### Cover Letter

{XXX}

Page 1 SANITIZED SUBMISSIONTS-PA13PW; Check #5400; PC-7067 PA13131230429786301 PA13PW

X X X X X X

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Page 3 SANITIZED SUBMISSIONMatthew Stershic Global General Manager PMC Organometallix 1288 Route 73 Suite 401 Mount Laurel NJ 08054 matthew.sterschic@pmc-group.com

Donna Mondimore Regulatory Manager PMC Organometallix 1288 Route 72 Suite 401 Mount Laurel NJ 08054 donna.mondimore@pmc-group.com 215-450-4197



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XXX 

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### X 370462-1 TS-PA13PW_IES 370462-1_Name-san.pdf UVCB

See Attachment 006 (TS-PA13PW_IES 370462-1_Name-san.pdf)

TS-PA13PW_IES 370462-1_Name-san.pdf

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Elimination

XXX 

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TS-PA13PW_IES 370462-1_Process-san.pdf

Page 6 SANITIZED SUBMISSIONPage 7 SANITIZED SUBMISSIONPage 8 SANITIZED SUBMISSIONAdvastab XXX, thermolite XXX, Reverse Ester Organotin

Mixed Alkyltin mercaptoester sulfides

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XXX 

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XXX 

### X 370462-3 TS-PA13PW_IES 370462-3_Name-san.pdf UVCB

See Attachment 009 (TS-PA13PW_IES 370462-3_Process-san.pdf)

TS-PA13PW_IES 370462-3_Process-san.pdf

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Elimination

See attachment 

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TS-PA13PW_IES 370462-3_Process-san.pdf

Page 11 SANITIZED SUBMISSIONPage 12 SANITIZED SUBMISSIONPage 13 SANITIZED SUBMISSIONAdvastab XXX, thermolite XXX, Reverse Ester Organotin

Mixed Alkyltin mercaptoester sulfides

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XXX 

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### X 370462-5 TS-PA13PW_IES 370462-5_Name-san.pdf UVCB

See Attachment 011 (TS-PA13PW_IES 370462-5_Process-san.pdf)

TS-PA13PW_IES 370462-5_Process-san.pdf

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Elimination

see attachment 

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TS-PA13PW_IES 370462-5_Process-san.pdf

Page 16 SANITIZED SUBMISSIONPage 17 SANITIZED SUBMISSIONPage 18 SANITIZED SUBMISSIONAdvastab XXX, thermolite XXX, Reverse Ester Organotin

Mixed Alkyltin mercaptoester sulfides

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X X TS-PA13PW-Pt1SecC_ProductionInfo-san.pdf

Stabilizer for PVC XXX X XXX X XXX XXX XXX XXX X

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7416 12 365 

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Page 21 SANITIZED SUBMISSIONSee Attachment 004 (TS-PA13PW-Pt2SecA_SubmitterControlledSites-process-san.pdf)

TS-PA13PW-Pt2SecA_SubmitterControlledSites-process-san.pdf

Page 22 SANITIZED SUBMISSIONX X X

Sampling/QC analysis XXX XXX 2 XXX XXX X X
Sampling of final product and QC analysis XXX XXX 2 XXX XXX X X
Filling containers XXX XXX 2 XXX XXX X X

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XXX 

### X See Attachment 005 (TS-PA13PW-Pt2SecB-OthercontrolledSites-process-san.pdf)

TS-PA13PW-Pt2SecB-OthercontrolledSites-process-san.pdf See continuation page. id: <P10SB1(b)1>

Page 25 SANITIZED SUBMISSIONP10SB1(b)1 Part II, Section B, 1(b). Optional Text Description

Operation Description: The PMN substance is distributed to US customers in 1043 kg totes. They compound it with polyvinyl chloride and other additives into pellets, blocks or powders. Approximately 1-2% of the PMN substance is mixed with PVC additives and then blended. The PMN substance is unloaded into the blender via a closed system. Worker exposure occurs when the siphon is connected to and then removed from the tote tank (A). PPE is required during this step. The best practice to empty totes requires that the user tilt the container for maximum removal. The stabilizer represents one of the most expensive components in PVC and it is incumbent upon the user to dispose of as little as possible. For many years, stabilizers were sold in returnable totes. Today only a small percentage of totes are returned to the submitter facility. Based on this experience, typically about 1.13 kgs of residue is found in the returned tote. This residual amount can be used as the basis for determining environmental exposure for users sending their totes to a recycling facility instead of returning to the submitter. Water (a small amount of Acetone) and hot air drying is used to clean returned totes. The solvent/wash water is sent to a waste water treatment site by the submitter and typical tote recyclers. 20% of the PMN substance is exported and the containers are not returned. At worst case for a yearly production of 2706840 kg of stabilizer, of which 20% is exported, there would be 519 totes used in the US which would translate to 586 kg of residual PMN substance sent for disposal in a year. The blending process is a closed system so there is no chance of exposure to the PMN substance. The blended substance [referred to as PVC compound] is a solid. The blender is cleaned approximately 5 times/year. The cleaning process is through agitation and done by pressurized air through the blender. The walls of the blender are metal (anti-sticking walls) so they are easily cleaned with air pressure. The blender is not rinsed with any solvent or with water; the PMN substance is bound within the PVC and there is no chance for exposure. The amount of substance in the blender is usually less than 5 tons. Once the PVC compound leaves the blender, it is cooled and packaged in paper bags or Gaylord boxes that measure 48L x 40W x 36H" for distribution and on-site use. There is no chance for exposure to the PMN substance during packaging since it is bound within the PVC compound. The compounders either store the compounded PVC on-site for use or package it and ship to their customers for molding or extrusion applications. 20% of the PMN substance is exported. 23 customers with 37 sites among them compound both for self-use and shipment to their customers. PVC compound is extruded to produce final articles containing 1-2% of the PMN substance. Worker exposure during processing is regulated by occupational exposure limit of a TLV <0.1 mg/m3 (B). Ventilation is provided to keep the exposure limit below the TLV. The predecessor companies have conducted or sponsored many air monitoring studies to assess the levels of orgaontin compounds present in the air in PVC processing facilities. Earlier studies were conducted during both PVC pipe and PVC siding production. The air samples were taken within inches of the die face. The concentration of tin from the stabilizer in these air samples was found to be about 0.001-0.002 mg/kg. In 1976, a study was conducted by Van Battum in a German calendering plant. In the calendaring operation, a much higher surface of hot PVC melt is exposed to the air than in normal extrusion operations. This might be considered a worst case for volatilizing organotin compounds during PVC processing. Van Battum's study showed that less than 0.01 mg/m3 of tin was found when the air samples were obtained only one meter from the hot calendar rolls [D. Van Battum, Centraal Institut voor Voedingsonderzock (CIVO), Zeist, Netherlands, Report Nos. 06236/76 and 07822A. 75 (1976).] Extruders require cleaning which is performed monthly by a plastic purge using over-processed material. Off-specification plastics are usually ground up and reworked into virgin resin therefore disposal would be minimal. If required, the solid PVC material would be disposed of in a landfill according to local, state and federal regulations. A study by Ejlertsson, Hörsing and Mersiowsky [PVC in Landfills Add-on Project (METS) — Behaviour of PVC Products at Different Temperatures; 2000] demonstrated that organotin species in PVC that go into landfills are subject to biological or abiotic dealkylation processes and are successively transformed and possibly mineralized to inorganic tin. Over the years sales, marketing and technical service professionals [of the predecessor and current companies producing stabilizers] have visited all of our customer sites and some of our customer’s customer sites. Compounded PVC containing the PMN substance for on-site use is stored in silos or cardboard gaylords with plastic linings. The cardboard gaylords and plastic liners are disposed of either by incineration or landfill. The gaylords hold about 2600lbs of compounded PVC. Neither the gaylords, their liners, nor the silos are cleaned with water. Normal cleaning of the silos and compounding equipment (i.e. blender) is done by air pressure and collecting any fines for reuse or landfill. The behavior of the PMN substance in a landfill was previously outlined. Under incineration, the carbon-tin bond is rapidly broken in the first step, leading to C02 , H20 and Sn02 at about 950°C [C. Bruneau, N. Soyer, and J. P. Anger, J. Anal. Appl. Pyrolysis, 16, 183 (1989).] Compounded PVC containing the PMN substance shipped by our customers to their customers from any of the facilities mentioned above is generally done either in cardboard gaylords with plastic liners or in railcars. An environmental, health and safety representative of one typical customer indicated that the railcars hold approximately 140,000 lbs of compounded PVC and that railcars are usually used for transport of cube or pellet forms. This individual indicated that normal cleaning of the railcars is by air pressure. On rare occasion, the powder form is shipped by railcar and then it is wiped down by hand. Collected material is land filled; they use no water to clean rail cards. Material is removed from the railcars at the downstream customer site by vacuum suction and stored in a silo. This is a close system transfer. Material is removed from the gaylords by suction hose and put directly into the extrusion or molding equipment. We have been told that companies conduct routine air monitoring for total dust and respirable dust levels. In compounding operations, typical

Page 26 SANITIZED SUBMISSIONP10SB1(b)1 Part II, Section B, 1(b). Optional Text Description

dust levels are 0.5 mg/m3 from are sampling. This about 20 times below the 10 mg/m3 ACGIH 8-hour time weighted average limit for Particulates Not Otherwise Classified (PNOC).

Page 27 SANITIZED SUBMISSIONP10SB1(a)(4)1 Part II, Section B, 1(a)(4). Operation Site Locations

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Page 28 SANITIZED SUBMISSIONA 4 0.75 260 See continuation page. id: <P10ASB2(6)C1R1> 100 80

1 0 0 No release expected B 12 8 260 See continuation page. id: <P10ASB2(6)C1R2> 100 1.5

2 0 0.01 Exhaust/Condenser

Page 29 SANITIZED SUBMISSIONP10ASB2(6)C1R1 Part II, Section B, 2.(6) Protective Equip./Eng. Controls, etc., Row 1

Gloves, Goggles Ventilation Liquid

Page 30 SANITIZED SUBMISSIONP10ASB2(6)C1R2 Part II, Section B, 2.(6) Protective Equip./Eng. Controls, etc., Row 2

Gloves, Safety Glasses Ventilation solid

Page 31 SANITIZED SUBMISSIONPage 32 SANITIZED SUBMISSION001 FT-IR of PMN substances TS-PA13PW-FTIR-370462-1-3-5 -san.pdf 3
002 TS-PA13PW-Pt1SecC-Additional Production Information TS-PA13PWPt1SecC_ProductionInfo-san.pdf Pt.I, Sec.C, 1. 1 003 MSDS for PMN substance TS-PA13PW-MSDS.pdf 9
004 TS-PA13PW Pt2SecA Process Diagram TS-PA13PWPt2SecA_SubmitterControlledSit Pt.2, Sec.A, 1d. 3 005 Process Diagram for Use of PMN substance TS-PA13PW-Pt2SecBOthercontrolledSites-processPt.2, Sec.B, 1a. 1 006 CAS IES Order 370462-1 TS-PA13PW_IES 370462- 1_Name-san.pdf Pt.I, Sec.B, 1c. | Pt.I, Sec.B, 1e. 1 007 CAS IES Structure for PMN substance 370462-1 TS-PA13PW_IES 370462- 1_Process-san.pdf Pt.I, Sec.B, 1e(3). 1 008 CAS IES Order 370462-3 TS-PA13PW_IES 370462- 3_Name-san.pdf Pt.I, Sec.B, 1c. (Chem 2) 1 009 CAS IES Structure for PMN Substance 370462-3 TS-PA13PW_IES 370462- 3_Process-san.pdf Pt.I, Sec.B, 1e. (Chem 2) | Pt.I, Sec.B, 1e(3). (Chem 2) 1 010 CAS IES Order 370462-5 TS-PA13PW_IES 370462- 5_Name-san.pdf Pt.I, Sec.B, 1c. (Chem 3) 1 011 CAS IES Structure for PMN substance 370462-5 TS-PA13PW_IES 370462- 5_Process-san.pdf Pt.I, Sec.B, 1e. (Chem 3) | Pt.I, Sec.B, 1e(3). (Chem 3) 1
012 OECD SIDS Initial Assessment Report, TS-PA13PW- 55 013 OECD SIDS Initial Assessment Report, Dibutyltin dichloride, selected esters and TS-PA13PWOECD_SIDS_IAR_dibutyltins.pdf 88 014 TS-PA13PW - Risk Assessment no exposure TS-PA13PW-Risk Assessment_RC+RJ-san.pdf 173
015 Risk Asssessment - EPA Category of Concern TS- 56 016 Risk Asssessment - EPA Category of Concern Organotins - DeWitt-Copeland- Lubke-Immune TSPA13PW_ImmuneResponse_DB 11 017 Risk Asssessment - EPA Category of Concern Organotins - DeWitt_Copeland_Lubke_An TS_PA13PW_OrganotinMixPVC _pipe_not immunotoxic to adult 7 018 Risk Asssessment - EPA Category of Concern Organotins - TSPA13PW_DevelopmentalExposu 9 019 Risk Asssessment - EPA Category of Concern TS_PA13PW_EvalDevNeurotoO 12 020 Risk Asssessment - EPA Category of Concern Organotins - Data Summary and Review TS-PA13PW_PositionPapersan.pdf 5 021 Rational for the use of surrogate data for PMN TS-PA13PW-RationalSurrogate- 5 

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026 MONOBUTYL TIN TRI CHLORIDE: ASSESSMENT OF CLASTOGENIC ACTION TS-PA13PW-MBTCBoneMarrowErythrocytesTest.pdf 34
027 In-Vivo Mouse micronucleus test on surrogate substance TS-PA13PWMouseMicronucleusTest-san.pdf 50 028 Determination of Water Solubility Test of butyltrichlorostanne TS-PA13PW-MBTCWaterSolubility.pdf 32

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1 Estimate

>200 Estimate

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Flash Point >200C Estimate

Page 35 SANITIZED SUBMISSION

### ATTACHMENT HEADER SHEET

Attachment Number 001 Attachment Name FT-IR of PMN substances 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 002 Attachment Name TS-PA13PW-Pt1SecC-Additional Production Information 

### Associated PMN Section Number

Pt.I, Sec.C, 1.
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 003 Attachment Name MSDS for PMN substance 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 004 Attachment Name TS-PA13PW Pt2SecA Process Diagram 

### Associated PMN Section Number

Pt.2, Sec.A, 1d.
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 005 Attachment Name Process Diagram for Use of PMN substance 

### Associated PMN Section Number

Pt.2, Sec.B, 1a.
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 006 Attachment Name CAS IES Order 370462-1 

### Associated PMN Section Number Pt.I, Sec.B, 1c. | Pt.I, Sec.B, 1e.
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 007 Attachment Name CAS IES Structure for PMN substance 370462-1 

### Associated PMN Section Number

Pt.I, Sec.B, 1e(3).
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 008 Attachment Name CAS IES Order 370462-3 

### Associated PMN Section Number Pt.I, Sec.B, 1c. (Chem 2)
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 009 Attachment Name CAS IES Structure for PMN Substance 370462-3 

### Associated PMN Section Number Pt.I, Sec.B, 1e. (Chem 2) | Pt.I, Sec.B, 1e(3). (Chem 2)

Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 010 Attachment Name CAS IES Order 370462-5 

### Associated PMN Section Number Pt.I, Sec.B, 1c. (Chem 3)
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 011 Attachment Name CAS IES Structure for PMN substance 370462-5 

### Associated PMN Section Number Pt.I, Sec.B, 1e. (Chem 3) | Pt.I, Sec.B, 1e(3). (Chem 3)

Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 012 Attachment Name OECD SIDS Initial Assessment Report, Monobutyltins, selected esters and catalysts SIAM 23



### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 013 Attachment Name OECD SIDS Initial Assessment Report, Dibutyltin dichloride, selected esters and catalysts SIAM 23 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 014 Attachment Name TS-PA13PW - Risk Assessment no exposure 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 015 Attachment Name Risk Asssessment - EPA Category of Concern Organotins - T-340: A Prolonged Sediment Toxicity Test with CHIRONOMUS riparius 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 016 Attachment Name Risk Asssessment - EPA Category of Concern Organotins - DeWitt-Copeland- Lubke-Immune Responses in

Sprague-Dawley Rats Exposed to Dibutyltin in Drinking Water as Adults



### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 017 Attachment Name Risk Asssessment - EPA Category of Concern Organotins - DeWitt_Copeland_Lubke_An Organotin Mixture Found

in Polyvinyl Chloride (PVC) Pipe is not Immunotoxic to Adult Sprague-Dawley Rats



### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 018 Attachment Name Risk Asssessment - EPA Category of Concern Organotins - DeWitt_Copeland_Lubke_Developmental Exposure to 1.0 or 2.5 mg/kg of Dibutyltin Dichloride Does Not Impair Immune Function in Sprugue-Dawley Rats 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 019 Attachment Name Risk Asssessment - EPA Category of Concern Organotins - Moser_Barone_Phillips_McDanie_Ehman_Evaluation

of Developmental Neurotoxicity of Organotins via Drinking Water in Rats



### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 020 Attachment Name Risk Asssessment - EPA Category of Concern Organotins - Data Summary and Review



### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 021 Attachment Name Rational for the use of surrogate data for PMN substance 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 026 Attachment Name MONOBUTYL TIN TRI CHLORIDE: ASSESSMENT OF CLASTOGENIC ACTION ON BONE MARROW ERYTHROCYTES IN THE HICRONUCLEUS TEST 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 027 Attachment Name In-Vivo Mouse micronucleus test on surrogate substance 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301

### ATTACHMENT HEADER SHEET

Attachment Number 028 Attachment Name Determination of Water Solubility Test of butyltrichlorostanne 

### Associated PMN Section Number

N/A
Does not contain CBI 

### Report Number PA13131230429786301