### GREENWICH CHEMICAL CONSULTING, INC. 3300 PGA BouLEVARD • SuiTE 635

April 15, 2014

By Central Data Exchange PALM BEACH GARDENS, 

### FL 33410 TELEPHONE 561.578.8110 FACSIMILE 561.578.8120

CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

OPPT Document Control Office U.S. Environmental Protection Agency EPA East Building Room E6428 1201 ConstitutionAve., NW Washington, DC 20004 Attn.: TSCA Section 4

Re: 

### Study Plan Submission and Request for Modification of Test Standards for Testing ConductedbyUnivarUSA under theTSCA Section4 Test Rule onthe 

### Testing ofCertain 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 CFR 799.5087

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 ortheAgency) study plans and a request for the modification oftest standards conducted on the chemical substance, D-erythro-hex-2-enonic acid, .gamma.-U.S. Environmental ProtectionAgency Apri115, 2014 Page2 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

lactone, monosodium salt [CAS RN 6381-77-7] which is currently subject to a Toxic Substances Control Act (TSCA) Section 4 test rule. 1 Univar files this request in accordance with this testrule and the regulations set forth at 40 CFR 790.50 and 790.55. 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 substantial quantities; there is 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 and test protocols on sodium erythorbate:

• n-Octanol/WaterPartition Coefficient [40 CFR 799.6755, ASTM E 1147-92, or 40 CFR 799.6756] • Ready Biodegradation3 • Aquatic Toxicity Testing 4: Acute toxicity to fish [ASTM E 729-96] Acute toxicity to 

### Daphnia [ASTM E 729-96] Toxicity to plants (algae) [ASTM E 1218-04e1] 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 oftheletterofintentandtestreports were notapplicable. Univar subsequently submitted its letter ofintent to test onJanuary 27, 2014. 5 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. 6

1January 7, 2011; 76 Fed. Reg. 1067. zId. at 1069. 3 The test rule identifies six ISO protocols and one ASTM standard for biodegradation testing. The protocol selection depends on the test substance's physical and chemical properties. 4 Because the n-octanol/water partition coefficient is expected to be significantly less than 4.2 based on the compound's high water solubility, Test Group 1 is expected to apply. 5 Upon EPA's receipt ofits January 27, 2014 letter ofintent to test, Univar planned to begin importing this substance for bothTSCA purposes and for continuing exempt FDApurposes. 6 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.U.S. Environmental Protection Agency April 15, 2014 Page 3

II. Study Plan Submission CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

As required under 40 CFR 790.50 and 799.5087, the Company is required to submit to the Agency study plans prior to the initiation oftesting. Univar has selected Harlan Laboratories Ltd. (Harlan Laboratories) to conduct all of these tests. The laboratory will conduct these studies at a single location. Also, Greenwich Chemical Consulting is serving as the study monitor for this testing. The study plans included herein identify administrative information, the TSCA Section 4 test rule, the sodium erythorbate test material, primary laboratorypersonnel, study objectives, test guidelines, materials and methods, observance of Good Laboratory Practice standards, and other related testing and procedural information. III. Request for Modification ofTest Standards for the Use ofOECD Test Guidelines All of the studies require the use of an ASTM, CFR, or ISO standard. Because of the validation. widespread use, andbroad acceptance ofOrganization for Economic Cooperation and Development (OECD) test guidelines, as well as the near equivalency amongthe OECD, ASTM, CFR, and ISO protocols, Univar requests that EPA permit Univar's lab, Harlan Laboratories, to perform 

### all five studies under the corresponding OECD guidelines. Specifically, we request that the testing be performed under the OECD test guidelines listed below.

• n-Octanol/Water Partition Coefficient [OECD 107f • Ready Biodegradation [OECD 301B] 8 • Aquatic Toxicity Testing: Acute toxicity to fish [OECD 203] 9 Acute toxicity to 

### Daphnia [OECD 202f0 Toxicity to plants (algae) [OECD 201f1 One significant benefit in permitting Harlan Laboratories to utilize the OECD protocols for this testing is that it will allow for more straightforward and expedient development of the data. Because it has significant experience and familiarity with the OECD test guidelines, Harlan Laboratories can begin testing immediately. Alternatively, the required use of the ASTM standards would delay the development ofthe test data. 12

7 Harmonized with EPA's guidelines under OCSPP 830.7550. 8 Harmonizedwith EPA's guidelines under OCSPP 835.3110. 9 Harmonized with EPA's guidelines under OCSPP 850.1075. 10 Harmonizedwith EPA's guidelines under OCSPP 850.1010. 11 Harmonizedwith EPA's guidelines under OCSPP 850.5400. 12 Thelabs contactedby Univar for testingunder anotherTSCA Section 4 testing obligation advised thatbecause ofthe additional time involved, the costs ofperforming tests under the ASTM standards is expected to be 20% to 30% higher.U.S. EnvironmentalProtectionAgency April15, 2014 Page4 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION



### In addition, Harlan Laboratories was not familiar with the ASTM standards that EPA identifies in this and otherrecent TSCA Section 4 HPVrulemakings. Indeed, the lab was not familiar with orhadexperiencewith theASTM standards andwas surprisedtolearn thatEPA was requiring their use in lieu of EPA's own Harmonized Test Guidelines or OECD guidelines. 13 

### Also, the use offamiliar OECD protocols decreases the chances for errors due to inadvertent deviations from the guidelines. Presumably, the Agency intends to eventually submit these data as part ofdossiers under the international OECD HPV SIDS Program. The development ofdata on sodium erythorbate, under the internationally adopted and accepted OECD guidelines, would facilitate the Agency's efforts at the OECD level. Itis also notedthatall ofthe aboveASTM standardsinternallyreference 

### otherASTM standards which eithermustor shouldbe observed. This adds to the complexity and duration oftesting. Forexample, inthe algae study alone, ASTM E 1218-04el 

### references 11 

### otherASTM standards. Similarly, in the combinedfish and

### Daphnia standardunderASTM E 729-96, nine 

### otherASTM standards are cited. Conversely,itis notable thatnone oftheASTM standards reference either the OECD guidelines or EPA's HarmonizedTest Guidelines. Eventhoughmostofthe discussion abovepertains to theASTM standards, Univaris formally requesting that EPA also approve the use ofequivalent OECD test guidelines for these tests for which EPA has citedASTM, CFR, or ISO guidelines. 

## * * *
Univar thanks the Agency for its consideration in this matter. For all questions, comments, and determinations concerningthis 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

13 See EPA's Harmonized Test Guidelines at: http://w"vw.epa.gov/ocspp/pubs/frs/home/g:uidelin.htm.U.S. EnvironmentalProtectionAgency Apri115, 2014

**~** Page 5 Sincerely,

JohnV. Massingale Principal

cc: Ms. K. Gilje

- Univar Ms. S. Lilley

- Univar Mr. J. Schaeffer

- EPA CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION