CBIC Control Number 

# 363633 GREENWICH CHEMICAL CoNSULTING,**IN D::** **['r.~"'FO \C** **vLl~-** 

### QPPT CB IC 3300 PGA BOULEVAR D. S UITE 635

PA L

M BEAC H GARDENS, 

### FL 33410

T E LEI'HO Nio 561.578.8110 F ACSiivii LE 561.578.8120 

## 2 01 5JJ'.N 28 

## Mi I I: 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 SubstancesU.S
. Environmental Protection Agency J anuaty 27 , 2015 Page 2 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

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 ofASTM, 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 ofthe letter ofintent and test reports were not applicable. Univar subsequently submitted its letter of intent to test on January 27, 2014
.3 Based on this, EPA

1January 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 Januar y 27, 20 15 Page 3 CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION

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. Iv

ioreover, 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 itwill 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 Thi s letter was transmitted from Mr. John Schaeffer (EPA) to Mr. John V. Massingale (Greenwich Chemical Consulting) onJanuar y 21,2015.CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION 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 ofthe 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 E PA 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 tl1 e tests as descr ibed in 790.55. 

## * * 

## *
Univar thanks the Agency for its consideration in this matter. For all questions , comments, and deternlinations concerning this matter, please u se the contact information given below
. Mr. John V. Massingale Greenwich Chemical Consulting, Inc. 33 00 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 Januar y 27, 2015 Page 5 Sincerely,
John V . Massingal e Principal



### cc: Ms. K. 

### Gilje

- Univar Ms. S. 

### Lilley

- Univar Mr. ]. Schaeffer

- EPJ\ CONTAINS NO CONFIDENTIAL BUSINESS INFORMATION