GREENWICH CHEMICAL CoNSULTING, INc. 

### 3300 PGA BouLEVARD • SUITE 

### 635

October 19,2015



### By CentralData Exchange PALM BEACH GARDENS, 

### FL 33410 TELEPHONE 561.578.8110 fACSIMILE 561.578.8120

CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION



### OPPTDocument Control Office U.S. EnvironmentalProtectionAgency EPA EastBuilding RoomE6428 1201 ConstitutionAve., NW Washington, DC 20004 Attn.: TSCA Section 4

Re: ExtensionRequestbyUnivarUSAInc. undertheTSCASection4 TestRule 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) a pair of extension requests for additional time to conduct testing 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. EnvironmentalProtection Agency October 19, 2015 Page2 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

Control Act (TSCA) Section 4 test rule. 1 The Company ftles this request in accordance with this testrule and the regulations set forth at40 CFR 790.55 and 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/chemicalproperties. 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 fmal 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 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, theAgency granted this request. HarlanLaboratories Ltd. (Harlan Laboratories) was selected to conduct all ofthese tests. Itis notedthat on September21,2015, the legal entity ofHarlanLaboratories changedits name to Envigo Research Limited. No other changes to this legal entity have occurred. 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

1January 7, 2011; 76 Fed. Reg. 1067. zId. at 1069.U.S. Environmental ProtectionAgency October 19,2015 Page 3 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

subsequently submitted its letter ofintent to test onJanuary 27, 2014. 3 Based on this, EPA stated in its response letter dated February 11, 2014 that study plans would be due April 15, 2014 and fmal reports would be due February 11, 2015. 4 In Greenwich Chemical Consulting's letter dated January 27, 2015, Univar requested an extension to the original February 11, 2015 deadline through October 31, 2015 due to significant technical issues encountered during the development of the analytical method which used in support ofthe three ecotoxicity studies. 5 In its response letter dated February 12, 2015, EPA approved this request. II. Extension Requests Univaris requesting an additional extension to this October 31,2015 deadline due to technical issues which have delayed the development and submission of the study plans and the additional time needed for EPA to review the study plans and provide technical comments. Specifically, the Company is requesting separate dates for the fmal submission ofthe: (1) fish and

### Daphnia testreports and (2) algae testreport. Extension for the Fish and DaphniaTest Reports Based on helpful technical guidance provided by EPA early in 2015, the laboratory was able to conductpreliminary stabilityworkinvolving the sodiumerythorbateinwater. Based on this work, the laboratory issued revised and amended study plans for the fish and 

### Daphnia tests. These updated study plans were promptly submitted to the Agency on June 2, 2015 with EPA's response and comments datedJuly 2, 2015. As a result ofthese comments, the study plans were fmalized and issued by the laboratory and then signed by Greenwich Chemical Consulting onAugust 14, 2015. Afterthelaboratory's preliminary analyticalwork, the fish range-fmding studywas undertaken and completed in early October. The range-finding work for the 

### Daphnia study is currentlyin progress. At this time, the fish and 

### Daphnia studies are going well and no technical issues are being encountered. 6 Despite the recent success with these two studies, it has taken additional time to reach this pointandthelaboratoryprojects thatitwilltake atleastthroughthe endofthis yearto conduct the defmitive tests and then issue draft and final test reports. Therefore. Univar respectfully

3 Upon EPA's receipt of this January 27, 2014letter ofintent to test, Univar planned to begin importing this substance for both TSCA purposes and for continuing exempt FDA purposes. 4 It is 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. s Specifically, Harlan Laboratories advised Greenwich Chemical Consulting on November 7, 2014 that in the method development work preceding the ecotoxicity testing, it was determined that the sodium erythorbate rapidly hydrolyzes in water. 6 In particular, the laboratory is able to sufficiently stabilize the sodium erythorbate in water.U.S. Environmental ProtectionAgency October 19, 2015 Page4 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

requests an extension throughJanuary 15, 2016 for the submission ofthe fmal testreports on the fish and

### Daphnia studies. Extension for the Algae Test Report Workassociatedwiththe algae studyhas been significandymorechallengingprimarilybecause none ofthe conditions used to stabilize the sodium erythorbate in the fish and 

### Daphnia tests could be applied in the algae study.7 For these reasons, a suitable analytical test method could notbe established. Based onthis, a requestwas sentto EPA onAugust 10, 2015 for additional guidance on the best manner to conduct the algae test. This request included a suggested testing approach proposedby the laboratory. In its guidance dated September28,2015, EPA providedits technical comments on the algae study. These comments havebeenforwarded to thelaboratory, andatthis time, thelaboratory is developing a revised and amended studyplan for the algae test. This updated studyplan still needs to be submitted to the Agency for fmal review and concurrence. Once EPA grants concurrence, the analytical, preliminary, range-fmding, and defmitive testworkwill needto be conducted. After that, draft and final reports still must be issued. It is projected that this process will take a number ofmonths. Therefore, Univar respectfully requests an extension throughApril15, 2016 for the submission ofthe final testreport on the algae study. Other Comments The Company understands that EPA will accept a schedule modification request if such a request is

**ma~e** in accordance with 40 CPR 790.55. Concurrent with this, the Agency stated the following in the final rule: 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... 8 Withrespect to the requirements set forth at 40 CPR 790.55, Univar does notbelieve that the requested modifications to the test schedule requested herein would "significandy alter the scope of the test[s] or significandy change the schedule for completing the test[s]" because they does not meet any ofthe conditions set forth at 790.55(b)(4)(i)-(iv) and further because they does notrise to thelevel of"significant" in terms oftime.9 Moreover, this alleviates EPA from having to seekpublic commentbefore approving these modifications.

7 This is because: (1) the algae test may only be conducted under static conditions; flow-through or semi-static conditions can not be used, (2) acetic acid can not be used since itwould lower the pH and thus induce toxicity to the algae, and (3) actinic lighting can not be used because the algae require normal light to grow under the conditions ofthe test. s 76 Fed. Reg. 65397. 9 40 CFR 790.55(b)(3).U.S. Environmental Protection Agency October 19,2015 Page 5 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

Univar believes that this extension to the test schedule 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, these schedule modification requests do not significantly change the schedule for completing the tests as described in 790.55. 

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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. John V. 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,
JohnV. Massingale Principal

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

- EPA