GREENWICH CHEMICAL CONSULTING, lNC. 

### 3300 PGA BouLEVARD • SuiTE 

### 635

PALM BEACH GARDENS, 

### FL 33410 TELEPHONE 561.578.8110 fACSIMILE 561.578.8120



### October 29, 2012

By UPS Express Delivery



### OPPTDocumentControl Office 

# NOV 08Z01Z

CONTAINSNO CONFIDENTIAL BUSINESS INFORMATION



### U.S. EnvironmentalProtectionAgency EPA EastBuilding Room E6428 1201 ConstitutionAve., NW Washington, DC 20004 1111111111111111111111111111111111111111111111111111111111111111 4 0 1 3 0 0 0 0 0 0 7


### Attn.: 40 CFR799.5087 DocketID Number: EPA-HQ- OPPT-2007-0531
Re: 

### Request for an Additional Modification of the Test Schedule for Testing Conducted by Univar USA Inc. and WEGO Chemical and Mineral Corporation under the TSCA Section 4 Test Rule on the Testing ofCertain HighProduction Volume Chemicals:SecondGroupof Chemicals Ethanedioic acid (Oxalicacid) CAS RN 144-62-7] DocketIDNumberEPA-HQ-OPPT-2007-0531 40 CFR799.5087

DearSir/Madam: On behalf of Univar USA Inc. and WEGO Chemical and Mineral Corporation (the Companies), Greenwich Chemical Consulting, Inc. submits to the U.S. Environmental Protection Agency (EPA or the Agency) a request by the Companies for an additional 

## CONTAINS NO CBIU.S. EnvironmentalProtectionAgency October 29, 2012 Page 2 CONTAINSNO CONFIDENTIAL BUSINESSINFORMATION

modification of the test schedule for the studies conducted on the chemical substance, ethanedioic acid [CAS RN 144-62-7] which is currently subject to a Toxic Substances Control Act (TSCA) Section 4 test rule. 1The Companies file this request in accordance with this testrule and the regulations set forth at40 CFR799.5087 and 790.55. I. General Background Greenwich Chemical Consulting functions and operates as the panel manager for and authorized representative ofthe Companies for the testing of oxalic acid under this TSCA Section 4 testrule. This testrule addresses 19 high productionvolume (HPV) chemicals that wentunsponsored under the Agency's voluntary HPV Chemical Challenge Program. One of the 19 chemicals identified in the rule is ethanedioic acid which is identified herein as 

### oxalic 

### acid. The final rule identifies the following nine studies on oxalic acid:


### • • • 

### • • •



### • II. MeltingPoint BoilingPoint VaporPressure Water Solubility ReadyBiodegradation AquaticToxicityTesting: Acute toxicity to fish Acute toxicity to 

### Daphnia Toxicity toplants (algae) InVitro Mammalian ChromosomeAberrationTest Requestfor TestScheduleModification The deadline set forth in the original TSCA Section 4 test rule requires that the test data on oxalic acid be submitted to EPA by March 7, 2012 unless the Agency grants a test schedule modification. Earlier in the year, the Agency granted an extension to the Companies in which this test data submission date was moved to December31, 2012.2 Because ofchemical nomenclature, study plan, and minor technical delays that have arisen in the course ofthis testing, the Companies are requesting a second extension ofthree months. The Companies understand that EPA will accept schedule modification requests if such requests are made in accordance with 40 CFR 790.55. Concurrent with this, the Agency statedthe following in the final rule:

1January 7, 2011; 76 Fed. Reg. 1067. 2 The two Companies separately requested extensions from EP.\ due to the fact that a testing consortium had not been formally established at the time each Company had submitted its own extension request. EPA approved and grantedWEGO Chemical and i\fineral's request on April19, 2012 and Univar's request on May 2, 2012.CONTAINSNO CONFIDENTIAL BUSINESS INFORMATION U.S. EnvironmentalProtectionAgency October29, 2012 Page 3
A company that submits a letter of intent to test under the final rule and that subsequently anticipates difficulties in completing the testing by the deadline set forth in the final rule may submit a modification request to the Agency, pursuant to 40 CFR 790.55. EPA will determine whether modification of the test schedule is appropriate
... 3 In accordance with the requirements under 40 CFR 790.55 and EPA's comments in the final rule. the Companies respectfully request a three-month extension ofthe current December 31. 2012 deadline to March 31. 2013 for the required studies on oxalic acid. Thebasis ofthis requestis set forth below. The principal reason for this extension requestis because ofa nomenclature issue associated with the test material that arose in earlyJune 2012. Specifically, the test material, as formally identified in the rule, is ethanedioic acid [CAS RN 144-62-7]. This CAS Registry Number pertains to the anhydrous form meaning that no water is present as part of the crystalline structure. However, oxalic acid is highly hygroscopic which means that exposure of the anhydrous form to water (including water present in the air) results in the formation ofthe dihydrate material through the absorption ofwater. Testing of oxalic acid in its anhydrous form is irnpractical.4 During its review of the study plans, EPA in June 2012 raised the question ofhow the test material shouldberepresentedin the studyplans and test reports. It was not until late September that this issue was resolved among the Agency, Greenwich Chemical Consulting, and the test lab. This process resulted in a delay ofover three months. Once this issue was resolved, it was then necessary to amend the study plans (which had already been approved by EPA) with the lab so that the plans properly identified the test material. This added an additional month to the process resulting in a total delay ofnearly four months. Another reason for the extension request was that EPA was not able to provide its approval of the biodegradation study plan and the four physical properties study plans until early October 2012. This delay was partially attributable to the above nomenclature issue, as well as theAgency's limitedresources. There are also two minor other reasons for the delay. First, after the test rule was issued, it took the two Companies a few months to develop the Consortium agreement. This delayed the Company's initiation of these studies. Second, and as stated in the original extension request, the Companies' expected thatthey wouldbe able, for purposes ofthe TSCA Section 4 test rule, to obtain and rely on quality data submitted to the European Chemicals Agency (ECHA) under the European Cnion's Registration, Evaluation, Authorization, and Restriction ofChemicals (REACH) program. No such data became available. With respect to the requirements set forth at 40 CFR 790.55, the companies do not believe that the requested modification to the test schedule requested herein would "significandy

3 76 Fed. Reg. 1080. 4 Virtually all oxalic acid manufactured, imported, and processed in the U.S. is the dihydrate form.U.S. EnvironmentalProtectionAgency October29, 2012 Page 4 CONTAINSNO CONFIDENTIAL BUSINESS INFORMATION



### alter the scope ofthe test[s] or significantly change the schedule for completing the test[s]" because it does not meet any of the conditions set forth at 790.55(b)(4)(i)-(iv) and further because it does not rise to the level of "significant" in terms of time.5 

### Moreover, this alleviates EPA from having to seek public commentbefore approving these modifications. In compliance with the timing requirements set forth at 790.55(d)(1), this test schedule modification application is beingmade priorto the 60-day deadline for suchrequests. The Companies believe that a three-month extension to the test schedule to March 31, 2013 is a minor schedule modification and would not prevent the Agency from meeting its statutory obligations under TSCA Section 4 or its voluntary commitments under either the HPV Chemical Challenge Program or the OECD HPV SIDS Program. In addition, this schedule modification request does not significantly change the schedule for completing the tests as described in 790.55. 

## * * *
The Companies thank the Agency for its consideration in this matter. For all questions, comments, and determinations concerning this matter, please use the contact information givenbelow. Mr.JohnV. Massingale Greenwich Chemical Consulting, Inc. 3300 PGABoulevard, Suite 635 Palm Beach Gardens, FL33410 Telephone: (561) 578-8110 Facsimile: (561) 578-8120 E-mail: john@grcci.com Sincerely,
JohnV. Massingale Principal

s40 CFR 790.55(b)(3).U.S. EnvironmentalProtectionAgency October29, 2012 Page 5



### cc: Dr. PaulCampanella- U.S. EPA Univar USA Inc. WEGO Chemicaland Mineral Corporation CONTAINSNO CONFIDENTIAL BUSINESS INFORMATION

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