# [ March 13, 2015 U.S. Environmental ProtectionAgency Office ofPollution Prevention andTaxies Confidential Business Information Center (CBIC)- TS7407M EPA East Building, Room 6428 1201 ConstitutionAvenue, NW Washington, DC 20004-3302 Dear Sir ofMadam: Reference: ConsolidatedPMNP-12 04SO andP-12-0451 [( ConsentOrder 

# EPA

# SANITIZED

Please find enclosedthe above-identified Consent Orderexecuted onbehalfof

### I ] orthe Company). We very much appreciate the time andresources thatthe Environmental ProtectionAgency (EPA ortheAgency) devoted to timelynegotiating the Consent Orderwith[· ·]. We do wish to emphasize thatthenegotiationsfocused onthebinding requirements in the ConsentOrder section ofthe document andthatthelanguageinthe non-binding Preamble section, particularly thatwhich reflects EPA's assessments and conclusions, was notnegotiated. To thatend, itis reiterated that, as statedin SectionVII ofthe Consent Ordersection, consentingto the entryof the Order and agreeing tobeboundby its terms does notconstitutean admissionbythe Companyas tothefacts orconclusions underlying theAgency's determinations in·this matter. Again, we thanktheAgency for the time and effort it expendedtofinalize the Consent Order and we lookforward to its successful implementation. Very trulyyours, 

# [

Via Federa] Express Enclosure: 

# l

J'• UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

. OFFICE OF POLLUTION PREVENTION AND TOXICS



# 03mJJ.fAa~~ULATION OF NEW CHEMICAL SUBSTANCES PENDINGDEVELOPMENT OF INFORMATION

Inthe matter of: ) PremanufactureNotice Numbers: ) ) ) ) ) [' "] ) P-12-450 and 451 ) ) ) ) )

Consent Order and Determinations Supporting Consent OrderII


### TABLE OF CONTENTS

. Preamble I. Introduction II. Summary ofTerms 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

ConsentOrder 

### I. Scope ofApplicability and Exemptions II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation III. Recordkeeping IV. Requests for Pre-InspectionInformation V. SuccessorLiability Upon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order Attachment A
- Definitions Attachment B- Notice ofTransfer ofConsent Order'iii 

### I. INTRODUCTION Under the authority of§ 5(e) ofthe Toxic Substances Control Act ('TSCA'') (15 U.S.C. 2604(e)), the Environmental Protection Agency ("EPA" or •:the Agency") issues the attached Order, regarding premanufacture notices ("PMNs") P-12-450 and 451 for the chemical substances P-12-450-[_ )- ]andP-12-451-{:


### Jsubmittedby [ ] ("the Company"), to take effect upon expiration ofthe PMN review period. The Company submitted the PMNs to EPA pursuant to§ 5(a)(l) ofTSCA and 40 CFRPart 720. Under§ 15 ofTSCA, it is unlawful for anyperson 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 pursuantto § 16, andto specific enforcement and seizure pursuant to §.17. In addition, chemical substances subjectto 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 andphysical/chemical testing on a representative PMN substance, P-09-245. For Tier 1testing, it must be submitted on thelV 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 ofthefour 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 Companyinay use 

## a Contract Manufacturer in the future, ifa 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 ifa Contract Manufacturer manufactures the PMN substances. Prior to using a Contract Manufacturer, the Company must submit to EPAthe Contract Manufacturer identity and other m::t.nufacturing process, and exposure, and release information concerning the ContractManufacturer. The Contract Manufacturer would be required to keep records ofquantities 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 withinbrackets and that any information that is not bracketed is not claimed as confidential. To makethis document available for publicviewing, 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 withphosporus oxide (P205) amine salts Use: Specific: [

Generic use: Coating additive, surface active agent Maximum 12-MonthProduction Volume: [ ] kgs
(many acronyms are subsequently explained more fully in sectionIV below where the. results of the studies are discussed): Local LymphNode Assay; Skin irritation, Eye irritation, Oral LDSO (rat); Bacterial Reverse·Mutation, Chromosome Aberration inMammalianCells; AcuteVl Inhalation Toxicity; Biopersistence andpharmacokinetic Screen (rat); 7-day repeated dose oral gavage (rat); Daphnia Screen; 48-hr Daphnia EC 50; 21-day Daphnia Chronic study; 96-hrAlgae 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; Flashpoint (Flammability, Solids); Octanol/Water Partition Coefficient; Relative Density Surface Tension; Appearance ofSubstance; 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 Studywith 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 ofthe 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 decompositionproducts ofthe PMN substances. EPA also has concerns for the PMN substances that under some conditions ofuse-- particularly non-industrial, commercial, or consumeruse-- could cause lung effects, based on limited data on someperfluorinated 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 exposureperiod. 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 estimatedto be greater than 2.0 mg/L (2000 mg/m3). The ALC is consistent with a low concern for acute inhalation toxicity. EPA expects thatthe 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 reviewperiod, the PMN substances have[< ' ], EPAhas·agreed that
- for routine analysis, the Companymay analyze the starting material, the[· following analytes: 

### I ] for the

the starting material, [ ] . The Company will also annually analyze 

## Jfor 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 ofthe PMN substances. "Initially Isolated Formulations" is defined inthe Definitions section ofthis Consent Order (Attachment A). The Company will continue to work towards reducing the maximum amount of impurities [ ]. During commercial production, these impurities are produced partlyby (

**~**
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 limitthe maximum impurity levels in the starting material, 

### [1 ] notto exceed the currently attainable levels (see Tables I and 2 in the Chemical Synthesis and Composition section ofthe attached Consent Order), a:nd will report the various impurities [ ] annually. EPA is concerned that these perfluorinated degradationproducts may be released to the environment from incomplete incineration ofthe PMN substances at lowtemperatures. EPA has preliminary evidence, including data on other [ ], that

**suggest~** that, under
some conditions, the PMN substances could degrade inthe environment. EPAhas concerns that these degradationproducts will persist in the environment, could bioaccumulate or biomagnify, and could betoxic (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 ] orprecursors, which is summarized below. PFOA is expected to persistfor years inthe enyironment. Biodegradatiqn and photolysis tests ofanalogous substances indicate little or no biodegradation or photolysis ofperfluoroalkyl compounds. Bioaccumulation concerns are based on the measured presence ofcertainix 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 ofconcern. These factors, taken together, raise concerns for potential ' ' adverse chronic effects in humans and wildlife. For additional information about PFOA, consult the EPAregulatory docket at OPPT-2003-0012. Additional information about PFOA, 

### J, and otherperfluorinated substances may also be found in theAdministrativeRecord for PFOS, PFOA, and Telomers andRelatedChemicals (AR-226). Administrative Record (AR-226) is not currently available online, but copies canberequested on CD-ROM from the EPA Docket office by calling 202/566-0280 or sendingan email request to oppt.ncic@epa.gov. Limited toxicological, ecological, and fate data now exist on [: ] and some ofthe 

## 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 inmonkeys 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 ofone hour or less. These data and assessments support the assessment ofreduced 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. EPAreview ofthis study concluded that.a no-observed adverse effect level (NOAEL) was not established in this study forX systemic effects. There were

**num~rous** effects at 100 and 500 mg/kg/day onnasal tissue, liver, and thyroid, and at 500 mg/kg/day on body weight, the red blood cell system, clotting, andthe kidney. The EPA reviewer concluded that although not clearly dose related, the elevation oftwo markers for livertoxicity across all treated groups ofmales in clinical chemistry, and the finding offocal necrosis in the liver across all treated groups ofmales, as well as, intreated recovery males, and the absence , ofthis result inthe controls, leads to the conclusion that noNOAEL was achieved. For the one:generation reproductive"foxicity study component ofthis study, the reproductive toxicityNOAEL is 500 mg/kg/day (the highest dose tested). The systemictoxicity NOAELfor 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/daybased on reduced bodyweights/body weight gains andreduced 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 of2 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) inrats 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 oftoxicity). However; systemic effects-primarilyliver effects--were seen.- EPA reviewxi places the NOAEL for [ ] at 50 mg/kg/day. Forthe [ ], 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 ontheprevious Combined Study (OECD 422). EPAreview set the

- Lowest- Effect Level (LOEL) orLOAEL

# at 10 mg/kg/day, based onthe boay weight gain bei-ng lower in all treated groups ofmales. There was treatment-related toxicity in the liver and the red blood cell system (anemia) inmales at 200 mglkg/day. There was also increased peroxisomal beta oxidation activity atthis dose level. Hepatotoxicity and.peroxisomal beta oxidation activity have also been seen in studies on PFOA.

. The significance ofthe finding ofa benign brain tumor (astrocytoma) in one male rat 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,

**~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 ofconcern 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 ofimmunotoxic effects should await the corroborative testing now being conducted by

**EPA~** Office ofResearch an(i Development. There
were no clinical signs ofneurotoxicity and there were no treatment-related effects inthe func'tional observation battery or motor behavior.

## .. Xll Another 90-day study has been submitted to EPA on [ ]. EPA review ofthat study concluded thatblood and liver effects were seen at the highest dose. This studyhad comparable doses withthe other studies. A one-generation reproduction/developmental toxicity study inmice onthe [ ] was submitted to the Agency. Inthis 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 ofdevelopmental toxicity were observed at 175 mg/kg/day onthe postnatal day 1 and.consisted 6fincreases inthe numberof stillborn pups and pup deaths, reductions inthe 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 inthe studyno determination could be made for the highest doses. These and other data indicate a different and less toxic profile for 

## I ] (apresumed environmental degradant ofthePMN 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 inthe 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 amodified 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 ofthe 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 ofsexual 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 ofthe National Toxicology Program (NTP) in the so-called Perfluorinated Compounds Class Study. Environmental Effects Summary: EPA expects the PMN substances orthe degradants to be highlypersistent.

**Durin~** the review period, the Companyprovided acute fish (rainbow trout), aquatic invertebrate (Daphnia magna), and algae (Pseudokirchneriella subcapitata) toxicityxiv 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 of0 (dilution water control), 7.5, 15, 30, 60, and 120 mg a.i./L total solids with onerenewal after 48 hours. The 96-hour LC50 was 

### >102 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 ofConcern (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-dayDaphnid chronic toxicity test. This testresulted 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 lowecological 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, orreproductive parameters. In addition, no effects were observed in the offspring ofthe 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 ofthe offspring for the presence of ,the fact that

**~he** analysis was not performed did not alterthe validation ofthe study considering the lack ofeffects seen in adult tissue at necropsy and the lack ofsigns oftoxicity inboththe 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 environmentaleffects 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. Ithas been detected in
a number ofspecies ofwildlife, including marine mammals. Itis toxic to mammalian and other species. The presence in the environment and toxicological propetiies ofPFOA continue to be investigated. Some limited ecotoxicological effects data exist on [ ] in fish, daphnia, algae, and birds. EPA believes development ofadditional 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 somerelatedp( lyroers. Thistesting indicates that incomplete; incinerationproducts


### are formed at

### lowerinciJ

**~ration**

### temperatures. ModifiedZahn-Wellens and Semi-Continu<JUS Actf"Vated 

### Sludge

**(SCA~** 

### )biodegradationtests have beenconducted on some related polymers.

I ' • ' 

### EPA has 

### determined. tha: s.omerelatedpolymers

**degrade~** 

### while another didnot show signs of 

### degradation durl.n,g the tl neframe ofthe test. EPA has received andreviewed

### testdata 

### showingtb:at certain poJ: 

### mers with perfluoroalkyl 

### substituents

**degrad~** 

### to form perfluoroalkyl

**~ntaining i~tennediatef**  

### and

### perfluoroalkyl containing organic acids. EPA expects thatthese

.. ... 

### . 

## . PMN

### substances will de

**~ade .**  

### ThePMN subst nces 

### w.ill be

### manufactured at one submitter 

### site in [



### . 

# . Idays per 

### year. The 

### PMN substanceswill be
**~anufactured**

### into an 

## I ], The

### PMN substances ma:y be releasedto· water
orvia incineration to th• 

### atr. ThCfe could.be dermal exposur.eto 3

### workers. Inhalationis expectedto benegligibJ >based on low vaporpressLire. ThePMN s11bstt nces will beprocessed 1nto formulations

# of[1

]at[ 

### : ]orfonnulatio:os 

### of[waxes/floorfinishes ao.d stripper/cleaner

### fonnuJ1 : ionB] at [ 

### J ThePM:N' substances may bereleased to wate ·, l.andfillcd. orto the airviaincineration. 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** 

### areXVll expected to be primarily dermal. The coatings contain 

## I· ThePMN substances maybe released to water, landfilled, orvia incineration to the air during use. EPA does not expect a significant risk from spray use ofthetested formulation. Based
on the NOAEL of24 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 ofexposure of greater than 1 00, This would be considered an episodic exposure so an acute inhalation study addresses potential consumerrisk.



### V. EPA'S CONCLUSIONS OF LAW The following findings constitutethe basis ofthe 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) ofTSCA, that the information available to the Agency is

. . . insufficient to permit a reasoned evaluation ofthe human health and environmental effects of the PMN substances and potential degradationproducts. (b) In light ofthe potential risk ofhuman health and environmental effects posed by the uncontrolled manufacture, processing, distribution in commerce, use, and disposal ofthe PMN substances, EPAhas concluded, pursuant to§ 5(e)(l)(A)(ii)(I) ofTSCA, that uncontrolled manufacture (which includes import), processing, distribution in commerce, use, and disposal ofthe PMN substances may present an unreasonable risk ofinjury to human health and the envirorunent.xviii (c) In light ofthe estimatedproduction 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 maybe significant (or substantial) human exposure to the substance and potential degradationproducts.

. 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 submitsthe information described in the Testing section ofthis Order in accordance with the conditions and test substance specified inthe Testing section. The physical properties ofthe PMN substances and. target analytes present technical challenges in conducting the requiredtesting. EPA will review submitted protocols in a timely fashion as stated inthe Consent Order and provide additional relevant information and inputto the extent that it is known andnot claimed confidential by other companies. Pending Testing. The Order does not require submission ofthe 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 substanceswill remain in effect until the Order is modified . orrevoked by EPA based .on submission ofthe follqwing or other relevant information.XIX EPA expects that protocols would be submitted prior to any additional toxicological testing required underthis Consent Order. Due to the limited water solubility ofsome ofthese substances and consequent analytical difficulties, some modification ofthe protocols may be necessary. These and othermodifications 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 degradationproduct ofthe PMN substances, the following additional information on 

## I ]would be necessary to ·evaluate the human health and environmental effects whichmay be caused l5y the PMN

substances: an avian reproduction test (OECD Guideline 206) in mallard ducks. (2) Information oninhalation toxicology ifthe substance were to be sprayed by [commercial applicators that would generate significant respirable particles orrespirable 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 otherrelevant 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 ofthis Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal ofthe 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 ofthe PMN substances is exempt from the requirements ofthis 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 ofthe 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 ofthe 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 Paper2 for use in the United States, the requirements ofthis Order do not applyto 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 inthe United States, no further activity bythe Company involving the PMN substances is exempt as "soielyfor export" even ifsome amount of the PMN substances is later exported. Atthatpoint, the requirements ofthis Order apply to all activities associated withthe PMN substances while intheterritory ofthe United States. Priorto leaving U.S. territory, even those quantities orbatches ofthe PMN substances that are destined for export are subject to terms of-the Order, and cotmt towards any production volume testtriggers in the Testing section ofthis Order. (2) Research & Development ("R&D"). The

**requir~ments** of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe 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. Therequirements ofthis Order also do not apply to

. . manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances when they are manufactured solely for non-commercial research and developmentper40 CFR 720.30(i) andTSCA §5(i). (3) Byproducts. The requirements ofthis 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 ofthe exemptions in40 CFR 720.30(h), with no commercial purpose separate from the substance. , mixture, or articl(f ofwhich3 they are a part. (5) Imported Articles. The requirements ofthis Order do not apply to the PMN substances whenthey are imported as part ofan "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 TestMarket Exemption ("TME") under TSCA §5(h)(l) and 40 CPR 720.38 or a LowVolume Exemption ("LVE") or LowRelease 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 ofthe effective date ofthis Consent Order.

II. TERMS OF MANUFACTURE, PROCESSING, DISTRIBUTION IN COMMERCE, USE. AND DISPOSAL PENDING SUBMISSIONAND 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 ofinformation necessary for a reasoned evaluation ofthe human health and environmental effects ofthe substances, and the completion ofEPA's review of, and regulatory action based on, that information, in accordance withthe conditions described in this Order.
CHEMICALSYNTHESIS 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 limits4 specified in Table 1 and Table 2.

**T~e** Company shall analyze the Initially Isolated Formulations ofthe 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 ofthe lastjointmanufacture or processing ofa product that contains products at the facility. The Company shall report to the Agency the levels'ofimpurities 

## Iassociated with the PMN substances, P-12-450 and 451 manufactured by the Company, as specified below. Forroutine analysis, the Company shall analyze the starting material, [ below: analyze the starting material, [' 

## Ifor 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 ofthe Initially Isolated Formulations ofthePMN 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 ofthe PMN substances at each manufacturing facility both (1) at the initial commencement ofnon-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. Ifany new facility ofmanufacture is added or ifthe process ofmanufacture ofthe PMN substances is significantly altered, then the Initially Isolated Formulation ofthe PMN substances must be analyzed at commencement, and annually5 annually thereafter as set forth above. Ifthe PMN substances are imported, the Company shall obtain from the foreign manufacturer written documentation to certify that representative samples ofthe imported form ofthe PMN substances have been analyzed, consistent withthe requirements ofthis paragraph (b), and determined to comply with the requirements ofparagraph (a). The Company shall report the above analysis to EPA at iriitial commencement ofmanufacture (which

**0~** includes import) and again ifany new manufacturing facility is added or ifthe process of manufacture ofthe PMN substances or any intermediate thereofis significantly altered. The Company shall continue to report these impurity levels to EPA annually, in a cycle ·complementaryto·the [ · · ']. In addition to the ·

reporting for the Initially Isolated Formulations ofthe PMN substances themselves, the Company shall, for the [ ] starting material, annually report (1) the average values and the range ofvalues, including outlying data, for the routine analysis for the analyies specified in Table 1 and (2) the results ofthe annual analysis for the analyte specified in Table 2.

### 6 TABLE 1: 

### TO BEROUTINELY 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 BEANALYZED A ' LEAST ANNUALLY IN [ MATERIAL 

### Analyte CAS Nun, \ber 

### [J [ l] I] 

### TABLE3: 

### ISTARTING

### MATERIAL

. - 

### Limitin [ 

## - . . 

### - -- ]minimum [ (C(Jtnbined)"' 

### [ [r 

## I(combined)

l ] (I 

### ] (contbined)

- 

### -- - 1 

## ISTARTING Limitin [i 

### '] [ )



# . TO BE ANALYZEO 

### AT 

### :;r ART·UP

### AND 

### ATLEASTANNUALLY THEREAFTER 

### JN THE INI' '!ALLYISOLATED FORMULATIONS OF THE PMN

**SUB~** 

### fANCES 

### EstimatedMaximumin Initially 

### Isolated Analyte CAS Number 

### For.tO.ulations ofthePMN 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) ofthe PMN substances by any other person. However, the Company may communicateto 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 ofa final significant new use rule ("SNUR") governing the PMN substances under section 5(a)(2) ofTSCAunless the Company is notified on or before that day ofan action in a Federal Court seekingjudicial 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 SNURhave been resolved and the validity ofthe SNUR affirmed. (3) Notice ofSNUR. When EPApromulgates a final SNURfor 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 importthe PMN substances ofthe existence ofthe 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 ContractManufacturer a signed copy ofthe8 Consent Order for Contract Manufacturer (to be attached to this Order as Attachment C) and submitthe copy to EPA along withthe name, address, and telephone number ofa responsible official ofthe Contract Manufacturer. The Con: tract Manufacturer or Companymustreceive a fully executed copy ofthe Consent Order for Contract Manufacturer from EPA before the Contract Manufacturermaybegin manufacture orimport. (3) Ifat any time, the Companylearns that the Contract Manufacturerhas failed to comply with any ofthe 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-forthe PMN substances, or unless the Company is able to document each ofthe following: (i) Thatthe Companyhas, within 5 working days, notified the Contract Manufacturer in writing that the ContractManufacturerhas failed to comply with any ofthe conditions specified in the Consent Orderfor Contract manufacturer. (ii) That, within 15 working days ofnotifying the Contract Manufacturer ofthe noncompliance, the Companyreceived from the Contract Manufacturer, in writing, a statement ofassurance.that the Contract Manufacturer is aware ofthe terms ofthe Consent Orderfor Contract Manufacturer and will comply with those terms. (iii) If, after receiving a statement ofassurance from the Contract Manufacturer under subparagraph (b)(ii) ofthis Section, the Company has notice or knowledge that the Contract Manufacturer has failed to complywith any ofthe conditions specified iri the Consent Orderfor Contract Manufacturer, the Company shall immediately cease to cause the Contract ' . Manufacturer to manufacture or import the PMN substances, shall notify EPA ofthe failure to comply, and shall resume causing the Contract Manufacturerto manufact11re or import the PMN9 substances only upon written notification from the Agency. DISTRIBUTION (a) ExportNotice Requirement. No later thanthe date ofdistribution, the Company shall notify in writing any personto whom it distributes the PMN substances for "commercial use" or "industrial use" that, due to the issuance ofthis Consent Order under s'ection 5(e) ofTSCA, the PMN substances are subjectto the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in the form in whichit appears inthis Consent Order, the following information: (1) the PMN number, and (2) either (A) the specific chemical identity ofthe PMN substance, or (B) ifthe specific chemical identity is confidefttial, the generic chemical identity.
TESTING (a) Section 8(e) Reporting. Reports ofinformation on the PMN substances which reasonably supports the conclusion that the PMN substances present a substantial risk ofinjury to health or



### . - the environment, which is required to be reported under TSCA section 8(e) shall reference the appropriate PMNidentification 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 ofStudy 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 PennsylvaniaAvenue, N.W., Washington, D.C. 20460, ofthe following information within 10 days ofscheduling any study10 required to be performed pursuant to this Order, or within 15 days after the effective date ofthis Order, whichever is later: (1) The date when the study is scheduled to commence; (2) The name and address ofthe laboratory which will conduct the study; (3) The name and telephone

**numb~r** ofa person at the Company or the laboratory whom EPA may contactregarding 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 (2227A) Office ofEnforcement and Compliance Assurance 1200 PennsylvaniaAvenue, 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 (2227A) Office ofEnforcement and Compliance Assurance Room 7117B1200 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 Ordermustbe conducted according to TSCA Good Laboratory Practice Standards at40 CFRPart 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 Companymust obtain approval oftestprotocols from EPAby submitting written protocols. EPA will respond to the C-ompany Within 4 weeks ofreceiving the writtenprotocols. Published test guidelines specified inparagraph (d) provide general guidance for development of testprotocols, but are notthemselves acceptable protocols. Approval ofthe test protocol does not meanpre-acceptance oftest results.
(d) Triggered Testing Requirements. 

### (i) The Company must conduct the following studies on the related substance [ ] (P-09-245), onthe schedule established for the Consent Order for PremanufactureNoticeNumbers 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 inthe 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, ifwavelengths OPPTS 835.2210 greaterthan 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 

### inDigested 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 importvolumes of [ 

### Ikilograms and [ 

## Ikilograms ofthe 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 withthe conditions specified in the Testing section ofthe Consent Ord,er for PremanufactureNotice Numbers P-09- 245 and P-09-246 and as modified.13 

### [ ] kgs Phototransformation ofChemicals 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) Thetest substance shall be the PMN substance described in P-09-245. Chemical composition ofthetest substance shall be verified and a certificate ofanalysis submitted to EPA. (iii) Chemical composition ofthe test substance mustbe fully characterized. For polymers, characterization includes all information required onpages 5 and 6 ofthe PMNform (i.e. EPA Form 7710-25), except that data on residuals are only required for fluorinated substances. AlthoughEPA 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 Companytest the commercial substance. (iv) The Companymust test for the following analytes inthe BiodegradationTests (OECD 307, OECD 308, OECD 311, OPPTS 835.5045 or OECD 302A, and OECD 303A) : 

### [1:

]. (v) Because the environmental fate pathway for photolysis inaybe different than for biodegradation, the Company must test for the following analytes inthe 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 EPAthe results ofany interimphase of each study; and (3) submit,with an additional sanitized copy, ifconfidential business information is involved), the final report ofeach study and all underlying data ("thereport and data") to EPA

· no later than 14 weekspriorto e.xceeding the applicable production limit. -The final repmt shall containthe contents specified in40 CFR 792.185. Underlying data shall be submitted to EPA in accordance withthe applicable "Repmting," "Data and Reporting," and "TestReport" subparagraphs in the applicabletest guidelines. However, for purposes ofthis Consent Order, the word "should" inthose subparagraphs shall be interpretedto mean "shall' 1 to make clearthat the submission ofsuch information is mandatory. EPAwill require the submission ofraw data such as slides and laboratory notebooks only ifEPA finds, on the basis ofprofessionaljudgment, that an adequate evaluation ofthe study cannot take place inthe absence ofthese items.


### (f) Testing Waivers. The Company is notrequired to conduct a study specified 

### inparagraph (d) ofthis Testing section ifnotified in writing by EPAthat it is unnecessaryto conduct that study.
(g) Equivocal Data. IfEPA 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 relieffrom any otherrestrictions ofthis On;ler, the Companymay15 make a second

**a~tempt** to obtain unequivocal data by reconducting the studyunder 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 ofthe risks presented by the PMN substances, only by mutual consent ofEPA and the Company.
(h) EPA Determination ofInvalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's receipt ofa test report and data, the Company receives written notice thatEPA finds thatthe data generated

· by a study are scientifically invalid, the Companyis prohibited from further manufacture ofthe

PMN substances beyond the applicable production limit. (2) The Company may continue to manufacture the PMN substances beyond the applicable production limit only ifso notified, in writing, by EPA in response to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) The Companymay reconductthe study in compliance with paragraphs (b), (c), and (e)(l) and (e)(2). Ifthere is sufficient time to reconductthe study and submit the report and data to EPA at least 14 weeks before exceedingthe 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 submitthe report and data intriplicate 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 ofreceiving the Company's report and data. (ii) The Company may, within 4 weeks ofreceiving from EPA the notice described in subparagraph (h)(l), submit to EPA a written report refuting EPA's finding. EPA16 will respond to the Company, in writing, within 4 weeks ofreceiving 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 ofthe Company or laboratory will prevent, orhave prevented, development ofscientifically valid data under the conditions specified inparagraphs (c) and (e), the Companyremains prohibited from fmiher manufacture ofthe PMN substances beyond the applicable production limit. (2) The Company may submitto EPA, within 2 weeks offirstbecoming aware ofsuch
- circumstances, a written statement explaining why circumstances clearly beyond the control of the Company or laboratory will cause orhave caused development ofscientifically invalid data. EPA will notify the Company ofits response, inwriting, within 4 weeks ofreceiving the Company's report. EPA's written response may either: (i) allowthe Company to continueto manufacture the PMN substances beyond the applicable production limit, or (ii) require the Companyto continue to conduct, orto . reconduct, the study in compliance with paragraphs (b), (c), and (e)(l) and (e)(2). Ifthere is sufficient time to conduct
orreconduct 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). Ifthere

### is insufficienttime 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 inthe notice

. described in subparagraph (i)(2), EPA will respond to the Company, in writing, within 6
- weeks17 ofreceiving the Company's report and data, as to whether the Companymay continue to manufacture beyond the applicable production limit.
(j) Unreasonable Risk. (1) EPAmay notify the Company in writing that EPA finds thatthe data generated by a study are scientifically valid and unequivocal and indicate that, despitethe terms ofthis Order, the PMN substances will ormaypresent anunreasonable risk ofinjury to human health or the environment. EPA's notice may specifythat the Company undertake certain actions concerning ·furthertesting, manuflfcture, processing, distribution, use and/or disposal ofthe PMN substances to mitigate exposures to orto better characterize the risks presentedby the PMN substances. Within 2 weeks from receipt ofsuch a notice, the Company must cease all manufacture, processing, distribution, use and disposal ofthe 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 ofthe 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 byEPA. The Companymay continue to manufacture, process, distribute, use and dispose ofthe PMN substances in accordance with the terms ofthis Order pending EPA's response to the Company's written report. EPAwill respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks of receipt ofEPA's written response, the Company shall comply with anyrequirements imposed by



### . . EPA's response or cease all manufacture, processing, distribution, use and disposal ofthe PMN substances. .18 (k) Other Requirements. Regardless ofthe satisfaction ofany other conditi<;ms in this Testing section, the Companymust continue to obey all the terms ofthis Consent Order until otherwise notified inwriting by EPA. The Company may, based upon submitted test data or other relevant information, petition EPAto modify orrevoke provisions ofthis Consent Order pursuant to Part 

## VI. ofthis Consent Order.
RISKNOTIFICATION (a) Ifas a result ofthe test data required under the terms ofthis Order, the Company becomes

· awarethat any·ofthe PMN substances may present a risk ofinjuryto 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 suchrisk, into a Material Safety Data Sheet ("MSDS") for those PMN substances, as described in 40 CFR section 721.72(c), within 90 days from thetime the Company becomes aware ofthenewinformation. Ifthe

**P~** substances are not being manufactured, processed, or used inthe Company's workplace, the Company must add the newinformationto anMSDS 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 orindustrial use, within 5 years from the date the Company becomes aware ofthe new information described in paragraph (a) ofthis section, are

, < provided an MSDS containing the information required underparagraph (a) within 90 days from the time the Company becomes aware ofthe 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 oftheexemptions 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 ofthe PMN substances eligible for the Export exemption in Section I, Paragraph (b)(l) ofthis Order, are exemptfrom all the requirements in this Recordkeeping section, ifthe 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 orbatches ofthe PMN substances eligible for the Research and Development exemption in Section I, Paragraph (b)(2) ofthis Order, are exemptfrom all the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, the records required by40 CFR 720.78(b). For any amounts orbatches ofthe 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 otherrecord keeping requirements inthis Record keeping section; (2) Records documenting compliance with the Chemical Synthesis and Composition section ofthis Order, including the results from routine analysis ofrepresentative samples ofthe

### 20 starting material, 

## I ], and at start-up and mmually thereafter ofthe InitiallyIsolated 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 ofthePMN substances and the corresponding dates ofmanufacture and import. (5) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture to whom the Company directly sells or transfers the PMN substances, the date ofe.ach sale ortransfer, andthe quantity ofthe substance sold ortransfeiTed on such date, whereintransfer does not include the distribution of small sample quantities (less than [ ] kilograms mmually) ofthe PMN substm1ces without charge.(6) Records documenting the address ofall sites ofmanufacture, processing, and use; (7) Copies ofmaterial safety data sheets required by the RiskNotification section ofthis Order; (8) Copies ofany Transfer Docwnents and notices required by the Successor Liability section ofthis Order, ifapplicable; and (9) The Company shall keep a copy ofthis Order (electronic orhard copy) at each ofits sites where the PMN substances are manufactured, processed, or used.
(b) Applicability. The provisions ofthis Record keeping Section are applicable only to activities ofthe Company and its Contract Manufacturer, ifapplicable, and notto activities ofthe 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 notrequired to respond to this "collection ofinformation" unless this Order qisplays a currentlyvalid control number from the Office ofManagement and Budget (OMB), and.EPA so infonns the Company. The "collection ofinformation" required in this TSCA §5(e) Consent Orders has been approved under currently valid OMB Control Number 2070-0012.



### IV. REQUESTS FORPRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuant to section 11 ofTSCA and 40 CFR720.122, EPA may occasionally conduct on-site compliance inspections ofCompany facilities and conveyances associated with the PMN substances. To facilitate such inspections, EPA personnel may contact the . Company in advance to request informationpertinent to the scheduling and conduct ofsuch inspections. Such requests maybe written or oral. The types ofinformation that EPA may



### . . request may include, but are not limited to, the following: (i) Expected dates and times when the PMN substances will be inproduction 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) Currentjobtitles 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 mayreasonably be exposed to the PMN.substances;22 (v) Records required by the Record keeping section ofthis Order; and/or (vi) Any other informationreasonably related to detetmining compliance with this Order
orconducting an inspection for that purpose.
(b) Company's Response. The Company shali respond to such requests·within a reasonable ' period oftime, butin no event later than 30 days after receiving EPA's request. Whenrequested in writing by EPA, the Company's response shall be in writing. To the extentthe information is known to orreasonably ascertainable to the Company atthe time oftherequest, the Company's response shall demonstrate a good faith effortte:> providereasonably accurate and detailed
answers to all ofEPA?s requests.
(c) Confidential Business Information. Any Confidential Business Infonnation (CBI) thatthe Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with §14 of TSCA and 40 CFRPatt2.



### V. SUCCESSORLIABILITYUPON 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 whenthe Companytransfers its interests inthe PMN substances, including the right to manufacture the PMN substances, to anotherperson outside the Company (the "Successorin Interest").
(b) Relation ofTransfer Date to Notice ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from.the.Company to the SucGessor in Interest is23 effective before EPA receives a notice ofcommencement ofmanufacture ("NOC") for the PMN substances from the Companypursuant 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 CFRpart 720 before commencing manufacture ofthe PMN substances. (2) AfterNOC. Ifthe transfer from.the Companyto the

**Succ~ssor** in Interest is effective after EPA receives aNOC, the Successor in Interest shall comply with the terms ofthis 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 inthe 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 ofthe 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 inthe 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 Onorbefore the effective date ofthe transfer, the24 Company shall provide to the Successor in Interest, byregistered mail, a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated by reference as Attachment B to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthetransfer, the Company shall,byregistered mail, submit the fully executed Notice" ofTransfer documentto: U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Documentmustbemaintained bythe Successor in Interest at its principal place of-business; and at all sites where the·PMN substances
are manufactured. Copies ofthe Transfer Documentmust also be made available for inspection pursuant to Section 11 ofTSCA, must state the effective date and time oftransfer, and must containprovisions which expressly transfer liability for the PMN substances under the terms of this Order from the Company to the Successor inInterest.
(e) Liability. (1) The Company shall be liable for compliance withthe requirements ofthis Order until the effective date andtime ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements ofthis 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 ofthe transfer for actions taken,
or omissions made, during the time inwhichthe Company manufactured, processed, used, distributed in commerce, or disposed ofthe PMN substances pursqant to the terms.ofthis25 Consent Order.
(f) Obligations to Submit Test Data under Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Orderrequires the Companyto submittest datato EPA at a specifiedproduction volume ("testtrigger"), the aggregate voiume ofthe PMN substances manufactured (which includes imported) by the Company up to the date oftransfer shall count towards the test trigger applicable to the Successor in Interest.

· VI. MODIFICATION AND REVOCATIONDF·CONSENT ORDER· The Company maypetition EPA at any time, based upon new information onthe health effects of, or human exposure to, the PMN substances, to modify orrevoke substantive provisions ofthis Order. The exposures and risks identified by EPA during its review ofthe PMN substances and the information EPA determined to bene. 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 ofnew test data or other information or analysis, and any other relevant information. EPA will issue a modification or revocation ifEPA determines that the activities proposed therein will not present an unreasonable risk ofinjury to health orthe environment and will not result in significant or substantial human exposure or substa:htial environmental release in the absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects ofthe PMN substances.26 In addition, the CompanymaypetitionEPA at any time to make other modifications to the language ofthis Order, including modifications to productionvolume limits and timeperiods for submission ofreports and data which are necessary due to no fault of, or circumstances beyondthe control of, the Company. EPA in its sole discretion, may issue such a modificationif EPA determines that the modificationis useful, appropriate, andconsistentwiththe structure and intent ofthis Order as issued.27 VII. EFFECT OF CONSENT ORDER (a) Waiver. This Order is effective when signed belowby both parties and received by EPA. By consenting to the entry ofthis Order, the Company waives its rights to file objections to this Orderpursuant to section 5(e)(l)(C) ofTSCA, to receive service ofthis Orderno later than 45 days before the end ofthe reviewperiod pursuant to section 5(e)(l)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound byits tenns, do not constitute an admission by the Company as to, the facts or conclusions underlying the Agency's determinations inthis proceeding. This waiver does not affect any otherrights that the Company may·have under TSCA.- (b) CBI Brackets. By signing this Order, the Company represents that it has carefullyreviewed this document andhereby agrees that all information herein claimed as confidential by the Company (per section 14 ofTSCA, 40 CFRPart 720 SubpartE, and 40 CFR Part 2) is correctly identified within brackets and that any informationthat is not bracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained withinthe brackets.

Date



# -

**-~** 

# 6 MariaJ. Doa, 

### 1 1 

### .I . Director 

# ·-
Chemical Control Division Office ofPollution 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 ofa chemical substance inaccordance 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 orpersons subjectto this Order. "Commercial use" means the use ofa 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, brandname, or generic chemical name used to identify a chemical substance other than byits chemical name. "Consumer" means a private individual who uses a chemical substance or any product containing the chemical substance in oraround a permanent oi· tempormy household or residence, during recreation, orfor anypersonal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, or as part ofa mixture, sold or made available to consumers for their use in or around a permanent or temporary household orresidence, in or around a school, or inrecreation. "Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, orthe like that contains a hazardous chemical. Forpurposes ofthis 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. ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Final Formulation ofthe PMN substances" means the formulated dispersion or solution ofthe PMN substa11ces in the form in which it is sold to customers outside the Company or transferred to a different business unit withinthe Company. The term does not include intermediate dilutions ofthe 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" ofa person ifit is underthe 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 atwhich one ormore chemical substances or mixtures are manufactured (including imported) orprocessed.

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

**fonn~lation,** as it exists when first produced and isolated after the polymermanufacturing process, that can be further processed orrepackaged at the direction ofthe Company to result ultimately in one or more final formulations ofthe PMN substances. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. "MSDS" means material safety data sheet, the written listing ofdatafor the chemical substance. "NIOSH'' means theNational Institute for Occupational Safety and Health ofthe U.S. Department ofHealth and Human

**Services~** "Non-enclosed process" means any equipment system (such as an open-top reactor, storage tank, or mixing vessel) inwhich a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe 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, orprocessed. "PMN substances" means the chemical substance (see TSCA s. 3(2)) described in the Premanufacture notices submitted bythe Companyrelevant to this Order. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofprocessing, includingthe cleaning ofequipment. "Scientifically invalid"means any significant departure from the EPA-approved protocol or the Good Laboratory Practice Standards at 40 CFRPart 792 without prior or subsequent Agency approval that prevents a reasoned evaluation ofthe health or envirorimental effects ofthe 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 thepotential risk ofinjuryto humanhealth orthe environment ofthe PMN substances.
"Sealed container" means a closed containerthat is physically andchemically suitable for long-term containment ofthe PMN substances, and from whichthere will beno human exposure to, nor environmental release of, the PMN substances duringtransport and storage. "Use stream" means all reasonably apticipatedtransfer, 

### flow, !)f .disposal ofa chemi. cal substance, regardless ofphysical state or concentration, through allintended operations of . industrial, commercial, orconsuineruse. "Workplace" means an establishment at one geographic location containing oneormore work areas.**Co~pany** (Transferor) ATTACHMENTB NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER
PMNNumper 1. Transfer ofManufacture Rights. Effective on the Company did sell or otherwise transfer to ("Successor inInterest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substance, which was the subject ofa premanufacture notice (PMN) and is governed by a Consent Orderissued 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 ofLiability. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the responsibility ofthe Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in the United States inaccordance 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 ofTSCA and 40 CFRpart 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 ofTransfer;

. .2 

### TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER NOTICE OFTRANSFER (continued)

**~o.D;lpany** 

### (Transferor) 

# fMN NUilJ.ber
Signature ofAuthorized Official Date PrintedName ofAuthorized Official
Title ofAuthorized Offici.al



## ------------------------------ Successor in Interest
Signature ofAuthorized Official Date
PrintedName ofAuthorized Official
Title ofAuthorized Official Address City, State, Zip Code

### 3


### TOXIC SUBSTANCES CONTROL ACT SECTION5(e) CONSENT ORDER NOTICE OFTRANSFER (continued)

Successor's Technical Contact Address City, State;Zip Cede Phone