### Re: Fw: Response to Harcos Chemicals regarding review for CASRN 31138-65-5 Paul Campanella to: Ann Marie Savini 02/07/2012 04:10 PM Cc: Donald Meuschke, Howard Stevenson, James Grantham, John Miles, Peter Radford Bcc: John Schaeffer, Marcus Aguilar From: Paul Campanella/DC/USEPA/US To: Ann Marie Savini <AnnMarie.Savini@harcros.com> Cc: Donald Meuschke <Don.Meuschke@harcros.com>, Howard Stevenson <HStevenson@harcros.com>, James Grantham <JGrantham@harcros.com>, John Miles <JMiles@harcros.com>, Peter Radford <PRadford@harcros.com> Bcc: John Schaeffer/DC/USEPA/US@EPA, Marcus Aguilar/DC/USEPA/US Ann Marie, After talking with you regarding the request for an extension, this is to confirm our decision to extend the date for receipt of test data on CASRN 31138-65-5to December 31, 2012 to provide enough time for testing and report preparation.

Paul J. Campanella, Ph.D. Chemical Information and Testing Branch Chemical Control Division U.S. Environmental Protection Agency Washington, D.C. 202-564-8091 Ann Marie Savini 01/17/2012 12:53:55 PM Paul, Please find attached the request for an ext...
From: Ann Marie Savini <AnnMarie.Savini@harcros.com> To: Paul Campanella/DC/USEPA/US@EPA Cc: Peter Radford <PRadford@harcros.com>, Howard Stevenson <HStevenson@harcros.com>, Donald Meuschke <Don.Meuschke@harcros.com>, John Miles <JMiles@harcros.com>, James Grantham <JGrantham@harcros.com> Date: 01/17/2012 12:53 PM Subject: Re: Fw: Response to Harcos Chemicals regarding review for CASRN 31138-65-5

Paul, Please find attached the request for an extension for the Section 4 testing on CAS# 31138-65-5. I am also sending a hard copy to you via UPS. Regards, Ann Marie 

### (See attached file: R equest for Extension 1-17-12..p df )

Ann Marie Savini Harcros Chemicals , Inc

.Phone: (913) 621-7802 Fax: (913) 621-7876 Paul Campanella ---01/17/2012 11:40:27 AM---Ann Marie, I apologize for the confusion on this. The OECD Method 102 ( Melting Point) is an accepta

From: Paul Campanella <Campanella.Paul@epamail.epa.gov>
To: Ann Marie Savini <AnnMarie.Savini@harcros.com>
Cc: John Schaeffer <Schaeffer.John@epamail.epa.gov>, Marcus Aguilar <Aguilar.Marcus@epamail.epa.gov>
Date: 01/17/2012 11:40 AM Subject: Re: Fw: Response to Harcos Chemicals regarding review for CASRN 31138-65-5

Ann Marie, I apologize for the confusion on this. The OECD Method 102 ( Melting Point) is an acceptable substitute for ASTM E 324-99. In addition, OECD Method 105 ( Water Solubility) is an acceptable substitute for ASTM E 1148-02. Thanks for calling to make sure we were discussing the same issue. Now to get the testing done. Good luck. Paul

Paul J. Campanella, Ph.D. Chemical Information and Testing Branch Chemical Control Division U.S. Environmental Protection Agency Washington, D.C. 202-564-8091

From: Ann Marie Savini <AnnMarie.Savini@harcros.com> To: Paul Campanella/DC/USEPA/US@EPA Date: 01/17/2012 11:04 AM Subject: Re: Fw: Response to Harcos Chemicals regarding review for CASRN 31138-65-5

Paul, I was wondering if you had a chance to review the change in the Boiling Point and Water Solubility protocols. Also, I am going to write a letter asking for an extension for the testing. It looks like we should be done testing around June. However, I had read that although EPA does grant extensions, they will most likely only grant one extension. Although we should be done by the end of June, I want to be sure that we have extra time in case any problems arise during the testing. Can you give me some guidance on how long of an extension EPA is likely to approve?
Thanks! Ann Marie(Embedded image moved to file: pic13303.gif)Ann Marie Savini Harcros Chemicals, Inc. Phone: (913) 621-7802 Fax: (913) 621-7876 (Embedded image moved to file: pic14992.gif)Inactive hide details for Ann Marie Savini---01/04/2012 01:04:40 PM---Paul, The revised protocol mostly had to do with the requAnn Marie Savini---01/04/2012 01:04:40 PM---Paul, The revised protocol mostly had to do with the request for a change in the method for Boiling (Embedded (Embedded image moved to file: pic04948.gif) image moved to Ann Marie Savini/Harcros file: pic13959.gif) From: (Embedded (Embedded image moved to file: pic14613.gif) image moved to Paul Campanella <Campanella.Paul@epamail.epa.gov> file: pic19206.gif) To: (Embedded (Embedded image moved to file: pic15639.gif) image moved to 01/04/2012 01:04 PM file: pic28969.gif) Date: (Embedded (Embedded image moved to file: pic06561.gif) image moved to Re: Fw: Response to Harcos Chemicals regarding review file: for CASRN 31138-65-5 pic19455.gif) Subject:

Paul, The revised protocol mostly had to do with the request for a change in the method for Boiling Point (per ASTM E 1719-05) and Water Solubility (per ASTM E 1148-02 or 40 CFR 799.67784). There was some miscommunication between us and the testing facility and they do not have the equipment to perform the ASTM methods but can run alternate methods which I included in my December 6th e-mail. I wanted to make sure that this would be ok with EPA. I sent copies of the revised protocols as well (mostly for your records). Please let me know if you need any further explanations. Best regards, Ann Marie(Embedded image moved to file : p ic 0 2651

. g if ) Ann Marie Savini Harcros Chemicals, Inc. Phone: (913) 621-7802 Fax: (913) 621-7876
(Embedded image moved to file: pic04410.gif)Inactive hide details for Paul Campanella ---01/04/2012 12:51:24 PM---Ann Marie, Thanks you for the good wishes. I thought thatPaul Campanella ---01/04/2012 12:51:24 PM---Ann Marie, Thanks you for the good wishes. I thought that our response answered your questions but, (Embedded (Embedded image moved to file: pic16576.gif) image moved to Paul Campanella <Campanella.Paul@epamail.epa.gov> file: pic32677.gif) From: (Embedded (Embedded image moved to file: pic17222.gif) image moved to Ann Marie Savini <AnnMarie.Savini@harcros.com> file: pic22539.gif) To: (Embedded (Embedded image moved to file: pic32224.gif) image moved to John Schaeffer <Schaeffer.John@epamail.epa.gov> file: pic27502.gif) Cc: (Embedded (Embedded image moved to file: pic06849.gif) image moved to 01/04/2012 12:51 PM file: pic03196.gif) Date: (Embedded (Embedded image moved to file: pic13912.gif) image moved to Fw: Response to Harcos Chemicals regarding review for file: CASRN 31138-65-5 pic24023.gif) Subject:

Ann Marie, Thanks you for the good wishes. I thought that our response answered your questions but, since I have a lot of these requests, reviews coming in, under review, etc I may have missed something. Please take a close look and see if this meets your needs . If not we will go back and do whatever is necessary. When you are satisfied and have things under way please submit a request for an extension if you think you will need one to meet the deadline of March 2012 for submitting testing results. A happy and healthy New year to you. Paul

Paul J. Campanella, Ph.D.Chemical Information and Testing Branc h Chemical Control Division U.S. Environmental Protection Agency Washington, D.C. 202-564-8091 ----- Forwarded by Paul Campanella/DC/USEPA/US on 01/04/2012 01:44 PM

----- From: Paul Campanella/DC/USEPA/US To: Ann Marie Savini <AnnMarie.Savini@harcros.com> Cc: John Schaeffer/DC/USEPA/US@EPA, Mike Mattheisen/DC/USEPA/US@EPA, David Brooks/DC/USEPA/US, Chuantung Lin/DC/USEPA/US Date: 10/20/2011 03:26 PM Subject: Response to Harcos Chemicals regarding review for CASRN 31138-65-5

Dear Ann Marie:
Regarding your letter of intent to test for D-gluco Heptonic acid , monsosdium salt (2.xi.)- [CASRN 31138-65-5] and the proposed modifications to the testing and test methods specified in the final rule, EPA has reviewed these and has made the following determinations:
Physical/Chemical Properties
1. Regarding the required testing for melting point (A.1.): EPA agrees that OECD 102 in lieu of ASTM E 324-99 is acceptable.
2. Regarding the required testing for boiling point (A.2.): Your letter specifies no change of the required test method (ASTM E 1719-05 (Ebulliometry).
3. Regarding the required testing for n-octanol/water partition coefficient (A.4.): EPA accepts the estimated value provided in your letter in lieu of testing.
4. Regarding the required testing for water solubility (A.5.): Your letter specifies either of two of the specified test methods: Method A: ASTM E 1148-02 (Reapproved 2008)(shake flask) or Method B: (40 CFR 799.6784 (shake flask). Either of these two methods is acceptable.
Biodegradation
1. Regarding the required testing for ready biodegradability: EPA agrees that either OECD 310 or OECD 301F in lieu of one of the (ASTM or ISO) methods specified in the final rule is acceptable.
Additional Toxicity testing required:Aquatic Toxicity C1, Mammalian Toxicity D1,E1,E2 and F1. The Protocol Review conducted by EPA’s Conractor and approved by the Risk Assessment Division is attached. This review contains more explicit detail including stipulations for conducting the tests and reporting the results.
(See attached file: Harcos CASRN 31138-65-5_Protocol Final 10.19.11.pdf)
Compositional Analysis
Please note that the test rule specifies 99% purity. The substance used for testing must be 99% pure. If that purity cannot be attained, please explain and make a request for a modification specifying what purity will be used.

Paul J. Campanella, Ph.D. Chemical Information and Testing Branch Chemical Control Division U.S. Environmental Protection Agency Washington, D.C. 202-564-8091[attachment "Harcos CASRN 31138-65-5_Protocol Final 10.19.11.pdf" deleted by Ann Marie Savini/Harcros] [attachment "pic13303.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic14992.gif" deleted by Ann Marie Savini/ Harcros] [attachment "pic13959.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic04948.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic19206.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic14613.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic28969.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic15639.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic19455.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic06561.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic02651.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic04410.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic32677.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic16576.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic22539.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic17222.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic27502.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic32224.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic03196.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic06849.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic24023.gif" deleted by Ann Marie Savini/Harcros] [attachment "pic13912.gif" deleted by Ann Marie Savini/Harcros]

Request for Extension 1-17-12..pd f