[ 

March 13, 2015 

U.S. Environmental Protection Agency 

Office of Pollution Prevention and Taxies 

Confidential Business Information Center (CBIC)- TS7407M 

EPA East Building, Room 6428 

1201 Constitution Avenue, NW 

Washington, DC 20004-3302 

Dear Sir of Madam: 

Reference: Consolidated PMN P-12 04SO and P-12-0451 [( 

Consent Order 

EPA SANITIZED 

Please find enclosed the above-identified Consent Order executed on behalf of I 

] or the Company). 

We very much appreciate the time and resources that the Environmental Protection Agency (EPA 

or the Agency) devoted to timely negotiating the Consent Order with[· ·]. We do wish to 

emphasize that the negotiations focused on the binding requirements in the Consent Order 

section of the document and that the language in the non-binding Preamble section, particularly 

that which reflects EPA's assessments and conclusions, was not negotiated. To that end, it is 

reiterated that, as stated in Section VII of the Consent Order section, consenting to the entry of 

the Order and agreeing to be bound by its terms does not constitute an admission by the 

Company as to the facts or conclusions underlying the Agency's determinations in· this matter. 

Again, we thank the Agency for the time and effort it expended to finalize the Consent Order and 

we look forward to its successful implementation. 

Very truly yours, 

[ 

Via Federa] Express 

Enclosure: 

l 

J 
'• 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

. OFFICE OF POLLUTION PREVENTION AND TOXICS 

03mJJ.fAa~~ULATION OF NEW CHEMICAL SUBSTANCES 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) Premanufacture Notice Numbers: 

) 

) 

) 

) 

) 

[' "] ) P-12-450 and 451 

) 

) 

) 

) 

) 

Consent Order and Determinations Supporting Consent Order 
II 

TABLE OF CONTENTS 

.Preamble 

I. Introduction 

II. Summary of Terms ofthe Order 

III. Contents of PMN s 

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 
'iii 

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 premanufacture notices ("PMNs") P-12-450 and 451 for the chemical 

substances P-12-450-[_ )-

]and P-12-451-{: 

J submitted by [ 

] ("the Company"), to take effect upon expiration of the 

PMN review period. The Company submitted the PMNs to EPA pursuant to§ 5(a)(l) ofTSCA 

and 40 CFR Part 720. 

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

provision of§ 5 or any order issued under§ 5. Violat~rs 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 two PMN substances requires the Company to: 

(a) submit to EPA certain tiered environmental fate and physical/chemical testing on a 

representative PMN substance, P-09-245. For Tier 1 testing, it must be submitted on the 
lV 

schedule established for Consent Order P-09-245 and 246 and for Tiers 2 and 3 at least 14 weeks 

before manufacturing (including impmi) a total of [ ] kilograms (kgs) and [ ] 

kgs ofthe four PMN substances, P-09-245 and 246 and P-12-450 and 451; 

(b) analyze and report to EPA [ ] * impurities; 

(c) not exceed the maximum established levels of [ ] impurities; and 

(d) maintain certain records. 

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

requirements in this Order to ·an identified Contract Manufacturet, the Company inay use a 

Contract Manufacturer in the future, if a modification ofthis Order to add a Consent Order for a 

Contract Manufacturer is approved and signed by EPA and signed by the Contract Manufacturer. 

This Consent Order establishes the requirements for the Company if a Contract Manufacturer 

manufactures the PMN substances. Prior to using a Contract Manufacturer, the Company must 

submit to EPA the Contract Manufacturer identity and other m::t.nufacturing process, and 

exposure, and release information concerning the Contract Manufacturer. The Contract 

Manufacturer would be required to keep records of quantities manufactured, but the Company 

must submit to EPA the required testing. 

Ill. CONTENTS OF PMNS 

By signing this Order, the Company represents that it has carefully revie"Wed this 

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

*As used in both the Preamble and Consent Order ofthis document, the terms[. .J 

mean I ] 
v 

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 infom1ation contained within the brackets. 

identity, specific chemical identity, production volumes, manufacturing process, processing, and 

use information, and other information. 

Chemical Identities: 

Specific: P-12-450-- [ 

] and P:-12-451--1 

1 

Generic: Partially fluorinated alcohol, reaction products with phosporus oxide (P205) amine salts 

Use: Specific: [ 

Generic use: Coating additive, surface active agent 

Maximum 12-Month Production Volume: [ ] kgs 

(many acronyms are subsequently explained more fully in section IV below where the. results of 

the studies are discussed): Local Lymph Node Assay; Skin irritation, Eye irritation, Oral LDSO 

(rat); Bacterial Reverse· Mutation, Chromosome Aberration in Mammalian Cells; Acute 
Vl 

Inhalation Toxicity; Biopersistence and pharmacokinetic Screen (rat); 7-day repeated dose oral 

gavage (rat); Daphnia Screen; 48-hr Daphnia EC 50; 21-day Daphnia Chronic study; 96-hr Algae 

Growth InhibitionTrout LC50; 2 Algal Screens; 96-hr Algae Growth Inhibition; Ready 

Biodegradability; Activated Sludge Respiration Inhibition; Flash Point; Adsorption/Desorption; 

Auto Ignition Temperature; Melting Point; Flash point (Flammability, Solids); Octanol/Water 

Partition Coefficient; Relative Density Surface Tension; Appearance of Substance; Boiling Point 

Vapor Pressure; and Water Solubility. 

Toxicity Studies on l. . j. . . 

J-lls6o l J-24748: r- - ] Screening 1 0-Dose Oral Gavage Study in 

R::~ts; 

[: ]-18510 [ ]: Repeated Dose Oral Toxicity Two-Week 

Gavage Study 3 volumes; Repeated dose, 90-day Study with Reproductive Screen 

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 

decomposition products of the PMN substances. EPA also has concerns for the PMN substances 

that under some conditions of use-- particularly non-industrial, commercial, or consumer use--

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

required the Company to perform an Acute Inhalation study before manufacture to test whether 

these substances caused lung effects. An Acute Inhalation study in rats on a formulation of P-
vii 

11-91 was conducted over a 4-hour exposure period. The doses for the study were 1.2 and 2.0 

mg/L. No deaths were seen at these concentrations. The approximate lethal concentration 

(ALC) was estimated to be greater than 2.0 mg/L (2000 mg/m3). The ALC is consistent with a 

low concern for acute inhalation toxicity. 

EPA expects that the PMN substances will degrade based on [other perfluorinated 

acids]. The PMN substances may degrade to [1 ] 

Based on information submitted to EPA during the PMN review period, the PMN substances 

have[< '], EPA has·agreed that -

for routine analysis, the Company may analyze the starting material, the[· 

following analytes: I 

] for the 

the starting material, [ 

] . The Company will also annually analyze 

J for perfluorooctanoic acid (PFOA), including establishing 

calibration curves where the LOQ is [ . J. However, at initial manufacture and at least 

annually thereafter, the Company has agreed to analyze representative samples of the "Initially 

Isolated Formulations"ofthe final formulation of the PMN substances. "Initially Isolated 

Formulations" is defined in the Definitions section of this Consent Order (Attachment A). 

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

impurities [ ]. During commercial production, 

these impurities are produced partly by ( ~ 

The Company has agreed to seek ways to minimjze these impurities. The 

Company, in consultation with EPA, has agreed to [ 
viii 

] . The Company is also 

evaluating other chemical management steps, which include I 

]. To further document and control the actual 

contamination and efforts to reduce the impurity levels, the Company will limit the maximum 

impurity levels in the starting material, [1 ] not to exceed the currently attainable 

levels (see Tables I and 2 in the Chemical Synthesis and Composition section of the attached 

Consent Order), a:nd will report the various impurities [ 

] annually. 

EPA is concerned that these perfluorinated degradation products may be released to the 

environment from incomplete incineration of the PMN substances at low temperatures. EPA has 

preliminary evidence, including data on other [ ] , that suggest~ that, under 

some 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 and I ]. The presumed perfluorinated 

degradants for these PMN substances include [ .]. There is limited toxicological data in 

animals on I ] or precursors, which is summarized below. 

PFOA is expected to persist for years in the enyironment. Biodegradatiqn 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 
ix 

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 OPPT-2003-0012. Additional information about PFOA, J, 

and other perfluorinated substances may also be found in the Administrative Record for P FOS, 

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 request to oppt.ncic@epa.gov. 

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

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

PMNs. A pharmacokinetics study on [ .] and for comparison perfluorobutane sulfonate 

(PFBS) in the cynomolgus monkey was submitted previously. This study indicates that the . . 

serum half-life of I · ] in these monkeys is less than 24 hours, whereas the half-life of 

PFOA in monkeys is 20.9 days in female monkeys, 32.6 days in male monkeys, and 3.8 years in 

humans. Another company also conducted a pharmacokinetics study on [ ] in rats that 

showed a serum half-life of one hour or less. These data and assessments support the 

assessment of reduced bioaccumulation of [ ] relative to PFOA. 

The Company subject to this Consent Order has conducted a 90..:day study with a 

reproductive screen on [ ]. Dose levels for this study were 0, 20, 100, 

and 500 mg/kg/day. EPA received this study at the end of .July 2007. EPA review ofthis study 

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

systemic effects. There were num~rous effects at 100 and 500 mg/kg/day on nasal tissue, liver, 

and thyroid, and at 500 mg/kg/day on body weight, the red blood cell system, clotting, and the 

kidney. The EPA reviewer concluded that although not clearly dose related, the elevation oftwo 

markers for liver toxicity across all treated groups of males in clinical chemistry, and the finding 

of 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"foxicity study component of this study, the 

reproductive toxicity NOAEL is 500 mg/kg/day (the highest dose tested). The systemic toxicity 

NOAEL for P1 rats was 20 mg/kg/day based on decreased body weights/body weight gains at 

100 and 500 mg/kg/day. The systemic toxicity NOAEL for Fl adults is 100 mg/kg/day based on 

reduced body weights/body weight gains and reduced food consumption at 500 mg/kg/day. The 

developmental toxicity NOAEL for F1 pups was 1 qo mg/kg/day based on decreased pup weights 

at 500 mg/kg/day. The rats (PI generation; 20/sex/group) were administered gavage doses ofO, 

20, 100 or 500 mg/kg/day for 70 days pre-mating, and then mated for a maximum of 2 weeks to 

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

In addition, in 2005, another company conducted a Combined Repeated-Dose Toxicity 

Study with Reproduction/Developmental Screening Test, (OECD 422) in rats for [ ] and 

the [ 

the r· 

]. The EPA review ofthese subchronic and reproductive data on(: .] and 

,] concluded that for [ ] nq 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 review 
xi 

places the NOAEL for [ ] at 50 mg/kg/day. For the [ ], the doses were 25, 

75, and 225 mg/kg/day. For systemic effects, no NOAEL was achieved with the LowestObserved Adverse Effect Level (LOAEL) at 25 mg/kg/day. For reproductive or developmental 

effects, the NOAEL is 75 mg/kg/day and the LOAEL is 225 mglkg/day. 

In 2006, another company submitted a 90-day Oral Repeated Dose Toxicity Study 

(OECD 408) for I ] . Dose levels for this study were 0 (vehicle control), 10, 50, or 200 

mg/kg/day and were based on the previous Combined Study (OECD 422). EPA review set the 

- Lowest- Effect Level (LOEL) or LOAEL at 10 mg/kg/day, based on the boay weight gain bei-ng 

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 mglkg/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 in 

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

compounds, is not a rare tumor, ~nd 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 EPA~ Office of Research an(i Development. There 

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

func'tional observation battery or motor behavior. 
.. Xll 

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 

comparable doses 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 6fincreases 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. 

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 indicate a different and less toxic profile for I ] (a presumed 

environmental degradant ofthe PMN substances) than for PFOA. However, based on: (1) the 

persistence of l ]; (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 I ] and possibly other 

environmental degradants, and the fate and physical/chemical properties of [ .]-derived or 

related polymers in the environment. 
xiii 

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

] in animals is warranted. To this end, the Company has conducted a 90-day Repeated 

Dose Study With Reproductive Screen. EPA expects that a modified reproductive test (OECD 

421 ~modified) will be conducted by another company. The modifications for the reproductive . . 

test include: (1) increase the parental sample size to 20; (2) the duration ofthe 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 mitil they reach sexual maturation; 

(5) pup body weight should be recorded on lactation 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 matuation should be recorded (i.e. vaginal opening and preputial 

~eparation). 

EPA may still seek additional avian reproduction testing (OECD 206) in mallard 

ducks and Life-Cycle testing in fish. In addition, comparative data, especially on the 

pharmacokinetics of [ ] and other perfluorinated substances will be developed by testing 

of the National Toxicology Program (NTP) in the so-called Perfluorinated Compounds Class 

Study. 

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

highly persistent. Durin~ the review period, the Company provided acute fish (rainbow trout), 

aquatic invertebrate (Daphnia magna), and algae (Pseudokirchneriella subcapitata) toxicity 
xiv 

studies on a formulation [ ] containing P-12-450. The t~sts were acceptable. Two 

additional algal "range-finding" tests were conducted on two different fonnulations ofP-12-

450 ]. 

For fish, the semi-static 96-hour test with nominal concentration of 0 (dilution water 

control), 7.5, 15, 30, 60, and 120 mg a.i./L total solids with one renewal after 48 hours. The 

96-hour LC50 was > 1 02 mg/L (mean-measured value). 

Green algae at a nominal cell desity of 10,000 cell/ml, were exposed to the test 

.substance.at nominal concentrations ofO (blind control), 1.48, 4.44, 13.3, 40.0, and 120.mg 

total solids/L. The 96-hour EC50 for biomass, growth rate, and yield was > 105 mg/L. The 

NOEC was 34.3 mg/L, the LOEC 105 mg/L and the chronic value was 60.0 mg/L 

From the submitted test data, the updated acute Concentration of Concern (COC) for 

both P-12-450 and 451 is 20,000 ppb. Based on fish and aquatic invertebrate acute to chronic 

ratios (ACR) of 10, the chronic values were 10 mg/L The assessment factor of 10 yields 1.0 

mg/L or 1000 ppb. This indicates a low ecological toxicity hazard for P-1 2-450 and 451. 

Also, [- - 1 conducted a 21-day Daphnid chronic toxicity test. This test resulted in 

no statistically significant adverse effects at the hightest test concentration. From the 

acceptable 21-day Daphnid chronic toxicity test data and the previous data the COCs remain at 

20,000 ppb (acute) and 1,000 ppb (chronic) which indicates a low ecological hazard. There 

may be a high degree'ofuncertainty for fish since the chronic COC is based on acute data and 

chronic fish testing (fish early life stage testing) could be warranted. This testing is "pended'' 

in the Consent Order. 
XV 

Some ecotoxicity data on I > has been submitted to EPA including an Avian 

Reproduction Test in Bobwhite quail. EPA received the Avian Reproduction test on I .] 

in 2011. The test was conducted according to OPPTS 850.2300, OECD 206, and FIFRA 

Subdivision E, Section 71-4 guidelines and under GLP conditi~ms. Results showed no adverse 

effects in adult northem bobwhite quail exposed to 1,000 ppin, 5,000 ppm or 10,000 ppm for 

body weight, feed consumption, or reproductive parameters. In addition, no effects were 

observed in the offspring of the exposed adults. The NOEC is 10,000 ppm or 964 mg/kg/day. 

Although the original test reco·mmendations included analysis for ofthe livers ofthe 

adult birds as well as the blood and livers of the offspring for the presence of , the fact 

that ~he analysis was not performed did not alter the validation of the study considering the lack 

of effects seen in adult tissue at necropsy and the lack of signs of toxicity in both the adult and 

offspring as a whole. In summary, the NOEC remains 10,000 ppm or 964 mg/kg/day. 

However, there is high concern for possible environmental effects from the potential 

. persistent degradation product [ .]. As stated previously, 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 species of wildlife, including marine mammals. It is toxic to mammalian and 

other species. The presence in the environment and toxicological propetiies of PFOA continue 

to be investigated. Some limited ecotoxicological effects data exist on [ ] in fish, 

daphnia, algae, and birds. EPA believes development of additional chronic data on [ ] 

is warranted . . These studies are being c~mducted by other compa!).ies. 

Exposure and Environmental Release Summary: Thermal and simulated incineration testing · 
xvi 

exists on some related p( lyroers. This testing indicates that incomplete; incineration products 

are formed at lower inciJ ~ration temperatures. Modified Zahn-Wellens and Semi-Continu<JUS 

Actf"Vated Sludge (SCA~ ) biodegradation tests have been conducted on some related polymers. 

I ' • ' 

EPA has determined. tha: s.ome related polymers degrade~ while another did not show signs of 

degradation durl.n,g the tl ne frame of the test. EPA has received and reviewed test data 

showing tb:at certain poJ: mers with perfluoroalkyl substituents degrad~ to form perfluoroalkyl 

~ntaining i~tennediatef and perfluoroalkyl containing organic acids. EPA expects that these .. ... . . 

PMN substances will de ~ade. 

The PMN subst nces w.ill be manufactured at one submitter site in [ . . 

I days per year. The PMN substances will be ~anufactured into an I 

] , The PMN substances ma:y be released to· water 

or via incineration to th• atr. ThCfe could. be dermal exposur.e to 3 workers. Inhalation is 

expected to be negligibJ >based on low vapor pressLire. 

The PMN s11bstt nces will be processed 1nto formulations of [1 

]at[ :] or fonnulatio:os of [waxes/floor finishes ao.d 

stripper/cleaner fonnuJ1 :ionB] at [ J The PM:N' substances 

may be released to wate ·, l.andfillcd. or to the air via incineration. Dermal exposure to workers 

is possible. 

The P.MN subs· mc~s will be used in [ 

] for [ ] 

Occupation.al exposure: are dermal and inhalation. There may be exposure to consumers and 

. the coatings containing :he PMN substances may be .spray applied although exp~sures are 
XVll 

expected to be primarily dermal. The coatings contain I· ThePMN 

substances may be released to water, landfilled, or via incineration to the air during use. 

EPA does not expect a significant risk from spray use ofthe tested formulation. Based 

on the NOAEL of 24 mg/m3 in the second acute inhalation study and the projected consumer 

inhalation exposure, there is not a risk to consumers with an adequate margin of exposure of 

greater than 1 00, This would be considered an episodic exposure so an acute inhalation study 

addresses potential consumer risk. 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 

(a) EPA is tmable 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 )(I )(A)(i) of TSCA, that the information available to the Agency is . . . 

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

the PMN substances and potential degradation products. 

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

uncontrolled manufacture, processing, distribution in commerce, use, and disposal ofthe PMN 

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

manufacture (which includes import), processing, distribution in commerce, use, and disposal 

of the PMN substances may present an unreasonable risk of injury to human health and the 

envirorunent. 
xviii 

(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)(l)(A)(ii)(II) ofTSCA, 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 exposure to the substance and potential 

degradation products. 

. VI: INFORMATION REQUIRED TO EVALUATE HUl\1AN 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 ofthis Order in accordance with the conditions and test substance specified in the 

Testing section. The physical properties of the PMN substances and. target analytes present 

technical challenges in conducting the required testing. EPA will review submitted protocols 

in a timely fashion as stated in the Consent Order and provide additional relevant information 

and input to the extent that it is known and not claimed confidential by other companies. 

Pending 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 of the PMN substanceswill remain in 

effect until the Order is modified .or revoked by EPA based .on submission of the follqwing or 

other relevant information. 
XIX 

EPA expects that protocols would be submitted prior to any additional toxicological 

testing required under this Consent Order. 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) Because some concerns for the PMN substances are based on analogy between 

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

PMN substances, the following additional information on I ] would be necessary to 

·evaluate the human health and environmental effects which may be caused l5y the PMN 

substances: an avian reproduction test (OECD Guideline 206) in mallard ducks. 

(2) Information on inhalation toxicology if the substance were to be sprayed by 

[commercial applicators that would generate significant respirable particles or respirable 

aerosol droplets and the exposure is chronic in nature] or sold for spray application use by 

consu~ers where use might be typically repeated in a chronic manner. This could include a 

repeated dose inhalation study with a bronchoalveolar lavage component and special attention 

to histopathology (inflammation and cell proliferation) or other relevant information. Based on 

current expected use, no additional mammalian toxicology testing is recommended for this 

exposure via inhalation. 

(3) A chronic fish study (OPPTS 850.1300) on P-12-450 to better characterize chronic 

exposures and toxicity to fish. 
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 following two chemical substances [ 

I (P-12-450) and [ 

] (P-12-451) (the "PMN 

substances") in.the United States by [ I ("the Company"), 

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

(b) Exemptions. Manufacturing of the PMN substances 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 record keeping as required in the Recordkeeping section 

ofthis Order. 

. . . 

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

Interne! Address (URL) • http:liwww.epa gov 

Rocycled/Recyclabl9 • Printed with Vegetable Oil Based Inks on 100% Pos!consumer. Process Chlorine Free Recycled Paper 
2 

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

processing or distribution in commerce of the 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 activity by the 

Company involving the PMN substances is exempt as "soiely for export" even if some amount of 

the PMN substances is 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 of the PMN substances that are destined for 

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

the Testing section of this Order. 

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

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 ofthis Order also do not apply to . . 

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

when they are manufactured solely for non-commercial 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 ofthis 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 purpose separate from the substance., mixture, or articl(f of which 
3 

they are a part. 

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

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

with 40 CFR 720.22(b)(l). 

(c) Automatic Sunset. Ifthe Compru1y has obtained for the PMN substances a Test Market 

Exemption ("TME") under TSCA §5(h)(l) and 40 CPR 720.38 or a Low Volume Exemption 

("LVE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)(4) ru1d 40 CFR 

71J.50(c)(l) and (2) respectively, any such exemption-is automatically rendered~null and void as 

of the effective date of this Consent Order. 

II. TERMS OF MANUFACTURE, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE. AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

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 of the human health and environmental effects of the substances, and the 

completion of EPA's review of, and regulatory action based on, that information, in accordance 

with the conditions described in this Order. 

CHEMICAL SYNTHESIS AND COMPOSITION 

(a) Restriction. The Company shall not manufacture the PMN substances, P-12-450 and 451 

unless the [ I starting material is in compliance with and does not exceed the limits 
4 

specified in Table 1 and Table 2. T~e Company shall analyze the Initially Isolated Formulations 

of the PMN substances for the analytes specified in Table 3 upon initial commencement of 

manufacture, aild 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 products at the 

facility. The Company shall report to the Agency the levels' of impurities 

I associated with the PMN substances, P-12-450 and 451 

manufactured by the Company, as specified below. For routine analysis, the Company shall 

analyze the starting material, [ 

below: 

analyze the starting material, [' 

I for the following analytes shown in Table 1 

] . The Company will also annually 

• - 1

], for the analyte [ . ] 

shown in Table 2, below. The Company shall make its best effort to minimize these impurities 

and to seek to eliminate them. 

(b) Analysis and Reporting. The Company shall analyze representative samples of the Initially 

Isolated Formulations ofthe PMN substances, P-12-450 and 451 manufactured (which includes 

import) by the Company to determine compliance with the requirements in paragraph (a). The 

Company shall also analyze the Initially Isolated Formulations of the PMN substances at each 

manufacturing facility both (1) at the initial commencement of non-exempt manufacture ofthe 

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

PMN substances are manufactured at that facility. If any new facility of manufacture is added or 

if the process of manufacture of the PMN substances is significantly altered, then the Initially 

Isolated Formulation of the PMN substances must be analyzed at commencement, and annually 
5 

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 ofthe PMN substances 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 iriitial commencement of manufacture (which 0~ 

includes import) and again if any new manufacturing facility is added or if the process of 

manufacture of the PMN substances 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 [ · · ']. In addition to the · 

reporting for the Initially Isolated Formulations of the PMN substances themselves, the Company 

shall, for the [ ] starting material, annually report (1) the average values and the range 

of values, including outlying data, for the routine analysis for the analyies specified in Table 1 and 

(2) the results of the annual analysis for the analyte specified in Table 2. 
6 

TABLE 1: 

TO BE ROUTINELY AN ~o.L YZED IN [ 

Analyte CASNwnber 

r -· - . [ 1 

] 

[l ] ] - [< 1 

[" r J 

(C I [ ] 

[f ( J [ __ . 1 

[( '1- r - -') 

[' 1 I ] 

t :.] L 1 

* 

TABLE2: 

. TO BE ANALYZED A ' LEAST ANNUALLY IN [ 

MATERIAL 

Analyte CAS Nun,\ber 

[J [ l] 

I] 

TABLE3: 

I STARTING MATERIAL . -

Limit in [ - . . - --

] minimum 

[ 

(C(Jtnbined)"' 

[ 

[r I (combined) 

l ] 

(I ] ( contbined) 

- -- - 1 

I STARTING 

Limit in [i '] 

[ ) 

. 

TO BE ANAL YZEO AT :;r ART·UP AND AT LEAST ANNUALLY THEREAFTER 

JN THE INI' '!ALLY ISOLATED FORMULATIONS OF THE 

PMN SUB~ fANCES 

Estimated Maximum in 

Initially Isolated 

Analyte CAS Number For.tO.ulations of the PMN 

substances 

r-- - -- I 1 [ ](combined) 

[ ] I ] 

[ 

[ - .. - -- . l] 

I ' ] [I I (combine~) 

I ] 

I r···--. ------- [ ] [ ] 

J ' )] ___ _ 
7 

MANUFACTURING 

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

(including import) of the PMN substances by any other person. However, the Company may 

communicate to any o!her person the existence C!fthe 5(e) Consent Order ~nd TSCA Inventory· 

status for the PMN substances. 

(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 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 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 or 

import 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 
8 

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 Con:tract Manufacturer or Company must receive a 

fully executed copy ofthe 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 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·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 ofthe 

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)(ii) ofthis Section, the Company has notice or knowledge that the 

Contract Manufacturer has failed to comply with any of the conditions specified iri the Consent 

Order for Contract Manufacturer, the Company shall immediately cease to cause the Contract ' . 

Manufacturer to manufacture or import the PMN substances, shall notify EPA of the failure to 

comply, and shall resume causing the Contract Manufacturer to manufact11re or import the PMN 
9 

substances 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 substances for "commercial use" or 

"industrial use" that, due to the issuance of this Consent Order under s'ection 5(e) ofTSCA, the 

PMN substances are subject to the export notification requirements ofTSCA 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: (1) the PMN number, and (2) either (A) the specific 

chemical identity of the PMN substance, or (B) if the specific chemical identity is confidefttial, 

the generic chemical identity. 

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 identification number for these substances and contain a statement that the 

substances are 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 of Enforcement. and Compliance 

Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., 

Washington, D.C. 20460, of the following information within 10 days of scheduling any study 
10 

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 numb~r 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 shouid be submitted to EPA 3S follows: 

Postal Mail Address 

U.S. Environment.al 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 

Courier Delivery Address 

U.S. Environmental Protection Agency 

GLP Section Chief- Pesticides, Water and Taxies Branch . 

Monitoring Assistance and Media Programs Division (2227 A) 

Office ofEnforcement and Compliance Assurance 

Room 7117B 
1200 Pennsylvania Avenue, N.W. 

Washington, DC 20004 

11 

(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be 

performed pursuant to 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, the Company must obtain approval of test protocols from EPA by submitting written 

protocols. EPA will respond to the C-ompany Within 4 weeks of receiving the written protocols. 

Published test guidelines specified in paragraph (d) provide general guidance for development of 

test protocols, but are not themselves acceptable protocols. Approval of the test protocol does 

not mean pre-acceptance of test results. 

(d) Triggered Testing Requirements. (i) The Company must conduct the following studies on 

the related substance [ 

] (P-09-245), on the schedule established for the 

Consent Order for Premanufacture Notice Numbers P-09-245 and P-09-246 as representative 

testing for the PMN substances, P-12-450 and P-12-451. The Company must submit final 

reports and underlying data in accordance with the conditions specified in the Testing section of 

the Consent Order for P-09-245 and p..,Q9-246 and as modified. 
Production Limit 

As the schedule for 

the Consent Order for 

P-09-245 and 246 

12 

Modified Semi-Continuous 

Activated Sludge (SCAS) with 

Analysis for degradation products 

Guideline 

OPPTS 835.5045; OECD 

302A 

UV visible light absorption OPPTS 830.7050, OECD 101 

Direct Photolysis, if wavelengths OPPTS 835.2210 

greater than 290 nm are absorbed in 

the previous test (OPPTS 830.7050) 

Indirect Photolysis Screening Test OPPTS 835.5270 

Hydrolysis as a function ofpH OPPTS 835.2130, OECD Ill 

and temperature 

Anaerobic Biodegradability of OECD 311 

Organic Compounds in Digested 

Sludge 

(ii) The Company is prohibited from manufacturing or importing the PMN substances P-12-450 

and P-12-451 beyond the aggregated manufacture and import volumes of [ I kilograms 

and [ I kilograms of the two PMN substances, and the two chemical substances [ 

] (P09-245) and [ 

] (P-09-246) combined ("the production 

limits"), unless the Company conducts the following studies on the substance described in PMN 

P-09-245 and submits final reports and underlying data in accordance with the conditions 

specified in the Testing section of the Consent Ord,er for Premanufacture Notice Numbers P-09-

245 and P-09-246 and as modified. 
13 

[ ] kgs Phototransformation of Chemicals Draft OECD guideline Jan. 2002 

On Soil Surfaces-2 soils 

Aerobic Sewage Treatment Plant OECD 303A 

(STP) (Activated Sludge Units) 

Aerobic and Anaerobic OECD 308 

Transfonnatio!l in Aquatic Sediment 

Systems 

Aerobic Transformation in Soil OECD 307 

[ '] kgs Anaerobic Transformation in Soil OECD 307 

(ii) The test substance shall be the PMN substance described in P-09-245. Chemical 

composition of the test substance shall be verified and a certificate of analysis submitted to EPA. 

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

polymers, characterization includes all information required on pages 5 and 6 of the PMN form 

(i.e. EPA Form 7710-25), 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 arialytes, 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 Tests 

(OECD 307, OECD 308, OECD 311, OPPTS 835.5045 or OECD 302A, and OECD 303A) : [1: 

]. 

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

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

the major fluorinated fragments and volatiles including: [ 
14 

(e) Test Reports. The Company sl1all: (1) conduct each study in good faith, with due care, and 

in a scientifically valid mrumer; (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 

· no later than 14 weeks prior to e.xceeding the applicable production limit. -The final repmt shall 

contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in 

accordance with the applicable "Repmting," "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'1 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. 

(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. If EPA finds that the data generated by a study are scientifically equivocal, . . 

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

production limit. To seek relief from any other restrictions of this On;ler, the Company may 
15 

make a second a~tempt to obtain unequivocal data by reconducting the study under the conditions 

specified in paragraphs (b), (c), and (e)(l) and (e)(2). The testing requirements may be modified, 

as necessary to permit a reasoned evaluation of the 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 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) The Company may reconduct the study in compliance with paragraphs (b), (c), 

and (e)(l) and (e)(2). If there is sufficient time to reconduct the study 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). Ifthere 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 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 
16 

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

(i) Company Determi11ation of Invalid Data. 

(1) Except as described in subparagraph (i)(2), ifthe 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 fmiher manufacture 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 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 (e)(2). If there is sufficient time to conduct 

or reconduct the study and submit the report and data to EPA at least I 4 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 
17 

of receiving the Company's report and data, as to whether the Company may continue to 

manufacture beyond the applicable production limit. 

(j) 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, manuflfcture, 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, 

processing, distribution, use and disposal of the PMN substances, unless either: 

(2) within 2 weeks from receipt ofthe notice described in subparagraph G)(l), the 

Company complies with such requirements as EPA's notice specifies; or 

(3) within4 weeks from receipt of the notice described in subparagraph (j)(l), the 

Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of 

any additiona1 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 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 of the PMN 

substances. . 
18 

(k) Other Requirements. Regardless of the satisfaction of any other conditi<;ms 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 

VI. 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 infom1ation, 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 ofthe new information. If the P~ 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 persons who will receive the PMN substances from the 

Company for either commercial or industrial use, or who have received the PMN substances 

from the Company for either commercial or industrial use, 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. 
19 

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 quality for 

any one or more ofthe exemptions described in Section I, Paragraph (b) ofthis 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) 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, copies ofthe 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) 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, 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 records 

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 this Order, including the results from routine analysis of representative samples ofthe 
20 

starting material, I ], and at start-up and mmually thereafter of the Initially Isolated 

Formulations ofthe PMN substances. 

(3) Records documenting compliance with the Manufacturing, Distribution, and Testing 

sections ofthis Order. 

(4) Records documenting the manufactur~ (including importation) volume ofthe PMN 

substances and the corresponding dates of manufacture and import. 

(5) Records documenting the names and addresses (including shipment destination 

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

sells or transfers the PMN substances, the date of e.ach sale or transfer, and the quantity of the 

substance sold or transfeiTed on such date, wherein transfer does not include the distribution of 

small sample quantities (less than [ ] kilograms mmually) of the PMN substm1ces without 

charge. 

( 6) Records documenting the address of all sites of manufacture, processing, and use; 

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

Order; 

(8) Copies of any Transfer Docwnents and notices required by the Successor Liability 

section of this Order, if applicable; and 

(9) The Company shall keep a copy of this Order (electronic or hard copy) at each of its 

sites where the PMN substances are manufactured, processed, or used. 

(b) Applicability. The provisions of this Record keeping Section are applicable only to activities 

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

Compm1y's customers . . 
21 

(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" unless this Order qisplays a currently valid control number from the 

Office of Management and Budget (OMB), and.EPA so infonns 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. 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

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

may occasionally 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 ex;posed to the PMN substat.tces; 

(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; 
22 

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

(vi) Any other information reasonably related to detetmining compliance with this Order 

or conducting an inspection for that purpose. 

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

' 

period oftime, 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 demonstrate a good faith effort te:> provide reasonably accurate and detailed 

answers to all ofEPA?s requests. 

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

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

TSCA and 40 CFR Patt 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 SucGessor in Interest is 
23 

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

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

submit new PMN s to EPA and comply fully with Section 5( a)( 1) of TSCA and 40 CFR part 720 

before commencing manufacture of the PMN substances. 

(2) After NOC. If the transfer from.the Company to the Succ~ssor 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 PMNs to EPA. 

(c) Definitions. The following definitions apply to this Successor Liability section ofthe·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 

inte_rest 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 
24 

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 ofthe effective date ofthe 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 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 substances 

are manufactured. Copies of the Transfer Document must also be made available for inspection 

pursuant to Section 11 of TSCA, 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 of the 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 ofthe PMN substances pursqant to the terms.ofthis 
25 

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 voiume of the PMN substances manufactured (which 

includes 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 DF·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. The exposures and risks identified by EPA during its review of the 

PMN substances and the information EPA determined to be ne.cessary 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 substa:htial environmental release 

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

effects ofthe PMN substances. 
26 

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

the language of this Order, including modifications to production volume limits and time periods 

for submission of reports and data which are necessary due to no fault of, or circumstances 

beyond the control of, the Company. EPA in its sole discretion, may 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. 
27 

VII. EFFECT OF CONSENT ORDER 

(a) Waiver. This Order is effective when signed below by both parties and received by EPA. By 

consenting to the entry of this Order, the Company waives its rights to file objections to this 

Order pursuant to section 5(e)(l)(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 tenns, 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 claimed as confidential by the 

Company (per section 14 ofTSCA, 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. 

Date 

-~ -6 

Maria J. Doa, 11 .I . 

Director 

·-

Chemical Control Division 

Office of Pollution Prevention and Toxics 

Man~e: [. J 

Title: [ ~ 

Company: [ ] 
ATTACHMENT A 

DEFINITIONS 

[Note: The attached Order may not contain some ofthe 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 

nomencl~ture, or a name which wiJI clearly.identify a chemi<;.al substance for the purpqse 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 establislunent or painting contractor). 

"Common name" means any designation or identificatiem 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 oi· tempormy 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. 

"Final Formulation ofthe PMN substances" means the formulated dispersion or solution 

of the PMN substa11ces 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 the PMN sub~tances 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. 
2 

"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. 

"Industrial use." An industrial use is a use at a site at which one or more chemical 

substances or mixtures are manufactured (including imported) or processed . 

. ·"Initially Isolated Formulations of the PMN substances" means a common intermediate 

PMN fonn~lation, 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. 

"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 

air may occur. 

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

mixtures are manufactured, imported, or processed. 

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

Premanufacture notices 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 envirorimental effects of the 

PMN substances. · 

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

confom1ity wjth the Good Laboratory .Practice Standards and EPA-approved protocols, an:? 

inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of 
3 

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

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

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

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

"Use stream" means all reasonably apticipated transfer, flow, !)f. disposal of a chemi.cal 

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

industrial, commercial, or consuiner use. 

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

work areas. 
Co~pany (Transferor) 

ATTACHMENTB 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

PMNNumper 

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 §S(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 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 

720.22(3). 

3. Confidel)tial Business Information. The Successor in Interest hereby: 

_ reasserts, 

_ relinquishes, or 

modifies 

all Confidential Business Inf01mation (CBI) claims made by the Company, pursuant to Section 

14 of TSCA 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 

NOTICE OF TRANSFER 

(continued) 

~o.D;lpany (Transferor) fMN NUilJ.ber 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Offici.al 

------------------------------

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 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State;Zip Cede 

Phone