EPA SANITIZED 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF NEW CHEMICAL SUBSTANCES 

PENDING DEVELOPMENT OF INFORMATION 

Or \l/11/li 

1Cc t,Jn/ri 

In the matter of: ) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

Premanufacture Notice Numbers: 

[. - . . - . ..... .. .. .. ] P-13-646,64 7,648,649 ,678, and 679 

Consent Order and Determinations Supporting Consent Order 
11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms ofthe Order 

III. Contents ofPMNs 

IV. EPA's Assessment ofExposure and Risk 

V. EPA's Conclusions ofLaw 

VI. Information Required to Evaluate Human Health and Environmental Effects 

onsent Order 

I. Scope of Applicability and Exemptions 

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

Submission and Evaluation of Information 

III. Record-keeping 

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 
111 

PREAMBLE 

I. INTRODUCTION 

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

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

Order, regarding six premanufacture notices ("PMNs"), P-13-646, 647, 648, 649, 678, and 679 

submitted by I ] ("the Company"). The Company submitted the PMNs to 

EPA pursuant to § 5(a)(l) 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 ofTSCA, 

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

II. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for these PMN substances requires the Company to: 

(a) submit to EPA certain toxicity and physical/ chemical and environmental fate testing relevant 

to the hazard and risk assessment ofthe fluorinated portion of the six current PMN substances 

governed by the attached Consent Order; 

(b) report annually and comply with the impurity content of all the [. j and impurities 

with carbon chain lengths greater than [, ] by analyzing representative samples; and 

( c ) maintain certain records. 
IV 

Although a Consent Order for Contract Manufacturer is not attached to extend these 

requirements to an identified Contract Manufacturer, the Company may use a Contract 

Manufacturer to manufacture these substances in the future. The Consent Order establishes the 

requirements for the Company if a Contract Manufacturer manufactures the PMN substances. 

The Company must submit the Contract Manufacturer identity and other manufacturing process 

and exposure and release information concerning the Contract Manufacturer and then this 

Consent Order could be modified upon approval by EPA. The Contract Manufacturer would be 

required to keep records of quantities manufactured, but the Company must submit to EPA the 

required testing. 

III. CONTENTS OF PMN 

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

identity, specific chemical identities, physical form, production volumes, processing, and use 

information, and other information 

Chemical Identities: 

Specific: P-13-646: [ 

J; 
v 

P-13-647: [ 

j; 

P-13-648: [-

j; 

P-13-649: l· 

]; 

P-13-678: [: 

1 and 

P-13-679: [-

]. 

Generic Name: P-13-646 and 648-- Fluoroalkyl acrylate copolymer modified with polysiloxanes; 

P-13-647, 649, and 679-Fluoroalkyl acrylate copolymer; and P-13-678-Fluoroalkyl methacrylate 

copolymer 

Use: 

Specific: P-13-646-[ ]; P-13-647-[ 

J; P-13-648-[ ]; 

P-13-649-1 ]; P-13-678-[' 

1; and P-13-679- ]. 

Generic use: P-13-646, 648-tile treatment; P-13-647,649-textile treatment; P-13-678-water and oil 

repellent for plastic and inorganic substrates; P-13-679-paper treatment 
Vl 

Maximum 12-Month Production Volume: P-13-646-[: l kgs; P-13-647-r ] kgs; 

P-13-648-[ ] kgs; P-13-649-l ] kgs; P-13-678-[ ] kgs; and P-13-679-[ ] kgs. 

Test Data Submitted with PMNs: P-13-647 and 649-Ames test. 

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK 

The following are EPA's predictions regarding the probable toxicity, human exposure and 

environmental release of the PMN substances, based on the information currently available to the 

Agency. 

Human Health Effects and Fate Summary: EPA has concerns for potential incineration or other potential 

degradation products, byproducts, unreacted material, and low molecular weight species of the PMN 

substances. EPA also has concerns that the PMN polymeric substances themselves under some 

conditions of use-- particularly non-industrial, commercial, or consumer use-- could cause lung effects, 

based on limited data on some L J compounds. 

EPA has concerns for the potential degradation of these polymers and for the subsequent 

[: .]. The PMN substances degrade to~~- · ]. Based 

on information submitted to EPA during the PMN review period, these substances have some [ 

-l impurities. 

To further document the actual contamination and efforts to reduce impurity levels, the Company 

has agreed to limits in the starting materials and report the various fluorinated [ J impurities and 

[ l periodically. [ ] has reported the [ ] impurities and [ 

J in compliance with previous Consent Orders. [ -- · ·- -- t] no longer makes the L J products 
Vll 

at the same facilities as the PMN substances. EPA strongly encourages the continued effort to maintain 

these low levels of l 

there are no longer any l· 

' l impurities and to make improvements until 

l] in these products. 

Perfluorinated products may be released to the environment from incomplete incineration of the 

PMN substances at low temperatures. Preliminary evidence suggests that under some other conditions, 

the PMN substances could degrade in the environment. EPA has concerns that these degradation 

products will persist in the environment, could bioaccumulate or biomagnify, and could be toxic ("PBT") 

to people, wild mammals, and birds based on data on analog chemicals, including PFOA. The potential 

J degradants for these PMN substances include [ •]. 

The analog 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. Cancer may 

also be of concern. 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 

EPA-HQ-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). 

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

l. .]-derived polymers and other related substances; see the PMN docket for these specific PMNs. 

There are limited pharmacokinetics studies on [ "J in the rat and the monkey. These studies 
Vlll 

indicate that the serum half-life is less than 24 hours in monkeys, which is considerably less than the 

half-life ofPFOA in monkeys and humans. The half-life ofPFOA in monkeys is 20.9 days in female 

monkeys, 32.6 days in male monkeys, and 4.4 years in humans. These data and assessments support the 

assessment of reduced bioaccumulation of [ j relative to PFOA. 

In addition, EPA has reviewed a Combined Repeated-Dose Toxicity Study with 

Reproduction/Developmental Screening Test, (OECD 422) in rats for [ ] and the[· - 1

] 

conducted for another company and submitted to EPA. EPA's review of these subchronic and 

reproductive data on [. ~ and the [t 'J concluded that for _ ] no reproductive 

effects were seen at any dose. Dose levels were 50, 150, and 450/300 mg/kg/day (450 was reduced to 

300 in the study on day 4 because of toxicity). However, systemic effects-primarily liver effects-were 

seen. EPA's review places the No-Adverse Effect Level or NOAEL for [' , at 50 mg/kg/day. 

For the L j, the doses were 25, 75, and 225 mg/kg/day. For systemic effects, there 

was no NOAEL achieved with the Lowest-Adverse Effect level (LOAEL) at 25 mg/kg/day. For 

reproductive or developmental effects, the NOAEL is 75 mg/kg/day and LOAEL is 225 mg/kg/day. 

In 2006, another company submitted a 90-day oral repeated dose toxicity study (OECD 408) on 

_J. Dose levels for this study were 0 (vehicle control), 10, 50, and 200 mg/kg/day and were based 

on the previously described Combined Study (OECD 422). EPA's review sets the Lowest- Effect or 

Lowest-Adverse Effect Level (LOEL or LOAEL) at 10 mg/kg/day, based on the body weight gain being 

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

cell system (anemia) in males at 200 mg/kg/day. There was also increased peroxisomal beta oxidation 

activity at this dose level. Hepatotoxicity and peroxisomal beta oxidation activity have also been seen in 

studies on PFOA. The significance ofthe finding of a benign brain tumor (astrocytoma) in one male rat 
IX 

in the high dose group is not clear. It is not the type oftumor normally associated with PFOA-type 

compounds, is not a rare tumor, and may be incidental. Abnormal histopathology was observed in the 

testes (2 males) and epididymides (1 male) at 200 mg/kg/day and is a sign of concern for male 

reproductive toxicity. Further testing should investigate male reproductive effects. From this study, the 

potential for immunotoxic effects is low. There have been some studies showing immunotoxic effects 

from PFOA. Any investigation of immunotoxic effects should await the corroborative testing now being 

conducted by the EPA 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 in the study. 

Another 90-day study has been submitted to EPA on [ ]. EPA review of that study 

concluded that blood and liver effects were seen at the highest dose. This study had doses comparable 

with the other studies. 

Another 90-day study has been submitted to EPA on LJ ]. EPA review ofthat study concluded that 

blood and liver effects were seen at the highest dose. This study had doses comparable with the other 

studies. 

A one-generation reproduction/developmental toxicity study in mice on the 

] was submitted to the Agency. In this study, pregnant mice were 

administered the test substance via gavage during gestation days 6-18. The NOAEL for maternal toxicity 

was 175 mg/kg/day (the highest dose tested). Signs of developmental toxicity were observed at 175 

mg/kg/day on the postnatal day 1 and consisted of increases in the number of stillborn pups and pup 

deaths, reductions in the average pup body weight per litter with a pup with lenticular opacity. The 

NOAEL for developmental toxicty is 35 mg/kg/day. 
X 

A Chronic Toxicity, Carcinogenicity study was submitted in 2011. Doses were 2.5, 15, and 100 

mg/kg/day for males and 5, 30, and 200 mg/kg/day for females. EPA review determined that no chronic 

toxicity or carcinogenicity effects were seen in the two lower doses. Due to limitations in the study no 

determination could be made for the highest doses. 

These and other data to date also indicate a different and less toxic profile for I ], a 

potential environmental degradant ofthe PMN substances, than for PFOA. Based on: 1) the persistence 

of[' ], 2) potential intermediate fate products, and 3) the likelihood that these substances may be 

used as major substitutes for some uses ofPFOA, EPA believes that information is needed on the 

toxicity of [ 

properties of[~ 

] and possibly other environmental degradants, and on the fate and physical/chemical 

] and I ]-derived polymers in the environment. 

Additional relevant testing on analogous L , ] substances will be developed by the 

National Toxicology Program or NTP in the so-called Perfluoro Class Study. 

Environmental Effects Summary: EPA has a low concern for the intact PMNs substances P-13-

646,647,648,649, and 678 based on data on [ 

potential concern based on [- --

_]. For P-13-679, EPA has a 

]. EPA does not expect a significant environmental 

risk from any of the intact polymers. However, there is concern for possible environmental effects of 

the potential persistent degradation products of the PMN substances, including [ ], particularly in 

wild mammals and birds, and possibly to the reproductive capacity of other species. The analog PFOA is 

persistent in the environment and has a long bioretention time in various species. It has been detected in 

a number of wildlife species including marine mammals. It is toxic to mammalian and other species. 

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

EPA believes development of additional data is warranted. The Company has agreed to conduct, 
Xl 

and the Consent Order requires the Company to conduct, a Fish Full Life Cycle study test and a Fish 

Reproduction study on a salt of [ ]. 

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. EPA does not believe further thermal and simulated 

incineration testing is warranted for these polymers. 

Modified Zahn-Wellens biodegradation tests have been conducted on some related polymers. In 

addition, other fate tests have been conducted that show that analogous polymers degrade. EPA 

believes that additional data on the fate and transport of the PMN substances is warranted. EPA is 

requiring the Company to test the polymers in physical/chemical and environmental fate tests. 

Physical/Chemical Property Testing OPPTS or OECD Guideline 

Hydrolysis as a function of pH OCSPP 835.2130, OECD Ill 

Environmental Fate Testing OPPTS or OECD Guideline 

Modified Semi-Continuous Activated OCSPP 835.5045, OCSPP 835. 3210, 

Sludge (SCAS) or Zahn-Wellens with Analysis fdDECD 302A or OCSPP 835.3200, 

degradation products OECD 302B 

Indirect Photolysis Screening Test OPPTS 835.5270 

The fluorinated starting materials for the PMN substances will be imported. 

For processing of the PMN substances into a polymer, the PMN substance will be processed at 

t]. Presently, all releases are [ ']. Environmental 

release to air via incineration is expected. The PMN substances are [ · ] in solution and diuted/mixed 

down to [ ] in solution. These new chemicals are intended to be used in [ ] settings only. 

Use ofthe PMN substances: EPA expects that there is potential for dermal exposure to workers, 
xu 

but does not expect inhalation exposure to workers from processing or use at industrial sites. During use 

for P-13-646,647 678, EPA expects releases to air from incineration. During use for P-13-648,649, and 

679 [ ], the substances may be released to water, 

incineration, or landfill. EPA estimates that the substances could be used at [. · · · '] sites for [ ] 

days per year. 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis ofthe Consent Order: 

(a) EPA is unable to determine the potential for human health and environmental effects from exposure 

to the PMN substances 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 ofthe PMN substances and potential 

degradation products. 

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

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

EPA has concluded, pursuant to§ 5(e)(1)(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 substances and 

potential degradation products, EPA has further concluded, pursuant to § 5( e )(1 )(A)(ii)(II) of TSCA, that 

the PMN substances 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 
X111 

exposure to the substances and potential degradation products. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 

ENVIRONMENTAL EFFECTS 

Triggered Testing. The Order prohibits the Company from exceeding specified production 

volumes unless the Company submits the information described in the Testing section of this Order in 

accordance with the conditions specified in the Testing section. 

Pended Testing. The Order does not require submission of the following information at any 

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

distribution in commerce, use, and disposal ofthe PMN substances will remain in effect until the Order 

is modified or revoked by EPA based on submission of the following or other relevant information. 

1. Information on inhalation toxicology if the substances were to be sprayed by non-industrial, 

commercial or consumer applicants. This could include a 90-day inhalation study in rats with a 60-day 

holding period (OPPTS Guideline 870.3465 or OECD 413) or other relevant information. 

2. The following physical/chemical properties and fate and transport tests (also discussed 

previously in this preamble): 

Physical/Chemical Property Testing OPPTS or OECD Guideline 

UV visible absorption OPPTS 830.7050 

Environmental Fate Testing OPPTS or OECD Guideline 

Aerobic and Anaerobic transformations in OECD 308 

Aquatic Sediment Systems 

Direct Photolysis in Water OPPTS 835.2210 
XIV 

Phototransformation Chemicals on Soil Surface s OECD Jan. 2002 Draft 

Simulation test-Aerobic Sewage Treatment OECD 303A 

(Activated Sludge Units) 

Anaerobic biodegradability of organic OECD 311 

compounds in digested sludge 

Because ofthe physical/chemical properties ofthese substances, some modifications ofthe protocols 

may be necessary. These modifications will be agreed upon by EPA and the Company. 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

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

distribution in commerce, use and disposal of the following six chemical substances (the "PMN 

substances") in the United States by [ ] ("the Company"), except to the extent 

that those activities are exempted by paragraph (b). The six PMN substances subject to this 

Order are: l 

] P-13-646; I' 

] P13-647; 

.] P-13-648; 

Internet Address (URL) ·http://www epa gov 

Recycled/Recyclable • Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper 
2 

· :] P-13-649; 

. I P-13-678· , and 

J P-13-679. 

(b) Exemptions. Manufacturing of the PMN substances is exempt from the requirements of this Order 

(except the requirements in the Record keeping 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 record 

keeping as required in the Record keeping section of this Order. 

(1) Export. Until the Company begins commercial manufacture of the PMN substances for use in 

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

in commerce ofthe PMN substances solely for export in accordance with TSCA §12(a) and (b), 40 CFR 

720.3(s) and 40 CFR Part 707. However, once the Company begins to manufacture the PMN substances 

for use in the United States, no further activities by the Company involving the PMN substances are 

exempt as "solely for export" even if some amount of the PMN substances are later exported. At that 

point, the requirements of this Order apply to all activities associated with the PMN substances while in 

the territory of the United States. Prior to leaving U.S. territory, even those quantities or batches ofthe 

PMN substances 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 
3 

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

quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 720.3(cc), and 

40 CFR 720.36. The requirements of this Order also do not apply to manufacturing, processing, 

distribution in commerce, use and disposal of the PMN substances when manufactured solely for noncommercial research and development per 40 CFR 720.30(i) and TSCA §5(i). 

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

are produced, without separate commercial intent, only as a "byproduct" as defined at 40 CFR 720.3(d) 

and in compliance with 40 CFR 720.30(g). 

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

substances when they are manufactured, pursuant to any of the exemptions in 40 CFR 720.30(h), with no 

commercial purJ,ose separate from the substance, mixture, or article of which they are a part. 

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

they are imported as part of an "article" as defined at 40 CFR 720.3(c) and in compliance with 40 CFR 

720.22(b )(1 ). 

(c) Automatic Sunset. If the Company has obtained for the PMN substances a Test Market Exemption 

(TME) under TSCA §5(h)(l) and 40 CFR 720.38 or a Low Volume Exemption (LVE) or Low Release 

and Exposure Exemption (LoREX) under TSCA §5(h)(4) and 40 CFR 723.50(c)(l) and (2) respectively, 

any such exemption is automatically rendered null and void as ofthe effective date of this Consent Order. 

II. TERMS OF MANUFACTURE, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 
4 

PROHIBITION 

The Company is prohibited from manufacturing the PMN substances in the United States, for any 

nonexempt commercial purpose, pending the development of information necessary for a reasoned 

evaluation ofthe human health and environmental effects ofthe substances, and the completion of EPA's 

review of, and regulatory action based on, that information, except in accordance with the conditions 

described in this Order. 

CHEMICAL SYNTHESIS AND COMPOSITION 

(a) Restriction. The Company shall not manufacture the PMN substances, P-13-646, 647,648, 649, 678, 

and 679 unless the I ] starting material and the [ 

] intermediate material is in compliance with and does not exceed the 

limits specified in Table 1 and Table 2. The Company shall analyze the products containing the PMN 

substances for the analytes specified in Table 3 upon initial commencement of manufacture, and for any 

of the PMN substances manufactured since the last required analysis at least annually analyze and report 

thereafter, until one year after the date of the last joint manufacture or processing of a product that 

contains ~ j products at the facility. The Company shall report annually to the Agency the 

levels of impurities [' ·1 associated with the PMN 

substances, P-13-646,647,648,649,678, and 679 manufactured by the Company, as specified below. For 

routine analysis, the Company shall analyze the starting material, [, 1 for the following 

analytes shown in Table 1 below: l 

quarterly analyze the intermediate material, l 

J, for the analyte [ 

below. The Company shall make its best effort to minimize[: 

. ]. The Company will also 

,] shown in Table 2, 
5 

] and to seek to eliminate them. 

(b) Analysis and Reporting. The Company shall analyze representative samples of products containing 

the PMN substances, P-13-646, 647, 648, 649, 678, and 679 manufactured by the Company to determine 

compliance with the requirements in paragraph (a). The Company shall also analyze the products 

containing the PMN substances at each manufacturing facility both (1) at the initial commencement of 

non-exempt manufacture of the PMN substances at that facility, and (2) at least annually thereafter during 

every year in which the PMN substances are manufactured at that facility or imported. If any new facility 

of manufacture is added or if the process of manufacture of the PMN substances are significantly altered, 

then the products containing the PMN substances or corresponding products containing the PMN 

substances must be analyzed at commencement, and annually thereafter as set forth above. If the PMN 

substances are imported, the Company shall obtain from the foreign manufacturer written documentation 

to certify that representative samples of the imported form of the PMN substance or corresponding 

products containing the PMN substance have been analyzed, consistent with the requirements of this 

paragraph (b), and determined to comply with the requirements of paragraph (a). The Company shall 

report the above analysis to EPA at initial commencement of manufacture and again if any new 

manufacturing facility is added or if the 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 annually, in a cycle complementary to the [ J. In 

addition to the reporting for the products containing the PMN substances themselves, the Company shall, 

for the r· 1 starting material, annually report (1) the average values and the range of values, 

including outlying data, for the routine analysis for the analytes specified in Table 1 and (2) the results of 

the quarterly analyses for the analyte specified in Table 2. 
6 

TABLE 1: 

TO BE ROUTINELY ANALYZED IN [ ] STARTING MATERIAL 

Analyte CAS Number 

[i [ ] 

. J 

[ - - -- - l r ] 

I ] [ ] 

TABLE2: 

TO BE ANALYZED AT LEAST QUARTERLY IN[. 

] 

MATERIAL 

I ~naJyte I CASNumber 

. J [ J 

TABLE 3: 

Limit in [ .J 

[' l minimum 

I ] (combined) 

']INTERMEDIATE 

] 

I ~imit in [ ] 

TO BE ROUTINELY ANALYZED AT START-UP AND AT LEAST ANNUALLY THEREAFTER 

IN THE PMN SUBSTANCES OR PRODUCTS CONTAINING THE PMN 

SUBSTANCES 

Limit inC . 

-

Analyte CAS Number ] 

l ] [. ] l 

[ ] [· -- ... ] .. 

] 

[ [ ] r .. ----- -----------

l 

] 

MANUFACTURING 

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

substances by any other person. 
7 

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

final significant new use rule ("SNUR") governing the PMN substances 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 ofthe SNUR. Ifthe 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 ofSNUR. When EPA promulgates a final SNUR for the PMN substances 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 substances of the 

existence of the SNUR. 

(b) Contract Manufacturer. Notwithstanding paragraph (a), the Company may cause a "Contract 

Manufacturer" outside the Company to manufacture or import the PMN substances according to the 

following conditions: 

(1) The Contract Manufacturer must be under contract to the Company to manufacture the PMN 

substances solely for the Company. The contract must specify the identity of the PMN substances, 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 signed copy of the Consent 

Order for Contract Manufacturer (to be 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 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 
8 

any of the conditions specified in the Consent Order for Contract manufacturer, the Company shall 

im~ediately cease to cause the Contract Manufacturer to manufacture of the PMN substances, unless the 

Contract Manufacturer is in compliance with a SNUR for the PMN substances, 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 any of 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 of the 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 

the PMN substances, shall notify EPA ofthe failure to comply, and shall resume causing the Contract 

Manufacturer to manufacture or import the PMN substances only upon written notification from the 

Agency. 

TESTING 

(a) Section 8(e) Reporting. Reports of information on the PMN substances which reasonably supports 

the conclusion that the PMN substances present a substantial risk of injury to health or the environment, 

which is required to be reported under TSCA section 8( e) shall reference the appropriate PMN 
9 

identification number for these substances and contain a statement that the substance is subject to this 

Consent Order. Additional information regarding section 8( e) reporting requirements can be found at 

www.epa.gov/oppt/tsca8e. 

(b) Notice of Study Scheduling. The Company shall notify, in writing, the EPA Monitoring Assistance 

and Media Programs Division (2227A), Office ofEnforcement and Compliance Assurance, U.S. 

Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, ofthe 

following information within 10 days of scheduling any study required to be performed pursuant to this 

Order, or within 15 days after the effective date of this Order, whichever is later: 

(1) The date when the study is scheduled to commence; 

(2) The name and address of the laboratory which will conduct the study; 

(3) The name and telephone number of a person at the Company or the laboratory whom EPA 

may contact regarding the study; and, 

( 4) The appropriate PMN identification number for each substance and a statement that the 

substance is subject to this Consent Order. 

The written notice should be submitted to EPA as follows: 

Postal Mail Address 

U.S. Environmental Protection Agency 

GLP Section Chief- Pesticides, Water and Toxics Branch 

Monitoring Assistance and Media Programs Division (2227 A) 

Office of Enforcement and Compliance Assurance 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 
10 

Courier Delivery Address 

U.S. Environmental Protection Agency 

GLP Section Chief- Pesticides, Water and Toxics Branch 

Monitoring Assistance and Media Programs Division (2227 A) 

Office of Enforcement and Compliance Assurance 

Room 7117B 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20004 

(c) Good Laboratory Practice Standards and Test Protocols. Each study performed to address the risks 

identified in this Order must be conducted according to TSCA Good Laboratory Practice Standards at 40 

CFR Part 792 and using methodologies generally accepted in the relevant scientific community at the 

time the study is initiated. Before starting to conduct any study that will use a modified version of a 

published test guideline, the Company must submit written test protocols to EPA for review (submission ( 

of written test protocols is optional for tests that are to be conducted using unmodified published test 

guidelines). Protocols must be submitted as a support document for the PMN, using the procedures set 

out in 40 CFR 720.40. EPA will respond to the Company within 4 weeks of receiving the written 

protocols. EPA review of a test protocol does not mean pre-acceptance of test results. 

(d) Triggered Testing Requirements. (i) The Company is prohibited from manufacturing or causing 

another person (including a Contract Manufacturer) to manufacture of the six PMN substances P-13-

646, 647, 648, 649, 678, and 679 beyond the aggregate production volumes as specified below. 
Production Volume 

] kgs 

] kgs 

Tier 3 

[. · · '] kgs 

11 

Modified SCAS for Insoluble and Volatile 

Chemicals, with analysis for degradation products 

or Zahn-Wellens inherent biodegradation 

test, w/analysis for degradation products 

Guidelines 

OPPTS 835.5045, OECD 

302A 

OPPTS 835.3200, 

OECD 302B 

Hydrolysis as a Function of pH and temperature OECD 111, 

OPPTS 835.2130 

Indirect Photolysis OPPTS 835.5270 

Fish Life-Cycle Toxicity OPPTS 850.1500 

Fish Short-Term Reproduction Assay OECD 229,0PPTS 890.1350 

(ii) The test substances for the Physical/Chemical and fate tests shall be the PMN substances 

P-13-649 and P-13-679. The test substance for the ecotoxicity fish studies shall be [ 

] . Chemical composition of the test substance shall be verified and a certificate 

of analysis submitted .. 

(iii) Chemical composition of the test substance must be fully characterized. For polymers, 

characterization includes all information required on pages 5 and 6 ofthe PMN form (i.e. EPA Form 

771 0-25), except that data on residuals are only required for fluorinated substances. Although EPA 

understands that complete mass balance may not be achievable for the specified analytes, the Company 

shall attempt mass balance to the greatest extent practicable. EPA prefers that the Company test the 

commercial substance. 

(iv) The Company must test for the following analytes in the Biodegradation Test OECD 302A, 

and OECD 302B) : I 
12 

(v) Because the environmental fate pathway for photolysis may be different than for 

biodegradation, the Company must test for the following analytes in the photolysis test: identify the 

major fluorinated fragments and volatiles including: [ _ 

]. 

(vi) For the hydrolysis test, the company must test for the analyte, 

(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in a 

scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of each study; 

and (3) submit (with an additional sanitized copy, if confidential business information is involved), the 

final report of each study and all underlying data ("the report and data") to EPA prior to exceeding the 

applicable production limit. The final report and data must be submitted as a support document for the 

PMN substances, using the procedure set out in 40 CFR 720.40. The final report shall contain the 

contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with 

the applicable "Reporting", "Data and Reporting", and "Test Report" subparagraphs in the applicable test 

guidelines. However, for purposes of this Consent Order, the word "should" in those subparagraphs 

shall be interpreted to mean "shall" to make clear that the submission of such information is mandatory. 

EPA will require the submission of raw data such as slides and laboratory notebooks only if EPA finds, 

on the basis of professional judgment, that an adequate evaluation of the study cannot take place in the 

absence of these items. 
13 

(f) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) of this 

Testing section if notified in writing by EPA that it is unnecessary to conduct that study. 

(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal, the 

Company may continue to manufacture and import the PMN substances beyond the applicable 

production limit. To seek relief from any other restrictions of this Order, the Company may make a 

second attempt to obtain unequivocal data by reconducting the study under the conditions specified in 

paragraphs (b), (c), and (e)(l) and (2). The testing requirements may be modified, as necessary to permit 

a reasoned evaluation ofthe risks presented by the PMN substances, only by mutual consent ofEPA and 

the Company. 

(h) EPA Determination of Invalid Data. 

(1) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA's receipt of a test 

report and data, the Company receives written notice that EPA finds that the data generated by a study 

are scientifically invalid, the Company is prohibited from further manufacture of the PMN substances 

beyond the applicable production limit. 

(2) The Company may continue to manufacture and import the PMN substances beyond the 

applicable production limit only if so notified, in writing, by EPA in response to the Company's 

compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii). 

(i) If there is sufficient time to reconduct the study in compliance with paragraphs (b), (c), 

and (e) before exceeding the production limit specified in paragraph (d), the Company may recondut the 

study. Ifthere is insufficient time to recondut the study in compliance with paragraphs (b), (c), and (e) 

before exceeding the production limit specified in paragraph (d), the Company may exceed the 
14 

production limit, but must otherwise comply with paragraphs (b), (c) and (e), and shall submit the report 

and data to EPA with a reasonable period oftime, all as specified by EPA in the notice described in 

subparagraph (h)(l ). EPA will respond to the Company, in writing, within 6 weeks of receiving the 

Company's report and data. 

(ii) The Company may, within 4 weeks of receiving from EPA the notice described in 

subparagraph (h)(l ), submit to EPA a written report refuting EPA's finding. EPA will respond to the 

Company, in writing, within 4 weeks of receiving the Company's report. 

(i) Company Determination oflnvalid Data. 

(1) Except as described in subparagraph (i)(2), if the Company becomes aware that 

circumstances clearly beyond the control of the Company or laboratory will prevent, or have prevented, 

development of scientifically valid data under the conditions specified in paragraphs (c) and (e), the 

Company remains prohibited from further manufacture and import of the PMN substances beyond the 

applicable production limit. 

(2) The Company may submit to EPA, within 2 weeks of first becoming aware of such 

circumstances, a written statement explaining why circumstances clearly beyond the control of the 

Company or laboratory will cause or have caused development of scientifically invalid data. EPA will 

notifY the Company of its response, in writing, within 4 weeks of receiving the Company's report. EPA's 

written response may either: 

(i) allow the Company to continue to manufacture and import the PMN substances 

beyond the applicable production limit, or 

(ii) require the Company to continue to conduct, or to reconduct, the study in compliance 

with paragraphs (b), (c), and (e)(l) and (2). If there is sufficient time to conduct ot reconduct the study 
15 

and submit the report and data to EPA at least 14 weeks before exceeding the production limit as 

required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). If there is 

insufficient time for the Company to comply with subparagraph (e)(3), the Company may exceed the 

production limit and shall submit the report and data in triplicate to EPA within a reasonable period of 

time, all as specified by EPA in the notice described in subparagraph (i)(2). EPA will respond to the 

Company, in writing, within 6 weeks of receiving the Company's report and data, as to whether the 

Company may continue to manufacture beyond the applicable production limit. 

G) Unreasonable Risk. 

(1) EPA may notifY the Company in writing that EPA finds that the data generated by a study are 

scientifically valid and unequivocal and indicate that, despite the terms of this Order, the PMN 

substances will or may present an unreasonable risk of injury to human health or the environment. 

EPA's notice may specifY that the Company undertake certain actions concerning further testing, 

manufacture, processing, distribution, use and/or disposal of the PMN substances to mitigate exposures 

to or to better characterize the risks presented by the PMN substances. Within 2 weeks from receipt of 

such a notice, the Company must cease all manufacture, import, processing, distribution, use and 

disposal of the PMN substances, unless either: 

(A) within 2 weeks from receipt of the notice, the Company complies with such requirements as 

EPA's notice specifies; or 

(B) within 4 weeks from receipt ofthe notice, the Company submits to EPA a written report 

refuting EPA's finding and/or the appropriateness of any additional requirements imposed by EPA. The 

Company may continue to manufacture, process, distribute, use and dispose of the PMN substances in 

accordance with the terms ofthis Order pending EPA's response to the Company's written report. EPA 
16 

will respond to the Company, in writing, within 4 weeks of receiving the Company's report. Within 2 

weeks of receipt of EPA's written response, the Company shall comply with any requirements imposed 

by EPA's response or cease all manufacture, processing, distribution, use and disposal ofthe PMN 

substances. · 

(k) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing section, 

the Company must continue to obey all the terms of this Consent Order until otherwise notified in 

writing by EPA. The Company may, based upon submitted test data or other relevant information, 

petition EPA to modify or revoke provisions of this Consent Order pursuant to Part IV. of this Consent 

Order. 

RISK NOTIFICATION 

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

any of the PMN substances may present a risk of injury to human health or the environment (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 those PMN substances, 

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 substances are not being manufactured, processed, or used in the 

Company's workplace, the Company must add the new information to an MSDS before the PMN 

substances are reintroduced into the workplace. 

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

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

or who have received the PMN substances from the Company within 5 years from the date the Company 
17 

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. 

III. 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 substances did in fact qualify for any one 

or more of the exemptions described in Section I, 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 substances eligible for the Export exemption in 

Section I, Paragraph (b)(l) ofthis 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 12(a)(l)(B) and 12(b), respectively. Any amounts 

or batches of the PMN substances eligible for the Research and Development exemption in Section I, 

Paragraph (b)(2) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe 

Company maintains, for 5 years from the date of their creation, the records required by 40 CFR 

720.78(b). For any amounts or batches of the PMN substances claimed to be eligible for any other 

exemption described in Section I, Paragraph (b) ofthis Order, the Company shall keep record~ 

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

below, but is exempt from the other record keeping requirements in this Record keeping section; 

(2) Records documenting compliance with the Chemical Synthesis and Composition section of 
18 

this Order, including the results from analyzing representative samples of these substances. 

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

the corresponding dates of manufacture and import; 

(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 substances, 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 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 substances 

are manufactured, imported, processed, or used. 

(b) Applicability. The provisions of this Recordkeeping section are applicable only to activities of the 

Company and its Contract Manufacturer, if applicable, and not to activities ofthe Company's customers. 

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CPR Part 1320, 

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

unless 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 Orders has been approved under currently valid OMB Control Number 2070-0012. 
19 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

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

ocassionally conduct on-site compliance inspections of Company facilities and conveyances associated 

with the PMN substances. 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 may include, but are not 

limited to, the following: 

(i) Expected dates and times when the PMN substances will be in production within the 

subsequent 12 months; 

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

PMN substances and may reasonably be exposed to the PMN substances; 

(iii) Current job titles or categories for workers who are involved in activities associated with the 

PMN substances and may reasonably be exposed to the PMN substances; 

(iv) Existing exposure monitoring data for workers who are involved in activities associated with 

the PMN substances and may reasonably be exposed to the PMN substances; 

(v) Records required by the Record keeping section of this Order; and/or 

(vi) 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 known to or 

reasonably ascertainable to the Company at the time of the request, the Company's response shall 
20 

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 

this Order may be transferred when the Company transfers its interests in the PMN substances, including 

the right to manufacture the PMN substances, 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 

substances from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit new 

PMNs to EPA and comply fully with Section 5(a)(1) 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 of this Order and shall not be 

required to submit new PMN s to EPA. 
21 

(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 substances, 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 substances, such as a licensee who has acquired a limited license to the patent 

or manufacturing rights associated with the PMN substances. A Successor in Interest must be 

incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(3). 

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

substances, including the right to manufacture the PMN substances, from the Company to the Successor 

in Interest. 

(d) Notices. 

(1) 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 C to this Order. 

(2) Notice to EPA. Within 10 business days ofthe 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. 

(3) Transfer Document. Copies ofthe Transfer Document must be maintained by the Successor 

in Interest at its principal place of business, and at all sites where the PMN substances are manufactured 
22 

or imported. Copies of the Transfer Document must also be made available for inspection pursuant to 

Section 11 ofTSCA, must state the effective date and time of transfer, and must contain provisions 

which expressly transfer liability for the PMN substances under the terms of this 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 and time of the transfer described above. 

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

effective as ofthe date and time oftransfer. 

(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 substances pursuant to the terms of this Consent Order. 

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

Consent Order requires the Company to submit test data to EPA at a specified production volume ("test 

trigger"), the aggregate volume of the PMN substances manufactured and imported by the Company up 

to the date of transfer shall count towards the test trigger applicable to the Successor in Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Company may petition EPA at any time, based upon new information on the health effects 

of, or human exposure to, the PMN substances, to modify or revoke substantive provisions of this Order. 
23 

The exposures and risks identified by EPA during its review of the PMN substances 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 substances. 

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. 
24 

VII. EFFECT OF CONSENT ORDER 

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

this Order pursuant to section S(e)(l)(C) offSCA, to receive service ofthis 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) CBI 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 offSCA, 40 CPR Part 720 Subpart E, and 40 CPR 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. 

~J ~ ?)!)~ D e \ ' 

Chemical Control Division 

Office of Pollution Prevention and Taxies 

Date Name: L 

Title: [ 

Company: [ · · . . - . 1 

J 

J 

-

l 
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 International Union of Pure and Applied 

Chemistry or 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. 

"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 than 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 

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

Consent Order and in the Consent Order for Contract Manufacturer. 

"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 labelled 

container. 
2 

"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 

mr may occur. 

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

mixtures are manufactured, imported, or processed. 

"PMN substance" means the chemical substance (see TSCA s. 3(2)) described in the 

Premanufacture notice submitted by the Company relevant to this Order. 

"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. 

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

work areas. 
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) 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 of the 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) ofthe Toxic 

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

2. Assumption of Liability. The Successor in Interest hereby certifies that, as ofthe 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 

720.22(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. 
2 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

Company (Transferor) 

Signature of Authorized Official 

NOTICE OF TRANSFER 

(continued) 

PMNNumber 

Date 

Printed N arne 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 
3 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone