UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

 In the matter of: ) Premanufacture Notice Number: 

 ) 

 ) 

 ) 

 ) 

 ) 

 P13-0292 ) [

 ) 

 ) 

 ) 

 ) 

 ) 

_________________________________________________________________ 

Consent Order and Determinations Supporting Consent Order 

_________________________________________________________________ 
ii 

 TABLE OF CONTENTS 

Preamble

I. Introduction 

II. Summary of Terms of the Order 

III. Contents of PMN 

IV. EPA’s Assessment of Exposure 

V. EPA’s Conclusions of Law 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order

I. Scope of Applicability and Exemptions 

II. Terms of Manufacture (Including 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 – Draft Basis for Protocol Development 

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

Order, regarding premanufacture notice (“PMN”) P-13-0292 for the chemical substance 

[ (“the PMN substance”) 

submitted by [ (“the Company”), to take effect upon expiration of the PMN 

review period. The Company submitted the PMN to EPA pursuant to § 5(a)(1) of TSCA and 40 

CFR Part 720. 

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

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

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

pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 of 

TSCA, such as this one, are subject to the § 12(b) export notice requirement. 

II. SUMMARY OF TERMS OF THE ORDER

The Consent Order for this PMN substance requires the Company to maintain certain 

records and submit to EPA certain toxicity and other testing. 
iv 

III. CONTENTS OF PMN

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

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

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): Chemical 

identity, company name and representative, precursor substance name, composition, chemical 

identity information, production volume, use, exposure scenarios. 

Chemical Identity: [ 

Generic: Organophosphorus polymer 

Use: [

Generic: Additive for polymers 

Maximum 12-Month Production Volume: [ kg

Test Data Submitted with PMN: 

Bacterial Reverse Mutation Test 

Acute Oral toxicity in Rats 

In vitro skin corrosivity test 

In vitro skin irritation 

Ocular irritation test 

Acute Daphnia toxicity 

IV. EPA’S ASSESSMENT OF EXPOSURE

Using available exposure information from the public literature (i.e., measured values for 

 

[ in house dust in homes), and certain assumptions for mouthing behavior by 

young children, EPA is concerned that there might be a potential exposure to the general 

population. However, there is uncertainty about the risk from this scenario due to the absence of 
v 

hazard data on the PMN substance itself and information on the ability for the PMN 

substance to migrate or leach out of [ Consumer exposure is possible if the 

PMN migrates from the [ or decomposes to form dust particles that can 

be inhaled or ingested. Analogous chemicals, including Tris(2-chloroethyl)phosphate (TCEP) 

and Tris(1,3-dichloro-2 propyl) phosphate (TDCPP), can be found in household dust, and are 

widespread in the environment. Assuming similar use patterns over time, the PMN substance 

may be expected to display similar exposure patterns. 

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 of the PMN substance 

from exposure of humans to the PMN substance. 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 substance. 

(b) In light of the estimated production volume and human exposure to the PMN substance, 

EPA further concluded, pursuant to § 5(e)(1)(A)(ii)(II) of TSCA, that the PMN substance will be 

produced in substantial quantities, will be present in consumer products, and there may be 

significant (or substantial) human exposure to the substance. 
vi 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH 

AND ENVIRONMENTAL EFFECTS

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

production volume unless the Company submits the information described in the Testing section 

of this Order in accordance with the conditions specified in the Testing section. 
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 substance 

 (P-13-0292) (“the PMN substance”) in the 

United States by [ (“the Company”), 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 substance is 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) Export. Until the Company begins commercial manufacture of the PMN substance 

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

processing or distribution in commerce of the PMN substance 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 
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begins to manufacture the PMN substance for use in the United States, no further activity by the 

Company involving the PMN substance is exempt as “solely for export” even if some amount of 

the PMN substance is later exported. At that point, the requirements of this Order apply to all 

activities associated with the PMN substance while in the territory of the United States. Prior to 

leaving U.S. territory, even those quantities or batches of the PMN substance 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. 

(2) Research & Development (“R&D”). The requirements of this Order do not apply to 

manufacturing, processing, distribution in commerce, use and disposal of the PMN substance 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. The requirements of this Order also do not apply to 

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

when manufactured solely for non-commercial research and development per 40 CFR 720.30(i) 

and TSCA §5(i). 

(3) Byproducts. The requirements of this Order do not apply to the PMN substance 

when it is produced, without separate commercial intent, only as a “byproduct” as defined at 40 

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

(4) No Separate Commercial Purpose. The requirements of this Order do not apply to 

the PMN substance when it is 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 

it is a part. 

(5) Imported Articles. The requirements of this Order do not apply to the PMN 
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substance when it is imported as part of an “article” as defined at 40 CFR 720.3(c) and in 

compliance with 40 CFR 720.22(b)(1). 

(b) Automatic Sunset. If the Company has obtained for the PMN substance 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 (INCLUDING IMPORT), PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL

PENDING SUBMISSION AND EVALUATION

OF INFORMATION

PROHIBITION

The Company is prohibited from manufacturing (defined by statute to include import), 

processing, distributing in commerce, using, or disposing of the PMN substance in the United 

States, for any nonexempt commercial purpose, pending the development of information 

necessary for a reasoned evaluation of the human health and environmental effects of the 

substance, and the completion of EPA’s review of, and regulatory action based on, that 

information, except in accordance with the conditions described in this Order. 

. 
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TESTING

(a) Section 8(e) Reporting. Reports of information on the PMN substance which reasonably 

supports the conclusion that the PMN substance presents 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 this substance and contain a statement that the 

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

reporting requirements can be found at www.epa.gov/oppt/tsca8e. 

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

Assistance and Media Programs Division (2227A), 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 each substance and a statement that 

the substance is subject to this Consent Order. 
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The written notice should be submitted to EPA as follows: 

Postal Mail Address

U.S. Environmental Protection Agency 

GLP Section Chief – Pesticides, Water and Toxics Branch 

Monitoring Assistance and Media Programs Division (2227A) 

Office of Enforcement and Compliance Assurance 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 

Courier Delivery Address

U.S. Environmental Protection Agency 

GLP Section Chief – Pesticides, Water and Toxics Branch 

Monitoring Assistance and Media Programs Division (2227A) 

Office of Enforcement and Compliance Assurance 

Room 7117B 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20004 

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

the risks identified in 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 
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study that will use a modified version of a published test guideline, the Company must submit 

written test protocols to EPA for review (submission of written test protocols is optional for tests 

that are to be conducted using unmodified published test guidelines). Protocols must be 

submitted as a support document for the PMN, using the procedures set out in 40 CFR 720.40. 

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

review of a test protocol does not mean pre-acceptance of test results. 

(d) Triggered Testing Requirements. The Company is prohibited from manufacturing (defined 

by statute to include import) the PMN substance after a certain date and/or aggregate domestic 

manufacture volume (“the production limit”), unless the Company conducts the following 

studies on the PMN substance and submits all final reports and underlying data in accordance 

with the conditions specified in this Testing section. 

Production Limit Study Guideline

 

[ kg Repeated dose 28-day oral OPPTS Test Guidelines 870.3050, 

or years months toxicity study in rodents 

whichever comes later 

Mouse erythrocyte OPPTS Test Guidelines 870.5395, 

micronucleus test 

Hydrolysis OECD Method 111 

[ kg or -Migration into simulated Develop protocols based on the 

[ years, saliva; head over heels, US Consumer Product Safety 

months, -Migration into simulated Commission protocols # 3, 4, 

whichever comes later, sweat; filter paper/skin, and 5 as directed by EPA 

 and (Attachment C) 

- Mechanical removal 

of chemicals from articles to 

suspended particulates in 

the air, vapor phase air, or 

settled dust. 

 
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(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and 

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

each study; and (3) submit the final report of each study (with an additional sanitized copy, if 

confidential business information is involved) and all underlying data (“the report and data”) to 

EPA prior to exceeding the applicable production limit. The final report and data must be 

submitted as a support document for the PMN, using the procedures set out in 40 CFR 720.40. 

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 require the 

submission of raw data such as slides and laboratory notebooks only 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. 

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

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

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

the Company may continue to manufacture (defined by statute to include import) the PMN 

substance 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 
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the study under the conditions specified in paragraphs (b), (c), and (e) (except that the study may 

be submitted after reaching the applicable production limit). The testing requirements may be 

modified, as necessary to permit a reasoned evaluation of the risks presented by the PMN 

substance, only by mutual consent of EPA and the Company. 

(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 Company receives written notice that EPA finds that the data generated 

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

(defined by statute to include import) of the PMN substance beyond the applicable production 

limit. 

(2) The Company may continue to manufacture (defined by statute to include import) the 

PMN substance 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) If there is sufficient time to reconduct the study in compliance with paragraphs 

(b), (c), and (e) before exceeding the production limit specified in paragraph (d), the Company 

may reconduct the study. If there is insufficient time to reconduct the study in compliance with 

paragraphs (b), (c), and (e) before exceeding the production limit specified in paragraph (d), the 

Company may exceed the production limit, but must otherwise comply with paragraphs (b), (c), 

and (e), and shall submit the report and data to EPA within a reasonable period of time, all as 
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specified by EPA in the notice described in subparagraph (h)(1). 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), 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), 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 (defined by statute to 

include import) of the PMN substance 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 (defined by statute to include 

import) the PMN substance 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), if there is sufficient time to conduct or reconduct 

the study and submit the report and data to EPA before exceeding the production limit specified 
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in paragraph (d). If there is insufficient time for the Company to comply with paragraphs (b), 

(c), and (e) before exceeding the production limit specified in paragraph (d), the Company may 

exceed the production limit, but must otherwise comply with paragraphs (b), (c), and (e), and 

shall submit the report and data 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 Company, in 

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

may continue to manufacture (defined by statute to include import) beyond the applicable 

production limit. 

(j) Unreasonable Risk.

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 substance 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 (defined by statute to include import), processing, distribution, use 

and/or disposal of the PMN substance to mitigate exposures to or to better characterize the risks 

presented by the PMN substance. Within 2 weeks from receipt of such a notice, the Company 

must cease all manufacture (defined by statute to include import), processing, distribution, use 

and disposal of the PMN substance, unless either: 

(1) within 2 weeks from receipt of the EPA notice, the Company complies with 

such requirements as the notice specifies; or 
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(2) within 4 weeks from receipt of the EPA notice, 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 (defined by statute to include 

import), process, distribute, use and dispose of the PMN substance in accordance with the terms 

of this Order pending EPA’s response to the Company’s written report. EPA will respond to the 

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

receipt of EPA’s written response, the Company shall comply with any requirements imposed by 

EPA’s response or cease all manufacture (defined by statute to include import), processing, 

distribution, use and disposal of the PMN substance. 

(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. 

RISK NOTIFICATION 

(a) If as a result of the test data required under the terms of this Order, the Company becomes 

aware that the PMN substance may present a risk of injury to health or the environment (or is so 

notified by EPA), the Company must incorporate this new information, and any information on 

methods for protecting against such risk, into a Material Safety Data Sheet (“MSDS”), as 

described in 40 CFR section 721.72(c), within 90 days from the time the Company becomes 
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aware of the new information. If the PMN substance is not being manufactured (defined by 

statute to include import), processed, or used in the Company’s workplace, the Company must 

add the new information to an MSDS before the PMN substance is reintroduced into the 

workplace. 

(b) The Company must ensure that persons who will receive the PMN substance from the 

Company, or who have received the PMN substance from the Company within 5 years from the 

date the Company becomes aware of the new information described in paragraph (a) of this 

section, are provided an MSDS containing the information required under paragraph (a) within 

90 days from the time the Company becomes aware of the new information. 

MANUFACTURING

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

(defined by statute to include import) of the PMN substance 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 substance 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. 

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

subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Company shall notify 
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each person whom it causes, encourages or suggests to manufacture or import the PMN 

substance of the existence of the SNUR. 

III. RECORDKEEPING

(a) Records. 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: 

(1) Exemptions. Records documenting that the PMN substance 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 substance 

eligible for the Export exemption in Section I, Paragraph (b)(1) 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 substance 

eligible for the Research and Development 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, the records required by 40 CFR 720.78(b). 

For any amounts or batches of the PMN substance claimed to be eligible for any other exemption 

described in Section I, Paragraph (b) of this Order, the Company shall keep records 

demonstrating qualification for that exemption as well as the records specified in paragraphs (2) 
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and (3) below, but is exempt from the other recordkeeping requirements in this Recordkeeping 

section; 

(2) Records documenting the manufacture (defined by statute to include import) volume 

of the PMN substance 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 substance, the date of each sale or transfer, and the 

quantity of the substance sold or transferred on such date; 

(4) Records documenting the address of all sites of manufacture (defined by statute to 

include import), processing, and use; 

(5) Copies of Material Safety Data Sheets required by the Risk Notification section of 

this Order; 

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

section of this Order, if applicable; and, 

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

substance is manufactured (defined by statute to include import), processed, or used. 

(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. 
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(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR 

Part 1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this 

“collection of information” unless this Order displays a currently valid control number from the 

Office of Management and Budget (“OMB”), and EPA so informs the Company. The 

“collection of information” required in this TSCA §5(e) Consent Order 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 Company facilities and conveyances 

associated with the PMN substance. 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 include, but are not limited to, the following: 

(1) Expected dates and times when the PMN substance will be in production within the 

subsequent 12 months; 

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

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

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

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

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

associated with the PMN substance and may reasonably be exposed to the PMN substance; 
- 16 - 

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

(6) 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

(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 

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

Company (the “Successor in Interest”). 

(b) Relation of Transfer Date to Notice of Commencement (“NOC”).
- 17 - 

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

effective before EPA receives a notice of commencement of manufacture or import (“NOC”) for 

the PMN substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest 

must submit a new PMN 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 substance. 

(2) 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 a new PMN to EPA. 

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

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

Company’s full interest in the rights to manufacture the PMN substance, 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 substance, such as a licensee who has acquired a limited 

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

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 substance, including the right to manufacture the PMN substance, from the Company 

to the Successor in Interest. 
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(d) Notices.

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

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

Order and the “Notice of Transfer” document which is incorporated by reference as Attachment 

B to this Order. 

(2) Notice to EPA. 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. 

(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 substance 

is 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 substance under the terms of 

this Order from the Company to the Successor in Interest. 

(e) Liability.

(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. 
- 19 - 

(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 substance 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 substance manufactured 

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

applicable to the Successor in Interest. 
- 20 - 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER

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

or environmental effects of, or human exposure to, or environmental releases of the PMN 

substance, to modify or revoke substantive provisions of this Order. The exposures and risks 

identified by EPA during its review of the PMN substance 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 substance. 

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. 
- 21 - 

VII. EFFECT OF CONSENT ORDER

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

objections to this Order 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. 

(b) 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 Maria J. Doa, PhD, 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 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 substances 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 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. 
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 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. 
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 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 substance, which was 

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

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

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 substance, shall 

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

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

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 

TOXIC SUBSTANCES 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 SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued)

___________________________________ 

Successor’s Technical Contact

___________________________________ 

Address 

___________________________________ 

City, State, Zip Code 

___________________________________ 

Phone 
4 

Attachment C - Basis for Protocol Development