### GREENWICH CHEMICAL CONSULTING, INC. 3300 PGA BOULEVARD • SUITE 

### 635

February 9, 2015

By CDX and Federal Express 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 EastBuil<ling RoomE6428 1201 ConstitutionAve., NW Washington, DC 20004 Attn.: TSCA Section 4

Re: Submission ofthe Final Test Report on the Biodegradation Study by Univar USA Inc. under the TSCA Section4 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) DocketIdentificationNo. 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 Protection Agency (EPA or the Agency) the final test report on the biodegradation study conducted on the chemical substance, D-erythro-hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77-7] which is currendy subject to a Toxic SubstancesU.S. Environmental ProtectionAgency February 9, 2015 Page2 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

Control Act (TSCA) Section 4 test rule. 1 The Company submits this final test report in accordance with this test rule 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 test rule under its 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 Toxicity Testing: Acute toxicity to fish Acute toxicity to 

### Daphnia Toxicity to plants (algae) In the final 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, the Agency granted this request.3 HarlanLaboratoriesLtd. (HarlanLaboratories) was selectedto conductall ofthese tests. 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 ofthe letter ofintentandtestreportswere notapplicable. Univar

1January 7, 2011; 76 Fed. Reg. 1067. 2 Id. at 1069. 3 With respect to thebiodegradation study, the Companyrequested the use ofOECD test guideline 301B for the biodegradation test.U.S. EnvironmentalProtection Agency February 9, 2015 Page 3 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

subsequendy submitted its letter ofintent to test onJanuary 27, 2014.4 Based on this, EPA stated in its response letter dated February 11, 2014 that study plans would be due April 15, 2014 and final reports wouldbe due February 11, 2015. 5 II. Recent Extension Request In its recent letter datedJanuary 27,2015, Univar requested 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 usedin support ofthe three ecotoxicity studies. Thelaboratoryhas also indicatedthatthis same technicalissue is being encountered during thepartition coefficient test, though to a somewhatlesser degree. Therefore, Univarrequested an extension through October 31, 2015 for the submission ofthe fmal test reports. However, this extension need not apply to the biodegradation test which was timely completed andis being submittedherein ahead ofthe February 11,2015 deadline. 6 III. FinalTestReport List Consistentwiththe finalTSCA Section4 testrule, thefollowing final testreport, datedJanuary 28, 2015, is included herein:
• D-erythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77- 

### 7]: Assessment ofReady Biodegradability; COz Evolution Test IV. Submission ofRobust Summaries through HPVIS In the final 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 ofthese robust 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 certainly provide them.

4 Upon EPA's receipt ofthis January 27, 2014letter ofintent to test, Univar planned to begin importing this substance for both TSCA purposes and for continuing exempt FDA purposes. 5 Itis noted that since the time this test rule was issued through today, no other companies have come forward indicating their intent to test sodium erythorbate under this rule. 6 This was also conveyed to the Agency in an electronic mail to Mr. John Schaeffer (EPA) from Mr. John V. Massingale (Greenwich Chemical Consulting) onJanuary 29,2015.U.S. Environmental ProtectionAgency February 9, 2015 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@g<ccLcom /' 

### Sincerely,
JohnV. Massingale Principal

cc: Ms. K. Gilje- Univar Ms. S. Lilley

- Univar Mr.

## J. Schaeffer- EPA 

### I