UNITED STATES ENVIRONMENTALPROTECTIONAGENCY OFFICE OF POLLUTION PREVENTIONAND TOXICS REGULATION OF SIGNIFICANT NEW USES PENDING DEVELOPMENT OF INFORMATION

In the matter of: ) Significant New Use Notice Number: ) ) ) ) ) KurarayAmerica, Inc. ) S-05-3 ) ) ) ) 

# CONTAINS NO ) 

# CSt )

Consent Order and Detenninations Supporting Consent Orderii TABLE OF CONTENTS Preamble 1. Introduction II. Sunnnary ofTenns ofthe Order ill. Contents ofSNUN IV. EPA's Assessment ofRisk V. EPA's Conclusions ofLaw VI. Infonnation Required to Evaluate Human Health Effects
Consent Order I. Scope ofApplicability and Exemptions II. Tenns ofManufactnre, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInfonnation III. Recordkeeping IV. Requests for Pre-Inspection Infonnation V. Successor Liability Upon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order
Attachment A - Definitions Attachment B - Notice ofTransfer ofConsent Orderiii 

## 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 Significant New Use Notice C'SNUN") S-05-3 for the chemical substance 1- Butanol, 3-methoxy-3-methyl-, acetate (the "SNUN substance") submittedbyKurarayAmerica, Inc. ("the Company"), to take effect upon expiration ofthe SNUN reviewperiod. The Company submitted the SNUN to EPApursuant to section 5(a)(1) ofTSCA and the Significant New Use Rule at 40 CFR Part 721.532. EPApromulgated this SNURpursuant to TSCA § 5 (a)(2) in response topremanufacture notice (PMN) P-00-618, which was submitted and subsequently commenced (per 40 CFR 720.1 02) byanother company. The SNUN S-05-3 described the Company'sproposed significant new uses as use as an 1) organic solvent ofpolyurethane plastic coating, 2) ingredient in various kinds ofpaint thinner, 3) organic solvent of polyurethane resin, 4) ingredient ofcleaning agent, especiallyfor commercial use, 5) organic solvent for screen ink, and 6) ingredient in airplane paint. Under § 15 ofTSCA, it is uulawful for anyperson to fail orrefuse to complywith any provision of§ 5 or anyorder issued under § 5. Violators maybe subject to variouspenalties 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 § l2(b) export notice requirement.iv II. SUMMARY OF TERMS OF THE ORDER The Consent Order for this SNUN substance requires the Companyto: (a) Submit to EPA certain toxicity testing at least 14 weeks before importing a total of 1 million kilograms and 1.5 million kilograms ofthe SNUN substance; (b) Provide its workers personal protective equipment to prevent dermal exposure; (c) Label the SNUN substance andprovide Material Safety Data Sheets (MSDS) and worker training in accordance with the provisions ofthe Hazard Communication Program section; (d) Not manufacture the SNUN substance in the United States; (e) Not use the substance in consumerproducts; (f) Limit the percent concentration ofthe SNUN substance to 10% or less in final products whose uses involve an application method that generates a vapor, mist, or aerosol; (g) Distribute the SNUN substance only to a person who agrees to follow the same restrictions (except the testing requirements); and (h) Maintain certain records.

1lI. CONTENTSOFSNUN Confidential Business Information Claims (Bracketed in the Preamble and Order): The SNUN contains no TSCA CBI. Specific Chemical Identity: I-Butanol, 3-methoxy-3-methyl-, acetate (CASRN 103429-90-9)v Specific Uses: (l) Organic solvent of polyurethaneplastic coating, 50% ofproduction volume, 100% industrial use. (2) Ingredient ofvarious kinds of 

### paint thinner, 27.5% of production volume, 100% industrial use. (3) Organic solvent ofpolyurethane resin, 6.5% of production volume, 100% industrial use. (4) Ingredient ofcleaning agent, especiallyfor connnercial use, 3% of production volume, 100% commercial use. (5) Organic solvent for screen ink, 3% of production volume, 100% industrial use. (6) Ingredient in airplane paint, 10% of production volume, 100% industrial use.

Maximum 12-Month ProductionVohune: 200,000 kglyr Test Data Submitted with SNUN: Biodegradation data, a health effects summary (Toxicity Testing Reports ofEnvironmental Chemicals, Volume 10,2003,p. 571-655), and physical/chemical properties data were submitted with the SNUN.



### IV. EPA'S ASSESSMENT OF RISK The following are EPA's predictions regarding the probable toxicity, human exposure, and environmental release ofthe SNUN substance, based on the information currently available to the Agency.VI Hmnan Health Effects Smnmary: Absorption: Skin, 70%; Lung, 100%; GI tract, 100%. Toxicological Endpoints ofConcern: The SNUN substance may cause systemic effects and developmental toxicity in workers and consmners exposed to the SNUN substance by inhalation and/or dermal routes. Basis: These concerns are based onpreviously submitted test data on the SNUN substance and
on an expected metabolite ofthe SNUNmaterial as well as Structure Activity Relationship (SAR) analysis derived from test data on structurally similar ethylene glycol ethers and other ethers. See www.XJla.gov/opptlnewchemsichemcat.htm for further information regarding the chemical category ofconcern, ethylene glycol ethers.

Testresults on the SNUN substance: Acute oral study in rats
- LD50 = 4.6 g/kg Negative in the Ames assay

Testresults on the hydrolysis product ofSNUN substance (3-methoxy-3-methyl-l-butanol): Negative in the Ames assay Acute oral study in rats
- LD50 = 4.4 g/kg Acute dermal study in rats
- LD50 > 2 g/kg Negative for dermal sensitization in guineapigs Not a dermal irritant Moderate eye irritantVll Not a photoirritant orphotosensitizerin guinea pigs Negative in human skinpatch test 28-day de=al irritation study inrabbits

- slight irritant at 100% concentration, not an irritant at 50% concentration

Oral developmental toxicity range-finding study inrats
- maternal toxicity at 2000 mglkg; developmental toxicity at 1000 mg/kg;**l~OEL** = 500 mg/kg 28-dayinhalation studyin rats (100,300,500ppm)

- some liver andkidney effects at 

### all dose levels

Environmental Effects Summary: Based on SAR analyses for esters (see www.epa.gov/oppt.newchemslchemcat.htm). EPA predicts that the chronic aquatic concentration ofconcern for the SNUN substance is 900 ppb. As described 

### in the SNUN, releases ofthe substance are not expected to result 

### in surface water concentrations exceeding 900 ppb. Therefore, potential risks to the enviroument are expected to be low.viii Exposure Summary: Use Wood 

### Auto Cleaning Screen Manufacture Process Furuiture OEM Agent Printing Coating Ink # Sites NA 4 143 I 189 27 Workers NA 12 1,000's 17 567 222 (#/site) Exposure NA 250 250 237 250 250 (days/year) Dermal Exposure 120 to 120 to (mg/day) NA 1,800 610 610 120 120 Inhalation 0.33 to 0.017 to 0.31 to 0.002 to 0.008 to Exposure NA 20 0.99 18 0.09 0.49

- Vapor (mg/day) Inhalation not not Exposure

- Mist NA expected 10 6.4 expected 0.3 to 4.3 (mg/day)
Risk to Workers: Dermal Risk: In the absence of personal protective equipment (impervious gloves), EPA's estimated dermal Margins ofExposure (MOEs) in all the use scenarios indicate a potential risk ofsystemic effects and developmental toxicity. The MOEs range from less than 1 for dermal contact during processing to 100 for the use scenarios. EPA considers MOEs under 100 to be of
concern when calculatedbased on a NOEL, and MOEs under 1,000 to be ofconcern when based
on a LOAEL.IX Inhalation Risk: The MOEs for inhalation exposure for all the use scenarios indicate a low potential for risk associated with inhalation exposure ifthe concentration ofthe SNUN substance in the final product is 10% orless. Therefore, use ofrespiratoryprotection in these scenarios is not warranted. For estimated typical inhalation exposures, the MOEs for systemic and developmental toxicity are greater than 1,000. However, for estimated high end inhalation exposures, there are three systemic toxicityMOEs that are less than 1,000: 400 (vapor during processing); 460 (vapor during automotive OEM); and 850 (mist from wood furniture processing). Developmental toxicityMOEs based on the NOEL from the range-finding studyfor the hydrolysis product are 1,500 and greater. Developmental toxicityMOEs based on a LOEL for an analog for estimated high-end exposures are slightlyhigher than those for systemic toxicity. The lowest developmental toxicity MOE based onhigh-end exposure estimates is 460 (inhalation ofvapor duringprocessing).

Risk to Consumers: There is a potential risk ofdevelopmental toxicity from inhalation and dermal contact during consumer use ofthe SNUNmaterial, based on potential exposures estimated during the review ofa closely analogous substance. The MOE for developmental toxicity is 50-60 for inhalation and 55 for dermal contact, based on the NOEL from the range-finding developmental toxicity study for the hydrolysis product ofthe SNUN substance. Systemic toxicity was not evaluated for consumer use because consumer use is expected to be episodic rather than continuous.x V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis ofthe Consent Order: (a) EPA is unable to determine the potential for hill11an health effects (especially systemic and developmental toxicity) from exposure to the SNUN substance. EPA therefore concludes, pursuant to § 5( e)(1)(A)(i) ofTSCA, that the information a.vailable to the Agencyis insufficient to permit a reasoned evaluation ofthe hill11an health effects ofthe SNUN substance.
(b) Inlight ofthe potential risk ofhuman health effects (especially systemic and developmental toxicity) posedbythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe SNUN substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe SNUN substance maypresent an unreasonable risk ofinjuryto hill11an health.

VI. INFORMATION REOUIRED TO EVALUATE HEALTH EFFECTS Triggered Testing. The Orderprohibits the Companyfrom exceeding a specified production volill11e unless the Company submits the information described in the Testing section ofthis Order in accordance with the conditions specified in the Testing section. Pending Testing. The following additional information wouldbe required to evaluate the following effects which maybe caused by the PMN substance: Information Effects Guidelines 2nd Prenatal Developmental Developmental toxicity OPPTS 870.3700 Toxicity Study conducted on another species (not rats)Xl The Order does not require submission ofthe abovepended 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 wiII remain in effect until the Order is modified orrevoked byEPA based on submission ofthat orotherrelevant 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 I-Butanol, 3-methoxy-3- methyl-, acetate (S-05-3) ("the SNUN substance") in the United States by KurarayAmerica, Inc. ("the Company"), except to the extent that those activities are exempted byparagraph (b).
(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe SNUN substance is exempt from the requirements ofthis Order (except the requirements in the Recordkeeping and Successor Liability Upon Transfer OfConsent Order sections) only to the extent that (1) these activities are conducted in full compliance with all applicable requirements ofthe following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required in the Recordkeeping section ofthis Order.2

.(1) Completely Reacted (Cured). The requirements ofthis Order do not applyto quantities ofthe SNUN substance that have been completelyreacted (cured). (2) De Minimis Concentrations. The requirements ofthis Order do not applyto quantities ofthe SNUN substance that are (1) present in the work area onlyas a mixture and (2) at a concentration not to exceed 1.0 percent byweight orvolume (0.1 percent byweight or volume ifthe SNUN substance is identified as a potential carcinogen inparagraph (f) ofthe Hazard Communication Program section ofthis Order). TIris exemption is not available ifthe Companyhas reason to believe that, during intended activities, the SNUN substance in the mixture maybe reconcentrated above the 1.0 or 0.1 percent level, whichever applies. (3) Export. Until the Companybegins commercial manufacture orimport ofthe SNUN substance for use in the United States, the requirements ofthis Order do not apply to manufacture, processing or distribution in commerce ofthe SNUN substance solely for export in accordance with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Companybegins to manufacture or import the SNUN substance for use in the United States,
no further activitybythe Companyinvolving the SNUN substance is exempt as "solely for export" even ifsome amount ofthe SNUN substance is later exported. At that point, the requirements ofthis Order apply to all activities associated with the SNUN substance while in the territory ofthe United States. Priorto leaving U.S. territory, even those quantities orbatches ofthe SNUN 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.3' (4) Research & Development (R&D). The requirements of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe SNUN substance in small quantities solely for research and development in accordance with TSCA §5(b)(3), 40 CPR 720.3( cc), and 40 CPR 720.36.

(5) Byproducts. The requirements ofthis Order do not apply to the SNUN substance when it is produced, without separate commercial intent, only as a "byproducf' as defined at 40 CPR 720.3(d) and in compliance with 40 CPR 720.30(g). (6) No Separate Commercial Pm;pose. The requirements ofthis Order do not apply to the SNUN substance when it is manufactured, pursuant to any ofthe exemptions in 40 CPR 720.30(b), with no commercial purpose separate from the substance, mixture, or article ofwhich it is a part.
(c) Automatic Sunset. Ifthe Companyhas obtained for the SNUN substance a Test Market Exemption (TME) under TSCA §5(b)(1) and 40 CPR 720.38 or a Low Volume Exemption (LVE) or Low Release and Exposure Exemption (LoREX) under TSCA §5(h)( 4) and 40 CPR 723.sO( c)(1) and (2) respectively, any such exemption is automatically rendered null and void as ofthe effective date ofthis Consent Order.4 ll. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION

PROIDBITION The Companyis prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing ofthe SNUN substance in the United States, for anynonexempt commercial purpose, pending the development ofinformationnecessary for a reasoned evaluation ofthe humanhealth effects of the substance, andthe completion ofEP A's review of, andregulatory actionbased on, that information, except in accordance with the conditions described in this Order.
AUTHORIZED USES AND COMPLIANCE WITH SNUR This Consent Order authorizes onlythe significant new uses ofthe SNUN substance expresslyidentified in this Order and only to the extentpermitted and conditioned bythis Order. The authorized uses are use other than [as described in the PMN], provided that the Company complies with all the requirements ofthis Consent Order, including: (a) Submit to EPA certain toxicity testing at least 14 weeks before importing a total of I million kilograms and 1.5 million kilograms ofthe SNUN substance; (b) Provide its workers personal protective equipment to prevent dermal exposure;5 (c) Label the SNUN substance andprovide Material SafetyData Sheets (MSDS) and worker training in accordance with the provisions ofthe Hazard Connnunication Program section; (d) Notmanufacture the SNUN substance in the United States; (e) Not use the substance in consumerproducts; and (f) Limit the percent concentration ofthe SNUN substance to 10% or less in [mal products whose uses involve an application method that generates a vapor, mist, or aerosol. For anyother significant new uses, the Companyremains subject to all requirements ofthe SNUR and shall not manufacture, process, use, ordistribute the SNUN substance for these significant new uses without first submitting another SNUN and complying with all requirements ofthe SNUR. Except as provided inthis Consent Order, compliance with this Order does not constitute grounds to exempt the Company, per40 CFR 721.45 (i), from compliance with the SNUR at 40 CFR 721.532.
TESTING (a) Section 8ee) Reporting. Any information on the SNUN substance which reasonably supports the couclusion that the SNUN substance presents a substantial risk ofinjury to health or the enviroument required to be reported under EPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978) as amended at 52 Federal Register 20083 (May 29, 1987), shall reference the appropriate SNUN identification number for this substance and shall contain a statement that the substance is subject to this Consent Order. Additional information regarding6 section 8( e) reporting requirements can be 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 IntegrityBranch (2225A), Office ofEnforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvauia Avenue, N.W., Washington, D.C. 20460, ofthe following information within 10 days ofscheduling any study required to beperformed pursuant to this Order, or within 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 Company or the laboratory whom EPAmay contact regarding the study; and (4) The appropriate SNON 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 study is initiated. Before starting to conduct any such study, the Companymust obtain approval oftestprotocols from EPA by submitting written protocols. 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 of

### 7 test protocols, but are not themselves acceptable protocols. Approval ofthe test protocol does not meanpre-acceptance oftest results.
(d) Triggered Testing Requirements. The Company is prohibited from importing the SNUN substance beyond the following aggregate import volumes ("the production limits"), unless the Company conducts the following studies on the SNUN substance and submits all final reports and underlying data in accordance with the conditions specified in this Testing section.
Production Limit 1 million kilograms 1.5 million kilograms Study 90-Day Inhalation Toxicity Study Prenatal Developmental Toxicity Study Guideline OPPTS 870.3465 OPPTS 870.3700 (e) Test Reports. The Company shaH: (1) conduct each studyin good faith, with due care, and in a scientifically valid 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 info=ationis involved), the final report ofeach study and all underlying data ("the report and data") to EPA no later than 14 weeks priorto exceeding the applicable production limit. The final report shall contain the contents specified in 40 CFR 792. I85. 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 info=ationis mandatory. EPA will not require the submission ofraw data such as slides and laboratory notebooks unless ifEPA finds, on the basis

### 8 of professionaljudgment, that an adequate evaluation ofthe study canuot 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 writingbyEPA that it is unnecessary to conduct that study.
(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal, the Companymay continue to import theSNUN substance beyond the applicableproduction limit. To seek relieffrom any otherrestrictions ofthis Order, the Companymay make a second attempt to obtain unequivocal data byreconducting the studyunder the conditions specified in paragraphs (b), (c), and (e)(1) and (2). The testing requirements maybe modified, as necessary to pennit a reasoned evaluation ofthe risks presented bythe SNUN substance, onlybymutual consent ofEPA and the Company.
(h) EPA Dete=ination ofInvalid 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 by a study are scientifically invalid, the Company isprohibited from further import ofthe SNUN substance beyond the applicable production limit. (2) The Companymay continue to import the SNUN 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).9 (i) The Companymayreconduct the studyin compliance withparagraphs (b), (c), and (e)(1) 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 Companymay exceed the production limit and shall submit the report and data intriplicate to EPA within a reasonable period oftime, all as specified byEPA inthe 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)(1), submit to EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 weeks ofreceivingthe Company's report.
(i) Company Determination ofInvalid Data. (1)Except as described in subparagraph (i)(2), ifthe Company becomes aware that circumstances clearlybeyond the control ofthe Company or laboratory will prevent, or have prevented, development ofscientifically valid data under the conditions specified inparagraphs (c) and ( e), the Companyremains prohibited from further import ofthe SNUN substance beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining whycircumstances clearlybeyond the control of the Company or laboratorywill cause or have caused development ofscientifically invalid data.

### 10 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 import the SNUN substance beyond the applicable production limit, or (ii) require the Companyto continue to conduct, or to reconduct, the studyin compliance with paragraphs (b), (c), and (e)(l) 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 exceedingthe 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 Companymayexceed the production limit and shall submit the report and data in triplicate to EPA within a reasonable period oftime, all as specifiedbyEPA 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 whetherthe Companymay continue to import beyond the applicable production limit.
(j) Unreasonable Risk. (l) EPA maynotifY the Companyin writing that EPA finds that the data generated by a study are scientifically valid and unequivocal imd indicate that, despite the terms ofthis Order, the SNUN substance will ormaypresent an unreasonable risk ofinjuryto human health or the enviromnent. EPA's notice may specifY that the Companyundertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthe SNUN substance to mitigate exposures to or to better characterize the risks presented by the SNUN11 substance. Within 2 weeks from receipt ofsuch a notice, the Companymust cease 

### all import, processing, distribution, use and disposal ofthe SNUN substance, unless either:
(2) within 2 weeks from receipt ofthe notice described in subparagraph (j)(I), the Company complies with such requirements as EPA's notice specifies; or (3) within 4 weeks from receipt ofthe notice described in subparagraph (j)(1), the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of any additional requirements imposed byEPA. The Companymaycontinue to import, process, distribute, use and dispose ofthe SNUN 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 ofreceipt ofEPA's written response, the Company shall complywith anyrequirements imposed byEPA's response
or cease all import, processing, distribution, use and disposal ofthe SNUN 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 Companymay, based upon submitted test data or otherrelevant information, petition EPA to modifY orrevoke provisions ofthis Consent Orderpursuant to Part VI. ofthis Consent Order.12 PROTECTION IN THE WORKPLACE (a) Establishment ofProgram. During importing, processing, and use ofthe SNUN substance at any site controlled bythe Company (including any associated packaging and storage and during any cleaning ormaintenance ofequipment associated with the SNUN substance), the Company must establish a program whereby: (1) General Dermal Protection. Eachperson who is reasonablylikelyto be dermally exposed in the work area to the SNUN substance through direct handling ofthe substance or through contact with equipment on which the substance mayexist, orbecause the substance becomes airborne in a form listed in subparagraph (a)(5) ofthis section, is provided with, and is required to wear, personal protective equipment that provides a barrier toprevent dermal exposure to the substance in the specific work area where it is selected for use. Each such item of personalprotective equipment must be selected and used in accordance with OSHA dermal protectionrequirements at 29 CFR 1910.132,1910.133, and 1910.138. (2) Specific Dermal Protective Equipment. The dermal personal protective equipment required by subparagraph (a)(1) ofthis sectionmust include, but is not limited to, the following items: (i) Gloves.
• Butyl rubber gloves with a minimum thickness of 16.6 mils or Silver Shield gloves with a minimum thickness of2.7 mils when handling the neat SNUN substance.

### 13
• Silver Shield gloves with a minimum thickness of2.7 mils when handlingpaint formulations, where concentration ofthe SNUN substance is 10% or less.
• Other gloves that satisfyparagraph (a)(3) below. As ofthe date of signature ofthis Order, glove imperviousness has not been demonstrated for formulations containing the SNUN substance in combination with cleaning agents and screen inks. (3) Demonstration ofImperviousness. The Company is able to demonstrate that each item ofchemical protective clothing selected, including gloves, provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions ofexposure within the work area as follows: (i) Permeation Testing. Testing the material used to make the chemical protective clothing and the construction ofthe clothing to establish that the protective clothing will be impervious for the expected duration and conditions ofexposure. The testing must subject the chemical protective clothing to the expected conditions ofexposure, including the likely combinations ofchemical substances to which the clothing maybe exposed in the work area. Permeation testing shall be conducted according to the American Society for Testing and Materials (ASTM) F739 "Standard Test Method for Resistance ofProtective Clothing materials to Permeation byLiquids or Gases." Results shall be recorded as a cumulative permeation rate as
a function oftime, and shaH be documented in accordance with ASTM F739 usingthe format specified inASTM F 1194-89 "Guide for Documenting the Results ofChemical Permeation Testing on Protective Clothing Materials." Gloves may not be used for a time period longer than14 they are actualIy tested andmust be replaced at the end ofeach work shift during which they are exposed to the SNUN substance.

HAZARD COMMUNICATIONPROGRAM (a) Written Hazard Communication Program. The Company shall develop and implement a written hazard communicationprogram for the SNUN substance in each workplace. The written program will, at a minimum, describe how the requirements ofthis section for labels, MSDSs, and other fonus ofwarning material will be satisfied. The Companymust make the written hazard communicationprogram available, upon request, to all employees, contractor employees, and their designated representatives. The Companymayrely on an existing hazard connnunicationprogram, including an existing program established under the Occupational Safetyand Health Administration (OSHA) Hazard Communication Standard (29 CFR 19I0.1200), to complywith this paragraphprovided that the existing hazard communication program satisfies the requirements ofthis section. The written program shall include the following: (1) A list ofchemical substancesknown 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 must be maintained in each work area where the SNUN substance is known to be present and must use the identityprovided on the MSDS for the substance required under paragraph (c) ofthis section. The list maybe compiled for the workplace or for individual work areas. Ifthe Company is required either by another Order issued under section 5(e) ofTSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR Part 721,15 subpart E, to maintain a list ofsubstances, the lists shall be combined with the list under this subparagraph. (2) The methods the Companywill use to inform employees ofthe hazards ofnonroutine tasks involving the SNUN substance (e.g., cleaning ofreactor vessels), and the hazards associated with the SNUN substance contained in unlabeled pipes in their work area. (3) The methods the Companywill use to inform contractors ofthe presence ofthe SNUN substance in the Company's workplace and ofthe provisions ofthis Order ifemployees of the contractor work in the Company's workplace and are reasonably likelyto be exposed to the SNUN 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)(l). (i) The label shall, at a minimum, contain the following information: (I) A statement ofthe health hazards(s) andprecautionarymeasure(s), if any, identified inparagraph (f) ofthis section orbythe Company, for the SNUN substance. (II) The identitybywhich the SNUN substance maybe commonly recognized. (III) A statement ofthe environmental hazard(s) and precautionary measure(s), ifany, identified inparagraph (f) ofthis section, or bythe Company, for the SNUN substance.16 (N) A statement ofexposure andprecautionarymeasure(s), ifany, identified inparagraph (f) ofthis section, orbythe Company, for the SNUN substance. (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 info=ation specified by subparagraph (b)(1)(i) ofthis section. Any written materials must bereadily accessible to the employees in their work areas throughout each work shift. (iii) The Companyneed not label portable containers into which the SNUN substance is transferred from labeled containers, and which are intended only for the immediate
use ofthe employee who perfo=s the transfer. (iv) The Company shall not remove or deface an existing label on containers of the SNUN substance obtained from persons outside the Companyunless the container is immediately re-Iabeled with the info=ation specified in subparagraph (b)(1)(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 info=ation: (1) The info=ationprescribed in subparagraph (b)(1)(i) ofthis section. (11) The name and address ofthe manufacturer or a responsible partywho
canprovide additional info=ation on the substance for hazard evaluation and any appropriate emergencyprocedures.17 (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. (3) The label, or alternative forms ofwaming, shall be legible and prominentlydisplayed. (4) The label, or alternative forms ofwaming, shall be printed in English; however, the information maybe repeated in otherlanguages. (5) Ifthe label or alternative form ofwaming is to be applied to a mixture containing the SNUN substance in combination with anyother 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 CFRPart 721, subpart E, or defined as a "hazardous chemical" under the Occupational Safety andHealthAdministration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the Companymayprescribe on the label, MSDS, or alternative form ofwaming, 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 Company must seek a determination ofequivalency for such alternative control measures pursuant to 40 CFR 721.30 before prescribingthem under this subparagraph (b)(5). (6) Ifthe Companybecomes aware ofany significant new informationregarding the hazards ofthe SNUN substance or ways 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 SNUN substance is not being manufactured, imported, processed, or used in

### 18 the Company's workplace, the Companymust add the new information to the label before the SNUN substance is reintroduced into the workplace.
(c) Material SafetyData Sheets. (1) The Companymust obtain or develop an MSDS for the SNUN substance. (2) The MSDS shall contain, at a minimum, the following information: (i) The identityused on the containerlabel ofthe SNUN substance underthis section, and, ifnot claimed confidential, the chemical and common name ofthe SNUN 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., vaporpressure, flash point). (iii) Thephysical 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 (:I) ofthis section. (v) Signs and symptoms ofexposure, and anymedical conditions which are expected to be aggravated by exposure to the SNUN substance known to the Company. (vi) The primaryroutes ofexposure to the SNUN substance. (vii) Precautionarymeasures to control worker exposure and/or environmental release required bythis Order, or alternative control measures which EPA has determined under

### 19 40 CFR 721.30 provide substantially the same degree ofprotection as the identified control
measures. (viii) Anygenerally applicable precautions for safe handling and use ofthe SNUN substance which are known to the Company, including appropriate hygienic practices, protective measures during repair and maintenance ofcontaminated equipment, andprocedures for response to spills and leaks. (ix) Any generally applicable control measures which are known to the Company, such as appropriate engineering controls, work practices, orpersonal protective equipment. (x) Emergencyfirst aidprocedures 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 party who canprovide additional information on the chemical substance and any appropriate emergencyprocedures. (3) Ifnorelevant information is found or known for any given category on the MSDS, the Company must mark the MSDS to indicate that no applicable information was found. (4) Where multiple mixtures containing the SNUN substance have similar compositions (i.e., the chemical ingredients are essentially the same, but the specific composition varies from mixture to mixture) and similar hazards, the Company mayprepare one MSDS to apply to all of these multiple mixtures. (5) Ifthe Companybecomes aware ofany significant new information regarding the hazards ofthe SNUN substance or ways 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

### 20 infonnatiol}. litheSNUN substanceisnotbeingmanufactured,imported, processed; 

### 6fuseclfu the Company's workplace, the Company must add the new infonnation to the MSDS before the SNUN substance is reintroduced into the workplace. (6) The Companymust ensure that persons receiving the SNUN 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 eitherprovide the MSDS with the shipped containers or send it to the personpriorto 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 maybekept in any fonn, including as operatingprocedures, and maybe designed to cover groups ofsubstances in a work area where itmaybe more appropriate to address the potential hazards ofa process rather than individual substances. However, in all cases, the required information must be provided for the SNUN substance and must be readily accessible during each work shift to employees when they are in their work areas. (9) The MSDS must be printed inEnglish; however, the infonnation maybe repeated in other languages.
(d) EmployeeInfonnation and Training. The Company must ensure that employees are provided with infonnation and training on the SNUN substance. This information and training must be provided at the time ofeach employee's initial assignment to a work area containing the21 SNUN substance and whenever the SNUN substance is introduced into the employee's work area for the first time. (1) The informationprovided to employees under this paragraph shall include: (i) The requirements ofthis section. (ii) Any operations in the work area where the SNUN substance ispresent. (iii) The location and availability ofthe written hazard communicationprogram required underparagraph (a) ofthis section, including the list ofsubstances required by subparagraph (a)(l) ofthis section and MSDSs required byparagraph (c) ofthis section. (2) The training provided to employees shall include: (i) Methods and observations that maybe used to detect the presence orrelease of the SNUN substance in or from an employee's work area (such as exposure monitoring conducted by the Company, continuous monitoring devices, visual appearance, or odor ofthe substance when being released). (ii) The potential human health and environmental hazards ofthe SNUN substance as specified inparagraph (f) ofthis section. (iii) The measures employees can take to protect themselves and the environment from the SNUN substance, including specific procedures the Companyhas implemented to protect employees and the environment from exposure to the SNUN substance, including appropriate work practices, emergencyprocedures, personal protective equipment, engineering controls, and other measures to control worker exposure and/or environmental release required under this Order, or alternative control measures which EPA has determined under 40 CFR 721.30 provide the same degree ofprotection as the specified control measures.22 (iv) The requirements ofthe hazard communicationprogram developed bythe Companyunder this section, including an explanation ofthe labeling system and the MSDS required bythis section and guidance on obtaiuing and using appropriate hazard information.
(e) Existing Hazard Communication Program. The Companyneednot take additional actions if existing programs andprocedures satisfY the requirements ofthis section.
(f) Human Health. Environmental Hazard. Exposure. and Precautionary Statements. The following human health and environmental hazard andprecautionary statements shall appear on each label as specifiedinparagraph (b) and the MSDS as specified inparagraph (c) ofthis section: (1) Human healthhazard statements. This substance maycause: (i) internal organ effects. (ii) developmental effects. (2) Human hazard precautionary statements. When using this substance: (i) avoid skin contact. (ii) avoid breathing the substance. (iii) avoid ingestion. (iv) use skin protection. (3) The human hazard and precautionary statement on the label prepared pursuant to paragraph (b) ofthis section must be followed bythe statement: "See the MSDS for details."23 MANUFACTURING & IMPORTING (a)(1) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import ofthe SNUN substance byany otherperson. (2) Sunset Following SNUR. Subparagraph (a)(1) shall expire 75 days after promulgation ofa final significant new use rule (HSNURH ) governing the SNUN substance under section 5(a)(2) ofTSCA unless the Companyis notified on or before that day ofan action in a

. Federal Court seekingjudicial review ofthe SNUR. Ifthe Company is so notified, subparagraph

(a)(1) shall not expire until EPA notifies the Companyin 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 SNUN substance and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shalI notifY eachperson whom it causes, encourages or suggests to manufacture or import the SNUN substance ofthe existence ofthe SNUR.
(b) The Company shall not manufacture the SNUN substance in the United States.

USE (a) The Company shall not use the SNUN substance: (1) In consumerproducts; (2) In an application method that generates a vapor, mist, or aerosol when the percent concentration ofthe SNUN substance in the fmal product exceeds 10%.24 DISTRIBUTION (a) Distribution Requirements. Except after the SNUN substance has been completelyreacted or
asprovided inparagraph (b), the Company shall distribute the SNUN substance outside the Company, otherthan for disposal, onlyto a person who has agreed in writingprior to the date of distribution, to: (1) Complywith the same requirements and restrictions, ifany, required ofthe Company in the Protection inthe Workplace section ofthis Order. (2) Complywith the same requirements and restrictions, ifany, required ofthe Company in the Hazard Communication Program section ofthis Order. (3) Not use the SNUN substance: (i) In consumerproducts; (ii) In an application method that generates a vapor, mist, or aerosol when the percent concentration ofthe SNUN substance in the final product exceeds 10%.
(b) Temporary Transport and Storage. Notwithstandingparagraph (a), the Companymay distribute the SNUN substance outside the Companyfor temporarytransport and storage in sealed containers Qabeled in accordance withparagraph (b)(2) ofthe Hazard Communication Program section ofthis Order) provided the following two conditions are met: (1) Subsequent to any such exempt temporary transport or storage ofsealed containers, the SNUN substance maybe distributed onlyto the Company or a person who has given the Company the written agreementrequired byparagraph (a).25 (2) Anyhuman exposure or environmental release resulting from opening the sealed containers and removing or washing out the SNUN substance may occur only while the SNUN substance is in the possession and control ofthe Company or a person who has given the Company the written agreement required byparagraph (a).
(c) Recipient Non-Compliance. If, at any time after commencingdistribution in commerce ofthe SNUN substance, the Companyobtains knowledge that a recipient ofthe substance has failed to comply with any ofthe conditions specified inparagraph (a) ofthis Distribution section or, after paragraph (a)(1) expires in accordance with subparagraph (d)(1), has engaged in a significant new
use ofthe SNUN substance (as defined in 40 CFRPart 721, Subpart E) without submitting a significant new use notice to EPA, the Company shaU cease supplying the substance to that recipient, unless the Companyis able to document each ofthe foUowing: (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 inparagraph (a) ofthis Distribution section, orhas engaged in a significant new use ofthe SNUN substance without submitting a significant new use notice to EPA. (2) That, within 15 working days ofnotif'ying 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 comply with those terms,
or is aware ofthe terms ofthe significant new use rule for the SNUN substance and will not engage in a significant new use without submitting a significant new use notice to EPA.

### 26 (3) If, afterreceiving 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 inparagraph (a) ofthis Distribution section, orhas engaged 

### in
a significant new use ofthe SNUN substance without submitting a significant new use notice to EPA, the Company shall cease supplying the SNUN substance to that recipient, shall notifY EPA of the failure to comply, and shall resmne supplying the SNUN substance to that recipient onlyupon written notification from the Agency.
(d) Sunset Following SNUR. (1) Paragraph (a)(1) ofthis Distribution section shall expire 75 days afterpromulgation ofa final SNUR for the SNUN 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, paragraph (a)(1) ofthis Distribution section shall not expire until EPAnotifies the Companyinwriting that 

### all Federal Court actions involving the SNUR have been resolved and the validity ofthe SNUR affrrmed. (2) When EPA promulgates a final SNUR for the SNUN substance and paragraph (a)(l) of this Distribution section expires in accordance with subparagraph (d)(1), the Company shall notifY eachperson to whom it distributes the SNUN substance ofthe existence ofthe SNUR. Such notification must be in writing and must specifically include alllirnitations contained in the SNUR which are defined as significant new uses, and which would invoke significant new use notification to EPA for the SNUN substance. Such notice must also reference the pUblication ofthe SNUR for this SNUN substance in either the Federal Register or the Code ofFederal Regulations. After promulgation ofa SNUR and expiration ofsubparagraph (a)(l), such notice may substitute for the27 written agreement required in the introductory clause of paragraph (a); so that, ifthe Company provides such notice to the persons to whom it distributes the SNUN substance, then the Company is not required to obtain from suchpersons the written agreement specified in paragraph (a).

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 copyingby EPA in accordance with section 11 ofTSCA: (1) Exemptions. Records documenting that the SNUN substance did in fact qualifY for any
one ormore ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Suchrecords must satisfY all the statutory and regulatoryrecordkeeping requirements applicable to the exemptionbeing claimedbythe Company. Any amounts or batches ofthe SNUN substance eligible for the Export exemption in SectionI, 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 by TSCA sections 12(a)(1)(B) and 12(b), respectively. Any amounts orbatches ofthe SNUN 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 Companymaintains, for 5 years from the date oftheir creation, the records required by40 CFR nO.78(b). For any amounts
orbatches ofthe SNUN substance claimed to be eligible for any other exemption described in Section I, Paragraph (b) ofthis Order, the Company shall keep records demonstrating qualification

### 28 for that exemption as well as the records specified inparagraphs (2) and (3) below, but is exempt from the other recordkeeping requirements in this Recordkeeping section; (2) Records documenting the importation volume ofthe SNUN substance and the corresponding dates ofimport; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofimport to whom the Companydirectly sells or transfers the SNUN substance, the date ofeach sale ortransfer, and the quantity ofthe substance sold or transferred on such date; (4) Records documenting the address ofall sites ofimport, processing, and use; (5) Records documenting establishment and implementation ofa program for the use of any applicable personal protective equipmentrequired pursuant to the Protection in the Workplace section ofthis Order; (6) Records documenting the determinations required by the Protection in the Workplace section ofthis Order that chemical protective clothing is impervious to the SNUN substance; (9) Records documenting establishment and implementation ofthe hazard communication program required bythe Hazard Communication Program section ofthis Order; (10) Copies oflabels required under the Hazard Communication Program section ofthis Order; (II) Copies ofmaterial safetydata sheets required bythe Hazard Communication Program section ofthis Order; (12) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing & Importing, Use, and Distribution sections of

### 29 this Order, including distributees' written agreement to comply with the Distribution section of

### this Order; (13) Copies ofany Transfer Documents and notices required by the Successor Liability section ofthis Order, ifapplicable; and (14) The Company shall keep a copyofthis Order at each ofits sites where the SNUN substance is imported.
(b) Applicability. The provisions ofthis Recordkeeping Section are applicable only to activities of the Company and not to activities ofthe Company's customers.
(c) OMB Control Number. Under the Paperwork Reduction Act and its regnlations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Companyis not required to respond to this "collection of information" unless this Order displays a currently valid control number from the Office of Management and Budget (OMB), and EPA so informs the Company. The "collection of information" required in this TSCA §5(e) Consent Orders has been approved under currently valid OMB Control Number 2070-0012.

IV. REOUESTS FOR PRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuant to section I I ofTSCA and 40 CFR 720.122, EPA may occasionally conduct on-site compliance inspections ofCompany facilities and conveyances associated with the SNUN substance. To facilitate such inspections, EPA personnel may contact the Company in advance to request information pertinent to the scheduling and conduct ofsuch30 inspections. Such requests maybe written or oral. The types ofinformationthat EPA mayrequest mayinclude, but are not limited to, the following: (i) Expected dates and times when the SNUN substance will be inproduction within the subsequent 12 months; (ii) Current workshift schedules for workers who are involvedin activities associated with the SNUN substance andmayreasonablybe exposed to the SNUN substance; (iii) Currentjob titles or categories for workers who are involved in activities associated with the SNUN substance and mayreasonablybe exposed to the SNUN substance; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the SNUN substance andmayreasonably be exposed to the SNUN substance; (v) Records requiredbythe Recordkeeping section oftl>is Order; and/or (vi) Anyother information reasonablyrelated to determining compliance with this Order or conducting an inspection for thatpurpose.
(b) Company's 

### Response. The Company shall respond to such requests within a reasonable period oftime, but inno event later than 30 days afterreceiving 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's requests.31 (c) Confidential Business Infonnation. Any Confidential Business Infonnation (CBI) that the Company submits to EPApursuant to paragraph (b) shall be protected 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 SNUN substance, including the right to import the SNUN substance, to anotherperson outside the Company (the "Successor in Interest").
(b) Definitions. The following definitions apply to this Successor Liability section ofthe Order: (l) "Successor in Interest" means a person outside the Companywho has acquired the Company's full interest in the rights to import the SNUN substance, including all ownership rights and legal liabilities, through a transfer document signed bythe Company, as transferor, and the Successorin Interest, as transferee. The tenn excludes persons who acquire less than the full interest ofthe Companyin the SNUN substance, such as a licensee who has acquired a limited license to the patent or manufacturing rights associated with the SNUN substance. A Successor in Interest must be incorporated, licensed, or doing business in the United States in accordance with 40 CFR nO.22(a)(3). (2) "Transfer Document" means the legal instrument(s) used to convey the interests in the SNUN substance, including the right to import the SNUN substance, from the Company to the Successor in Interest.

### 32 (c) 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 Order and the "Notice ofTransfer" documentwhich is incorporated byreference as Attachment C to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the Company shall, byregistered mail, submit the fully executed Notice ofTransfer document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405),1200 PennsylvaniaAvenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Documentmust be maintained bythe Successor in Interest at its principal place ofbusiness, and at all sites where the SNUN substance is manufactured orimported. Copies ofthe Transfer Document must also be made available for inspectionpursuant to Section 11 ofTSCA, must state the effective date oftransfer, and must containprovisions which expresslytransfer liability For the SNUN substance under the tenus of this Order from the Companyto the Successor in Interest.
(d) 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.33 (3) Nothing inthis 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 Companyimported, processed, used, distributed in commerce, or disposed ofthe SNUN substance pursuant to the terms ofthis Consent Order.
(e) Obligations to Submit Test Data under Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Orderrequires the Companyto submit test data to EPA at a specifiedproduction volume ("test trigger"), the aggregate volume ofthe SNUN substance importedbythe Company up to the date oftransfer shall count towards the test trigger applicable to the Successor in Interest.34 VI. MODIFICATIONAND REVOCATION OF CONSENT ORDER The Companymaypetition EPA at any time, based upon new infonnation on the health effects of, orhuman exposure to, the SNUN substance, to modifY orrevoke substantive provisions ofthis Order. The exposures and risks identifiedbyEPA during its review ofthe SNUN substance and the infonnation EPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend orrevoke this Order, EPA will consider all relevant infonnation available at the time the Agencymakes that detennination, 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 otherrelevant infonnation. EPA will issue a modification orrevocation ifEPA detennines that the activities proposed therein will notpresent an unreasonable risk ofinjuryto health orthe enviroument and wiII not result in significant or substantial human exposure or substantial environmental release in the absence ofdata sufficient to pennit a reasoned evaluation ofthe health or environmental effects of the SNUN substance. In addition, the Companymaypetition EPA at anytime to make other modifications to the language ofthis Order. EPA wiII issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.35 VII. EFFECT OF CONSENT ORDER By consenting to the entry ofthis Order, the Company waives its rights to file objections to this Orderpursuant to section 5(e)(1)(C) ofTSCA, to receive service ofthis Order no later than 45 days before the end ofthe reviewperiodpursuant to section 5( e)(1)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound byits terms, do not constitute an admissionbythe Company as to, the facts
or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any otherrights that the Companymayhave



# ...

. s, Director

. al Control Division ce ofPollution Prevention and Toxics

Company: Kuraray America, Inc..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 or the Chemical Abstracts Service's rules ofnomenclature, ora name which will clearly identity a chemical substance for the purpose ofconducting a hazard evaluation. "Chemical protective clothing" means items ofclothingthat provide a protective barrier 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 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 anydesignation or identification such as code name, code number, trade name, brand name, 01' generic chemical name used to identitya chemical substance other than 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 temporary household orresidence, during recreation, or for anypersonal use or enjoyment. "Consumerproduct" means a chemical substancethat is directly, or as part ofa mixture, sold or made available to consumers for their use inor around a permanent or temporaryhousehold or residence, in or around a school, orinrecreation. "Container" means anybag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the 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 SNUN 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 identity a chemical substance or a mixture containing that substance.2 "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is under the control of, and used onlyby, the person who transferred it from a labeled container and will onlybe used bythat person within the work shift in whichit is transferred from the labeled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe 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 otherwise used where significant direct contact ofthe bulk chemical substance and the workplace air may occur. "Non-industrial use" means use other than at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "SNUN 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 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 of processing, including the cleauing ofequipment. "Scientificallyinvalid" means any significant departure from the EPA-approved protocol or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency approval that prevents a reasoned evaluation ofthe health or environmental effects ofthe SNUN substance.3 "Scientifically equivocal data" means data which, although developed in apparent confonnitywith the Good Laboratory Practice Standards and EPA-approvedprotocols, are inconclusive, intemaIlyinconsistent, or otherwise insufficient topennit a reasoned evaluation of the potential risk ofirUury to human health orthe environment ofthe SNUN substance. "Sealed container" means a closed container that is physically and chemically suitable for long-tenn containment ofthe SNUN substance, andfrom which there wiIl be no human exposure to, norenvironmental release of, the SNUN substance during transport and storage.

. "Use stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless of physical state or concentration, through all intended operations of industrial, commercial, or consumer use. "Waters ofthe United States" has the meaning set forth in40 CFR 122.2. "Work area" means a room ordefined space in a workplace where the SNUN substance is manufactured, processed, or used and where employees are present. "Workplace" means an establishment at one geographic location containing one ormore work areas.Kuraray America, Inc. Company (Transferor) ATTACHMENTB NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER
S-05-3 SNUNNumber
1. Transfer ofImportation Rights. Effective on , the Company did sell or otherwise transfer to , ("Successor in Interest") the rights and liabilities associated with importation ofthe above-referenced chemical substance, which was the subject ofa Significant NewUse Notice (SNUN) and is governed by a Consent Order issued by the U.S. Environmental Protection Agency (EPA) under the authority of §5( e) ofthe Toxic Substances Control Act (TSCA, 15 U.S.C. §2604(e)).
2. Assumption ofLiability. The Successorin Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe SNUN substance, shall be the responsibility ofthe Successor inInterest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in the United States in accordance with 40 CFR n0.22(a)(3).3

TOXIC SUBSTANCES CONTROL ACT SECTION 5( e) CONSENT ORDER NOTICE OF TRANSFER (continued)

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