UNITED STATES ENVIRONMENTALPROTECTION AGENCY OFFICE OF POLLUTIONPREVENTION AND TOXICS REGULATION OF A NEW CHEMICAL SUBSTANCE PENDINGDEVELOPMENT OF INFORMATION


### In the matter of:

Nanocomp Technologies Inc 

### ) ) ) 

### ) ) ) 

### ) ) 

### ) ) ) ) ) ) ) ) ) ) ) ) ) ) 

### ) ) ) ) PremanufactnreNoticeNumber:

P-10-0039 and P-10-0040 

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# £_ 2-/ll/2<171

Consent Order and Determinations Supporting Consent Order

### TABLE OF CONTENTS

Preamble I. Introduction II. Summary 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

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 Liability Upon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order Attachment A - Definitions Attachment B - Notice ofTransfer ofConsent Order11 

## PREAMBLE I INTRODUCTION Under the authority of§ 5(e) ofthe Toxic Substance 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-l0-0039 and P-l0-0040 for the chemical substances described in the notices as multi-waH carbon nanotubes (MWCNT) and single- and multi-wall carbon nanotubes (MWCNT) (the "PMN substances"), submitted by Nanocomp Technologies Inc ("the Company"), to take effect upon expiration ofthe PMN review period. The Company submitted the PMNs to EPA pursuantto section 5(a)(1) of TSCA and 40 CFR Part 720.

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

### § 5 or any order issued under 

### § 5. Violators may be subject to various penalties and to both criminal and civil liability pursuant to 

### § 16, and to specific enforcement and seizure pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 of TSCA, such as this one, are subject to the § 12(b) export notice requirement.



### II. SUMMARY OF TERMS OF THE ORDER The Consent Order for these PMN substances requires the Company to: 1. submitto EPA the following tiered testing:
a. workplace exposure monitoring and/or characterization testing on both the PMN substances following the notice ofcommencement ofboth the PMN substances (this data could change EPA's finding ofsubstantial human exposure and might obviate or change the need to conductthe human health tests specified under b. below);11I b. subsequent to the exposure monitoring and/or characterization testing, submit to EPAthe following toxicity testing on the substance or substances to which workers at the manufacturing or use sites might be exposed as a result ofthe manufacturing or handling processes ofthe PMN substances:
1. 90-day inhalation toxicity test, by nose-only exposure with a postexposure observation period ofup to 3 months (OPPTS 870.3465), with additional analysis and characterization ofthe bronchoalveolar lavage fluid (BALF), aggregation! agglomeration state, shape, size/size particle distribution and surface properties ofmaterials as-administered, aggregation! agglomeration state, shape, size/size particle distribution and surface properties ofmaterials ofthe delivered materials after administration, determination ofcardiovascular toxicity, heart histopathology, and data on pulmonary deposition, or otherrelevant data as determined by the initial tier oftesting; 2. submit to EPA the certain material characterization data on the PMN substances obtained from either scanning electron microscopy ortransmission electron microscopy analysis plus X-Ray analysis (X-ray diffraction, X-ray fluorescence, energy dispersive X-ray spectroscopy) no later than nine months following the commencement ofcommercial manufacturing; 3. require workers at the manufacturing sites to wearpersonal protective equipment including chemical protective clothing and gloves impervious to nanoscale particles while exposed dermally in the work area; 4. require workers at the manufacturing facilities while exposed to the PMN substances via the inhalationroute in the work area to wear a NIOSH-certified full face, air purifying respirator with N -100 or equivalent cartridges (cartridge selection appropriate to facility conditions); 5. maintain the isolated forms ofthe PMN substances as described in the notices:
a. P-IO-0039: sheets; b. P-IO-0040: yarns; 6. not release the PMN substances to the waters ofthe United States; 7. limit use ofthe substances to the specific uses specified in the PMNs, as follows: P-IO-0039: In defense, electronic, and aerospace applications as 

## ; P-IO-0040: In defense, electronic, and aerospace applications asIV

. 8. limittheprocessing and use ofthe PMN substances to industrial settings; 9. providethe

## u.s. EPAwith a 1 g sample ofthe PMNmaterials uponrequest byEPA; 10. distribute thePMN substances onlyto a person who agrees to follow the samerestrictions applicable to the company (except thetesting requirements) and to notfurther distribute thePMN substances unless they are used explicitlyfor thepurposes outlinedunder (7) and until after theyhavebeen (i) completelyreacted (cured); (ii) incorporated or embeddedinto a polymermatrix that itselfhasbeen completelyreacted (cured); (iii) embedded in a permanent solidpolymer, metal, glass, orceramic form; or (iv) completely embedded in an article; 11. maintainrelevantrecords.
In summary, the "Scope ofApplicability and Exemption" section ofthe Order exempts the following: 1. quantities ofthe PMN substances thathavebeen completelyreacted (cured), incorporated or embedded into a polymermatrixthatitselfhasbeenreacted (cured), embeddedin a permanent solidpolymer, metal, glass, orceramic form, or completely embedded in an article. These exemptions do not applybeyondtheuses that are specifically authorized by the Orderin theManufacturing, and Processing and Use sections, but do allow use for commercial or consumeruse, orin a consumerproduct. 2. quantities designated solelyfor exportbeforethe Companycommences import ofthe PMN substances for usewithin the United States; 3. research & development ("R&D"); 4. thePMN substances as a byproductwithout separate commercialintent; and 5. thePMN substances in a substance, mixture, or article with no separate commercialpurpose.v


### III. CONTENTS OF PMN By signingthis Order, the Company represents that it has carefully reviewedthis document and hereby agrees that all information herein that is claimed as confidential bythe Company (per section 14 ofTSCA, 40 CFR Part 720 SubpartE, and 40 CFRPart 2) is correctly identified within brackets and that any informationthat is notbracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained withinthe brackets. Confidential Business Information Claims (Bracketed inthe Preamble and Order): Production volume, physical properties, material characterization, precursor substances, typical composition, process information, impurities, specific uses, and byproducts. Chemical Identity: Specific identity: P-10-0039: multi-walled carbon nanotubes. P-10-0040: single-and multi-walled carbon nanotubes. Chemical Form: TheNotices identifies two isolated forms ofthe PMN substances: I. P-10-0039: Sheets 2. P-10-0040: Yams
Specific: P-IO-0039: In defense, electronic, and aerospace applications as
];VI P-I0-0040: In defense, electronic, and aerospace applications as

]. Generic: P-IO-0039: Composite structures for defense, electronic, and aerospace, applications P-1O-0040: Composite structures for defense, electronic, and aerospace, applications. Maximum 12-MonthProduction Volume: P-1O-0039: [ kg/yr. P-1O-0040: [ kg/yr. TestData Submitted with the PMNs: • Occupational exposure monitoring and characterization at the site ofmanufacture.
IV. EPA'S ASSESSMENT OF 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 tlJe Agency.

Human Health Effects Summary: Absorption is expected to be poor via all routes for the manufactured substances, based on test data for chemicals with similar molecular structures and chemicals with similar physical/chemical properties. Dataon the PMN substances and other analogous substances indicate tlJe potential for generation ofincreased amounts ofrespirable or absorbable particles during processing and use ofnanoscale materials. Much more evaluation is needed to determinevii 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 pulmonarytoxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity ofthe PMN substances. There are also data suggesting that pulmonary deposition ofsome nanoscale materials, including carbon nanotubes in the agglomerated form, may induce cardiovascular toxicity when these nanoscale materials are inhaled. The major health concerns are for potential pulmonary toxicity, fibrosis and cancer to workers exposed via inhalation. The PMN substances as manufactured testednegative for skin sensitization in the Local LymphNode Assay (LLNA) and were slightly irritating 

### in an acute dermal irritation study in rabbits. Based on the uncertainty ofthe characterization and exposure ofnanoscale materials in general, there may be additional potential for translocation across the dermis and effects on target organs.

Environmental Effects Summary; Toxicity from carbon nanotube (CNT) 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 CNTs combine with dissolved organic matter (DOM) to form stable aqueous suspensions. No studies on CNTs are available inwhich a broad range ofproduction methods, sources, purification, functionalization, etc. were investigated. EPA expects that some fraction ofthe CNTs, ifreleased into the environment, will eventually become suspended in water.viii Sublethal effects have been 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 the possibility ofliver tumor formation over longer exposure periods. This response is also notable because effects were seen in cells closest to blood vessels, suggesting transport ofrespired or ingested SWCNTs via the blood 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 control for the effects ofcontaminants, solvents, and physical factors such as blockage ofgills or intestines. Before such testing is conducted, advanced fate testing would be necessary to ascertain what substance is likely to present the highest environmentally relevant concentrations.
Exposure and Environmental Release SummarY for:


### Manufacture Processing Use Consumer P-10- P-10- Either P-10- P-10- Either 0039 0040 0039 0040 [ [ 

### # Sites 1 1 Not expected N/A under current uses [ 

### Workers 3 3 Not expected N/A 

### (#/site) Exposure 260 260 Not expected [ ] None 

### (days/year) expected 2.5 0.12 Not expected 0.32 0.023 NoneIX Inhalation (worst (worst (worst (worst expected Exposure case) case) case) case) (mg/day) 0.73 0.037 0.095 0.007 (typical) (typical) (typical) (typical)

Manufacture Processing Use Consumer
P-10- P-10- Either P-10- P-10- Either 0039 0040 0039 0040 Not expected None Dermal 3100 3100 3100 3100 expected Exposure (particul (particul (particul (particul (mg/day) ate) ate) ate) ate)
Releases to all 260 260 Not expected 260 365 None environmental expected media (days/year) Release

### to 0.15 O.OOB Not expected 0.04 0.004 None Water expected (kg/day) Drinking Water 9.4E-4 4.BE-5 3.1 E-4 2.2E-5 Exposure (ADR)1 (ADR)1 Not expected (ADR)1 (ADR)1 Not expected (mg/kg/day) 2.1e-05 1.0E-6 6.6E-6 6.9E-7 (LADD)2 (LADD)2 (LADD) 2 (LADDf Fugitive Air 1.9E-5 1.0E-6 2.5E-4 1.BE-5 Exposure (ADR)1 (ADR)1 Not expected (ADR)1 (ADR)1 Not expected (mg/kg/day) 4.4E-7 2.3E-B 5.5E-6 5.6E-7 (LADD)2 (LADD)2 (LADD)2 (LADD)2 Stack Air 2.BE-4 1.4E-5 6.2E-5 4.3E-6 Exposure (ADR)1 (ADR)1 Not expected (ADR)1 (ADR)1 Not expected (mg/kg/day) 1.6E-5 B.1 E-7 3.4E-6 3.5E-7 (LADDf (LADD) 2 (LADD)2 (LADD)2

1ADRrefers to Acute Dose Rate. 2 LADD refers to Lifetime Average Daily Dose.x Landfill 3.5E-5 1.8E-6 7.4E-06 7.5E-7 Exposure (LADD)2 (LADD)2 Not expected (LADD)2 (LADD)2 Not expected I (mg!kg/day) I I I I I I 

### ,

Risk to Workers: The PMN substances may present a risk to workers exposed to the PMN substances and associated byproducts viainhalation. In the table above, the worst case worker inhalation value is 2.5 mg/day (0.25 mg/m3) during manufacturing. There is a concern for pulmonary toxicity, fibrosis and cancer and a potential for cardiovascular effects to workers exposedto the PMN substances and associated byproducts via the inhalationroute. To mitigate potential health effects via inhalation, the Order requires appropriate respiratory protection. EPA believes the PMN substances as manufactured present a low risk to workers exposed to the PMN substances itselfdermally, but does nothave enough information to evaluate the risks when the PMN substances are handled. To mitigate potential health effects via dermal exposure, the Order requires dermal protection.

Risk to general population: There is potential for exposure to the PMN substances ofthe general population and the environment from landfill releases, fugitive, and stack air emissions. Human ingestion may result from landfill or direct water releases. Direct water releases are restricted by the Order.

Environmental Risk: The amount ofPMN substances expected to be released into the environment, in the absence ofsite-specific risk management practices described in the notice, could lead to surface water concentrations that exceeded environmental toxicities identified by EPA. Therefore, the attached Order prohibits releases ofthe PMN substances to surface waters.xi

.V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis ofthe Consent Order: (a) EPA is unable to determine thepotential for effects to human health and the environment from exposure to the PMN substances. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation ofthe human health and environmental effects ofthe PMN substances.
(b) In light ofthe potential risk to human health and the environment posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substances, 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 substances maypresent anunreasonable risk ofinjury to human health and the environment.

VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS Triggered Testing. The Order prohibits the Company from manufacturing the PMN substances beyond specifiedtime periods andproduction volumes, unless the Company submits the information described in the Testing section ofthis Order in accordance withthe conditions specified inthe 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 orrevoked by EPA based on submission ofthat or other relevant information. EPA encourages the Company to develop additional environmental andXli health effects testing in coordination with other manufacturers ofcarbon nanotubes. Ibis canbe done under the in-depth portion ofEPA'sNanoscale Materials Stewardship Program or through independent testing. EPA is willing to facilitate the process in coordination with other ongoing environmental and health effects testing for the PMN substances nationally and internationally.

## ,. 2 (1) CompletelyReacted, Cured, orEmbedded. Ifquantities ofthe PMN substances (A)
areused solely for the uses authorizedinparagraph (b) ofthe Manufacturing section and paragraphs (a) and (b), ofthe ProcessinglUse section ofthis Order; and (B) those quantities have been (i) completelyreacted (cured); (ii) incorporated or embeddedinto a polymermatrixthatitself hasbeenreacted (cured); (iii) embeddedin a permanent solid polymer, metal, glass, orceramic form thatis notintendedto undergo further processing except for mechanicalprocessing; (iv) or completely embeddedin an article; thenthe otherrequirements ofthis Order do not apply. (2) Export. Untilthe Companybegins commercialmanufacture ofthePMN substances for use intheUnited States, therequirements ofthis Orderdo not applyto manufacture, processing
or distribution in commerce ofthe PMN substances solelyfor export in accordance withTSCA §12(a) and (b), 40 CFR 720.3(s) and40 CFRPart 707. However, oncethe Companybegins to manufacturethe PMN substances for use in the United States, no further activities bythe Company involvingthePMN substances are exempt as "solelyfor export" evenifsome amounts ofthe PMN substances are later exported. Atthatpoint, therequirements ofthis Order applyto all activities associated with thePMN substances while in the territory oftheUnited States. Priorto leaving U.S. territory, eventhose quantities orbatches ofthePMN substances that are destined for export
are subjectto terms ofthe Order, and counttowards anyproduction volumetest triggers inthe Testing section ofthis Order. (3) Research & Development ("R&D"). Therequirements of this Order do not applyto manufacturing, processing, distribution in commerce, use and disposal ofthePMN substances in small quantities solelyforresearch and development in accordance withTSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CFR 720.36.3 (4) Byproducts. The requirements ofthis Order do not apply to the PMN substances when they are produced, without separate commercial intent, only as "byproducts" as defined at 40 CFR nO.3(d) and in compliance with 40 CFR nO.30(g). (5) No Separate Commercial Purpose. The requirements ofthis Orderdo not apply to the PMN substances when they are manufactured, pursuantto any ofthe exemptions in40 CFR nO.3o(h), with no commercial purpose separate from the substance, mixture, or article ofwhich they are a part. (c) Automatic Sunset. Ifthe Company has obtained for the PMN substances Test Market Exemptions ("TME") under TSCA §5(h)(1) and 40 CFR n0.38 or LowVolume Exemptions ("L VE") or LowRelease and Exposure Exemptions ("LoREx") under TSCA §5(h)( 4) and 40 CFR n3.50(c)(1) and (2) respectively, any such exemption is automatically rendered null and void as ofthe effective date ofthis Consent 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 manufactnring, importing, processing, distributing in commerce, using, or disposing ofthe PMN substances inthe United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe human health and environmental effects ofthe substance, and the completion ofEPA's review of, andregulatory action based on, that information, except in accordance withthe conditions described inthis Order.;-1- 4 TESTING (a) Section 8ee) 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 and which is required to be reported under TSCA section 8(e) shall reference the appropriate PMN identification numberfor the substance and contain a statementthat the substance is subject to this Consent Order. Additional information regarding section 8(e) reporting requirements canbe found at www.epa.gov/opptitsca8e.
(b) Notice ofStudy Scheduling. The Company shall notify, in writing, the EPA Laboratory Data Integrity Branch (2225A), Office ofEnforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, ofthe following information within 10 days ofscheduling any study required to be performedpursuant 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 statementthat the substance is subject to this Consent Order.
(c) Good Laboratory Practice StaIldards and Test Protocols. Each study required to be performed pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards at 40 CFRPart 792 and using methodologies generally accepted in the relevant scientific

### 5 community at the time the study is initiated. Before starting to conduct any such study, the Company must 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 in paragraph (d) provide general guidance for development oftest protocols, but are not themselves acceptable protocols. Approval ofthe test protocol does not meanpreacceptance oftest results.
(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or importing the PMN substances beyond either ofthe following time or aggregate manufacture and import volumes ofboth PMN substances combined (collectively "the production limit") unless the Company conducts the following tests on the PMN substances and/or associated byproducts (as identified from the workplace exposure monitoring and characterization testing) and submits all final reports and underlying data in accordance withthe conditions specified in this Testing section. (2) Exposure and Toxicitv Tests. The production limit for these tests shall be calculated starting two years after expiration ofthe PMN review period.

Production Limit Test Guideline 2 years Workplace exposure monitoring and characterization testing (including byproducts) as well as quantification and characterization ofsubstances that may be released during exposures typical during the use phase such as handling,6 tearing and cutting the PMN substances. 20 years or 120,000 kilograms 90-day inhalation toxicity test, OPPTS 870.3465 whichever comes first with a post-exposure 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 onpulmonary deposition. (2) Material Characterization and Physical-Chemical Properties. The Company must submit the following material characterization data onboth PMN substances (including data summaries and procedures). Description ofthe physical-chemical 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 of Manufactured Nanomaterials. These tests shall be due 6 months after expiration ofthe PMN review period. The Company may propose alternative methods or guidelines subject to EPA's approval.7
Characteristic or Property Guideline or method Average number molecular weight Number ofwalls ofPMN substances (average and range) Tube type ofSWCNT (P-I0-0039) Configuration ofthe nanotube ends Transmission-electron microscopy (TEM) Branching Scanning electron microscopy (SEM) and TEM

. Tube length SEM& TEM Alignment ofthe nanotube along long axis . SEM&TEM Hexagonal arrayorientation XRD Chiral ortwist angle 

### XRD Particle sizes ofcatalystused inthe manufacture ofthe SEM& TEM nanotubes Characterization ofthe final physical form including mesh SEM&TEM thickness, yarn diameter, and dispersibility (e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in
a scientificallyvalid manner; (2) promptlyfurnish to EPA the results ofany interim phase ofeach study; and(3) submit, in triplicate (withan additional sanitized copy, ifconfidentiaLbusiness information is involved), the final report ofeach study and all underlying data ("the report and data") to EPA no laterthan 14 weeks priorto exceeding the applicable production limit. The final report shall containthe contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting", "Data and Reporting", and "Test Report" subparagraphs in the applicable test guidelines. However, for purposes ofthis Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clearthat the submission ofsuch information is mandatory. EPA will not require the submission ofraw data8
such as slides and laboratory notebooks unless ifEPA finds, on the basis ofprofessionaljudgment, that an adequate evaluation ofthe study cannottake place in the absence ofthese items.
(f) Testing Waivers. The Company is not required to conduct a study specified inparagraph (d) ofthis Testing section ifnotified in writing by EPA that it is unnecessary to conductthat study.
(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal, the Company may continue to manufacture and import the PMN substances beyondthe applicable production limit. To seek relieffrom any other restrictions ofthis Order, the Company may make
a second attemptto obtain unequivocal databy reconducting the studyunderthe conditions specified.in paragraphs (b), (c), and (e)(l) and (2). Thetesting requirements may be modified, as necessary to permit a reasoned evaluation ofthe risks presented bythe PMN substances, onlyby mutual consent ofEPA and the Company.
(h) EPA Determination ofInvalid Data. (I) Except as described in subparagraph (h)(2) ofthis Section, if, within 6 weeks ofEPA's receipt ofa testreport and data, the Company receives written notice thatEPA finds thatthe data generated by a study are scientifically invalid, the Company is prohibited from further manufacture and import ofthe PMN substances beyondthe applicable production limit. (2) The Company may continue to manufacture and import 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 Company may reconduct the study in compliance with paragraphs (b), (c),9
and (e)(1) and (2). Ifthere is sufficient time to reconduct the study and submitthe report and data to EPA at least 14 weeks before exceeding the production limit as required 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 (f)(3) ofthis Section, the Company may exceedthe production limit and shall submit the report and data intriplicate to EPA within a reasonable period oftime, 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 Company may, within 4 weeks ofreceiving from EPAthe notice described in subparagraph (h)(I) ofthis Section, submitto EPA a written report refuting EPA's finding. EPAwill respondto the Company, in writing, within 4 weeks ofreceiving the Company's report.
(i) Company Determination ofInvalid Data. (1) Except as described in subparagraph (i)(2) ofthis Section, ifthe Company becomes
aware that circumstances clearly beyondthe control ofthe Company or laboratory will prevent, or have prevented, development ofscientifically valid data under the conditions specified in paragraphs (c) and (e), the Company remains prohibited from further manufacture and import of the PMN substances beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearly beyondthe control ofthe Company or laboratory will cause or have caused development ofscientifically invalid data EPA will notifY the Company ofits response, in writing, within 4 weeks ofreceiving the Company's report. EPA's written response may either:,J 10 (i) allow the Companyto continue to manufacture and import the PMN substances beyondthe applicable production limit, or (ii) require the Company to continue to conduct, orto reconduct, the study in compliance withparagraphs (b), (c), and (e)(1) and (2). Ifthere is sufficient time to conduct or reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3) 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 Company may exceed the production limit and shall submit the report and data in triplicate to EPA within a reasonable period oftime, all as specified by EPA in the notice described in subparagraph (i)(2) ofthis Section. EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data, as to whether the Company may continue to manufacture and importbeyond the applicable production limit.


### G) Unreasonable Risk. (1) EPA may notify the Company in writing that EPA finds that the data generated by a study are scientifically valid and unequivocal and indicate that, despite the terms ofthis Order, the PMN substances will or may present an unreasonable risk ofinjury to humanhealth or the environment. EPA's notice may specify that the Company undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthe PMN substances to mitigate exposures to orto better characterizetherisks presented by the PMN substance. Within 2 weeks from receipt ofsuch a notice, the Company must cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substances, unless either:11 (2) within 2 weeks from receipt ofthe notice described in subparagraph 0)(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 G)(l) ofthis Section, the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness ofany additional requirements imposed by EPA. The Company may continue to manufacture, import, 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. 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 Company shall comply with any requirements imposed by EPA's response or cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substances.
(k) Other Requirements. Regardless ofthe satisfaction ofany other conditions in this Testing section, the Company must continue to obey all the terms ofthis Consent Order until otherwise notified in writing by EPA. The Company may, based upon submitted test data or other relevant information, petition EPAto modify or revoke provisions ofthis Consent Order pursuant to Part VI ofthis Consent Order.

PROTECTION IN THE WORKPLACE (a) Establishment ofProgram. During manufacturing, processing, and use ofthe PMN substances at any site controlled by the Company (including any associated packaging and storage and during any cleaning ormaintenance ofequipment associated with the PMN substance), the Company must establish a program whereby:" 12 (1) Applicable Protective Requirements for Different Workplace Settings ofthe PMN Substance. The Company shall determine and implement the minimum dermal and respiratory personal protective equipmentrequirements for activities involving the different workplace settings ofthe PMN substances according to the following table:
Workplace activity Minimum Dermal Protection Minimum ResniratlLry Protection Manufacturing, general and specific dermal respiratory protection required in Processing, and Use protection required in a(2) and a(5) and a(6)(i). a(3). (2) General Dermal Protection. When required by the table in subparagraph (a)(1) ofthis section, each person who is reasonably likely to be dermally exposed in the work areato the PMN substances through direct handling ofthe substance, release from sheet or yarn articles containing the substances, orthrough contact with equipment onwhich the substances may exist, is required to wear, at a minimum, personal protective equipment that provides a barrier to prevent dermal exposure to the substances as specified in the minimum dermal protection column ofthe table in subparagraph (a)(1) in the specific work area where the substances are selected for use. Each such item ofpersonal protective equipment must be selected and used in accordance with OSHA dermal protectionrequirements at 29 CFR 1910.132, 1910.133, and 1910.138. (3) Specific Dermal Protective Equipment. Whenrequired by the table in subparagraph (a)(I) ofthis section, the dermal personal protective equipmentrequired by subparagraph (a)(2) must include, but is not limited to, the following items: (1) Gloves impervious to the PMN substances. (ii) Full body clothing impervious to the PMN substances.(4) Demonstration ofImperviousness. The Company must be able to demonstrate that eachitem ofchemical protective clothing selected, including gloves, provides an impervious barrier to 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. Testingthe 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 subjectthe chemical protective clothing to the expected conditions ofexposure, including the likely combinations ofchemical substance to which the clothing may be exposed in the work area. Testing may be conducted 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 specified in ASTM Fl194-89 "Guide for Documenting the Results ofChemical Permeation Testing on Protective Clothing Materials." Testing may also be conducted according to the ASTM F1671-07 "StandardTest Method for Resistance ofMaterials Used in Protective Clothing to Penetrationby Blood-Borne Pathogens Using Phi-Xl74 Bacteriophage Penetration as a Test System". Gloves may not be used for a time period longer than they are actually tested and must be replaced at the end ofeach work shift during which they are exposed to the PMN substances. (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 substances alone and in likely combination with other chemical substance in the work, , 14

area.

.(5) Respiratory Protection. When required by the table in subparagraph (a)(l) ofthis section, each person who is reasonably likely to be exposedby inhalation in the work areato the PMN substances orrelease from sheet or yarn articles containing the PMN substances, is provided with, and is required to wear, at a minimum, aNIOSH-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 respiratory protection requirements at 29 CFR 1910.134 and 42 CFR Part 84. "Reasonably likely to be exposed by inhalation" includes, but is not limitedto, any worker in the work area during activities (including
a reasonable time period following any such activities) involving handling quantities ofthe nonexempt PMN substances by manufacturing, cleaning, harvesting, cutting, loading, and unloading, and maintaining machines in or on enclosed areas. All respirators must be issued, used, and maintained according to an appropriate respiratory protectionprogram underthe OSHA requirements in 29 CFR 1910.134. (6) Authorized Respirators. The following NIOSH-certifiedrespirators meet the minimum requirements for subparagraph (a)(5) ofthis section: (i) Atthe site ofmanufacture, processing, and use. NIOSH-certified airpurifYing, tight-fitting full-face respirator equipped withN-I00, P-I00, or R100 filter with an APF of50 or greater.

MANUFACTURING (a)(l) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import ofthe PMN substances by any otherperson." 15 (2) SunsetFollowing SNUR. Subparagraph (a)(l) ofthis Section shall expire 75 days after promulgation ofa final significant newuse rule ("SNUR") governing the PMN substances under section 5(a)(2) ofTSCA unless the Company is notified on or before that day ofan action in a Federal Court seekingjudicialreview ofthe SNUR. Ifthe Company is so notified, subparagraph (a)(l) shall not expire until EPA notifies the Companyin writing that all Federal Court actions involvingthe SNURhave beenresolved and thevalidity ofthe SNURaffirmed. (3) Notice ofSNUR. When EPApromulgates a final SNURfor the PMN substances and subparagraph (a)(l) 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 importthe PMN substances ofthe existence ofthe SNUR.


### (b) Prohibited Uses. The Company shall not: (l) manufacture or importthe PMN substances for use other than as: (i) P-IO-0039. In defense, electronic, and aerospace applications as

]; (ii) P-lO-0040. 

### In defense, electronic, and aerospace applications as

].16 (2) manufacture or import the PMN substances for commercial or consumer use, or in a consumer product.
(c) Sample. The Company shall provide to EPA a 1 gram sample ofeach ofthe PMN substances
as specifiedby EPA in a future written request along with a copy ofthe MSDS for the substances.

PROCESSING AND USE (a) The Company shall notprocess or use the PMN substances other than as follows: (1) P-10-0039. In defense, electronic, and aerospace applications as
]; (2) P-1O-0040. In defense, electronic, and aerospace applications as

.
(b) The Company shall not process oruse the PMN substances for commercial or consumer use,
or in a consumerproduct.

DISTRIBUTION (a) Export Notice Requirement. No later than the date ofdistribution, the Company shall notify in writing any person to whom it distributes the PMN substances that, due to the issuance ofthis Consent Order under section 5(e) ofTSCA, the PMN substances are subject to the export17
notificationrequirements ofTSCA section 12(b) and 40 CFRPart 707 SubpartD. Such notice shall contain, inthe form in which they appearin the Consent Order, the following information: (1) the PMN number and (2) either (A) the specific chemical identity ofthe chemical substance, or (B) ifthe specific chemical identityis confidential, thegeneric chemical identity.
(b) (l) DistributionRequirements. Except as provided inparagraph (c) or after the PMN substances havebeen: (i) completelyreacted (cured); (ii) incorporated orembeddedinto a polymermatrixthat itselfhas been completelyreacted (cured); (iii) incorporated or embedded in a permanent solidpolymerform thatis notintendedto undergo further processing, except formechanical processing; or (iv) completelyembedded in an article
the Company shall distribute thePMN substances outsidethe Company, otherthan for disposal, onlyto a personwhohas agreed in writing priorto the date ofdistribution, to complywith all the requirements in (b)(2) below: (2) (i) NotifY inwriting anyperson to whom it distributes the PMN substances that, due to the issuance ofthis Consent Orderunder section 5(e) ofTSCA, the PMN substances are subject to the export notificationrequirements ofTSCA section 12(b) and 40 CFRPart 707 SubpartD. Such notice shall contain, in the form inwhich it appears in this Consent Order, the following information: (1) thePMN number, and (2) either (A) the specific chemical identity ofthePMN substance, or (B) ifthe specific chemical identityis confidential, the generic chemical identity. (ii) Not further distribute thePMN substances to anyotherperson, otherthan for disposal, until afterthePMN substances arein an exempted form (as described in (b)(1)(i), (ii), (iii), or (iv)).18 (iii) Comply with the same requirements and restrictions required ofthe Company inthe Protection inthe Workplace section. (iv) Notprocess or use the PMN substances otherthan as follows:
a. P-IO-0039: In defense, electronic, and aerospace applications as ]; b. P-IO-0040: In defense, electronic, and aerospace applications as


## ; (v) Not use the PMN substances for commercial or consumer use, or in a consumerproduct. (vi) Comply with the same environmental release restrictions required ofthe Company inthe Release to Water Section ofthe Order.
(c) Temporary Transport and Storage. Notwithstandingparagraph (b), 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) Subsequentto any such exempt temporary transport or storage ofsealed containers, the PMN substances may be distributed onlyto the Company or a person who has given the Company the written agreementrequired by paragraph (b). (2) Any human exposure or environmental release resulting from openingthe sealed containers and removing or washing outthe PMN substances may occur only while the PMN substances are in the possession and control ofthe Company or a person who has given the Company the written agreement requiredby paragraph (b).19 (d) RecipientNon-Compliance. If, at any time after commencing distribution in commerce ofthe PMN substances, the Company obtains knowledge that a recipient ofthe substances has failed to comply with any ofthe conditions specified in paragraph (b) ofthis Distribution section or, after subparagraph (b)(2) ofthis Section expires in accordance with subparagraph (e)(I) ofthis Section, has engaged in a significant new use ofthe PMN substances (as defined in 40 CFRPart 721, SubpartE) 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: (I) That the Company has, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any ofthe conditions specified in paragraph (b) ofthis Distribution section, or has engaged in a significant new use ofthe PMN substances without submitting a significant new use noticeto EPA. (2) That, within 15 working days ofnotifying the recipient ofthe noncompliance, the Company received from the recipient, in writing, a statement ofassurance that the recipient is
aware ofthe terms ofparagraph (b) ofthis Distribution section and will comply 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 new use notice to EPA. (3) If, after receiving a statement ofassurance from a recipient under subparagraph (d)(2) ofthis Distribution section, the Company obtains knowledge that the recipient has failed to comply with any ofthe conditions specified in paragraph (b) ofthis Distribution section, or has engaged in
a significant new use ofthe PMN substances without submitting a significant newuse notice to EPA, the Company shall cease supplyingthe PMN substances to that recipient, shall notify EPA of

### 20
the failure to comply, and shall resume supplying the PMN substances to that recipient only upon written notification from the Agency.
(e) Sunset Following SNUR. (I) Subparagraph (b)(2) (ii) ofthis Distribution section shall expire 75 days after promulgation ofa final SNUR for the PMN substances under section 5(a)(2) of TSCA, unless 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 (b)(2)(ii) ofthis Distribution section shall not expire until EPA notifies the Company in writing that all Federal Court actions involving the SNUR have beenresolved and the validity ofthe SNUR affirmed. (2) When EPA promulgates a final SNURfor the PMN substances and subparagraph (b)(2)(ii) ofthis Distribution section expires in accordance with subparagraph (e)(1), the Company shall notify eachpersonto whom it distributes the PMN substances ofthe existence ofthe SNUR. Suchnotification must be in writing and must specifically include all limitations contained in the SNURwhich 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 the publication of the SNUR for these PMN substances in either the Federal Register orthe Code ofFederal Regulations. Afterpromulgation ofa SNUR and expiration ofsubparagraph (b)(2)(ii) ofthis Section, such notice may substitute for the written agreement required in the introductory clause of paragraph (b)(i); so that, ifthe Company provides such notice to the persons to whom it distributes the PMN substances, then the Company is not required to obtain from such persons the written agreement specified in paragraph (b).21 RELEASE TO WATER This provision does not supersede orpreempt any applicable federal, state, and local laws and regulations. (Those other laws may be more stringent than the requirements below.) The Company is prohibited from any predictable orpurposeful release ofthe PMN substances, or any waste stream from processing and use containing the PMN substances into the waters ofthe United States. This prohibition does not apply to quantities ofthe PMN substances that have been exempted in the Scope ofApplicability and Exemption section ofthis Order.

RECORDKEEPING (a) Records. After the effective date ofthis Order and, consistent with any otherrequirements 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 and copying by EPA in accordance with section 11 ofTSCA: (I) Exemptions. Records documenting that the PMN substances did in fact qualifY for any
one or more ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Such records must satisfy all the statutory and regulatory recordkeeping requirements applicable to the exemption being claimed by the Company. Any amounts or batches ofthe PMN substances eligible for the Export exemption in Section I, Paragraph (b)(2) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, copies ofthe export label and export notice to EPA, required by TSCA sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches ofthe PMN substances eligible for the Research and Development exemption in Section I, Paragraph (b)(3) ofthis Order,
are exempt from all the requirements inthis Recordkeeping section, ifthe Company maintains, for

### 22 5 years from the date oftheir creation, the records required by 40 CFR nO.78(b). For any amounts or batches 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 thatexemption as well as the records specified in paragraphs (2) and (3) below, butis exempt from the otherrecordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture and importation volume ofthe PMN substances 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 ortransfers the PMN substances, the date ofeach sale ortransfer, and the quantity ofthe substance sold or transferred 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 equipmentrequired pursuant to the Protection in the Workplace section ofthis Order; (6) Records documenting the determinations required by the Protection inthe Workplace section ofthis Order that chemical protective clothing is impervious to the PMN substances; (7) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing, Processing, and Use, and Distribution sections ofthis Order, including distributees' written agreement to comply with the Distribution section of this Order;

### : 23 (8) Copies ofany Transfer Documents and notices required by the Successor Liability section ofthis Order, ifapplicable; and (9) The Company shall keep a copy ofthis Order at each ofits sites where the PMN substances 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. Underthe Paperwork Reduction Act and itsregulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this "collection of information" unless this Order displays a currently valid control number from the Office of Management and Budget ("OMB"), and EPA so informs the Company. The "collection of information" required in this TSCA §5(e) Consent Orders has been approved under currently valid OMB Control Number2070-0012.

IV. REOUESTS FOR PRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuant to section II ofTSCA and 40 CFR 720.122, 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 information pertinent to the scheduling and conduct ofsuch inspections. Such requests may be written or oral. The types ofinformation that EPA may request may include, but are not limited to, the following:24 (i) Expected dates and times whenthe 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 andmay 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 exposed to the PMN substances; (iv) Existing exposure monitoring data for workers who are involved in activities associated withthe PMN substances and may reasonably be exposedto the PMN substances; (v) Records required by the Recordkeeping section ofthis Order; and/or (vi) Any other information reasonably related to determining compliance with this Order or conducting an inspection for thatpurpose.
(b) Company's Response. The Company shallrespond to suchrequests within a reasonableperiod oftime, but in no event later than 30 days after receiving EPA's request. When requested in writing by EPA, the Company's response shall be in writing. To the extentthe information is known to or reasonably 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 Information. Any Confidential Business Information ("CBI") that the Company submits to EPA pursuantto paragraph (b) shall be protected in accordance with 

### §14 of TSCA and 40 CFRPart 2., , 

### 25

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by which the Company's rights and obligations under this Order may be transferredwhen the Company transfers its interests in the PMN substances, including the right to manufacture the PMN substances, to another person outside the Company (the "Successor in Interest").
(b) Relation ofTransfer Date to Notice ofCommencement ("NOC"). (I) Before NOC. Ifthe transfer from the Company to the Successor in Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN substances from the Company pursuantto 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 or import ofthe PMN substance. (2) After NOC.
.Ifthe transfer from the Company to the Successor in Interest is effective after EPA receives a NOC, the Successor in Interest shall comply with the terms ofthis Order and shall not be required to submit newPMNs to EPA.
(c) Definitions. The following definitions apply to this Successor Liability section ofthe Order: (1) "Successor in Interest" means a person outside the Company who has acquired the Company's full interest in the rights to manufacture the PMN substances, including all ownership rights and legal liabilities, through a transfer document signed by the Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe Company in the PMN substances, such as a licensee who has acquired a limited26 license to the patent ormanufacturing rights associated with the PMN substances. A Successor in Interest must be incorporated, licensed, or doing business in the United States in accordance with 40 CFR nO.22(a)(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 Companyto the Successor in Interest.
(d) Notices. (I) Notice to Successor in Interest. On or before the effective date ofthe transfer, the 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 C to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the Company shall, by registered mail, submit the fully executed Notice 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 must be maintained bythe Successor in Interest at its principal place ofbusiness, and at all sites where the PMN substances
are manufactured or imported. Copies ofthe Transfer Document must also be made available for inspection pursuant to Section 11 ofTSCA, must state the effective date oftransfer, and must containprovisions which expressly transfer liability for the PMN substances under the terms of this Order from the Company to the Successor in Interest.

# · , 27

(e) Liability. (1) The Company shall be liable for compliance with the requirements ofthis Order until the effective date ofthetransfer described above. (2) The Successor in Interest shall be liable for compliance withthe requirements ofthis Order effective as ofthe date oftransfer. (3) Nothing in this section shall be construed to prohibitthe Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken, or omissions made, during the time inwhich the Companymanufactured, processed, used, distributed in commerce, or disposed ofthe PMN substances pursuant to the terms ofthis Consent Order.
(f) Obligations to Submit Test Dataunder Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Order requires the Company to submittest data to EPA at a specified production volume ("test trigger"), the aggregate volume ofthe PMN substances manufactured and imported by the Company up to the date oftransfer shall counttowards the testtrigger applicable to the Successor in Interest., , 

### 28
VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company may petition EPA at any time, based upon newinformation on the health effects of, or human exposure to, the PMN substances, to modify or revoke substantive provisions ofthis Order. The exposures andrisks identified by EPA during its review ofthe PMN substances and the information EPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend orrevoke this Order, EPA will consider all relevant information available atthe time the Agency makes that determination, including, where appropriate, any reassessment ofthe 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 substantial environmental release in the absence ofdata sufficient to permita reasoned evaluation ofthehealth or environmental effects of the PMN substances. In addition, the Company may petition EPA at any time to make other modifications to the language ofthis Order. EPAwill issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued."'1 ' , ;!. 

### VII. EFFECT OF CONSENT ORDER (a) Waiver. Byconsenting to the entry ofthis Order, the Company waives its rights to file objections to this Order pursnant to section 5(e)(l)(C) ofTSCA, to receive service ofthis Order no later than 45 days before the end ofthe review period pursuant to section 5(e)(I)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound by its 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 thatthe Company may have under TSCA. (b) CEI Brackets. By signing this Order, the Company represents that it has carefully reviewed this document and hereby agrees that all information herein thatis claimed 

### as confidential by the Company (per section 14 ofTSCA, 40 CFRPart 720 SubpartE, and 40 CFR Part 2)iscorrectly identified within brackets and that any information thatis not bracketed is not claimed as confidential. To make this document available for public viewing, EPAwill remove only the information contained within the brackets.

Date

Dltte ' 

# /in Jim Willis, Director Chemical Control Division Office ofPollution Prevention and Toxics

Name: ] Title: [ ] Company: [ ]

### ATTACHMENT A DEFINITIONS [Note: The attached Order may notcontain some of the terms definedbelow.] "Chemical name" means the scientific designation ofa chemical substance in accordance withthe nomenclature system developedbythe International Union ofPure and Applied Chemistry orthe 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 thatprovide a protective barrier to prevent dermal contact with 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 any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment or painting contractor). "Common name" means any designation oridentification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other thanby its chemical name. "Consumer" means a private individual who uses a chemical substance or any product containing the chemical substance in or around apermanent or temporary household or residence,

.during recreation, or for any personal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, oras part ofa mixture, sold or made available to consumers for their use in or arQund a pennanentortempQrary 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 tobe containers. "ContractManufacturer" means a person, outside the Company, who is authorized to manufacture and import the PMN'substances under the conditions specified in Part II. ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Identity" means any chemical or common name used to identify a chemical substance or a mixture containing that substance.

### 3 "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is under the control of, and used only by, theperson who transferred itfrom a labeled container and will only be used by that 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 chemicalprotective 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 ofdatafor the chemical substance. "NIOSH" means theNational Institute for Occupational Safety and Health ofthe U.S. Department ofHealth and Human Services. "Non-enclosedprocess" 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 andthe workplace air may occur. "Non-industrialuse"means use otherthan at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described inthePremanufacture notice submitted by the Company relevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed onthe body topreventcontact with, and exposure to, an identified chemical substance or substance inthe work area. Examples include, but are not limitedto, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types of respirators. Barrier creams are not included inthis definition. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of processing, including the cleaning ofequipment. "Scientifically invalid" means any significant departure from theEPA-approved protocol orthe Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency approval thatprevents a reasoned evaluation ofthe health or environmental effects ofthe PMN substance.4 "Scientifically equivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to pennit a reasoned evaluation of the potential risk ofinjury to humanhealth orthe environment ofthe PMN substance. "Sealed container" means a closed containerthat is physically and chemically suitable for long-term containment ofthe PMN substance, and from which there will be neither human exposure to, nor environmental release of, the PMN substances 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, orconsumeruse. "Waters ofthe United States"has the meaning setforth in 40 CFR 122.2. "Workarea" means a roomor defined space in a workplace where thePMN substances is manufactured, processed, orused and where employees are present. "Workplace" means an establishment at one geographic location containing one or more work areas.Company (Transferor) ATTACHMENT B NOTICE OFTRANSFER OF TOXIC SUBSTANCE CONTROL ACT SECTION See) CONSENT ORDER

PMNNumber I. 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, IS U.S.C. §2604(e». 2. Assumption ofLiabilitv. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed bythe applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposalofthe PMN substance, shall bethe responsibilityofthe Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doingbusiness inthe United States in accordance with 40 CFR nO.22(a)(3). 3. Confidential Business Information. The Successor in Interest hereby: reasserts,

_ relinquishes, or modifies all COJ)[Jdential Business Information ("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 beenpreviously disclosedto the public (e.g., a chemical identity that was not claimed as CBIby the original submitter) would not subsequently be eligible for confidential treatment under this Notice ofTransfer.
.2

TOXIC SUBSTANCE CONTROL ACT SECTION S(e) CONSENT ORDER NOTICE OF TRANSFER (continued)
Company (Transferor) PMNNumber

Signature ofAuthorized Official Date
Printed Name ofAuthorized Official
Title ofAuthorized Official

Successor in Interest
Signature ofAuthorized Official Date
Printed Name ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip Code

### 3

TOXIC SUBSTANCE CONTROLACT SECTION 5(e) CONSENT ORDER NOTICE OF TRANSFER (continued)

Successor's Technical Contact
Address City, State, Zip Code
Phone**Jfon!'l3'al~OO**1.:)21' lIOiTAMJiOlV!l**~~lJa** JA,'!OITAj,'I w,ArI"!OOTO!.1**~** (i:W!:i 

### .0.3)**io'!o!iA~~**