EPA SANITIZED '~ONTAINS ;, . CBI 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ~ ( (t 1 /a f 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) Premanufacture Notice Number: 

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Consent Order and Determinations Supporting Consent Order 
11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms ofthe Order 

III. Contents of PMN 

IV. EPA's Assessment ofRisk 

V. EPA's Conclusions ofLaw 

VI. Information Required to Evaluate Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

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

Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Successor Liability Upon Transfer of Consent Order 

V. Modification and Revocation of Consent Order 

VI. Effect of Consent Order 

Attachment A - Definitions 

Attachment B- Notice of Transfer of Consent Order 
iii 

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) P06-153 for the chemical substance [ 

] (P06-153) (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 section 5(a)(1) ofTSCA 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 the PMN substance requires the Company to: 

(1) not manufacture or import the PMN substance with more than three [ 

(2) analyze representative samples to determine compliance with the chemical composition 

requirement in (1); and 

(3) maintain certain records. 

]; 
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III. CONTENTS OF PMN 

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

name, chemical identity, production volume, manufacturing, processing, and use information, 

and other information. 

Chemical Identity: 

Specific: [ ] 

Generic: iso-tridecanol 

Use: 

Specific: [ 

Generic: reactant 

]. 

Maximum 12-Month Production Volume: [ ] kg/year, import only 

Test Data Submitted with PMN: Studies on PMN with an [ 

] : rat acute oral LDO = 2.0 glkg with no significant toxic signs; severe skin irritation in rabbits 

which took 14 days to clear; moderate to severe eye irritation in rabbits which took 7 days to 

clear; negative Ames test; rat developmental toxicity test oral-gavage with doses= 750, 250, and 

60 mg/kg/day with fetal NOAEL = 750 mg/kg/day, maternal NOAEL = 250 mg/kg/day, and 

maternal LOEL = 750 mg/kg/day based on toxicity to the liver; acute aquatic ecotoxicity baseset: fish (golden orfe) 96-h LC50 = 2.8; (zebra fish) 96-h LC50 = 0.550; daphnid 48-h LC50 = 

0.390; algal 72-h EC50 = 1.3. 
v 

IV. EPA'S ASSESSMENT OF RISK 

The following are EPA's predictions regarding the probable toxicity and environmental 

releases of the PMN substance, based on the information currently available to the Agency. 

Environmental Effects Summary: 

EPA expects the PMN substance to cause toxicity to aquatic organisms at a 

Concentration of Concern (CoC) of 8 parts per billion (ppb ), based on test data on the PMN 

substance and Structural Activity Relationship (SAR) analysis for other neutral organic 

chemicals. 1 The PMN substance is also predicted to be, under certain conditions, a potential 

persistent, bioaccumulative, and toxic (PBT) chemical.2 

Based on these SAR analyses, however, aquatic toxicity and PBT potential vary 

depending on the isoindex. Company test data indicate that the PMN substance has an average 

of[ .) This degree of [ 

this alcohol; a [ 

] is typical of the manufacturing process for 

] . The alcohol 

is more resistant to aerobic biodegradation as the isoindex increases. If the isoindex is greater 

than three, EPA estimates that the PMN substance will persist in the environment more than two 

months and estimates a bioaccumulation factor of greater than or equal to 1000. If the isoindex 

is less than three, the PMN is not expected to persist. 

1 See www.epa.gov/opptintr/newchems/pubs/chemcat.htm 

2 See www.epa.gov/opptintr/newchems/pbtpolicy.htm and 64 FR 60914, Nov. 4, 1999. 
VI 

Exposure and Environmental Release Summary: 

Environmental Process (Import) Use #1- Use #2-

Releases [: r -

- - j 

] 

#of sites [ ] [ ] [ ] 

Amount released to Not expected [ ] Not expected 

water (kg/site/day) 

Release days per year N/A 145 N/A 

Surface water N/A 576 N/A 

concentration (ppb) 

Days exceeding concern N/A 138 N/A 

level (8 ppb) 

Fish ingestion dose N/A 0.75 N/A 

(mg/kg/day) 

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 aquatic toxicity from environmental release of 

the PMN substances. EPA therefore concludes, pursuant to§ 5(e)(l)(A)(i) ofTSCA, that the 

information available to the Agency is insufficient to permit a reasoned evaluation of the 

environmental effects of the PMN substance. 

(b) In light of the potential risk of aquatic toxicity posed by the uncontrolled manufacture, 

import, processing, distribution in commerce, use, and disposal of the PMN substances, EPA has 

concluded, pursuant to§ 5(e)(l)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, 
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processing, distribution in commerce, use, and disposal of the PMN substances may present an 

unreasonable risk of injury to the environment. 

VI. INFORMATION REQUIRED TO EVALUATE ENVIRONMENTAL EFFECTS 

Pending Testing. The following additional information would be required to evaluate the 

following effects which may be caused by the PMN substance: 

Study Guidelines 

1. Ready Biodegradation OECD 303A or OPPT 835.3110 

2. Fish early-life stage toxicity test (rainbow trout) OECD 210 or OPPTS 850.1400 

3. Daphnid chronic toxicity test OECD 202 or OPPTS 850.1300 

The Order does not require submission of the above pended testing at any specified time or 

production volume. However, the Order's restrictions on manufacture, import, processing, 

distribution in commerce, use, and disposal of the PMN substance will remain in effect until the 

Order is modified or revoked by EPA based on submission of that or other relevant information. 
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 [ ] 

(P06-153) ("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) Completely Reacted (Cured). The requirements of this Order do not apply to 

quantities of the PMN substance that have been completely reacted (cured). 
2 

(2) De Minimis Concentrations. The requirements of this Order do not apply to 

quantities of the PMN substance that are (1) present in the work area only as a mixture and (2) at 

a concentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or volume 

if the PMN substance is identified as a potential carcinogen in paragraph (f) ofthe Hazard 

Communication Program section of this Order). This exemption is not available ifthe Company 

has reason to believe that, during intended activities, the PMN substance in the mixture may be 

reconcentrated above the 1.0 or 0.1 percent level, whichever applies. 

(3) 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 CPR 720.3(s) and 40 CPR Part 707. However, once the Company 

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. 

(4) 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 CPR 

720.3(cc), and 40 CPR 720.36. The requirements of this Order also do not apply to 
3 

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). 

(5) 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). 

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

the PMN substance 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 

it is a part. 

(7) Imported Articles. The requirements of this Order do not apply to the PMN 

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)(l). 

(c) Automatic Sunset. Ifthe Company has obtained for the PMN substance a Test Market 

Exemption (TME) under TSCA §5(h)(l) 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)(l) 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 
4 

PENDING SUBMISSION AND EVALUATION OF INFORMATION 

PROHIBITION 

The Company is prohibited from manufacturing, importing, 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 environmental effects of the substances, and the completion of EPA's review of, 

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

described in this Order. 

CHEMICAL COMPOSITION 

(a) Chemical Restrictions. The Company shall not manufacture or import the PMN substance 

with more than three [ ]. 1 

(b) Analysis. The Company shall analyze representative samples of the PMN substance to 

determine compliance with the requirements in paragraph (a). The Company shall analyze the 

number of[ ] of the PMN substance produced at each manufacturing facility 

both (1) at the time of initial commencement of non-exempt manufacture at that facility or upon 

initial import, and (2) at least annually thereafter during every year in which the PMN substance 

is manufactured at that facility or imported. The number of [ ] from production at 
5 

any new facility, or any significantly altered facility of process, must be analyzed at 

commencement and annually thereafter. If the PMN substance is imported, the Company shall 

obtain from the foreign manufacturer written documentation to certify that representative 

samples of the PMN substance have been analyzed, consistent with the requirements of this 

paragraph (b), and determined to comply with the requirements in paragraph (a). 

MANUFACTURING 

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

import of the PMN substance by any other person. 

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

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

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

Federal Court seeking judicial review of the SNUR. Ifthe Company is so notified, subparagraph 

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

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

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

subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify 

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

substances of the existence of the SNUR. 

TESTING 

(a) Section 8(e) Reporting. Any information on the PMN substance which reasonably supports 
6 

the conclusion that the PMN substance presents 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), shall reference the appropriate PMN identification number for 

this substance and shall contain a statement that the substance is 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 Company shall notify, in writing, the EPA Laboratory Data 

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

Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, 

of the following information within 10 days of scheduling any study required to be performed 

pursuant to this Order (including studies identified in section VI. of the Preamble), 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. 

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

performed pursuant to this Order (including studies identified in section VI. of the Preamble) 
7 

must be conducted according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 

and using methodologies generally accepted in the relevant scientific community at the time the 

study is initiated. Before starting to conduct any such study, the Company must obtain approval 

of test protocols from EPA by submitting written protocols. EPA will respond to the Company 

within 4 weeks of receiving the written protocols. Published test guidelines provide general 

guidance for development of test protocols, but are not themselves acceptable protocols. 

Approval ofthe test protocol does not mean pre-acceptance of test results. 

(d) Unreasonable Risk. 

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

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

the PMN 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, 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, import, processing, distribution, use and disposal of the PMN substance, unless 

either: 

(2) within 2 weeks from receipt of the notice described in subparagraph (d)(l), the 

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

(3) within 4 weeks from receipt of the notice described in subparagraph (d)(l), the 

Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of 
8 

any additional requirements imposed by EPA. The Company may continue to manufacture, 

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, import, processing, distribution, use and disposal of the 

PMN substance. 

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 ofTSCA: 

(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)(3) of this Order, are exempt from all 

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

date of their creation, copies of 

eligible for the Research and Development exemption in Section I, Paragraph (b)(4) of this 
9 

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) 

and (3) below, but is exempt from the other recordkeeping requirements in this Recordkeeping 

section; 

(2) Records documenting compliance with the requirements in the Chemical Composition 

section of this Order, including the results from analyzing representative samples of the PMN 

substance; 

(3) Records documenting the manufacture and importation volume of the PMN 

substance and the corresponding dates of manufacture and import; 

( 4) 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; 

(5) Records documenting the address, of all sites of manufacture, import, processing, and 

use; 

( 6) Records documenting compliance with any applicable manufacturing and testing 

requirements in the Manufacturing and Testing sections of this Order; 

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

(8) The Company shall keep a copy of this Order at each of its sites where the PMN 
10 

substance are manufactured of imported. 

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

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

Company's customers. 

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

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

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

Office ofManagement and Budget (OMB), and EPA so informs the Company. The "collection 

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

valid OMB Control Number 2070-0012. 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA's Request for Information. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA 

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

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

subsequent 12 months; 
11 

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

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

(iii) 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; 

(iv) 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; 

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

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

or conducting an inspection for that purpose. 

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

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

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

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

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

answers to all ofEPA'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. 
12 

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 ofTransfer Date to Notice of Commencement ("NOC"). 

(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)(l) 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 
13 

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. 

(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 

C to this Order. 

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

Company shall, by registered mail, submit the fully executed Notice 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 ofbusiness, 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 ofTSCA, 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. 
14 

(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. 

(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 

ofthis 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. 
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VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

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

environmental effects or environmental release 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 ofthis Order. EPA will issue such a modification ifEPA determines that the 

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

issued. 
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VII. EFFECT OF CONSENT ORDER 

By consenting to the entry of this Order, the Company waives its rights to file objections 

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

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

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

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

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

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

Date 

Date 

Jim Willis, Director 

Chemical Control Division 

Office ofPollution Prevention and Toxics 

Name: 

Title: 

Company: [ ] 
ATTACHMENT A 

DEFINITIONS 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

other than by its chemical name. 

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

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

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

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

sold or made available to consumers for their use in or 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 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 ofHealth 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 

mr may occur. 

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

mixtures are manufactured, imported, or processed. 

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

submitted by the Company relevant to this Order. 

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

on the body to prevent contact with, and exposure to, an identified chemical substance or 

substance in the work area. Examples include, but are not limited to, chemical protective 

clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and 

various types of respirators. Barrier creams are not included in this definition. 

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

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

of processing, including the cleaning of equipment. 

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

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

Agency approval that prevents a reasoned evaluation of the health or environmental effects of the 
3 

PMN substance. 

"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. 
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

P06-153 

PMNNumber 

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

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

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

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

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

Substance Control Act (TSCA, 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 ofTSCA 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 

Company (Transferor) 

Signature of Authorized Official 

NOTICE OF TRANSFER 

(continued) 

P06-153 

PMNNumber 

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