UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF NEW CHEMICAL SUBSTANCES 

PENDING DEVELOPMENT OF INFORMATION 

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Premanufacture Notice Numbers: 

[ P-08-0733/0734 

Modified Consent Order and Determinations Supporting Consent Order 
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TABLE OF CONTENTS

Preamble

I. Introduction

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 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
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PREAMBLE

I. INTRODUCTION

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

2604(e)) ans section VI of the existing Consent Order, the Environmental Protection Agency 

(“EPA” or “the Agency”) issues the attached Modified Consent Order, regarding premanufacture 

notice (“PMN”) P-08-0733/0734 for the chemical substances, multi walled carbon nanotubes, 

(“MWCNT” or the “PMN substances”) submitted by [ ] (“the Companies” or, where referred 

to individually, “the Company”). The Companies submitted the PMNs to EPA pursuant to 

section 5(a)(1) of TSCA and 40 CFR Part 720. This is the second modification of a Consent 

Order originally effective on February 13, 2009 and first modified effective August 21, 2009. 

This second modification shall become effective on the date when fully executed by all three 

parties.

The first modification added [ ] as a “Company” to the original Consent Order between 

the EPA and [ ]. [ ]. The first modifications was necessary to accommodate changes in 

market demand for different uses of the PMN substances, and so that [ ] can legally submit the 

Notice of Commencement (NOC) of non-exempt commercial manufacture per 40 CFR 720.102. 

Both Companies are each liable for complying with the requirements of this Modified Consent 

Order. Neither Company shall exceed the time limits in the Testing section of the Order unless 

the required study, reports and data have been submitted in satisfaction of the conditions 

specified in the Testing section of the Order.

This second modification is necessary to (1) revise the deadline for delivery of the final 

report on the 90-day subchronic study in rats currently underway, (3) amend the use of the PMN 
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substance, (3) clarify and expand the meaning of “completely reacted (cured)” in the Scope and 

Exemption section and in the Distribution section and (4) prohibit release of the PMN substances 

to surface waters. Modifications (3) and (4) are a result of EPA’s evolving policy for nano 

materials.

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 Modified Consent Order for these PMN substances requires the Companies to: 

(1) Deliver to EPA a 1 gram sample of each PMN substance, upon request, along with 

copies of Material Safety Data Sheets (MSDS);

(2) Submit to EPA the results of a 90-day inhalation toxicity study in rats with a post 

exposure observation period of up to 3 months, including bronchoalveolar lavage fluid 

(“BALF”) analysis (OPPTS 870.3465 or OECD 413), a determination of cardiovascular toxicity 

(clinically-based blood/plasma protein analyses), and histopathology of the heart at least 14

weeks before September 21, 2011;

(3) Within 6 months of commencing non-exempt commercial manufacture of the PMN 

substances, submit certain material characterization data;

(4) Provide workers with impervious gloves and chemical protective clothing;
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(5) Provide workers with a NIOSH–approved full-face respirator with an N -100 cartridge 

while exposed by inhalation in the work area;

(6) Use the PMN substances only as: [ ];

(7) Not manufacture the PMN substances in the United States;

(8) Not release the PMN substance to the waters of the United States;

(9) Distribute the PMN substances only to a person who agrees to follow the same 

restrictions (except the testing requirements); and

(10) Maintain certain records.

III. CONTENTS OF PMN

By signing this Order, the Companies represent that they have carefully reviewed this 

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

Companies (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):

Contact names, companies identities, impurities, production volume, uses, byproducts, trade

identification name, MSDS, physical/chemical properties, worker exposure, environmental 

release, process information, test data in attachments.

Chemical Identity: multi-walled carbon nanotubes
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Use: 

Specific: [ ]

Generic: (1) reinforcement for composites; open, non-dispersive use, (2) conductive additive for 

composites; open, non-dispersive use; (3) conductive additive for batteries; contained use

Maximum 12-Month Production Volume: [ ]

Test Data Submitted with PMN: Acute Oral Toxicity Studies of substances under PMN 08-733 

and 734, Acute Inhalation Toxicity Studies for PMN-08-733 and 734, Bacterial Reverse 

Mutation Studies for PMN-08-733 and 734, Chromosomal Aberration Tests for PMN-08-733 

and 734, Skin Sensitization Tests of PMN-08-733 and 734, Acute Dermal Irritation Studies of 

PMN-08-733 and 734, Fish Acute Toxicity Test of PMN-08-733 and 734, Daphnia sp. Acute 

Immobilization Test of PMN-08-733 and 734, Alga Growth Inhibition of PMN-08-733, and 

Carcinogenicity Study of PMN-08-733.

IV. EPA’S ASSESSMENT OF RISK

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.

Human Health Effects Summary:

Absorption: Absorption of the PMN chemicals is expected to be poor via all routes of exposure

based on structurally similar poorly soluble respirable particles. 

Toxicological Endpoints:
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- Lung overload from poorly soluble, respirable particles;

- Possible mutagenic effects of MWCNT;

- Possible immunotoxic effects of MWCNT;

- Potential for lung cancer from respirable MWCNT nanoparticles or agglomerates.

Basis: Based on the SAT Report, absorption of the PMN chemicals is expected to be poor via all 

routes based on the behavior of analogous substances. There are concerns for lung effects if 

inhaled, based on lung overload of poorly soluble high molecular weight particles. PMNs 08-

733 and 08-734 did not induce gene mutations in bacteria or chromosome mutations in 

mammalian cells in culture. Based on reviewed data on similar materials, they may be weak 

inducers of aneuploidy, and inducers of DNA effects, both in mammalian cells in culture. There 

is potential for immunotoxic effects from P08-0733/0734. To the extent it they are respirable to 

the deep lung, these PMNs could cause adverse effects to the lung, including inflammation, cell 

damage, reduced bacterial clearance, and systemic immunotoxicity. Although there were no 

other immunotoxicity data available for the substances, published data on analogous materials 

indicates that, in general, inhalation of particulates to the deep lung may lead to reduced alveolar 

macrophage phagocytosis and impaired clearance of inhaled bacteria. Such inhalation may also 

lead to pulmonary inflammation, which may damage cells of the lung and exacerbate asthma 

symptoms. Carbon nanotube inhalation can also cause systemic and pulmonary 

immunotoxicity, inducing such ailments as granulomatous lung disease, asthma, exacerbation of 

asthma, and increased respiratory infections.
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There is evidence that ultrafine particles penetrate membranes in the respiratory tract and 

possibly in the GI tract. If so, these particles can migrate to other organs such as the liver, 

kidney, and brain to produce potentially harmful effects. There may also be physical penetration 

through the skin. Tested CNTs have been shown to cause fibrosis of the lung and lung cancer, 

and induce systemic effects. Some recent data suggest cardiovascular effects also are possible 

from inhalation of carbon nanotubes

Based on the submitter’s data, inhalation of respirable particles of P08-0733/0734 may lead to 

lung overload and associated problems, because these chemically inert and insoluble PMN 

substances of very high molecular weight exemplify materials known to cause such effects. The 

results of another study submitted under P09-0733/0734 suggest that P08-0733 is weakly 

carcinogenic in hamsters.

Environmental Effects Summary: No significant effects expected. A potential risk to the 

environment is considered low, based on low hazard due to low toxicity. Further, risk to aquatic 

organisms is considered to be low because of the extremely low solubility of carbon nanotubes in 

water. While a predicted environmental concentration of the PMN substances cannot be 

calculated, the maximum concentration of any nanotubes released into the aqueous environment 

will likely be so low as to be negligible and would likely have no adverse effects on aquatic 

species.

Exposure and Environmental Release Summary: 
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Scenario No. of Sites No. of 

Workers

Inhalation 

(mg/day) -

Dermal 

(mg/day)

Release to 

water

reinforcement for 

composites; open, 

non-dispersive use

[] [] 1.6 NA NA

conductive additive 

for composites; open, 

non-dispersive use

[] [] 0.53 NA NA

conductive additive 

for batteries; 

contained use

[ ] [] 0.54 NA NA

Risk to Workers: Based on available data, EPA concludes the PMN substances may present a 

risk to workers exposed to the PMN substances via the inhalation route.

Risk to General Public: A qualitative evaluation of estimated releases indicates a low potential 

risk to the general population from exposure to water, landfill, and/or incineration releases. 

V. EPA’S CONCLUSIONS OF LAW

The following findings constitute the basis of the Consent Order:

(A) EPA is unable to determine the potential for human health effects 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 effects of the PMN substances.
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(B) In light of the potential risk to human health 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 manufacture, import, 

processing, distribution in commerce, use, and disposal of the PMN substances may present an 

unreasonable risk of injury to human health.

VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS

Triggered Testing. The Order prohibits the Companies from exceeding a specified

production time period or production volume unless the Companies submit the information 

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

Testing section. The Order requires submission of the following triggered testing:

Information Effects Guidelines

90-day inhalation toxicity lung, heart OPPTS 870.3465 or OECD 413

study on rats with a post-exposure

observation period of up to 3 months,

including bronchoalveolar lavage fluid 

(“BALF”) analysis, a determination of 

cardiovascular toxicity (clinically-based 

blood/plasma protein analyses), and

histopathology of the heart. 

Description of the physical-chemical properties of the material tested should take into 

consideration the characterizations identified in most recent version of the Guidance Manual for 
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Sponsors of OECD Sponsorship Programme for the Testing of Manufactured Nanomaterials. 

The Order’s restrictions on manufacture, import, processing, distribution in commerce, use, 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 Companies to develop additional health effects testing in coordination with 

other multi-walled carbon nanotube (MWCNT) manufacturers. This can be done under the indepth portion of EPA’s Nanoscale Materials Stewardship Program or through independent 

testing. EPA would be willing to facilitate the process in coordination with other ongoing health 

effects testing for MWCNT nationally and internationally.
CONSENT ORDER

I. SCOPE OF APPLICABILITY AND EXEMPTIONS

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

distribution in commerce, use and disposal of the chemical substances, multi-walled carbon 

nanotubes (MWCNT), P-08-0733/0734 (“the PMN substances”), in the United States by [ ]

(“the Companies”), except to the extent that those activities are exempted by paragraph (b).

(b) Exemptions. 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 

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.

(1) Completely Reacted (Cured). The requirements of this Order do not apply to quantities 

of the PMN substances that have been completely reacted (cured); embedded or incorporated into 

a polymer matrix that has been reacted (cured); embedded, encapsulated or incorporated by the 

polymer binder into a permanent solid matrix (does not include slurries) that is not intended to 

undergo further processing, except mechanical.
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(2) Export. Until the Companies begin 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 Companies begin to 

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

Companies 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.

(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.

(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 

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

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

they are a part.
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(c) Automatic Sunset. If the Companies have obtained for the PMN substances a Test Market 

Exemption (“TME”) under TSCA §5(h)(1) and 40 CFR 720.38 or a Low Volume Exemption 

(“LVE”) or Low Release and Exposure Exemption (“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

PROHIBITION

The Companies are 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 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. 

TESTING

(a) Section 8(e) Reporting. Any 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 required to be reported under EPA’s section 8(e) policy statement at 43 Federal 

Register 11110 (March 16, 1978) as amended at 52 Federal Register 20083 (May 29, 1987), shall 

reference the appropriate PMN identification numbers for these substances and shall contain a 
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statement that the substances are subject to this Consent Order. Additional information regarding 

section 8(e) reporting requirements can be found in the reporting guide referenced at 56 Federal 

Register 28458 (June 20, 1991).

(b) Notice of Study Scheduling. The Companies 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 Companies or the laboratory whom 

EPA may contact regarding the study; and

(4) The appropriate PMN identification numbers for the substances and a statement that 

the substances are subject to this Consent Order. 

(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 

Companies must obtain approval of test protocols from EPA by submitting written protocols. EPA 

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

guidelines specified in paragraph (d) provide general guidance for development of test protocols, 
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but are not themselves acceptable protocols. Approval of the test protocol does not mean preacceptance of test results.

(d) Triggered Testing Requirements.

(1) 90-day inhalation toxicity study. The Companies are prohibited from manufacturing or 

importing the PMN substances after September 21, 2011, (“the production limit”), unless the 

Companies conduct the following study on one of the PMN substances and submit all final 

reports and underlying data in accordance with the conditions specified in this Testing section.

Production Limit Study Guideline

September 21, 2011 90-day inhalation toxicity OPPTS 870.3465

 study on rats with a post-exposure or OECD 413 

 observation period of up to 3 months, 

 including bronchoalveolar lavage fluid

 (“BALF”) analysis, a determination 

 of cardiovascular toxicity (clinically-based 

 blood/plasma protein analyses), and

 histopathology of the heart. 

If an appropriate adaptation of the 90-day inhalation study for the evaluation of MWCNT is not 

developed within two years of the date the Companies sign this Consent order or if the Companies

commit to an appropriate program to test representative MWCNTs, e.g., under the in-depth portion 

of the Nanoscale Materials Stewardship Program, the Companies may petition EPA, pursuant to 

Section VI of this Consent Order, to modify the above testing requirement. If a consortium of 

companies commits to test a representative set of MWCNT for subchronic mammalian toxicity, 

EPA will consider waiving the above requirement.
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(2) Material Characterization. If the Companies own or control any site in the United States 

where the PMN substances are processed or used, the Companies are prohibited from 

manufacturing or importing the PMN substances beyond 6 months after commencing such 

processing or use of the PMN substances in the United States, unless the Companies submit the 

following material characterization data: 

- Particle size distribution (that include both individual MWCNTs and their agglomerates) in 

the workplace, at sites controlled by the Companies where the PMN substances are

processed or used.

(e) Test Reports. The Companies 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 time 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 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.
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(f) Testing Waivers. The Companies are 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 Companies 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 

Companies 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 Companies.

(h) EPA Determination of Invalid Data.

(1) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA’s receipt of a 

test report and data, the Companies receive written notice that EPA finds that the data generated by 

a study are scientifically invalid, the Companies are prohibited from further manufacture and 

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

(2) The Companies 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 

Companies’ compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii).

(i) The Companies 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), 

the Companies shall comply with subparagraph (e)(3). If there is insufficient time for the 
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Companies to comply with subparagraph (f)(3), the Companies 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). EPA will respond to the 

Companies, in writing, within 6 weeks of receiving the Companies’ report and data.

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

described in subparagraph (h)(1), submit to EPA a written report refuting EPA’s finding. EPA will 

respond to the Companies, in writing, within 4 weeks of receiving the Companies’ report.

(i) Companies Determination of Invalid Data. 

(1) Except as described in subparagraph (i)(2), if the Companies becomes aware that 

circumstances clearly beyond the control of the Companies or laboratory will prevent, or have 

prevented, development of scientifically valid data under the conditions specified in paragraphs (c) 

and (e), the Companies remain prohibited from further manufacture and import of the PMN 

substances beyond the applicable production limit.

(2) The Companies 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 

Companies or laboratory will cause or have caused development of scientifically invalid data. 

EPA will notify the Companies of its response, in writing, within 4 weeks of receiving the 

Companies’ report. EPA’s written response may either:

(i) allow the Companies to continue to manufacture and import the PMN 

substances beyond the applicable production limit, or

(ii) require the Companies 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 
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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), the Companies shall comply with 

subparagraph (e)(3). If there is insufficient time for the Companies to comply with subparagraph 

(e)(3), the Companies 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). EPA will respond to the Companies, in writing, within 6 weeks 

of receiving the Companies’ report and data, as to whether the Companies may continue to 

manufacture and import beyond the applicable production limit.

(j) Unreasonable Risk.

(1) EPA may notify the Companies 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 Companies 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 Companies 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), the 

Companies comply with such requirements as EPA’s notice specifies; or 

(3) within 4 weeks from receipt of the notice described in subparagraph (j)(1), the 

Companies submit to EPA a written report refuting EPA’s finding and/or the appropriateness of 
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any additional requirements imposed by EPA. The Companies 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 Companies’ written report. EPA will respond to the 

Companies, in writing, within 4 weeks of receiving the Companies’ report. Within 2 weeks of 

receipt of EPA’s written response, the Companies 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 Companies must continue to obey all the terms of this Consent Order until otherwise 

notified in writing by EPA. The Companies 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 of the PMN substances

at any site controlled by the Companies (including any associated packaging and storage and 

during any cleaning or maintenance of equipment associated with the PMN substances), the 

Companies must establish a program whereby:

(1) General Dermal Protection. 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, or because the substances become airborne in a 

form listed in subparagraph (a)(5) of this section, is provided with, and is required to wear, 
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personal protective equipment that provides a barrier to prevent dermal exposure to the substances

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.

(2) Specific Dermal Protective Equipment. The dermal personal protective equipment required 

by subparagraph (a)(1) of this section must include, but is not limited to, the following items:

(i) Gloves impervious to the PMN substances

(ii) Full body clothing impervious to the PMN substances

(3) Demonstration of Imperviousness. The Companies are 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: 

(i) 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. 

Permeation testing shall 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.” Gloves may not be used for a time period longer than 
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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 substances in the work 

area.

(4) Respiratory Protection. Each person who is reasonably likely to be exposed by inhalation in the 

work area to the PMN substances in the form listed in subparagraph (a)(5) of this section, 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. All respirators must be issued, 

used, and maintained according to an appropriate respiratory protection program under the OSHA 

requirements in 29 CFR 1910.134.

(5) Physical States. The following physical states of airborne chemical substances are listed for 

subparagraphs (a)(1) and (4) of this section:

(i) Particulate (including solids or liquid droplets).

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

requirements for subparagraph (a)(4) of this section: NIOSH-certified air-purifying, tight-fitting 

full-face respirator equipped with N100 cartridges.

MANUFACTURING
13

(a)(1) Prohibition. The Companies shall not cause, encourage, or suggest the manufacture or 

import of the PMN substances by any other person.

 (2) Sunset Following SNUR. Subparagraph (a)(1) 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 Companies are notified on or before that day of an action in a Federal Court 

seeking judicial review of the SNUR. If the Companies are so notified, subparagraph (a)(1) shall 

not expire until EPA notifies the Companies 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)(1) expires in accordance with subparagraph (a)(2), the Companies shall notify 

each person whom it causes, encourages or suggests to manufacture or import the PMN substances

of the existence of the SNUR.

(b) The Companies shall not:

(1) Manufacture the PMN substances in the United States (excluding import)

(2) Import the PMN substances for use other than as [ ].

(c) The Companies 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 MSDS for each of the PMN 

substances. 

PROCESSING AND USE

The Companies shall not process or use the PMN substances other than as [ ].
14

DISTRIBUTION

(a) Distribution Requirements. Except after the PMN substances have been completely 

reacted (cured); embedded or incorporated into a polymer matrix that has been reacted (cured); 

embedded, encapsulated or incorporated by the polymer binder into a permanent solid matrix (does 

not include slurries) that is not intended to undergo further processing, except mechanical, the 

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

only to a person who has agreed in writing prior to the date of distribution, to:

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

until after the PMN substances have been completely reacted (cured); embedded or incorporated 

into a polymer matrix that has been reacted (cured); embedded, encapsulated or incorporated by 

the polymer binder into a permanent solid matrix (does not include slurries) that is not intended to 

undergo further processing, except mechanical.

(2) Comply with the same requirements and restrictions required of the Companies in the 

Protection in the Workplace section.

(3) Not process or use the PMN substances other than as [ ].

(b) Temporary Transport and Storage. Notwithstanding paragraph (a), the Companies may 

distribute the PMN substances outside the Companies for temporary transport and storage in sealed 

containers (labeled in accordance with paragraph (b)(2) of the Hazard Communication Program 

section of this Order) 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 Companies or a person who has given the 
15

Companies the written agreement required by paragraph (a).

(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 Companies or a person who has given the 

Companies the written agreement required by paragraph (a).

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

PMN substances, the Companies obtain knowledge that a recipient of the substances have failed to 

comply with any of the conditions specified in paragraph (a) of this Distribution section or, after 

paragraph (a)(1) expires in accordance with subparagraph (d)(1), 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 Companies shall cease supplying the substances to that 

recipient, unless the Companies are able to document each of the following:

(1) That the Companies have, within 5 working days, notified the recipient in writing that 

the recipient has failed to comply with any of the conditions specified in paragraph (a) 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 

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

aware of the terms of paragraph (a) 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 (c)(2) 
16

of this Distribution section, the Companies obtain knowledge that the recipient has failed to 

comply with any of the conditions specified in paragraph (a) 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 Companies 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.

(d) Sunset Following SNUR. (1) Paragraph (a)(1) 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 Companies are notified on or before that day of an action in a Federal Court seeking 

judicial review of the SNUR. If the Companies are so notified, paragraph (a)(1) of this 

Distribution section shall not expire until EPA notifies the Companies 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 paragraph (a)(1) of 

this Distribution section expires in accordance with subparagraph (d)(1), the Companies 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 this PMN substances in either the Federal Register or the Code of Federal 

Regulations. After promulgation of a SNUR and expiration of subparagraph (a)(1), such notice 

may substitute for the written agreement required in the introductory clause of paragraph (a); so 

that, if the Companies provide such notice to the persons to whom it distributes the PMN 
17

substances, then the Companies are not required to obtain from such persons the written agreement 

specified in paragraph (a).

RELEASE TO WATER

This provision does not supercede or preempt any applicable federal, state, or local laws 

and regulations. Those may be more stringent than the requirements below. The Companies are 

prohibited from any predictable or purposeful release of the PMN substances, or any waste stream 

from manufacturing, processing or use containing the PMN substances into the waters of the 

United States.

III. RECORDKEEPING

(a) Records. The Companies 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:

(1) 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 Companies. Any amounts or batches of the PMN substances

eligible for the Export exemption in Section I, Paragraph (b)(3) of this Order, are exempt from all 

the requirements in this Recordkeeping section, if the Companies maintain, 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, 
18

are exempt from all the requirements in this Recordkeeping section, if the Companies maintain, 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 I, Paragraph (b) of this Order, the Companies 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 

Companies directly sell 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, use, 

and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections of 

this Order, including distributees’ written agreement to comply with the Distribution section of this 
19

Order; 

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

section of this Order, if applicable; and

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

substances are manufactured of imported.

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

of the Companies and their Contract Manufacturer, if applicable, and not to activities of the 

Companies’ 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 Companies are 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 Companies. The “collection of 

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

OMB Control Number 2070-0012.

IV. REQUESTS FOR PRE-INSPECTION INFORMATION

(a) EPA’s Request for Information. Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA 

may occasionally conduct on-site compliance inspections of the Companies’ facilities and 

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

may contact the Companies 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:
20

(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) Companies’ Response. The Companies 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 Companies’ response shall be in writing. To the extent the information is 

known to or reasonably ascertainable to the Companies at the time of the request, the Companies’

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 

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

TSCA and 40 CFR Part 2.
21

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER

(a) Scope. This section sets forth the procedures by which the Companies’ rights and obligations 

under this Order may be transferred when the Companies transfer their interests in the PMN 

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

Companies (the “Successor in Interest”). 

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

(1) Before NOC. If the transfer from the Companies 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 Companies 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.

(2) After NOC. If the transfer from the Companies 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 Companies who has acquired a

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 Companies, as transferor, and 

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

interest of the Companies 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 
22

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

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 Companies to 

the Successor in Interest.

(d) Notices.

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

Companies 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 of the transfer, the 

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

U.S. Environmental Protection Agency, New Chemicals Management Branch (7405M), 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 Companies to the Successor in Interest.

(e) Liability.
23

(1) The Companies 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 Companies after the effective date of the transfer for actions taken, 

or omissions made, during the time in which the Companies 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 Companies 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 Companies up to the date of transfer shall count towards the test trigger applicable to the 

Successor in Interest.
24

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER

The Companies 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 

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 Companies 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.
26 

VII. EFFECT OF CONSENT ORDER 

(a) Waiver. By consenting to the entry of this Order, the Companies waive their rights to file 

objections to this Order pursuant to section 5(e)(I)(C) ofTSCA, to receive service ofthis Order no 

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

to challen~e 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 Companies as 

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

waiver does not affect aily other rights that the Companies may have under TSCA. 

(b) ,CBl Brackets. By signing this Order, the Companies represent that the have carefully 

reviewed this document and hereby agrees that all information herein that is claimed as 

confidential by the Companies (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 brackJ:!§';' 

Date 
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 substances 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 substances 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 substances of concern. Examples can include, but are not 

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

“Companies” and “Company” mean 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 substance 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. 

“Immediate use.” A chemical substance is for the “immediate use” of a person if it is under 
2

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 labelled 

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 

substances 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. 

“Scientifically equivocal data” means data which, although developed in apparent 
3

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 no human exposure to, 

nor environmental release of, the PMN substance during transport and storage.

“Use stream” means all reasonably anticipated transfer, flow, or disposal 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 substance 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 SUBSTANCES 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 

Substances Control Act (TSCA, 15 U.S.C. §2604(e)).

2. Assumption of Liability. 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 

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

720.22(a)(3).

3. Confidential Business Information. The Successor in Interest hereby:

___ reasserts, 

___ 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

SECTION 5(e) CONSENT ORDER

 NOTICE OF TRANSFER (cont)

__________________________________ _____________________

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

SECTION 5(e) CONSENT O RDER

 NOTICE OF TRANSFER (cont)

__________________________________

Successor’s Technical Contact 

___________________________________

Address

___________________________________

City, State, Zip Code

___________________________________

Phone