## Cover Letter

The product subject to this submission is a process intermediate used in the manufacture of the substance WESTON® 705. WESTON® 705 is approved for manufacture within the US, and is also subject to approval as a food contact material (US FDA Food Contact Approval (FCN 1251, FCN 1422 and FCN 1466) [reference http://www.accessdata.fda.gov/scripts/fcn/fcnDetailNavigation.cfm?rpt=fcsListing&id=1251] The product is manufactured at a single EU site (Addivant France, located at Catenoy, France). Within the EU it is registered under the EU REACH scheme as a “Transported Isolated Intermediate” (Registration number:01- 2120064353-61-0000; EC 941-702-5). Subsequent to manufacture, it is shipped to the single US site within isotankers for subsequent transformation into the WESTON® 705 product. There is envisage to be negligible release of the substance during the WESTON® 705 manufacturing process. The substance is known to be non-volatile (on the basis of the components vapour pressures) so release to air is negligible, given the engineering measures in place at the site. Upon arrival at the US site, it is pumped directly from isotanker to the closed system storage vessel. From here it is transferred directly to the reaction vessel. The isotanker is returned to the EU for re-loading without subsequent cleaning (the isotanker utilised is dedicated to the substance alone), so release from waste water washings is not anticipated. Following completion of the reaction process, excess product present from the distillation purification stage is recycled for use within the next batch. Hazardous waste from the production process is disposed of via registered hazardous waste disposal outlet, where it is incinerated. Filter residues contaminated with the substance are also disposed of by incineration. There will be no significant release of the material therefore to the environment. The site of use has approvals for the disposal of WESTON® 705 and amylphenol wastes via two facilities as follows: (1) Tradebe Treatment and Recycling, LLC located in East Chicago, Indiana, 46312, US EPA ID # IND000646943. Tradebe is permitted to accept hazardous and non-hazardous waste and conduct associated treatment. The site sends hazardous waste to an incinerator if it is reactive, or they fuel blend it and send to a cement kiln. The understanding is that the 705 would be fuel blended and sent to a cement kiln, hence it is destroyed via incineration as part of the fuel burning process. (2) Greencastle WDF Facility in Greencastle, IN 46135, US EPA ID# IND006419212. Greencastle is a cement kiln that is permitted to accept hazardous and non-hazardous waste . It is regulated in a similar manner to an incinerator , and hence waste is destroyed via incineration as part of the fuel burning process. Exposure to the workforce will also be negligible. Main sources for exposure are during the loading of the storage vessel, loading of the reaction vessel, and as an impurity within the WESTON® 705 completed product. The loading process is automated, so exposures will be negligible – the product is pumped directly from the isotanker to the storage vessel, so exposures will be limited to the coupling process at point of transfer. Transfer to the reaction vessel from the storage tank is automated, with no exposure, as the system is closed. Post reaction, it is known that there are no significant hazardous effects associated with the product WESTON® 705, as this has been fully tested for regulatory purposes, and is deemed “not hazardous”. Therefore the presence of the substance subject to Page 1 SANITIZED SUBMISSION

### this PMN as an impurity is not anticipated to cause hazardous effects.

It is considered that the use of the substance as a process intermediate under these conditions is appropriate and safe, with no hazardous effects proposed to man or the environment.

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## X 388769 CAS IES CBI.pdf 

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## X See Attachment 001 (SANITIZED STRUCTURE.pdf)

SANITIZED STRUCTURE.pdf Page 6 SANITIZED SUBMISSIONPage 7 SANITIZED SUBMISSIONPage 8 SANITIZED SUBMISSIONPage 9 SANITIZED SUBMISSIONXXX

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Phenol, 1, 1-dimethylalkyl derivatives 

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X The product is a process intermediate used in the production of a final product. It is consumed during the reaction process of the final product at a single site. XXX 

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Page 12 SANITIZED SUBMISSIONSee Attachment 003 (SANITIZED REACTION PROCESS.pdf)

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Page 16 SANITIZED SUBMISSIONPage 17 SANITIZED SUBMISSIONThere is envisage to be negligible release of the substance during the WESTON® 705 manufacturing process. The substance is known to be

non-volatile (on the basis of the components vapour pressures) so release to air is negligible, given the engineering measures in place at the site. Upon arrival at the US site, it is pumped directly from isotanker to the closed system storage vessel. From here it is transferred directly to the reaction vessel. The isotanker is returned to the EU for re-loading without subsequent cleaning (the isotanker utilised is dedicated to the substance alone), so release from waste water washings is not anticipated. Following completion of the reaction process, excess product present from the distillation purification stage is recycled for use within the next batch. Hazardous waste from the production process is disposed of via registered hazardous waste disposal outlet, where it is incinerated. Filter residues contaminated with the substance are also disposed of by incineration. There will be no significant release of the material therefore to the environment. The site of use has approvals for the disposal of WESTON® 705 and amylphenol wastes via two facilities as follows: (1) Tradebe Treatment and Recycling, LLC located in East Chicago, Indiana, 46312, US EPA ID # IND000646943. Tradebe is permitted to accept hazardous and non-hazardous waste and conduct associated treatment. The site sends hazardous waste to an incinerator if it is reactive, or they fuel blend it and send to a cement kiln. The understanding is that the 705 would be fuel blended and sent to a cement kiln, hence it is destroyed via incineration as part of the fuel burning process. (2) Greencastle WDF Facility in Greencastle, IN 46135, US EPA ID# IND006419212. Greencastle is a cement kiln that is permitted to accept hazardous and non-hazardous waste . It is regulated in a similar manner to an incinerator , and hence waste is destroyed via incineration as part of the fuel burning process.

Page 18 SANITIZED SUBMISSION001 SANITIZED Phenol, 1, 1-dimethylpropyl derivs. SANITIZED STRUCTURE.pdf Pt.I, Sec.B, 1e. 1 002 SANITIZED CAS IES CAS IES CBI.pdf Pt.I, Sec.B, 1c. 4 003 Amylated phenol Reaction Process - NonConfidential SANITIZED REACTION PROCESS.pdf Pt.2, Sec.A, 1d. 2 004 SANITIZED AMYLATED ANALYTICAL DATA PACK SANITIZED AMYLATED ANALYTICAL DATA PACK.pdf 13 005 SANITIZED SDS & LABEL INFORMATION SANITIZED SDS AND LABEL DATA.pdf 14

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## X

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## ATTACHMENT HEADER SHEET Attachment Number 001 Attachment Name SANITIZED Phenol, 1, 1-dimethylpropyl derivs. 

## Associated PMN Section Number

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

## Report Number FINA150220772866835

## ATTACHMENT HEADER SHEET Attachment Number 002 Attachment Name SANITIZED CAS IES 

## Associated PMN Section Number

Pt.I, Sec.B, 1c. Does not contain CBI 

## Report Number FINA150220772866835

## ATTACHMENT HEADER SHEET Attachment Number 003 Attachment Name Amylated phenol Reaction Process - Non-Confidential 

## Associated PMN Section Number

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

## Report Number FINA150220772866835

## ATTACHMENT HEADER SHEET Attachment Number 004 Attachment Name SANITIZED AMYLATED ANALYTICAL DATA PACK 

## Associated PMN Section Number

N/A Does not contain CBI 

## Report Number FINA150220772866835

## ATTACHMENT HEADER SHEET Attachment Number 005 Attachment Name SANITIZED SDS & LABEL INFORMATION 

## Associated PMN Section Number

N/A Does not contain CBI 

## Report Number FINA150220772866835