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UNITED STATES ENVIRONMENTALPROTECTION AGENCY

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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 Order11 

### 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. Scope ofApplicability and Exemptions II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation III. Recordkeeping IV. Successor LiabilityUpon Transfer ofConsent Order V. Modification and Revocation ofConsent Order VI. Effect ofConsent Order
Attachment A

- Definitions Attachment B- Notice ofTransfer ofConsent Order

### iii PREAMBLE I. INTRODUCTION Under the 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, regarding premanufacture notice ("PMN) P06-153 for the chemical substance [ ] (P06-153) (the "PMN substance) submittedby [ ] ("the Company"), to take effect upon expiration ofthe PMN review period. The Company submitted the PMN to EPA pursuant to section 5(a)(1) ofTSCA and 40 CFR Part 720. Under § 15 ofTSCA, it is unlawful for anyperson to fail orrefuse to comply with any provision of§ 5 or any order issued 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 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 orimport 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. ];lV 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 toxicitytest oral-gavage with doses= 750, 250, and 60 mg/kg/daywith fetal NOAEL = 750 mg/kg/day, maternal NOAEL = 250 mg/kg/day, and maternal LOEL = 750 mg/kg/daybased on toxicity to the liver; acute aquatic ecotoxicitybaseset: 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 ofthe PMN substance, based on the information currently available to the Agency. Environmental Effects Summary: EPA expects the PMN substance to cause toxicityto aquatic organisms at a Concentration ofConcern (CoC) of

### 8parts perbillion (ppb), based on test data on the PMN substance and Structural Activity Relationship (SAR) analysis for otherneutral organic chemicals. 1 The PMN substance is also predicted to be, under certain conditions, a potential persistent, bioaccumulative, and toxic (PBT) chemical.2 Based onthese SAR analyses, however, aquatic toxicity and PBTpotential vary depending on the isoindex. Companytest dataindicate thatthe PMN substancehas an average of[ .) This degree of[ this alcohol; a [ ] is typical ofthemanufacturingprocess for ] . The alcohol is moreresistant to aerobic biodegradation as the isoindex increases. Iftheisoindex is greater than three, EPA estimates that the PMN substance willpersistinthe environment more than two months and estimates a bioaccumulation factor ofgreaterthan orequal to 1000. Ifthe isoindex is less than three, the PMNis 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 ] 

### #ofsites 

### [ ] [ ] [ ] Amountreleased to Not expected 

### [ ] Not expected water (kg/site/day) Release days peryear 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 ofthe 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 Agencyis insufficient to permit a reasoned evaluation ofthe environmental effects ofthe PMN substance. (b) In

### light ofthe potential risk ofaquatic toxicityposedbythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substances, EPA has concluded, pursuant to§ 5(e)(l)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import,Vll 

### processing, distribution in commerce, use, and disposal ofthe PMN substances maypresent an unreasonable risk ofinjuryto the environment.

VI. INFORMATION REQUIRED TO EVALUATE ENVIRONMENTAL EFFECTS

Pending Testing. The following additional information wouldberequired to evaluate the following effects which maybe caused bythe 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 ofthe 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 ofthe PMN substance will remain in effect until the Order is modified orrevoked byEPAbased on submission ofthat or otherrelevant information.CONSENT ORDER

I. SCOPE OF APPLICABILITY AND EXEMPTIONS (a) Scope. The requirements ofthis Order apply to all commercial manufacturing, processing, ] distribution in commerce, use and disposal ofthe chemical substance [ (P06-153) ("the PMN substance") in the United Statesby [ ] ("the Company"), except to the extent that those activities are exemptedbyparagraph (b).
(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance is exempt from the requirements ofthis Order (except the requirements in the Recordkeeping and Successor LiabilityUpon Transfer OfConsent Order sections) onlyto the extent that (1) these activities are conducted in full compliance with all applicable requirements ofthe following exemptions, and (2) such compliance is documented byappropriate recordkeeping as required in the Recordkeeping section ofthis Order. (1) CompletelyReacted (Cured). The requirements ofthis Order do not apply to quantities ofthe PMN substance that have been completelyreacted (cured).2 

### (2) De Minimis Concentrations. The requirements ofthis Order do not apply to quantities ofthe PMN substance that are (1) present in the work area only as a mixture and (2) at
a concentration not to exceed 1.0 percentbyweight orvolume (0.1 percentbyweight or volume ifthe PMN substance is identified as a potential carcinogen in paragraph (f) 

### ofthe Hazard Communication Program section ofthis 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 Companybegins commercial manufacture ofthe PMN substance for use in the United States, the requirements ofthis Order do not apply to manufacture, processing or distribution in commerce ofthe 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 activitybythe Company involving the PMN substance is exempt as "solely for export" even ifsome amount of the PMN substance is later exported. At that point, the requirements ofthis Order apply to all activities associated with the PMN substance while in the territory ofthe United States. Prior to leaving U.S. territory, even those quantities orbatches ofthe PMN substance that are destined for export are subject to terms ofthe Order, and count towards anyproduction volume test triggers in the Testing section ofthis Order. (4) Research & Development (R&D). The requirements of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe 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 applyto3 

### manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance when manufactured solely for non-commercial research and development per40 CFR 720.30(i) and TSCA §5(i). (5) Byproducts. The requirements ofthis 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 ofthis Order do not apply to the PMN substance when they are manufactured, pursuant to any ofthe exemptions in 40 CFR 720.30(h), with no commercial purpose separate from the substances, mixture, or article ofwhich it is a part. (7) Imported Articles. The requirements ofthis Order do not apply to the PMN substance when it is imported as part ofan "article" as defined at 40 CFR 720.3(c) and in compliance with 40 CFR 720.22(b)(l).
(c) Automatic Sunset. Ifthe Companyhas 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 ofthe effective date ofthis Consent Order.

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL

### 4 PENDING SUBMISSION AND EVALUATION OF INFORMATION
PROHIBITION The Companyis prohibited from manufacturing, importing, processing, distributing in commerce, using, ordisposing ofthe PMN substance in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for areasoned evaluation ofthe environmental effects ofthe substances, and the completion ofEPA'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 orimport the PMN substance with more than three [ ]. 1


### (b) Analysis. The Company shall analyze representative samples ofthe PMN substance to determine compliance with the requirements in paragraph (a). The Company shall analyze the number of[ ] ofthe PMN substance produced at each manufacturing facility both (1) at the time ofinitial commencement ofnon-exempt manufacture at that facility orupon 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 ofprocess, mustbe analyzed at commencement and annually thereafter. Ifthe PMN substance is imported, the Company shall obtain from the foreign manufacturer written documentation to certify that representative samples ofthe PMN substance have been analyzed, consistent with therequirements ofthis 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 ofthe PMN substance by any other person. (2) Sunset Following SNUR. Subparagraph (a)(l) shall expire 75 days after promulgation ofa final significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2) ofTSCAunless the Company is notified on orbefore that day ofan action in a Federal Court seekingjudicial review ofthe 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 SNURhave been resolved and the validity ofthe SNUR affirmed. (3) Notice ofSNUR. 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 orimport the PMN substances ofthe existence ofthe SNUR.

TESTING (a) Section 8(e) Reporting. Anyinformation on the PMN substance which reasonably supports

### 6 the conclusion that the PMN substance presents a substantial risk ofinjuryto health orthe environment required to bereported 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 canbe found in the reporting guide referenced at 56 Federal Register 28458 (June 20, 1991).
(b) Notice ofStudy Scheduling. The Company shall notify, in writing, the EPA LaboratoryData Integrity Branch (2225A), Office ofEnforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, ofthe following information within 10 days ofscheduling any studyrequired to beperformed pursuant to this Order (including studies identified in section VI. ofthe Preamble), orwithin 15 days after the effective date ofthis Order, whichever is later: (1) The date when the studyis scheduled to commence; (2) The name and address ofthe laboratory which will conduct the study; (3) The name and telephone number ofa person at the Companyorthe 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 studyrequired to be performed pursuant to this Order (including studies identified in section VI. ofthe Preamble)7 mustbe 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 startingto conduct any such study, the Companymust obtain approval oftest protocols from EPAby submitting written protocols. EPA will respond to the Company within 4 weeks ofreceiving the written protocols. Published test guidelines provide general guidance for development oftestprotocols, but are not themselves acceptable protocols. Approval ofthetest protocol does not mean pre-acceptance oftest results.
(d) Unreasonable Risk. (1) EPA maynotify the Companyin writing that EPA finds that the data generatedby a study are scientificallyvalid and unequivocal and indicate that, despite the terms ofthis Order, the PMN substance will ormaypresent an unreasonable risk ofinjury to human health orthe environment. EPA's notice may specifythat the Companyundertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthe PMN substance to mitigate exposures to orto better characterize the risks presented bythe PMN substance. Within 2 weeks from receipt ofsuch a notice, the Companymust cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substance, unless either: (2) within 2 weeks from receipt ofthe notice described in subparagraph (d)(l), the Company complies with such requirements as EPA's notice specifies; or (3) within 4 weeks from receipt ofthe notice described in subparagraph (d)(l), the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of8 any additional requirements imposed byEPA. The Companymay continue to manufacture, import, process, distribute, use and dispose ofthe PMN substance in accordance with the terms ofthis Orderpending EPA's response to the Company's written report. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks of receipt ofEPA's written response, the Company shall comply with any requirements imposedby EPA's response or cease all manufacture, import, processing, distribution, use and disposal ofthe 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 EPAin accordance with section 11 ofTSCA: (1) Exemptions. Records documenting that the PMN substance did in fact qualify for any
one ormore ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Such records must satisfy all the statutory and regulatoryrecordkeeping requirements applicable to the exemptionbeing claimedby the Company. Any amounts orbatches ofthe PMN substance eligible for the Export exemption in Section I, Paragraph (b)(3) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Companymaintains, for 5 years from the date oftheir creation, copies of

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

### 9 Order, are exempt from all the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, the records required by40 CFR 720.78(b). For any amounts orbatches ofthe PMN substance claimed to be eligible for any other exemption described in Section I, Paragraph (b) ofthis Order, the Company shall keep records demonstrating qualification for that exemption as well as the records specified in paragraphs (2) and (3) below, butis exempt from the otherrecordkeeping requirements in this Recordkeeping section; (2) Records documenting compliance with the requirements inthe Chemical Composition section ofthis Order, including the results from analyzing representative samples ofthe PMN substance; (3) Records documenting the manufacture and importation volume ofthe PMN substance and the corresponding dates ofmanufacture and import; ( 4) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture or import to whom the Companydirectly sells or transfers the PMN substance, the date ofeach sale ortransfer, and the quantity ofthe substance sold or transferred on such date; (5) Records documenting the address, ofall sites ofmanufacture, import, processing, and use; (6) Records documenting compliance with any applicable manufacturing and testing requirements in the Manufacturing and Testing sections ofthis Order; (7) Copies ofany Transfer Documents and notices required bythe Successor Liability (8) The Company shall keep a copy ofthis Order at each ofits sites where the PMN

### 10 substance are manufactured ofimported.
(b) Applicability. The provisions ofthis Recordkeeping Section are applicable onlyto activities ofthe Company and its Contract Manufacturer, ifapplicable, 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 Companyis 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 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 ofCompany facilities and conveyances associated with the PMN substance. To facilitate such inspections, EPA personnel may contact the Companyin advance to request information pertinent to the scheduling and conduct ofsuch inspections. Such requests maybe written or oral. The types ofinformation that EPA may request mayinclude, 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 mayreasonablybe exposed to the PMN substance; (iii) Currentjob titles or categories for workers who are involved in activities associated with the PMN substance and mayreasonablybe exposed to the PMN substance; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substance and mayreasonablybe exposed to the PMN substance; (v) Records required bythe Recordkeeping section ofthis Order; and/or (vi) Anyother information reasonablyrelated 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 oftime, butin no event later than 30 days after receiving EPA's request. When requested in writingbyEPA, the Company's response shall be in writing. To the extent the information is known to orreasonably ascertainable to the Company at the time ofthe request, the Company's response shall demonstrate a good faith effort to provide reasonably accurate and detailed
answers to all ofEPA'srequests.
(c) Confidential Business Information. Any Confidential Business Information (CBI) that the Company submits to EPApursuant to paragraph (b) shall beprotected in accordance with §14 of TSCA and 40 CFRPart 2.12 V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures bywhich the Company's rights and obligations under this Ordermaybetransferred 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").
(b) Relation ofTransferDate to Notice ofCommencement ("NOC"). (1) BeforeNOC. Ifthe transfer from the Companyto the Successorin Interest is effectivebefore EPAreceives a notice ofcommencement ofmanufacture orimport ("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 CFR part 720 before commencing manufacture orimport ofthe PMN substance. (2) After NOC. Ifthe transfer from the Companyto the Successor in Interest is effective after EPAreceives a NOC, the Successorin Interest shall complywith the terms ofthis Order and shall notberequired 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 Companywho 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 bythe Company, as transferor, and the Successor in 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 limited13 

### license to the patent ormanufacturing rights associated with the PMN substance. A Successorin Interest mustbe 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 conveythe interests in the PMN substance, including the right to manufacture the PMN substance, from the Companyto the Successorin Interest.
(d) Notices. (1) Notice to Successorin Interest. On orbefore the effective date ofthe transfer, the Company shall provide to the Successorin Interest, byregistered 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 Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Document mustbe maintained bythe Successor in 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 inspection pursuant to Section 11 ofTSCA, must state the effective date oftransfer, and must contain provisions which expresslytransfer 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 ofthis Orderuntil the effective date ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date oftransfer. (3) Nothing in this section shall be construed to prohibit the Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken,
or omissions made, during the time in which the Companymanufactured, processed, used, distributed in commerce, or disposed ofthe PMN substance pursuant to the terms ofthis Consent Order.
(f) Obligations to Submit Test Dataunder Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Orderrequires the Companyto 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.15 VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Companymaypetition EPA at any time, based upon new information on the environmental effects or environmental release ofthe PMN substance, to modify orrevoke substantive provisions ofthis Order. The exposures and risks identifiedbyEPA during its review ofthe PMN substance and the information EPA determined to benecessaryto evaluate those exposures and risks are described in thepreamble to this Order. However, in determining whether to amend orrevoke this Order, EPA will consider all relevant information available at the time the Agency makes that determination, including, where appropriate, anyreassessment of the test data or other information that supports the findings in this Order, an examination ofnew test data or other information or analysis, and any otherrelevant information. EPA will issue a modification orrevocation ifEPA determines that the activities proposed therein will not present an unreasonable risk ofinjury to health orthe environment and will not result in significant or substantial human exposure or substantial environmental release in the absence ofdata sufficient to permit a reasoned evaluation ofthe health orenvironmental effects ofthe PMN substance. In addition, the Companymaypetition EPA at any time to make othermodifications 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.16 VII. EFFECT OF CONSENT ORDER By consenting to the entry ofthis Order, the Companywaives 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 review period pursuant to section 5(e)(l)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to bebound byits terms, do not constitute an admission bythe 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 Companymayhave 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 maynot 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 clearlyidentify a chemical substance for the purpose ofconducting a hazard evaluation. "Chemical protective clothing" means items ofclothing that provide a protectivebarrier to prevent dermal contact with chemical substance ofconcern. Examples can include, but are not limited to: full bodyprotective clothing, boots, coveralls, gloves,jackets, and pants. "Company" means the person orpersons subject to this Order. "Commercial use" means the use ofa chemical substance or anymixture 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). "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 byits chemical name. "Consumer" means a private individual who uses a chemical substance or any product containing the chemical substance in or around a permanent ortemporaryhousehold or residence, during recreation, or for any personal use or enjoyment. "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 or temporary household orresidence, in or around a school, orin recreation. "Container" means anybag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, orthe like that contains a hazardous chemical. Forpurposes ofthis section, pipes orpiping 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. 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.

### 2 "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is underthe control of, and used onlyby, the person who transferred it from a labeled container and will onlybeused bythat 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 ormechanical degradation, permeation, orpenetration ofthe chemical protective clothingunder the conditions of, and the duration of, exposure. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance. "NIOSH" means the National Institute for Occupational Safety and Health ofthe U.S. Department ofHealth and Human Services. "Non-enclosed process" means any equipment system (such as an open-top reactor, storage tank, ormixing vessel) in which a chemical substance is manufactured, processed, or otherwiseused where significant direct contact ofthe bulk chemical substance and the workplace mr mayoccur. "Non-industrial use" means use otherthan at a facility where chemical substance or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the Premanufacture notice submittedbythe Companyrelevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on thebodyto 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 ofrespirators. Barrier creams are not included in this definition. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofprocessing, including the cleaning ofequipment. "Scientificallyinvalid" means any significant departure from the EPA-approved protocol orthe Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency approval that prevents a reasoned evaluation ofthe health or environmental effects ofthe3 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 ofinjuryto human health or the environment ofthe PMN substance. "Sealed container" means a closed containerthat 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, or consumeruse. "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.

### Company (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER
P06-153 PMNNumber
1. 

### Transfer ofManufacture Rights. Effective on , the Company did sell or othetwise transfer to , ("Successor in Interest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substance, which was the subject ofa 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 Substance 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 bythe 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, 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 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. Information which has been previously disclosed to the public (e.g., a chemical identitythat was not claimed as CBI bythe original submitter) would not subsequentlybe eligible for confidential treatment under this Notice ofTransfer.2 TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER

Company (Transferor)
Signature ofAuthorized Official NOTICE OF TRANSFER (continued) P06-153 PMNNumber

Date
Printed Name ofAuthorized Official
Title ofAuthorized Official

Successorin Interest
Signature ofAuthorized Official Date
Printed Name ofAuthorized Official
Title ofAuthorized 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