CBIC Control Number 

363633 

GREENWICH CHEMICAL CoNSULTING, IN D:: ['r.~"'FO \C vLl~-

QPPT CBIC 3300 PGA BOULEVARD. SUITE 635 

PALM BEACH GARDENS, FL 33410 

T ELEI'HONio 561.578.8110 

F ACSiiviiLE 561.578.8120 

2015 JJ'.N 28 Mi II: 23 

January 27, 2015 

By Federal Express 

OPPT Document Control Office 

U.S. Enviromnental Protection Agency 

EPA East Building 

Room E6428 

1201 Constitution Ave., NW 

Washington, DC 20004 

Attn.: TSCJ\ Section 4 

CONTAINS NO CONFIDENTIAL 

BUSINESS INFORMATION 

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 eryth01bate) 

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) an extension request for additional time to conduct 

testing on the chemical substance, D-etythro-hex-2-enonic acid, .gamma.-lactone, 

monosodium salt [CAS RN 6381-77-7] which is currently subject to a Toxic Substances 
U.S. Environmental Protection Agency 

J anuaty 27, 2015 

Page 2 

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Control Act (TSCA) Section 4 test rule. 

1 The Company flies 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 sodittm 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 

etythorbate: 

• 

• 

n-Octanol/Water Partition Coefficient 

Ready Biodegradation 

Aquatic Toxicity 'l'esting: 

Acute toxicity to fish 

Acute toxicity to Dapbnia 

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 0 ECD 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. 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 

fmal rule, for the submission of the letter of intent and test reports were not applicable. U nivar 

subsequently submitted its letter of intent to test on January 27, 2014.

3 Based on this, EPA 

1 January 7, 2011; 76 ~ ~ 1067. 2 Id. at 1069. 3 Upon EPA's receipt of this January 27, 2014 letter of intent to test, Univar planned to begin importing this 

substance for both TSCA purposes and for continuing exempt FDi\ purposes. 
U.S. Environmental Protection Agency 

January 27, 2015 

Page 3 

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stated in its response letter dated February 11, 2014 that study plans would be due April15, 

2014 and final reports would be due fiebruary 11, 2015. 4 

II. Extension Request 

Univar is requesting an extension to the February 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. 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.5 The laboratoq undertook additional efforts 

to stabilize the material in water. However, none of these efforts were successful. 

A conference call between the laboratory and Greenwich Chemical Consulting was 

subsequently held on November 20, 2014 to discuss this issue. During the call the laboratory 

indeed confirmed that it was not possible to sufficiently stabilize the test item in water to 

enable the quantitative analysis to be performed during the planned ecotoxicity testing. 

Ivioreover, Harlan Laboratmy had no suggestions on how to stabilize the material in water 

despite its significant experience in conducting ecotoxicity testing. 

In its November 21, 2014 letter, Greenwich Chemical Consulting, on behalf of Univar, 

notified the Agency of this significant issue and included technical information provided by 

the laboratory. In response to this letter, EPA provided its comments dated January 6, 2015.6 

This response letter provided a significant number of comments regarding possible ways in 

which the laboratmy may be able to stabilize the material for purposes of developing the 

analytical method, as well as conduct the ecotoxicity tests. 

Harlan Laboratories has signaled that it will require additional time to review EPA's comments 

to address this complex technical issue of tl1e test material's rapid hydrolysis. It will also take 

the laboratoq additional time to develop an analytical method that can effectively measure tl1e 

concentration of sodium erythorbate in water in em·h of the three ecotoxicity tests. As the 

Agency has signaled in its comments, somewhat different approaches may be needed in each 

of these tests thus compounding tl1e amount of time needed to complete this work. Also, it is 

Wcely that additional guidance and input will be needed from the Agency during tlus process. 

fiinally, time will be needed to prepare, review, and finalize the test reports. Therefore, for 

tl1ese reasons, Univar respectfully requests an extension tluough October 31, 2015 for the 

submission of the final test reports. 

4 It is noted that since the time this test mle was issued through today, no other companies have come forward 

indicating their intent to test sodium erythorbate under tlus mle. 

5 The laboratory reported that a 100 mg/L aqueous solution undergoes 60% hydrolysis within three (3) hours. 

In addition, a 10 mg/L aqueous solution undergoes 100% hydrolysis wit!Un tlus same time period. 

6 This letter was transmitted from Mr. John Schaeffer (EPA) to Mr. John V. Massingale (Greenwich Chemical 

Consulting) on January 21,2015. 
CONTAINS NO CONFIDENTIAL 

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U.S. Environmental Protection Agency 

January 27, 2015 

Page 4 

The Company understands that EPA will accept a schedule modification request if such a 

request is made in accordance with 40 CFR 790.55. Concurrent with tlus, the Agency stated 

the following in the finalmle: 

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 ... 7 

Witl"l respect to the requirements set forth at 40 CFR 790.55, The Consortium does not believe 

that the requested modification to the test schedule requested herein would "sigtlificantly alter 

the scope of the test[s] or significantly change tl"le schedule for completing tl"le test[s]" because 

it does not meet any of the conditions set forth at 790.55(b)(4)(i)-(iv) and further because it 

does not rise to the level of "sigtlificant" in terms of time. 

8 Moreover, this alleviates EPA from 

having to seek public comment before approving these modifications. 

Univar believes that tlus 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 voluntaty commitments under either tl"le HPV Chenlical Challenge Program or tl1e 

OECD HPV SIDS Program. In addition, tlus schedule modification request does not 

sigtlificantly change the schedule for completing tl1e tests as described in 790.55. 

* * * 

Univar thanks the Agency for its consideration in this matter. For all questions, comments, 

and deternlinations 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 

Facsinllle: (561) 578-8120 

E-mail: john@grcci.com 

7 76 ~Reg. 65397. 

X 40 CFR 790.55(b)(3). 
U.S. Environmental Protection Agency 

January 27, 2015 

Page 5 

Sincerely, 

John V. Massingale 

Principal 

cc: Ms. K. Gilje - Univar 

Ms. S. Lilley - Univar 

Mr. ]. Schaeffer - EP J\ 

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