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 Federal Express 

OPPT Document Control Office 

U.S. Environmental Protection Agency 

EPA East Building 

Room E6428 

1201 Constitution Ave., NW 

Washington, DC 20004 

Attu.: TSCA Section 4 

Re: Submission of the 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 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 

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 

7 { t;'li) 

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U.S. Environmental Protection Agency 

Febmaty 9, 2015 

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Conttol Act (I'SCA) Section 4 test rule. 1 The Company submits tllis final test report in 

accordance witl1 this test rule 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 and inlporters of these HPV chemicals, including sodium etytl1orbate, 

to conduct testing to obtain screening level data for htunan healtl1 effects, environmental 

effects, chemical fate, and physical/ chemical properties. 

The Agency has issued tllls test rule under its TSCA Section 4(a)(1)(B) autllority based on its 

determination tllat HPV compounds, including sodium erytllorbate, are "produced in 

substantial quantities; there is or may be substantial human exposure to tl1em; existing data 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 Toxicity Testing: 

Acute toxicity to fish 

Acute toxicity to Daph11ia 

Toxicity to plants (algae) 

In the final TSCA Section 4 test rule, EPA specified the use of AS1M, 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 of these studies. In its May 19, 

2014 response letter, the Agency granted tllls request.' 

Harlan Laboratories Ltd. (Harlan Laboratories) was selected to conduct all of these tests. Also, 

Greenwich Chemical Consulting is serving as the study monitor for this testing. 

Because Univar had not yet begun inlporting sodium erythorbate with tlle intent to sell it for 

TSCA purposes at tlle time of the rule's effective date, tl1e specific dates, as set forth in the 

fmalmle, for the submission of the letter of intent and test reports were not applicable. Univar 

1 January 7, 2011; 76 Fed Reg. 1067. 

2 !d. at 1069. 

3 \Vith respect to the biodegradation study, the Company requested the use of OECD test guideline 301B for the 

biodegradation test. 
U.S. Environmental Protection Agency 

Febmaty 9, 2015 

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subsequently submitted its letter of intent 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 would be 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 of the analytical method which is to be used in support 

of the three ecotoxicity studies. The laboratoty has also indicated that this same technical issue 

is being encountered dming the partition coefficient test, tlwugh to a somewhat lesser degree. 

Therefore, Univar requested an extension tltrough October 31,2015 for the submission of the 

final test reports. However, tlus extension need not apply to the biodegradation test which 

was timely completed and is being submitted herein ahead of the Febmaty 11, 2015 deadline.6 

III. Final Test Report List 

Consistent with the fmal TSCA Section 4 test rule, tlte following ftnal test report, dated J anuaty 

28, 2015, is included herein: 

• D-etythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt [CAS RN 6381-77-

7]: Assessment of Ready Biodegradability; COz Evolution Test 

IV. Submission of Robust 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 of these robust summaries is unnecessaty. For example, EPA advised the PCBTF 

Testing Consortium (of which Univar is a member) in early 2013 that robust 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 of intent to test, Univar planned to begin importing this 

substance for both TSCA purposes and for continuing exempt FDA purposes. 5 It is 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) on january 29, 2015. 
U.S. Envitonmental Protection Agency 

Febmary 9, 2015 

Page4 

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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 contact information 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, 

John V. Massingale 

Principal 

cc: Ms. K. Gilje- Univar 

Ms. S. Lilley- Univar 

Mr. J. Schaeffer - EPA