UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OF NEW CHEMICAL SUBSTANCES

PENDING DEVELOPMENT OF INFORMATION

In the matter of: ) Premanufacture Notice Number:

)

 

)

)

)

)

 )

[ ] ) P-10-115 through 126

)

)

)

)

)

)

)

Consent Order and Determinations Supporting Consent Order 

_______________________________________________________________________
TABLE OF CONTENTS

I. Introduction

Preamble

II. Summary of Terms of the Order

III. Contents of PMN 

IV. EPA’s Assessment of Risk

V. EPA’s Conclusions of Law

VI. Information Required to Evaluate Human Health and Environmental Effects

I. Scope of Applicability and Exemptions

Consent Order

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

Attachment C - Consent Order for Processor
iii

PREAMBLE

I 

Under the authority of § 5(e) of the Toxic Substance Control Act (“TSCA”) (15 U.S.C. 

INTRODUCTION

2604(e)), the Environmental Protection Agency (“EPA” or “the Agency”) issues the attached 

Order, regarding premanufacture notices (“PMNs”) P-10-0115 through P-10-0126 for the chemical 

substances described in the notices as carbon nanofibers (“CNFs”) (the “PMN substances”), submitted by [ ] (“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.

The Consent Order for these PMN substances requires the Company to: 

SUMMARY OF TERMS OF THE ORDER

(1) submit to EPA certain exposure and physical-chemical property testing within a specified time 

period and certain toxicity testing at least 14 weeks before manufacturing or importing a total of [ 

 ] of the PMN substances; 

(2) provide its workers personal protective equipment to prevent dermal exposure;

(3) provide its workers respirators to prevent inhalation exposure;
iv

(4) comply with the Release to Water Provisions; 

(5) use the PMN substances only as electrical and thermal conductivity additives, mechanical reinforcement additives, energy storage additives, and chemical intermediates;

(6) limit the processing and use of the PMN substances to industrial settings; 

(7) provide the U.S. EPA with a 1 g sample of the PMN materials upon request by EPA;

(8) 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 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) incorporated into an article as defined at 

40 CFR 720.3(c); and

(9) maintain certain records.

III. 

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.

CONTENTS OF PMN

Confidential Business Information Claims (Bracketed in the Preamble and Order)

Company, production volume, and process information

:

Chemical Identity:

Specific identity: 
v

Generic: Carbon Nanofibers 

Specific: Electrical conductivity additive in thermoplastics and thermosets, mechanical reinforcement additive in thermoplastics and thermosets, energy storage additive, and chemical intermedi

Use: 

ate. 
vi

Forms: The notice described three forms of the PMN substances as powdered, liquid polymer 

form with a concentration of the PMN substances up to [ ] (“liquid polymer form”), and solid 

polymer form with a concentration of the PMN substances up to [ ] (“solid polymer form”). The 

notice also described “pre-preg forms” of the PMN substances. For purposes of this order the prepreg form described as “agglomerates coated with polymeric substances” is considered a powdered 

form, and the pre-preg form described as “uncured pre-impregnated composite fibers” is considered a liquid polymer form. 

Maximum 12-Month Production Volume

P-10-115 – [ ]

: 

P-10-116 – [ ]

P-10-117 – [ ]

P-10-118 – [ ]

P-10-119 – [ ]

P-10-120 – [ ]

P-10-121 – [ ]

P-10-122 – [ ]

P-10-123 – [ ]

P-10-124 – [ ]

P-10-125 – [ ]

P-10-126 – [ ]

Test Data Submitted with the PMNs: - None
vii

The following are EPA’s predictions regarding the probable toxicity, human exposure and 

environmental release of the PMN substances, based on the information currently available to the 

Agency.

IV. EPA’S ASSESSMENT OF RISK

Absorption is expected to be poor via all routes for the PMN 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 the 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 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/oppt/newchems/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. 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. 

Human Health Effects Summary:
viii

Environmental effect studies have not been conducted specifically on CNFs, but based on 

chemical structure and physical-chemical properties, EPA is assessing CNFs to behave similarly in 

the environment to carbon nanotubes (“CNT”). Toxicity from CNT exposures has been reported 

in many aquatic species at concentrations much higher than any estimated solubility limits. Even 

though CNT 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 CNT combine with dissolved organic matter to form stable aqueous suspensions. 

No studies on CNT are available in which a broad range of production methods, sources, purification, functionalization, etc. were investigated. EPA expects that some fraction of the CNT, if released into the environment, will eventually become suspended in water. 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 SWCNT 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. 

Environmental Effects Summary:
ix

TABLE 1. - Exposure and Environmental Release Summary for the P-10-0115 – P-10-0120:

Manufacture

Processing for

Electrical 

Conductivity 

Additive for 

Composites

Processing for 

Mechanical 

Reinforcement 

for Composites

Processing and 

Use for Crucible handling 

for Heat 

Treatment of

Carbon 

Nanofibers 

(intermediate)

Use as an Intermediate 

(milling)

# Sites [ ] [ ] [ ] [ ] (same as 

manufacturing)

[ ] (same as 

manufacturing)

Workers 

(#/site)

[ ] [ ] [ ] [ ] [ ]

Exposure

(days/year)

[ ] [ ] [ ] [ ] [ ]

Dermal Exposure 

(mg/day)

[ ] to solid particulate

[ ] to liquid

[ ] to solid 

particulate

[ ] to liquid

[ ] to solid 

particulate

[ ] to liquid

[ ] to solid 

particulate

[ ] to solid 

particulate

Inhalation Exposure 

(mg/day)

[ ] mg/day worst 

case 

[ ] mg/day 

worst case 

[ ] mg/day 

worst case 

[ ] mg/day 

worst case

[ ] mg/day 

worst case 

Drinking Water Exposure (mg/day)[ ] mg/kg/day 

acute dose rate 

(“ADR”)

0.0004 

mg/kg/day Lifetime average dose 

rate (“LADD”)

[ ] 

mg/kg/day 

ADR

0.000016 

mg/kg/day 

LADD

[ ]

mg/kg/day 

ADR

0.000016 

mg/kg/day 

LADD

[ ]

mg/kg/day 

ADR

0.0004 

mg/kg/day 

LADD

[ ]

mg/kg/day 

ADR

0.0004 

mg/kg/day 

LADD

Releases

(days/year)

[ ] [ ] [ ] [ ] [ ]

Surface Water Concentration (ppb)

[ ] worst case [ ] [ ] [ ] worst case [ ]
x

TABLE 1(continued). - Exposure and Environmental Release Summary for the P-10-0115 –

P-10-0120:

Uses as an Electrical Conductivity 

Additive and mechanical Reinforcement for 

Composites

(thermoplastics and 

solid thermosets)

Use as an 

Electrical 

Conductivity 

Additive for 

Composites

(liquid thermosets)

Use as a Mechanical Reinforcement for 

Composites

(thermosets)

Use as an Additive for Battery 

Electrodes

# Sites [ ] [ ] [ ] [ ] (same as 

manufacturing)

Workers 

(#/site)

Not assessed [ ] [ ] [ ]

Exposure

(days/year)

Not expected [ ] [ ] [ ]

Dermal Exposure 

(mg/day)

Not expected [ ] to liquid [ ] to liquid [ ] to solid particulate

[880] to liquid

Inhalation Exposure 

(mg/day)

Not expected Negligible Negligible [ ] mg/day 

worst case exposure

Drinking Water Exposure (mg/day)

Not expected [ ] 

mg/kg/day 

ADR

0.000012 

mg/kg/day 

LADD

[ ]

mg/kg/day 

ADR

0.000012 

mg/kg/day 

LADD

[ ] mg/kg/day 

ADR

0.0004 

mg/kg/day 

LADD

Releases

(days/year)

Not expected [ ] [ ] [ ]
xi

TABLE 2. - Exposure and Environmental Release Summary for the P-10-0121 – P-10-0126:

Manufacture

Processing and 

use as a Crucible handling 

for Heat 

Treatment of 

Carbon

Nanofibers 

(intermediate 

use)

Processing as 

an Electrical 

Conductivity 

Additive for 

Composites

Processing as a 

Mechanical 

Reinforcement 

for Composites

Electrical 

Conductivity 

Additive for 

Composites

(thermoplastics and solid 

thermosets)

# Sites [ ] [ ] (same as 

manufacture)

[ ] [ ] [ ]

Workers 

(#/site)

[ ] [ ] [ ] [ ] Not assessed

Exposure

(days/year)

[ ] [ ] [ ] [ ] Not expected

Dermal Exposure 

(mg/day)

[ ] to solid particulate

[ ] to liquid

[ ] to solid 

particulate

[ ] to solid 

particulate

[ ] to liquid

[ ] to solid 

particulate

[ ] to liquid

Not expected

Inhalation Exposure 

(mg/day)

[ ] mg/day 

worst case 

[ ] mg/day 

worst case 

[ ] mg/day 

worst case 

[ ] mg/day 

worst case

Not expected

Drinking Water Exposure (mg/day)[ ] mg/kg/day 

ADR

[ ] mg/kg/day 

LADD

[ ] 

mg/kg/day 

ADR

[ ]

mg/kg/day 

LADD

[ ]

mg/kg/day 

ADR

[ ]

mg/kg/day 

LADD

[ ]

mg/kg/day 

ADR

[ ]

mg/kg/day 

LADD

Not expected

Releases

(days/year)

[ ] [ ] [ ] [ ] Not expected
xii

TABLE 2(continued). - Exposure and Environmental Release Summary for the P-10-0121 –

P-10-0126:

Use 2b: Electrical 

Conductivity Additive for Composites

(liquid thermosets)

Use 3a: Mechanical 

Reinforcement for 

Composites

(thermoplastics)

Use 3b: Mechanical Reinforcement for 

Composites

(thermosets)

Use 4: Additive 

for Battery Electrodes

# Sites [ ] [ ] [ ] [ ]

Workers 

(#/site)

[ ] Not assessed [ ] [ ]

Exposure

(days/year)

[ ] Not expected [ ] [ ]

Dermal Exposure 

(mg/day)

[ ] to liquid Not expected [ ] to liquid [ ] to solid particulate

[ ] to liquid

Inhalation Exposure 

(mg/day)

Negligible to liquids

Not expected Negligible to 

liquids

[ ] mg/day 

worst case exposure

Drinking Water Exposure (mg/day)[ ] mg/kg/day 

ADR

[ ] mg/kg/day 

LADD

Not expected [ ] mg/kg/day 

ADR

[ ] mg/kg/day 

LADD

[ ] mg/kg/day 

ADR

[ ] mg/kg/day 

LADD

Releases

(days/year)

[ ] Not expected [ ] [ ]

Risk to Workers: The PMN substances may present a risk to workers exposed to the PMN substances and associated byproducts via inhalation. In the tables above, the worst case worker inhalation value is [ ] during manufacturing, but other inhalation exposures may occur during 

processing and use. There is a concern for pulmonary toxicity, fibrosis and cancer and a potential 
xiii

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 sufficient 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. 

The following findings constitute the basis of the Consent Order:

V. EPA’S CONCLUSIONS OF LAW

(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 of the 

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) of TSCA, that uncontrolled manufac-
xiv

ture, 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 health effects testing in 

coordination with other manufacturers of carbon nanotubes. This 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.
CONSENT ORDER

I. 

(a) 

SCOPE OF APPLICABILITY AND EXEMPTIONS

Scope. The requirements of this Order apply to all commercial manufacturing, processing, 

distribution in commerce, use and disposal, in the United States, of the chemical substances described in the notices P-10-0115, P-10-0116, P-10-0117, P-10-0118, P-10-0119, P-10-0120, P-10-

0121, P-10-0122, P-10-0123, P-10-0124, P-10-0125, P-10-0126, generically described as carbon 

nanofibers (“CNFs”) and specifically described by the physical-chemistry properties in the Notice 

(the “PMN substances”) by [ ] (“the Company”), except to the extent that those activities are exempted by paragraph (b).

(b) Exemptions

extent that (1) these activities are conducted in full compliance with all applicable requirements of 

the following exemptions, and (2) such compliance is documented by appropriate recordkeeping as 

required in the Recordkeeping section of this Order.

. Manufacturing, processing, distribution in commerce, use and disposal of the 

PMN substances are exempt from the requirements of this Order (except the requirements in the 

Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the 
2

(1) Completely Reacted, Cured, or Embedded

(2) 

. The requirements of this Order do not apply to quantities of the PMN substances that are used solely for the uses authorized in paragraph 

(b) of the Manufacturing section and paragraphs (a) and (b) of the Processing/Use section of this 

Order, after 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; or (iv) incorporated into an article as defined at 40 CFR 720.3(c).

Export

(3) 

. 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 of the PMN 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. 

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

(5) 

. 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 

720.3(d) and in compliance with 40 CFR 720.30(g). 

No Separate Commercial Purpose

(c) 

. 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 

720.30(h), with no commercial purpose separate from the substance, mixture, or article of which 

they are a part.

Automatic Sunset. If the Company has obtained for the PMN substances Test Market Exemptions (“TME”) under TSCA §5(h)(1) and 40 CFR 720.38 or Low Volume Exemptions (“LVE”) or 

Low Release and Exposure Exemptions (“LoREx”) under TSCA §5(h)(4) and 40 CFR 

723.50(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

The Company is prohibited from manufacturing, 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 substances, 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. 

PROHIBITION
4

(a) 

TESTING

Section 8(e) Reporting. Reports of information on the PMN substances which reasonably supports the conclusion that the PMN substances present a substantial risk of injury to health or the 

environment and which is required to be reported under TSCA section 8(e) shall reference the appropriate PMN identification number for the substances and contain a statement that the substances are subject to this Consent Order. Additional information regarding section 8(e) reporting requirements can be found at www.epa.gov/oppt/tsca8e.

(b) Notice of Study Scheduling. For toxicological testing, 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 substances and a statement that the 

substances are subject to this Consent Order. 
5

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

pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards

at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific community at the time the study is initiated. Before starting to conduct any 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 pre-acceptance of 

test results. 

(d) Triggered Testing Requirements.

(1) 

 The Company is prohibited from manufacturing or importing the PMN substances beyond the following time periods or aggregate manufacture and import 

volumes of all 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. 

Exposure and Toxicity Tests. The production limit for these tests shall be calculated starting two years after expiration of the PMN review period.

TABLE 3. – Required Exposure and Toxicity Tests:

Production Limit Test

[ ]

Guideline

Workplace exposure monitoring and characterization testing (including byproducts) as 

well as quantification and 

characterization of substances 
6

that may be released during 

exposures typical during the 

use phase, such as handling, 

tearing and cutting the PMN 

substances. This should be 

conducted considering aggregate exposures to all PMN 

substances, but with characterization of the exposures to individual substances/particles. 

[ ] or 

[ ] kg, whichever comes 

first.

Using a representative PMN 

substance in the group P-10-

0115, P-10-0116, P-10-0117, 

P-10-0118, P-10-0119, and P10-0120: a 90-day inhalation 

toxicity test, with a postexposure 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.

OPPTS 870.3465

[ ] or 

[ ] kg, whichever comes 

first. 

Using a representative PMN 

substance in the group P-10-

0121, P-10-0122, P-10-0123, 

P-10-0124, P-10-0125, and P10-0126: a 90-day inhalation 

toxicity test, with a postexposure observation period 

of up to 3 months, 

bronchoalveolar lavage fluid 

(BALF) analysis, aggregation/agglomeration state, 

OPPTS 870.3465
7

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.

• Within 1 year following a notice of commencement, by means of transmission electron microscopy (“TEM”), scanning electron microscopy (“SEM”), scanning transmission electronic microscopy (“STEM”) plus X-ray analysis [ 

 The Company must submit 

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

procedures). Description of the physical-chemical properties of the 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. 

 ], or other means acceptable to the Agency, the 

 Company shall attempt to establish whether the chemical structure of their carbon 

 nanofibers are stacked cups or bowls, scrolled sheets, ribbons, or another structure. 

• Within 1 year following a notice of commencement, the Company shall conduct dustiness 

studies utilizing DIN 15051 on PMN substances P-10-0119 and P-10-0125. 
8

• Within 1 year following a notice of commencement, the Company shall measure or identify 

the following properties on PMN substances, P-10-0119, P-10-0121, P-10-0122, P-10-

0123, P-10-0124, P-10-0125, and P-10-0126:

TABLE 4. – Required Propertie

Characteristic or Property

s:

Guideline or method

Determine the nature of the fiber ends – open, 

closed or both (in which case the Company 

shall identify the distribution of the fiber ends)

SEM, TEM, and/or STEM

Number of overlapping “walls” or layers from 

the edge of the fiber to the core

SEM, TEM, and/or STEM

Ring size/connectivity - 5,6 and/or 7 or other SEM, TEM, and/or STEM

Alignment of long “z” axis - straight, bent, 

bucked, branched, helical, or other

SEM, TEM, and/or STEM

Presence, nature, and density of any ring deformities 

Dry particle size of agglomerates via particle 

count

SEM, TEM, and/or STEM

Inside diameter of fiber (where no overlap of 

the walls or layers occurs)

SEM, TEM, and/or STEM

• Within 1 year following a notice of commencement, the Company shall provide details 

about the catalyst(s) used including particle size and shape of the catalyst utilized in the 
9

manufacture of each PMN substance for P-10-0115 and P-10-0118. The company shall also provide residual catalyst information (particle size, composition, nature of residue) on 

substances P-10-0115, P-10-118, P-10-0124, P-10-0125, P-10-0126. 

• Within 1 year following a notice of commencement, the Company shall provide details on 

the reasonably ascertainable chemical compositions (chemical identity and percent of the 

substances in the encapsulation) of the substances encapsulating the PMN substances including thermosets, thermoresins, elastomers, glasses, metals, and ceramics. 

(e) Test Reports.

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 

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 of these items. 

 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 confidential business information is involved), the final report of each study and all underlying data (“the report and data”) 

to EPA no later than 14 weeks prior to 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 

(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.
10

(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 relief from 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)(1) and (2). The testing requirements may be modified, as necessary to permit a reasoned evaluation of the risks presented by the PMN substances, only by mutual consent of EPA and the Company.

(h) EPA Determination of Invalid Data.

(1) 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), 

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 
11

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)(1) 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, if the Company becomes 

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

have prevented, development of scientifically valid data under the conditions specified in paragraphs (c) and (e), the Company remains prohibited from 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:

(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 
12

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.

(j) Unreasonable Risk.

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

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

PMN substances will or may present an unreasonable risk of injury to human health or the environment. EPA’s notice may specify that the Company undertake certain actions concerning further testing, 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 substances. 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: 

 

(2) within 2 weeks from receipt of the notice described in subparagraph (j)(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 (j)(1) of this 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 
13

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 of the 

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.

(a) 

PROTECTION IN THE WORKPLACE

Establishment of Program.

(1) The Company shall determine and implement the minimum dermal and respiratory 

personal protective equipment requirements for the different forms of the PMN substances according to the following table: 

 During manufacturing, processing, and use of the 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 substances), the Company 

must establish a program whereby:
14

Table 5. - Applicable Protective Requirements for Different Forms of the PMN Substances

(2) General Dermal Protection.

Physical Forms

 Each person who is reasonably likely to be dermally exposed in the work area to the PMN substances through direct handling of 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 Table 5, 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, 

Maximum concentration of the PMN substancesMinimum Dermal 

Protection

Powdered

Minimum Respiratory Protection

[ ] Full general and specific dermal protection 

required in paragraphs 

(a)(2) and (a)(3).

Respiratory protection 

required in paragraph 

(a)(5).

Liquid polymer form Less than or equal to 

[ ]

Full general and specific dermal protection 

required in paragraphs 

(a)(2) and (a)(3).

None required provided there is no generation of vapor, mist, or 

aerosol in a nonenclosed process and 

the concentration of 

the PMN substances is

less than or equal to 

, otherwise respiratory 

protection required in 

paragraph (a)(5)

Solid polymer form Less than or equal to 

[ ]

If there is no generation of dust and the 

concentration of the 

PMN substances are

less than or equal to , 

none required. Otherwise, full general and 

specific dermal protection required in paragraphs (a)(2) and (a)

(3).

If there is no generation of dust in a nonenclosed process and 

the concentration of 

the PMN substances is 

less than or equal to 

, none required. Otherwise, respiratory 

protection required in 

paragraph (a)(5).
15

1910.133, and 1910.138.

(3) Specific Dermal Protective Equipment

 (i) Gloves impervious to the PMN substances.

. When required by Table 5, the dermal personal protective equipment must include, but is not limited to, the following items:

(ii) Full body clothing impervious to the PMN substances.

(4) Demonstration of Imperviousness.

(i) 

 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 any one or a combination of the following: 

Permeation 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 substances 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 F1194-89 “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-X174 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 
16

which they are exposed to the PMN substances.

(ii) Manufacturer’s Specifications

(5) 

. 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 substances in the work area. 

Respiratory Protection.

(6) 

When required by Table 5, each person who is reasonably likely 

to be exposed by inhalation in the work area to 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 non-exempt 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.

Authorized Respirators.

meet the minimum requirements for subparagraph (a)(5) of this section: NIOSH-certified airpurifying, tight-fitting full-face respirator equipped with N-100, P-100, or R-100 filter with an 

APF of 50 or greater.

 The following NIOSH-certified respirators 

MANUFACTURING
17

(a)(1) Prohibition.

 (2) 

 The Company shall not cause, encourage, or suggest the manufacture or import 

of the PMN substances by any other person. 

Sunset Following SNUR.

 (3) 

 Subparagraph (a)(1) 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) 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 

(a)(1) 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.

Notice of SNUR. When EPA promulgates a final SNUR for the PMN substances and subparagraph (a)(1) 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)(1) The Company shall not manufacture or import the PMN substances for use other than as an:

 (i) Electrical and thermal conductivity additive in encapsulated thermoplastics, thermosets, 

elastomers, glass, metals, and ceramics;

 (ii) Mechanical reinforcement additive in encapsulated thermoplastics, thermosets, elastomers, 

glass, metals, and ceramics;

 (iii) Energy storage additive; or

 (iv) Chemical intermediate.

 (2) The Company shall not use the PMN substance for non-industrial applications. 

(c) Sample. The Company shall provide to EPA a 1 gram sample of each of the PMN substances
18

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

(a) The Company shall not process or use the PMN substances other than as:

PROCESSING AND USE

 (1) Electrical and thermal conductivity additive in encapsulated thermoplastics, thermosets, elastomers, glass, metals, and ceramics;

 (2) Mechanical reinforcement additive in encapsulated thermoplastics, thermosets, elastomers, glass, metals, and ceramics;

 (3) Energy storage additive; or

 (4) Chemical intermediate.

(b) The Company shall not use the PMN substance for non-industrial applications. 

 

(a) 

DISTRIBUTION

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 (a Distributee) that, due to the issuance of this Consent Order under section 5(e) of TSCA, the PMN substances are subject to the export notification requirements of TSCA 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(s) and (2) either (A) the specific chemical identity(ies) of the chemical substances, or (B) if the specific chemical identity(ies) are confidential, the generic chemical 

identit(ies). 
19

(b) Types of Distributees. This Distribution section authorizes the Company to distribute the 

PMN substances to three types of Distributees: (1) Distributees who will further distribute the 

PMN substances only when the PMN substances are in an exempted or mitigated state, as defined 

in paragraph (c); (2) Distributees who will further distribute the PMN substances in a nonexempted and unmitigated state after the attached Consent Order for Processor expires, 75 days 

after promulgation of a final SNUR governing all of the PMN substances; and (3) Distributees 

who will further distribute the PMN substances in a non-exempted and unmitigated state before the 

attached Consent Order for Processor expires, 75 days after promulgation of a final SNUR governing all of the PMN substances . The distribution requirements for the first two Distributees are 

identical and are stated in paragraph (e) below. The third type of Distributee must sign the attached Consent Order for Processor, as specified in paragraph (f) below.

(c) 

 (1) 

Mitigated and Exempted States of the PMN Substances.

Exempted State of the PMN Substances.

(i) completely reacted (cured); 

As described in Section I of this Order Scope of 

Applicability and Exemptions paragraph (b)(1), the provisions of this Order do not apply to quantities of the PMN substances after they have been:

(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; or

(iv) incorporated into an article as defined at 40 CFR 720.3(c).

 (2) Mitigated States of the PMN Substances. For purposes of further distribution, the PMN 
20

substances shall be considered to be in a “mitigated state” when the PMN substances are: 

(i) incorporated or embedded in a solid polymer form with a concentration of the PMN 

substances equal to or below [ ].

(d) Temporary Transport and Storage.

(1) Subsequent to any such temporary transport or storage of sealed containers, the PMN 

substances may be distributed only to the Company or to a Distributee compliant with paragraph 

(e) or (f).

 Notwithstanding paragraphs (e) and (f) in this Distribution 

section, 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:

(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 Distributee compliant with paragraph (e) or (f).

(e) Distribution Requirements in the Absence of Processor Order

(1) 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) of TSCA, the PMN substances are subject to the 

. Except when the PMN substances are in a exempted or mitigated state as described in paragraph (c) above, or as provided in 

the Temporary Transport and Storage paragraph (d) above, or for Distributees who sign Processor 

Orders as described in paragraph (f) below, the Company shall distribute the PMN substances outside the Company, other than for disposal, only to a Distributee who has agreed in writing prior to 

the date of distribution, to:
21

export notification requirements of TSCA 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 substances, or (B) if the specific chemical identity is confidential, the generic chemical identity.

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

until after the PMN substances are in an exempted or mitigated state as defined in subparagraph (c) 

of this Section. Thus, further distribution for processing and use may occur once the PMN substances are in an exempted or mitigated state. 

(3) Comply with the same requirements and restrictions required of the Company in the 

Protection in the Workplace section.

 (4) Not process or use the PMN substances other than as: 

(i) Electrical and thermal conductivity additive in encapsulated thermoplastics, thermosets, elastomers, glass, metals, and ceramics;

(ii) Mechanical reinforcement additive in encapsulated thermoplastics, thermosets, elastomers, glass, metals,. and ceramics;

(iii) Energy storage additive; and

(iv) Chemical intermediate.

(5) Limit use of the PMN substances to industrial applications. 

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

Release to Water Section of the Order.

(f) Consent Order for Processor. 
22

 (1) If the Company distributes the PMN substances to Distributees who will further distribute the PMN substances in a non-exempted and unmitigated state before the attached Consent 

Order for Processor expires, 75 days after promulgation of a final SNUR governing all of the PMN 

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

disposal, only to a Distributee who has signed the Consent Order for Processor in Attachment C to 

this Order (a “Processor”).

(2) The Company shall obtain from each such Processor a signed copy of the Consent Order for Processor and submit this copy to EPA along with the name, address, and telephone number of a responsible official of the Processor. The Processor or Company must receive a fully executed copy of the Consent Order for Processor from EPA before the Processor may begin to process any of the PMN substances.

(g) Sunset following SNUR.

(1) If the Company distributes the PMN substances to Distributees who will further distribute the PMN substances in a non-exempted and an unmitigated state before the attached Consent Order for Processor expires, 75 days after promulgation of a final SNUR governing all of the 

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

to processors who have signed the attached Consent Order for Processor in accordance with paragraph (f) of this Distribution section. After the attached Consent Order for Processor expires 75 

days after promulgation of a final SNUR governing all of the PMN substances, the Company shall 

distribute the PMN substances only to Distributees who comply with the requirements specified in 

paragraph (e) of this Distribution section. 

 

(2) Paragraphs (e) and (f) of this Distribution section shall expire 75 days after promulga-
23

tion 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, paragraphs (e)(2) and (f) 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. 

(3) When EPA promulgates a final SNUR for the PMN substances and paragraph (e) of 

this Distribution section expires in accordance with subparagraph (g)(2), the Company shall notify 

each Distributee to whom it distributes 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 require 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 paragraphs (e)(2) and (f), such notice may substitute 

for the written agreement required in the introductory clause of paragraph (f); so that, if the Company provides such notice to the Distributee, then the Company is not required to obtain from such 

Distributee the written agreement specified in paragraph (e). However, even absent such written 

agreement, the Company remains obligated to comply with the “Recipient Non-Compliance” paragraph (h) below.

(h) Recipient Non-Compliance. If, at any time after commencing distribution in commerce of the 

PMN substances, the Company obtains knowledge that a recipient (including a Processor) of the 

PMN substances has failed to comply with any of the applicable conditions specified in paragraphs 

(e) or (f) of this Distribution section or, after paragraphs (e) or (f) expires in accordance with para-
24

graph (g)(2), 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:

(1) That the Company has, within 5 working days, notified the recipient in writing that the 

recipient has failed to comply with any of the applicable conditions specified in paragraphs (e) or 

(f) 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.

(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 applicable terms of paragraphs (e) or (f) 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 (h)(2) 

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

with any of the applicable conditions specified in paragraphs (e) or (f) 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 the failure to comply, and shall resume supplying the PMN substances to that 

recipient only upon written notification from the Agency.
25

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 of the United States. 

RELEASE TO WATER

III.

(a) 

RECORDKEEPING

Records.

(1) 

 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:

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) of this Order, are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the date of their 

creation, 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 5 years 

from the date of their creation, the records required by 40 CFR 720.78(b). For any amounts or 

batches of the PMN substances claimed to be eligible for any other exemption described in Section 
26

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 substances 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, 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; 

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

section of this Order, if applicable; and
27

(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.

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.

 Under the Paperwork Reduction Act and its regulations at 5 CFR Part 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION

(a) EPA’s Request for Information

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

subsequent 12 months;

. Pursuant to section 11 of TSCA 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:
28

(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 

of time, 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.

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER
29

(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) 

(1) 

Relation of Transfer Date to Notice of Commencement (“NOC”).

Before NOC.

(2) 

 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) of TSCA and 40 CFR part 720 before 

commencing manufacture or import of the PMN substances.

After NOC. If the 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.

(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 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 

 The following definitions apply to this Successor Liability section of the Order:
30

40 CFR 720.22(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) 

(1) 

Notices.

Notice to Successor in Interest.

(2) 

 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 B to 

this Order. 

Notice to EPA.

(3) 

 Within 10 business days of the effective date of the 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.

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.

(e) Liability.
31

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

the effective date of the transfer described above.

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

Order effective as of the date 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 of this 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.

VI. 

The Company may petition EPA at any time, based upon new information on the health efMODIFICATION AND REVOCATION OF CONSENT ORDER
32

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

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

and the information EPA determined to be 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 of the 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. EPA will 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.
33

(a) 

VII. EFFECT OF CONSENT ORDER

Waiver.

(b) 

By consenting to the entry of this Order, the Company waives its rights to file objections to this Order pursuant to section 5(e)(1)(C) of TSCA, to receive service of this Order no later 

than 45 days before the end of the review period pursuant to section 5(e)(1)(B) of TSCA, 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. 

CBI 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 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.

_________________ ________________________________ 

Date Jim Willis, Director

Chemical Control Division

Office of Pollution Prevention and Toxics

 

___________________ ________________________________ 

Date 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 around a permanent or temporary household or residence, in or around a school, or in recreation.

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

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

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

containers.

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

manufacture and import the PMN 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. 
2

“Immediate use” A chemical substance is for the “immediate use” of a person if it is under 

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

only be used by that person within the work shift in which it is transferred from the 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 substances” means the chemical substances 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. 
3

“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 permit a reasoned evaluation of the potential 

risk of injury to human health or the environment of the 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.
ATTACHMENT B

NOTICE OF TRANSFER OF

TOXIC SUBSTANCE CONTROL ACT

SECTION 5(e) CONSENT ORDER

___________________________ _________________

Company (Transferor) PMN Number

1. Transfer of Manufacture Rights. Effective on _______________, the Company did sell or otherwise transfer to ________________________________, (“Successor in Interest”) the rights and 

liabilities associated with manufacture of the above-referenced chemical substances, 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, 15 U.S.C. §2604(e)).

2. Assumption of Liability.

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

720.22(a)(3).

 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 substances, shall be the 

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

3. Confidential Business Information.

___ reasserts, 

 The Successor in Interest hereby:

___ relinquishes, or

___ modifies

all Confidential 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 5(e) CONSENT ORDER

 NOTICE OF TRANSFER

 (continued)

__________________________________ _____________________

Company (Transferor) PMN Number

___________________________________ _____________________

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