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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 

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P-02-120

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Consent Order and Determinations Supporting Consent Order

### ii TABLE OF CONTENTS

Preamble I. Introduction II. Summary ofTerms ofthe Order III. Contents ofPMN IV. EPA's Assessment ofRisk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Environmental Effects
Consent Order I. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation II. Recordkeeping III. Successor Liability Upon Transfer ofConsent Order IV. Modification and Revocation ofConsent Order V. Effect ofConsent Order
Attachment A

- Definitions Attachment B- Notice ofTransfer ofConsent Orderiii I. INTRODUCTION Underthe authority of§ 5(e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e)), the Environmental Protection Agency ("EPA" or "the Agency") issues the attached Order, regardingpremanufacture notice ("PMN") P-02-120 submitted by 

## J("the Company"), to take effect upon expiration ofthe PMN review period. The Company submittedthe PMN to EPA pursuant to section 5(a)(l) ofTSCA and 40 CFRPart 720. Under § 15 ofTSCA, it is unlawful for any person to fail orrefuse to comply with any provision of§ 5 orany orderissued under§ 5. Violators maybe subject to various penalties and to both criminal and civil liabilitypursuant to § 16, and to specific enforcement and seizure pursuant to§ 17. In addition, chemical substances subject to an Order issuedunder§ 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
orimporting the PMN substance unless the average number molecular weight is equal to or greater than 850 daltons. The Companymay only manufacture orimport 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 maintainrelevant 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-MonthProduction 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 ofthe 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 offreshwater 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 basisofthe Consent Order: 3477 ppb

A. EPA is unable to determine the potential for environmental effects from environmental re.lease ofthe 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 ofthe environmental effects ofthe PMN substance. B. In light ofthe potential risk ofenvironmental toxicityposedby the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance, and the Agency's conclusion that issuing the Order will not result in any significant loss ofbenefits to society, EPAh.as concluded, pursuant to§ 5(e)(l)(A)(ii)(l) ofTSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance maypresent an unreasonable risk ofinjury to the environment.vi C. In light ofthe estimatedproduction volume and environmental release ofthe 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 causedby 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 shouldbe tested with average molecular weight less than 850 daltons, and the stock solution pH adjusted to 7.0.
The Order does not require submission ofthe above information at any specified time or production volume. However, the Order's restrictions onmanufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance will remain in effect until the Orderis modified orrevoked by EPA based on submission ofthat or otherrelevant 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 ofthe chemical substance
] ("the PMN substance") in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe environmental effects ofthe substance, and the completion ofEPA's review of, andregulatory actionbased 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 orgreaterthan 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-2- compliance withthe requirements in paragraph (a). The company shall analyze the average molecular weight ofthe PMN substance produced at each manufacturing facility both (1) at the time ofinitial commencement ofnon-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 ofthe PMN substance by any otherperson. (2) Subparagraph (a)(1) shall expire 7 5 days afterpromulgation ofa final significant
new use rule ("SNUR") governing the PMN substance under section 5(a)(2) ofTSCAunless the Company is notified on or before that day ofan action in a Federal Court seekingjudicialreview 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 SNURhave been resolved and the validity ofthe 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 eachperson whom it causes, encourages or suggests to manufacture or import the PMN substance ofthe existence ofthe SNUR. Such notification mustbe in writing and must specifically include all limitations contained in the SNUR which are defined as significant new uses, and which would 

# q-3- invoke significant new use notification to EPA for the PMN substance. Such notice must also reference the publication ofthe SNUR for this PMN substance in either the Federal Register or the Code ofFederal 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 copyingbyEPA in accordance with section 11 ofTSCA: (1) Records documenting compliance with the requirements in the Average Molecular Weight section ofthis Order, including the results from analyzing representative samples ofthe PMN substance; (2) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture orimport to whom the Company directly sells ortransfers the PMN substance, the date ofeach sale ortransfer, and the quantity ofthe substance sold or transferred on such date; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture orimport to whom the Company directly sells ortransfers the PMN substance, the date ofeach sale or transfer, and the quantity ofthe substance sold ortransferred on such date; (4) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing section ofthis Order;



## (0-4- (5) Records documenting the location, including address, ofall sites ofmanufacture, import, processing and use; and (6) Copies ofany Transfer Documents and notices requiredbythe Successor Liability section ofthis Order, ifapplicable. (b) APPLICABILITY. The provisions ofthis Recordkeeping Section are applicable only to the activities ofthe Company and not to activities ofthe 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 ofinformation" unless this Order displays a currently valid control number from the Office ofManagement and Budget (OMB), and EPA so informs the Company. The "collection ofinformation" required in this TSCA §5(e) Consent Orderhas 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 underthis Ordermaybe transferred when the Company transfers its interests in the PMN substance, including the right to manufacture the PMN substance, to anotherperson outside the Company (the "Successor in Interest").



## lf-5- (b) Relation ofTransferDate to Notice ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from the Company to the Successor in Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN substance from the Companypursuant 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 CFRpart 720 before commencingmanufacture or import ofthe PMN substance. (2) After NOC. Ifthe transfer from the Company to the Successor in Interest is effective after EPAreceives a NOC, the Successor in Interest shall comply with the terms ofthis Order and is not required to submit a new PMN to EPA.
(c) Definitions. The following definitions apply to this Successor Liability section ofthe 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 signedby the Company, as transferor, and the Successorin Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe 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 Interestmust 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 Companyto the Successor in Interest.



### IJ.-6- (d) Notices. (1) Notice to Successor in Interest. On or before the effective date ofthe transfer, the Company shall provide to the Successor in Interest, by registered mail, a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated byreference as Attachment C to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthetransfer, the Company shall, byregistered mail, submit the fully executed Notice ofTransfer document to: U.S. Environmental ProtectionAgency, New Chemicals Branch (7405), 401 M Street, S.W., Washington, D.C. 20460. (3) TransferDocument. Copies ofthe Transfer Document must bemaintained by the Successorin Interest at its principal place ofbusiness, and at all sites where the PMN substance is manufactured orimported. Copies ofthe Transfer Document must also be made available for inspectionpursuant to Section 11 ofTSCA, must state the effective date and time oftransfer, and must contain provisions which expressly transfer liability for the PMN substance under the terms ofthis Order from the Company to the Successor in Interest.
(e) Liability. (I) The Company shall be liable for compliance with the requirements ofthis Order until the effective date and time ofthe transfer described above. (2) The Successorin Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date and time oftransfer.


# (3-7- (3) Nothing in this section shall be construed toprohibit the Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken, oromissions made, during the time in which the Company manufactured, processed, used, distributed in commerce, ordisposed ofthe PMN substance pursuant to the terms ofthis Consent Order.
(f) Obligations to Submit Test Data under Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Orderrequires the Company to submit test data to EPA at a specified production volume ("test trigger"), the aggregate volume ofthe PMN substance manufactured and imported bythe Companyup to the date oftransfer shall count towards the test trigger applicable to the Successorin Interest.

IV. MODIFICATION AND REVOCATION OF CONSENT ORDER The Companymaypetition EPA at any time, based upon new information onthe environmental effects orenvironmental release ofthe PMN substance, to modify orrevoke substantive provisions ofthis Order. The exposures and risks identified byEPA 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 whetherto amend orrevoke this Order, EPA will consider all relevant information available at the time the Agencymakes that determination, including, where appropriate, any reassessment of the test data orotherinformation that supports the findings in this Order, an examination ofnew test data orotherinformation or analysis, and any otherrelevant information.



# llf-8- EPA will issue a modification orrevocation ifEPA determines that the activities proposed therein will notpresent an unreasonable risk ofinjury to health orthe environment and will not result in significant or substantial human exposure or substantial environmental release inthe absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects ofthe 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 ofthis Order as issued.-9- IV. EFFECT OF CONSENT ORDER Byconsenting to the entry ofthis Order, the Company waives its rights to file objections to this Orderpursuant to section 5(e)(l)(C) ofTSCA, to receive service ofthis Orderno later than 45 days before the end ofthe reviewperiodpursuant to section 5(e)(l)(B) ofTSCA, and to challenge the validity ofthis Order, ormodifications made thereto, in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound byits terms, does not constitute
an admissionbythe Company as to the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any otherrights that the Company mayhave under TSCA.



# crfz/UtS**~** Date ( Philip o'shida, Acting Director Chemi al Control Division Office ofPollution Prevention

and Toxics

Name:' Title:
. Company:
_ATTACHMENT A DEFINITIONS [Note: The attached Order may not contain some ofthe terms defined below.] "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed bythe International Union ofPure and Applied Chemistry orthe Chemical Abstracts Service's rules ofnomenclature, or a name which will clearly identify a chemical substance for the purpose ofconducting a hazard evaluation. "Company" means the person orpersons subject to this Order. "Commercial use" means the use ofa 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 orpainting contractor). "Commonname" means any designation oridentification 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 anyproduct containing the chemical substance in oraround a permanent ortemporary household or residence, during recreation, or for any personal use orenjoyment. "Consumerproduct" means a chemical substance that is directly, or as part ofa mixture, sold ormade available to consumers for their use in or around a permanent ortemporary household orresidence, 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. ofthis 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" ofa person ifit is under the control of, and used onlyby, the person who transferred it from a labeled container and will onlybe used bythat**per~on** within the work shift in which it is transferred from the labelled container. "Manufacturing stream" means all reasonably anticipated transfer, flow, ordisposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. 

# 17-2- "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance as required under § 721.72(c). "Non-enclosedprocess" means any equipment system (such as an open-top reactor, storage tank, ormixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe bulk chemical substance andthe workplace air may occur. "Non-industrial use" means use otherthan at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the Premanufacture notice submittedby the Company relevant to this Order. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofprocessing, includingthe cleaning ofequipment. "Scientifically invalid" means any significant departure from the EPA-approvedprotocol orthe Good Laboratory Practice Standards at 40 CFR Part 792 withoutprioror subsequent Agency approval that prevents a reasoned evaluation ofthe health orenvironmental effects ofthe PMN substance. "Scientifically equivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approvedprotocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk ofinjury to human health or the environment ofthe PMN substance. "Sealed container" means a closed container that is physically and chemically suitable for long-term containment ofthe 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 ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, orconsumer use. "Waters ofthe 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, orused and where employees are present. "Workplace" means an establishment at one geographic location containing one ormore work areas.


## 18Company (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER

PMNNumber
1. Transfer ofManufacture Rights. Effective on , the Company did sell or otherwise transfer to , ("Successor in Interest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substance, which was the subject ofapremanufacture 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 ofLiability. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the responsibility ofthe Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, ordoing 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 bythe Company, pursuant to Section 14 ofTSCA and 40 CFRpart 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.



# 11TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER

Company (Transferor)
Signature ofAuthorized Official NOTICE OF TRANSFER (continued)

PMNNumber

Date
PrintedName ofAuthorized Official
Title ofAuthorized Official

Successor in Interest
Signature ofAuthorized Official Date
PrintedName ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip Code

## .. -3- 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