GREENWICH CHEMICAL CoNSULTING, INc. 

### 3300 PGA BouLEVARD • SuiTE 

### 635

January 15, 2016

ByCDX PALM BEACH GARDENS, 

### FL 33410 TELEPHONE 561.578.8110 fACSIMILE 561.578.8120

CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

OPPT Document Control Office U.S. EnvironmentalProtectionAgency EPA East Building RoomE6428 1201 ConstitutionAve., NW Washington, DC 20004 Attn.: TSCA Section 4

Re: 

### Submission ofFinal Test Reports on the Fish and Daphnia Studies by Univar USA Inc. under the TSCA Section 4 Test Rule on the Testing of Certain High Production Volume Chemicals: Second Group of Chemicals D-erythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt CAS RN 6381-77-7 (Sodium erythorbate) Docket IdentificationNo. EPA-HQ-OPPT-2007-0531; 40 CFR799.5087

Dear Sir/Madam: On behalf of its client, Univar USA Inc. (Univar or the Company), Greenwich Chemical Consulting, Inc. (Greenwich Chemical Consulting) submits to the U.S. Environmental ProtectionAgency (EPA or the Agency) the fmal testreports on the fish and 

### Daphnia studies conducted on the chemical substance, D-erythro-hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77-7] which is currently subject to a Toxic SubstancesU.S. EnvironmentalProtection Agency January 15, 2016 Page2 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

Control Act (TSCA) Section 4 test rule. 1 The Company submits these final test reports in accordance with this testrule and the regulations set forth at 799.5087. I. General Background As a matter of background, this test rule addresses 19 high production volume (HPV) chemicals that went unsponsored under the Agency's voluntary HPV Chemical Challenge Program. One of the 19 chemicals identified in the rule is D-erythro-hex-2-enonic acid, .gamma.-lactone, monosodium salt which is identified herein as 

### sodium erythorbate. The rule requires manufacturers andimporters ofthese HPV chemicals, including sodium erythorbate, to conduct testing to obtain screening level data for human health effects, environmental effects, chemical fate, andphysical/chemical properties. The Agency has issued this testrule underits TSCA Section 4(a)(1)(B) authority based on its determination that HPV compounds, including sodium erythorbate, are "produced in substantialquantities; thereis ormaybe substantialhuman exposure to them;existing data are insufficient to determine or predict their health and environmental effects; and testing is necessary to develop such data."2 The final rule identifies the following studies on sodium erythorbate:

• n-Octanol/WaterPartition Coefficient • Ready Biodegradation • Aquatic ToxicityTesting: Acute toxicity to fish Acute toxicity to 

### Daphnia Toxicity to plants (algae) In the fmal TSCA Section 4 testrule, EPA specified the use ofASTM, ISO, and/or CFR test guidelines for this testing. In its letter dated April 15, 2014, Univar requested that the corresponding OECD test guidelines be used in the conduct ofthese studies. In its May 19, 2014 response letter, theAgency granted this request. Harlan Laboratories Ltd. (Harlan Laboratories) was selected to conduct all of these tests. 3 Also, Greenwich Chemical Consultingis serving as the study monitor for this testing. Because Univar had notyet begun importing sodium erythorbate with the intent to sell it for TSCA purposes at the time ofthe rule's effective date, the specific dates, as set forth in the final rule, for the submission oftheletter ofintentandtestreportswere notapplicable. Univar subsequendy submitted its letter ofintent to test onJanuary 27, 2014.4 Based on this, EPA

1January 7, 2011; 76 Fed. Reg. 1067. 2 Id. at 1069. 3 Recently, the laboratory changedits name to Envigo Research Limited. 4 Upon EPA's receipt ofthis January 27, 2014 letter ofintent to test, Univar planned to begin importing this substance for bothTSCA purposes and for continuing exempt FDApurposes.U.S. EnvironmentalProtectionAgency January 15, 2016 Page3 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

stated in its response letter dated February 11, 2014 that study plans would be due April 15, 2014 and final reports would be due February 11, 2015. 5 II. Extension Requests In its letter datedJanuary 27,2015, Univarrequested from EPA an extension to the February 11, 2015 deadline due to the fact that there has been a significant technical issue encountered during the development ofthe analytical method which is to be used in support ofthe three ecotoxicity studies. The laboratory has also indicated that this same technical issue is being encountered during the partition coefficient test, though to a somewhat lesser degree. Therefore,Univarrequested an extensionthrough October31,2015 for the submission ofthe final test reports. The Agency granted this extension request in its response letter dated February 12, 2015. Subsequendy, in its letter dated October 19, 2015, Univar requested an additional set of extensions for the ecotoxicity tests based on continued technical issues associated with the stability ofthe test material in water. In its letter dated October 22, 2015, EPAgrantedtheCompany's extensionrequestfor the fish and

### Daphnia studies thoughJanuary 16, 2016 and the algae study throughApril16, 2016. III. FinalTestReport List Consistentwith the final TSCA Section4 testrule, the following final testreports areincluded herein:

• D-erythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77- 7]: Acute Toxicity to Rainbow Trout
• D-erythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77- 7]: Daphnia sp., 48-HourAcute Immobilization Test IV. Submission ofRobust Summaries through HPVIS In the fmal test rule, EPA requests, but does not require, that a robust summary also be included for each test identified in the rule consistent with the Agency's 

### Drcift Guidance on Developing Robust Summaries. The Agency has signaled to other testing consortia that the submission oftheserobust summaries is unnecessary. For example, EPA advised the PCBTF Testing Consortium (ofwhich Univar is a member) in early 2013 thatrobust summaries were not necessary under the TSCA Section 4 HPV test rules. IfEPA decides that it wishes to receive such robust summaries, Univarwill certainlyprovide them.

5 Itis noted that since the time this test rule was issued through today, no other companies have come forward indicating their intentto test sodium erythorbate under this rule.U.S. EnvironmentalProtection Agency January 15, 2016 Page4 

## * * * CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION



### Univar thanks the Agency for its consideration in this matter. For all 

### questions, comments, and determinations concerning this matter, please use the contactinformation given below. 

### Mr.JohnV. Massingale Greenwich Chemical Consulting, Inc. 3300 PGA Boulevard, Suite 635 PalmBeach Gardens, FL 33410 Telephone: (561) 578-8110 Facsimile: (561) 578-8120 E-mail: john@grcci.com Sincerely,
JohnV. Massingale Principal

cc: Ms. K. Gilje

- Univar Ms. S. Lilley

- Univar Mr.J. Schaeffer- EPA