CBICControl 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 SubstancesCONTAINS 

### NO CONFIDENTIAL BUSINESS 

### INFORMATION U.S. Environmental Protection Agency January 27,20'15 Page 2



### Conttol 

### Act (ISCA) Section 

### 4test 

### rule.l 

### The Company filesthis request 

### in accordance 

### with this test 

### rule and the regulations set

### forth at40 

### CFR 790.55 and 799.5087. 

## I. General 

### Backgtound 

### As a matter

## of backgtound,

### this test 

### rule addresses 

### 19 high productionvolume (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 

### toxicityto fish Acute 

### toxicity to Daphnia 

### Toxicity to plants (algae)


### In the final TSCA Section 4test 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 

### rnthe 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 

### notyet begun 

### importing sodium erythorbate 

### with the 

### intentto sell 

### itfor TSCA purposes 

### atthe 

### time

### of the rule's effective date,

### the specific dates, asset

### 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. 

## , -_ 2Id. at 1069. 3Upon EPA's teceiptof thisJanuary 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 factthat there has 

### been

### a significant technical issue 

### encounteted 

### during the development 

### of the analytical 

### methodwhich is

### to be used 

### in support

### of thethree 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 waterto 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 hassignaled 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 timeto 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. sThe 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. 6This lettet was transmitted from Mr. John Schaeffer @,PA) to Mr. JohnY. 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 thefinal rule: 

### A company 

### that submits 

### a letter

### of intent 

### to test under 

### the final rule and that subsequently anticipates difficulties in completingthe testing bythe deadline set forth inthe final rule may submit a modification request totheAgency, pursuant to 

### 40 CFR 790.55. EPA will determine whether modification ofthe test schedule is appropriate...7 

### With respect

### tothe requirements set

### forth at40 CFR 790.55, 

### The Consortium does 

### not believe 

### thatthe 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 

### thatthis 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 asdescdbed 

### 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: iohn(rt).rrrcci.conr



## -

776 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

ActWgt 0.5 LB CAD: 103160523/WSX|2600 Delivery Address Ear Code GREEMIVICH CHEMICAL CONSULTING, INC. 33OO PGA BLVD SUITE 035 PALM BEACH GARDENS, FL 33410

SHIPTo: (202) 56{-8930 OPPT Document 

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