11 

### TABLE OF CONTENTS

Preamble I. Introduction II. Sunnnary ofTerms ofthe Order III. Contents ofPMN IV. EPA's Assessment ofRisk V. EPA's Conclusions ofLaw 

### VI. Information Required to Evaluate Human Health and Environmental Effects

Modified Consent Order 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-Inspection Information V. Successor LiabilityUpon Transfer ofModified Consent Order VI. Modification and Revocation ofModified Consent Order VII. Effect ofModified Consent Order Attachment A - Definitions Attachment B - Notice ofTransfer ofModified Consent Order Attachment C - Consent Order for Processor111 

## PREAMBLE This is a modified Consent Order ofthe original Consent Order, which became effective
on April 22, 2010. Thepurpose ofthis Modified Consent Order is to 1) modifY the terms ofthe Distribution Section ofthe Toxic Substances Control Act (TSCA) section 5(e) Consent Order between the U.S. Environmental Protection Agency (EPA) and [ ] (the "Company"); and 2) Extend the time allowed to generate certain material characterization data which was triggeredunderthe original Consent Order. The Modifications are necessaryto allow, prior to promulgation ofa final Significant New Use Rule, for distribution 

### in commerce byProcessors who have signed a Consent Order for Processor ofthe multi-walled carbon nanotubes in a liquid polymer form for use in [ , one ofthe original specific uses in the PMN. Additionally, the Company has relinquished certain claims ofConfidential Business Information (CBI) on the specific chemical identifY oftheir PMN substance, namely, the Agencymaynow refer to the PMN substance as multi-walled carbon nanotubes ("MWCNTs"). The Companymaintains their CBI claims on the specific material characteristics oftheir MWCNTs such as, but not limited to inner diameter and length. Dueto difficulties in developing appropriate protocols on these particular nanoscale materials and finding a laboratory, the Companyrequested, and theAgencyhas granted, an extension on the time period to generate certain triggered testing for material characterization.



### I INTRODUCTION Under the authority of

### § 5(e) ofthe Toxic Substance Control Act ("TSCA") (I5 U.S.C. 2604(e», the Environmental Protection Agency ("EPA" or "theAgency") issuesthe attachedIV Order, regarding premanufacture notice ("PMN") P-09-0188 for the chemical substance, multiwall carbon nanotubes ("MWCNTs") (the "PMNsubstance"), submitted by [ ("the Company"), to take effect upon expirati()n ofthe PMN review period. The Company submitted the PMN to EPA pursuant to section 5(a)(I) ofTSCA and 40 CFR Part 720. Under 

### § 15 ofTSCA, it is unlawful for anyperson to fail orrefuse to comply with any provision of

### § 5 or any order issued under 

### § 5. Violators maybe subject to various penalties and to both criminal and civil liabilitypursuant to § 16, and to specific enforcement and seizure pursuant to § 17. In addition, chemical substances subject to an Order issued under 

### § 5 of TSCA, such as this one, are subjectto the § 12(b) export noticerequirement.



### II. SUMMARY OF TERMS OF THE ORDER The Modified Consent Order for this PMN substance requires the Companyto: I. submit to EPA certain toxicity testing on the powder form ofthe PMN substance before exceeding either the specified production volume or a specified timeperiod; 2. before exceeding a specified time period, submit to EPA certain material and physicalchemical data on the PMN substance in the powder form; 3. require workers to wear personal protective equipment including gloves, chemical protective clothing and goggles in the work area whenever reasonably likely to be dermally exposed to the PMN substance in the work area; 4. whenever workers are reasonably likely to be exposed to the PMN substance byinhalation require workers to wear a NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with N-I00, P-I00, or R-I00 filter; a NIOSH-certified powered air-purifying respirator with a loose-fitting hood orhehnet and a HEPA filter with documented evidence of y .c:: " 'p
..v
an APF of 1,000; a NIOSH-certified continuous flow supplied air-purifYing respirator with a loose-fitting hood orhehnet and a HEPA filter with documented evidence ofan APF of 1,000; or a NIOSH-certified continuous flow supplied air-purifying respirator with a loosefitting hood orhelmet and a HEPA filter with docuri:Jented evidence ofan APF of 1,000, exceptwhen the PMN substance is in the following forms:
• in a liquid polynier form with a concentration ofthe PMN substance equal to or below 7%, provided the activity does not generate a vapor, mist, or aerosol; or
• embedded in a solid polymer form with a concentration ofthe PMN substance equal to orbelow 30% provided the activity does not generate a dust; 5. use and distribute thePMN substance only for the following uses specified in the PMN:

; 6. not use the PMN substance for commercial or consumer use, or in a consumerproduct

. (quantities ofPMN substance that are completely reacted, cured, or embedded as described

in the Order maybe USed for commercial or consumer use, or in a consumerproduct); 7. not manufacture the PMN substance in the United States; 8. provide the U.S. EPA with a 1 g sample ofthe PMN substance upon request by EPA; 9. distribute the PMN substance onlyto a person who agrees to follow the same restrictions applicable to the company (except the testing requirements) and to not further distribute the PMN substance until after ithas been completely reacted (cured), incorporated into aVI polymermatrix that itselfhas beenreacted (cured), or embedded into a solid polymer form

. with a concentration ofthe PMN substance equal to orbelow 30%; 10. not release the PMN substance to the waters ofthe United States except where the PMN substance is embedded in a solid polymer form with a concentration ofthe PMN substance equal to orbelow 30%; and 11. maintain relevant records.
A Consent Order for Processors is attached to extend these requirements to any Processor.
In summary, the "Scope ofApplicability and Exemption" section ofthe Order exempts the following: 1. quantities ofthe PMN substance thathave been completely reacted (cured), incorporated or embedded into a polymer matrix that itselfhas beenreacted (cured), or embedded in a permanent solid polymer form with a concentration ofthePMN substance equal to orbelow 30% that will not undergo further processing except for mechanical processing. These exemptions do not apply beyond the uses that are specifically authorized bythe Orderin the Manufacturing, and Processing and Use sections, but do allow use for commercial or
consumer use, or in a consumer product. 2. quantities designated solely for export before the Company commences import ofthe PMN substance for use within the United States; 3. research & development ("R&D"); 4. the PMN substance as a byproduct without separate commercial intent; and 5. the PMN substance in a substance, mixture, or article with no separate commercial purpose.VII 

### HI. CONTENTS OF PMN By signing this Order, the Companyrepresents that ifhas carefully reviewed this document and hereby agrees that all information herein that is claimed as confidential bythe Company (persection 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) is correctly identified within brackets and that any information that is notbracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove onlythe information contained within the brackets. Confidential BusinessInformation Claims {Bracketed inthePreamble and Order): Company name, specific chemical identity, production volume, physical properties, material

.characterization, precursor substances, typical composition, pr()cess infornation, impurities, use, byproducts, and worker/occupational exposure. Chemical Identitv:
. Specific identity:
. Generic identity: multi-walled carbon nanotubes. Chemical Form: The Notice identifies four forms ofthePMN substance: 1. Powdered

- [

. 2. Liquid polymer form with a concentration ofthe PMN substance 

### up to'[ ] ("liquidpolymer form"):

3. Solid polymer form with a concentration ofthe PMN substance 

### up to [ ] ("solid polymer form"):Vl1l

. 4. The PMN also describes the final end use form ofthe PMN substance. Forthis Modified Consent Order, this form is described as being completelyreacted (cured), incorporated or embedded into a polymer matrix that itselfhas been reacted (cured), or embedded in a permanent solid polymer form with a concentration ofthe PMN substance equal to or below 30% that will not undergo further processing, except for mechanical processing ("PMN substance that is reacted, cured, or embedded in a permanent solid polymer").
Specific: [

] Generic: electric conductive filler to replace conventional material such as carbon black, or carbon fiber in matrices such as polymerresin for conductive applications.

Maximum 12-Month Production Volume: [ kglyr; Import ouly..1:0 IX Test Data Submitted with PMN: " Toxicityto bacteria;

.. Chromosomal aberrations in cultured human cells; • Skin sensitization in mouse lymph node assay; • Acute dermal toxicityin the rat; • Acute oral toxicityinthe rat;

.. Acute eye irritation in rabbits; • Acute dermal irritation in rabbits; • Intratracheal insertion ofsingle-walled cmbon nanotubes produced inflammatory reactions in mouse and rat lungs, with fibrogenic responses (MSDS); • Study ofthe granulometry ofthe carbon nanotube powder; • Coatil1g with

### a polystyrene polymerprotects against respiratory toxicity ofcarbon nanotubes 

### in vitro and 

### in vivo inmice;



### .. In vitro mammalian cell genemutation in LSl78Y TK 

### +/- mouse lymphoma cells; • Adverse effects ofindustrial multiwalled carbon nanotubes on hUll1an pulmonarycells; • Degradation and release ofpolymernanocomposites exposed to ultraviolet radiation; • Baseline carbon nanotubes air san1pling conducted at the ]; • Absence ofcarcinogenic response to MWCNTs in a 2-yearbioassayin the peritoneal cavity oftherat on an analogous substance to the PMN; • Detection of [ ] carbon nanotubes in waterby UV-Vis spectrometryto determine [ ] transferability from liquids and pastes to water; and • Detection ofrespirable nanoparticles released from a viscous paste consisting of [ ] MWCNTs following vigorous manipulation.


### N. EPA'S ASSESSMENT OF RISK The following are EPA's predictions regarding theprobable toxicity, hUll1an exposure and environmental release ofthe PMN substance, based on the information currently available to the Agency.

RUll1an Health Effects Summary: Absorption isexpected to be poorvia all routes for the manufactured substance, based on test data for chemicals with similarmolecular structures and chemicals with similar physical/chemical properties. Data on the PMN substance and other analogous substancesx indicate the potential for generation ofincreased amounts ofrespirable or absorbable particles during processing and use ofnanoscale materials. Much more evaluation is needed to determine the toxicity ofnanoscale materials for all routes ofexposure. There are concerns for lung effects, based on the EPA Respirable, Poorly Soluble Particulates chemical category. See www.epa.gov/opptlnewchems/pubs/cat02.htm#Respirable. Based on test data for analogous chemicals there are concerns for pulmonary toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity of the PMN substance. There are also data suggesting that pulmonary

.deposition of some nanoscale materials, including carbon nanotubes in the agglomerated form, may induce cardiovascular toxicitywhen these nanoscale materials are inhaled. The major health concerns are for potential pulmonarytoxicity, fibrosis and cancer to workers exposed via inhalation. The PMN substance as manufactured tested negative for skin sensitization in the Local LymphNode Assay (LLNA) and was slightly irritating in an acute dermal irritation study in rabbits. Based on the uncertainty ofthe characterization and exposure ofnanoscale materials in general, there maybe additional potential for translocation across the dermis and effects on target organs.

Environmental Effects Summary; Toxicity from carbon nano[ ] ( ]) exposures has been reported in many aquatic species at concentrations much higher than any estimated solubility limits. Even though CNTs are not appreciably water soluble as manufactured, aqueous CNT suspensions can be easily made through reaction with strong acids, ozone, or dispersing agents. Recent laboratory research shows that ] combine with dissolved organic matter (DOM) to form stable aqueous suspensions. No studies on CNTs are available in which a broad range ofproduction methods,Xl sources, purification, functionalization, etc. were investigated. EPA expects that some fraction ofthe CNTs, ifreleased into the enviromnent, will eventuallybecome suspended in water. Sublethal effects havebeen noted for single-walled carbon nanotubes (SWCNT) in fish at levels
as low as 100 ppb. Noted effects included respiratory stress, ventilation rate, gill mucus secretion, gill damage, and aggressive behaviors. Liver cell injuries were also readily apparent at these exposure levels and suggest thepossibIlity oflivertumor formation over longer exposure periods. This response is also notablebecause effectswere seen in cells closest to bloodvessels, suggesting transport ofr<:,spired or ingested SWCNTs viatheblood stream. Some effects in the· gut lumen were also observed at these exposure levels. Further studies need to be conducted before EPA can determine a concentration ofconcern. Such studies must measure actual concentrations ofcarbon nanotubes and controlfor the effects ofcontaminants, solvents,and physical factors such as blockage ofgills orintestines. Before such testing is conducted, advanced fate testing would be necessary to ascertain what substance is likelyto present the highest enviromnentallyrelevant concentrations.
Exposure and Enviromnental Release Summary:
Manufacture Processing Use Consumer 

### # Sites Imported 

## [ [ N/A
Workers Imported 

## [ [ N/A (#/site) Exposure Imported 

### [ ] [ None (days/year) expectedXlI

. 

### Manufacture Processing
_ Use Consumer Imported [ ] None Inhalation [ [ expected Exposure ] (mg/day)

- 

### Imported None Dermal Exposure ] expected (mg/day) Drinking Water Imported [ None Exposure expected (mg/kg/day) )]

.

.


### Releases to all Imported [ days [ days .None environmental expected media (days/year)



# . Release to Water Imported [ [ None (kg/day) expected Fugitive Air 

### Imported [ [ None Exposure [ expected (mg/kg/day)

Risk to Workers: The PMN substance maypresent a risk to workers exposed to the PMN substance via inhalation. In the table above, the worst case worker inhalation value is [ / during processing. As the PMN substance is manufactured, 1% ofthe particles are expected to be in the respirable size, though test data included with the PMNX111 suggest that.this percentage is expected to increase as the PMN substance is handled. Previous similar cases havepredicted occupational exposures as high as 0.05 mg/m3 for respirable particles. Therefore, there is a concern for pulmonary toxicity, fibrosis and cancer and a potential for cardiovascular effects to workers exposed to the PMN via the inhalation route. To mitigate potential health effects viathe inhalation route ofexposure, the Order requires respiratory protection for the powdered form ofthe PMN substance and when a dust,vapor, mist, or aerosol

. containing the PMN substance isgenerated. EPA believes the PMN substance as manufactured presents a low risk to workers exposed to the PMN substance dermally, but does nothave enough information to evaluate therisks when the PMN substance is handled. To mitigate potential health effects via the dennal route of**expo~ure,** the Order requires varying degrees of dermal protection based on theform ofthe PMN substance.

Risk to general population: There is potential for exposure ofthe general population and the environment from landfill releases. Human ingestion mayresult from landfill releases.

Environmental 

### Risk: The amount ofPMN substance expected to be released into the environment, in the absence ofsite-specific risk management practices described in the notice, would lead to surface water concentrationsthat exceeded environmental toxicities identified by EPA. Therefore, the attached Orderprohibits releases ofthe PMN substance to surface water except for the solid polymer form with a concentration ofthe PMN substance equal to orbelow 30%.XIV



### V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis ofthe Modified Consent Order: (a) EPA is unable to determine the potential for effects to human health and the environment from exposure to the PMN substance. EPA therefore concludes, pursuant to § 5(e)(l)(A)(i) of TSCA, that theinformation available to the Agencyis insufficient to permit a reasoned evaluation ofthehuman health and environmental effects ofthe PMN substance. (b) In light ofthe potential risk to humanhealth and the environment posed bythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance, EPA has concluded, pursuant to 

### § 5( e)(1)(A)(ii)(I) ofTSCA, that uncontrolled manufacture,import, processing, distribution in commerce, use, and disposal ofthe PMN substance maypresent an unreasonable risk ofinjury to humanhealth and the environment.



### VI. INFORMATION REOUIRED TO EVALUATE HEALTH EFFECTS Triggered Testing. The Orderprohibits the Company from exceeding specified time periods or production volumes urtless the Company submits the information described in the Testing section ofthis Order in accordance with the conditions specified in the Testing section. The Order's restrictions on manufacture, import, processing, distribution in commerce, use, release to water, and disposal ofthe PMN substances will remain in effect until the Order is modified or revoked byEPA based on submission ofthator otherrelevant information. EPA encourages the Companyto develop additional health effects testing in coordination with other manufacturers of carbon nanotubes. This canbe done under the in-depth portion ofEPA's Nanoscale Materials Stewardship Program or through independent testing. EPA is willing to facilitate the process inxv coordination with other ongoing health effects testing for the PMN substances nationally and internationally.

Pended Testing. The following additional information would be required to evaluate the following effects which maybe caused bythe PMN substance: Environmental Exposures The Company may submit the following environmental exposure data on a representative set of liquid polymer forms ofthe PMN substance.(EPA identified [ ] in the PMN). The Companymaypropose alternative methods, guidelines, orrepresentative sets subject to EPA's approval.
Characteristic or Property Release of MWCNTs after landfill disposal . . Guideline or method
EPA Method 1320: Multiple Extraction Procedure todeterrnine the fraction ofMWCNTs released during the leaching that the liquid polymer forms will undergo from repetitive precipitation ofacid rain. Method 1320 uses EPA Method 13 lOB: Extraction Procedure (EP) Toxicity Test Method and Structural Integrity Test as the basis for the multiple extraction method. Chapters 3 and 4 cited in Section 7.17 ofMethod l3l0B refer to chapters in the**SW~846** "Test Methods for Evaluating Solid Waste, Physical/Chemical Methods". However, instead ofusing these analyses methods, the analysis ofMWCNTs in the extracts should be performed using EPA Method 100.1: Analytical Method for Determination ofAsbestos Fibers in Water, which has an analytical· sensitivity ofapproximately**~.3** flg/L for a MWCNT that is 10 nm ]. An allowable alternative analytical approach would be to use Raman spectroscopy (see Liu et al., PNAS, 2008,105(5),1410-1415).XVI
Characteristic or Guideline or method Property

. Release ofMWCNTs Consult ASTM E1354-09: Standard Test Method for Heat and during the burning of Visible Smoke Release Rates for Materials and Products Using an liquid polymer forms Oxygen Consumption Calorimeter as the basis for this test. For example, this test method was used to determine the flammability of polyamide 11 and 12 nanocomposites (see Lao et al., J. Compo Mat. 2009,43,1803-1818). Given that the airborne fractionofMWCNTs is ofinterest, the ASTM E1354-09 test would have to be modified so that samples ofthe off-gas could be collected and analyzedfor MWCNT content. For the analytical method, consider using methods developed for airborne asbestos fibers found inAppendix A to Subpart E-Interim Transmission Electron Microscopy Analytical Methods found in 40 CFR Part 763. [ ] maywant to consult with Dr. Marc R. Nyden, Building and Fire Research Laboratory, National Institute ofStandards andTechnology, Gaithersburg, MD.

. .

. Release ofMWCNTs Polymeric resins are known to degrade after exposure to sunlight. from after exposure of (see Polymer Photodegradation: Mechanisms and Experimental liquid polymerforms to Methods, J.F Rabek, Chapman and Hall, London UK, 1995). Thus, if suulight the MWCNT containing resins were exposed to suulight, they are expected to degrade and release free MWCNTs into the enviromnent (see Nguyen et al., Degradation ofNanofiller Release ofPolymer Nanocomposites Exposed to Ultraviolet Radiation, NIST, Gaithersburg, MD). ASTM D2565-99(2008) Standard Practice for Xenon-Arc Exposure ofPlastics Intended for Outdoor Applications should be consulted.I xvii TheCompanymay submit the following enviromnental exposure data on a representative set of solidpolymer forms ofthe PMN substance (EPA identified [ ] in the PMN). The Companymaypropose alternative methods, guidelines, orrepresentative sets subject to EPA's approval. Characteristic or Guideline or method Property Release ofMWCNTs EPA Method 1320: Multiple Extraction Procedure to determine the after landfill disposal fraction ofMWCNTs released during the leaching that the solid polymer forms will undergo from repetitive precipitation ofacid rain. Method 1320 uses EPA Method 

### BlOB: Extraction Procedure (EP) Toxicity Test Method and Structural Integrity Test as the basis for

. . the multiple extraction method. Chapters 3 and 4 cited in Section 7.17 of Method 

### BlOB refer to chapters inthe SW-846 "Test Methods for EvaluatingSolidWaste, Physical/Chemical Methods". However, instead ofusing these analyses methods, the analysis of MWCNTs in the extracts should beperformed using EPA MethOd 100.1: Analytical Method for Determination ofAsbestos Fibers in Water, which has an analYtical sensitivity ofapproximately 3.3 /lgiL for a MWCNT that is [ ]. An alternative analytical approach would be to use Raman spectroscopy (see Liu et al., PNAS, 2008,105(5), 1410-1415). Release ofMWCNTs Consult ASTM E1354-09: Standard Test Method for Heat and during the burning of Visible Smoke Release Rates for Materials and Products Using an solidpolymerresins Oxygen Consumption Calorimeter as the basis for this test. For example, this test method was used to determine the flammability of polyamide 11 and 12 nanocomposites (see Lao et aI., 

### J. Compo Mat. 2009,43, 1803-1818). Given that the airborne fraction ofMWCNTs is ofinterest, the ASTM E1354-09 test would have to be modified so that samples ofthe off-gas could be collected and analyzed for IXVlll MWCNT content. For the analytical method, consider using methods developed for airborne ]. [ ] may want to consult with Dr. Marc R. Nyden, Building and Fire Research Laboratory, National Institute ofStandards and Technology, Gaithersburg, MD. Characteristic or Guideline or method Property Release ofMWCNTs Polymeric resins are known to degrade after exposure to sunlight (see from after Exposure of Polymer Photodegradation: Mechauisms and Experimental Methods, solid polymer forms to . J.F Rabek, Chapman and Hall, London UK, 1995). Thus, ifthe sunlight MWCNT containing polymer forms were exposed to sunlight, they are expected to degrade and release free MWCNTs into the environment (see Nguyen et al., Degradation ofNanofiller Release of Polymer Nanocomposites Exposed to Ultraviolet Radiation, NIST, Gaithersburg, MD). ASTM D2565-99(2008) Standard Practice for Xenon-Are Exposure ofPlastics Intended for Outdoor Applications should be consulted. Release ofMWCNTs [ during solid polymer which are resin based composites (

. form shipping and use 3]). Presumablythe MWCNTs would also be released from the solid resins during mechauical agitation ofthe solid resins. Mechauical agitation could potentially occur during shipping and transfer ofthe [ containing solid resins. [ ] should develop a testing protocol to determine ifMWCNTs are released from solid resins during mechauical agitation. While no standard methods exist, [



### . should consider developing a simple short-term test consisting of placing the solid polymer forms in a standard rock tumbler and det=iuing the amount offree MWCNTs after a period ofl, 5,15,XIX and 30 days to screen for significant release ofMWCNTs from the solid polymer forms.

The Order does not reqnire submission ofthe above pended testing at any specified time or production volume. However, the Order's restrictions on manufacture, import, processing, distribution 

### in com:riJ.erce, use, and disposal ofthe PMN substance will remainin effect until the Order is modified or revoked by EPAbased on submission ofthat or other relevant information.r ' UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



## MODIFIED CONSENT ORDER I. SCOPE OF APPLICABILITY AND EXEMPTIONS OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

(a) Scope. The requirements ofthis Order applyto all commercial manufacturing, processing, distribution in commerce, use and disposal, in the United States, ofthe chemical substance multiwalled carbonnanotubes ("MWCNTs") (the "PMN substance") by ] ("the Company"), except to the extent that those activities are exemptedbyparagraph (b). The Original Consent Order, whichbecame effective on April 22, 2010, will be superseded bythe Modified Consent Order once the Modified Consent Order becomes effective.
(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance are exempt from therequirements ofthis Order (except the requirements in the Recordkeeping and Successor Liability Upon Transfer OfModified Consent Order sections) only

Internet Address (URL) • http://www.epa.gov Recycled/Recyclable" Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free'Recycled Paper2
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 recordkeeping as required in the Recordkeeping section ofthis Order. (1) CompletelyReacted, Cured, orEmbedded. Ifquantities of the PMN substance (A) are used solely for the uses authorized in paragraph (c) ofthe Manufacturing section andby paragraphs (a) and (b), ofthe ProcessingfUse section ofthis Order; and (B) those quantities have been (i) completelyreacted (cured); (ii) incorporated or embedded into a polymermatrix that itself has been reacted (cured); (iii) or embedded in a permanent solid polymer form with a concentration ofthe PMN substance equal to orbelow 30% that is not intended to undergo further processing except for mechanical processing; then the otherrequirements ofthis Order do not apply. (2) Export. Until the Companybegins commercial manufacture ofthe PMN substance for
use in the United States, the requirements ofthis Order do not applyto manufacture, processing or distribution in commerce ofthe PMN substance solelyfor export in accordance with TSCA 

### §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Companybegins to manufacture the PMN substance for use in the United States, no further activities by the Company involving the PMN substance are exempt as "solely for export" even ifsome amounts ofthe PMN substance are later exported. At that point, the requirements ofthis Order apply to all activities associated with the PMN substance while in the territory ofthe United States. Prior to leaving U.S. territory, even those quantities orbatches ofthe PMN substance that are destined for export
are subject to terms ofthe Order, and count towards anyproduction volume test triggers in the Testing section ofthis Order. (3) Research & Development ("R&D"). The requirements of this Order do not apply to 

# ,3 manufacturing, processihg,distribution in commerce, use and disposal ofthe**PM~** substance in small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CPR 720.3(cc), and 40 CPR 720.36. (4) Byproducts. The requirements ofthis Order do not applyto the PMN substance when it is produced., without separate commercial intent, only as "byproducts" as defined at 40 CPR 720.3(d) and in compliance with 40 CFR 720.30(g). (5) No·Separate Commercial Purpose. Therequirements ofthis Order do not applyto the PMN substance when it is manufactured, pursuant to any ofthe exemptions in 40 CFR 720.30(h), withno commercial purpose separate from the substance, mixture, or article ofwhich it is a part.
(c) Automatic Sunset. Ifthe Companyhas obtained for the PMN substance aTest Market Exemption ("TME") under TSCA §5(h)(1) and 40 CFR 720.38 or a LowVolume Exemption ("LVE") or Low Release and Exposure Exemption ("LoREx") under TSCA §5(h)(4) and 40 CFR 723.50( c)(l) and (2) respectively, any such exemption is automatically rendered null and void as ofthe effective date ofthis ModifiedConsent Order.



### II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND 

### EVALUATION OF INFORMATION
PROHIBITION The Company is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing ofthe PMN substance in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation4
ofthehuman health and environmental effects ofthe substance, and the completion ofEPA's review of, and regulatory action based on, thatinfonnation, except in accordance with the conditions described in this Order.



### TESTING (a) Section 8ee) Reporting. Reports ofinfonnation on the PMN substance which reasonably supports the conclusion that the PMN substance presents a substantial risk ofinjury to health orthe environment and which is required to be reported under TSCA section 8(e) shall reference the appropriate PMN identification number for this substance and contain a statementthat the substance is subject to

### .this Modified Consent Order. Additional informationregarding section 8( e) reporting requirements canbe found at www.epa.gov/opptltsca8e.
(b) Notice ofStudy Scheduling. The Company shall notify, in writing, the EPA Laboratory Data Integrity Branch (2225A), Qffice ofEnforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, ofthe following infonnation within 1(j days ofscheduling any studyrequired to beperfonned pursuant to this Order, orwithin 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 number ofa person at the Company orthe laboratory whom EPA may contact regarding the study; and (4) The appropriate PMN identification number for the substance and a statement that the

### 5 substance is subject to this Modified Consent Order.
(c) Good Laboratory Practice Standards and Test Protocols. Each studyrequired to be perfonned pUrsuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards at 40 CPR Part 792 and using methodologies generally accepted in the relevant scientific community at the time the study is initiated. Before starting to conduct any such study, the Companymust obtain approval oftest protocols from EPA by submitting written protocols. EPA will respond to the Company within 4 weeks ofreceiving the written protocols. Published test . guidelines specified inparagraph (d) provide general guidance fordevelopment oftest protocols, but are not themselves acceptable protocols. Approval ofthe test protocol does not mean preacceptanceoftest results.
(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or importing the PMN substance for non-exempt purposes beyond either ofthe following time or aggregate manufacture and import volume limits ofthe non-exempt PMN substance (collectively "the production limit") unless the Company conducts the following tests on the PMN substance and submits all final reports and underlying datain accordance with the conditions specified in this Testing section. (1) Toxicity Tests. The production limit for these tests shall be calculated starting two years

. after expiration ofthe PMNreview period.6



### Production Limit Test 

### Guideline [ ] 90-dayinhalation toxicity test, OPPTS 870.3465 or [ 2] kg, whichever with a post-exposure comes first observation period ofup to 3 months, bronchoalveolar

. lavage fluid (BALF) analysis,

aggregation!agglomeration state, shape, size/size particle distribution and surface properties ofmaterials asadministered, aggregation! agglomeration state, shape, size/size particle distribution and surface properties of materials ofthe delivered materials after administration, determination ofcardiovascular toxicity, heart histopathology, and data onpuhnonary deposition. (2) Material Characterization and Physical-Chemical Properties. The Companymust submit the following material characterization data on the PMN substance in thepowdered form (including data summaries and procedures), and is strongly encouraged to send inproposed procedures before conducting the studies to allow EPA review. Description ofthe physicalchemical properties ofthe material tested and material characterization tests should take into consideration the characterizations identified in the Guidance Manual for Sponsors ofthe OECD Sponsorship Programme for the Testing ofManufactured Nanomaterials. These tests shall be due 18 months after expiration ofthe PMNreview period. The Company maypropose alternative methods or guidelines subject to EPA's approval.7

Characteristic or Property Guideline or method [ ] Transmission-electron microscopy (TEM) [ ] Scanning electron microscopy (SEM) and TEM [ ] X-ray diffraction (XRD)

. [ ] SEM& TEM [ ]
. XRD XRD

. Particle sizes ofcatalyst used inthemanf. ofthe Vendor specifications nano[ ] Particle shape Optical microscopy and surface area

. measurements Particle size (average and distribution) Optical microscopy and surface area .

.. measurements Particle surface to volume ratio Optical microscopy and surface area measurements Agglomeration Optical microscopy and surface area measurements Particle surface area measurement Optical microscopy and surface area measurements Dustiness test Deutsches Institut fUr Niirmung ("DIN") EN 15051 method

(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care,and in
a scientifically valid manner; (2) promptlyfurnish to EPA the results ofany interim phase ofeach study; and (3) submit, in triplicate (with an additional sanitized copy, ifconfidential business information is involved), the final report ofeach study and all underlying data ("the report and data") to EPA no later than 14 weeks priorto exceeding the applicable production limit. The final report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting", "Data and Reporting", and "Test Report" subparagraphs in the applicable test gnidelines. However, for purpost;'s ofthis Modified Consent8 Order, the word "should" inthose subparagraphs shall be interpreted to mean "shall" to make clear that the submission ofsuch information is mandatory. EPA will not require the submission ofraw data such as slides and laboratory notebooks unless ifEP A finds, on thebasis ofprofessional judgment, that an adequate evaluation ofthe studycannottake place in the absence ofthese items.


### (1) Testing Waivers. The Companyis not required to conduct a studyspecified inparagraph (d) ofthis Testing section ifnotified in writing byEPA that it is unnecessary to conduct that study.
(g) Equivocal Data. IfEPA finds that the data generated by a study are scientificallyequivocal, the Companymay continue to manufacture and import the PMN substancebeyond the applicable production limit. To seekrelieffrom any otherTestrictions ofthis Order, the Company maymake
a second attempt to obtain unequivocal data byreconducting the studyunderthe conditions specified in paragraphs (b), (c), and (e)(l) and (2). The testing requirements maybemodified, as necessary to p=it a reasoned evaluation ofthe risks presentedbythe PMN substance, onlyby mutual consent ofEP A and the Company.
(h) EPA Det=ination ofInvalidData. (I) Except as described in subparagraph (h)(2) ofthis Section, if, within 6 weeks ofEPA's receipt ofa test report and data, the Companyreceives written notice that EPA fmds that the data generated bya study are scientifically invalid, the Company is prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit. (2) The Companymay continue to manufacture and import the PMN substance beyond the applicable production limit only ifso notified, in writing, by EPA in response to the Company's 

## , '

### 9 compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) The Companymayreconduct the studyin compliance with paragraphs (b), (c), and (e)(l) and (2). Ifthere is sufficient time to reconduct the study and submit thereport and data to EPA at least 14 weeks before exceeding theproduction limit as required by subparagraph (e)(3)

. ofthis Section, the Company shall comply with subparagraph (e)(3) ofthis Section. Ifthere is

insufficient timefor the Companyto comp1y'with subparagraph (f)(3) ofthis Section, the Companymay exceed the production limit and shall submit the report and data in triplicate to EPA within a reasonable periodoftime, all as specified by EPA in the notice described in subparagraph (h)(1) ofthis Section. EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data. (ii) The Companymay, within 4 weeks ofreceivingfrom EPA the notice described in subparagraph (h)(1) ofthis Section, subniit to EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report.
(i) CompanyDetermination ofInvalid Data. (l)Except as described in subparagraph (i)(2) ofthis Section, ifthe Companybecomes
aware that circumstances clearlybeyond the control ofthe Company or laboratory will prevent, or have prevented, development ofscientifically valid data under the conditions specified in paragraphs (c) and (e), the Companyremains prohibited from further manufacture and import of the PMN substance beyond the applicable production limit. (2) The Companymay submit to EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why' circumstances clearlybeyond the control ofthe Companyorlaboratory will cause orhave caused development ofscientifically invalid data. EPAlO
will notifY the Company ofits response, in writing, within 4 weeks ofreceiving the Company's report. EPA's written response may either: (i) allow the Company to continue to manufacture and import the PMN substance beyond the applicable production limit, or (ii) require the Company to continue to conduct, orto reconduct, the study in compliance with paragraphs (b), (c), and (e)(l) and (2). Ifthere is sufficient time to conduct or reconduct the study and submit the report and datato EPA at least 14 weeks before exceeding the production limit as tequired by subparagraph (e)(3) ofthis Section, the Company shall comply with subparagraph (e)(3) ofthis Section. Ifthere is insufficient time for the Company to comply with subparagraph (e )(3) ofthis Section, the Companymay 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 (i)(2) ofthis Section. EPA willrespond to the Company, inwriting, within 6 weeks ofreceiving the Company's report and data, as to whether the Companymay continue to manufacture and importbeyond the applicable production limit.
G) Umeasonable Risk. (1) EPA may notify the Companyin writing that EPA finds**th~t** the data generated by a study are scientifically valid and unequivocal and indicate that, despite the terms of this Order, the PMN substance will ormaypresent an umeasonable risk ofinjury to human health or the environment. EPA's notice may specify that the Companyundertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthe PMN substance to mitigate exposures to or to better characterize the risks presentedbythe PMN substance. Within 2 weeks from receipt ofsuch a notice, the Companymust cease all11 manufacture, import, processing, distribution, use and disposal ofthe PMN substance, unless either: (2) within 2 weeks from receipt ofthe notice described in subparagraph G)(1) ofthis Section, the Company complies with such requirements as EPA's notice specifies; or (3) within 4 weeks from receipt ofthe notice described in subparagraph 0)(1) ofthis Section, the Company submits to EPA a written report refuting EPA's finding andlor the appropriateness ofany additional requirements imposed byEPA. The Companymay continue to manufacture, import, process, distribute,use and dispose ofthe PMN substance in accordance with the terms ofthis Orderpending EPA's response to the Company's written report. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks ofreceipt ofEPA's written response, the Companyshall comply with anyrequirements imposed byEPA's response or cease all manufacture, import, processing, distribution, use and disposal ofthe PMNsubstance.
(k) Other Requirements. Regardless ofthe satisfaction ofany other conditions inthis Testing section, the Companymust continue to obey all the terms ofthis Modified Consent Orderuntil otherwisenotified in writingbyEPA. The Company may, based upon submitted test data or other relevant information, petition EPA to modifY or revoke provisions ofthis Modified Consent Order pursuant to Part VI ofthis Modified Consent Order.

PROTECTION IN THE WORKPLACE (a) Establishment ofProgram. During manufacturing, processing, and use ofthe non-exempt PMN substance at any site controlled bythe Company (including any associated packaging and12 storage and during any cleaning or maintenance ofequipment associated with the PMN substance), the Company must establish a program whereby: (1) Applicable Protective Requirements for Different Forms ofthe PMN Substance. The Company shall determine and implement the minimum dermal and respiratorypersonal protective equipment requirements for the different forms ofthe PMN substance according to the following table:
Physical Forms Maximum Minimum Dermal Minimum concentration ofthe Protection Resl!iraton:: PMN substance Protection Powdered· Any Full general and Respiratory protection specific dermal required in a(5) protection required in a(2) and a(3). Liquid polymer form Less than or equal to Full general and None required 7%

. specific dermal provided there is no protection required in generation ofvapor, a(2) and a(3). mist, or aerosol and the concentration of
. the PMN substance is less than or equal to 7%, otherwise respiratoryprotection required in a( 5) Solid polymer form Less than or equal to Ifthere is no Ifthere is no 30% generation ofdust and generation ofdust and the concentration of the Concentration of the PMN substance is the PMN substance is less than or equal to less than or equal to 30%, none required. 30%, none required
.. Otherwise, full general Otherwise, respiratory and specific dermal protectionrequired in protection required in a(5). a (2) and a (3).13 (2) General Dermal Protection. When required by the table in subparagraph a(l) ofthis section, each person who is reasonably likelyto be dermally exposed in the work area to the PMN substance through direct handling ofthe substance orthrough contact with equipment on which the substance may exist, is required to wear, at a minimum, personal protective equipment that provides abarrierto prevent dermal exposure to the substance as specified in the minimum dermal protection column ofthe table in subparagraph (a)(l) in the specific work area where the substance
are selected for use. Each such item ofpersonal protective equipment must be selected and used in accordance with OSHA dermal protection requirements at 29 CFR 1910.132,1910.133, and 1910.138. (3) Specific Dermal Protective Eguipment. When required bythe table in subparagraph (a)(l) ofthis section, the dermal personal protective eqnipment required by subparagraph (a)(2) must include, but is not limited to, the following items: (i) Gloves impervious to the PMN substance. (ii) Full body clothing impervious to the PMN substance. (4) DemonstrationofImperviousness. The Companymust be able to demonstrate that each item ofchemical protective clothing selected, including gloves, provides an impervious barrierto prevent dermal exposure during normal and expected duration and conditions of exposure within the work area by anyone or a combination ofthe following: (i) Testing. Testing the material used to make the chemical protective clothing and the construction ofthe clothing to establish that the protective clothing will be impervious for the expected duration and conditions ofexposure. The testing must subject the chemical protective clothing to the expected conditions ofexposure, including the likely combinations ofchemical substance to which the clothing maybe exposed in the work area. Testing maybe conducted14 according to the American Society for Testing and Materials ("ASTM") F739 "Standard Test Method for Resistance ofProtective Clothing materials to Permeation by Liquids or Gases," Results shall be recorded as a cumulative permeation rate as a function oftime, and shall be documented in accordance with ASTM F739 using the format specifiedin ASTM F1194-89 "Guide for Documenting the Results ofChemical Permeation Testing on Protective Clothing Materials," Testing may also be conducted according to the ASTM F1671-07 "Standard Test Method for Resistance ofMaterials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System", Gloves maynotbe used foratime period longer thafl they are actually tested and mustbereplaced at the end ofeach work shift during which they are exposed to the PMN substance, (ii) Manufacturer's Specifications, Evaluating the specifications from the manufacturer or supplier ofthe chemical protective clothing, or ofthe material used in construction ofthe clothing, to establish that the chemical protective clothing will be impervious to the PMN substance alone and in likely combination with other chemical substance in the work area, (5) Respiratory Protection, When required bythe table in subparagraph (a)(1) ofthis section, each person who is reasonably likely to be exposed byinhalation inthe work area to the PMN substance, is provided with, and is required to wear, at a minimum, a NIOSH-certified respirator from the respirators listed in subparagraph (a)(6) ofthis section, and the respirator is used in accordance. with the Occupational Safety and Health Administration ("OSHA") and NIOSH respiratoryprotection requirements at 29 CFR 1910.134 and 42 CFR Part 84. All respirators must be issued, used, and maintained according to an appropriate respiratoryprotection program under the OSHA requirements in 29 CFR 1910.134. , ', 

### , 15 (6) Authorized Respirators. The followllig NIOSH-certified respirators meet the minimum requirements for subparagraph (a)(5) ofthis section: NIOSH-certified airpurifYing, tight-fitting full-face respirator equipped with N-I00, P-I00, or R-I00 filter; a NIOSHcertified powered air-purifYing respirator with a loose-fitting hood orhelmet and a HEPA filter with documented evidence ofan APF of 1,000; a NIOSH-certified continuous flow supplied airpurifYing respirator with a loose-fittinghood orhelmet and a HEPA filter with documented evidence ofan APF ofl,OOO; or a NIOSH-certified continuous flow supplied air-purifYing respirator with a loose-fitting hood orhelmet and a HEP A filter with documented evidence ofan APF ofl,OOO.



### MANUFACTURING (a)(I) Prohibition. The Company shaIl not cause, encourage, or suggest the manufacture orimport ofthe PMN substance by anyotherperson. (2) Sunset Following SNVR. Subparagraph (a)(l) ofthis Section shaIl expire 75 days after promulgation ofa finaI significant newuse rule ("SNUR")govemingthe PMN substance under section 5(a)(2) ofTSCA unless the Companyis notified on orbefore that day ofan action in a FederaI Court seekingjudiciaI review ofthe SNUR. Ifthe Companyis so notified, subparagraph (a)(I) shaIl not expire until EPA notifies the Companyin writing that all FederaI·Court actions involving the SNUR have been resolved and the validity ()fthe SNUR affirmed
.. (3) Notice ofSNUR. When EPA promulgates a finaI SNUR for thePMN substance and subparagraph (a)(I) ofthis Section expires in accordance with.subparagraph (a)(2) ofthis Section, the Company shall notifY each person whom it causes; encourages or suggests to manufacture or import the PMN substance ofthe existence ofthe SNUR.16

(b) Import Only. The Company shall not manufacture the PMN substance in the United States. (c) Prohibited Uses. The Company shall not: (1) manufacture or import the PMN substance for use other than as:

]; (2) manufacture orimport the non-exempt PMN substance for commercial or consumeruse, or in
a consumerproduct. (d) Sample. The Company shallprovide to EPA a 1 gram sample ofthe PMN substance as specified by EPA in a future written request along with a copy ofthe MSDS for the substance.

PROCESSING AND USE (a) The Company shall not process oruse the PMN substance other than as:

]; and (b) The Company shall notprocess oruse the non-exempt PMN substance for commercial
or consumer use, orin a consumerproduct.h'

, 

### , 17

DISTRIBUTION (a) Export Notice Requirement. No later than the date ofdistribution, the Company shall notify in writing anyperson to whom it distributes the PMN substances ( a Distributee) that, due to the issuance ofthis Modified Consent Orderunder section 5(e)ofTSCA, the PMN substances are subjectto the export notification requirements ofTSCA section l2(b) and 40 CFRPart 707 Subpart D. Such notice shall contain, in the form in which**t.~ey** appear in the Modified Consent Order, the following information: (1) the PMN or accession numbers and (2) either (A) the specific chemical identities ofthe chemical substances, or (B) ifthe specific chemical identities are confidential, the generic chemical identities.
(b) Types ofDistributees. This Distribution section authorizes the Company to distribute the PMN substances to three types ofDistributees:· (1) Distributees who will further distribute the PMN substances onlywhen the PMN substances are in a exempted ormitigated state, as defined in paragraph (c); (2) Distributees who will further distribute the PMN substances in a non-exempted and unmitigated state after the attached Consent Order for Processor expires 75 days after promulgation ofa final SNUR governing all ofthe PMN substance; and (3) Distributees who will further distribute the PMN substances in a non-exempted and unmitigated state before the attached Consent Order for Processor expires 75 days after promulgation ofa final SNUR governing all of the PMN substances. The distribution requirements for the first two types ofDistributees are identical and are stated in paragraph (e) below. The third type ofDistributee must sign the attached Consent Order for Processor, as specified in paragraph (f) below.18 (c) Mitigated and Exempted States ofthe PMN Substance.

(1) Exempted State ofthe PMN Substance. As described in paragraph (b) o(the Scope of Applicability and Exemptions Section, several exempted states ofthe PMN substance for purposes offurther distribution are: (i) completely reacted (cured); (ii) incorporated or embedded into a polymer matrix that itselfhas been reacted (cured); or (iii) incorporated or embedded in a solid polymer form with a concentration ofthe PMN substance equal to orbelow 30% that is not intended to undergo further processing, except for mechanical processing. (2) MitigatedStates ofthe PMN Substance. Additionally, for purposes offurther distribution, the PMN substance shall be considered to be in a "mitigated state" (regarding risk) when the PMN substances are: (i) incorporated or embedded ina solid polymer form with a concentration ofthe PMN substance equal to orbelow 30%
(d) Temporary Transport and Storage. Notwithstanding paragraphs (e) and (t) in this**Distrib~tion** section, the Companymay distribute the PMN substances outside the Company for temporary transport and storage in sealed containers provided the following· two conditions are met: (1) Subsequent to any such exempt temporary transport or storage ofsealed containers, the PMN substances maybe distributed onlyto the Company orto aDistributee compliant with paragraph (e) or (t). (2) Anyhuman exposure or environmental release resulting from opening the sealed**contain~rs** and removing or washing outthe PMN substances may occur only while the PMN19
substances are in the possession and control ofthe Company or a Distributee compliant with paragraph (e) or 

### (t).
(e) Distribution Requirements in the Absence ofProcessor Order. Except when the PMN substances are in a exempted or mitigated state as described in paragraph (c) above, or as provided in the Temporary Transport and Storage paragraph (d) above, or for Distributees who sign Processor Orders as described inparagraph 

### (t) below, the Company shall distribute the PMN st!bstance outside the Company, otherthan for disposal, onlyto a Distributee who has agreed in writing priorto the date ofdistribution, to: (1) NotifY in writing anyperson to whom it distributes the PMN substance that, due to the issuance ofthis Modified Consent Order under section 5(e) ofTSCA, the PMN substance is subject to the export notification requirements ofTSCA section l2(b) and 40 CPR Part 707 SubpartD. Such notice shall cOntain, in the form in which it appears in this Modified Consent Order, the following information:(l) the PMN or accessionnumber, and (2) either (A) the specific chemical identity ofthe PMN substance, or (B) ifthe specific chemical identityis confidential, the generic chemical identity. (2) Not further distribute the PMN substance, to any other person, otherthan for disposal, until after thePMN substance is in an exempted or mitigated state as described in subparagraph (c) ofthis Section. Thus, further distribution for processing and use may occur once the PMN substance is in an exempted ormitigated state. However, the mitigated states are not exempted and the personreceiving the PMN substance must agree in writing priorto the date ofdistribution to subparagraphs (e)(1)-(6) oftbis Distribution Section. (3) Comply with the same requirements and restrictions required ofthe Company in the

### 20
Protection in the Workplace section. (4) Notprocess oruse the non-exempt PMN substance other than as:

]. (5) Not use the non-exempt PMN substance for commercial or consumeruse, or in a
consumerproduct. (6) Comply with the same environmental release restrictions required ofthe Company in the Release to Water Section ofthe Order.


### (:f) Consent Order for Processor. (1) Ifthe Company distributes the PMN substances to Distributees who will further distribute the PMN substances in an a non-exempted and unmitigated state, before the attached Modified Consent Order for Processor expires 75 days after promulgation ofa final SNUR governing all ofthe PMN substances, the Company shall distribute the PMN substances outside the Company, other than for disposal, onlyto a Distributee who has signed the Consent Order for Processorin Attachment C to this Order (a "Processor"). (2) The Company shall obtain from each such Processor a signed copy ofthe Consent Order for Processor and submit the copy to EPA along with the name, address, and telephone number ofa responsible official ofthe Processor. The Processor or Companymust receive a fully executed copy ofthe Consent Order for Processor from EPA before the Processor maybegin to process any ofthe PMN substances. , '/<.. .•
, , 

### 21

(g) Sunset following SNUR. (l) Ifthe Companydistributes thePMN substances to Distributees who will further

. 

# . distribute the PMN substances in a non-exempted and an unmitigated state, before theattached
. Consent Order for Processor expires 75 days after promulgation ofa final SNUR governing all of thePMN substances, the Company shall distribute the PMN substances, other than for disposal, only to processors who have signed the attached Consent Order for Processor in accordance with paragraph (f) ofthis Distribution section. After the attached Consent Order for Processor expires 75 days after promulgation ofa final SNUR governing all ofthe PMN substances, the Company shall distribute the PMN substances onlyto Distributees who complywith the requirements specifiedinparagraph (e) ofthis Distribution section
.

. (2) Paragraphs (e) and (f) ofthis Distribution section shall expire 75 days after promulgation ofa final SNUR for the PMN substances under section 5(a)(2) ofTSCA, unless the Companyis notified on orbefore that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Company is so notified, paragraphs (e )(2) and (f) ofthis Distribution section shall not expire until EPA notifies the Companyin writing that all Federal Court actions involving

.the SNUR havebeen resolved and the validity ofthe SNUR affinned. (3) When EPA promulgates a final SNUR for the PMN substances and paragraph (e) of this Distribution section expires in accordance with subparagraph (g)(2), the Company shall notifY each Distributee to whom it distributes thePMN substances ofthe existence ofthe SNUR. Such notification must be in writing and must specificallyinclude all limitations contained in the SNUR which are defined as significant new uses, and which would invoke significant new use notification to EPA for the PMN substances. Such notice must also reference thepublication of22
the SNUR for these PMN substances in either the Federal Register or the Code ofFederal Regulations. Afterpromulgation ofa SNUR and expiration ofparagraphs (e )(2) and (f), such notice may substitute for the written agreement required in the introductory clause ofparagraph (f); so that, ifthe Companyprovides such notice to the Distributee, thenthe Company is not required to obtain from such Distributee the written agreement specified inparagraph (e). However, even absent such written agreement, the Companyremains obligated to comply with the "RecipientNon-Compliance" paragraph (h) below.
(h) Recipient NoncCompliance. If, at any time after commencing distribution in commerce ofthe PMN substances, the Companyobtains knowledge that a recipient (including a Processor) ofthe PMN substances hasfailed to comply with any ofthe applicable conditions specified inparagraphs (e) or (f) ofthis Distribution section or, after paragraphs (e) or (f) expires in accordance with paragraph (g)(2), has engaged in a significant new use ofthe PMN substances (as defined in40 CFRPart 721, Subpart E) without submitting a significant new use notice to EPA, the Company shall cease supplying the substances to that recipient, unless the Company is able to document each ofthe following: (1) That the Companyhas, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any ofthe applicable conditions specified inparagraphs (e) or (f) ofthis Distribution section, orhas engaged in a significant newuse ofthe PMN substances without submitting a significant new use notice to EPA. (2) That, within 15 working days ofnotifying the recipient ofthe noncompliance, the Companyreceived from the recipient, in writing, a statement ofassurance that the recipient is
aware ofthe applicable t=s ofparagraphs (e) or (f) ofthis Distribution section and will comply.**t~,'** )! 23
with those terms, or is aware ofthe terms ofthe significant new use rule for the PMN substances and will not engage in a significant new use without submitting a significant newuse notice to EPA. (3) If, after receiving a statementofassurance from a recipient under subparagraph (h)(2) ofthis Distribution section, the Companyobtains knowledge that therecipient has failed to comply

.with any ofthe applicable conditions specified in paragraphs (e) or (f) ofthis Distributionsection,
orhas engaged in a significant new use ofthe PMN substances wiHlout submitting a significant
new use notice to EPA,the Companyshall ceasesupplying the PMN substances to thatrecipient, shall notifY EPA ofthe failure to comply, and shall resume supplying the PMN substances to that recipient onlyupon written notification from the Agency
.



### . RELEASE TO WATER

.This provision does not supersede orpreempt any applicable federal, state, and local laws and regulations. (Those other laws maybe more stringent than the requirements below.) The Companyis prohibited from anypredictable orpurposeful release ofthePMN substance, or any waste stream from processing and use containing the PMN substance into the waters ofthe United States. This prohibition does not apply to quantities ofthe PMN substance embedded in solid polymer form with a concentration ofthe PMN substance equal to orbelow 30%.



### RECORDKEEPING (a) Records. After the effective date ofthis Order and, consistent with any other requirements24 under TSCA, the Company shall maintain the following records until 5 years after the date they
are created and shall make them available for inspection ru:d copying by EPA in accordance with section 11 ofTSCA: (1) Exemptions. Records documenting that the PMN snbstance did in fact qnalifY for anyone or
more ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Snchrecords must satisfY all the statutory and regulatory recordkeeping requirements applicable to the exemption being claimed bythe Company. Any amounts orbatches ofthe PMN substance eligible for the Export exemption in Section I, Paragraph (b)(2) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Companymaintains, for 5 years from the date of their creation, copies ofthe export label and export notice to EPA;required by TSCA sections 12(a)(I)(B) and 12(b), respectively. Any amounts orbatches ofthe PMN substance eligible for the Research and Development exemption in Section I, Paragraph (b)(3) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, the records required by40 CFR nO.78(b). For any amounts or batches ofthe PMN substance claimedto 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 recordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture and importation volume ofthe PMN substance and the corresponding dates ofmanufacture and import; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture or import to whom the Company directly sells or transfers the PMN substance, the date ofeach sale ortransfer, and the**J~** ),
, , 

### 25 quantity ofthe substance sold ortransferred on such date; (4) Records documenting the addresses ofall sites ofmanufacture, import, processing, and use; 

### (5) Records documenting establishment and implementation ofa program for the use of any applicable personal protective equipment required pursuant to the Protection in the Workplace section ofthis Order; (6) Records documenting the determinations required bythe Protection in the Workplace sectionofthis Order that chemical protective clothing is impervious to the PMN substance; (7) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing, Processing, and Use, and Distribution sections ofthis Order, includingdistributees' written agreement to complywith the Distributionsection of this Order; (8) Copies ofanyTransfer Documents and notices required by the Successor Liability sectionofthis Order, ifapplicable; and (9) TheCompany shallkeep a Copy ofthis Order at each ofits sites where the PMN substance are manufactUred ofimported.
(b) Applicability. The provisions ofthis Recordkeeping Section are applicable only to activities ofthe Company and its Contract Manufacturer, ifapplicable, and not to activities ofthe Company's customers.
(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Company is not requiredto respond to this "collection of

### 26
information" unless this Order displays a currently valid control number from the Office of Management and Budget ("OMB"), and EPAso informs the Company. The "collection of information" required in this TSCA §5(e) Modified Consent Orders has been approved under currentlyvalid 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 ofCompany facilities and conveyances associated with the PMN substance. To facilitate such inspections, EPApersonnel may contact the Company in advance to requestinformation pertinent to the scheduling and conduct ofsuch inspections. Suchrequests maybewritten or oral. The types ofinformation that EPA mayrequest mayinclude, but are not limited to, the following: (i) Expected dates and times when the PMN substance will be in production within the subsequent 12 months; (ii) Current workshift schedules for workers who are involved in activities associated with the PMN substance and mayreasonably be exposed to the PMN substance; (iii) Currentjob titles or categories for workers who are involved in activities associated with the PMN substance and mayreasonablybe exposed to the PMN substance; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substance and mayreasonably be exposed to the PMN substance; (v) Records required bythe Recordkeeping section ofthis Order; and/or (vi) Any other information reasonably related to determining compliance with this Order or conducting an inspection for that purpose. .,' 

### "'



### , '27

(b) Company's Response. The Company shall 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 writingbyEPA, the Company's response shall be in writing. To the extent the infonnation is knoWn to orreasonably ascertainable to the Company at the time ofthe request, the Company's response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers to all ofEPA's requests.
(c) Confidential Business Infonnation. Any Confidential Businessinfonnation ("CBf') that the Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with §14 of TSCA and 40 CFR Part 2.



### V. SUCCESSOR LIABILITY UPON TRANSFER OF MODIFIED CONSENT ORDER (a) Scope. This section sets forth theprocedures bywhich the Company's rights and obligations. underthis Order maybe transferred when the Companytransfers its interests in the PMN substance, including the right to m'anufacture the PMN substance, to anotherperson outside the Company (the "Successorin Interest").
(b) Relation ofTransfer Date to Notice ofCommencement ("NOC"). (I) BeforeNOC. lfthe transferfrom the Company to the Successor in Interest is effective before EPA receives a notice ofcommencement ofmanufacture orimport ("NOC") for the PMN substance 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)(I) ofTSCA and 40 CFRpart 720 before

### 28 commencingmanufacture or import ofthe PMN substance. (2) AfterNOC. Ifthe transfer from the Companyto the Successorin Interestis effective after EPA receives a NOC, the Successor in Interest shall comply with the terms ofthis Order and shall notbe 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 C01TIpany's full interest in the rights to manufacture the PMN substance, including all ownership rights and legal liabilities, through a transfer document signed bythe Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe Companyin the PMN substance, such as a licensee who has acquired a limited license to thepatent ormanufacturing rights associated with the PMN substance. A Successor in Interest mustbe incorporated, licensed, or doing business inthe United States in accordance with 

### 40 CFR n0.22(a)(3). (2) "Transfer Document" means the legal instrument(s)used to convey the interests in the PMN substance, including the right to manufacture the PMN substance, from the Companyto the Successor in Interest.
(d) Notices. (1) Notice to Successor in Interest. On orbefore the effective date ofthe transfer, the Company shall provide to the Successor in Interest, byregistered mail, a copy ofthe Modified Consent Order and the "Notice ofTransfer" document which is incorporated byreference as Attachment C to this Order. 

# . 'I' , , 

### 29 (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the Company shall, byregistered mail, submit the fully executed Notice ofTransfer document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Document mustbemaintained bythe SuccessorinInterest at its principal place ofbusiness, and at all sites where the PMN substance are manufactured orimported. Copies ofthe Transfer Document must also be made available for inspection pursuant to Section 11 ofTSCA, must state the effectivedate oftransfer, and must contain provisions which expressly transfer liability for the PMN substance under the terms ofthis Order from the Companyto the Successorin Interest.
(e) Liability. (1) The Company shall be liable for compliance with the requirements ofthis Orderuntil the effective date ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance with therequirements ofthis. Order effective as ofthe date oftransfer. (3) Nothing in this section shall be consliued 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 in which the Companymanufactured, processed, used, distributed in commerce, or disposed ofthe PMN substance pursuant to the terms ofthis Modified Consent Order.
(f) Obligations to Submit Test Dataunder Modified Consent Order. Ifparagraph (d) ofthe30 Testing section ofthis Modified Consent Order requires the Companyto submit test data to EPA at
a specified production volume ("testtrigger"), the aggregate volume ofthe PMN substance manufachlred and importedbythe Companyup to the date oftransfer shall count towards the test trigger applicable to the Successor in Interest. VI. MODIFICATION AND REVOCATION OF MODIFIED CONSENT ORDER

The Companymaypetition EPA at any time, based upon new information on the health effects of, orhuman exposure to, the PMN substance, to modify orrevoke substantive provisions ofthis Order. The exposures and risks identified by EPA during its review ofthe PMN substance and the informationEPA determined to benecessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend orrevoke this Order, EPA will consider all relevant information available at the time the Agency makes that determination, including, where appropriate, anyreassessment ofthe test data or other information that supports the findings inthis Order, an examination ofnew test data or otherinformation or analysis, and any other relevant information. EPA will issue a modification orrrocation ifEPA determines that the activities proposed therein will notpresent an UI1feasonable risk ofinjnry to health or the environment and will not result in significant or substantial human exposure or substantial environmental releMejn

### ~e " absence ofdata sufficient to permit a reasoned evaluation ofthehealth or environmental effects of the PMN substance. In addition, the Company maypetition EPA at anytime to make other modifications to the langnage ofthis Order. EPA will issue such a modification ifEP A determines that the modification is useful, appropriate, and consistent with the struchlre and intent ofthis Order as issued. 

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" I ,./**\~** 1 '.J 31 VII. EFFECT OF MODIFIED CONSENT ORDER (a) Waiver. Byconsenting to theentry oftllls Order, the Companywaives its rights to file objections to this Orderpursuant to section 5(e)(1)(C) ofTSCA, to receive service ofthis Order no later than 45days before the end ofthereview period 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 terms, do not constitute an admission bythe 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 mayhave under TSCA. (b) 

## cm Brackets. By signing this Order, the Companyrepresents that it has carefully reviewed this document and hereby agrees thatall information herein that is claimed as confidential bythe Company (per section 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFRPart2) is correctly identified within brackets and that anyinformation that is notbracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained within the brackets. 

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llution Prevention and Toxics

Title: [ Company:[ .]

### ATTACHMENT A DEFINITIONS [Note: The attached Order may not contain some of the terms defined below.] "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed bythe International Union ofPure and Applied Chemistry or the Chemical Abstracts Service's rules ofnomenclature, or a name which will clearly identify a chemical substance for the purpose ofconducting a hazard evaluation. "Chemical protective clothing" means items ofclothing that provide a protective barrierto prevent dermal contactwith chemical substance ofconcern. Examples can include, but are not limited to: full bodyprotective clothing, boots, coveralls, gloves,jackets, and pants. "Company" means the person orpersons subject to this Order. "Commercial use" means the use ofa chemical substance or anymixture containing the

. chemical substance in a co=ercial enterprise providing saleable goods or a service to consumers

(e.g., a cOmniercial 

### dry cleaning establislunent orpainting contractor). "Co=onname" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical nameused to identify a chemical substance other than byits chemical name. "Consumer" means a private individual who uses a chemical substance or anyproduct containing the chemical substance in or around a permanent ortemporary householdorresidence, during recreation, or for 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 permanentor temporary household or residence, in or around a school, or in recreation. "Container" means anybag, barrel, bottle, box, can, cylinder, 

### drum, reaction vessel, storage tank, or the like that contains a hazardous chemical. Forpurposes ofthis section, pipes orpiping 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 Modified Consent Order and in the Consent Order for Contract Manufacturer. "Identity" means anychemical or common name used to identify a chemical substance or a mixture containing that substance. "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is under 

### , ', 

### , 2 the control of, and used onlyby, the person who transferred it from a labeled container and will onlybe used bythat person within the work shift in which it is transferred from the labeled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance causes no chemical ormechanical degradation, permeation, orpenetration ofthe chemical protective clothing under the conditions of, and the duration of, exposure. "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 ofdata for the chemical substance. "NIOSH" means the National 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,ormixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe bulk chemicalsubstance 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 substance" means the chemical substance described in the Premanufacture notice submittedbythe Companyrelevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the bodyto prevent contact with, and exposure to, an identified chemical substance or substance in the work area. Examples include, but are not limited to, chemical protective clothing, aprons; hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types of respirators. Barrier creams are not included in this definition. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all mtended operations of processing, including the cleaning ofequipment. "Scientificallyinvalid" 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 ofthe health or environmental effects ofthe PMN substance. "Scientificallyequivocal data" means data which, although developed in apparent3 confonnity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to pennit a reasoned evaluation of the potential risk ofinjury to human health or the environment ofthe PMN substance. "Sealed container" means a closed container that isphysically and chemically suitable for long-tenn containment ofthe PMN substance, and from which there will be no human exposure to, nor environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumer use. "Waters ofthe United States" has the meaning set forth in 40 CFR 122.2. "Work area" means a room or defined space in a workplace where the PMN substance is manufactured, processed, or used and where employees are present. "Workplace" means an establishment at one geographic location containing one ormore work areas.

### Company (Transferor) ATTACHMENT B NOTICE OF TRANSFEROF TOXIC SUBSTANCE CONTROL ACT SECTION See) MODIFIED CONSENT ORDER

PMNNumber 1. Transfer ofManufacture Rights. Effective on , the Company did sell or otherwise transfer to , ("Successor in Interest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substance, which was the subject ofa premanufacture notice ("PMN") and is governed by a Consent Order issued by the U.S. Environmental Protection Agency ("EPA") under the authority of§5( e} ofthe Toxic Substance 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 governedbythe applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall bethe responsibility ofthe Successorin Interest. Successor in Interest also certifies that itis incorporated, licensed, or doing business in the United States in accordance with 40 CFR n0.22(a)(3). 3. Confidential Business Infonnation. The Successorin Interest hereby: reasserts, relinquishes, or modifies all Confidential Business Information ("CBr') claims made bythe ComPiillY, pursuant to Section 14 ofTSCA and 40 CFRpart 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is indicated, that designation shallbe 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. Infonnation which has beenpreviously disclosedto the public (e.g., a chemical identity that was not claimed as CBI bythe original submitter) would not subsequently be eligible for confidential treatment under this Notice ofTransfer.2

TOXIC SUBSTANCE CONTROL ACT SECTION See) MODIFIED CONSENT ORDER NOTICE OF TRANSFER 

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Company (Transferor) PMNNumber

Signature ofAuthorized Official Date
Printed Natne ofAuthorized Official
Title ofAuthorized Official



### Successor in

### Interest
Signature ofAuthorized Official Date
Printed Name ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip Code3



### TOXIC SUBSTANCE CONTROL ACT SECTION See) MODIFIED CONSENT ORDER NOTICE OF TRANSFER (continued)

Successor's Technical Contact
Address City, State, Zip Code
Phone