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 

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OPPT Document Control Office 

U.S. Environmental Protection Agency 

EPA East Building 

Room E6428 

1201 Constitution Ave., NW 

Washington, DC 20004 

Attn.: TSCA Section 4 

Re: Study Plan Submission and Request for Modification of Test Standards for 

Testing Conducted by Univar USA 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) study plans and a request for the modification of test 

standards conducted on the chemical substance, D-erythro-hex-2-enonic acid, .gamma.-
U.S. Environmental Protection Agency 

Apri115, 2014 

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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 test rule 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 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 final rule identifies the following studies and test 

protocols on sodium erythorbate: 

• n-Octanol/Water Partition Coefficient [40 CFR 799.6755, ASTM E 1147-92, or 40 

CFR 799.6756] 

• Ready Biodegradation3 

• Aquatic Toxicity Testing4: 

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 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 

subsequently submitted its letter of intent to test on January 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 would be due February 11, 2015.6 

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

z Id. 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 of its January 27, 2014 letter of intent to test, Univar planned to begin importing this 

substance for both TSCA purposes and for continuing exempt FDA purposes. 

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 

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II. Study Plan Submission 

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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 of testing. 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 laboratory personnel, 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, and broad acceptance of Organization for Economic Cooperation 

and Development (OECD) test guidelines, as well as the near equivalency among the 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 201f 1 

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 of the test data.12 

7 Harmonized with EPA's guidelines under OCSPP 830.7550. 

8 Harmonized with EPA's guidelines under OCSPP 835.3110. 

9 Harmonized with EPA's guidelines under OCSPP 850.1075. 

10 Harmonized with EPA's guidelines under OCSPP 850.1010. 

11 Harmonized with EPA's guidelines under OCSPP 850.5400. 

12 The labs contacted by Univar for testing under another TSCA Section 4 testing obligation advised that because 

of the additional time involved, the costs of performing tests under the ASTM standards is expected to be 20% 

to 30% higher. 
U.S. Environmental Protection Agency 

April15, 2014 

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In addition, Harlan Laboratories was not familiar with the ASTM standards that EPA 

identifies in this and other recent TSCA Section 4 HPV rulemakings. Indeed, the lab was not 

familiar with or had experience with the ASTM standards and was surprised to learn that EPA 

was requiring their use in lieu of EPA's own Harmonized Test Guidelines or OECD 

guidelines.13 Also, the use of familiar 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 of dossiers under the 

international OECD HPV SIDS Program. The development of data on sodium erythorbate, 

under the internationally adopted and accepted OECD guidelines, would facilitate the 

Agency's efforts at the OECD level. 

It is also noted that all of the above ASTM standards internally reference other ASTM standards 

which either must or should be observed. This adds to the complexity and duration of testing. 

For example, in the algae study alone, ASTM E 1218-04el references 11 other ASTM standards. 

Similarly, in the combined fish and Daphnia standard under ASTM E 729-96, nine other ASTM 

standards are cited. Conversely, it is notable that none of the ASTM standards reference either 

the OECD guidelines or EPA's Harmonized Test Guidelines. 

Even though most of the discussion above pertains to the ASTM standards, U nivar is formally 

requesting that EPA also approve the use of equivalent OECD test guidelines for these tests 

for which EPA has cited ASTM, CFR, or ISO guidelines. 

* * * 

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 

13 See EPA's Harmonized Test Guidelines at: http://w"vw.epa.gov/ocspp/pubs/frs/home/g:uidelin.htm. 
U.S. Environmental Protection Agency 

Apri115, 

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2014 ~ 

Sincerely, 

John V. Massingale 

Principal 

cc: Ms. K. Gilje - Univar 

Ms. S. Lilley - Univar 

Mr. J. Schaeffer - EPA 

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