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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 

In the matter of: 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION of 7 6/ /frf, 

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Premanufacture Notice 

Number: 

P-02-120 

) 1 ~Ill\ !Ill \1111 ~Ill ~II ~Ill ~II ~II ~Ill ~Ill ~Ill ~II I !I~~~ II Ill\ 

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 Risk 

V. EPA's Conclusions ofLaw 

VI. Information Required to Evaluate Environmental Effects 

Consent Order 

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

Pending Submission and Evaluation of Information 

II. Recordkeeping 

III. Successor Liability Upon Transfer of Consent Order 

IV. Modification and Revocation of Consent Order 

V. Effect of Consent Order 

Attachment A - Definitions 

Attachment B- Notice of Transfer of Consent Order 
iii 

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-02-120 submitted by 

J ("the Company"), to take effect upon expiration of the PMN review period. The 

Company submitted the PMN to EPA pursuant to section 5(a)(l) 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 ofTSCA, 

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 prohibits the Company from manufacturing 

or importing the PMN substance unless the average number molecular weight is equal to or 

greater than 850 daltons. The Company may only manufacture or import the PMN as described 

above, unless the Company submits appropriate acute aquatic toxicity testing ofthe PMN 

substance with a lower average molecular weight. The Company must maintain relevant records 

to show compliance with these requirements. 

III. CONTENTS OF PMN 

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

identity, chemical identity, production volume, use information and process information. 

Chemical Identity: 

Specific: [, 

]. 

Generic: Acetic acid, hydroxymethoxy-, methyl ester, reaction products with substituted 

alkylamine. 

Use: 

Specific: [ 

]. 

Generic: Emulsifier. 

Maximum 12-Month Production Volume: 

Test Data Submitted with PMN: None. 

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: 

Concerns: The PMN substance is likely to be highly toxic to all groups of freshwater organisms 

(fish, invertebrates, and algae) when its average molecular weight is below 850 daltons based on 

structural activity relationships (SARs) for. ]. See 

www.epa.gov/oppt/newchems/chemcat.htm. 
v 

Environmental Release Summary: 

Manufacture Process/Use # 11 Process/Use #2 

#Sites 

Amt. Released/Site Not Expected Not Expected <250 kg/site/day 

# Release Days/Year 

Water Concentration 

Days Exceeding 

Concern Level 

0 

0 

0 

0 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 

3477 ppb 

A. EPA is unable to determine the potential for environmental effects from environmental 

re.lease of the PMN substance. 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 ofthe PMN substance. 

B. In light of the potential risk of environmental toxicity posed by the uncontrolled 

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

substance, and the Agency's conclusion that issuing the Order will not result in any significant 

loss ofbenefits to society, EPA h.as concluded, pursuant to§ 5(e)(l)(A)(ii)(l) ofTSCA, that 

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

PMN substance may present an unreasonable risk of injury to the environment. 
vi 

C. In light of the estimated production volume and environmental release of the PMN 

substance, EPA has further concluded, pursuant to§ 5(e)(l)(A)(ii)(II) ofTSCA, that the PMN 

substance will be produced in substantial quantities and may reasonably be anticipated to enter 

the environment in substantial quantities. 

VI. INFORMATION REQUIRED TO EVALUATE ENVIRONMENTAL EFFECTS 

The following additional information would be required to evaluate the environmental 

effects which maybe caused by the PMN substance with average molecular weight less than 850 

daltons: 

Information 

Fish Acute Toxicity Test, Freshwater 

Invertebrate Acute Toxicity Test, 

Freshwater Daphnids 

Algal Toxicity, Tier 1 

Guidelines 

OPPTS 850.1075 

OPPTS 850.1010 

OPPTS 850.5400 

The tests should use the static method and nominal concentrations. The chloride salt should be 

tested with average molecular weight less than 850 daltons, and the stock solution pH adjusted to 

7.0. 

The Order does not require submission of the above information 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. 

7 
[ . 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CONSENT ORDER 

OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

I. TERMS OF MANUFACTURE, IMPORT. PROCESSING, 

DISTRIBUTION IN COMMERCE, USE. AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

] ("the Company") is prohibited from manufacturing, 

importing, processing, distributing in commerce, using, or disposing of the chemical substance 

] ("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 ofthe substance, and the completion of EPA's 

review of, and regulatory action based on, that information, except under the following 

conditions: 

AVERAGE NUMBER MOLECULAR WEIGHT 

(a) The Company shall not manufacture or import the PMN substance unless the average number 

molecular weight is equal to or greater than 850 daltons. 

(b) The Company shall analyze representative samples ofthe PMN substance to determine 

g 

Internet Address (URL) • http://www.epa.gov 

Recycled/Recyclable •Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper 
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compliance with the requirements in paragraph (a). The company shall analyze the average 

molecular weight 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 average number molecular weight from 

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

at commencement and annually thereafter. 

MANUFACTURING 

(a)( 1) The Company shall not cause, encourage, or suggest the manufacture or import of the 

PMN substance by any other person. 

(2) Subparagraph (a)( 1) shall expire 7 5 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 

ofthe SNUR. Ifthe 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) When EPA promulgates a final SNUR for the PMN substance and subparagraph 

(a)(l) expiresin accordance with subparagraph (a)(2), the Company shall notify each person 

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

q 
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invoke significant new use notification to EPA for the PMN substance. Such notice must also 

reference the publication of the SNUR for this PMN substance in either the Federal Register or 

the Code of Federal Regulations. 

II. 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) Records documenting compliance with the requirements in the Average 

Molecular Weight section of this Order, including the results from analyzing representative 

samples of the PMN substance; 

(2) 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; 

(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 compliance with any applicable manufacturing, processing, 

use, and distribution restrictions in the Manufacturing section of this Order; 

(0 
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(5) Records documenting the location, including address, of all sites of manufacture, 

import, processing and use; and 

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

section of this Order, if applicable. 

(b) APPLICABILITY. The provisions ofthis Recordkeeping Section are applicable only to the 

activities of the Company 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 Order has been approved under currently 

valid OMB Control Number 2070-0012. 

III. 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"). 

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(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) ofTSCA 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 is not 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(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. 

IJ. 
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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 

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), 401 M Street, S.W., 

Washington, D.C. 20460. 

(3) Transfer Document. Copies ofthe 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 ofTSCA, must state the effective date and time 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. 

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

effective date and time 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 and time oftransfer. 

(3 
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(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 ofthe 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 ofthe 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. 

IV. 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 ofthe 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. 

llf 
-8-

EP A 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. 
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IV. 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, or modifications made thereto, in any subsequent action. 

Consenting to the entry of this Order, and agreeing to be bound by its terms, does 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. 

crfz/UtS ~ Date ( 

Philip o'shida, Acting Director 

Chemi al Control Division 

Office of Pollution Prevention 

and Toxics 

Name:' 

Title: . 

Company: _ 
ATTACHMENT A 

DEFINITIONS 

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

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

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

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

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

"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 

nuniber, 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. 

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

will only be used by that per~on within the work shift in which it is transferred from the labelled 

container. 

"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. 

17 
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"MSDS" means material safety data sheet, the written listing of data for the chemical 

substance as required under § 721. 72( c). 

"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. 

"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 

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. 

18 
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

PMNNumber 

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) ofthe 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(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. 

11 
TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

Company (Transferor) 

Signature of Authorized Official 

NOTICE OF TRANSFER 

(continued) 

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 
.. 

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TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

Successor's Technical Contact 

Address 

City, State, Zip Code 

03SITI~A2 Phone 

NOTICE OF TRANSFER 

(continued) 

Jl