-5603).

• If a user fee has been remitted for this notice (40 CFR 700.45), indicate in the boxes above the TS-user fee identification number you have generated. Remember, your user fee ID number must also appear on your corresponding fee remittance, which is sent to EPA, HQ Accounting Operations Branch (PM-226), P.O. 360399M, Pittsburgh, PA 15251-6399, Attn. TSCA User fee.

You must provide the currently correct Chemical Abstracts (CA) Name of the new chemical substance, even if you claim the identity as confidential. You may authorize another person to submit chemical identity information for you, but your submission will not be complete and the review will not begin until EPA receives this information. A letter in support of your submission should reference your TS user fee identification number. You must submit an original and two copies of this notice including all test data. If you claimed any information as confidential, a single sanitized copy must also be submitted.

Part II — HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE If there are several manufacture, processing, or use operations to be described in Part II, sections A and B of this notice, reproduce the sections as needed. You are required to submit all test data in your possession or control and to provide a description of all other data known to or reasonably ascertainable by you, if these data are related to the health and environmental effects on the manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance. Standard literature citations may be submitted for data in the open scientific literature. Complete test data (written in English), not summaries of data, must be submitted if they do not appear in the open literature. You should clearly identify whether test data is on the substance or on an analog. Also, the chemical composition of the tested material should be characterized. Following are examples of test data and other data. Data should be submitted according to the requirements of §720.50 of the Premanufacture Notification Rule (40 CFR Part 720).

Part LII — LIST OF ATTACHMENTS 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 HI, list these attachments, any test data or other data and any optional information included in the notice.

OPTIONAL INFORMATION You may include any infonnation that you want EPA to consider in evaluating the new substance. On page 11 of this form, space has been provided for you to described pollution prevention and recycling information you may have regarding the new substance.
So-called "binding" boxes are included throughout this form for you to indicate your willingness to be bound to certain statements you make in this section, such as use, production volume, protective equipment ... This option is intended to reduce delays that routinely accompany the development of consent orders or Significant New Use Rules. Except in the case of exemption applications (such as TMEA, LVE, LOREX) where certain information provided in such notification is binding on the submitter when the Agency approves the exemption application, checking a binding box in this notice does not by itself prohibit the submitter from later deviating from the information (except chemical identity) reported in the form.

CONFIDENTIALITY CLAIMS You may claim any information in this notice as confidential. To assert a claim on the form, mark (X) the confidential box next to the information that you claim as confidential. To assert a claim in an attachment, circle or bracket the information you claim as confidential. If you claim information in the notices as confidential, you must also provide a sanitized version of the notice (including attachments). For additional instructions on claiming infonnation as confidential, read the Instructions Manual.
Mark (x) if any information in this notice is claitned as confidential. Test Data (Check Below any included in this notice)
Environmental fate data 

### 0 Yes • Other data 0 Yes
Health effects data 

### 0 Yes Risk assessments
Environmental effects data 

### 0 Yes Structure/activity relationships Physical/Chemical Properties* (8) Yes Test data not in the possession or control of the submitter

• A physical and chemical properties worksheet is located on the last page of this fonn.
TYPE OF NOTICE (Check Only One) 

# LII PMN (Premanufacture Notice)

INTERMEDIATE PMN (submitted in sequence with final product

- PMN)
SNUN (Significant New Use Notice)
TMEA (Test Marketing Exemption Application)
LVE (Low Volume Exemption) @ 40 CFR 723.50(011)
LOREX (Low Release/Low Exposure Exemption) @ 40 CFR 723.50(c)(2)

IS THIS A CONSOLIDATED PIYIN? 

# •

Yes
# of chemicals (Prenotice Communication # required, enter # on page 3)

EPA FORM 7710-25 (Rev. 5-95) Replaces previous editions of EPA Form 7710-25. 

# 305057

### Pub'ic reporting burden for this collection of information is estimated to average 110 hours per response, including time for reviewing

instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy Branch, PM-223, U.S. Environmental Protection Agency, 401 M. St., S.W., Washington, D.C. 20460; and to the Office of Management and Budget, Paperwork Reduction Act (2070-0012), Washington, D.C. 20503. 

## CERTIFICATION

I certify 

### that to the best of my knowledge and belief:
1. The company named in Part I, section A, subsection la of this notice form commercial purpose, other than in small quantities solely for research and Section B.
2. All information provided in this notice is complete and truthful as of the
3. I am submitting with this notice all test data in my possession or control reasonably ascertainable by me as required by §720.50 of the Premanufacture

Additional Certification Statements:

If 

### you are submitting a PMN, Intermediate PMN, Consolidated PMN, or SNUN, statement that applies: intends to manufacture or import development, the substance identified

date of submission. and a description of all other data known Notification Rule.

check the following user fee certification

specified in 40 CFR 700.45(b), or for an Intermediate PMN (defined @

40 CFR 700.43 and has remitted

with 40 CFR 723.50(c)(1) or a 723.50(c)(2), check the following

the new chemical substance for commercial under the terms of 40 CFR 723.50. with those terms; and applicable exemption conditions.
the manufacturer intends to commence 1 year of the date of the expiration of

ed facts regarding the chemical substance USC 1001. 

### for a in Part I,

to or

40 CFR

a fee of $100

Low release certification

the 30 day The Company named in Part I, Section A has remitted the fee of $2500 The Company named in Part I, Section A has remitted the fee of $1000 700.43) in accordance with 40 CFR 700.45(b), or 

# LI The Company named in Part I Section A is a small business concern under in accordance with 40 CFR 700.45(b). If you are submitting a low volume exemption (LVE) application in accordance and low exposure exemption (LoRex) application in 

### accordance with 40 CFR statements: The manufacturer submitting this notice intends to manufacture or import purposes, other than in small quantities solely for research and development, 

# ri The manufacturer is familiar with the terms of this section and will comply
The new chemical substance for which the notice is submitted meets all 

# I 1 If this application is for an LVE in accordance with 40 CFR 723.50(c)(1), manufacture of the exempted substance for commercial purposes within review period.
The accuracy of the statements you make in this notice should reflect your best prediction of the anticipa described herein. Any knowing and willful misinterpretation is subject to criminal penalty pursuant to 18 ( milidentiAl Signature and title of Authorized Official (Original Signature Required) 

### Richard Green, M.S., Director, Regulatory Affairs Date

Signature of agent - (if applicable) Date

EPA FORM 7710-25 (Rev. 5-95) Page 2

## Part I -- GENERAL INFORMATION

Section A 

### — SUBMITTER IDENTIFICATION ConfiMark (X) the "Confidential" box next to any subsection you claim as confidential dential la. Person Name of authorized official Submitting Notice (in U.S.) 

### Richard Green, M.S. Position 

### Director, Regulatory 

### Affairs Company 

### CP Kelco Mailing address (number and street) 

### 8355 Aero Drive City, State, ZFP Code 

### San Diego, CA 92123 h Agent (if Name of authorized official Position applicable) 

### Martha Marrapese Partner

Company 

### Keller and Heckman LLP Mailing address (number and street) 

### 1001 G Street, N.W., Suite 500 West City, State, ZIP Code 

### Washington, DC 20001 Telephone Area Code Number 

### 202 434

- 

### 4123

c. If you are submitting this notice as part of a joint submission, mark (X) this box I I > Joint Submitter (if Name of authorized official applicable) Position

Company

Mailing address number and street)

City, State, ZIP Code Telephone Area Code Number

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

### Martha Marrapese Position 

### Partner Company 

### Keller and Heckman LLP Mailing address (number and street) 

### 1001 G Street, N.W., Suite 500 West City, State, ZIP Code 

### Washington, DC 20001 Telephone Area Code Number 

### 202 434-4123
3. If you have had a prenotice communication (PC) concerning this notice and EPA assigned a PC Number to the notice, enter the number. Mark (X) --INif none
4. If you previously submitted an exemption application for the chemical substance covered by this notice, enter the exemption number assigned by EPA. If you previously submitted a PMN for this substance enter the Mark (X) -NIif none PMN number assigned by EPA (i.e. withdrawn or incomplete). 5. If you have submitted a notice of Bona fide intent to manufacture or import for the chemical substance covered by this notice, enter the notice number assigned by EPA. Mark (X) ---0.- if none
I. Manufacture

. Type of Notice - Mark (X) Only Binding Option Mark (X) II 2. U Import

Only Jill Binding Option Mark (X) 3. U Both

EPA FORM 7710-25 (Rev. 5-95) Page 3

## p. 4 

## Part I -- GENERAL INFORMATION — Continued Section B -- CHEMICAL IDENTITY INFOR1VIATION: You must provide a currently correct Chemical Abstracts (CA) name of the substance based on the ninth Collective Index (9CI) of CA nomenclature rules and conventions. 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) If another person will submit chemical identity infonnation for Identify the name, company, and address of that person in a continuation as appropriate. Complete all other items. you (for either Item 1 or 2), mark (X) the box at the right. 0

sheet. Conlidential I. Class 1 or 2 chemical substances (for definitions of class 1 and class 2
a. Class of substance - Mark (X) I Class I substances, see (he Instructions Manual)
or 2 Class 2 b. Chemical name (Currently correct Chemical Abstracts (CA) Name that is consistent with TSCA Inventory listings for similar substances. For Class 1 substances a CA Index Name must be provided. For Class 2 substances either a CA Index Name or CA Preferred Name must be provided, which ever is appropriate based on CA 9CI nomenclature rules and conventions). 

### D-Glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt. (See Attachment 1)

c. Please identify which method you used to develop or obtain the

Method 1 (CAS Inventory Expert Service - a copy of the report obtained from the CAS Inventory Expert Services submitted as an attachment to this notice) (See Attachment specified chemical identity information reported in this notice: (check one). Identification Method 2 (Other Source) must be 

### I) EPA/IES d. Molecular formula and CAS Registry Number (if a number already



### (C38 H60 028)n (acetylated) (C36 H58 027)n (de-acetylated) exists for the substance)



### CAS# 595585-15-2

e. For a class 1 substance, provide a complete and correct chemica precursor substances with their respective CAS Registry Numbers. range of composition and the typical composition (where appropriate). diazram. as comnlete as can be known. if one can be reasonably 

### Class 2 substance: structure diagram. For a class 2 substance - (1) List the immediate (2) Describe the nature of the reaction or process. (3) Indicate the (4) Provide a correct representative or partial chemical structure ascertained.


### CAS Registry Numbers are provided on Page 5 in

provided on Page 5 in Section B.2.b. Continuation Sheet for Page 5, Section B.2.e. Section (1): The immediate precursor substances with their respective B.2. 

### b. (2): Fermentation process (3): The range of composition and typical composition is (4): The chemical structure diagram is provided on the



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

EPA FORM 7710-25 (Rev. 5-95) Page 4

### P. 5


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

a. Indicate the number-average weight of the lowest molecular weight composition Indicate maximum weight percent of low molecular weight species (not including below 1,000 absolute molecular weight of that composition. Describe the methods of measurement or the basis for your estimates: GPC i) lowest number average molecular weight: 3 x 10 6 of the polymer you intend residual monomers, reactants,

Other

of one subunit to manufacture.

(Specify) or solvents) below 500 and 

### Atomic 

### force Confidential

ii) maximum weight % below 500 molecular weight: Below MW iii) maximum weight % below 1000 molecular weight: Not available* available for quantitation. * Assumed to be "0" as this would represent one subunit. No standards are Mark (X) this box if you attach a continuation sheet. b. You must 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 (I) - 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) Confidential (2) Typical composition (3) Identity

Mad. (X) (4) Confidential (5) Maximum

residual (6) Confidential (7) 

### D-Glucose 50-99-7 32% 5% L-Rhamnose 3615-41-6 43% nd*% D-Glucuronic Acid 6556-12-3 16% nd"% Acetic Acid 64-19-7 6% 0.1% For salt components, see Attachment 2 Note: The above are monomers, not reactants. The polymer is synthesized as mixed (Na. K. Ca. Ma) salt. nd*: Not measured. Assumed to be close to zero, as polymer is synthesized inside bacterial cells and extruded through cell membrane. Mark (X) this box if you attach a continuation sheet. See Attachment 2 c. Please identify which method you used to develop or obtain the specified chemical identity information reported in this notice (check one). 

# LI Method 1 (CAS Inventory Expert Service - a copy of the identification report Method 2 (other source)

obtained from CAS Inventory Expert Service must be submitted as as attachment to this notice) d. The currently correct Chemical Abstracts (CA) name for the polymer that is consistent with TSCA Inventory listings for similar polymers. 

### D-Glucurono-6-deoxy-L-manno-D-glucan, acetate, calcium magnesium potassium sodium salt. (amended 1/23/05)

e. Provide a correct representative or partial chemical structure diagram, as complete 

### See Attachment 3 as can be known, if one can be reasonably ascertained.



# FA■ Mark (X) this box if you attach a continuation sheet
EPA FORM 7710-25 (Rev. 5-95) Page 5

## . 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) Confidential 

### Ash None 10%

Mixed salts of Lactate, Acetate, Formate, Glycerate, and Proprionate None 0.2% 

### Polyhydroxybutyric acid 52352


### - 27


### - 9 10%
Biomass (dead bacterial cells) None 17%
Glucose, Maltose, and other glucose-based oligosaccharides from corn syrup None 5%
Isopropyl alcohol 67-63-0 0.1%

Water 7732-18-5 15% 

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

### S

- 

### 657, Diutan

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

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

### Diutan, S-657, Kelcocrete, Geovis

Mark (X) this box if you attach a continuation sheet. 6. Generic chemical name - If you claim chemical identify as confidential, you must provide a generic name for your substance that reveals the specific chemical identity of the new chemical substance to the maximum extent possible. Refer to the TSCA Chemical Substance Inventory, 1985 Edition, Appendix B for guidance on developing generic names. 

### Not applicable

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 new chemical substance. Provide the CAS Registry

Number if available. Byproduct ( I ) CAS Registry Number (2) Confidential 

### Polyhydroxybutyric acid 52352-27-9


### Lactic acid 50


### - 21


### - 5


### Carbon dioxide 124-38-9



# Liii Mark (X) this box if you attach a continuation sheet. EPA FORM 7710-25 (Rev. 5-95) Page 6

## 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% new chemical substance basis. For a Low Volume Exemption application, if you choose to have your notice reviewed at a lower production volume than 10,000 kg/yr, specify the volume and mark (x) in the binding box. If granted, you are bound to this volume

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

Option Mark (x)

[ ] [ ] (See Attachment 

### 4) X
2. Use Information

— You must 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 new 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 new chemical substance by function and application.. (2) -- Mark (X) this column if entry column (1) is confidential business information (CBI). (3) -- Indicate your willingness to have the information provided in column (1) binding. (4) — Estimate the percent of total production for the first three years devoted to each category of use. (5) -- Mark (X) this column if entry in column (4) is confidential business information (CBI). (6) — Estimate the percent of the new 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. (7) — Mark (X) this column if entry in column (6) is confidential business information (CBI). (8) -- Indicate % of product volume expected for the listed "use" sectors. Mark more than one box if appropriate. Mark (X) to indicate your willingness to have the use type provided in (8) binding. (9) — Mark (X) this column if entry(ies) in column (8) is (are) confidential business information (CBI). Category of use (1) (by function and application i.e. a dispersive dye for finishing polyester fibers) CBI (2) Binding Option Mark (x) ( 3 ) Production % (4) CBI (5) % inFormulation (6) CBI (7) % of substance expected per use (8) CBI (9)Sitelimited Con- 5

sumer Industrial Commercial Binding

Option 

### For uses other than those usesalready approved in P-00-0007, S05-0001, and other prior SNUN submissions, manufacture of the chemical substance where greater than 5% of the chemical substance is below the 10 micron (respirable particles) threshold. [ ] X 0 0 100 0

* If you have identified a "consumer" use, please In addition include estimates of the concentration substance loses its identity in the consumer product. provide on a continuation sheet a detailed description of the use(s) of this chemical substance in consumer products. of the new chemical substance as expected in consumer products and describe the chemical reactions by which this

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

### b. Generic use 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. 

### description 

### Not applicable



# I I Mark (X) this box if you attach a continuation sheet. 3. Ilazard Information — Include in the notice a information which will be provided to any person for the safe handing, transport, use, or disposal copy of reasonable facsimile of any hazard warning statement, label, material safety data sheet, or other who is reasonably likely to be exposed to this substance regarding protective equipment or practices of the new substance. List in part III hazard information you include.

See Attachment 6 Binding Option Mark (x) 

# 11 Mark (X) this box if you attach hazard information. EPA FORM 7710-25 (Rev. 5-95) Page 7

## Part I -- GENERAL INFORMATION -- Continued p. 8

Seaton 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% new chemical substance basis. For a Low Volume Exemption application, if you choose to have your notice reviewed at a lower production volume than 10,000 kg/yr, specify the volume and mark (x) in the binding box. If granted, you are bound to this volume

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

Option Mark (x)

[ ] [ ] (See Attachment 4) X
2. Use Information

— You must 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 new substance, and other use information. Mark (X) the "Confidential" Box next to any item you claim as confidential. a. (I ) -- Describe each intended category of use of the new chemical substance by function and application.. (2) -- Mark (X) this column if entry column (1) is confidential business information (CBI). ae (3) -- Indicate your willingness to have the information provided in column (1) binding. C , 66‘

. (4) -- Estimate the percent of total production for the first three years devoted to each category of use. ....) (5) — Mark (X) this column if entry in column (4) is confidential business information (CBI). eSVi i (6) -- Estimate the percent of the new substance as formulated in mixtures, suspensions, emul00 ions, or gels as manufactured for commercial purposes at sites under your control associated with each category of use. (7) -- Mark (X) this column if entry in column (6) is confidential business information (CBI). (8) — Indicate % of product volume expected for the listed "use" sectors. Mark more than one box if appropriate. Mark (X) to indicate your willingness to have the use type provided in (8) binding. (9) -- Mark (X) this column if entry(ies) in column (8) is (are) confidential business information (CBI). Category of use (1) (by function and application i.e. a dispersive dye

for finishing polyester fibers) CBI (2) Binding Option Mark (x) ( 3 ) Production % (4) CBI

( 5 ) % inFormulation (6) CBI

(7) % of subs ance expected per use (8) CBI (9)Sitelimited Con-*

sumer Industrial Commercial Binding

Option 

### [For uses except those already approved in P-00-0007, S-05- 0001, and other prior SNUN submissions] Manufacture of the chemical substance where less than 5% of the chemical substance is below 10 microns in particle size. [ ] X 0 0 100o

* 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 new chemical substance as expected in consumer products and describe the chemical reactions by which this substance loses its identity in the consumer product. 

# 1 Mark (X) this box if you attach a continuation sheet. See Attachment 5 b. Generic use 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. description 

### Not applicable

MI IT 4

( I \ Ilt 4

r-l 4.1_,R r VIII 0 7 0 0 

# 4 11 0 11 0 11 0 1111 7 1 

# o c.D Il


# 67 1 / II S 

# -cici II :.)

-- : 7 -- -,



# .

Mark (X) this box if you attach a continuation sheet. 3. Hazard Information — Include in the notice 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 equipThent or practices for the safe handing, transport, use, or disposal of the new substance. List in part III hazard information you include. 

# a Mark (X) this box if you attach hazard information. See Attachment 6 Binding Option Mark (x)

EPA FORM 7710-25 (Rev. 5-95) Page 7 

# 70.5.• 

## 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 new chemical substance at industrial sites you contml. Importers do not have to complete this section for operations outside the U.S.; however, you may still have reporting requirements if there are further industrial processing or use operations after import. You must describe these operations. See instructions manual I. Operation description a. Identity -- Enter the identity of the site at which the operation will occur. Confidential Name 

### CP Kelco Site address (number and street) 

### 2145 Belt Street City, County, State, ZIP code 

### San Diego, CA 92113 If the same operation will occur 

### at more than one site, enter the number additional sites on a continuation sheet, and if any of the sites have production rates or operations, include all the information requested sites as attachments. of sites. Identify the significantly different in this section for those

411. Mark (X) this box if you attach a continuation sheet. b. Type — Mark (X) Processing 

## Lil Use Manufacturing


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

I . Batch Maximum kg/batch (100% new

chemical substance) [ } Hours/batch

[ i Batches/year

[ ] X

2. Continuous Maximum kg/batch (100% new chemical substance) Hours/batch Batches/year

d. Process description Mark (X) to indicate your willingness to have your process description binding. (1) Diagram the major unit operation steps and chemical conversions. Include interim storage and transport containers (specify- e.g. 5 gallon drum, rail car, tank truck, etc.). (2) Provide the identity , the approximate weight (by kg/day or kg/batch on a 100% new chemical substance basis), and entry point of all starting feedstocks (including reactants, solvents, catalysts, etc.), and of all products, recycle streams, and wastes. Include cleaning chemicals (note used daily or per batch.). (3) Identify by number the points of release, including small or intermittent releases, to the environment of the new chemical substance. 

### See Attachment 7

Mark (X) this box if you attach a continuation sheet pails, 55
materials frequency gallon
and if not

EPA FORM 7710-25 (Rev. 5-95) Page 8

## . -

- Part II-- HUMAN EXPOSURE AND ENVIRONMENTAL RELEASE -- Continued Section A -- INDUSTRIAL SITES CONTROLLED BY THE SUBMITTER — Continued 2. Occupational Exposure — You must make separate confidentiality claims for the description of worker activity, physical fonn of the new chemical substance, number of works 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) and (6) -- Indicate your willingness to have the information provided in column (3) or (5) binding. (5) — Indicate the physical form(s) of the new chemical substance (e.g., solid: crystal, granule, powder, or dust) and % new chemical substance (if part of a mixture) at the time of exposure. (7) --Mark (X) this column if entry in column (5) is confidential business infonnation (CBI). (8) — Estimate the maximum number of workers involved in each activity for all sites combined. (9) —Mark (X) this column if entry in column (8) is confidential business information (CBI). (10) and (11) -- Estimate the maximum duration of the activity for any worker in hours per day and days per year. (12) — Mark (X) this column if entries in columns (10) and (11) are confidential business infonnation (CBI). Worker activity (i.e., bag dumping, filling drums)

( I) CBI

(2) Protective Equipment/ Engineering Controls ( 3 ) Binding

Option Mark (x) (4) Physical

forms (s) and % new substance ( 5 ) Binding

Option Mark (x) (6) CBI

( 7 ) # of Workers Exposed (8) CBI

( 9 ) Maximum Duration CBI

( 12) Hrs/day (10) Days/yr

(11) 

### See Attachment 8



# I Mark (X) this box if you attach a continuation sheet. 3. Environmental Release and Disposal -- You must make separate confidentiality claims for the release number and the amount of the new 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 new 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 new 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 new 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).
Release Number (1) Amount of new substance

released CBI

( 3 ) Media of release e.g. stack air (4) Control technology and efficiency (you may wish to optionally attach efficiency data) CBI (6) (2a) (2b) (5a) Binding Mark (X) (5b) 

### See Attachment 8

(7) Mark (X) the I POTW provide name(s) below: destination (s) of releases to water 

### Pt. Loma Bloomfield CBI El Navigable 14 Other — waterway Specify Ocean Outfall provide NPDES # ( 131



### CA0107409 

# I2 Mark (X) this box if you attach a continuation sheet.
EPA FORM 7710-25 (Rev. 5-95) Page 9

## 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 new chemical substance at sites you do not control. Importers do not have to complete this section for operations outside the U.S.; however, you must report any processing or use activities after import. See the Instructions ManuaL Complete a separate section B for each type of processing, or use operation involving the new chemical substance. If the same operation is perfonned at more than one site describe the typical operation common to these sites. Identify additional sites on a continuation sheet. ( 1) (by

these 1. Operation drums, products, including



### See Attachment

Description -- To claim information in this section as confidential, circle or bracket the specific information -- Diagram the major unit operation steps and chemical conversions, including interim storage and transport containers rail cars, tank trucks, etc). On the diagram, identify by letter and briefly describe each worker activity. (2) -- Provide kg/day or kg/batch, on an 100% new chemical substance basis), and entry point of all feedstocks (including reactants, recycle streams, and wastes. Include cleaning chemicals (note frequency if not used daily or per batch). (3) -- Identify small or intermittent releases, to the environment of the new chemical substance. (4) Please enter the # of sites (remember sites on a continuation sheet):



### 9

Mark (X) this box if you attach a continuation sheet. that you claim as confidential. (specify - e.g. 5 gallon pails, 55 gallon the identity, the approximate weight solvents and catalysts, etc) and all by number the points of release, to identify the locations of

# of sites

### ■ 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 % new chemical substance (if in mixture), and any protective equipment and engineering controls, if any, used to protect workers. (7) -- Estimate the percent of the new substance as formulated when packaged or used as a fmal 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 new 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 new substance to the environment. (14) -- Identify byproducts which may result from the operation. (3), (5), (8), ( 1), (13) and (15) -- Mark (X) this column if any of the proceeding entries are confidential business information (CBI).

Letter of Activity (I) ti of Workers Exposed (2) CBI (3) Duration

of Exposure CBI

( 5 ) Protective Equip. /

Engineering Controls/ Physical Form and % new substance (6) % in

Formulation ( 7 ) CBI

(8) Release Number ( 9 ) Amount of

New Substance Released CBI

(I I) Media of Release

& Control Technology (12) ( 'In

( H ) (4a) (4b) (I0a) (I0b)

(14) -- Byproducts: ( 1 S )


# III Mark (X) this box if you attach a conttnuawn sheet,

EPA FORM 7710-25 (Rev. 5-95) Page 10

### p. 12



# 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 PMN substance. Please include new information pertinent to pollution prevention, including source reduction, recycling activities and safer processes or products available due to the new 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. The 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 PMN substance to potential alternatives may be provided. All information provided in this section will be taken into consideration during the review of this substance. 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 new chemical substance in comparison to existing chemical substances used in similar application; or (6) the extent to which the new chemical substance may be a substitute for an existing substance that poses a greater overall risk to human health or the environment. 

### See Attachment 10

I I Mark (X) this box if you attach a continuation sheet.
EPA FORM 7710-25 (Rev. 5-95) Page 11

### p. 13 

# 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. You must include with the sanitized copy of the notice form a sanitized version of any attachment in which you claim information as confidential. Attachment name Attachment page number(s) Contidential 

### Attachment 1: Inventory Expert Service Report (Part I Section B(1)) 14 Attachment 2: Chemical Identity Information — Monomer or Other Reactant (Part I Section B(2)(b)) 15 X 

### Attachment 3: Chemical Identity Information — Structural Diagram (Part I Section B(2)(e)) 16
Attachment 4: Production Volume 17 X Attachment 5: Production and Use Information (Part I Section C(2)(a)) 18 Attachment 6: MSDS and Product Label (Part I Section C(3)) 21 

### Attachment 7: Industrial Site Controlled by the Submitter — Process Description (Part II Section 

### A(1 )d) 29 X Attachment 8: Industrial Site Controlled by the Submitter — Occupational Exposure and 

### Environment Release (Part II Section A(2+3)) 39 

### X Attachment 9: Industrial Site Controlled by Others (Part II Section B(1+2)) 42 

### Attachment 10: Optional Pollution Prevention Information 45 

### X


### Attachment 11: Agent Letter 47 X



# LI Mark (X) this box if you attach a continuation sheet. Enter the attachment name and number.

EPA FORM 7710-25 (Rev. 5-95) Page 12

### p. 14
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 notice. Identify the property measured, the page of the notice 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 (% PMN substance in __). You are not required to submit this worksheet; however, EPA strongly recommends that you do so, as it will simplify review and ensure that confidential information is properly protected. You should submit this worksheet as a supplement to your submission of test data. This worksheet is not a substitute for submission of test data. Property

(a) Mark (X) if pi .ovided Page number (b) Value

(c) Measured or Estimate (M or E) Confidential Mark (X) (d) 

### Physical state of neat substance X 100% (s) (I) (g) M 

### Vapor pressure @ Temperature °C Not applicable Ton Density/relative density X 4 I 

### Approximately 30-50 lb/ft3 M Solubility @ Temperature oc Not applicable g/L Solvent Solubility in water @ Temperature 23°C > 40 g/L Melting temperature Not applicable °C Boiling / sublimation temperature@ ton pressure Not applicable °C Spectra Not applicable

Dissociation constant Not applicable

Particle size distribution Not applicable

Octanol / water partition coefficient Not applicable

Henry's Law constant Not applicable

Volitalization from water X 

### Not volatile

Volitalization from soil X 

### Not volatile

pH @ concentration 1% X 41 

### Approximately neutral

Flammability X 

### Combustible

Explodability Not applicable

Adsorption / coefficient Not applicable

Other — Specify



## 13 EPA FORM 7710-25 (Rev. 5-95) Replaces previous editions of EPA Form 7710-25.

### p. 15



# Confidential Copy [Contains Confidential Business Information]

Attachment to Inventory Expert Service Report Chemical Abstract Services Registry Number (CASRN) 125005-87-0, associated with Dglucuronic acid polymer, with 6-deaxy-L-mannose and D-glucose, acetate, calcium magnesium potassium sodium salt, reasonably describes diutan gum for most purposes. The terminology, c`...polymer with...", appears to be interpreted by the EPA as describing a polymerization process where the listed monomers are charged to the polymerization reactor. In this case, ingedients charged to a fermentation vessel are the organism and nutrients. For this reason, we submit this SNUN using CASRN 595585-15-2, associated with D-glucurono-6-deoxy-L-mannoD-glucan, acetate, calcium magnesium potassium sodium salt, which was provided by and preferred by the EPA for this substance.b. You must 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

Provide the specific chemical name and CM Registry Number (if a number exists) of each monomer or other reactant used in the manufacture of the polymer. Mark (X) this column if entry in column (I) is confidential. Indicate the typical weight percent of each monomer or other reactant in the polymer. Mark (X) the identity column if you want a monomer or other reactant used at Iwo weight percent or less to be listed as part of tbe polymer description on the TSCA Chemical Substance Inventory. Mark (X) this column if entries in columns (3) and (4) are confidential. Indicate the maximum weight percent of each monomer or other reactant that may be present as a residual in the polymer as manufactured for conuhercial purposes. Mark this column if entry in column (6) is confidential. 

### p. 16



## Confidential Copy [1 Contains Confidential Business Information Attachment 2: Chemical 

## Identity Information —Monomers and Reactant Identify (Part I Section B(2)(b)) (Continuation from page 5)



## PMN Substance Monomers and Reactants

Monomer or other reactant and CM Registry Number

(I) Confidential (2) Typical composition ( 3 ) Identity

Mark (X) (4) Confidential ( 5 ) Maximum residual ( 6 ) Confidenlial CO [ 1 X 

# x 11 x I 1 x x f 1 x f 1 x x f 1 x

[ 

# _1 x [ 

# 1 x x

[ ] [ 

# 1 x x

ATTACHMENT

## 0



## OH OH OH OH = Na, K, 1/2Ca, 1/2Mg 

## CH OH 

# N < 0 0

0 0 OH OH OH p. 17


## Confidential Copy [ I Contains Confidential Business 

## Information

Attachment 3: Chemical Identity Information — Structural Diagram

(Part I Section B(2)(e))

PUN Substance Structure

--- , --3)-(3-D-G1cp-(1 4)43-D-GlepA-(1 3

1 4)-a-L-Rhap


## Note: Location of the acetyl group 

## is not known at this time.



## ATTACHMENT

### p. 18



# KELLER AND HECKMAN LLP Serving Business through Law and Science ®



# MEMORANDUM

CONTAINS TSCA CONFIDENTIAL BUSINESS INFORMATION 

## TO: 

## The Environmental Protection Agency FROM: Martha Marrapese, Esq.
DATE: May 3, 2007
RE: Production Volume; SNUN Attachment 4

The SNUN provides a maximum production estimate in addition to the maximum 

## production estimate described in SNUN 05-0001. The production estimate includes 

# I 1 kg for coating uses and 

# [ 1 kg for cleaner uses. The submitter understands that these two uses do not add up to I ] kg, but allows for growth in both these uses and development of other potential commercial uses. To address EPA's concern for regulating this substance, the submitter has developed a method to ensure the respirable particles in the diutan gum are not greater than 5% of the total diutan gum, decreasing the potential worker exposure to a level of no concern during domestic processing and use. As a result of the process being proposed in this SNUN, any new commercial application of the finished product, other than those uses already approved by P-00- 0007, S-05-0001, and other prior SNUN submission, that contains greater than 5% respirable particles, would require a SNUN submission. This approach decreases exposure to workers during processing or use to a level that does not present a significant risk to human health.



# 17

### p. 19



# Confidential Copy [Contains Confidential Business Information]
Attachment 5: Production Import and Use Information — Categories of Use (Part I Section C(2)(a)) The Significant New Use Rule (SNUR) for diutan gum requires the PMN submitter to file a SNUN pursuant to 40 C.F.R. § 721.80(j) to seek EPA approval for each commercial use of diutan gum other than those described in the PMN. The approved uses listed at 40 C.F.R. §721.2076(2)(i) are:
1. Viscosifier for oil field drilling fluid 

## — Drilling fluids need a viscosifier to lubricate the drilling bit as it is pumped through and to bring cuttings to the surface. 2. Viscosifier for spacer/completion fluids 

## — Spacer fluids are viscous fluids used to displace an existing fluid such as a drilling fluid when the drilling phase is finished and a new phase of operation (i.e., well completion or cementing is to begin). The substance is used to viscosify the spacer fluid. 3. Oil field cementing 

## — Well capping ensures a hydraulic seal, reduces corrosion, and protects aquifiers. The substance is added to improve flow, suspendability, and pumpability. 4. Cernentitious packaged products 

## — The substance improves homogeneity and bleed in concrete and grouts when used at very low levels. 5. Concrete applications 

## — The addition of low levels of the substance to concrete improves its pumpability and flow properties making it an important additive to concrete used for self-compacting concrete, self-leveling floor underlayment, bridges, and underwater repair structures. When used, the use of vibrating equipment to remove large air bubbles is not required. 6. Foam applications 

## — The substance promotes foam stability in fire-fighting and landfill foams. In addition, the submitter is aware of one approved SNUN for a single customer use as a petroleum additive 

## to facilitate long distance piping of the petroleum product, and SNUN S-05- 0001, sealants where the substance is added to internal tire sealant products to promote filling of a puncture hole thereby preventing loss of pressure. No public record could be located for the petroleum additive 

## approved use. We are proposing the following additional use underlined below:

§ 721.2076 D-Glucuronic acid, polymer with 6-dexoxy-L-mannose and Dglucose, acetate, calcium magnesium potassium sodium salt. (a) Chemical substance and significant new uses subject to reporting. (1) Thechemical substance identified as D-Glucuronic acid, polymer with 6-deoxyL-mannose and D-glucose, acetate, calcium magnesium potassium sodium salt (PMN P-00-7; CAS No. 125005-87-0) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section.

18

### p. 20



# Confidential Copy [Contains Confidential Business Information]

(2) The significant new uses are: (i) Industrial, commercial, and consumer activities. LAj Requirements as specified in § 721.80(j) (oilfield drilling fluid, oilfield spacer fluid, oilfield cementing, cementitious packaged products, concrete applications, foam applications, 

# DI sealants, and (C) petroleum additives. 

# Dj For all other uses, manufacture of the chemical substance where greater than 5% of the chemical substance is below the 10 micron (respirable particles) threshold). (ii) [Reserved] 

# (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this chemical substance. (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

We have found EPA precedent for this approach at 40 C.F.R. § 721.9511, which is attached, in which the EPA lists as the significant new use for that product, "manufacture or import of the chemical substance where greater than 5% of the chemical substance is below 10 micron (respirable particles) threshold."



# 19Environmental Protection Agency § 721.9509 Perfluorinatedalkyl polyalkoxysilane (generic). (a) 

### Chemical substance and significant new uses subject to reporting. (1) Thechemical substance identified generically as perfluorinatedalkyl polyalkoxysilane (PMN P-95-1410) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: 

### (i) Hazard communication program. Requirements as specified in §721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(1)(ix), (g)(2)(i), (g)(2)(ii),(g)(2)(v), (g)(5). The following statement shall appear on each label as specified in §721.72(b) and the MSDS as specified in §721.72(c): This substance may cause death if inhaled. 

### (ii) Industrial, commercial, and consumer activities. Requirements as specified in §721.80(y)(1). Use in any formulation that contains alkylbenzenesulfonate emulsifiers. (b) 

### Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. 

### (1) Recordkeeping. The following recordkeeping requirements are applicableto manufacturers, importers, and processors of this substance as specified in §721.125 (a), (b), (c), (f), (g), (h), and (i). 

### (2) Limitations or revocation of certain 

### notification requirements. The provisions of §721.185 apply to this section. [65 FR 372, Jan. 5, 2000]§721.9511 Silicic acid (116Si0207), magnesium, strontium salt(1:1:2), dysprosium and europium-doped. 

### (a) Chemical substance and 

### significant new uses subject to reporting. (1) The chemical substance identified as silicic acid (116Si0207) magnesium, strontiumsalt(1:1:2), dysprosium and europiumdoped. (PMN P-98-848; CAS No.181828- 07-9) is subject to reporting under thissection for the significant new use described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) 

### Industrial, commercial, and consumer activities. Requirements as specified in §721.80(j) (manufacture or import of the chemical substance where greater than 5% of the chemical sub- § 721.9514stance is below the 10 micron (respirable particles) threshold). (ii) [Reserved] (b) 

### Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. 

### (1) Recordkeeping. Recordkeeping requirements as specified in §721.125(a),(b), (c), and (i) are applicable to manufacturers, importers, and processors of this chemical substance. 

### (2) Limitations or revocation of certain notification requirements. The provisions of §721.185 apply to this section. [68 FR 70183, Dec. 17, 2003] § 721.9513 Modified magnesium silicate polymer (generic). (a) 

### Chemical substance and significant new uses subject to reporting. (1) Thechemical substance identified generically as modified magnesium silicate polymer (PMN P-98404) is subject toreporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: 

### (i) Industrial, commercial, and consumer activities. Requirements as specified in §721.80 (v)(1), (w)(1), and (x)(1). (ii) [Reserved] (b) 

### Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. 

### (1) Recordkeeping. Recordkeeping requirements as specified in §721.125 (a),(b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance. 

### (2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section. [65 FR 372, Jan. 5, 2000]§ 721.9514 Ethyl silicate, reaction products with modified alkoxysilane salt (generic). 

### (a) Chemical substance and significant new uses subject to reporting. (1) Thechemical substance identified generically as Ethyl silicate, reaction products with modified alkoxysilane salt (PMN P-99-0157) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: 

### p. 21

429



## 20SAN DIEGOCAS:125005-87-0.595585-15-2 

## co c\1 (•\!
C.)

o 0



# w a — 

## 0 

# z ° --G 6

1) (15AHUBER COMPANY



## 21 0 0 0 CI) 

### 0


## E c r t s cn o •C 

### p. 

### 22

### p. 

## 23



# PKe!co Material Safety Data Sheet (So

A HUBER COMPANY 

### Revision Date 26/Sep12006 Revision Number 0.1 

## 1. PRODUCT AND COMPANY IDENTIFICATION
Product Name Diutan Gum- Industrial
Product Use Industrial (not for food or food contact use)
Chemical Name Diutan Gum Company CP Kelco A Huber Company 8355 Aero Drive San Diego, CA 92123 USA
Telephone 1+800-535-2687 (Main Number-Americas) 1+858-292-4900 or 1+800-535-2656 (8a-5p PST weekdays)
Fax 1+312-554-7810 Emergency Telephone Number CHEMTREC: 1+800-424-9300 or International 1+703-527-3887


### email customer.reguest@cpkelco.com
Internet www.cpkelco.com 

## 2. HAZARDS IDENTIFICATION Emergency Overview 

### Appearance white to tan Physical State 

### powder
Odor slight odor
D.O.T. Hazard Classification Non-hazardous material
OSHA Regulatory Status OSHA Hazard: Warning: Combustible dust. Ensure appropriate electrical classification and avoidance of ignition sources in dusty environments. Handle in a manner consistent with good industrial hygiene practices—avoid creating or inhaling aerosols of this or any other material.

Slip Hazard Slip hazard when spilled material becomes wet.
Potential Health Effects 

### Principle Routes of Exposure Inhalation. Skin contact.

### p. 24

CP Kelco Material Safety Data Sheet Page 2 of 7 Diutan Gum- Industrial Revision Date 26/Sep/2006 Revision Number 0.1 

### 2. HAZARDS IDENTIFICATION

Acute Effects
Eyes Dry powder may cause foreign body irritation in some individuals.

Skin Prolonged contact with the dry powder may cause drying or chapping.

Inhalation Hygroscopic properties of the gum can form a paste or gel in the airway Inhalation of dust may cause respiratory tract irritation_ Excessive inhalation of dust may cause coughing and sneezing Ingestion Not toxic if swallowed (less than a mouthful) based on available information.

Additional toxicology information Refer to Section 11

Potential Environmental Effects Refer to Section 12 for Ecological information Refer to Section 13 for Disposal Considerations



### 3. COMPOSITION/INFORMATION ON INGREDIENTS COMPONENT(S) Diutan Gum CAS Number 125005-87-0; 695585-15-2



### 4. FIRST AID MEASURES

General Advice

Eye contact Remove material from eyes, skin and clothing. In case of doubt or when symptoms persist, seek medical attention. Wash heavily contaminated clothing before reuse. Hold eyelids apart and flush eyes with a steady, gentle stream of water for several minutes. If eye irritation persists, seek medical attention.

Skin contact Wash off with soap and plenty of water.

Inhalation Move to fresh air. If symptoms persist, call a physician. If not breathing, give artificial respiration. Ingestion No significant adverse health effects are expected to develop if only small amounts (less than a mouthful) are swallowed.



### 5. FIRE-FIGHTING MEASURES

General Advice Treat as "Class A" fire. Product will burn when in contact with a flame. Self extinguishes when ignition source is removed. Tends to smoulder.

### p. 25

CP Kelco Material Safety Data Sheet Page 3 of 7 Diutan Gum- Industrial Revision Date 2615ep12006 Revision Number 0.1 

## 5. FIRE-FIGHTING MEASURES

Suitable Extinguishing Media Water. Dry chemical. Carbon dioxide (CO2).

Hazardous Combustion Products carbon dioxide carbon monoxide

Specific Hazards Can contain sufficient fines to cause a combustible dust explosion Do not breath smoke, gases or vapors generated Special Protective Equipment for As in any fire, wear self-contained breathing apparatus (SCBA) pressure-demand, Firefighters MSHA/NIOSH (approved or equivalent) and full protective gear

Health 1 Flammability 1 Instability 0 Health 1 Flammability 1 Physical Hazard (Reactivity) 0 NFPA HMIS 

## 6. ACCIDENTAL RELEASE MEASURES

Personal Precautions

Methods for Cleaning up

Other information Wet material on walking surfaces will be extremely slippery. Avoid dust formation. In case of exposure to high levels of airborne dust, wear a personal respirator in compliance with national legislation.

Use vacuum equipment designed specifically for combustible dust. Take precautionary measures against static discharges. The use of water wash down is not recommended unless the spilled material is aleady wet. Disposal information - Refer to Section 13.

Reportable quantities - Refer to Section 15. 

## 7. HANDLING 

## AND STORAGE
Handling

Storage Avoid dust formation. Provide appropriate exhaust ventilation in places where dust is formed. In case of insufficient ventilation, wear suitable respiratory equipment. Avoid conditions that generate airborne dust in handling, transfer and clean up. Product may form combustible dust-air mixtures. Keep away from heat, flame sparks and other ignition sources. Avoid emptying package in or near flammable vapors. Static charges may cause flash fire. Remove material from eyes, skin and clothing. Store in a cool (50-80 °F / 10-27 °C), dry (<65% relative humidity) place in a sealed container. Avoid storing near incompatible materials (Refer to Section 10). Refer to Product Data Sheet for "Storage Conditions/Shelf Life" information.

### p. 26

CP Kelco Material Safety Data Sheet Page 

### 4 of 7 Diutan Gum- Industrial Revision Date 26/Sep/2006 Revision Number 0.1 

## 8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Limits COMPONENT(S) OSHA PEL ACGIH TLV Diutan Gum [ 15 mghn 3 (total dust) 8-hr TWA 5 rng/m 3 (respirable) 8-hr TWA Not established

Dust: OSHA has not estabfished specific exposure limits for this material. However, OSHA has established limits for particulates not otherwise regulated (PNOR) which are the least stringent exposure limits applicable to dusts.

Engineering Controls

Personal Protective Equipment Ventilation: Provide natural or mechanical ventilation to control exposure levels below airborne exposure limits in this section. The use of local mechanical exhaust ventilation is preferred at sources of air contamination such as open process equipment.

Respiratory Protection Avoid breathing dust. Use NIOSH/MSHA approved respiratory protection equipment when airborne exposures exceeds established guidelines. Consult the respirator manufacturer to determine appropriate type equipment for a given application. Observe respirator use limitations specified by NIOSH or the manufacturer.
Hand Protection Gloves are recommended if extended exposure is anticipated. Eye Protection This product does not cause significant eye irritation or eye toxicity requiring special protection_ Where there is significant potential for eye contact, wear chemical goggles and have eye flushing equipment available. Skin and Body Protection Although this product does not present a significant skin concern, minimize skin contamination by following good industrial practice. Hygiene Measures Handle in accordance with good industrial hygiene and safety practice. 

## 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance Physical State Odor PH Flash point Melting Point/range

Water solubility white to tan powder slight odor Approximately neutral (as 1% solution) Not applicable Decomposes from approx. 448± 0.5 K without melting (OECD 101) Not highly flammable with a relative self-ignition temperature of 351°C. (93/69133C Method Al 0, A16) Soluble. Forms viscous solutions. NOTE: These physical data are typical values based on material tested but may vary from sample to sample. Typical values should not be construed as a guaranteed analysis of any specific lot or as specifications for the product. 

## 10. STABILITY AND REACTIVITY
Stability Stable under recommended storage conditions. Hazardous polymerization does not OMB'.

### p. 27

CP Kelco Material Safety Data Sheet Page 5 of 7 Diutan Gum- industrial Revision Date 26/Sep/2006 Revision Number 0.1 

## 10. STABILITY AND REACTIVITY

Conditions to Avoid
Materials to Avoid Hazardous Decomposition Products Avoid dust formation Strong oxidizing agents Thermal decomposition products: carbon monoxide carbon dioxide Possibility of Hazardous Hazardous polymerization will not occur. Reactions 

## 11. TOXICOLOGICAL INFORMATION

General The dry powder may cause foreign body irritation in some individuals. Prolonged contact with the dry powder may cause drying or chapping of the skin. Excessive inhalation of dust may be annoying and can mechanically impede respiration. Due to the hygroscopic properties, they can form a paste or gel in the airway.

Data from laboratory studies conducted by CP Kelco and/or from the scientific literature on components are summarized below.
Diutan Gum LD50 Oral >5,000 mg/kg rat LC50 inhalation >5 mg/I mg/I 4-hour rat Chronic Effects No adverse effects observed in long-term feeding studies with .0? (up to .1? mg/kg/day) (OECD 407) Irritation Non-Irritating Eye (rabbit) Skin sensitization (guinea pig): Non-sensitizer. (OECD 406) Mutagenicity/Genotoxicity Chromosomal Abberations (mammalian): Non-clastogenic. (OECD 473) AMES Test- S. Typhimurium, E. Coll: Non-mutagenic. (OECD 471) 

## 12. ECOLOGICAL INFORMATION
Ecotoxicity Contains no substances known to be hazardous to the environment or not degradable in waste water treatment plants.

Persistence / Degradability Rainbow trout: > 100 ai/l: No Observed Effect Concentration: 100 al/I (OECD 203) Scenedesmus subspicatus: >100 ai/l active ingredient. No observed Effect Concentration: 100 al/I (OECD 201) Daphnia magna: >100 ai/I active ingredient. No observed Effect Concentration: 100 al/I (OECD 202) Sewage sludge: > 1000 mg ai/l. No Observed Effect Concentration: 1000 mg ai/I (OECD 209) This material is considered readily biodegradable (OECD 310B): 28-Day - aerobic aqueous medium: 95% degradation 10-Day- aerobic aqueous medium: 60% degradation exceeding Diutan Gum 96-Hour LC50 72-Hour EC50
48-Hour EC50
3-Hour EC50

Bioaccumulative Potential Inherently biodegradable.p. 28

CP Kelco Material Safety Data Sheet Page 6 of 7 Diutan Gum- Industrial Revision Date 261Sep12006 Revision Number 0.1


## 13. DISPOSAL CONSIDERATIONS
Waste Disposal Method Dispose in accordance with local, state and national regulations_ Liquids may be sewered in accordance with local, state, and national regulations if care is taken to avoid pluggage or blockage of sewer systems recognizing that these materials are intended to increase viscosity and form gels. Dry or wet solid material can be landfilled in accordance with local, state, and national regulations. As a carbohydrate, this material is readily biodegradable, when at low concentrations, in a biological wastewater treatment plant.



## 14. TRANSPORT INFORMATION

General Information The data provided in this section is for information only. Please apply the appropriate regulations to properly classify your shipment for transportation.
D.O.T. Hazard Classification Non-hazardous material

TDG Not hazardous
IMO / IMDG Not hazardous
ICAO / IATA Not hazardous



## 15. REGULATORY INFORMATION

International Inventories Component(s) of the product are on the following Inventory lists:

• TSCA [non-5(e)SNUR]

• Canada (DSL)

• ELINCS 439-070-6

• CEFAS under the HOCNF scheme (OCNS Group E: the most favourable category)

• DTI/CEFAS -drilling products

• Korea (ECL)

• Australia. Certificate issued 20 September 2006. CAS: 595585-15-2

Regulatory Restrictions For information on approved use of this product, or products in which this product is an ingredient, in other countries/regions not specified herein, please contact CP Kelco Regulatory Affairs.

Harmonized Tariff Code 3913.90
USA
Federal Regulations

### p. 29

CP Kelco Material Safety Data Sheet Page 7 of 7 Diutan Gum- Industrial Revision Date 26/Sep/2006 Revision Number 0.1 

## 15. REGULATORY INFORMATION SARA 313 Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any chemicals which are subject to the reporting requirements of the Act and Title 40n of the Code of Federal Regulations, Part 372.

SARA 3111312 Hazardous Categorization None Clean Air Act, Section 112 Hazardous Air Pollutants (HAPs) (see 40 CFR 61) The components of this product are not regulated under any of the following sections of the Clean Air Act: Section 111 Volatile Organic Compounds, Section 112 Hazardous Air Pollutants, Section 112 Statutory Air Pollutants, Section 112 High-Risk Pollutants, Section 112(r) Accidental Release Prevention Substances or Section 602 Ozone Depleting Substance. As a powder product, it would be regulated under Section 109 Criteria Pollutants particulates. State Regulations California Safe Drinking Water and Toxic Enforcement Act (Proposition 65) This product is in compliance with California's Proposition 65.

Canada WHMIS This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations (CPR) and the MSDS contains all the information required by the CPR.
WHM1S Hazard Class Not classified



## 16. OTHER INFORMATION Prepared By CP Kelco Regulatory Affairs email: regulatory.affairs@cpkelco.com tel: 1-858-467-4503 fax:1-858-467-6505
Reason for Version Revised in entirety
Disclaimer The information contained in this Safety Data Sheet to the best of CP Kelco's knowledge and belief as of the date indicated is believed to be accurate and reliable. However, no representation, warranty or guarantee is implied or expressed regarding the accuracy, reliability or completeness of this information or the use of the product. Nothing contained herein should be construed as a recommendation to use this product in conflict with National or local regulations or existing patents covering any material or its use.

END OF SAFETY DATA SHEET

## p. 30



# Confidential Copy [Contains Confidential Business Information]
Attachment 7: Industrial Site Controlled by the Submitter — Process Description 

## (Part II Section A(1)d)
Process Overview The PMN Substance, also known as S-657, is a biogum produced by bacterial fermentation, similar to many other biogums manufactured by Kelco Biopolymers for food and industrial applications. The Sphingomonas 

## bacteria used to produce the PMN substance is a naturally occurring organism, which was isolated due to its gum forming attributes. 1 In the fermentor, a Sphingomonas 

## bacteria culture is introduced into a sterile environment with media to provide necessary nutrients and is provided an optimum controlled environment to produce the PMN substance, a polysaccharide gum. Once nutrients are depleted and gum content has increased to the desired level, the fermentation is complete, and the broth, a viscous liquid, must be processed to obtain the final dry powder containing the actual gum. The fermentation broth is pasteurized to inactivate the bacterial culture, and precipitated using isopropyl alcohol (IPA) to form a solid cake. This cake is then dried and milled to a powder, sent through a series a sieves in order remove respirable particles, and packaged for transport to industrial customers in fifty pound product bags or fiber drums of various sizes. The IPA is recycled and reused which provides a number of benefits. Enclosed are two multiple page attachments. Attachment 1 shows the unfiltered diutan gum, which is similar to the material in 40 C.F.R. § 721.2076. Attachment 2 is an example of the sieved diutan gum, which is the subject of this SNUN. The diutan gum was sifted on 100 mesh which allows for selection of larger particle sizes from smaller particle sizes. By using 100 mesh, particles below 70 Ilm will be separated out, eliminating most of the respirable sized particles from the finished product. The PMN substance is water soluble and biodegradeable, and will undergo natural decomposition in the environment. The PMN substance will decompose to its original starting monomers, which will subsequently be biodegraded. Treatment in a Publicly Owned Treatment Works (POTW), or other wastewater effluent treatment plant, will accelerate the decomposition of the S-657 gum. The following pages provide information required in Part II Section A(1)d of the PMN, including the major operation steps for manufacture, the identity of all starting materials and feedstocks, and the points of environmental release.

1 

### This organism was originally identified as a Xanthomonas species by the ATCC. Subsequently, it has bettrfound

- to be a species of Sphinogomonas.



## 29

# Removed as TSCA CBI p. 31



# Pages 30-38

### p. 

### 32



## Confidential Copy [] Contains Confidential Business Information 

## Attachment 8: In(lustrial Site Controlled by the Submitter: Occupational Exposure and

Environmental Release (Part 11 Section A(2+3))

Section A(2) Occupational Exposure

( 1 ) ( 3 ) (5) (8) (10) (11)* 1_1 Sampling fermentor broth PPE/bottle broth 3 8 50 1.2 Analyzing fermentor broth PPE broth 5 8 50 1.3 Cleaning fennentor PPE broth 9 8 50 1.4 Sampling dry product PPE/ powder 6 

### 3 40 1,5 Packaging dry Product PPE/BH powder 6 

### 8 40 1.6 Analyzing dry product PPE powder 3 8 40 1.7 Cleaning dry equipment PPE powder/dust 6 

### 2 40 1.8 Dry waste product disposal PPE dust 6 1 40

*(11) 250 days/year is based on a five day work week with two weeks vacation/year. An 8 hour work day is normal, but a 12 hour work day is possible. These days have a 15 minute break every two hours and a 30 minute lunch break. An 8 hour day would have 7 hours of potential exposure, and a 12 hour day would have 10.5 hours. 1 r l Fermentors are sampled every 3 - 4 hours by the Culture Development Lab (CDL) technician, using a sterile bottle, which ensures the sampler will have no contact with the broth. Technicians use proper personal protective equipment (PPE), which includes gloves (latex or nitrite), safety glasses, and long sleeve lab jackets, smocks or other outer covering. The sampling takes one person less than one hour 3-4 times per Shift on a 12 hour shift, 2-3 times on an 8 hour shift. 1.2 The CDL technician will perform routine analysis of the 100 ml samples, wearing gloves (latex or nitrite) and safety glasses to avoid contact with the material, as good lab practice dictates. When the analysis is complete, the technician will inactivate the bacteria by treating the sample with a small amount of bleach (1m1/100mls of water) or by autoclaving. This broth is washed down the drain as the sample bottle is cleaned. -This process can take 1-2 hours per group of samples. 1.3 Once a fermentor has been emptied, the fennentation technicians will wash the inside of the fermentor.with water to remove any residual broth. This is done with a water hose through the top of the fennentor, and 

## the broth drains out a valve in the bottom to the ditches, which lead to the plant sewer. The amount of water will vary with the length of time needed to rinse the interior of the fermentor, which could be 1-10 minutes. There is little to no contact with the broth, and technicians wear gloves, safety glasses, hard hats, and rubber boots (if necessary in wet conditions). 1.4 Samples are taken of dry product by the milling/blending area personnel. As product contamination is a concern, personnel wear long sleeve smocks, gloves (latex or nitrile), hair nets, hard hats, and safety glasses. The powder produces little dust in normal sampling,. so dust masks are not required, but can also be used. 1.5 Packaging dry product can be done as much as 7 hours of an 8 hour shift. The dry powder product is packaged in boxes, fiber drums, or 50 pound bags. The workers wear standard PPE, long sleeve smocks, gloves (latex or nitrile), hair nets, hard hats and safety glasses. Dust masks can be worn, but are not usually necessary. Fine
ATTACHMENT

## p. 33



## Confidential Copy []Contains Confidential Business Information stray dust generated is captured by vacuum systems, and collected by a control device (baghouse) into disposal drums. 1.6 Dry product samples taken by the milling/blending personnel are delivered to the Quality Control Lab (QC) for testing. Any of the 33 technicians there could spend an entire .shift running tests on the 4-8 ounce samples. Due to the small amounts and controlled conditions in the QC lab, normal lab PPE of gloves and glasses are sufficient when handling the material. In rare cases, a dust mask could be worn. 1.7 Blending /milling personnel will perform some general cleaning of the equipment/area to capture any powder from small spills, etc. This would be done using vacuum cleaners, and normal PPE. 1.8 The stray dust captured by the control device (baghouse) is collected in a fiber drum which should be changed once a shift. This involves adding a lid to the full drum, and placing an empty drum in the collection device. Normal PPE is used, and this would take one person 15 minutes /shift or less than one hour/day for all three shifts

Section A(3) Environmental Release and Disposal - kg/batch
(1) (2a) (2b) (3) (4) (5a) (5b) (6) 1) none none exhaust air none 0.0 kg/day 2) none 0.8 kg sink drain POTW 0.0 kg/day* 3) none 0.45 kg sewer drain POTW 0.0 kg/day* 4) none none exhaust air none • 0.0 kg/day 5) none 3.2 kg sink drain POTW 0.0 kg/day* 

## 6) f ] X [ ] X

. 

# 7) i ] x I I x 8) none none air emissions none 0.0 kg/day 9) 1 I X [ I X

Releases 1, 4, 8 are all air emissions which contain no S-657 Releases 2,5 are from samples taken during the fermentation to analyze the process. These are sterilized with heat or chemicals before they are washed into the lab sink drain, which will go to the plant sewer, then to the POTW.

ATTACHMENT



## 40 38

### p. 

### 34



## Confidential Copy () Contains Confidential Business Information

ATTACHMENT

39 

# 41

## p. 35



## KELLER AND HECKMAN LLP Serving Business through Law and S c i ence ®



# MEMORANDUM

CONTAINS TSCA CONFIDENTIAL BUSINESS INFORMATION 

## TO: 

## The Environmental Protection Agency
FROM: 

## Martha Marrapese, Esq.
DATE: June 1, 2007


## RE: Attachment 9; Industrial Sites Controlled by Others

The Significant New Use Rule (SNUR) for diutan gum requires the PMN submitter to file a SNUN pursuant to 40 C.F.R. § 721.80(j) to seek EPA approval for each and every commercial use of diutan gum other than those described in the PMN. The new use proposed in this SNUN is in addition to the uses already approved by EPA for diutan gum. When EPA issued the Significant New Rule Rule (SNUR) for diutan gum, codified at 40 C.F.R. § 721.2076, EPA stated that the basis for the SNUR was "concern[] for lung effects from inhalation exposure to the PMN substance." 68 Fed. Reg. at 70162. We understand that EPA has previously concluded that this polymer need not be regulated as a High Molecular Weight (HMW) polymer. See 

## EPA's Polymer Exemption Guidance Manual, June 1997. For uses other than those already approved by P-00-0007, S-05-0001, and prior SNUN submissions, to address the potential for exposure to respirable particles, CP Kelco will employ the use of sieves to leave no more than 5% of respirable sized particles of 10 microns or less in the finished product. Specifically, once the dried cake is milled to a powder, the newly milled powder will be subjected to sieving using a screen mesh that will allow respirable sized particles to be separated from the larger particle sizes. The diutan gum will be sifted on 100 mesh. In addition to allowing the submitter to leave no more than 5% of respirable sized particles of 10 microns or less in the finished product (Table 3 in enclosed attachment), separation of particles below 70 gm removes thoracic particulate mass (Table 2 in enclosed attachment). Further, the inhalable particulate mass fraction decreases to between 52.5 and 50% (Table 1 in enclosed attachment). Therefore, this process will significantly decrease the potential for inhalation exposure. Precedent for issuing a SNUR with an allowable use (as per subpart j) based upon the amount of respirable size particles in the product is found at 40 C.F.R. § 721.9511. Specifically, this SNUR lists the significant new use as "manufacture or import of the chemical substance where greater than 5% of the chemical substance is below 10 micron (respirable particles) threshold." We respectfully request that EPA update the SNUR in 40 C.F.R. to reflect this and the other uses approved subsequent to the PMN.



# 42=Orme:

co • 

### 80 — Appendices

A4 — Not Classifiable as a Human Carcinogen: Agents which cause concern that they could be carcinogenic for humans but which cannot be assessed conclusively because of a lack of data. In vitro or animalstudies do not provide indications of carcinogenicity which are sufficient to classify the agent into one of the other categories. A5 — Not Suspected as a Human Carcinogen: The agent is not suspectedto be a human carcinogen on the basis of properly conducted epidemiologic studies in humans. These studies have sufficiently longfollow-up, reliable exposure histories, sufficiently high dose, and adequate statistical power to conclude that exposure to the agent does not convey a significant risk of cancer to humans; OR, the evidencesuggesting a lack of carcinogenicity in experimental animals is supported by mechanistic data. Substances for which no human or experimental animal carcinogenic data have been reported are assigned no carcinogenicity designation. Exposures to carcinogens must be kept to a minimum. Workers exposed to Al carcinogens without a TLV®-should be properly equipped to eliminate to the fullest extent possible all exposure to the carcinogen. For Al carcinogens with a TLV® and for A2 and A3 carcinogens, worker exposure by all routes should be carefully controlled to levels as low as possible below the TLV®. Refer to the "Guidelines for the Classification of Occupational Carcinogens" in the Introduction to the Chemical Substances in the Documentation of the Threshold Limit Values and Biological Exposure Indices for a complete description and derivation of these designations. 

### APPENDIX B: Particles (insoluble or poorly soluble) Not Otherwise Specified [PNOS]The goal of the TLV®-CS Committee is to recommend TLVs® for all substances for which there is evidence of health effects at airborne concentrations encountered in the workplace. When a sufficient body of evidence exists for a particular substance, a TLV® is established. Thus, by definition the substancescovered by this recommendation are those for which little data exist The recomrnendation at the end of this Appendix is supplied as a guideline rather than a TLV® because it is not possible to meet the standard level of evidence used to assign a TI_V®. In addition, the PNOS TLV® and its predecessors have been misused in the past and applied to any unlisted particles rather than those meeting the criteria listed below. The recommendations in this Appendix apply to particles that

• Do not have an applicable TLV 0 ;

• Are insoluble or poorly soluble in water (or, preferably, in aqueous lung fluid if data are available); and

• Have low toxicity (i.e., are not cytotoxic, genotoxic, or otherwise chemically reactive with lung tissue, and do not emit ionizing radiation, cause immune sensitization, or cause toxic effects other than by inflammation or the mechanism of lung overload"). 

### Appendices — 

### 81
ACG111® believes that even biologically inert, insoluble, or poorly soluble parlicles may have adverse effects and recommends that airborne concentrations should be kept below 3 ing/rn 3 , respirable particles, and 10 mg/r11 3 , inhalable particles, until such time as a 11V® is set for a particular substance.



### APPENDIX C: Particle Size-Selective Sampling Criteria for Airborne Particulate MatterFor chemical substances present in inhaled air as suspensions of solid particles or droplets, the potential hazard depends on particle size as well as mass concentration because of 1) effects of particle size on the deposition site within the respiratory tract and 2) the tendency for many occupational diseases to be associated with material deposited in particular regions of the respiratory tract.ACGIH® has recommended particle size-selective TLVs® for crystalline silica for many years in recognition of the well-established association between silicosis and respirable mass concentrations. The TLV®-CS Committee is now re-examining other chemical substances encountered in particulate form in occupational environments with the objective of defining: 1) the size-fraction most closely associated for each substance with the health effect of concern and 2) the Mass concentration within that se fraction which should represent the ILA The Particle Size-Selective TLVs® (PSS-TLVs) are expressed in three forms: 1. Inhalable Particulate Mass TLVso (IPM-TLVs) for those materials that are hazardous when deposited anywhere in the respiratory tract. 2. Thoracic Particulate Mass MVO (TPM-TLVs) for those materials that arehazardous when deposited anywhere within the lung airways and the gasexchange region. 3. Respirable Particulate Mass TLVO (RPM-TLVs) for those materials that are hazardous when deposited in the gas-exchange region.The three particulate mass fractions described above are defined in quantitative terms in accordance with the following equafione 4
A. IPM consists of those particles that are captured according to the following collection efficiency regardless of sampler orientation with respect to wind direction: IPM (d„) = 0.5 [1 + exp(-0.06 d„)] for 0 < d„ < 100 gm where: IPM (d„) = the collection efficiency

d a , = aerodynamic diameter of particle in gm
B. TPM consists of those particles that are captured according to the following collection efficiency:

TPM (d„) = IPM (d„) [1 - F(x)J



### 43

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# t m .t al

- where: F(x) = cumulafive probability function of the standardized normal

vadable, x In(d a dr) x - In(2) In = natural logarithm 

### r = 

### 11.64 E = 1.5C. RPM consists of those particles that are captured according to the following collection efficiency:

RPM (d w ) = IPM (d ae ) 

### El - F(x)] where F(x) = same as above, but with 

### r = 4.25 pm and E = 1.5 The most significant difference from previous definitions is the increase in the median cut point for a respirable particulate matter sampler from 3.5 pm to 4.0 pm; thls is in accord with the International Organization for Standardization/ European Standardiiation Committee (ISO/CEN) intocol." At this time, no change is recornmended for the measurement of respirable particulates using a 10-mm nylon cyclone at a flow rate of 1.7 liters per minute. Two analyses of available data indicate that the flow rate of 1.7 fiters per minute allows the 10- mm nylon cyclone to approximate the particulate matter concentration whichwould be measured by an ideal respirable particulate sampler as defined hereCollection efficiencies representative of several sizes of particles in each of the respective mass fractions are shown in Tables 1, 2, and 3. 

### Documentation for the respective algorithms representative of the three mass fractions is found in the literature." )
TABLE 1. Inhalable Particle Aerodynamic Diameter (pm) Inhalable Particulate Mass (LPM) (%) 0 100 1 97 2 94 5 87 10 77 20 65 30 58 40 54.5 50 52.5 100 50 TABLE 2. Thoracic Particle Aerodynamic Diameter (pm) Thoracic Particulate Mass (TPM) (%) 0 100 2 94 4 89 6 80.5 8 67 10 50 12 35 14 23 16 15 18 9.5 20 6 25 2
TABLE 3. Respirable Particle Aerodynamic Diameter (gm) Respirable Particulate Mass (RPM) (%) 0 100 1 97 2 91 3 74 4 50 5 30 6 17 7 9 8 5 10 1



### References

1. American Conference of Governmental Industrial Hygienists: Particle Size-Selective Sampling in the Workplace. ACGIHO, Cincinnati, OH (1985). 2. American Conference of Governmental Industrial Hygienists: Particle Size-Selective Sampling for Particulate Air Contaminants. JH Vincent, Ed. ACGII-1 0 , Cincinnati, OH (1999). 3. Soderholm, SC: Proposed International Conventions for Particle Size-Selective Sampling. Ann. Occup. Hyg. 33:301-320 (1989). 4. International Organization for Standardization (ISO): Air Quality-Particle Size Fraction Definitions for Health-Related Sampling. ISO 7708:1995. ISO, Geneva (1995). 5. European Standardization Committee (CEN): Size Fraction Definitions for Measurement of Airborne Particles. CEN EN481:1993. CEN, Biussels (1993). 6. Bartley, DL Letter to J. Doull, TLVO Committee, July 9, 1991. 7. Lidén, G; Kenny, LC: Optimization of the Performance of Existing Respirable Dust Samplers. Appl. Occup. Environ. Hyg. 8(4)386-391 (1993).



## 44

### p. 38



## Confidential Copy I J Contains Confidential Business Information

Attachment 10: Optional Pollution Prevention Information

ATTACHMENT

### p. 39 

## Confidential Copy I Contains Confidential Business Information



# ATTACHMENT 46