### GREENWICH CHEMICAL CoNSULTING, INc.

February 9, 2015 

### 3300 PGA BouLEVARD • SuiTE 

### 635 PALM BEACH GARDENS, 

### FL 33410 TELEPHONE 561.578.8110 fAcsiMILE 561.578.8120 CBIC Control Number 

# 363866

CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION By 

### CDX and FederalExpress

OPPTDocument Control Office U.S. EnvironmentalProtectionAgency EPA EastBuilding Room E6428 1201 ConstitutionAve., NW Washington, DC 20004 Attu.: TSCA Section 4

Re: Submission ofthe Final Test Report on the Biodegradation Study 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 Identification No. 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-etydlro-hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77-7] which is currendy subject to a Toxic Substances
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cC!U.S. EnvironmentalProtection Agency Febmaty 9, 2015 Page 2 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

Conttol Act (I'SCA) Section 4 test rule. 1 The Company submits tllis final test report in accordance witl1 this testrule and the regulations set forth at 799.5087. I. General Background As a matter of background, tllis test mle addresses 19 high production volume (HPV) chemicals that went unsponsored under the Agency's voluntaty HPV Chemical Challenge Program. One of the 19 chemicals identified in tl1e mle is D-erythro-hex-2-enonic acid, .gamma.-lactone, monosodium salt which is identified herein as 

### sodittm erythorbate. The mle requires manufacturers andinlporters ofthese HPV chemicals, including sodiumetytl1orbate, to conduct testing to obtain screening level data for htunan healtl1 effects, environmental effects, chemical fate, andphysical/chemical properties. TheAgency has issued tllls test rule underits TSCA Section 4(a)(1)(B) autllority based on its determination tllat HPV compounds, including sodium erytllorbate, are "produced in substantial quantities; there is ormay be substantial humanexposure to tl1em; existingdata arc insufficient to determine or predict tlleir health and environmental effects; and testing is necessary to develop such data."2 The final rule identifies tl1e following studies on sodium erythorbate:
• n-Octanol/Water Partition Coefficient • Ready Biodegradation • Aquatic ToxicityTesting: Acute toxicity to fish Acute toxicity to 

### Daph11ia Toxicity to plants (algae) In the final TSCA Section 4 testrule, EPA specified the use ofAS1M, ISO, and/or CFR test guidelines for tllis testing. In its letter dated April 15, 2014, Univar requested tllat tlle corresponding OECD test guidelines be used in the conduct ofthese studies. In its May 19, 2014response letter, theAgency granted tllls request.' HarlanLaboratoriesLtd. (HarlanLaboratories) was selected to conductall ofthese tests. Also, Greenwich Chemical Consultingis serving as the study monitor for this testing. Because Univar had notyet begun inlporting sodium erythorbate with tlle intent to sell it for TSCA purposes at tlle time ofthe rule's effective date, tl1e specific dates, as set forth in the fmalmle, for the submission oftheletter ofintentandtestreportswere notapplicable. Univar

1January 7, 2011; 76 Fed Reg. 1067. 2 !d. at 1069. 3 \Vithrespectto the biodegradation study, the Companyrequested theuse ofOECD testguideline 301B for the biodegradation test.U.S. EnvironmentalProtection Agency Febmaty 9, 2015 Page 3 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

subsequently submitted its letter ofintent to test onJanuaty 27, 2014! Based on this, EPA stated in its response letter dated Febtuaty 11, 2014 that study plans would be due April 15, 2014 and final reports wouldbe due Febtuaty 11,2015. 5 II. Recent Extension Request In its recent letter datedJanuaty 27, 2015, Univar requested from EPA an extension to the Februaty 11, 2015 deadline due to the fact that there has been a significant technical issue encountered during the development ofthe analytical method whichis to be used in support ofthethree ecotoxicity studies. Thelaboratotyhas also indicated thatthis same technicalissue is being encountered dmingthe partition coefficient test, tlwugh to a somewhatlesser degree. Therefore,Univar requested an extension tltrough October 31,2015 for the submission ofthe final test reports. However, tlus extension need not apply to the biodegradation test which was timely completed andis being submittedherein ahead ofthe Febmaty 11, 2015 deadline. 6 III. FinalTest Report List Consistentwiththe fmalTSCA Section4 testrule, tlte following ftnal test report, datedJanuaty 28, 2015, is included herein:
• D-etythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77- 7]: Assessment ofReady Biodegradability; COz EvolutionTest IV. Submission ofRobust Summaries through HPVIS In the final test rule, EPA requests, but does not require, that a robust summaty also be included for each test identified in the rule consistent with the Agency's Draft Gtttda!lte 011 DetJeloping Robt1st Stimmmies. The Agency has signaled to other testing consortia that tlte submission ofthese robust summaries is unnecessaty. For example, EPA advised the PCBTF Testing Consortium (ofwhich Univaris a member) in early 2013 thatrobust summaries were not necessaty under the TSCJ\ Section 4 HPV test rules. If EPA decides that it wishes to receive such robust summaries, Univar will certainly provide them.

4 Upon EPA's receipt of this January 27, 2014letter ofintent to test, Univar planned to begin importing this substance for bothTSCA purposes and for continuing exemptFDA purposes. 5 Itis noted that since the rime this test rule was issued through today, no other companies have come forward indicating their intent to test sodium eqthorbate under this rule. 6 This was also conveyed to the Agency in an electronic mail to l\{r. John Schaeffer (EPA) from Mr. john V. 1vfassingale (Greenwich Chemical Consulting) onjanuary29, 2015.U.S. Envitonmental Protection Agency Febmary 9, 2015 Page4 

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### 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 Palm Beach Gardens, FL 33410 Telephone: (561) 578-8110 Facsimile: (561) 578-8120 E-mail: john@.grcci.com Sincerely,
John V. Massingale Principal

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

## J. Schaeffer

- EPA