CBIC Control Number

36363S

GNEENWICH CHEMICAL CoNSULTING, I *fff.q:Ii,i i]fi

cllFT [illt: 3300 PGA Bour-EvnRD r Surrr 635

ParH,t BEecH GanotHs, FL 33410

TF.r,r,.pHONu 561.578.81 10

Fnc:srH.rrr,ri 561.178.8 120

tfil$ Jf,,l{ ?ts fl.[,I llr ?3

January 27,201,5

CONTAINS NO CONFIDENTIAL

BUSINESS INFORMATION

Bv Fedetal Exuress

-

OPPT Document Contol Office

U.S. Environmental Protection Agency

EPA East Building

Room 86428

1"201 Constitution Ave., NW

Washington, DC 20004

Attn.: TSCA Section 4

Extension Request by Univar USA Inc. under the TSCA Section 4 Test Rule on

the 2les ting of Certain Iligh Production Volume Chemicals: Second Group of

Chemicals

D-erythto-Hex-2-enonic acid, .gamma.-lactone, monosodium salt

cAs RN 6381-77-7

(Sodium erythotbate)

Docket Identification No. EPA-HQ-OPPT-2007-0531; 40 CFR 799.5087

Dear Sit/Madam:

On behalf of its client, Univar USA Inc. pnivar or the Company), Greenwich Chemical

Consulting, Inc. (Greenwich Chemical Consulfl"g) subrnits to the U.S. Envfuonmental

Ptotection Agency FPA ot the Agency) an extension request for additional time to conduct

testing ori the chernical substance, D-erythro-hex-2-enonic acid, .gafilma.-lactone,

monosodium salt [CAS RN 6381-77-71 which is currently subject to a Toxic Substances
CONTAINS NO CONFIDENTIAL

BUSINESS INFORMATION

U.S. Environmental Protection Agency

January 27,20'15

Page 2

Conttol Act (ISCA) Section 4 test rule.l The Company files this request in accordance with

this test rule and the regulations set forth at 40 CFR 790.55 and 799.5087.

I. General Backgtound

As a matter of backgtound, this test rule addresses 19 high production volume (HP\D

chemicals that u/ent unsponsored under the Agency's voluntary HPV Chemical Challenge

Ptogtam. One of the 19 chemicals identified in the rule is D-erythro-hex-2-enonic acid,

.gafirma.-lactone, monosodium salt which is identified herein as sodium erjtthorbate. The rule

requites manufacturers and importeffi of these HPV chemicals, including sodium erythorbate,

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

effects, chemical fate, and physical/ chemical properties.

The Agency has issued this test rule under its TSCA Section +(a)(t)@) authoriry based on its

determination that HPV cornpounds, including sodium erythorbate, are "produced in

substantial quantities; there is ot may be substantial human exposure to them; existing data are

insufficieflt to deterrnine ot predict their health and environmental effects; and testing is

rrecessaq/ to develop such data."z The final rule identifres the following studies on sodium

erythorbate:

n-Octanol/Water Partition Coefficient

Ready Biodegadation

Aquatic Toxicity Testing:

Acute toxicity to fish

Acute toxicity to Daphnia

Toxicity to plants (algae)

In the final TSCA Section 4 test rule, EPA specifi.ed the use of ASTM, ISO, andf or CFR test

guidelines for this testing. In its letter dated Ap.il 75, 2074, Univar requested that the

coffesponding OECD test guidelines be used rn the conduct of these studies. In its May 19,

2014 response letter, the Agency granted this request.

Hadan Laboratories Ltd. ftIadan Labotatories) was selected to conduct all of these tests. Also,

Greenwich Chemical Consulting is serving as the srudy 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, fot the subrnission of the letter of intent and test reports were not applicable. Univar

subsequendy subrnitted its letter of intent to test on January 27,2074.3 Based on this, EPA

rTanuarv l-201,1:76 , Fed. ReE. 1067.

-_

2 Id. at 1069.

3 Upon EPA's teceipt of this January 27, 201,4letter of intent to test, Univar planned to begin importing this

substance for both TSCA purposes and for continuing exempt FDA pu{poses.

T

T

I
t"*TJ,t',t,][B-tfl ,]51"*H'#

U.S. Environmental Protection r{gefl cy

January 27,2015

Page 3

stated in its response letter dated February 1,1.,201"4 that study plans would be due April 15,

2014 and final reports would be due February 11,2015.4

II. Extension Request

Univar is requesting an extension to the February 77,2075 deadline due to the fact that there

has been a significant technical issue encounteted during the development of the analytical

method which is to be used in support of the three ecotoxicity studies. Specifically, Hadan

Laboratories advised Greenwich Chemical Consulting on Novemb er 7 , 2014 that in the

method development work pteceding the ecotoxicity tesdng, it was determined that the

sodium erythotbate tapidly hydrolyzes in water.s The laboratory undertook additional efforts

to stabilize the material in water. However, flone of these effots were successful.

A conference call between the laboratory and Greenwich Chemical Consult*g was

subsequently held on November 20,2074 to discuss this issue. During the call the laboratory

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

enable the quantitative analysis to be petformed dudng the planned ecotoxicity testing.

Moreover, Hadan Laboratory had no suggestions on how to stabilize the material in water

despite its significant experience in conducting ecotoxicity testing.

In its November 27,2074 letter, Gteenwich 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 6,201.5.6

This response lettet provided a significant number of conrments regarding possible ways in

which the laborutory may be able to stabilize the matedal fot 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 addtess this complex technical issue of the test material's rapid hydrolysis. It will also take

the labotatory additional time to develop an analytical rnethod that can effectively measure the

concentration of sodium erythorbate in water tn eailt of the three ecotoxicity tests. As the

Agency has signaled in its comments, somewhat different approaches lr;iay be needed in each

of these tests thus cornpounding th. amount of time needed to complete this work. AIso, it is

Iikely that additional guidance and input will be needed ftom the Agency during this process.

Finally, time will be needed to ptepare, review, and finalize the test reports. Therefote, for

these reasons. Univar tespectfully requests an extension throuEh October 3L, 2015 for the

submission of the final test reports.

+ It is noted that since the time this test nrle was issued through today, no other companies have come for:ward

indicanng their intent to test sodium erythorbate undet this rule.

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

In addition, a 10 rrlg/L aqueous solution undergoes 100% hydrolysis witlun this same time period.

6 This lettet was transmitted from Mr. John Schaeffer @,PA) to Mr. John Y. Nfassingale (Greenwich Chemrcal

Consulting) on January 21,, 201,5.
CONTAINS NO CONFIDENTIAL

BUSINESS INFORMATION

U.S. Envrronmental Protection Agency

January 27,201,5

Page 4

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

tequest is rnade in accordance with 40 CFR 790.55. Concutrent 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...7

With respect to the requirements set forth at40 CFR 790.55, The Consortium does not believe

that the requested modification to the test schedule requested herern would "significantly alter

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

it does not meet any of the conditions set forth at 790.55&)(4xr)-(r") and further because it

does not rise to the level of "sigrrifrcattt" in terms of time.8 Moreover, this alleviates EPA from

havrng to seek public comfllent before approving these modifications.

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 comrnitments under either the HPV Chemical Challenge Program or the

OECD HPV SII)S Program. In addition, this schedule modification request does not

significantly change the schedule fot completing the tests as descdbed in 790.55.

Univat thanks the Agency fot its considetation in this matter. For all questions, cofiunents,

and determinations conceming this matter, please use the contact information given below.

Mt. John V. Massingale

Gteenwich Chemical Consulting, Inc.

3300 PGA Boulevard, Suite 635

Palm Beach Gardens, FL 33410

Telephone (561) 578-81 10

Facsirnile: (561) 578-8120

E -mail: i ohn(rt).rrrcci. conr

-

7 76 Fed. ReE. 65397.

I40 CFR 790.ssfrX3).
CONTAINS NO CONFIDENTIAL

BUSINESS INFORMATION

U.S. Environmental Protection Agency

January 27,201,5

Page 5

Sincetely,

John V. Massingale

Principal

Ms. I( Gilje - Univar

Ms. S. Lilley - Univar

Mt.J, Schaeffer - EPA
FedEx Ship Manager API Label Page Page I of I

From: (561) 57&8110

JOHN V. MASSINGALE

Origin lD; PBIA FEGBK"

Exprms

Ship Date: 27JAN15

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CAD: 1 03160523/WSX|2600

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GREEMIVICH CHEMICAL CONSULTING, INC.

33OO PGA BLVD

SUITE 035

PALM BEACH GARDENS, FL 33410

SHIP To: (202) 56{-8930

OPPT Document Control Office

U.S. Environmental Protection Agenc

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