UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: 

Nanocomp Technologies Inc 

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Premanufactnre Notice Number: 

P -10-0039 and P -10-0040 

Y £_ 2-/ll/2<171 

Consent Order and Determinations Supporting Consent Order 
TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms of the Order 

III. Contents ofPMN 

IV. EPA's Assessment of Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

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

Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Notice of Transfer of Consent Order 
11 

PREAMBLE 

I INTRODUCTION 

Under the authority of § 5(e) of the 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-l 0-0039 and P-l 0-0040 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 of the PMN review period. 

The Company submitted the PMNs to EPA pursuant to section 5(a)(1) of TSCA and 40 CFR 

Part 720. 

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

provision of § 5 or any order issued under § 5. Violators may be subject to various penalties and 

to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure 

pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 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. submit to EPA the following tiered testing: 

a. workplace exposure monitoring and/or characterization testing on both the PMN 

substances following the notice of commencement of both the PMN substances 

(this data could change EPA's finding of substantial human exposure and might 

obviate or change the need to conduct the human health tests specified under b. 

below); 
11I 

b. subsequent to the exposure monitoring and/or characterization testing, submit to 

EPA the 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 of the PMN substances: 

1. 90-day inhalation toxicity test, by nose-only exposure with a postexposure observation period of up to 3 months (OPPTS 870.3465), with 

additional analysis and characterization of the bronchoalveolar lavage 

fluid (BALF), aggregation! agglomeration state, shape, size/size particle 

distribution and surface properties of materials as-administered, 

aggregation! agglomeration state, shape, size/size particle distribution and 

surface properties of materials ofthe delivered materials after 

administration, determination of cardiovascular toxicity, heart 

histopathology, and data on pulmonary deposition, or other relevant data 

as determined by the initial tier of testing; 

2. submit to EPA the certain material characterization data on the PMN substances obtained 

from either scanning electron microscopy or transmission 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 of commercial 

manufacturing; 

3. require workers at the manufacturing sites to wear personal 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 inhalation route 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 of the 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 of the United States; 

7. limit use of the 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 as 
IV 

. 

8. limit the processing and use of the PMN substances to industrial settings; 

9. provide the u.s. EPA with a 1 g sample of the PMN materials upon request by EPA; 

10. distribute the PMN substances only to a person who agrees to follow the same restrictions 

applicable to the company (except the testing requirements) and to not further distribute 

the PMN substances unless they are used explicitly for the purposes outlined under (7) 

and until after they have been (i) completely reacted (cured); (ii) incorporated or 

embedded into a polymer matrix that itself has been completely reacted (cured); (iii) 

embedded in a permanent solid polymer, metal, glass, or ceramic form; or (iv) completely 

embedded in an article; 

11. maintain relevant records. 

In summary, the "Scope of Applicability and Exemption" section of the Order exempts the 

following: 

1. quantities of the PMN substances that have been completely reacted (cured), incorporated or 

embedded into a polymer matrix that itself has been reacted (cured), embedded in a 

permanent solid polymer, metal, glass, or ceramic form, or completely embedded in an 

article. These exemptions do not apply beyond the uses that are specifically authorized by 

the Order in 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 of the PMN 

substances for use within the United States; 

3. research & development ("R&D"); 

4. the PMN substances as a byproduct without separate commercialintent; and 

5. the PMN substances in a substance, mixture, or article with no separate commercial purpose. 
v 

III. CONTENTS OF PMN 

By signing this Order, the Company represents that it has carefully reviewed this 

document and hereby agrees that all information herein that is claimed as confidential by the 

Company (per section 14 of TSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) is correctly 

identified within brackets and that any information that is not bracketed is not claimed as 

confidential. To make this document available for public viewing, EPA will remove only the 

information contained within the brackets. 

Confidential Business Information Claims (Bracketed in the 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: The Notices 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-Month Production Volume: 

P-1O-0039: [ kg/yr. 

P-1O-0040: [ kg/yr. 

Test Data Submitted with the PMNs: 

• Occupational exposure monitoring and characterization at the site of manufacture. 

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. Data on the PMN substances and other analogous substances 

indicate tlJe potential for generation of increased amounts of respirable or absorbable particles 

during processing and use of nanoscale materials. Much more evaluation is needed to determine 
vii 

the toxicity of nanoscale materials for all routes of exposure. 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 substances. There are also data suggesting that pulmonary 

deposition of some 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 tested negative for skin sensitization in the 

Local Lymph Node Assay (LLNA) and were slightly irritating in an acute dermal irritation study 

in rabbits. Based on the uncertainty of the characterization and exposure of nanoscale 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 in which a broad range of production methods, 

sources, purification, functionalization, etc. were investigated. EPA expects that some fraction 

of the CNTs, if released 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 of liver tumor formation over longer exposure 

periods. This response is also notable because effects were seen in cells closest to blood vessels, 

suggesting transport of respired 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 of concern. Such studies must measure actual 

concentrations of carbon nanotubes and control for the effects of contaminants, solvents, and 

physical factors such as blockage of gills 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 None 
IX 

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 

1 ADR refers 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 via inhalation. 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 

exposed to the PMN substances and associated byproducts via the inhalation route. 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 itself dermally, but does not have 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 of the 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 of PMN substances expected to be released into the 

environment, in the absence of site-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 of the 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 the potential 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 of the PMN substances. 

(b) In light of the potential risk to human health and the environment posed by the uncontrolled 

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

substances, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) ofTSCA, that uncontrolled 

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

substances may present an unreasonable risk of injury 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 specified time periods and production volumes, unless the Company submits the 

information described in the Testing section of this Order in accordance with the conditions 

specified in the Testing section. The Order's restrictions on manufacture, import, processing, 

distribution in commerce, use, release to water, and disposal of the PMN substances will remain 

in effect until the Order is modified or revoked by EPA based on submission of that or other 

relevant information. EPA encourages the Company to develop additional environmental and 
Xli 

health effects testing in coordination with other manufacturers of carbon nanotubes. Ibis can be 

done under the in-depth portion of EPA's Nanoscale 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) Completely Reacted, Cured, or Embedded. If quantities of the PMN substances (A) 

are used solely for the uses authorized in paragraph (b) of the Manufacturing section and 

paragraphs (a) and (b), of the ProcessinglUse section of this Order; and (B) those quantities have 

been (i) completely reacted (cured); (ii) incorporated or embedded into a polymer matrix that itself 

has been reacted (cured); (iii) embedded in a permanent solid polymer, metal, glass, or ceramic 

form that is not intended to undergo further processing except for mechanical processing; (iv) or 

completely embedded in an article; then the other requirements of this Order do not apply. 

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

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

or distribution in commerce of the PMN substances solely for export in accordance with TSCA 

§12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to 

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

involving the PMN substances are exempt as "solely for export" even if some amounts of the PMN 

substances are later exported. At that point, the requirements of this Order apply to all activities 

associated with the PMN substances while in the territory of the United States. Prior to leaving 

U.S. territory, even those quantities or batches ofthePMN substances that are destined for export 

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

Testing section of this Order. 

(3) Research & Development ("R&D"). The requirements of this Order do not apply to 

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

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

720.3(cc), and 40 CFR 720.36. 
3 

(4) Byproducts. The requirements of this 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 of this Order do not apply to the 

PMN substances when they are manufactured, pursuant to any of the exemptions in 40 CFR 

nO.3o(h), with no commercial purpose separate from the substance, mixture, or article of which 

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 Low Volume Exemptions 

("L VE") or Low Release 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 

of the effective date of this 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 of the PMN substances in the United States, for any nonexempt 

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

of the human health and environmental effects of the substance, and the completion of EPA's 

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

conditions described in this Order. 
;-1-

4 

TESTING 

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

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

environment and which is required to be reported under TSCA section 8( e) shall reference the 

appropriate PMN identification number for the substance and contain a statement that the 

substance is subject to this Consent Order. Additional information regarding section 8( e) reporting 

requirements can be found at www.epa.gov/opptitsca8e. 

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

Integrity Branch (2225A), Office of Enforcement and Compliance Assurance, U.S. Environmental 

Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, of the following 

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

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

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

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

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

EPA may contact regarding the study; and 

(4) The appropriate PMN identification number for the substance and a statement that 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 CFR Part 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 of test protocols from EPA by submitting written protocols. EPA 

will respond to the Company within 4 weeks of receiving the written protocols. Published test 

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

but are not themselves acceptable protocols. Approval of the test protocol does not mean preacceptance of test 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 of both 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 with the 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 of the PMN review period. 

Production Limit Test Guideline 

2 years Workplace exposure 

monitoring and 

characterization testing 

(including byproducts) as well 

as quantification and 

characterization of substances 

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 of up to 3 

months, bronchoalveolar 

lavage fluid (BALF) analysis, 

aggregation!agglomeration 

state, shape, size/size particle 

distribution and surface 

properties of materials asadministered, aggregation! 

agglomeration state, shape, 

size/size particle distribution 

and surface properties of 

materials of the delivered 

materials after 

administration, determination 

of cardiovascular toxicity, 

heart histopathology, and data 

on pulmonary deposition. 

(2) Material Characterization and Physical-Chemical Properties. The Company must submit 

the following material characterization data on both PMN substances (including data summaries 

and procedures). Description of the physical-chemical properties ofthe material tested and 

material characterization tests should take into consideration the characterizations identified in the 

Guidance Manual for Sponsors of the OECD Sponsorship Programme for the Testing of 

Manufactured Nanomaterials. These tests shall be due 6 months after expiration of the 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 of walls ofPMN substances (average and range) 

Tube type ofSWCNT (P-I0-0039) 

Configuration of the nanotube ends Transmission-electron 

microscopy (TEM) 

Branching Scanning electron microscopy 

(SEM) and TEM . 

Tube length SEM& TEM 

Alignment of the nanotube along long axis . SEM&TEM 

Hexagonal array orientation XRD 

Chiral or twist angle XRD 

Particle sizes of catalyst used in the manufacture ofthe SEM& TEM 

nanotubes 

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

study; and(3) submit, in triplicate (with an additional sanitized copy, if confidentiaLbusiness 

information is involved), the final report of each study and all underlying data ("the report and 

data") to EPA no later than 14 weeks prior to 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 guidelines. However, for purposes of this Consent Order, the 

word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the 

submission of such information is mandatory. EPA will not require the submission of raw data 
8 

such as slides and laboratory notebooks unless if EPA finds, on the basis of professional judgment, 

that an adequate evaluation of the study cannot take place in the absence ofthese items. 

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

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

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

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

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

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

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

necessary to permit a reasoned evaluation ofthe risks presented by the PMN substances, only by 

mutual consent of EPA and the Company. 

(h) EPA Determination ofInvalid Data. 

(I) Except as described in subparagraph (h)(2) of this Section, if, within 6 weeks of EPA's 

receipt of a test report and data, the Company receives written notice that EPA finds that the data 

generated by a study are scientifically invalid, the Company is prohibited from further manufacture 

and import of the PMN substances beyond the applicable production limit. 

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

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

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

(i) The Company may reconduct the study in compliance with paragraphs (b), (c), 
9 

and (e)(1) and (2). If there is sufficient time to reconduct the study and submit the report and data 

to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e )(3) 

of this Section, the Company shall comply with subparagraph (e)(3) of this Section. If there is 

insufficient time for the Company to comply with subparagraph (f)(3) of this Section, the 

Company may exceed the production limit and shall submit the report and data in triplicate to EPA 

within a reasonable period of time, all as specified by EPA in the notice described in subparagraph 

(h)(1) of this Section. EPA will respond to the Company, in writing, within 6 weeks of receiving 

the Company's report and data. 

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

in subparagraph (h)(I) of this Section, submit to EPA a written report refuting EPA's finding. 

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

(i) Company Determination of Invalid Data. 

(1) Except as described in subparagraph (i)(2) of this Section, ifthe Company becomes 

aware that circumstances clearly beyond the control ofthe Company or laboratory will prevent, or 

have prevented, development of scientifically valid data under the conditions specified in 

paragraphs (c) and (e), the Company remains prohibited from further manufacture and import of 

the PMN substances beyond the applicable production limit. 

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

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

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

will notifY the Company of its response, in writing, within 4 weeks of receiving the Company's 

report. EPA's written response may either: 
,J 

10 

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

beyond the applicable production limit, or 

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

compliance with paragraphs (b), (c), and (e)(1) and (2). If there 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) of this Section, the Company shall comply 

with subparagraph (e)(3) of this Section. If there is insufficient time for the Company to comply 

with subparagraph (e )(3) of this Section, the Company may exceed the production limit and shall 

submit the report and data in triplicate to EPA within a reasonable period of time, all as specified 

by EPA in the notice described in subparagraph (i)(2) of this Section. EPA will respond to the 

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

the Company may continue to manufacture and import beyond the applicable production limit. 

G) Unreasonable Risk. 

(1) EPA may notify the Company in writing that EPA finds that the data generated by a 

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

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

environment. EPA's notice may specify that the Company undertake certain actions concerning 

further testing, manufacture, import, processing, distribution, use and/or disposal of the PMN 

substances to mitigate exposures to or to better characterize the risks presented by the PMN 

substance. Within 2 weeks from receipt of such a notice, the Company must cease all 

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

either: 
11 

(2) within 2 weeks from receipt ofthe notice described in subparagraph 0)(1) of this 

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

(3) within 4 weeks from receipt of the notice described in subparagraph G)(l) ofthis 

Section, the Company submits to EPA a written report refuting EPA's finding and/or the 

appropriateness of any additional requirements imposed by EPA. The Company may continue to 

manufacture, import, process, distribute, use and dispose of the PMN substances in accordance 

with the terms of this Order pending EPA's response to the Company's written report. EPA will 

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

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

imposed by EPA's response or cease all manufacture, import, processing, distribution, use and 

disposal ofthe PMN substances. 

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

section, the Company must continue to obey all the terms of this Consent Order until otherwise 

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

information, petition EPA to modify or revoke provisions of this Consent Order pursuant to Part 

VI of this Consent Order. 

PROTECTION IN THE WORKPLACE 

(a) Establishment of Program. 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 or maintenance of equipment 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 equipment requirements for activities involving the different workplace 

settings of the 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) of this 

section, each person who is reasonably likely to be dermally exposed in the work area to the PMN 

substances through direct handling of the substance, release from sheet or yarn articles containing 

the substances, or through contact with equipment on which 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 of the table in 

subparagraph (a)(1) in the specific work area where the substances are selected for use. Each such 

item of personal 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 Equipment. When required by the table in subparagraph 

(a)(I) ofthis section, the dermal personal protective equipment required 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 

each item of chemical 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 of the following: 

(i) Testing. Testing the material used to make the chemical protective clothing and 

the construction of the clothing to establish that the protective clothing will be impervious for the 

expected duration and conditions of exposure. The testing must subject the chemical protective 

clothing to the expected conditions of exposure, including the likely combinations of chemical 

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 of Protective Clothing materials to Permeation by Liquids or Gases." 

Results shall be recorded as a cumulative permeation rate as a function of time, and shall be 

documented in accordance with ASTM F739 using the format specified in ASTM Fl194-89 

"Guide for Documenting the Results of Chemical Permeation Testing on Protective Clothing 

Materials." Testing may also be conducted according to the ASTM F1671-07 "Standard Test 

Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne 

Pathogens Using Phi-Xl 74 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 of each work 

shift during which they are exposed to the PMN substances. 

(ii) Manufacturer's Specifications. Evaluating the specifications from the 

manufacturer or supplier of the chemical protective clothing, or of the material used in 

construction of the 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) of this 

section, each person who is reasonably likely to be exposed by inhalation in the work area to the 

PMN substances or release from sheet or yarn articles containing the PMN substances, is provided 

with, and is required to wear, at a minimum, a NIOSH-certified respirator from the respirators 

listed in subparagraph (a)(6) of this 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 limited to, any worker in the work area during activities (including 

a reasonable time period following any such activities) involving handling quantities of the 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 protection program under the OSHA 

requirements in 29 CFR 1910.134. 

(6) Authorized Respirators. The following NIOSH-certified respirators 

meet the minimum requirements for subparagraph (a)(5) of this section: 

(i) At the site of manufacture, processing, and use. NIOSH-certified airpurifYing, tight-fitting full-face respirator equipped with N-I00, P-I00, or R100 filter with an APF of 50 or greater. 

MANUFACTURING 

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

of the PMN substances by any other person. 
" 15 

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

promulgation of a final significant new use rule ("SNUR") governing the PMN substances under 

section 5(a)(2) ofTSCA unless the Company is notified on or before that day of an action in a 

Federal Court seeking judicial review ofthe SNUR. If the Company is so notified, subparagraph 

(a)(l) shall not expire until EPA notifies the Company in writing that all Federal Court actions 

involving the SNUR have been resolved and the validity of the SNUR affirmed. 

(3) Notice of SNUR. When EPA promulgates a final SNUR for the PMN substances and 

subparagraph (a)(l) of this Section expires in accordance with subparagraph (a)(2) of this Section, 

the Company shall notify each person whom it causes, encourages or suggests to manufacture or 

import the PMN substances of the existence of the SNUR. 

(b) Prohibited Uses. The Company shall not: 

(l) manufacture or import the 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 of each of the PMN substances 

as specified by EPA in a future written request along with a copy of the MSDS for the substances. 

PROCESSING AND USE 

(a) The Company shall not process 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 or use the PMN substances for commercial or consumer use, 

or in a consumer product. 

DISTRIBUTION 

(a) Export Notice Requirement. No later than the date of distribution, the Company shall notify in 

writing any person to whom it distributes the PMN substances that, due to the issuance of this 

Consent Order under section 5(e) ofTSCA, the PMN substances are subject to the export 
17 

notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice 

shall contain, in the form in which they appear in the Consent Order, the following information: 

(1) the PMN number and (2) either (A) the specific chemical identity of the chemical substance, or 

(B) if the specific chemical identity is confidential, the generic chemical identity. 

(b) (l) Distribution Requirements. Except as provided in paragraph ( c) or after the PMN 

substances have been: 

(i) completely reacted (cured); 

(ii) incorporated or embedded into a polymer matrix that itself has been completely reacted 

(cured); 

(iii) incorporated or embedded in a permanent solid polymer form that is not intended to 

undergo further processing, except for mechanical processing; or 

(iv) completely embedded in an article 

the Company shall distribute the PMN substances outside the Company, other than for disposal, 

only to a person who has agreed in writing prior to the date of distribution, to comply with all the 

requirements in (b )(2) below: 

(2) (i) NotifY in writing any person to whom it distributes the PMN substances that, due to 

the issuance of this Consent Order under section 5(e) ofTSCA, the PMN substances are subject to 

the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such 

notice shall contain, in the form in which it appears in this Consent Order, the following 

information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN 

substance, or (B) if the specific chemical identity is confidential, the generic chemical identity. 

(ii) Not further distribute the PMN substances to any other person, other than for disposal, 

until after the PMN substances are in 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 in the 

Protection in the Workplace section. 

(iv) Not process or use the PMN substances other than 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 consumer product. 

(vi) Comply with the same environmental release restrictions required of the Company in the 

Release to Water Section of the Order. 

(c) Temporary Transport and Storage. Notwithstanding paragraph (b), the Company may 

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 of sealed containers, the 

PMN substances may be distributed only to the Company or a person who has given the Company 

the written agreement required by paragraph (b). 

(2) Any human exposure or environmental release resulting from opening the sealed 

containers and removing or washing out the PMN substances may occur only while the PMN 

substances are in the possession and control of the Company or a person who has given the 

Company the written agreement required by paragraph (b). 
19 

(d) Recipient Non-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 of the conditions specified in paragraph (b) of this Distribution section or, after 

subparagraph (b)(2) of this Section expires in accordance with subparagraph (e)(I) of this Section, 

has engaged in a significant new use of the PMN substances (as defined in 40 CFR Part 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 of the 

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) of this 

Distribution section, or has engaged in a significant new use ofthe PMN substances without 

submitting a significant new use notice to EPA. 

(2) That, within 15 working days of notifying the recipient of the noncompliance, the 

Company received from the recipient, in writing, a statement of assurance that the recipient is 

aware of the terms of paragraph (b) of this Distribution section and will comply with those terms, 

or is aware of the terms of the 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 of assurance from a recipient under subparagraph (d)(2) 

of this Distribution section, the Company obtains knowledge that the recipient has failed to comply 

with any of the conditions specified in paragraph (b) of this Distribution section, or has engaged in 

a significant new use of the PMN substances without submitting a significant new use notice to 

EPA, the Company shall cease supplying the 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) of this Distribution section shall expire 

75 days after promulgation of a final SNUR for the PMN substances under section 5(a)(2) of 

TSCA, unless the Company is notified on or before that day of an action in a Federal Court 

seeking judicial review of the SNUR. If the Company is so notified, subparagraph (b)(2)(ii) of this 

Distribution section shall not expire until EPA notifies the Company in writing that all Federal 

Court actions involving the SNUR have been resolved and the validity of the SNUR affirmed. 

(2) When EPA promulgates a final SNUR for the PMN substances and subparagraph 

(b )(2)(ii) ofthis Distribution section expires in accordance with subparagraph (e )(1), the Company 

shall notify each person to whom it distributes the PMN substances of the existence of the SNUR. 

Such notification must be in writing and must specifically include 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 the publication of 

the SNUR for these PMN substances in either the Federal Register or the Code of Federal 

Regulations. After promulgation of a SNUR and expiration of subparagraph (b )(2)(ii) of this 

Section, such notice may substitute for the written agreement required in the introductory clause of 

paragraph (b )(i); so that, if the 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 or preempt 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 or purposeful release of the 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 of Applicability and Exemption section of this Order. 

RECORDKEEPING 

(a) Records. After the effective date of this Order and, consistent with any other requirements 

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 of TSCA: 

(I) Exemptions. Records documenting that the PMN substances did in fact qualifY for any 

one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records 

must satisfy all the statutory and regulatory recordkeeping requirements applicable to the 

exemption being claimed by the Company. Any amounts or batches of the PMN substances 

eligible for the Export exemption in Section I, Paragraph (b )(2) ofthis Order, are exempt from all 

the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the 

date of their creation, copies of the export label and export notice to EPA, required by TSCA 

sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches of the PMN substances 

eligible for the Research and Development exemption in Section I, Paragraph (b)(3) of this Order, 

are exempt from all the requirements in this Recordkeeping section, if the 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 of the PMN substances claimed to be eligible for any other exemption 

described in Section I, Paragraph (b) of this 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 of the PMN substances 

and the corresponding dates of manufacture and import; 

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

address, if different) of all persons outside the site of manufacture or import to whom the 

Company directly sells or transfers the PMN substances, the date of each sale or transfer, and the 

quantity of the substance sold or transferred on such date; 

(4) Records documenting the addresses of all sites of manufacture, import, processing, and 

use; 

(5) Records documenting establishment and implementation of a program for the use of 

any applicable personal protective equipment required pursuant to the Protection in the Workplace 

section of this Order; 

(6) Records documenting the determinations required by the Protection in the Workplace 

section of this 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 

of this Order, including distributees' written agreement to comply with the Distribution section of 

this Order; 
: 

23 

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

section of this Order, if applicable; and 

(9) The Company shall keep a copy of this Order at each of its sites where the PMN 

substances are manufactured of imported. 

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

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

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 required to respond to this "collection of 

information" unless this Order displays a currently valid control number from the Office of 

Management and Budget ("OMB"), and EPA so informs the Company. The "collection of 

information" required in this TSCA §5( e) Consent Orders has been approved under currently valid 

OMB Control Number 2070-0012. 

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 of Company facilities and conveyances 

associated with the PMN substances. To facilitate such inspections, EPA personnel may contact 

the Company in advance to request information pertinent to the scheduling and conduct of such 

inspections. Such requests may be written or oral. The types of information that EPA may request 

may include, but are not limited to, the following: 
24 

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

subsequent 12 months; 

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

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

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

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

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

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

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

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

conducting an inspection for that purpose. 

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

oftime, but in no event later than 30 days after receiving EPA's request. When requested in 

writing by EPA, the Company's response shall be in writing. To the extent the information is 

known to or reasonably ascertainable to the Company at the time of the request, the Company's 

response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers 

to all of EPA's requests. 

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

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

TSCA and 40 CFR Part 2. 
, , 

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 transferred when the Company transfers its interests in the PMN 

substances, including the right to manufacture the PMN substances, to another person outside the 

Company (the "Successor in Interest"). 

(b) Relation of Transfer Date to Notice of Commencement ("NOC"). 

(I) Before NOC. If the transfer from the Company to the Successor in Interest is effective 

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

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

new PMNs to EPA and comply fully with Section 5(a)(1) ofTSCA and 40 CFR part 720 before 

commencing manufacture or import of the PMN substance. 

(2) After NOC. . 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 of this Order and 

shall not be required to submit new PMNs to EPA. 

(c) Definitions. The following definitions apply to this Successor Liability section of the Order: 

(1) "Successor in Interest" means a person outside the Company who has acquired the 

Company's full interest in the rights to manufacture the PMN substances, including all ownership 

rights and legal liabilities, through a transfer document signed by the Company, as transferor, and 

the Successor in Interest, as transferee. The term excludes persons who acquire less than the full 

interest of the Company in the PMN substances, such as a licensee who has acquired a limited 
26 

license to the patent or manufacturing rights associated with the PMN substances. A Successor in 

Interest must be incorporated, licensed, or doing business in the United States in accordance with 

40 CFR 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 Company to 

the Successor in Interest. 

(d) Notices. 

(I) Notice to Successor in Interest. On or before the effective date of the transfer, the 

Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent 

Order and the "Notice of Transfer" document which is incorporated by reference as Attachment C 

to this Order. 

(2) Notice to EPA. Within 10 business days of the effective date ofthe transfer, the 

Company shall, by registered mail, submit the fully executed Notice of Transfer document to: 

U.S. Environmental Protection Agency, New Chemicals Branch (7405),1200 Pennsylvania 

Avenue, N.W., Washington, D.C. 20460. 

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

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

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

inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must 

contain provisions which expressly transfer liability for the PMN substances under the terms of 

this Order from the Company to the Successor in Interest. 
· , 27 

(e) Liability. 

(1) The Company shall be liable for compliance with the requirements of this Order until 

the effective date ofthe transfer described above. 

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

Order effective as of the date of transfer. 

(3) Nothing in this section shall be construed to prohibit the Agency from taking 

enforcement action against the Company after the effective date of the transfer for actions taken, or 

omissions made, during the time in which the Company manufactured, processed, used, distributed 

in commerce, or disposed of the PMN substances pursuant to the terms ofthis Consent Order. 

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

of this Consent Order requires the Company to submit test data to EPA at a specified production 

volume ("test trigger"), the aggregate volume of the PMN substances manufactured and imported 

by the Company up to the date of transfer shall count towards the test trigger applicable to the 

Successor in Interest. 
, 

, 

28 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

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

effects of, or human exposure to, the PMN substances, to modify or revoke substantive provisions 

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

and the information EPA determined to be necessary to evaluate those exposures and risks are 

described in the preamble to this Order. However, in determining whether to amend or revoke this 

Order, EPA will consider all relevant information available at the time the Agency makes that 

determination, including, where appropriate, any reassessment of the test data or other information 

that supports the findings in this Order, an examination of new test data or other information or 

analysis, and any other relevant information. 

EPA will issue a modification or revocation if EPA determines that the activities proposed 

therein will not present an unreasonable risk of injury to health or the environment and will not 

result in significant or substantial human exposure or substantial environmental release in the 

absence of data sufficient to permit a reasoned evaluation ofthe health or environmental effects of 

the PMN substances. 

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

language of this Order. EP Awill issue such a modification if EPA determines that the 

modification is useful, appropriate, and consistent with the structure and intent of this Order as 

issued. 
"'1 ' , ;!. 

VII. EFFECT OF CONSENT ORDER 

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

objections to this Order pursnant to section 5(e)(l)(C) ofTSCA, to receive service of this Order no 

later than 45 days before the end of the review period pursuant to section 5(e)(I)(B) ofTSCA, and 

to challenge the validity of this Order in any subsequent action. Consenting to the entry of this 

Order, and agreeing to be bound by its terms, do not constitute an admission by the Company as to 

the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver 

does not affect any other rights that the Company may have under TSCA. 

(b) CEI Brackets. By signing this Order, the Company represents that it has carefully reviewed this 

document and hereby agrees that all information herein that is claimed as confidential by the 

Company (per section 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2)is correctly 

identified within brackets and that any information that is not bracketed is not claimed as 

confidential. To make this document available for public viewing, EPA will remove only the 

information contained within the brackets. 

Date 

Dltte ' 

/in Jim Willis, Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 

Name: ] 

Title: [ ] 

Company: [ ] 
ATTACHMENT A 

DEFINITIONS 

[Note: The attached Order may not contain some of the terms defined below.] 

"Chemical name" means the scientific designation of a chemical substance in accordance 

with the nomenclature system developed by the International Union of Pure and Applied 

Chemistry or the Chemical Abstracts Service's rules of nomenclature, or a name which will clearly 

identify a chemical substance for the purpose of conducting a hazard evaluation. 

"Chemical protective clothing" means items of clothing that provide a protective barrier to 

prevent dermal contact with chemical substance of concern. Examples can include, but are not 

limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. 

"Company" means the person or persons subject to this Order. 

"Commercial use" means the use of a chemical substance or any mixture containing the 

chemical substance in a commercial enterprise providing saleable goods or a service to consumers 

(e.g., a commercial dry cleaning establishment or painting contractor). 

"Common name" means any designation or identification such as code name, code number, 

trade name, brand name, or generic chemical name used to identify a chemical substance other 

than by its chemical name. 

"Consumer" means a private individual who uses a chemical substance or any product 

containing the chemical substance in or around a permanent or temporary household or residence, 

. during recreation, or for any personal use or enjoyment. 

"Consumer product" means a chemical substance that is directly, or as part of a mixture, 

sold or made available to consumers for their use in or arQund a pennanent or tempQrary 

household or residence, in or around a school, or in recreation. 

"Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage 

tank, or the like that contains a hazardous chemical. For purposes of this section, pipes or piping 

systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be 

containers. 

"Contract Manufacturer" means a person, outside the Company, who is authorized to 

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

Consent Order and in the Consent Order for Contract Manufacturer. 

"Identity" means any chemical or common name used to identify a chemical substance or 

a mixture containing that substance. 
3 

"Immediate use." A chemical substance is for the "immediate use" of a person if it is under 

the control of, and used only by, the person who transferred it from a labeled container and will 

only be used by that person within the work shift in which it is transferred from the labeled 

container. 

"Impervious." Chemical protective clothing is "impervious" to a chemical substance if the 

substance causes no chemical or mechanical degradation, permeation, or penetration of the 

chemical protective clothing under the conditions of, and the duration of, exposure. 

"Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a 

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

of manufacture, including the cleaning of equipment. 

"MSDS" means material safety data sheet, the written listing of data for the chemical 

substance. 

"NIOSH" means the National Institute for Occupational Safety and Health of the U.S. 

Department of Health and Human Services. 

"Non-enclosed process" means any equipment system (such as an open-top reactor, storage 

tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise 

used where significant direct contact of the bulk chemical substance and the workplace air may 

occur. 

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

mixtures are manufactured, imported, or processed. 

"PMN substance" means the chemical substance described in the Premanufacture notice 

submitted by the Company relevant to this Order. 

"Personal protective equipment" means any chemical protective clothing or device placed 

on the body to 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 of a chemical 

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

processing, including the cleaning of equipment. 

"Scientifically invalid" means any significant departure from the EPA-approved protocol 

or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency 

approval that prevents a reasoned evaluation of the health or environmental effects of the PMN 

substance. 
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 of injury to human health or the environment ofthe PMN substance. 

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

long-term containment of the PMN substance, and from which there will be 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 of a chemical 

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

industrial, commercial, or consumer use. 

"Waters of the 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 substances is 

manufactured, processed, or used and where employees are present. 

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

work areas. 
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER OF 

TOXIC SUBSTANCE CONTROL ACT 

SECTION See) CONSENT ORDER 

PMNNumber 

I. Transfer of Manufacture Rights. Effective on , the Company did sell or 

otherwise transfer to , ("Successor in Interest") the rights 

and liabilities associated with manufacture of the above-referenced chemical substance, which was 

the subject of a premanufacture notice ("PMN") and is governed by a Consent Order issued by the 

U.S. Environmental Protection Agency ("EPA") under the authority of §5(e) of the Toxic 

Substance Control Act (TSCA, IS U.S.C. §2604(e». 

2. Assumption of Liabilitv. The Successor in Interest hereby certifies that, as of the effective date 

of transfer, all actions or omissions governed by the applicable Consent Order limiting 

manufacture, processing, use, distribution in commerce and disposal of the PMN substance, shall 

be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is 

incorporated, licensed, or doing business in the United States in accordance with 40 CFR 

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 of TSCA and 40 CFR part 2, for the PMN substance( s). Where "reasserts" or "relinquishes" is 

. indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is 

indicated, such modification shall be explained in detail in an attachment to this Notice of 

Transfer. Information which has been previously disclosed to the public (e.g., a chemical identity 

that was not claimed as CBI by the original submitter) would not subsequently be eligible for 

confidential treatment under this Notice of Transfer. . 
2 

TOXIC SUBSTANCE CONTROL ACT 

SECTION S(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Company (Transferor) PMNNumber 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Interest 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Address 

City, State, Zip Code 
3 

TOXIC SUBSTANCE CONTROL ACT 

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"!OO TO!.1 ~ 

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