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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

Petition

This 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

Agency to 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

to waive 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 for workers 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

molecular weight 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

molecular weight 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,

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bioaccurnulation 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 14 weeks prior to reaching a specified

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 less than 1 0 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 after the 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 less than 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 the Agency 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 on the results, the Agency reconlmended the fish (bluegiu) 28-day bioconcentration (BCF)

test.

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Currently, the Testing section of the Order requires the company to submit to the Agency

a Fish BCF study l4-weeks priorto reaching a combined aggregatemanufacture and import

volume of I Your company submitted a 96-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- 1 121) is not acutely toxic to rainbow trout fiy up to

the water solubility limit of 0.1 mglL of test substance 'i equal 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 the Testing

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 to Water

section are modified to read as stated 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)

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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 in this 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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Fish BCF

Guideli,ne

OPPTS 850.1730

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