UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF SIGNIFICANT NEW USES 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) Significant New Use Notice Number: 

) 

) 

) 

) 

) 

Kuraray America, Inc. ) S-05-3 

) 

) 

) 

) CONTAINS NO 

) CSt 

) 

Consent Order and Detenninations Supporting Consent Order 

EPA SANITIZED Page 1 of 52
ii 

TABLE OF CONTENTS 

Preamble 

1. Introducti on 

II. Sunnnary of Tenns of the Order 

ill. Contents of SNUN 

IV. EPA's Assessment of Risk 

V. EPA's Conclusions of Law 

VI. Infonnation Required to Evaluate Human Health Effects 

Consent Order 

I. Scope of Applicability 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 of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Notice of Transfer of Consent Order 

EPA SANITIZED Page 2 of 52
iii 

PREAMBLE 

I. INTRODUCTION 

Under the authority of § 5( e) of the Toxic Substances Control Act ("TSCA") (15 U.S.C. 

2604(e», the Environmental Protection Agency ("EPA" or "the Agency") issues the attached 

Order, regarding Significant New Use Notice C'SNUN") S-05-3 for the chemical substance 1-

Butanol, 3-methoxy-3-methyl-, acetate (the "SNUN substance") submitted by Kuraray America, 

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

submitted the SNUN to EPA pursuant to section 5(a)(1) of TSCA and the Significant New Use 

Rule at 40 CFR Part 721.532. EPA promulgated this SNURpursuant to TSCA § 5 (a)(2) in 

response to premanufacture notice (PMN) P-00-618, which was submitted and subsequently 

commenced (per 40 CFR 720.1 02) by another company. The SNUN S-05-3 described the 

Company's proposed significant new uses as use as an 1) organic solvent of polyurethane plastic 

coating, 2) ingredient in various kinds of paint thinner, 3) organic solvent of polyurethane resin, 

4) ingredient of cleaning agent, especially for commercial use, 5) organic solvent for screen ink, 

and 6) ingredient in airplane paint. 

Under § 15 ofTSCA, it is uulawful for any person to fail or refuse to comply with any 

provision of § 5 or any order issued under § 5. Violators may be subject to various penalties and 

to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure 

pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 of 

TSCA, such as this one, are subject to the § l2(b) export notice requirement. 

EPA SANITIZED Page 3 of 52
iv 

II. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for this SNUN substance requires the Company to: 

(a) Submit to EPA certain toxicity testing at least 14 weeks before importing a total of 1 

million kilograms and 1.5 million kilograms of the SNUN substance; 

(b) Provide its workers personal protective equipment to prevent dermal exposure; 

(c) Label the SNUN substance and provide Material Safety Data Sheets (MSDS) and worker 

training in accordance with the provisions of the Hazard Communication Program 

section; 

(d) Not manufacture the SNUN substance in the United States; 

(e) Not use the substance in consumer products; 

(f) Limit the percent concentration of the 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) 

EPA SANITIZED Page 4 of 52
v 

Specific Uses: 

(l) Organic solvent of polyurethane plastic coating, 50% of production volume, 100% 

industrial use. 

(2) Ingredient of various kinds of paint thinner, 27.5% of production volume, 100% 

industrial use. 

(3) Organic solvent of polyurethane resin, 6.5% of production volume, 100% industrial use. 

(4) Ingredient of cleaning agent, especially for 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 Production Vohune: 200,000 kglyr 

Test Data Submitted with SNUN: Biodegradation data, a health effects summary (Toxicity 

Testing Reports of Environmental 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 of the SNUN substance, based on the information currently available 

to the Agency. 

EPA SANITIZED Page 5 of 52
VI 

Hmnan Health Effects Smnmary: 

Absorption: Skin, 70%; Lung, 100%; GI tract, 100%. 

Toxicological Endpoints of Concern: 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 on previously submitted test data on the SNUN substance and 

on an expected metabolite of the SNUN material 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 of concern, ethylene glycol ethers. 

Test results on the SNUN substance: 

Acute oral study in rats - LD50 = 4.6 g/kg 

Negative in the Ames assay 

Test results on the hydrolysis product of SNUN 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 guinea pigs 

Not a dermal irritant 

Moderate eye irritant 

EPA SANITIZED Page 6 of 52
Vll 

Not a photoirritant or photosensitizer in guinea pigs 

Negative in human skin patch test 

28-day de=al irritation study in rabbits - slight irritant at 100% concentration, not an 

irritant at 50% concentration 

Oral developmental toxicity range-finding study in rats - maternal toxicity at 2000 mglkg; 

developmental toxicity at 1000 mg/kg; l~OEL = 500 mg/kg 

28-dayinhalation study in rats (100,300,500 ppm) - some liver and kidney 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 of concern for the SNUN substance is 900 ppb. 

As described in the SNUN, releases of the substance are not expected to result in surface water 

concentrations exceeding 900 ppb. Therefore, potential risks to the enviroument are expected to 

be low. 

EPA SANITIZED Page 7 of 52
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 of Exposure (MOEs) in all the use scenarios indicate a potential risk 

of systemic 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 calculated based on a NOEL, and MOEs under 1,000 to be of concern when based 

on a LOAEL. 

EPA SANITIZED Page 8 of 52
IX 

Inhalation Risk: The MOEs for inhalation exposure for all the use scenarios indicate a low 

potential for risk associated with inhalation exposure if the concentration of the SNUN substance 

in the final product is 10% or less. Therefore, use of respiratory protection 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 toxicity MOEs that are less than 1,000: 400 (vapor during 

processing); 460 (vapor during automotive OEM); and 850 (mist from wood furniture 

processing). Developmental toxicity MOEs based on the NOEL from the range-finding study for 

the hydrolysis product are 1,500 and greater. Developmental toxicity MOEs based on a LOEL 

for an analog for estimated high-end exposures are slightly higher than those for systemic 

toxicity. The lowest developmental toxicity MOE based on high-end exposure estimates is 460 

(inhalation of vapor during processing). 

Risk to Consumers: 

There is a potential risk of developmental toxicity from inhalation and dermal contact 

during consumer use of the SNUN material, based on potential exposures estimated during the 

review of a 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 of the SNUN substance. Systemic toxicity was not 

evaluated for consumer use because consumer use is expected to be episodic rather than 

continuous. 

EPA SANITIZED Page 9 of 52
x 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the 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) of TSCA, that the information a.vailable to the Agency is insufficient 

to permit a reasoned evaluation of the hill11an health effects of the SNUN substance. 

(b) In light of the potential risk of human health effects (especially systemic and developmental 

toxicity) posed by the uncontrolled manufacture, import, processing, distribution in commerce, 

use, and disposal of the 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 of the SNUN substance may present an unreasonable risk of injury to hill11an health. 

VI. INFORMATION REOUIRED TO EVALUATE HEALTH EFFECTS 

Triggered Testing. The Order prohibits the Company from exceeding a specified 

production volill11e unless the Company submits the information described in the Testing section 

of this Order in accordance with the conditions specified in the Testing section. 

Pending Testing. The following additional information would be required to evaluate the 

following effects which may be caused by the PMN substance: 

Information Effects Guidelines 

2nd Prenatal Developmental Developmental toxicity OPPTS 870.3700 

Toxicity Study conducted on 

another species (not rats) 

EPA SANITIZED Page 10 of 52
Xl 

The Order does not require submission of the above pended testing at any specified time or 

production volume. However, the Order's restrictions on manufacture, import, processing, 

distribution in commerce, use, and disposal of the PMN substance wiII remain in effect until the 

Order is modified or revoked by EPA based on submission of that or other relevant information. 

EPA SANITIZED Page 11 of 52
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 of the chemical substance I-Butanol, 3-methoxy-3-

methyl-, acetate (S-05-3) ("the SNUN substance") in the United States by Kuraray America, Inc. 

("the Company"), except to the extent that those activities are exempted by paragraph (b). 

(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal of the 

SNUN substance is exempt from the requirements of this Order (except the requirements in the 

Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the 

extent that (1) these activities are conducted in full compliance with all applicable requirements 

of the following exemptions, and (2) such compliance is documented by appropriate 

recordkeeping as required in the Recordkeeping section of this Order. 

EPA SANITIZED Page 12 of 52
2 

. (1) Completely Reacted (Cured). The requirements of this Order do not apply to 

quantities of the SNUN substance that have been completely reacted (cured). 

(2) De Minimis Concentrations. The requirements of this Order do not apply to 

quantities of the SNUN substance that are (1) present in the work area only as a mixture and (2) 

at a concentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or 

volume if the SNUN substance is identified as a potential carcinogen in paragraph (f) of the 

Hazard Communication Program section of this Order). TIris exemption is not available if the 

Company has 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 Company begins commercial manufacture or import ofthe SNUN 

substance for use in the United States, the requirements of this 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 Company begins to manufacture or import the SNUN substance for use in the United States, 

no further activity by the Company involving the SNUN substance is exempt as "solely for 

export" even if some amount of the 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 of the United States. Prior to leaving U.S. territory, even those quantities or batches 

of the SNUN substance that are destined for export are subject to terms of the Order, and count 

towards any production volume test triggers in the Testing section of this Order. 

EPA SANITIZED Page 13 of 52
3' 

(4) Research & Development (R&D). The requirements of this Order do not apply to 

manufacturing, processing, distribution in commerce, use and disposal of the 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 of this 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 of this Order do not apply to 

the SNUN substance when it is manufactured, pursuant to any of the exemptions in 40 CPR 

720.30(b), with no commercial purpose separate from the substance, mixture, or article of which 

it is a part. 

( c) Automatic Sunset. Ifthe Company has 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 

of the effective date of this Consent Order. 

EPA SANITIZED Page 14 of 52
4 

ll. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION OF INFORMATION 

PROIDBITION 

The Company is prohibited from manufacturing, importing, processing, distributing in 

commerce, using, or disposing of the SNUN substance in the United States, for any nonexempt 

commercial purpose, pending the development of information necessary for a reasoned 

evaluation of the human health effects of the substance, and the completion ofEP A's review of, 

and regulatory action based on, that information, except in accordance with the conditions 

described in this Order. 

AUTHORIZED USES AND COMPLIANCE WITH SNUR 

This Consent Order authorizes only the significant new uses of the SNUN substance 

expressly identified in this Order and only to the extent permitted and conditioned by this Order. 

The authorized uses are use other than [as described in the PMN], provided that the Company 

complies with all the requirements of this 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 of the SNUN substance; 

(b) Provide its workers personal protective equipment to prevent dermal exposure; 

EPA SANITIZED Page 15 of 52
5 

(c) Label the SNUN substance and provide Material Safety Data Sheets (MSDS) and worker 

training in accordance with the provisions of the Hazard Connnunication Program 

section; 

(d) Not manufacture the SNUN substance in the United States; 

(e) Not use the substance in consumer products; and 

(f) Limit the percent concentration of the SNUN substance to 10% or less in [mal products 

whose uses involve an application method that generates a vapor, mist, or aerosol. 

For any other significant new uses, the Company remains subject to all requirements of the 

SNUR and shall not manufacture, process, use, or distribute the SNUN substance for these 

significant new uses without first submitting another SNUN and complying with all requirements 

of the SNUR. Except as provided in this Consent Order, compliance with this Order does not 

constitute grounds to exempt the Company, per 40 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 of injury 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 regarding 

EPA SANITIZED Page 16 of 52
6 

section 8( e) reporting requirements can be found in the reporting guide referenced at 56 Federal 

Register 28458 (June 20, 1991). 

(b) Notice of Study Scheduling. The Company shall notifY, in writing, the EPA Laboratory Data 

Integrity Branch (2225A), Office of Enforcement and Compliance Assurance, U.S. 

Environmental Protection Agency, 1200 Pennsylvauia Avenue, N.W., Washington, D.C. 20460, 

ofthe following information within 10 days of scheduling any study required to be performed 

pursuant to this Order, or within 15 days after the effective date of this Order, whichever is later: 

(1) The date when the study is scheduled to commence; 

(2) The name and address of the laboratory which will conduct the study; 

(3) The name and telephone number of a person at the Company or the laboratory whom 

EPA may 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 study required 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 Company must obtain approval of test protocols from EPA by submitting written 

protocols. EPA will respond to the Company within 4 weeks of receiving the written protocols. 

Published test guidelines specified in paragraph (d) provide general guidance for development of 

EPA SANITIZED Page 17 of 52
7 

test protocols, but are not themselves acceptable protocols. Approval of the test protocol does 

not mean pre-acceptance of test 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 study in good faith, with due care, and 

in a scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of 

each study; and (3) submit, in triplicate (with an additional sanitized copy, if confidential 

business info=ation is involved), the final report of each study and all underlying data ("the 

report and data") to EPA no later than 14 weeks prior to exceeding the applicable production 

limit. The final report shall contain the contents specified in 40 CFR 792. I 85. 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 of this 

Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to 

make clear that the submission of such info=ation is mandatory. EPA will not require the 

submission of raw data such as slides and laboratory notebooks unless if EPA finds, on the basis 

EPA SANITIZED Page 18 of 52
8 

of professional judgment, that an adequate evaluation of the study canuot take place in the 

absence of these items. 

(f) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) 

of this Testing section if notified in writing by EPA that it is unnecessary to conduct that study. 

(g) Equivocal Data. If EPA finds that the data generated by a study are scientifically equivocal, 

the Company may continue to import theSNUN substance beyond the applicableproduction 

limit. To seek relief from any other restrictions of this Order, the Company may make a second 

attempt to obtain unequivocal data by reconducting the study under the conditions specified in 

paragraphs (b), (c), and (e )(1) and (2). The testing requirements may be modified, as necessary 

to pennit a reasoned evaluation of the risks presented by the SNUN substance, only by mutual 

consent of EPA and the Company. 

(h) EPA Dete=ination of Invalid Data. 

(1) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA's receipt ofa 

test report and data, the Company receives written notice that EPA finds that the data generated 

by a study are scientifically invalid, the Company is prohibited from further import of the SNUN 

substance beyond the applicable production limit. 

(2) The Company may continue to import the SNUN substance beyond the applicable 

production limit only if so notified, in writing, by EPA in response to the Company's compliance 

with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii). 

EPA SANITIZED Page 19 of 52
9 

(i) The Company may reconduct the study in compliance with paragraphs (b), ( c), 

and (e)(1) and (2). If there 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). If there 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 of time, all as 

specified by EPA in the notice described in subparagraph (h)(l ). EPA will respond to the 

Company, in writing, within 6 weeks of receiving the Company's report and data. 

(ii) The Company may, within 4 weeks of receiving 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 of receiving the Company's report. 

(i) Company Determination of Invalid Data. 

(1 )Except as described in subparagraph (i)(2), if the Company becomes aware that 

circumstances clearly beyond the control of the Company or laboratory will prevent, or have 

prevented, development of scientifically valid data under the conditions specified in paragraphs 

(c) and ( e), the Company remains prohibited from further import ofthe SNUN substance beyond 

the applicable production limit. 

(2) The Company may submit to EPA, within 2 weeks of first becoming aware of such 

circumstances, a written statement explaining why circumstances clearly beyond the control of 

the Company or laboratory will cause or have caused development of scientifically invalid data. 

EPA SANITIZED Page 20 of 52
10 

EPA will notifY the Company of its response, in writing, within 4 weeks of receiving the 

Company's report. EPA's written response may either: 

(i) allow the Company to continue to import the SNUN substance beyond the 

applicable production limit, or 

(ii) require the Company to continue to conduct, or to reconduct, the study in 

compliance with paragraphs (b), (c), and (e)(l) and (2). If there 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). If there 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 of time, all as specified by EPA in the notice 

described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks 

of receiving the Company's report and data, as to whether the Company may continue to import 

beyond the applicable production limit. 

(j) Unreasonable Risk. 

(l ) EPA may notifY the Company in writing that EPA finds that the data generated by a 

study are scientifically valid and unequivocal imd indicate that, despite the terms of this Order, 

the SNUN substance will or may present an unreasonable risk of injury to human health or the 

enviromnent. EPA's notice may specifY that the Company undertake certain actions concerning 

further testing, manufacture, import, processing, distribution, use and/or disposal of the SNUN 

substance to mitigate exposures to or to better characterize the risks presented by the SNUN 

EPA SANITIZED Page 21 of 52
11 

substance. Within 2 weeks from receipt of such a notice, the Company must cease all import, 

processing, distribution, use and disposal of the SNUN substance, unless either: 

(2) within 2 weeks from receipt of the notice described in subparagraph (j)(I), the 

Company complies with such requirements as EPA's notice specifies; or 

(3) within 4 weeks from receipt of the 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 by EPA. The Company may continue to import, process, 

distribute, use and dispose of the SNUN substance in accordance with the terms of this Order 

pending EPA's response to the Company's written report. EPA will respond to the Company, in 

writing, within 4 weeks of receiving the Company's report. Within 2 weeks of receipt of EPA's 

written response, the Company shall comply with any requirements imposed by EPA's response 

or cease all import, processing, distribution, use and disposal of the SNUN substance. 

(k) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing 

section, the Company must continue to obey all the terms of this Consent Order until otherwise 

notified in writing by EPA. The Company may, based upon submitted test data or other relevant 

information, petition EPA to modifY or revoke provisions of this Consent Order pursuant to Part 

VI. of this Consent Order. 

EPA SANITIZED Page 22 of 52
12 

PROTECTION IN THE WORKPLACE 

(a) Establishment of Program. During importing, processing, and use of the SNUN substance at 

any site controlled by the Company (including any associated packaging and storage and during 

any cleaning or maintenance of equipment associated with the SNUN substance), the Company 

must establish a program whereby: 

(1) General Dermal Protection. Each person who is reasonably likely to be dermally 

exposed in the work area to the SNUN substance through direct handling of the substance or 

through contact with equipment on which the substance may exist, or because the substance 

becomes airborne in a form listed in subparagraph (a)(5) of this section, is provided with, and is 

required to wear, personal protective equipment that provides a barrier to prevent dermal 

exposure to the substance in the specific work area where it is selected for use. Each such item 

of personal protective equipment must be selected and used in accordance with OSHA dermal 

protection requirements 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) of this section must 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. 

EPA SANITIZED Page 23 of 52
13 

• Silver Shield gloves with a minimum thickness of 2. 7 mils when 

handling paint formulations, where concentration of the SNUN 

substance is 10% or less. 

• Other gloves that satisfy paragraph (a)(3) below. As of the date of 

signature of this Order, glove imperviousness has not been 

demonstrated for formulations containing the SNUN substance in 

combination with cleaning agents and screen inks. 

(3) Demonstration of Imperviousness. The Company is able to demonstrate that each 

item of chemical protective clothing selected, including gloves, provides an impervious barrier to 

prevent dermal exposure during normal and expected duration and conditions of exposure within 

the work area as follows: 

(i) Permeation Testing. Testing the material used to make the chemical protective 

clothing and the construction of the clothing to establish that the protective clothing will be 

impervious for the expected duration and conditions of exposure. The testing must subject the 

chemical protective clothing to the expected conditions of exposure, including the likely 

combinations of chemical substances to which the clothing may be 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 of Protective Clothing materials 

to Permeation by Liquids or Gases." Results shall be recorded as a cumulative permeation rate as 

a function of time, and shaH be documented in accordance with ASTM F739 using the format 

specified in ASTM F 1194-89 "Guide for Documenting the Results of Chemical Permeation 

Testing on Protective Clothing Materials." Gloves may not be used for a time period longer than 

EPA SANITIZED Page 24 of 52
14 

they are actualIy tested and must be replaced at the end of each work shift during which they are 

exposed to the SNUN substance. 

HAZARD COMMUNICATION PROGRAM 

(a) Written Hazard Communication Program. The Company shall develop and implement a 

written hazard communication program for the SNUN substance in each workplace. The written 

program will, at a minimum, describe how the requirements of this section for labels, MSDSs, 

and other fonus of warning material will be satisfied. The Company must make the written 

hazard communication program available, upon request, to all employees, contractor employees, 

and their designated representatives. The Company may rely on an existing hazard 

connnunication program, including an existing program established under the Occupational 

Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 

19 I 0.1200), to comply with this paragraph provided that the existing hazard communication 

program satisfies the requirements of this section. The written program shall include the 

following: 

(1) A list of chemical substances known to be present in the work area which are subject 

to a TSCA section 5(e) consent order signed by the 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 identity provided on the MSDS for the 

substance required under paragraph (c) of this section. The list may be 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, 

EPA SANITIZED Page 25 of 52
15 

subpart E, to maintain a list of substances, the lists shall be combined with the list under this 

subparagraph. 

(2) The methods the Company will use to inform employees of the hazards of nonroutine tasks involving the SNUN substance (e.g., cleaning of reactor vessels), and the hazards 

associated with the SNUN substance contained in unlabeled pipes in their work area. 

(3) The methods the Company will use to inform contractors of the presence ofthe 

SNUN substance in the Company's workplace and of the provisions of this Order if employees of 

the contractor work in the Company's workplace and are reasonably likely to be exposed to the 

SNUN substance while in the Company's workplace. 

(b) Labeling. 

(1) The Company shall ensure that each container of the 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) and precautionary measure(s), if 

any, identified in paragraph (f) of this section or by the Company, for the SNUN substance. 

(II) The identity by which the SNUN substance may be commonly 

recognized. 

(III) A statement of the environmental hazard(s) and precautionary 

measure( s), if any, identified in paragraph (f) of this section, or by the Company, for the SNUN 

substance. 

EPA SANITIZED Page 26 of 52
16 

(N) A statement of exposure and precautionary measure(s), if any, 

identified in paragraph (f) of this section, or by the Company, for the SNUN substance. 

(ii) The Company may use signs, placards, process sheets, batch tickets, operating 

procedures, or other such written materials in lieu of affixing 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) of this section. Any 

written materials must be readily accessible to the employees in their work areas throughout each 

work shift. 

(iii) The Company need 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 Company unless the container is 

immediately re-Iabeled with the info=ation specified in subparagraph (b)(1 )(i) of this 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=ation prescribed in subparagraph (b)(1)(i) of this section. 

(11) The name and address of the manufacturer or a responsible party who 

can provide additional info=ation on the substance for hazard evaluation and any appropriate 

emergency procedures. 

EPA SANITIZED Page 27 of 52
17 

(ii) The label shall not conflict with the requirements of the Hazardous Materials 

Transportation Act (18 U.S.C. 1801 et. seq.) and regulations issued under that Act by the 

Department of Transportation. 

(3) The label, or alternative forms ofwaming, shall be legible and prominently displayed. 

(4) The label, or alternative forms ofwaming, shall be printed in English; however, the 

information may be repeated in other languages. 

(5) If the label or alternative form ofwaming is to be applied to a mixture containing the 

SNUN 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 

Company may prescribe 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 of protection. However, should these control measures differ from the applicable 

measures required under this Order, the Company must seek a determination of equivalency for 

such alternative control measures pursuant to 40 CFR 721.30 before prescribing them under this 

subparagraph (b)( 5). 

(6) If the Company becomes aware of any significant new information regarding the 

hazards of the 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 Company becomes aware of the new 

information. If the SNUN substance is not being manufactured, imported, processed, or used in 

EPA SANITIZED Page 28 of 52
18 

the Company's workplace, the Company must add the new information to the label before the 

SNUN substance is reintroduced into the workplace. 

(c) Material Safety Data Sheets. 

(1) The Company must obtain or develop an MSDS for the SNUN substance. 

(2) The MSDS shall contain, at a minimum, the following information: 

(i) The identity used on the container label of the SNUN substance under this 

section, and, ifnot claimed confidential, the chemical and common name of the SNUN 

substance. If the chemical and common name are claimed confidential, a generic chemical name 

must be used. 

(ii) Physical and chemical characteristics of the substance known to the 

Company, (e.g., vapor pressure, flash point). 

(iii) The physical hazards of the 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) 

of this section. 

(v) Signs and symptoms of exposure, and any medical conditions which are 

expected to be aggravated by exposure to the SNUN substance known to the Company. 

(vi) The primary routes of exposure to the SNUN substance. 

(vii) Precautionary measures to control worker exposure and/or environmental 

release required by this Order, or alternative control measures which EPA has determined under 

EPA SANITIZED Page 29 of 52
19 

40 CFR 721.30 provide substantially the same degree of protection as the identified control 

measures. 

(viii) Any generally applicable precautions for safe handling and use of the 

SNUN substance which are known to the Company, including appropriate hygienic practices, 

protective measures during repair and maintenance of contaminated equipment, and procedures 

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, or personal protective equipment. 

(x) Emergency first aid procedures known to the Company. 

(xi) The date of preparation of the MSDS or of its last revision. 

(xii) The name, address, and telephone number of the Company or another 

responsible party who can provide additional information on the chemical substance and any 

appropriate emergency procedures. 

(3) Ifno relevant 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 may prepare one MSDS to apply to all of 

these multiple mixtures. 

(5) If the Company becomes aware of any significant new information regarding the 

hazards of the 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 Company becomes aware of the new 

EPA SANITIZED Page 30 of 52
20 

infonnatiol}. lithe SNUN substanceisnot being manufactured, 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 Company must 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 Company may either provide the MSDS with the 

shipped containers or send it to the person prior to or at the time of shipment. 

(7) The Company must maintain a copy of the 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 may be kept in any fonn, including as operating procedures, and may be 

designed to cover groups of substances in a work area where it may be more appropriate to 

address the potential hazards of a 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 in English; however, the infonnation may be repeated in 

other languages. 

(d) Employee Infonnation 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 of each employee's initial assignment to a work area containing the 

EPA SANITIZED Page 31 of 52
21 

SNUN substance and whenever the SNUN 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 of this section. 

(ii) Any operations in the work area where the SNUN substance is present. 

(iii) The location and availability of the written hazard communication program 

required under paragraph (a) of this section, including the list of substances required by 

subparagraph (a)(l) of this section and MSDSs required by paragraph (c) of this section. 

(2) The training provided to employees shall include: 

(i) Methods and observations that may be used to detect the presence or release 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 of the SNUN 

substance as specified in paragraph (f) ofthis section. 

(iii) The measures employees can take to protect themselves and the environment 

from the SNUN substance, including specific procedures the Company has implemented to 

protect employees and the environment from exposure to the SNUN substance, including 

appropriate work practices, emergency procedures, 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 of protection as the specified control measures. 

EPA SANITIZED Page 32 of 52
22 

(iv) The requirements of the hazard communication program developed by the 

Company under this section, including an explanation of the labeling system and the MSDS 

required by this section and guidance on obtaiuing and using appropriate hazard information. 

(e) Existing Hazard Communication Program. The Company need not take additional actions if 

existing programs and procedures satisfY the requirements of this section. 

(f) Human Health. Environmental Hazard. Exposure. and Precautionary Statements. The 

following human health and environmental hazard and precautionary statements shall appear on 

each label as specified in paragraph (b) and the MSDS as specified in paragraph ( c) of this 

section: 

(1) Human health hazard statements. This substance may cause: 

(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) of this section must be followed by the statement: "See the MSDS for details." 

EPA SANITIZED Page 33 of 52
23 

MANUFACTURING & IMPORTING 

(a)(1) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or 

import of the SNUN substance by any other person. 

(2) Sunset Following SNUR. Subparagraph (a)(1) shall expire 75 days after 

promulgation of a final significant new use rule (HSNURH) governing the SNUN substance under 

section 5(a)(2) ofTSCA unless the Company is notified on or before that day of an action in a 

. Federal Court seeking judicial review of the SNUR. If the Company is so notified, subparagraph 

(a)(1) shall not expire until EPA notifies the Company in writing that all Federal Court actions 

involving the SNUR have been resolved and the validity of the SNUR affirmed. 

(3) 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 each person whom it causes, encourages or suggests to manufacture or import the SNUN 

substance of the 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 consumer products; 

(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%. 

EPA SANITIZED Page 34 of 52
24 

DISTRIBUTION 

(a) Distribution Requirements. Except after the SNUN substance has been completely reacted or 

as provided in paragraph (b), the Company shall distribute the SNUN substance outside the 

Company, other than for disposal, only to a person who has agreed in writing prior to the date of 

distribution, to: 

(1) Comply with the same requirements and restrictions, if any, required of the Company 

in the Protection in the Workplace section of this Order. 

(2) Comply with the same requirements and restrictions, if any, required of the Company 

in the Hazard Communication Program section of this Order. 

(3) Not use the SNUN substance: 

(i) In consumer products; 

(ii) In an application method that generates a vapor, mist, or aerosol when the 

percent concentration of the SNUN substance in the final product exceeds 10%. 

(b) Temporary Transport and Storage. Notwithstanding paragraph (a), the Company may 

distribute the SNUN substance outside the Company for temporary transport and storage in sealed 

containers Qabeled in accordance with paragraph (b )(2) of the Hazard Communication Program 

section of this Order) provided the following two conditions are met: 

(1) Subsequent to any such exempt temporary transport or storage of sealed containers, the 

SNUN substance may be distributed only to the Company or a person who has given the Company 

the written agreement required by paragraph ( a). 

EPA SANITIZED Page 35 of 52
25 

(2) Any human 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 of the Company or a person who has given the Company 

the written agreement required by paragraph (a). 

(c) Recipient Non-Compliance. If, at any time after commencing distribution in commerce of the 

SNUN substance, the Company obtains knowledge that a recipient of the substance has failed to 

comply with any of the conditions specified in paragraph (a) of this Distribution section or, after 

paragraph (a)(1) expires in accordance with subparagraph (d)(1), has engaged in a significant new 

use of the SNUN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a 

significant new use notice to EPA, the Company shaU cease supplying the substance to that 

recipient, unless the Company is able to document each of the foUowing: 

(1) That the Company has, within 5 working days, notified the recipient in writing that the 

recipient has failed to comply with any of the conditions specified in paragraph (a) of this 

Distribution section, or has engaged in a significant new use of the SNUN substance without 

submitting a significant new use notice to EPA. 

(2) That, within 15 working days ofnotif'ying the recipient of the noncompliance, the 

Company received from the recipient, in writing, a statement of assurance that the recipient is 

aware of the terms of paragraph (a) of this Distribution section and will comply with those terms, 

or is aware of the terms of the 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. 

EPA SANITIZED Page 36 of 52
26 

(3) If, after receiving a statement of assurance from a recipient under subparagraph (c )(2) 

of this Distribution section, the Company obtains knowledge that the recipient has failed to comply 

with any of the conditions specified in paragraph (a) of this Distribution section, or has engaged in 

a significant new use of the 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 only upon 

written notification from the Agency. 

(d) Sunset Following SNUR. (1) Paragraph (a)(1) of this Distribution section shall expire 75 days 

after promulgation of a final SNUR for the SNUN substance under section 5(a)(2) ofTSCA unless . , 

the Company is notified on or before that day of an action in a Federal Court seeking judicial 

review of the SNUR. If the Company is so notified, paragraph (a)(1) of this 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 of the 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 

each person to whom it distributes the SNUN substance of the existence of the 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 of the SNUR for 

this SNUN substance in either the Federal Register or the Code of Federal Regulations. After 

promulgation of a SNUR and expiration of subparagraph (a)(l), such notice may substitute for the 

EPA SANITIZED Page 37 of 52
27 

written agreement required in the introductory clause of paragraph (a); so that, if the Company 

provides such notice to the persons to whom it distributes the SNUN substance, then the Company 

is not required to obtain from such persons 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 copying by EPA in accordance with 

section 11 ofTSCA: 

(1) Exemptions. Records documenting that the SNUN substance did in fact qualifY for any 

one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records 

must satisfY all the statutory and regulatory recordkeeping requirements applicable to the 

exemption being claimed by the Company. Any amounts or batches of the SNUN substance 

eligible for the Export exemption in Section I, Paragraph (b )(3) of this Order, are exempt from all 

the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the 

date of their creation, copies of the export label and export notice to EPA, required by TSCA 

sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches of the SNUN substance 

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

are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 

5 years from the date of their creation, the records required by 40 CFR nO.78(b). For any amounts 

or batches of the SNUN substance claimed to be eligible for any other exemption described in 

Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating qualification 

EPA SANITIZED Page 38 of 52
28 

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 importation volume of the SNUN substance and the 

corresponding dates of import; 

(3) Records documenting the names and addresses (including shipment destination 

address, if different) of all persons outside the site of import to whom the Company directly sells or 

transfers the SNUN substance, the date of each sale or transfer, and the quantity of the substance 

sold or transferred on such date; 

(4) Records documenting the address of all sites of import, processing, and use; 

(5) Records documenting establishment and implementation of a program for the use of 

any applicable personal protective equipment required pursuant to the Protection in the Workplace 

section of this Order; 

(6) Records documenting the determinations required by the Protection in the Workplace 

section of this Order that chemical protective clothing is impervious to the SNUN substance; 

(9) Records documenting establishment and implementation of the hazard communication 

program required by the Hazard Communication Program section of this Order; 

(10) Copies oflabels required under the Hazard Communication Program section ofthis 

Order; 

(II) Copies of material safety data sheets required by the Hazard Communication Program 

section of this Order; 

(12) Records documenting compliance with any applicable manufacturing, processing, use, 

and distribution restrictions in the Manufacturing & Importing, Use, and Distribution sections of 

EPA SANITIZED Page 39 of 52
29 

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

Order; 

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

section of this Order, if applicable; and 

(14) The Company shall keep a copy of this Order at each of its sites where the SNUN 

substance is imported. 

(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities of 

the Company and not to activities of the 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 Company is 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 of Company 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 of such 

EPA SANITIZED Page 40 of 52
30 

inspections. Such requests may be written or oral. The types of information that EPA may request 

may include, but are not limited to, the following: 

(i) Expected dates and times when the SNUN substance will be in production within the 

subsequent 12 months; 

(ii) Current workshift schedules for workers who are involved in activities associated with 

the SNUN substance and may reasonably be exposed to the SNUN substance; 

(iii) Current job titles or categories for workers who are involved in activities associated 

with the SNUN substance and mayreasonably be exposed to the SNUN substance; 

(iv) Existing exposure monitoring data for workers who are involved in activities 

associated with the SNUN substance and may reasonably be exposed to the SNUN substance; 

(v) Records required by the Recordkeeping section oftl>is Order; and/or 

(vi) Any other information reasonably related to determining compliance with this Order or 

conducting an inspection for that purpose. 

(b) Company's Response. The Company shall respond to such requests within a reasonable period 

of time, but in no event later than 30 days after receiving EPA's request. When requested in 

writing by EPA, the Company's response shall be in writing. To the extent the information is 

known to or reasonably ascertainable to the Company at the time of the request, the Company's 

response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers 

to all of EPA's requests. 

EPA SANITIZED Page 41 of 52
31 

(c) Confidential Business Infonnation. Any Confidential Business Infonnation (CBI) that the 

Company submits to EPA pursuant 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 by which the Company's rights and obligations 

under this Order may be transferred when the Company transfers its interests in the SNUN 

substance, including the right to import the SNUN substance, to another person outside the 

Company (the "Successor in Interest"). 

(b) Definitions. The following definitions apply to this Successor Liability section of the Order: 

(l) "Successor in Interest" means a person outside the Company who 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 by the Company, as transferor, and the 

Successor in Interest, as transferee. The tenn excludes persons who acquire less than the full 

interest of the Company in 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. 

EPA SANITIZED Page 42 of 52
32 

(c) Notices. 

(1) Notice to Successor in Interest. On or before the effective date of the transfer, the 

Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent Order 

and the "Notice of Transfer" documentwhich is incorporated by reference as Attachment C to this 

Order. 

(2) Notice to EPA. Within 10 business days of the effective date of the transfer, the 

Company shall, by registered mail, submit the fully executed Notice of Transfer document to: U.S. 

Environmental Protection Agency, New Chemicals Branch (7405),1200 Pennsylvania Avenue, 

N.W., Washington, D.C. 20460. 

(3) Transfer Document. Copies of the Transfer Document must be maintained by the 

Successor in Interest at its principal place of business, and at all sites where the SNUN substance is 

manufactured or imported. Copies of the Transfer Document must also be made available for 

inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must 

contain provisions which expressly transfer liability For the SNUN substance under the tenus of 

this Order from the Company to the Successor in Interest. 

(d) Liability. 

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

the effective date of the transfer described above. 

(2) The Successor in Interest shall be liable for compliance with the requirements of this 

Order effective as of the date of transfer. 

EPA SANITIZED Page 43 of 52
33 

(3) Nothing in this section shall be construed to prohibit the Agency from taking 

enforcement action against the Company after the effective date of the transfer for actions taken, or 

omissions made, during the time in which the Company imported, processed, used, distributed in 

commerce, or disposed of the SNUN substance pursuant to the terms of this Consent Order. 

(e) Obligations to Submit Test Data under Consent Order. Ifparagraph (d) of the Testing section 

of this Consent Order requires the Company to submit test data to EPA at a specified production 

volume ("test trigger"), the aggregate volume of the SNUN substance imported by the Company up 

to the date of transfer shall count towards the test trigger applicable to the Successor in Interest. 

EPA SANITIZED Page 44 of 52
34 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Company may petition EPA at any time, based upon new infonnation on the health 

effects of, or human exposure to, the SNUN substance, to modifY or revoke substantive provisions 

of this Order. The exposures and risks identified by EPA during its review of the 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 or revoke this 

Order, EPA will consider all relevant infonnation available at the time the Agency makes that 

detennination, including, where appropriate, any reassessment of the test data or other information 

that supports the findings in this Order, an examination of new test data or other information or 

analysis, and any other relevant infonnation. 

EPA will issue a modification or revocation if EPA detennines that the activities proposed 

therein will not present an unreasonable risk of injury to health or the enviroument and wiII not 

result in significant or substantial human exposure or substantial environmental release in the 

absence of data sufficient to pennit a reasoned evaluation of the health or environmental effects of 

the SNUN substance. 

In addition, the Company may petition EPA at any time to make other modifications to the 

language of this Order. EPA wiII issue such a modification if EPA determines that the 

modification is useful, appropriate, and consistent with the structure and intent of this Order as 

issued. 

EPA SANITIZED Page 45 of 52
35 

VII. EFFECT OF CONSENT ORDER 

By consenting to the entry of this Order, the Company waives its rights to file objections to 

this Order pursuant to section 5(e)(1)(C) ofTSCA, to receive service of this Order no later than 45 

days before the end of the review period pursuant to section 5( e )(1 ) (B) of TSCA, and to challenge 

the validity of this Order in any subsequent action. Consenting to the entry of this Order, and 

agreeing to be bound by its terms, do not constitute an admission by the Company as to, the facts 

or conclusions underlying the Agency's determinations in this proceeding. This waiver does not 

affect any other rights that the Company may have 

... 

. s, Director 

. al Control Division 

ce of Pollution Prevention and Toxics 

Company: Kuraray America, Inc. 

EPA SANITIZED Page 46 of 52
. ATTACHMENT A 

DEFINITIONS 

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

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

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

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

identity a chemical substance for the purpose of conducting a hazard evaluation. 

"Chemical protective clothing" means items of clothing that provide a protective barrier to 

prevent dermal contact with chemical substances of concern. Examples can include, but are not 

limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. 

"Company" means the person or persons subject to this Order. 

. "Commercial use" means the use of a chemical substance or any mixture containing the 

chemical substance in a commercial enterprise providing saleable goods or a service to consumers 

(e.g., a commercial dry cleaning establishment or painting contractor). 

"Common name" means any designation or identification such as code name, code number, 

trade name, brand name, 01' generic chemical name used to identity a chemical substance other than 

by its chemical name. 

"Consumer" means a private individual who uses a chemical substance or any product 

containing the chemical substance in or around a permanent or temporary household or residence, 

during recreation, or for any personal use or enjoyment. 

"Consumer product" means a chemical substance that is directly, or as part of a mixture, 

sold or made available to consumers for their use inor around a permanent or temporary household 

or residence, in or around a school, or in recreation. 

"Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage 

tank, or the like that contains a hazardous chemical. For purposes ofthis section, pipes or piping 

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. of this 

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. 

EPA SANITIZED Page 47 of 52
2 

"Immediate use." A chemical substance is for the "immediate use" of a person if it is under 

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

only be used by that person within the work shift in which it is transferred from the labeled 

container. 

"Impervious." Chemical protective clothing is "impervious" to a chemical substance if the 

substance causes no chemical or mechanical degradation, permeation, or penetration of the 

chemical protective clothing under the conditions of, and the duration of, exposure. 

"Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a 

chemical substance, regardless of physical state or concentration, through all intended operations· 

of manufacture, including the cleaning of equipment. 

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

substance. 

''NIOSH'' means the National Institute for Occupational Safety and Health of the U.S. 

Department of Health and Human Services. 

"Non-enclosed process" means any equipment system (such as an open-top reactor, storage 

tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise 

used where significant direct contact of the bulk chemical substance and the workplace air may 

occur. 

"Non-industrial use" means use other than at a facility where chemical substances or 

mixtures are manufactured, imported, or processed. 

"SNUN substance" means the chemical substance described in the Premanufacture notice 

submitted by the Company relevant to this Order. 

"Personal protective equipment" means any chemical protective clothing or device placed 

on the body to 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 of respirators. Barrier creams are not included in this definition. 

"Process stream" means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

processing, including the cleauing of equipment. 

"Scientifically invalid" means any significant departure from the EPA-approved protocol or 

the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency 

approval that prevents a reasoned evaluation of the health or environmental effects of the SNUN 

substance. 

EPA SANITIZED Page 48 of 52
3 

"Scientifically equivocal data" means data which, although developed in apparent 

confonnity with the Good Laboratory Practice Standards and EPA-approved protocols, are 

inconclusive, intemaIly inconsistent, or otherwise insufficient to pennit a reasoned evaluation of 

the potential risk ofirUury to human health or the environment of the SNUN substance. 

"Sealed container" means a closed container that is physically and chemically suitable for 

long-tenn containment of the SNUN substance, and from which there wiIl be no human exposure 

to, nor environmental release of, the SNUN substance during transport and storage . 

. "Use stream" means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

industrial, commercial, or consumer use. 

"Waters of the United States" has the meaning set forth in 40 CFR 122.2. 

"Work area" means a room or defined space in a workplace where the SNUN substance is 

manufactured, processed, or used and where employees are present. 

"Workplace" means an establishment at one geographic location containing one or more 

work areas. 

EPA SANITIZED Page 49 of 52
Kuraray America, Inc. 

Company (Transferor) 

ATTACHMENTB 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

S-05-3 

SNUNNumber 

1. Transfer of Importation Rights. Effective on , the Company did sell or 

otherwise transfer to , ("Successor in Interest") the rights 

and liabilities associated with importation of the above-referenced chemical substance, which was 

the subject of a Significant New Use Notice (SNUN) and is governed by a Consent Order issued 

by the U.S. Environmental Protection Agency (EPA) under the authority of §5( e) of the Toxic 

Substances Control Act (TSCA, 15 U.S.C. §2604(e)). 

2. Assumption of Liability. The Successor in Interest hereby certifies that, as of the effective date 

of transfer, all actions or omissions governed by the applicable Consent Order limiting 

manufacture, processing, use, distribution in commerce and disposal of the SNUN substance, shall 

be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is 

incorporated, licensed, or doing business in the United States in accordance with 40 CFR 

n0.22(a)(3). 

EPA SANITIZED Page 50 of 52
3 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5( e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone 

EPA SANITIZED Page 51 of 52
EPA SANITIZED Page 52 of 52