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DATE RECEIVED DOCUMENT CONTHOL NUMBEH DOCUMENT DESCHIPTION 

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# $ 2ilt18 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



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OFFICE OF PREVENTION, PEST]CIOES AND TOXIC SUBSTANCES 

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Re: Modification to TSCA 5(e) Consent Order 

### for P-00 -1121 

### through 1126 Dear 

### PetitionThis letter responds to your 

### May 15, 2008 

### petition to 

### modiff the Consent Order 

### (Order) 

### for the above-referenced premanufacture notices 

### (PMNs). Specifically, 

### your cornpany asked the 

### Agencyto remove the Fish Bioconcentration Factor (Fish 

### BCF) study requirement 

### in paragraph 

### (d) of the 

### Testing section 

### of the 

### Order. In addition,

### yourpetition states that yor:r sornpanyhas a 

### continuing business interest only 

### in P-00- 

## ll21 and 

### is amenable to

### modifu"g the Order to 

### prohibit manufacture 

### of the other

### five 

### PMN subsiances (P-00 -1122 

### ttrough P-00- 1126) 

### in order 

### towaive the

### fish BCF study

### for 

### P-00-Ll2l. Consent Order Upon 

### review of the 

### PMN, the Agency 

### initially identified human health concerns

### for neurotoxicity, mutagenicity, immunotoxicity and 

### lung effects 

### forworkers exposed 

### to the 

### PMN substances

### via 

### inhalation. The human health concern was mitigated based on 

### particle size 

### distribution data 

### which showed that there were no particles 

### below I 1.56 

### rnicrons. EPA established concentrations 

### of concern (COCs) 

### for 

### P-00-Il2l, P-00-1 123, 

### P-00-l 124 andP-O0- 1125 aquatic

### toxicity at 500 pafis per

### billion (ppb), 600 ppb, 700 ppb and 300 ppb, respectively, based on the 

### structural activity relationship (SAR) analysis

### for with molecularweight adjustments. The COCs 

### for P-00-1122 and P-00-1126 were established 

### at 100 

### ppb and 200 ppb, respectively, based on the 

### SAF - and compounds 

### with molecularweight adjustments. The 

### Agency also determined that the PIvIN substances may be persistent, 

### bioaccumulative, and

### toxic (PBT) chemicals based on predicted and measured 

### physical/chemical 

### properties. hr 

### addition, the

### Agency is concerned about 

### potential 

### toxicity to 

### wildlife and humans 

### resulting from exposure to the 

### PMN substances 

### in the environment and 

### bioconcentration in the

### food 

### chain. Because 

### of the 

### potential PBT nature 

### of the 

### PMN substances,

lnlernet Address (URL) r http://www.epa.gov Recycled/Recyclabler Printed with Vegetable Oil Based lnks on 100% Postconsumerr Process Chlorine Free Recycled Paperbioaccurnulation and 

### signrficant exposure to humans and

### wildlife sould 

### result frorn 

### low surface

water 

### concenfrations. Therefore, 

### EpA determined that 

### it was necessary

### to 

### limit environrnental releases 

### of the 

### plvrN substances

### to a surfuce water concentration

### of

## t ppb 

### in the Release

### to

### water section 

### of the 

### consent order under sectfon 5(e) 

### of

### TscA' The 

### consent order, which became effective 

### March 23,2001, requires your company to: (1) 

### perform specified testing on the 

### pMN substance 14weeks 

### prior to reaching aspecified 

### production volume; (2) tabel containers 

### of the 

### pMN substances and 

### provide 

### M{erial safety Data sheets 

### (MSDss) and conduct 

### worker training 

### in accordance 

## *ith the provisions 

### of the Hazard 

### communication Program section; (3) not rnanufacture the 

### pMN substances

### if the 

### particle size is lessthan 10 rnicrons; (4) not process the 

### pMN substances 

### if the 

### particle size is less

### than 10 rnicrons; (5) not use the 

### pMN substances 

### if the 

### particle size is less than 10 

### microns; (6) distribute the 

### pMN substances outside the 

### company, including 

### for disposal, only 

### to a person 

### who has agreed 

### in

### writingprior to the date 

### of distribution, 

### to: (a) not 

### further distribute the 

### PMN substances

### to any other

### prrror, including 

## dJ"posal,

# *iit afterthe 

### PMN substances have been completely reacted;

## o) comply 

### with the same requirements and restrictions, 

### if any, required 

### of the 

### company in the irazard 

### -co*m,rnication Program section 

### of the 

### order; (c) comply 

### with the
same environmental release 

### restrictions,

### if

## Jy, ,"*qrrire! of the 

### company in the Release 

### to

### water section 

### of the 

### order; and (d) 

### notprocess 

### orurctrr*PMN substances 

### if theparticle size 

### of the 

### PMN substances is lessthan 10 

### microns; (7) not 

### release that 

### pMN substances

### to surface waters resulting 

### in stealn concenfrations above 1 

### ppb; and (8) 

### maintain certain records' Test Data 

### In 2001 theAgency 

### reviewed water 

### solubility data

# for G-00-t 122) and 

### (P-00-1126). Both measure

## d llppm

# (*glr'l in tap

### water at25 Co

### via shake

### flask' shaken 

### for 30 

### minutes, centrifuged, and 

### atomi" 

### atsorptionwith detectionlimit - 0'100

# mg 'L' Based onthe results, the 

### Agency reconlmended the

### fish (bluegiu) 28-day bioconcentration (BCF) test.



### -2-

### Currently, theTesting section 

### of the Order requires the company 

### to submit 

### to the Agency

a Fish 

### BCF study l4-weeks 

### priorto reaching acombined aggregatemanufacture and 

### import volume 

### of I 

### Your company submitted a96-hour 

### toxicity test 

### with rainbow trout (Oncorhynchus 

### mykiss) on P-00-1121 

### following OECD Guideline 

### 203. EPA determined the test to be

### scientificallyvalid. No 

### mortalitywas observed at

### anyof the 

### loadingrates up to the highest concentration tested (16,000 

### mg/L). Based on 

### this OECD 203 test, the water soluble 

### fraction (WSF) of the 

### pigment 10202 (P-00- 1121) is 

### not acutely 

### toxic to rainbow trout 

### fiy up 

### to the

### water

### solubility 

### limit of 0.1 

### mglL of test

# substance 'iequal

### to 0.03 

### mglL 

### of

The reported 

### No Observed 

### Effect loading rate was 16,000

### milL loading rate WSF. The 

### 96-hour LC50 for rainbow trout was reported as greater than 16,000 

### mglL loading rate WSF. 

### Conclusion Based on the submitted test data, the

### Agency has determined that P-00-1121 is an 

### mg/L

## of with very 

### low water 

### solubility (0.1 

### mg/L of test substance, equal 

### to 0.03



### i relative to its measured 

### toxicity, such that 

### no effects at saturation are expected and a

### fish BCF test is 

### not necessary

### for 

## P-00-ll2l Therefore, EPA is hereby granting 

### your request to 

### modiffparagraph (d) of theTesting 

### section. In addition, EPA is 

### modifoing paragraph (a)

### of the Release to 

### Watef section 

### to eliminate 

### P-00-l

# lzl Paragraph (d) 

### of the Testing section and Paragraph (a) 

### of the Release

### toWater section are 

### modified to read asstated 

### in the enclosed 

### Modified Consent Order Requirements. 

### All other terms and 

### conditions in the 

### original Consent Order shall remain 

### in

### full force and 

### efflect. This 

### modification is 

### effective on the date 

### of signature below. 

### If you have any questions regarding these 

### PMNs, please contact Darlene Jones, the Program Manager, at 

### (202) 564-9047

.



### Office of Pollution Prevention and

### Toxics Enclosure ical 

### Control 

### Division (7405M)

-3-

### MODIFIED CONSENT ORDER REQUIREMENTS FOR P-00-1121 

### THR OUGH P-00-1126



### TESTING 

### (d) The Company is 

### prohibited from manufacturing or 

### importing P-00-1122 through 

### P-00-1126 (excluding p-00- 1 I

### 2l ) beyond the

### following aggregate manufacture and 

### import volume ("the 

### productio, 

## li*it"), uiess the Company conducts the

### following study on the chemical substance described 

### in either p-00- 1122 or p-00- 1126 and submits all 

### final reports and 

### underlytng data 

### in accordance 

### with the conditions specified 

### inthis Testing section: Pro.duction 

### Limit

RELEASE TO 

### WATER 

## (a) The Company is 

### prohibited from any predictable 

### orJurposeful release 

### of P-00-1t22 through 

### p-00-1126 (excluding p-00-1121), or any waste stream from manufacturing, processing and use 

### sontaining the 

### PMN substances: 

## (IXi) Into the waters 

### of the 

### United States 

### if the quotient 

### from the

### formula: numb er 

### of kilo grams/daY/ site released 

### ---------

# x 1000

## - N parts per 

### billion receiving stream 

### flow (rnillion liters/daY) exceeds 

## I ppb

### for each 

### pMN substance when calculated using the methods described 

### in 40 CFR 721.91

. 

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