GREENWICH CHEMICAL CoNSULTING, INc. 

3300 PGA BouLEVARD • SUITE 635 

October 19,2015 

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 

RoomE6428 

1201 Constitution Ave., NW 

Washington, DC 20004 

Attn.: TSCA Section 4 

Re: Extension Request 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) 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 Substances 
U.S. Environmental Protection Agency 

October 19, 2015 

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Control Act (TSCA) Section 4 test rule. 1 The Company ftles this request in accordance with 

this test rule and the regulations set forth at 40 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 and importers of these HPV chemicals, including sodium erythorbate, 

to conduct testing to obtain screening level data for human health effects, environmental 

effects, chemical fate, and physical/ 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 

substantial quantities; there is or may be substantial human 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/Water Partition Coefficient 

• Ready Biodegradation 

• Aquatic Toxicity Testing: 

Acute toxicity to fish 

Acute toxicity to Daphnia 

Toxicity to plants (algae) 

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

2014 response letter, the Agency granted this request. 

Harlan Laboratories Ltd. (Harlan Laboratories) was selected to conduct all of these tests. It is 

noted that on September 21,2015, the legal entity of Harlan Laboratories changed its name to 

Envigo Research Limited. No other changes to this legal entity have occurred. Also, 

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

Because Univar had not yet begun importing sodium erythorbate with the intent to sell it for 

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

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

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

z Id. at 1069. 
U.S. Environmental Protection Agency 

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subsequently submitted its letter of intent to test on January 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 of the three ecotoxicity studies.5 In its response letter dated February 

12, 2015, EPA approved this request. 

II. Extension Requests 

Univar is 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 of the: (1) fish 

and Daphnia test reports and (2) algae test report. 

Extension for the Fish and Daphnia Test Reports 

Based on helpful technical guidance provided by EPA early in 2015, the laboratory was able 

to conduct preliminary stability work involving the sodium erythorbate in water. 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 dated July 2, 2015. As a result of these comments, the study 

plans were fmalized and issued by the laboratory and then signed by Greenwich Chemical 

Consulting on August 14, 2015. 

After the laboratory's preliminary analytical work, the fish range-fmding study was undertaken 

and completed in early October. The range-finding work for the Daphnia study is currently in 

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 

point and the laboratory projects that it will take at least through the end of this year to 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 of intent 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 Protection Agency 

October 19, 2015 

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requests an extension through January 15, 2016 for the submission of the fmal test reports on 

the fish and Daphnia studies. 

Extension for the Algae Test Report 

Work associated with the algae study has been significandy more challenging primarily because 

none of the 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 

not be established. Based on this, a request was sent to EPA on August 10, 2015 for additional 

guidance on the best manner to conduct the algae test. This request included a suggested 

testing approach proposed by the laboratory. 

In its guidance dated September 28,2015, EPA provided its technical comments on the algae 

study. These comments have been forwarded to the laboratory, and at this time, the laboratory 

is developing a revised and amended study plan for the algae test. This updated study plan still 

needs to be submitted to the Agency for fmal review and concurrence. Once EPA grants 

concurrence, the analytical, preliminary, range-fmding, and defmitive test work will need to be 

conducted. After that, draft and final reports still must be issued. It is projected that this 

process will take a number of months. Therefore, Univar respectfully requests an extension 

through April15, 2016 for the submission of the final test report 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 

With respect to the requirements set forth at 40 CPR 790.55, Univar does not believe 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 of the conditions set forth at 790.55(b)(4)(i)-(iv) and further because 

they does not rise to the level of "significant" in terms of time. 9 Moreover, this alleviates EPA 

from having to seek public comment before 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 it would 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 of the test. 

s 76 Fed. Reg. 65397. 

9 40 CFR 790.55(b)(3). 
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October 19,2015 

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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. 

* * * 

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