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11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms of the Order 

III. Contents ofPMN 

IV. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

II. Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal 

Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Notice of Transfer of Consent Order 

Attachment C - Consent Order for Contract Manufacturer 

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iii 

PREAMBLE 

I. INTRODUCTION 

Under the authority of § 5( e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 

2604( e», the Environmental Protection Agency ("EPA" or "the Agency") issues the attached 

Order, regarding premanufacture notice ("PMN") P-IO-0184 for the chemical substance 

("the PMN substance") submitted by 

("the Company"), to take effect upon expiration of the PMN review period. The Company 

submitted the PMN to EPA pursuant to § 5(a)(1) of TSCA and 40 CFR Part 720. 

Under § 15 of TSCA, it is unlawful for any person to fail or refuse to comply with any 

provision of § 5 or any order issued under § 5. Violators may be subject to various penalties and 

to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure 

pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 of 

TSCA, such as this one, are subject to the § 12(b) export notice requirement. 

II. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for the PMN substance requires the Company to: 

(a) not manufacture or import the PMN substance unless 

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(b) record and report 

impurities; 

iv 

(c) not exceed the maximum established levels of 

(d) maintain certain records. 

starting raw material 

impurities; and, 

A Consent Order for Contract Manufacturer is attached to extend these requirements to the 

identified Contract Manufacturers. The Contract Manufacturers must keep records of quantities 

manufactured, but the Company must submit to EPA all information required in the Consent 

Order. 

III. CONTENTS OF PMN 

By signing this Order, the Company represents that it has carefully reviewed this 

document and agrees that all information herein that is claimed as confidential by the Company 

is correctly identified within brackets and that any information that is not bracketed is not 

claimed as confidential. To make this document available for public viewing, EPA will remove 

only the information contained within the brackets. 

Confidential Business Information Claims (Bracketed in the Preamble and Order): Company 

identity; chemical identity; impurities; synonyms; production volume; specific use; operation 

descriptions, including exposure and release estimates; and physical/chemical properties. 

Chemical Identity: 

Specific: 

Generic: Alkyl ethoxylate 

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v 

Specific: 1 

Generic: Surfactant 

Maximum l2-Month Production Volume: kg/yr 

Test Data Submitted with PMN: none 

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK 

The following are EPA's predictions regarding theprobable toxicity, human exposure 

and enviromnental release of the PMN substance, based on the information currently available to 

the Agency. 

Human Health Effects Summary: EPA has concerns for potential fluorinated incineration or 

other decomposition products of the PMN substance. EPA also has concerns that the PMN 

substance under some conditions ofuse-- particularly non-industrial, commercial, or consumer 

use-- could cause lung effects, based on limited data on some perfluorinated compounds. 

An acute inhalation study in rats, with dose levels of 0.61 mg/L and 5.9 mg/L over a 4 

hour exposure period, was received on a close analog. The approximate lethal concentration 

("ALC") was estimated to be greater than 5.9 mg/L. The ALC value is consistent with a low 

concern for acute inhalation toxicity. 

EPA expects that the PMN substance will degrade based on data on 

. The PMN substance may degrade to 

Based on available information, EPA has determined that the PMN substance may have 

. The Company has arranged 

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VI 

for the raw material supplier to routinely test the 

following analytes: 

starting raw material for the 

and report those results to the Company in a Certificate of Analysis 

("COA"). Further, the raw material supplier will annually test the starting raw 

material for , including establishing calibration curves where 

the LOQ desired is 

The Company will continue to work towards reducing the maximum amount of 

impurities . During commercial production, 

these impurities are known to be produced partly by 

. To reduce these impurities, the Company has agreed to 

. The Company will require the 

Contract Manufacturer to manufacture the substance with starting raw materials 

that do not exceed the established impurities levels, and maintain "good housekeeping" practices 

so that limited impurity contamination occurs in the PMN 

substance from the manufacture of 

EPA is concerned that these perfluorinated products may be released to theenviromnent 

from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary 

evidence, including data on other , that suggests that, under some 

conditions, the PMN substance could degrade in the enviromnent. Based on data on analogous 

chemicals, including PFOA and , EPA has concerns that 

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VII 

these degradation products will persist in the environment, CQuld bioaccumulate or biomagnify, 

and could be toxic to people, wild mammals, and birds ("PBT"). The presumed perlluorinated 

degradants for the PMN substance include . There is limited toxicological data in 

aniruals on or precursors, which is summarized below. 

PFOA is expected to persist for years in the environment. Biodegradation and photolysis 

tests of analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl 

compounds. Bioaccumulation concerns are based on the measured presence of certain 

perfluoroalkyl compounds, including; PFOA, in wildlife and in human blood samples. Toxicity 

studies on PFOA indicate developmental, reproductive and systemic toxicity in various species, 

as well as possible cancer concerns. These factors, taken together, raise concerns for potential 

adverse chronic effects in humans and wildlife. For additional information about PFOA, consult 

the EPA regulatory docket at OPPT -2003-0012. Additional information about PFOA, 

. and other perfluorinated substances may also be found in the Administrative Record for PFOS, 

PFOA, and Telomers and Related Chemicals (AR-226). Administrative Record (AR-226) is not 

currently available online, but copies can be requested on CD-ROM from the EPA Docket office 

by calling (202) 566-0280 or sending an email requesttooppt.ncic@epa.gov. 

Limited toxicological, ecological, and fate data now exist on and some of the 

-derived polymers and other substances; see the PMN docket for data for these specific 

PMNs. EPA previously received a pharmacokinetics study on and, for comparison, 

perfluorobutane sulfonate ("PFBS") in the Cynomolgus Monkey. This study indicates that the 

serum half-life of is less than 24 hours in these monkeys. In comparison, the serum 

half-life ofPFOA has been shown to be 20.9 days in female monkeys and 32.6 days in male 

monkeys. In addition, the SerunI half-life ofPFOA in humans is approximately 3.8 years. 

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Vlll 

Another pharmacokinetics study on in rats showed a serum half-life of one hour or 

less. These data support the assessment of reduced bioaccumulation of relative to 

PFOA. 

In 2007, EPA received a 90-day study with a reproduction screen on 

with dose levels of 0, 20,100, and 500 mg/kglday. EPA's review of this study 

concluded that a no-observed adverse effect level ("NOAEL") was not established in this study 

for systemic effects. Nasal tissue, liver, and thyroid effects were observed at 100 and 500 

mg/kglday; while body weight, red blood cell system, clotting and kidney effects were observed 

at 500 mg/kglday. The EPA reviewer concluded that, although not clearly dose related, the 

elevation of two markers for liver toxicity across all treated groups of males in clinical chemistry 

and focal necrosis in the liver, across all treated groups of males, as well as in treated recovery 

males, and the absence ofthis result in the controls, leads to the conclusion that no NOAEL was 

achieved. 

For the one-generation reproductive toxicity component of this study, the reproductive 

toxicity NOAEL is 500 mg/kglday (the highest dose tested). The systemic toxicity NOAEL for 

PI rats was20 mg/kgldaybased on decreased body weightslbody weight gains at 100 and 500 

mg/kglday. The systemic toxicity for F1 adults is 100 mg/kgldaybased on reduced body 

weightslbody weight gains and reduced food consumption at 500 mg/kgl day. The 

developmental toxicity NOAEL for F1 pups was 100 mg/kglday based on decrease pup weights 

at 500 mg/kglday. The rats (PI generation; 20/sex/group) were administered gavage doses of 0, 

20,100 or 500 mg/kglday for 70 days pre-mating, and then mated for a maximum of2 weeks to 

produce 1 litter. Dosing was continued during mating, gestation, and lactation. 

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IX 

In 2005, a Combined Repeated-Dose Toxicity Stndy with ReproductionlDevelopmental 

Screening Test (OECD Test Guideline 422) in rats was conducted on and the 

. The EPA review of these sub chronic and reproductive data on and the 

concluded that for no reproductive effects were seen at 50, 150, and 450/300 

mg!k:glday (450 was reduced to 300 in the stndy on day 4 because oftoxicity) dose levels; 

however, systemic effects-prinIarily liver effects--were seen. EPA review places the NOAEL 

for at 50 mg!k:glday. For the , a NOAEL of75 mg!k:glday and a 

Lowest-Adverse Effect Level ("LOAEL") of225 mg!k:glday were established for reproductive or 

developmental effects at dose levels of25, 75, and 225 mg!k:glday. However, the Agency was 

only able to establish a LOAEL of25 mg!k:glday for systemic effects. 

In 2006, another 90-day oral repeated dose toxicity stndy (OECD Test Guideline 408) 

was submitted with dose levels of 0 (vehicle control), 10, 50, or 200 mg!k:glday, based on the 

previous Combined Stndy (OECD Test Guideline 422). EPA review sets the Lowest-Observed 

Effect Level ("LOEL") or LOAEL at 10 mg!k:glday, based on the lower body weight gains in all 

treated groups of males. There was treatment-related toxicity in the liver and the red blood cell 

system (anemia) in males, as well as increased peroxisomal beta oxidation activity at 200 

mg!k:glday. Hepatotoxicity and peroxisomal beta oxidation activity have been observed in 

stndies on PFOA. 

The significance of the finding of a benign brain tumor (astrocytoma) in one male rat in 

the high dose group is not clear. The tumor is not the type normally associated with PFOA-type 

compounds, is not rare, and may be incidental. Abnormal histopathology observations in the 

testes of 2 males and epididymides of 1 male, at the 200 mg!k:glday dose level, are a sign of male 

reproductive toxicity. Further stndies should investigate male reproductive effects. From this 

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x 

study, the potential for immunotoxic effects is low in contrast to some studies showing 

immunotoxic effects from PFOA. Any investigation of immunotoxic effects should await the 

corroborative studies now being conducted by EPA's Office of Research and Development. 

There were no clinical signs of neurotoxicity and there were no treatment-related effects in the 

functional observation battery or motor behavior. 

Another 90-day study on concluded that blood and liver effects were seen at the 

highest dose, with doses comparable to those in other studies. 

These and other data indicate a different and less toxic profile for , (a presumed 

enviromnental degradant of the PMN substance), than for PFOA. However, based on: (1) the 

persistence of ; (2) potential intermediate fate products; and, (3) the possibility or 

likelihood that this substance may be used as a major substitute for some uses ofPFOA, EPA 

believes that more information is needed on the toxicity of and possibly other 

enviromnental degradantsand the fate, and physical/chemical properties of 

related polymers in the enviromnent. 

-derived or 

EPA also believes that additional reproductive and long-term toxicological studies on 

in animals are warranted. EPA has received a 90-day Repeated Dose study with 

Reproductive Screen conducted by another company. Further, EPA expects that a modified 

reproductive test (OEeD Test Guideline 421, modified) will be conducted by another company. 

The modifications for the reproductive test include: (I) increase the parental sample size to 20, 

(2) the duration of the study should be extended to until the pups have reached sexual 

maturation, (3) parental males should be dosed for 10 weeks prior to mating, (4) dosing of the 

parental animals should be continued through lactation and then the pups should be directly 

dosed until they reach sexual maturation, (5) pup body weight should be recorded on lactation 

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Xl 

days 0, 4, 7, 14, and 21 and then at weekly intervals, (6) litter size can be standardized to 4 

pups/litter on lactation day 4 (optional), (7) at weaning one pup/sex/litter can be randomly 

selected to follow until sexual maturation, and (8) the time of sexual maturation should be 

recorded (i.e. vaginal opeillng and preputial separation). EPA also expects that a Combined 

Carcinogenicity/Chronic Toxicity test (Hannonized Test Guideline 870.4300 or OECD Test 

Guideline 453) and an avian reproduction test in bobwhite quail (OECD Test Guideline 206) will 

also be conducted by another company. EPA may still seek additional avian reproduction study 

(OECD Test Guideline 206) in mallard ducks, as well as comparative data. In addition, 

pharmacokinetics of and other perfluorinated substances will be developed in testing 

conducted by the National Toxicology Program ("NTP") in the so-called Perfluoro Class Studr. 

EPA believes that characterization in mammalian studies of the PMN substance would be 

valuable. The testing will not be required at any specified time. Therefore, the test is pended in 

this order, but could be required as specified on pgs. xv to xvii in order to adequately 

characterize this PMN substance. 

Environmental Effects Summary: EPA expects the PMN substance or the degradants to be 

highly persistent. 

EPA received acute fish, daphnia, and algae studies on a fonnulated substance similar to 

the PMN. Results of the studies were determined to be valid and showed moderate toxicity. 

EPA review of the fish study showed a Lowest Effect Concentration ("LOEC") of 29 mg/L and 

the No Effect Concentration ("NOEC") of 13.0 mg/L with no animal deaths and no sub-lethal 

effects observed. For the daphnia study, the LC50 was 28 mg/L, however, the LOEC was 2.40 

mg/L as mortality and sub-lethal effects were observed at this dose. The algae study had a 

EPA SANITIZED Page 11 of 41
Xl! 

NOEC of27.5 mglL and a LOEC of 54.8 mglL. Based upon these data, EPA would set a 

chronic concern concentration ("COC") at 288 ppb and an acute COC at 2,880 ppb. EPA has 

determined that, although the chronic testing would be valuable, the testing will not be requITed 

at any time. Therefore, the chronic fish, daphnid, and algae testing are pended in this order. For 

the fish and daphnia studies, the flow through method with analytical measurement of test 

substance should be used, and for the algae study, analytical measurement of test substance. The 

submitter should consult Harmonized Test Guideline 850.1000 for difficult to test substances 

with low water solubility. 

There is also high concern for possible environmental effects from the potential persistent 

degradation product As stated previously, the analog PFOA is persistent in the 

environment, has a long bioretention time in various species, has been detected in a number of 

species of wildlife, including marine mammals, and is considered toxic to mammalian and other 

species. The toxicological properties and presence ofPFOA in the environment continue to be 

investigated. While EPA has limited acute ecotoxicological effects data on in fish, 

daphnia, and algae, additional chrouic data on 

are being conducted by other companies. 

is desired. EPA anticipates these tests 

Exposure and Environmental Release Summary: Thermal and simulated incineration testing 

exists on some related polymers. This testing indicates that incomplete incineration products are 

formed at lower incineration temperatures. Modified Zalm-Wellens and Semi-Continuous 

Activated Sludge ("SCAS") biodegradation tests have been conducted on some related polymers. 

EPA has determined that some related polymers degrade, while another did not show signs of 

degradation during the time frame o~the test. EPA has received and reviewed test data showing 

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Xill 

that certain polymers with perfluoroalkyl substituents degrade to form perfluoroalkyl containing 

intermediates and perfluoroalkyl containing organic acids. EPA expects that the PMN substance 

will degrade in such a way. 

Exposure and Release Summaries: 

Manufacturing of the PMN substance will take place at 

Occupational exposures are 

the environmentduring manufacturing are 

Processing for 

. Occupational exposures are 

the environment during processing are 

Processing for 

Occupational exposures are 

. All releases of the PMN substance to 

will take place at 

All releases of the PMN substance to 

will take place at 

Environmental releases from these activities are 

Use of 

Occupational exposures are 

releases during use are 

will take place a1 

All environmental 

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XIV 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 

(a) EPA is unable to det=ine the potential for human health and environmental effects from 

exposure to the PMN substance and potential degradation products. EPA therefore concludes, 

pursuant to § 5( e) (1 )(A)(i) ofTSCA, that the information available to the Agency is insufficient 

to permit a reasoned evaluation of the human health and environmental effects of the PMN 

substance and potential degradation products. 

(b) In light of the potential risk of human health and environmental effects posed by the 

uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the 

PMN substance, EPA has concluded, pursuant to § 5( e)(l )(A)(ii)(l) ofTSCA, that uncontrolled 

. manufacture, import, processing, distribution in commerce, use, and disposal of the PMN 

substance may present an unreasonable risk of injury to human health and the environment. 

(c) In light of the estimated production volume of, and human exposure to, the PMN substance 

and potential degradation products, EPA has further concluded, pursuant to § 5( e)(1 )(A)(ii)(Il) of 

TSCA, that the PMN substance will be produced in substantial quantities and may reasonably be 

anticipated to enter the environment in substantial quantities, and there may be significant (or 

substantial) human exposure to the substance and potential degradation products. 

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xv 

VI. INFORMATION REOUIRED TO EVALUATE HUMAN HEALTH 

AND ENVIRONMENTAL EFFECTS 

Pended Testing. The Order does not require submission of the pended testing listed below at any 

specified time or production volume. However, the Order's restrictions on manufacture, import, 

processing, distribution in commerce, use, and disposal of the PMN substance will remain in 

effect until the Order is modified ouevoked by EPA based on submission of that or other 

relevant information. EPA expects that protocols would be submitted prior to any additional 

toxicological or ecological testing. Due to the limited water solubility of some of these 

substances and consequent analytical difficulties, some modification of the protocols may be 

necessary. These and other modifications will be agreed upon between EPA and the Company. 

(1) The following testing on the PMN substance would be necessary to evaluate the 

human health effects: 

Repeated dose inhalation study 

with a bronchoalveolar lavage 

component and special attention 

to histopathology (inflammation 

and cell proliferation) 

Guideline 

Harmonized Test Guideline 870.3050 

(2) The following testing on the PMN substance would be necessary to evaluate the 

ecotoxicityeffects: 

Guideline 

Fish early-life stage toxicity test Harmonized Test Guideline 850.1400 

Daphnid chronic toxicity test Harmonized Test Guideline 850.1300 

Algal toxicity test, Tiers I and II Harmonized Test Guideline 850.5400 

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XVI 

The Special Considerations for Conducting Aquatic Laboratory Studies (Harmonized 

Test Guideline 850.1000) should be used for these tests. 

(3) The following physicallchemical properties and fate and transport tests on the PMN 

substance would be necessary to evaluate the environmental fate and transport: 

Modified Semi-Continuous 

Activated Sludge (SCAS) with 

analysis for degradation products 

UV visible light absorption 

Direct Photolysis, if wavelengths 

greater than 290 iIm are absorbed 

the previous test (Harmouized Test 

Guideline 830.7050) 

Indirect Photolysis Screening Test 

Hydrolysis as a function of pH 

and temperature 

Aerobic Transformation in Soil 

Anaerobic biodegradability of 

organic compounds in digested sludge 

Phototransformation of Chemicals 

on Soil Surfaces - 2 soils 

Simulation Test-Aerobic 

Sewage Treatment 

(Activated Sludge Units) 

Aerobic and Anaerobic Transformations 

in Aquatic Sediment Systems 

Anaerobic Transformation in Soil 

Guideline 

Harmonized Test Guideline 835.5045, or 

Harmonized Test Guideline 835.3210, or 

OECD Test Guideline 302A 

Harmonized Test Guideline 830.7050 

Harmonized Test Guideline 835.2210 

Harmonized Test Guideline 835.5270 

Harmonized Test Guideline 835.2130 or 

OECD Test Guideline 111 

OECD Test Guideline 307 

OECD Test Guideline 311 

Draft OECD Test 

Guideline Jan. 2002 

OECD Test Guideline 303A 

OECD Test Guideline 308 

OECD Test Guideline 307 

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XVll 

(4) Because some concerns for the PMN substance are based on analogy between 

and PFOA, and because is a potential ultimate degradation product of the 

PMN substance? the following additional information on would be necessary to 

evaluate the human health and enviromnental effects which may be caused by the PMN 

substance: 

Modified I-generation reproduction 

study in rats or mice 

-OROther reproduction testing in animals 

that addresses concerns raised in other 

testing on 

Combined chronic toxicityl 

carcinogenicity test in Sprague 

Dawley rats 

Avian reproduction test 

in bobwhite quail and mallard ducks 

Guideline 

OECD Test Guideline 421, modified 

OECD Test Guideline 453 

OECD Test Guideline 206 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

(a) Scope. The requirements of this Order apply to all commercial manufacturing, processing, 

distribution in commerce, use and disposal of the chemical substance 

(P-1O-OI84) ("the PMN substance") in the United States by ("the Company"), 

except to the extent that those activities are exempted by paragraph (b). 

(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal of the 

PMN substance is exempt from the requirements of this Order (except the requirements in the 

Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the 

extent that (1) these activities are conducted in full compliance with all applicable requirements of 

the following exemptions, and (2) such compliance is documented by appropriate recordkeeping as 

required in the Recordkeeping section of this Order. 

(1) Export. Until the Company begins commercial manufacture of the PMN substance for 

use in the United States, the requirements of this Order do not apply to manufacture, processing or 

distribution in commerce of the PMN substance solely for export in accordance with TSCA §12(a) 

Internet Address (URL) • http://www.epa.gov 

RecycledIRecyclable • Printed with Vegetable OD Based Inks on Recycled Paper (Minimum 25% Postconsumer) 

EPA SANITIZED Page 18 of 41
-iand (b), 40 CFR 120.3(s) and 40 CFR Part 707. However, once the Company begins to 

manufacture the PMN substance for use in the United States, no further activity by the Company 

involving the PMN substance is exempt as "solely for export" even if some amount of the PMN 

substance is later exported. At that point, the requirements of this Order apply to all activities 

associated with the PMN substance while in the territory of the United States. Prior to leaving 

U.S. territory, even those quantities or batches of the PMN substance that are destined for export 

are subject to terms of the Order, and count towards any production volume test triggers in the 

Testing section of this Order. 

(2) Research & Development ("R&D"). The requirements of this Order do not apply to 

manufacturing, processing, distribution in commerce, use and disposal of the PMN substance in 

small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 

120.3( cc), and 40 CFR 120.36. The requirements of this Order also do not apply to manufacturing, 

processing, distribution in commerce, use and disposal of the PMN substance when manufactured 

solely for non-commercial research and development per 40 CFR 120.30(i) and TSCA §5(i). 

(3) Byproducts. The requirements of this Order do not apply to the PMN substance when 

they are produced, without separate commercial intent, only as a "byproduct" as defined at 40 CFR 

120.3( d) and in compliance with 40 CFR 120.30(g). 

(4) No Separate Commercial Purpose. The requirements ofthis Order do not apply to the 

PMN substance when it is manufactured, pursuant to any of the exemptions in 40 CFR 120.30(h), 

with no commercial purpose separate from the substance, mixture, or article of which it is a part. 

(5) Imported Articles. The requirements of this Order do not apply to the PMN substance 

when it is imported as part of an "article" as defined at 40 CFR 120.3( c) and in compliance with 40 

CFR 120.22(b)(I). 

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(c) Automatic Sunset. If the Compauy has obtained for the PMN substauce a Test Market 

Exemption ("TME") under TSCA §5(h)(1) aud 40 CFR 720.38 or a Low Volume Exemption 

("L VE") or Low Release aud Exposure Exemption ("LoREX") under TSCA §5(h)( 4) aud 40 CFR 

723.50(c)(1) aud (2) respectively, auy such exemption is automatically rendered null aud void as 

of the effective date ofthis Consent Order. 

II. TERMS OF MANUFACTURE. IMPORT. PROCESSING. 

DISTRIBUTION IN COMMERCE. USE. AND DISPOSAL 

PENDING SUBMISSION AND EV ALUA TlON OF INFORMATION 

PROHIBITION 

The Compauy is prohibited from mauufacturing the PMN substauce in the United States, 

for auy non-exempt commercial purpose, pending the development of information necessary for a 

reasoned evaluation of the humau health aud environmental effects ofthe substauce, aud the 

completion of EPA's review of, aud regulatory action based on, that information, except in 

accordauce with the conditions described in this Order. 

(a) The compauy shall not mauufacture or import the PMN substauce unless 

(b) The Compauy and/or the Contract Mauufacturer shall aualyze representative samples of the 

PMN substauce to determine compliauce with the requirements in paragraph (a). The Compauy 

EPA SANITIZED Page 20 of 41
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and/or the Contract Manufacturer shall analyze the ofthePMN 

substance produced at each manufacturing facility both (1) at the time of initial commencement of 

non-exempt manufacture or upon initial import, and (2) at least annually every year the PMN 

substance is manufactured or imported. The from production at 

any new facility, or any significantly altered facility of process, must be analyzed at 

commencement and annually thereafter. 

CHEMICAL SYNTHESIS AND COMPOSITION 

(a) Restrictions. The Company and/or the Contract Manufacturer shall not manufacture the PMN 

substance unless testing of the starting raw material, as supplied by the raw 

material supplier in a Certificate of Analysis ("COA"), is below the maximum established levels 

of impurities as specified in Table I and Table 2. If within one year 

before the date of manufacture of the PMN substance a product that contained 

products was processed or manufactured in the equipment at the facility where the PMN substance 

is to be made, the Company shall test the Initially Isolated Formulations of the PMN substance for 

the analytes specified in Table 3 to confirm that cross-contamination from the manufacture of 

product with has not occurred. Testing shall be conducted upon initial 

commencement of manufacture and at least annually thereafter, until one year after the date ofthe 

last manufacture or processing of a product that contains products at that facility. 

No testing ofinitially Isolated Formulations ofthe PMN substance will be required if 

have not been previously manufactured or processed in the facility. The Company 

shall submit all test protocols to EPA for review prior to initiating testing. The Company shall 

record the levels of impurities associated 

EPA SANITIZED Page 21 of 41
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with the PMN substance manufactured by the Company and/or the Contract Manufacturer, as 

specified below. For routine reporting, the Company shall record at each manufacturing facility 

the starting raw material, the , for the following analytes shown in Table 1 below: 

Further, the Company will also annually record the starting raw material, 

, for the analyte shown in Table 2, below. The Company 

shall make its best effort to minimize these impurities. If any new manufacturing facilities are 

added, or the manufacture process is significantly altered, then the PMN substance must be tested 

at commencement of these actions and annually thereafter. 

(b) Reporting. The Company shall test representative samples of the Initially Isolated 

Formulations of the PMN substance manufactured or imported by the Company and/or the 

Contract Manufacturer to determine compliance with the requirements in paragraph (a). The 

Company shall test the Initially Isolated Formulations of the PMN substance at each 

manufacturing facility both (J) at the initial commencement of non-exempt manufacture of the 

PMN substance at that facility, and (2) at least annually thereafter during every year in which the 

PMN substance is manufactured at that facility or imported. If any new manufacturing facility is 

added or ifthe process of manufacture of the PMN substance or any intermediate thereof is 

significantly altered, then the Initially Isolated Formulation ofthe PMN substance must be tested at 

commencement of these actions and annually thereafter, as set forth above. If the PMN substance 

is imported, the Company shall obtain from the foreign manufacturer written documentation to 

certify that representative samples of the imported form of the PMN substance have been tested, 

consistent with the requirements of this paragraph (b) and determined to comply with the 

EPA SANITIZED Page 22 of 41
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requirements of paragraph (a). The Company shall report the above testing to EPA at initial 

commencement of manufacture or import and again if any new manufacturing facility is added or 

ifthe process of manufacture of the PMN substance or any intermediate thereof is significantly 

altered. The Company shall continue to report these impurity levels to EPA armually. This is 

consistent with the current armual reporting cycle 

. In addition to the reporting for the Initially Isolated 

Formulations ofthe PMN substance itself, the Company shall, for the starting raw 

material, armually report (I) the average values and the range of values, including outlying data, 

for the routine testing for the analytes specified in Table 1, and (2) the results ofthe armual testing 

for the analyte specified in Table 2. 

TABLE 1: Chemicals to be Routinely Tested in Starting Raw Material 

Analyte CAS Number Limit in 

TABLE 2: Chemicals to be Tested at least Annually in Starting Raw Material 

Analyte CAS Number Limit in 

EPA SANITIZED Page 23 of 41
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TABLE 3: Chemicals to be Tested in the Initially Isolated Formulations of the PMN Substance 

Estimated Maximmn in Initially 

Analyte CAS Nmnber Isolated Formulations of the PMN 

Substance 

MANUFACTUIDNG 

(a)(l) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import 

of the PMN substance by any other person outside the Company, except a Contract Manufacturer 

as described in paragraph (b). 

(2) Sunset Following SNUR. Subparagraph (a) (1 ) shall expire 75 days after promulgation 

of afinal significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2) 

ofTSCA unless the Company is notified on or before that day of an action in a Federal Court 

seeking judicial review of the SNUR. If the Company is so notified, subparagraph (a)(l) shall not 

expire until EPA notifies the Company in writing that all Federal Court actions involving the 

SNUR have been resolved and the validity of the SNUR affirmed. 

(3) Notice of SNUR. When EPA promulgates a final SNUR for the PMN substance and 

subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify each 

person whom it causes, encourages or suggests to manufacture or import the PMN substance of the 

existence ofthe SNUR. Such notification must be in writing and must specifically include all 

limitations contained in the SNUR which are defined as significant new uses, and which would 

EPA SANITIZED Page 24 of 41
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invoke significant new use notification to EPA for the PMN substance. Such notice must also 

reference the publication of the SNUR for the PMN substance in either the Federal Register or the 

Code of Federal Regulations. 

(4) Subparagraph (a)(2) shall not negate the effects of any fully executed Consent Order 

for Contract Manufacturer entered into under paragraph (b )(2). 

(b) Contract Manufacturer. Not withstanding paragraph (a), the Company may cause a Contract 

Manufacturer outside the Company to manufacture or import the PMN substance according to the 

following conditions: 

(I) The Contact Manufacturer must be under contract to the Company to manufacture or 

import the PMN substance solely for the Company. The contract must specifY the identity of the 

PMN substance, the total quantities to be manufactured, and the basic technology to be used for 

manufacturing. 

(2) The Company shall obtain from each Contract Manufacturer a sigued copy of the 

Consent Order for Contract Manufacturer (attached to this Order as Attachment C) and submit the 

copy to EPA along with the name, address, and telephone number of a responsible official of the 

Contract Manufacturer. The Contract Manufacturer or Company must receive a fully executed 

copy of the Consent Order for the Contract Manufacturer from EPA before the Contract 

Manufacturer may begin manufacture or import. 

(3) If at any time, the Company learns that the Contract Manufacturer has failed to comply 

with any of the conditions specified in the Consent Order for Contract Manufacturer, the Company 

shall immediately cease to cause the Contract Manufacturer to manufacture or import the PMN 

EPA SANITIZED Page 25 of 41
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substance, unless the Contract Manufacturer is in compliance with a SNUR for the PMN 

substance, or unless the Company is able to document each of the following: 

(i) That the Company has, within 5 working days, notified the Contract 

Manufacturer in writing that the Contract Manufacturer has failed to comply with the conditions 

specified in the Consent Order for Contract Manufacturer. 

(ii) That, within 15 working days of notifying the Contract Manufacturer of the 

noncompliance, the Company received from the Contract Manufacturer, in writing, a statement of 

assurance that the Contract Manufacturer is aware of the terms ofthe Consent Order for Contract 

Manufacturer and will comply with those terms . 

. (iii) If, after receiving a statement of assurance from the Contract Manufacturer under 

subparagraph (B) of this Section, the Company has notice or knowledge that the Contract Manufacturer 

has failed to comply with any of the conditions specified in the Consent Order for Contract 

Manufacturer, the Company shall immediately cease to cause the Contract Manufacturer to 

manufacture or import the PMN substance, shall notify EPA of the failure to comply, and shall resume 

causing the Contract Manufacturer to manufacture or import the PMN substance only upon written 

notification from the Agency. 

DISTRIBUTION 

(a) Export Notice Requirement. No later than the date of distribution, the Company shall notify in 

writing any person to whom it distributes the PMN substance that, due to the issuance of this 

Consent Order under section 5( e) of TSCA, the PMN substance is subject to the export notification 

requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in 

the form in which it appears in this Consent Order, the following information: (I) the PMN 

EPA SANITIZED Page 26 of 41
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number, and (2) either (A) the specific chemical identity of the PMN substance, or (B) if the 

specific chemical identity is confidential, the generic chemical identity. 

RISK NOTIFICATION 

(a) If as a result of the test data required under the terms of this Order, the Company becomes 

aware that the PMN substance may present a risk of injury to human health or the enviromnent (or 

is so notified by EPA), the Company must incorporate this new information, and any information 

on methods for protecting against such risk, into a Material Safety Data Sheet ("MSDS ") for the 

PMN substance, as described in 40 CFR section 721. 72( c), within 90 days from the time the 

Company becomes aware of the new information. If the PMN substance is not being 

manufactured, imported, processed, or used in the Company's workplace, the Company must add 

the new information to an MSDS before the PMN substance is reintroduced into the workplace. 

(b) The Company must ensure that any Contract Manufacturer (as described in paragraph (b) of 

the Manufacturing section of this Order), persons who will receive the PMN substance from the 

Company, or who have received the PMN substance from the Company within 5 years from the 

date the Company becomes aware of the new information described in paragraph (a) of this 

section, are provided an MSDS containing the information required under paragraph (a) within 90 

days from the time the Company becomes aware of the new information. 

EPA SANITIZED Page 27 of 41
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m. RECORDKEEPING 

(a) Records. The Company shall maintain the following records until 5 years after the date they 

are created and shall make them available for inspection and copying by EPA in accordance with 

section 11 ofTSCA: 

(1) Exemptions. Records documenting that the PMN substance did in fact qualifY for any 

one or more of the exemptions described in Section 1, Paragraph (b) of this Order. Such records 

must satisfY all the statutory and regulatory recordkeeping requirements applicable to the 

exemption being claimed by the Company. Any amounts or batches of the PMN substance 

eligible for the export only exemption in Section I, Paragraph (b )(1) of this Order are exempt from 

all the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the 

date of their creation, copies of the export label and export notice to EPA, required by TSCA 

sections l2(a)(1 )(B) and 12(b), respectively. Any amounts or batches of the PMN substance 

eligible for the research and development exemption in Section I, Paragraph (b )(2) of this Order 

are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 

5 years from the date oftheir creation, the records required by 40 CFR nO.78(b). For any 

amounts or batches of the PMN substance claimed to be eligible for any other exemption described 

in Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating 

qualification for that exemption as well as the records specified in paragraphs (2) and (3) below, 

but is exempt from the other recordkeeping requirements in this Recordkeeping section; 

(2) Records documenting compliance with the requirement, and 

Chemical Synthesis and Composition and Distribution sections of this Order; 

(3) Records documenting the manufacture and importation volume of the PMN substance 

and the corresponding dates of manufacture and import; 

EPA SANITIZED Page 28 of 41
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(4) Records documenting the names and addresses (including shipment destination 

address, if different) of all persons outside the site of manufacture or import to whom the Company 

directly sells or transfers the PMN substance, the date of each sale or transfer, and the quantity of 

the substance sold or transferred on such date; 

(5) Records documenting the address of all sites of manufacture, import, processing, and 

use; 

(6) Copies of the material safety data sheets required by the Risk Notification section of 

this Order; 

(7) Copies of any Transfer documents and notices required by the Successor Liability 

section of this Order, if applicable; and, 

(8) The Company shall keep a copy of this Order at each of its sites where the PMN 

substance is manufactured, imported, processed, or used. 

(b) Applicability. The provisions ofthis Recordkeeping Section are applicable only to activities 

of the Company and its Contract Manufacturer, if applicable, and not to activities of the 

Company's customers. 

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 

1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this "collection of 

information" uuless this Order displays a currently valid control number from the Office of 

Management and Budget ("OMB"), and EPA so informs the Company. The "collection of 

information" required in this TSCA §5( e) Consent Order has been approved under currently valid 

OMB Control Number 2070-0012. 

EPA SANITIZED Page 29 of 41
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IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA's Request for Information. Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA 

may occasionally conduct on-site compliance inspections of Company facilities and conveyances 

associated with the PMN substance. To facilitate such inspections, EPA personnel may contact the 

Company in advance to request information pertinent to the scheduling and conduct of such 

inspections. Such requests may be written or oral. The types of information that EPA may request 

include, but are uot limited to, the following: 

(1) Expected dates and times when the PMN substance will be in production within the 

subsequent 12 months; 

(2) Current workshift schedules for workers who are involved in activities associated with 

the PMN substance and may reasonably be exposed to thePMN substance; 

(3) Current job titles or categories for workers who are involved in activities associated 

with the PMN substance and may reasonably be exposed to the PMN substance; 

(4) Existiug exposure monitoring data for workers who are involved in activities 

. associated with the PMN substance and may reasonably be exposed to the PMN substance that are 

collected during the manufacture or processing of the PMN substance; 

(5) Records required by the Recordkeeping section of this Order; and/or, 

(6) Any other information reasonably related to determining compliance with this Order or 

conducting an inspection for that purpose. 

(b) Company's Response. The Company shall respond to such requests within a reasonable 

period of time, but in no event later than 30 days after receiving EPA's request. When requested 

in writing by EPA, the Company's response shall be in writing. To the extent the information is 

EPA SANITIZED Page 30 of 41
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known to or reasonably ascertainable by the Company at the time of the request, the Company's 

response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers 

to all of EPA's requests. 

( c) Confidential Business Information. Any Confidential Business Information ("CBI") that the 

Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with § 14 of 

TSCA and 40 CFR Part 2. 

v. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

(a) Scope. This section sets forth the procedures by which the Company's rights and obligations 

under tills Order may be transferred when the Company transfers its interests in the PMN 

substance, including the right to manufacture the PMN substance, to another person outside the 

Company (the "Successor in Interest"). 

(b) Relation of Transfer Date to Notice of Commencement ("NOC"). 

(1) Before NOC. If the transfer from the Company to the Successor in Interest is effective 

before EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN 

substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a 

new PMN to EPA and comply fully with Section 5(a)(I) ofTSCA and 40 CFR part 720 before 

. commencing manufacture or import of the PMN substance. 

(2) After NOC. If the transfer from the Company to the Successor in Interest is effective 

after EPA receives a NOC, the Successor in Interest shall comply with the terms ofthis Order and 

shall not be required to submit a new PMN to EPA. 

EPA SANITIZED Page 31 of 41
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( c) Definitions. The following definitions apply to this Successor Liability section of the Order: 

(1) "Successor in Interest" means a person outside the Company who has acquired the 

Company's full interest in the rights to manufacture the PMN substance, including all ownership 

rights and legal liabilities, through a transfer document signed by the Company, as transferor, and 

the Successor in Interest, as transferee. The term excludes persons who acquire less than the full 

interest of the Company in the PMN substance, such as a licensee who has acquired a limited 

license to the patent or manufacturing rights associated with the PMN substance. A Successor in 

Interest must be incorporated, licensed, or doing business in the United States in accordance with 

40 CPR nO.22(a)(3) and 40 CPR nO.3(z). 

(2) "Transfer Document" means the legal instrument(s) used to convey the interests in the 

PMN substance, including the right to manufacture the PMN substance, from the Company to the 

Successor in Interest. 

(d) Notices. 

(I) Notice to Successor in Interest. On or before the effective date of the transfer, the 

Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent 

Order and the "Notice of Transfer" document which is incorporated by reference as Attachment B 

to this Order. 

(2) Notice to EPA. Within 10 business days of the effective date of the transfer, the 

Company shall, by registered mail, submit the fully executed Notice of Transfer document to: 

U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania 

Avenue, N.W., Washington, D.C. 20460. 

EPA SANITIZED Page 32 of 41
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(3) Transfer Document. Copies of the Transfer Document must be maintained by the 

Successor in Interest at its principal place of business, and at all sites where the PMN substance is 

manufactured or imported. Copies of the Transfer Document must also be made available for 

inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must 

contain provisions which expressly transfer liability for the PMN substance under the terms oftbis 

Order from the Company to the Successor in Interest. 

( e) Liability. 

(1) The Company shall be liable for compliance with the requirements of this Order until 

the effective date of the transfer described above. 

(2) The Successor in Interest shall be liable for compliance with the requirements of this 

Order effective as of the date of transfer. 

(3) Nothing in this section shall be construed to prohibit the Agency from taking 

enforcement action against the Company after the effective date of the transfer for actions taken, or 

omissions made, during the time in which the Company manufactured, processed, used, distributed 

in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order. 

(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) ofthe Testing section 

of this Consent Order requires the Company to submit test data to EPA at a specified production 

volume ("test trigger"), the aggregate volume of the PMN substance manufactured and imported 

by the Company up to the date of transfer shall count towards the test trigger applicable to the 

Successor in Interest. 

EPA SANITIZED Page 33 of 41
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VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Company may petitionEP A at any time, based upon new information on the human 

health or environmental effects of, or human exposure to or environmental release of, the PMN 

substance, to modif'y or revoke substantive provisions of this Order. The exposures and risks 

identified by EPA during its review of the PMN substance and the information EPA determined to 

be necessary to evaluate those exposures and risks are described in the preamble to this Order. 

However, in determining whether to amend or revoke this Order, EPA will consider all relevant 

information available at the time the Agency makes that determination, including, where 

appropriate, any reassessment of the test data or other information that supports the findings in this 

Order, an examination of new test data or other information or analysis, and any other relevant 

information. 

EPA will issue a modification or revocation if EPA determines that the activities proposed 

therein will not present an unreasonable risk of injury to health or the environment and will not 

result in significant or substantial human exposure or substantial environmental release in the 

absence of data sufficient to permit a reasoned evaluation of the health or environmental effects of 

the PMN substance. 

In addition, the Company may petition EPA at any time to make other modifications to the 

language of this Order. EPA will issue such a modification if EPA determines that the 

modification is useful, appropriate, and consistent with the structure and intent of this Order as 

issued. 

EPA SANITIZED Page 34 of 41
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VII. EFFECT OF CONSENT ORDER 

(a) Waiver. By consenting to the entry ofthis Order, the Company waives its rights to file 

objections to this Order pursuant to section 5(e)(1)(C) ofTSCA, to receive service of this Order no 

later than 45 days before the end of the review period pursuant to section 5( e)(l )(B) ofTSCA, and 

to challenge the validity of this Order in any subsequent action. Consenting to the entry of this 

Order, and agreeing to be bound by its terms, do not constitute an admission by the Company as to 

the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver 

does not affect any other rights that the Company may have under TSCA. 

(b) CBl Brackets. By signing this Order, the Company represents that it has carefully reviewed 

this document and hereby agrees that all information herein that is claimed as confidential by the 

Company (per section 14 of TSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) is correctly 

identified within brackets and that any information that is not bracketed is not claimed as 

confidential. To make this document available for public viewing, EPA will remove only the 

information contained within the brackets. 

( 

q jZ3/1Olb 

Date 

Pollution Prevention and Toxics 

Date Name: i1 

Title: 

Company: 

EPA SANITIZED Page 35 of 41
ATTACHMENT A 

. DEFINITIONS 

[Note: The attached Order may not contain some of the terms defined below.] 

"Chemical name" means the scientific designation of a chemical substance in accordance 

with the nomenclature system developed by the Chemical Abstracts Service's rules of 

nomenclature, or a name which will clearly identifY a chemical substance for the purpose of 

conducting a hazard evaluation. 

"Chemical protective clothing" means items of clothing that provide a protective barrier to 

prevent dermal contact with chemical substances of concern. Examples can include, but are not 

limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. 

"Company" means the person or persons subject to this Order. 

"Commercial use" means the use of a chemical substance or any mixture containing the 

chemical substance in a commercial enterprise providing saleable goods or a service to consumers 

(e.g., a commercial dry cleaning establishment or painting contractor). 

"Common name" means any designation or identification such as code name, code number, 

trade name, brand name, or generic chemical name used to identifY a chemical substance other 

thin by its chemical name. 

"Consumer" means a private individual who uses a chemical substance or any product 

containing the chemical substance in or around a permanent or temporary household or residence, 

during recreation, or for any personal use or enjoyment. 

"Consumer product" means a chemical substance that is directly, or as part of a mixture, 

sold or made available to consumers for their use in or around a permanent or temporary 

household or residence, in or around a school, or in recreation. 

"Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage 

tank, or the like that contains a hazardous chemical. For purposes of this section, pipes or piping 

systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be 

containers. 

"Contract Manufacturer" means a person, outside the Company, who is authorized to 

manufactnre and import the PMN substance under the conditions specified in Part II. of this 

Consent Order and in the Consent Order for Contract Manufacturer. 

"Final Formulation of the PMN substances" means the formulated dispersion ofthe PMN 

substances in the form in which it is sold to customers outside the Company or transferred to a 

different business unit within the Company. The term does not include intermediate dilutions of 

EPA SANITIZED Page 36 of 41
-2-

the PMN substances that are intended only for use within the Company for further dilution prior to 

sale. 

"Identity" means any chemical or common name used to identifY a chemical substance or a 

mixture containing that substance. 

"Immediate use." A chemical substance is for the "immediate use" of a person if it is under 

the control of, and used only by, the person who transferred it from a labeled container and will 

only be used by that person within the work shift in which it is transferred from the labeled 

container. 

"Initially Isolated Formnlations of the PMN substances" means a common intermediate 

PMN formulation, as it exists when first produced and isolated after the polymer manufacturing 

process, that can be further processed or repackaged at the direction of the Company to result 

ultimately in one or more final formulations of the PMN substances. 

"Impervious." Chemical protective clothing is "impervious" to a chemical substance if the 

substance causes no chemical or mechanical degradation, permeation,· or penetration of the 

chemical protective clothing under the conditions of, and the duration of, exposure. 

"Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a 

chemical substance, regardless of physical state or concentration, through all intended operations 

of manufacture, including the cleaning of equipment. 

"MSDS" means material safety data sheet, the written listing of data for the chemical 

substance. 

"NIOSH" means the National Institute for Occupational Safety and Health of the U.S. 

Department of Health and Human Services. 

"Non-enclosed process" means any equipment system (such as an open-top reactor, 

storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or 

otherwise used where significant direct contact of the bulk chemical substance and the workplace 

alr may occur. 

"Non-industrial use" means use other than at a facility where chemical substances or 

mixtures are manufactllred, imported, or processed. 

"PMN substance" means the chemical substance described in the Premanufacture notice 

submitted by the Company relevant to this Order. 

"Personal protective equipment" means any chemical protective clothing or device placed 

on the body to prevent contact with, and exposure to, an identified chemical substance or 

substances in the work area. Examples include, but are not limited to, chemical protective 

EPA SANITIZED Page 37 of 41
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clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and 

various types of respirators. Barrier creams are not included in this definition. 

"Process stream" means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

processing, including the cleaning of equipment. 

"Scientifically invalid" means any significant departure from the EPA-approved protocol 

or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent 

Agency approval that prevents a reasoned evaluation of the health or environmental effects of the 

PMN substance. 

"Scientifically equivocal data" means data Which, although developed in apparent 

conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are 

inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of 

the potential risk of injury to human health or the environment of the PMN substance. 

"Sealed container" means a closed container that is physically and chemically suitable for 

long-term containment of the PMN substance, and from which there will be no human exposure 

to, nor environmental release of, the PMN substance during transport and storage. 

"Use stream" means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

industrial, commercial, or consumer use. 

"Waters of the United States" has the meaning set forth in 40 CFR 122.2. 

"Work area" means a room or defined space in a workplace where the PMN substance is 

manufactured, processed, or used and where employees are present. 

"Workplace" means an establishment at one geographic location contaiuing one or more 

work areas. 

EPA SANITIZED Page 38 of 41
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

PMNNumber 

1. Transfer of Manufacture Rights. Effective on , the Company did sell or 

otherwise transfer to , ("Successor in Interest") the rights 

and liabilities associated with manufacture ofthe above-referenced chemical substance, which was 

the subject of a premanufacture notice ("PMN") and is governed by a Consent Order issued by the 

U.S. Environmental Protection Agency ("EPA") under the authority of §5(e) of the Toxic 

Substances Control Act ("TSCA," 15 U.S.C. §2604(e)). 

2. Assumption of Liabilitv. The Successor in Interest hereby certifies that, as of the effective date 

of transfer, all actions or omissions governed by the applicable Consent Order limiting 

manufacture, processing, use, distribution in commerce and disposal of the PMN substance, shall 

be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is 

incorporated, licensed, or doing business in the United States in accordance with 40 CFR 

nO.22(a)(3). 

3. Confidential Business Information. The Successor in Interest hereby: 

_ reasserts, 

_ relinquishes, or 

modifies 

all Confidential Business Information ("CBI") claims made by the Company, pursuant to Section 

14 ofTSCA and 40 CFR part 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is 

indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is 

indicated, such modification shall be explained in detail in an attachment to this Notice of 

Transfer. Information which has been previously disclosed to the public (e.g., a chemical identity 

that was not claimed as CBI by the original submitter) would not subsequently be eligible for 

confidential treatment under this Notice of Transfer. 

EPA SANITIZED Page 39 of 41
Company (Transferor) 

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TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

PMNNumber 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Interest 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Address 

City, State, Zip Code 

EPA SANITIZED Page 40 of 41
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TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone 

EPA SANITIZED Page 41 of 41