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 31138-65-5 to 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 Paul, Please find attached the request for an ext... 01/17/2012 12:53:55 PM

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: Request for Extension 1-17-12..pdf)

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

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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

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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: pic02651.gif)Ann Marie Savini

Harcros Chemicals, Inc.

Phone: (913) 621-7802

Fax: (913) 621-7876

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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,

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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 Branch

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]

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Request for Extension 1-17-12..pdf