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# TSCA NON-CONFIDENTIAL BUSINESS INFORMATION

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# -!\\'**~J,~IIDhlo,r** UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

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# t \ OFFICE OF POLLUTION PREVENTION AND TOXICS

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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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111111111111111111111111111111111111111111111111111111111111111111111111111 ) ) s o o 9 0 0 0 0 2 4 0 I S P07-327 and P07-328

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__________________ __!.(J1 Consent Order and Determinations Supporting Consent Order -**:~·** 7
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### TABLE OF CONTENTS
Preamble I. Introduction II. Summary ofTerms ofthe Order III. Contents ofPMN IV. EPA's Assessment ofExposure and Risk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health and Environmental Effects

Consent Order I. Scope ofApplicability and Exemptions II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation oflnformation III. Recordkeeping IV. Requests for Pre-Inspection Information V. Successor LiabilityUpon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order
Attachment A

- Definitions Attachment B- Notice ofTransfer ofConsent Order111


## 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 notices ("PMNs") P07-327 and P07-328 for the chemical substances: [ ]- (P07- 327) and [ ] (P07-328) (the "PMN substances") submitted by [ ] ("the Company"), to take effect upon expiration ofthe PMNs review period. The Company submitted the PMNs 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 this PMN substance requires the Companyto:IV

- Submit to EPA certain toxicity testing at least 14 weeks before manufacturing orimporting a total of] kilograms ofthe PMN substances, combined. -Label containers ofthe PMN substance, P07-327, and provide Material SafetyData Sheets (MSDSs) and worker training in accordance with the provisions ofthe Hazard Communication Program section for P07-327;

- Complywith the Release to Waterprovisions; and -Maintain certain records.



### III. CONTENTS OF PMN Confidential Business Information Claims (Bracketed in the Preamble and Order): Company name, chemical identity, production volume, import, processing and use information, other information. Chemical Identity: Specific: P07-327: [ P07-328: [ Generic: P07-327: Substituted phenol P07-328: Substituted phenol Use: Specific: ]P07-327: [ P07-328: [ Generic: P07-327: Antioxidant P07-328: Antioxidant 

### v

Maximum 12-Month Production Volume: P07-327: [ kilograms/year. ]

### . ].

] kilograms/year; P07-328: [ ]

Test Data Submitted with PMN: P07-327- Rat acute oral toxicity study OECD 425: LDO = 2.0 glkg with no toxic signs. 

### IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK The following are EPA's predictions regarding the probablehuman and environmental toxicity, human exposure and environmental release ofthe PMN substance, based on the information currently available to the Agency. Human Health Exposure Summary ForP07-327 and P07-328, dermal exposure to the PMN substance is estimated to be greaterthan 250 workers for over 100 days per year. Environmental Effects Summary: Based on Quantitative Structural Activity Relationship ("QSAR") analysis derived from test data on structurally similarphenols, EPA expects toxicity to aquatic organisms to occur at a concentration of 1 part perbillion PMN substance in surface waters for P07-327 (See www.epa.gov/oppt/newchems/chemcat.htm).VI

Exposure and Environmental Release Summary:
P07-327 P07-327 P07-327 P07-327 P08-328 P08-328 Processing 1 Processing 2 Use 1 Use 2 Processing Use [ [ I [ [ I [ [ I I I I #ofSites [ ] [ ] 

### [ ] [ ] [ ] [ 

### ] Total# of [ ] [ ] [ ] [ ] [ ] [ ] Workers Exposure [ ] [ ] 

### [ ] [ ] [ ] [ ] (days/year) Dermal 3100 [ ] 3100 [ ] 52 [ ] 87 [ ] [ ] [ ] Exposure 11 [ ] 18 [ ] (mg/day) Inhalation 1.6 150 N/A Negligble Negilgible Negligible Exposure (mg/day) Release to None None None None None Negligible Water (kg/day) Surface Not N/A 

### NIA N/A 

### NIA NIA Water applicable Concen- (N/A) tration Days N/A N/A N/A 

### NIA N/A 

### NIA Exceeding Concern Level



### V. EPA'S CONCLUSIONS OF LAW The following findings constitute thebasis ofthe Consent Order:Vll 

### (a) EPA is unable to determine the potential for human health effects from exposure ofhumans to P07-327 and P07-328 and EPA is also unable to determine the potential for environmental toxicity from exposure ofaquatic organisms to P07-327. 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 human health and environmental effects ofthe PMN substances. (b) In light ofthe potential risk ofaquatic toxicity posed bythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe P07-327, EPA has concluded, pursuant to§ 5(e)(l)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance maypresent an unreasonable risk ofinjury to the environment. (c) In light ofthe estimated production volume of, and human exposure to, the PMN substances, EPA has further concluded, pursuant to§ 5(e)(l)(A)(ii)(II) ofTSCA, that the PMN substances will beproduced in substantial quantities and there maybe significant (or substantial) human exposure to the substances.



### VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND ENVIRONMENTAL EFFECTS 

### Triggered Testing. The Orderprohibits the Company from exceeding a specified production volume unless the Company submits the information described in the Testing section ofthis Order in accordance with the conditions specified in the Testing section.Vlll Pended Testing. The following additional information would berequired to evaluate the following effects which maybe causedbythe PMN substance P07-327: Algal toxicity, Tiers I and II (OPPTS 850.5400) Fish early-life stage toxicitytest (rainbow trout) (OPPTS 850.1400) Daphnid chronic toxicitytest (OPPTS 850.1300)
The Order does not require submission ofthe above pended testing on P07-327 at any specified time orproduction volume. However, the Order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal ofthe P07-327 will remain in effect until the Order is modified orrevoked byEPAbased on submission ofthat 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 ofthe chemical substances P07-327: [ ] and P07-328: [ ("the PMN substances") in the United States by [ ]("the Company"), except to the extent that those activities are exempted byparagraph (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 Liability Upon Transfer OfConsent Order sections) onlyto the extent that (1) these activities are conducted in full compliance with all applicable requirements2 

### ofthe following exemptions, and (2) such compliance is documented by appropriate 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 havebeen completelyreacted (cured). (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 or volume (0.1 percentbyweight orvolume 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 maybe reconcentrated above the 1.0 or 0.1 percent level, whichever applies. (3) Export Only. 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 40 CFR 720.3(s). However, once the Companybegins 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 ofthe 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 export3


### are subject to terms ofthe Order, and count towards any production 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 CFR 720.3(cc), and 40 CFR 720.36. (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 it is manufactured, pursuant to any ofthe exemptions in 40 CFR 720.30(h), with no commercial purpose separate from the substance, mixture, or article ofwhich it is a part.
(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.4 

### II. TERMS OFMANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION
PROHIBITION The Company is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing ofthe PMN substance in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe human health and environmental effects ofthe substance, and the completion of EPA's review of, and regulatory action based on, that information, except in accordance with the conditions described in this Order.



### TESTING (a) Section 8(e) Reporting. Reports ofinformation on the PMN substance which reasonably supports the conclusion that the PMN substance presents a substantial risk ofinjuryto health or the environment, which is required to bereported under EPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978), 68 Federal Register 33129 (June 3, 2003), and 70 Federal Register 2162 (January 12, 2005), shall reference the appropriate PMN identification number for this substance and contain a statement that the substance is subject to this Consent Order. Additional information regarding section 8(e) reporting requirements can be found in the reporting guidereferenced at 56 Federal Register 28458 (June 20, 1991).5 

### (b) Notice ofStudy Scheduling. The Company shall notify, in writing, the EPA Laboratory Data 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 1 0 days ofscheduling any studyrequired to beperformed pursuant to this Order, or within 15 days after the effective date ofthis Order, whichever is later: (1) The date when the study is 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 Company orthe 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 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 studyis initiated. Before starting to conduct any study, the Companymust obtain approval oftest protocols from EPA by submitting written protocols to EPA. EPA will respond to the Company within 4 weeks ofreceiving the written protocols. Published test guidelines specified in paragraph (d) provide general guidance for development oftest protocols, but are not themselves acceptable protocols. EPA approval ofa test protocol does not mean pre-acceptance oftest results.

### 6 (d) Triggered Testing Requirements. The Companyis prohibited from manufacturing or importing the PMN substances beyond the following aggregate manufacture and import volumes ("the production limits"), unless the Company conducts the following studies on PMN substance P07-327 and submits all final reports and underlying data in accordance with the conditions specified in this Testing section.
Production Limit ] kilograms Study/Guideline Mouse lymphoma assay (mammalian cell gene mutation test), in vitro (Test Guideline OPPTS 870.5300) Repeated Dose 28-day oral toxicity in rodents. Should include a neurotoxicitybattery as described in OPPTS 870.6200 (Test Guildeline OPPTS 870.3050 or OECD 407). (e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in a scientificallyvalid manner; (2) promptlyfurnish to EPA the results ofany interim phase of each study; and (3) submit, in triplicate (with an additional sanitized copy, ifconfidential business information is involved), the final report ofeach study and all underlying data ("the report and data") to EPA no laterthan 14 weeks prior to exceeding the applicable production limit. The final report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting", "Data and Reporting", and "Test Report" subparagraphs in the applicable test guidelines. However, for purposes ofthis Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the submission ofsuch information is mandatory. EPA will require the submission ofraw data such as slides and laboratorynotebooks onlyifEPA finds, on the basis of7 professionaljudgment, that an adequate evaluation ofthe study cannot take place in the absence ofthese items.
(f) Testing Waivers. The Companyis not required to conduct a study specified in paragraph (d) ofthis Testing section ifnotified in writing byEPA that it is unnecessaryto conduct that study.
(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal, the Companymay continue to manufacture and import the PMN substancebeyond the applicable production limit. To seekrelieffrom any otherrestrictions ofthis Order, the Company may make a second attempt to obtain unequivocal databyreconducting the studyunder the conditions specified in paragraphs (b), (c), and ( e)(1) and (2). The testing requirements maybe modified, as necessary to permit a reasoned evaluation ofthe risks presented bythe PMN substance, onlyby mutual consent ofEPA and the Company.
(h) EPA Determination oflnvalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's receipt ofa test report and data, the Companyreceives written notice that EPA finds that the data generated bya study are scientificallyinvalid, the Companyis prohibited from further manufacture and import ofthe PMN substancebeyond the applicable production limit. (2) The Companymaycontinue to manufacture and import the PMN substance beyond the applicable production limit only ifso notified, in writing, byEPA in response to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii).8 

### (i) The Companymayreconduct the study in compliance with paragraphs (b), 

### (c), and (e)(l) and (2). Ifthere is sufficient time to reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). Ifthere is insufficient time for the Company to comply with subparagraph (e)(3), the Company may exceed the production limit and shall submit the report and data in triplicate to EPA within a reasonable period oftime, all as specified by EPA in the notice described in subparagraph (h)(l). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data. (ii) The Companymay, within 4 weeks ofreceiving from EPA the notice described in subparagraph (h)(l), submit to EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report.
(i) Company Determination ofInvalid Data. (1) Except as described in subparagraph (i)(2), ifthe Companybecomes aware that circumstances clearlybeyond the control ofthe Company orlaboratory will prevent, orhave prevented, development ofscientifically valid data under the conditions specified in paragraphs (c) and (e), the Companyremains prohibited from further manufacture and import ofthe PMN substancebeyond the applicable production limit. (2) The Companymay submit to EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearlybeyond the control of the Company or laboratory will cause orhave caused development ofscientifically invalid data.9 EPA will notify the Company ofits response, in writing, within 4 weeks ofreceiving the Company's report. EPA's written response may either: (i) allow the Companyto continue to manufacture and import the PMN substance beyond the applicable production limit, or (ii) require the Companyto continue to conduct, or to reconduct, the study in compliance with paragraphs (b), (c), and (e)(1) and (2). Ifthere is sufficient time to conduct or reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). Ifthere is insufficient time for the Companyto comply with subparagraph ( e)(3), the Companymay exceed the production limit and shall submit the report and data in triplicate to EPA within a reasonable period oftime, all as specified byEPA in the notice described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data, as to whether the Companymay continue to manufacture and importbeyond the applicable production limit.


### G) Unreasonable Risk. (1) EPA maynotify the Companyin writing that EPA finds that the data generated by a study are scientifically valid 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 specify that 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 PMN10 

### 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: (A) within 2 weeks from receipt ofthe notice described in subparagraph G)(l), the Company complies with such requirements as EPA's notice specifies; or (B) within 4 weeks from receipt ofthe notice described in subparagraph (j)(l), the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of any additional requirements imposed byEPA. The Company may continue to manufacture, import, process, distribute, use and dispose ofthe PMN substance in accordance with the terms ofthis Order pending 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 imposed by EPA's response or cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substance.
(k) Other Requirements. Regardless ofthe satisfaction ofany other conditions in this Testing section, the Companymust continue to obey all the terms ofthis Consent Order until otherwise notified in writing by EPA. The Company may, based upon submitted test data or otherrelevant information, petition EPA to modify orrevoke provisions ofthis Consent Orderpursuant to Part IV. ofthis Consent Order.11 HAZARD COMMUNICATION PROGRAM [The provisions ofthis section apply only to P07-327] (a) Written Hazard Communication Program. The Company shall develop and implement a written hazard communication program for the PMN substance in each workplace. The written program will, at a minimum, describe how the requirements ofthis section for labels, MSDSs, and other forms ofwarning material will be satisfied. The Companymust make the written hazard communication program available, upon request, to all employees, contractor employees, and their designated representatives. The Companymayrely on an existing hazard communication program, including an existing program established under the Occupational Safety and Health Administration ("OSHA") Hazard Communication Standard (29 CFR 1910.1200), to comply with this paragraph provided that the existing hazard communication program satisfies the requirements ofthis section. The written program shall include the following: (1) A list ofchemical substances known to be present in the work area which are subject to a TSCA section 5(e) consent order signed bythe Company or to a TSCA section 5(a)(2) SNUR at 40 C.F.R. Part 721, subpart E. The list mustbemaintained in each work area where the PMN substance is known to bepresent and must use the identityprovided on the MSDS for the substance required underparagraph (c) ofthis section. The list maybe compiled for the workplace or for individual work areas. Ifthe Companyis required eitherby another Order issued under section 5(e) ofTSCA, orby a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, to maintain a list ofsubstances, the lists shall be combined with the list under this subparagraph.12 (2) Themethods the Companywill use to inform employees ofthe hazards ofnonroutine tasks involving the PMN substance (e.g., cleaning ofreactor vessels), and thehazards associated with the PMN substance contained in unlabeled pipes in their work area. (3) The methods the Companywill use to inform contractors ofthe presence ofthe PMN substance in the Company's workplace and ofthe provisions ofthis Order ifemployees ofthe contractor work in the Company's workplace and are reasonably likelyto be exposed to the PMN substance while in the Company's workplace.
(b) Labeling. (1) The Company shall ensure that each container ofthe substance in the workplace is labeled in accordance with this subparagraph (b)(1). (i) The label shall, at a minimum, contain the following information: (I) A statement ofthe health hazards(s) and precautionarymeasure(s), if any, identified in paragraph (f) ofthis section orbythe Company, for the PMN substance. (II) The identitybywhich the PMN substance maybe commonly recognized. (III) A statement ofthe environmental hazard(s) and precautionary measure(s), ifany, identified in paragraph (f) ofthis section, orbythe Company, for the PMN substance. (IV) A statement ofexposure and precautionarymeasure(s), ifany, identified in paragraph (f) ofthis section, orbythe Company, for the PMN substance.13 

### (ii) The Companymayuse signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu ofaffixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys information specified by subparagraph (b)(l)(i) ofthis section. Any written materials mustbereadily accessible to the employees in their work areas throughout each work shift. (iii) The Companyneed not label portable containers into which the PMN substance is transferred from labeled containers, and which are intended only for the immediate
use ofthe employee who performs the transfer. (iv) The Company shall not remove ordeface an existing label on containers of the PMN substance obtained from persons outside the Companyunless the container is immediatelyre-labeled with the information specified in subparagraph (b)(l)(i) ofthis section. (2) The Company shall ensure that each container ofthe substance leaving its workplace for distribution in commerce is labeled in accordance with this subparagraph (b)(2). (i) The label shall, at a minimum, contain the following information: (I) The information prescribed in subparagraph (b)(l)(i) ofthis section. (II) The name and address ofthe manufacturer or a responsible party who
can provide additional information on the substance for hazard evaluation and any appropriate emergencyprocedures. (ii) The label shall not conflict with the requirements ofthe Hazardous Materials Transportation Act (18 U.S.C. 1801 et. seq.) and regulations issued under that Act bythe Department ofTransportation.14 (3) The label, or alternative forms ofwarning, shall be legible and prominently displayed. (4) The label, or alternative forms ofwarning, shall beprinted in English; however, the information maybe repeated in other languages. (5) Ifthe label or alternative form ofwarning is to be applied to a mixture containing the PMN substance in combination with any other substance that is either subject to another TSCA section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, or defined as a "hazardous chemical" under the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the Companymayprescribe on the label, MSDS, or alternative form ofwarning, the measures to control worker exposure or environmental release which the Company determines provide the greatest degree ofprotection. However, should these control measures differ from the applicable
measures required under this Order, the Companymust seek a determination ofequivalency for such alternative control measures pursuant to 40 CFR 721.30 before prescribing them under this subparagraph (b)(5). (6) Ifthe Companybecomes aware ofany significant new information regarding the hazards ofthe PMN substance orways to protect against the hazards, this new information must be added to the label within 3 months from the time the Companybecomes aware ofthe new information. Ifthe PMN substance is not being manufactured, imported, processed, orused in the Company's workplace, the Companymust add the new information to the label before the PMN substance is reintroduced into the workplace.15 

### (c) Material Safety Data Sheets. (1) The Companymust obtain or develop an MSDS for the PMN substance. (2) The MSDS shall contain, at a minimum, the following information: (i) The identity used on the container label ofthe PMN substance under this section, and, ifnot claimed confidential, the chemical and common name ofthe PMN substance. Ifthe chemical and common name are claimed confidential, a generic chemical name must be used. (ii) Physical and chemical characteristics ofthe substance known to the Company, (e.g., vapor pressure, flash point). (iii) The physical hazards ofthe substance known to the Company, including the potential for fire, explosion, and reactivity. (iv) The potential human and environmental hazards as specified in paragraph (f) 

### ofthis section. (v) Signs and symptoms ofexposure, and any medical conditions which are expected to be aggravated byexposure to the PMN substance known to the Company. (vi) The primaryroutes ofexposure to the PMN substance. (vii) Precautionarymeasures to control worker exposure and/or environmental release required bythis Order, or alternative control measures which EPA has determined under 40 CFR 721.30 provide substantiallythe same degree ofprotection as the identified control
measures. (viii) Anygenerally applicable precautions for safe handling and use ofthe PMN substance which are known to the Company, including appropriate hygienic practices, protective16
measures during repair and maintenance ofcontaminated equipment, and procedures for response to spills and leaks. (ix) Anygenerally applicable control measures which are known to the Company, such as appropriate engineering controls, work practices, orpersonal protective equipment. (x) Emergency first aid procedures known to the Company. (xi) The date ofpreparation ofthe MSDS or ofits last revision. (xii) The name, address, and telephone number ofthe Company or another responsible partywho can provide additional information on the chemical substance and any appropriate emergencyprocedures. (3) Ifno relevant information is found orknown for any given category on the MSDS, the Companymust mark the MSDS to indicate that no applicable information was found. (4) Where multiple mixtures containing the PMN substance have similar compositions (i.e., the chemical ingredients are essentially the same, but the specific composition varies from mixture to mixture) and similarhazards, the Companymayprepare one MSDS to apply to all of these multiple mixtures. (5) Ifthe Companybecomes aware ofany significant new information regarding the hazards ofthe PMN substance orways to protect against the hazards, this new information must be added to the MSDS within 3 months from the time the Companybecomes aware ofthe new information. Ifthe PMN substance is not being manufactured, imported, processed, orused in the Company's workplace, the Companymust add the new information to the MSDS before the PMN substance is reintroduced into the workplace.17 

### (6) The Companymust ensure that persons receiving the PMN substance from the Company are provided an appropriate MSDS with their initial shipment and with the first shipment after an MSDS is revised. The Companymay either provide the MSDS with the shipped containers or send it to the person priorto or at the time ofshipment. (7) The Companymust maintain a copy ofthe MSDS in its workplace, and must ensure that it is readily accessible during each work shift to employees when they are in their work
areas. (8) The MSDS maybe kept in any form, including as operating procedures, and maybe designed to cover groups ofsubstances in a work area where itmaybemore appropriate to address the potential hazards ofa process rather than individual substances. However, in all cases, the required information mustbeprovided for the PMN substance and mustbereadily accessible during each work shift to employees when they are in their work areas. (9) The MSDS must be printed in English; however, the information mayberepeated in other languages.
(d) Employee Information and Training. The Companymust ensure that employees are provided with information and training on the PMN substance. This information and training must be provided at the time ofeach employee's initial assignment to a work area containing the PMN substance and whenever the PMN substance is introduced into the employee's work area for the first time. (1) The information provided to employees under this paragraph shall include: (i) The requirements ofthis section.18 (ii) Anyoperations in the work area where the PMN substance is present. (iii) The location and availability ofthe written hazard communication program required underparagraph (a) ofthis section, including the list ofsubstances required by subparagraph (a)(1) ofthis section and MSDSs required byparagraph (c) ofthis section. (2) The training provided to employees shall include: (i) Methods and observations that maybeused to detect the presence orrelease of the PMN substance in or from an employee's work area (such as exposure monitoring conducted bythe Company, continuous monitoring devices, visual appearance, or odor ofthe substance when being released). (ii) The potential human health and environmental hazards ofthe PMN substance
as specified in paragraph (f) ofthis section. (iii) The measures employees can take to protect themselves and the environment from the PMN substance, including specific procedures the Companyhas implemented to protect employees and the environment from exposure to the PMN substance, including appropriate workpractices, emergencyprocedures, personal protective equipment, engineering controls, and othermeasures to control worker exposure and/or environmental release required underthis Order, or alternative control measures which EPA has determined under 40 CFR 721.30 provide the same degree ofprotection as the specified control measures. (iv) The requirements ofthe hazard communication program developed bythe Companyunderthis section, including an explanation ofthe labeling system and the MSDS required bythis section and guidance on obtaining and using appropriate hazard information.19 (e) Existing Hazard Communication Program. The Company need not take additional actions if existing programs and procedures satisfythe requirements ofthis section.
(f) Environmental Hazard and Precautionary Statements for P07-327. The following environmental hazard and precautionary statements shall appear on each label as specified in paragraph (b) and the MSDS as specified in paragraph (c) ofthis section: (1) Environmental hazard statements. This substance maybe: (i) toxic to fish. (ii) toxic to aquatic organisms. (2) Environmental hazard precautionary statements. Notice to users: (i) do not release to water. (3) The environmental hazard and precautionary statement on the label prepared pursuant to paragraph (b) ofthis section mustbe followed bythe statement: "See the MSDS for details."

MANUFACTURING (1) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import ofthe PMN substance by any otherperson. (2) Sunset Following SNUR. Subparagraph (a)(1) shall expire 75 days after promulgation ofa final significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2) ofTSCA unless the Companyis notified on orbefore that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Companyis so notified, subparagraph20 (1) shall not expireuntil EPA notifies the Company in writing that all Federal Court actions involving the SNURhavebeen resolved and the validity ofthe SNUR affirmed. (3) Notice ofSNUR. When EPA promulgates a final SNUR for the PMN substance and subparagraph (1) expires in accordance with subparagraph (2), the Company shall notify each person whom it causes, encourages or suggests to manufacture or import the PMN substance of the existence ofthe SNUR.

DISTRIBUTION (a) Distribution Requirements. Except after the PMN has been completelyreacted or as provided in paragraph (b), the Company shall distribute the PMN substance outside the Company, including for disposal, onlyto a person who has agreed in writing priorto the date of distribution, to: (1) Not further distribute the PMN substance to any otherperson, including for disposal, until after the PMN substancehas been completelyreacted (cured). (2) Complywith the samerequirements and restrictions, ifany, required ofthe Company in the Hazard Communication Program section ofthis Order. (3) Complywith the same environmental release restrictions, ifany, required ofthe Companyin the Release to Water section ofthis Order. (b) TemporaryTransport and Storage. Notwithstanding paragraph (a), the Companymay distribute the PMN substance outside the Company for temporary transport and storage in sealed containers**(lab~led** in accordance with paragraph (b)(2) ofthe Hazard Communication Program section ofthis Order) provided the following two conditions are met:21 (1) Subsequent to any such exempt temporary transport or storage ofsealed containers, the PMN substance maybe distributed onlyto the Company or a person who has given the Companythe written agreement required byparagraph (a). (2) Anyhuman exposure or environmental release resulting from opening the sealed containers and removing or washing out the PMN substance may occur onlywhile the PMN substance is in the possession and control ofthe Companyor a person who has given the Companythe written agreement required byparagraph (a).
(c) Recipient Non-Compliance. If, at anytime after commencing distribution in commerce of the PMN substance, the Company obtains knowledge that a recipient ofthe substance has failed to comply with any ofthe conditions specified in paragraph (a) ofthis Distribution section or, after paragraph (a)(1) expires in accordance with subparagraph (d)(1), has engaged in a significant new use ofthe PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a significant new use notice to EPA, the Company shall cease supplying the substance to that recipient, unless the Company is able to document each ofthe following: (1) That the Companyhas, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any ofthe conditions specified in paragraph (a) ofthis Distribution section, orhas engaged in a significant new use ofthe PMN substance without submitting a significant new use notice to EPA. (2) That, within 15 working days ofnotifying the recipient ofthe noncompliance, the Companyreceived from the recipient, in writing, a statement ofassurance that the recipient is
aware ofthe terms ofparagraph (a) ofthis Distribution section and will complywith those terms,22
or is aware ofthe terms ofthe significant new use rule for the PMN substance and will not engage in a significant new use without submitting a significant new use notice to EPA. (3) If, after receiving a statement ofassurance from a recipient under subparagraph (c)(2) ofthis Distribution section, the Company obtains knowledge that the recipient has failed to comply with any ofthe conditions specified in paragraph (a) ofthis Distribution section, orhas engaged in a significant new use ofthe PMN substance without submitting a significant new use notice to EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA ofthe failure to comply, and shall resume supplying the PMN substance to that recipient onlyupon written notification from the Agency.
(d) Sunset Following SNUR. (1) Paragraph (a)(l) ofthis Distribution section shall expire 75 days after promulgation ofa final SNUR for the PMN substance under section 5(a)(2) ofTSCA, unless the Company is notified on orbefore that day ofan action in a Federal Court seeking judicial review ofthe SNUR. Ifthe Companyis so notified, paragraph (a)(l) ofthis Distribution section shall not expire until EPA notifies the Company in writing that all Federal Court actions involving the SNUR have been resolved and the validity ofthe SNUR affirmed. (2) When EPA promulgates a final SNUR for the PMN substance and paragraph (a)(l) of this Distribution section expires in accordance with subparagraph (d)(l), the Company shall notify each person to whom it distributes the PMN substance ofthe existence ofthe 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 invoke significant new use notification to EPA for the PMN substance. Such notice must also reference the publication of23 the SNUR for this PMN substance in eitherthe Federal Register orthe Code ofFederal Regulations. Afterpromulgation ofa SNUR and expiration ofsubparagraph (a)(l), such notice may substitute for the written agreement required in the introductory clause ofparagraph (a); so that, ifthe Companyprovides such notice to the persons to whom it distributes the PMN substance, then the Companyis not required to obtain from such persons the written agreement specified in paragraph (a).

RELEASE TO WATER This provision does not supersede orpreempt any applicable federal, state, and local laws and regulations. (Those other laws maybe more stringent than the requirements below.) The Companyis prohibited from anypredictable orpurposeful release ofthe PMN substance, P07- 327, or anywaste stream from manufacturing/processing/use containing the PMN substance into the waters ofthe United States.

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 byEPA in 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 exemption being claimed bythe Company. Any amounts orbatches ofthe PMN substance

### 24 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 ofthe export label and export notice to EPA, required byTSCA sections 12(a)(l)(B) and 12(b), respectively. Any amounts orbatches ofthe PMN substance eligible for the Research and Development exemption in Section I, Paragraph (b)(4) ofthis 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, but is exempt from the other recordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture and importation volume ofthe PMN substance and the corresponding dates ofmanufacture and import; (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 ortransfer, and the quantity ofthe substance sold ortransferred on such date; ( 4) Records documenting the address, ofall sites ofmanufacture, import, processing, and use; (5) Records documenting establishment and implementation ofthe hazard communication program required bythe Hazard Communication Program section ofthis Order;25 (6) Copies oflabels required underthe Hazard Communication Program section ofthis Order; (7) Copies ofmaterial safety data sheets required bythe Hazard Communication Program section ofthis Order; (8) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing and Distribution sections ofthis Order, including distributees' written agreement to complywith the Distribution section ofthis Order; (9) Records documenting establishment and implementation ofprocedures that ensure compliance with any applicable water discharge limitation in the Release to Water section ofthis Order; (10) Copies ofany Transfer Documents and notices required bythe Successor Liability section ofthis Order, ifapplicable; and (11) The Company shall keep a copy ofthis Order at each ofits sites where the PMN substance is 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

### 26 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 occasionally 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; (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 mayreasonably be exposed to the PMN substance; (v) Records required bythe Recordkeeping section ofthis Order; and/or (vi) Any other information reasonably related to determining compliance with this Order
or conducting an inspection for that purpose.27 (b) Company's Response. The Company shall respond to such requests within a reasonable period oftime, but in no event later than 30 days after receiving EPA's request. When requested in writing byEPA, the Company's response shall be in writing. To the extent the information is known to orreasonably ascertainable bythe 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's requests.
(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the Company submits to EPA pursuant to paragraph (b) shall beprotected in accordance with 

### §14 of TSCA and 40 CFR Part 2.

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures bywhich the Company's rights and obligations under this Order maybe transferred when the Companytransfers 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 ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from the Companyto the Successor in Interest is effectivebefore 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

### 28 must submit a new PMNto 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 Successor in Interest shall complywith the terms ofthis Order and shall not berequired 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 signed bythe Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe Companyin the PMN substance, such as a licensee who has acquired a limited 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 convey the interests in the PMN substance, including the right to manufacture the PMN substance, from the Companyto the Successorin Interest.
(d) Notices. (1) Notice to Successor in Interest. On orbefore the effective date ofthe transfer, the Company shall provide to the Successor in Interest; byregistered mail, a copy ofthe Consent

### 29 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 mustbemaintained bythe Successor in Interest at its principal place ofbusiness, and at all sites where the PMN substance is manufactured or imported. 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.
(e) Liability. (1) The Company shall be liable for compliance with the requirements ofthis Order until 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,

### 30 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 Successor in Interest. 

### VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Companymaypetition EPA at anytime, based upon new information on the human health or environmental effects of, orhuman exposure to orenvironmental release of, the 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 benecessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend orrevoke this Order, EPA will consider all relevant information available at the time the Agencymakes that determination, including, where appropriate, anyreassessment ofthe test data or other information that supports the findings in this Order, an examination ofnew test data or other information or analysis, and any other relevant 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 release31 in the absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects ofthe PMN substance. In addition, the Companymaypetition EPA at anytime 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.32 

### VII. EFFECT OF CONSENT ORDER Byconsenting 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 Orderin any subsequent action. Consenting to the entry ofthis Order, and agreeing to beboundbyits terms, do not constitute an admission bythe Companyas to the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any otherrights 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 may not contain some of the 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 substances ofconcern. Examples can include, but are not limited to: full bodyprotective clothing, boots, coveralls, gloves,jackets, and pants. "Company" means theperson 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 otherthan byits chemical name. "Consumer" means a private individual who uses a chemical substance or anyproduct containing the chemical substance in or around a permanent or temporaryhousehold or residence, during recreation, orfor anypersonal 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 ortemporary 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 orcommon 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 clothing under 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 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 submitted bythe Companyrelevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the bodyto prevent contact with, and exposure to, an identified chemical substance or substances in the work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types 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. "Scientifically invalid" means any significant departure from the EPA-approvedprotocol orthe Good Laboratory Practice Standards at 40 CFR Part 792 withoutprior or subsequent Agency approval that prevents a reasoned evaluation ofthe health or environmental effects ofthe PMN substance.3 "Scientifically equivocal data" means data which, although developed in apparent conformitywith the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internallyinconsistent, or otherwise insufficient to permit a reasoned evaluation of thepotential risk ofinjuryto human health orthe 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, ordisposal ofa chemical substance, regardless ofphysical state orconcentration, through all intended operations of industrial, commercial, orconsumeruse. "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 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 ofa premanufacture notice ("PMN") and is governed by a Consent Order issued bythe 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 bythe applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the responsibility ofthe Successorin 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 CFR part 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is indicated, that designation shall be deemed to applyto 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 S(e) CONSENT ORDER

Company (Transferor)
Signature ofAuthorized Official 

### NOTICE OF TRANSFER (continued)
PMNNumber

Date
Printed Narne ofAuthorized Official
Title ofAuthorized Official



### Successor in Interest
Signature ofAuthorized Official Date
Printed Name ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip CodeTOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER NOTICE OF TRANSFER (continued)

Successor's Technical Contact
Address City, State, Zip Code
Phone