FUJ=f=ILM 

FUJIFILM Hunt Chemicals U.S.A., Inc. 

411 Manufacturer's Road 

Dayton, TN 37321 

423-775-2281 

Via Federal Express 

June 9, 2010 

Ms. Virginia Lee 

US Environmental Protection Agency 

Office ofPollution Prevention and Toxics 

EPA East Building, Room 4133G 

1201 Constitution Ave., NW 

Washington, DC 20004 

RE: Submittal of 5( e) Consent Order for PMN- 09-636 

Dear Ms. Lee, 

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Enclosed is the signed consent order for PMN 09-636. It has been a pleasure to work 

with you over the past nine months to resolve this matter. If the Agency has any 

questions or requires additional information please contact me at 423-775-2281 XI 031 or 

via email at lmcdermott@fujihuntusa.com. Again, thank you for all your assistance with this 

matter. 

Sincerely, 

Lawrence McDermott 

Manager EHS and Quality Processes 

FUJIFILM Hunt Chemicals U.S.A., Inc. 

Dayton, TN 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) Premanufacture Notice Number: 

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FUJIFILM Hunt Chemicals USA, Inc. ) P-09-636 

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Consent Order and Determinations Supporting Consent Order 
11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary ofTerms of the Order 

III. Contents ofPMN 

IV. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions ofLaw 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal 

Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Requests for Pre-Inspection Information 

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 
lll 

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 premanufacture notice ("PMN") P-09-636 for the chemical substance 

Benzenamine, 5-( 1, 1-dimethylethyl)-2-[ (2-ethylhexyl)thio ]-, 4-methylbenzenesulfonate ( 1: 1) 

("the PMN substance") submitted by FUJIFILM Hunt Chemicals USA, Inc. ("the Company"), to 

take effect upon expiration of the PMN review period. The Company submitted the PMN to 

EPA pursuant to§ 5(a)(1) ofTSCA and 40 CFR Part 720. 

Under § 15 ofTSCA, it is unlawful 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§ 12(b) export notice requirement. 

II. SUMMARY OF TERMS OF THE ORDER 

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

(a) submit to EPA certain toxicity testing at least 14 weeks before manufacturing or importing a 

total of 15,000 kilograms of the PMN substance for the first tier of testing, 170,000 kilograms of 

the PMN substance for the second tier of testing, and 496,000 kilograms of the PMN substance 

for the third tier of testing; 
IV 

(b) label containers of the PMN substance and provide Material Safety Data Sheets ("MSDSs") 

and worker training in accordance with the provisions of the Hazard Communication Program 

section; 

(c) not use the PMN substance other than as a site-limited intermediate; 

(d) distribute the PMN substance only to a person who agrees to follow the same restrictions 

(except the testing requirements) and to not further distribute the PMN substance until it has 

been completely reacted; 

(e) comply with the Release to Water provisions; and, 

(f) maintain certain records. 

III. CONTENTS OF PMN 

By signing this Order, the Company represents that it has carefully reviewed this document and 

agrees that all information herein that is claimed as confidential by the Company is correctly 

identified within brackets and that any information that is not bracketed is not claimed as 

confidential. To make this document available for public viewing, EPA will remove only the 

information contained within the brackets. 

Confidential Business Information Claims (Bracketed in the Preamble and Order): none 

Chemical Identity: Benzenamine, 5-(1, 1-dimethylethyl)-2-[ (2-ethylhexyl)thio ]-, 4-

methylbenzenesulfonate ( 1: 1) 

Use: isolation of intermediate in the production of substance P-03-840 

Maximum 12-Month Production Volume: 107,800 kilograms/year 

Test Data Submitted with PMN: physical and chemical properties, acute oral toxicity, acute 

dermal irritation/corrosion, skin sensitization Kligman maximization, acute eye 

irritation/corrosion, and AMES mutagenicity 
v 

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK 

The following are EPA's predictions regarding the probable human and environmental 

toxicity, human exposure and environmental release of the PMN substance, and its cation's 

persistence, bioaccumulation, and toxicity (PBT) qualities, based on the information currently 

available to the Agency. 

PBT Summary: 

Generally, PBT chemical substances are chemical substances that partition to water, sediment or 

soil and are not removed at rates adequate to pr~vent their bioaccumulation in aquatic or 

terrestrial species, with the potential to pose a risk via food chain toxicity. The PMN substance's 

cation is estimated to persist in the environment more than two months, to have a 

bioaccumulation factor greater than or equal to 5000, and to cause chronic risk to the 

environment and human health. See the category: Persistent, Bioaccumulative, and Toxic (PBT) 

Chemicals at www.epa.gov/oppt/newchems/pubs/chemcat.htm 

Human Health Effects Summary: 

Absorption: Low absorption from the lung and gastrointestinal tract 

Toxicological Endpoints of Concern: Blood toxicity, mutagenicity, developmental toxicity, 

marginal oncogenicity, and irritation to mucous membranes and eyes 

Basis: analogy to some anilines and submitted test data on the PMN substance 

Environmental Effects Summary: 

The environmental risk determination is based on Structural Activity Relationship (SAR) 

analysis derived from test data on structurally similar aromatic amines. (See 

www.epa.gov/oppt/newchems/tools/ecosartechfinal.pdf.) Based on this SAR analysis, EPA 
VI 

expects toxicity to aquatic organisms to occur at a concentration of 1.0 part per billion (ppb) 

PMN substance in surface waters. 

Exposure and Environmental Release Summary: 

As stated in the amended PMN, water releases are not expected. However, release of the PMN 

substance to the air during the manufacturing and use scenario is expected to yield inhalation 

exposures to the general public measuring 0.18 mg/kg/day. 

Risk to Workers and the General Public: 

Potential risks to human health were determined to be significant due to possible PBT 

characteristics of the cation. However, risk to workers and the general public is mitigated when 

the substance is used as a site-limited intermediate because significant inhalation and ingestion 

exposures are not expected. 

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 the PMN substance, including its cation, to act 

as a persistent, bioaccumulative, and toxic chemical, which includes its aquatic toxicity and 

human health effects, such as blood toxicity, mutagenicity, developmental toxicity, and 

oncogenicity, from exposure ofhumans and aquatic organisms to the PMN substance. EPA 

therefore concludes, pursuant to§ 5(e)(1)(A)(i) ofTSCA, that the information available to the 

Agency is insufficient to permit a reasoned evaluation of the human health and environmental 

effects of the PMN substance. 
Vll 

(b) In light of the potential risk of persistence, bioaccumulation, aquatic toxicity and human 

health effects posed by the uncontrolled manufacture, import, processing, distribution in 

commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 

5(e)(l)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, processing, distribution in 

commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to 

human health and the environment. 

(c) In light of the estimated production volume of, and human exposure to the PMN substance, 

EPA has further concluded, pursuant to§ 5(e)(l)(A)(ii)(II) ofTSCA, that the PMN substance 

will be produced in substantial quantities and may reasonably be anticipated to enter the 

environment in substantial quantities, and there may be significant (or substantial) human 

exposure to·the substance. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 

ENVIRONMENTAL EFFECTS 

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

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

of this Order in accordance with the conditions specified in the Testing section. 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

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 Benzenamine, 5-(1, 1-

dimethylethyl)-2-[(2-ethylhexyl)thio ]-, 4-methylbenzenesulfonate (1: 1) (P-09-636)("the PMN 

substance") in the United States by FUJIFILM Hunt Chemicals USA, 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 ofthe 

PMN 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. 

Internet Address (URL) • http:/twww.epa.gov 

Racycled/Racyclabla • Printed with Vegetable 01 Based Inks C'n Recycled Paper (Minimum 25% Postconsumer) 
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(1) Completely Reacted (Cured). The requirements of this Order do not apply to quantities 

of the PMN substance after they have been completely reacted (cured). 

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

of the PMN 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 PMN substance is identified as a potential carcinogen in paragraph (f) of the Hazard 

Communication Program section of this Order). This exemption is not available if the Company 

has reason to believe that, during intended activities, the PMN substance in the mixture may be 

reconcentrated above the 1.0 or 0.1 percent level, whichever applies. If this Order contains New 

Chemical Exposure Limits provisions or Release to Water provisions that, respectively, specify a 

NCEL concentration ("TWA") or in-stream concentration ("N") less than the de minimis 

concentration specified here, then this de minimis exemption does not apply to those provisions. 

(3) Export. Until the Company begins commercial manufacture of the PMN substance for 

use in the United States, the requirements of this Order do not apply to manufacture, processing or 

distribution in commerce ofthe PMN substance solely for export in accordance with TSCA §12(a) 

and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to 

manufacture the PMN substance for use in the United States, no further activity by the Company 

involving the PMN substance is exempt as "solely for export" even if some amount of the PMN 

substance is later exported. At that point, the requirements of this Order apply to all activities 

associated with the PMN substance while in the territory of the United States. Prior to leaving 

U.S. territory, even those quantities or batches of the PMN substance that are destined for export 
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are subject to terms of the Order, and count towards any production volume test triggers in the 

Testing section of this Order. 

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

manufacturing, processing, distribution in commerce, use and disposal of the PMN substance in 

small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CPR 

720.3(cc), and 40 CPR 720.36. The requirements of this Order also do not apply to manufacturing, 

processing, distribution in commerce, use and disposal of the PMN substance when manufactured 

solely for non-commercial research and development per 40 CPR 720.30(i) and TSCA §5(i). 

(5) Byproducts. The requirements of this Order do not apply to the PMN substance when 

it is produced, without separate commercial intent, only as a "byproduct" as defined at 40 CPR 

720.3(d) and in compliance with 40 CPR 720.30(g). 

(6) No Separate Commercial Purpose. The requirements ofthis Order do not apply to the 

PMN substance when it is manufactured, pursuant to any of the exemptions in 40 CPR 720.30(h), 

with no commercial purpose separate from the substance, mixture, or article of which it is a part. 

(7) Imported Articles. The requirements of this Order do not apply to the PMN substance 

when it is imported as part of an "article" as defined at 40 CPR 720.3( c) and in compliance with 40 

CPR 720.22(b )(1 ). 

(c) Automatic Sunset. If the Company has obtained for the PMN substance a Test Market 

Exemption ("TME") under TSCA §5(h)(l) and 40 CPR 720.38 or a Low Volume Exemption 

("L VE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)( 4) and 40 CPR 

723.50(c)(l) and (2) respectively, any such exemption is automatically rendered null and void as 

of the effective date of this Consent Order. 
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II. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

PROHIBITION 

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

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

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

of the persistent, bioaccumulative, and human health and environmental effects of the substance, 

and the completion ofEPA's review of, and regulatory action based on, that information, except in 

accordance with the conditions described in this Order. 

TESTING 

(a) Section 8(e) Reporting. Reports of information on the PMN substance which reasonably 

supports the conclusion that the PMN substance presents a substantial risk of injury to health or the 

environment, which is required to be reported under EPA's section 8(e) policy statement at 43 

Federal Register 11110 (March 16, 1978), 68 Federal Register 33129 (June 3, 2003), and 70 

Federal Register 2162 (January 12, 2005), shall reference the appropriate PMN identification 

number for this substance and contain a statement that the substance is subject to this Consent 

Order. Additional information regarding section 8(e) reporting requirements can be found in the 

reporting guide referenced at 56 Federal Register 28458 (June 20, 1991). 
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(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 Pennsylvania Avenue, N.W., Washington, D.C. 20460, of the following 

information within 1 0 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 PMN identification number for each substance and a statement that the 

substance is subject to this Consent Order. 

(c) Good Laboratory Practice Standards and Test Protocols. Each 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 study, the Company 

must obtain approval of test protocols from EPA by submitting written protocols to EPA. 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 test protocols, 

but are not themselves acceptable protocols. EPA approval of a test protocol does not mean preacceptance of test results. 
' ' 

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(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or 

importing the PMN substance beyond the following tiered aggregate manufacture and import 

volumes ("the production limits"), unless the Company conducts the following studies on the PMN 

substance's cation and submits all final reports and underlying data in accordance with the 

conditions specified in this Testing section. 

' ~•• ~' H ~ ~ .. ---~ 

!Tier 1. Production 

1

Limit 

~Study and Guideline 

I 

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15,000 kilograms ILogKow • Liquid chromatography (OPPTS 

830.7570/0ECD 117) or generator column 

(OPPTS 830.7560) method ~ 

Ready biodegradability I. Ready biodegradability (OPPTS 

835.3110/0ECD 301) 6 methods (choose one, 

or an equivalent test): DOC Die-Away, C02 

Evolution, Modified MITI (I), Closed Bottle, 

Modified OECD Screening, Manometric 

Respirometry or Sealed-vessel C02 production 

test (OPPTS 835.3120) 

Results: If the measured log Kow is <4.2 or if the test chemical passes the ready biodegradability 

test (i.e., not persistent in the environment), no further PBT -related testing is required. If the 

measured log Kow is greater than or equal to 4.2 and the chemical does not pass the ready 

biodegradability test, the chemical would require Tier 2 testing. 

~ "" 

Tier 2. Production ~Study and Guideline 

Limit --HO 

170,000 kilograms ~Biodegradability • Shake-flask die-away test (OPPTS 835.3170) 

(cumulative) or an equivalent test. " ' 

B ioaccumulation • Fish bioconcentration test (OPPTS 

850.1730/0ECD 305), or an equivalent test. 

Measured BCF should be based on 1 00 percent 

' active ingredient and measured 

I I concentration(s). 

" 

Results: Ifthe measured biodegradation half-life is >60 days and measured BCF is >1000, Tier 3 

testing will be required. If only one condition is met, releases and exposure are further considered 

to determine if additional testing is required. 
-6-

~ 

/Tier 3. Production ~Study and Guideline 

Limit 

I ~- - ~~ -

1496,000 kilograms Human health toxicity • Combined repeated dose oral toxicity with the 

(cumulative) reproductive/developmental toxicity screening 

test (OECD No. 422) in rats and the mammalian 

erythrocyte micronucleus test (intraperitoneal 

route) (OPPTS Harmonized Test Guideline 

870.5395). Other health testing will be considered 

where appropriate. 

Environmental fate • Sediment/water microcosm biodegradation test 

(OPPTS 835.3180). 

Chronic environmental • Fish early-life stage toxicity test using rainbow 

toxicity trout (OPPTS 850.1400) and 

I 

• Daphnid chronic toxicity test (OPPTS 850.1300). 

• Additional testing to evaluate other biota (e.g., 

avian, sedill1ent dwelling organisms) or other 

effects (e.g., endocrine disrupting potential) will 

be considered where appropriate. 

(e) Test Reports. The Company shall: (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 

information 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 792.185. Underlying data shall be submitted 

to EPA in accordance with the applicable "Reporting," "Data and Reporting," and "Test Report" 

subparagraphs in the applicable test guidelines. However, for purposes of this Consent Order, the 

word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the 

submission of such information is mandatory. EPA will require the submission of raw data such as 

slides and laboratory notebooks only if EPA finds, on the basis of professional judgment, that an 

adequate evaluation of the study cannot take place in the absence of these items. 
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(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 manufacture and import the PMN substance beyond the applicable 

production 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)(l) and (2). The testing requirements may be modified, as 

necessary to permit a reasoned evaluation of the risks presented by the PMN substance, only by 

mutual consent of EPA and the Company. 

(h) EPA Determination of Invalid Data. 

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

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 manufacture and import 

of the PMN substance beyond the applicable production limit. 

(2) The Company may continue to manufacture and import the PMN 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). 

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

and (e)(l) 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), 
- 8-

the Company shall comply with subparagraph (e)(3). Ifthere is insufficient time for the Company 

to comply with subparagraph (e)(3), the Company may exceed the production limit and shall 

submit the report and data in triplicate to EPA within a reasonable period oftime, all as specified 

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

writing, within 6 weeks 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)(l), 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 manufacture and import of the PMN 

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 

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 manufacture and import the PMN substance 

beyond the applicable production limit, or 
- 9-

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

compliance with paragraphs (b), (c), and (e)(l) and (2). lfthere 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). lfthere 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 manufacture and import beyond the 

applicable production limit. 

(j) Unreasonable Risk. 

(1) EPA may notify the Company in writing that EPA finds that the data generated by a 

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

PMN substance and/or cation will or may present an unreasonable risk of injury to human health 

or the environment. EPA's notice may specify that the Company undertake certain actions 

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

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

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

manufacture, import, processing, distribution, use and disposal of the PMN substance, unless 

either: 

(A) within 2 weeks :from receipt of the notice described in subparagraph (j)(1), the 

Company complies with such requirements as EPA's notice specifies; or 
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(B) within 4 weeks from receipt of the notice described in subparagraph (j)(l), the 

Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of 

any additional requirements imposed by EPA. The Company may continue to manufacture, 

import, process, distribute, use and dispose ofthe PMN 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 manufacture, import, processing, distribution, use and disposal of the 

PMN 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. ofthis Consent Order. 

HAZARD COMMUNICATION PROGRAM 

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

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

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

other forms 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 communication 
- 11 -

program, including an existing program established under the OSHA Hazard Communication 

Standard (29 CFR 1910.1200), 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 PMN 

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. If the 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, 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 non-routine 

tasks involving the PMN substance (e.g., cleaning of reactor vessels), and the hazards associated 

with the PMN substance contained in unlabeled pipes in their work area. 

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

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 PMN 

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)( 1 ). 
- 12-

(i) The label shall, at a minimum, contain the following information: 

(I) A statement of the health hazards(s) and precautionary measure(s), if 

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

(II) The identity by which the PMN 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 PMN 

substance. 

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

identified in paragraph (f) ofthis section, or by the Company, for the PMN 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 information specified by subparagraph (b)(l)(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 PMN 

substance is transferred from labeled containers, and which are intended only for the immediate 

use of the employee who performs the transfer. 

(iv) The Company shall not remove or deface an existing label on containers of the 

PMN substance obtained from persons outside the Company unless the container is immediately 

re-labeled with the information specified in subparagraph (b)(l)(i) of this section. 

(2) The Company shall ensure that each container of the substance leaving its workplace 

for distribution in commerce is labeled in accordance with this subparagraph (b )(2). 
- 13-

(i) The label shall, at a minimum, contain the following information: 

(I) The information prescribed in subparagraph (b)(1)(i) of this section. 

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

can provide additional information on the substance for hazard evaluation and any appropriate 

emergency procedures. 

(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 of warning, shall be legible and prominently displayed. 

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

information may be repeated in other languages. 

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

PMN substance in combination with any other substance that is either subject to another TSCA 

section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 

CFR Part 721, subpart E, or defined as a "hazardous chemical" under the OSHA Hazard 

Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS, 

or alternative form of warning, 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 PMN substance or ways to protect against the hazards, this new information must be 
- 14-

added to the label within 3 months from the time the Company becomes aware of the new 

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

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

substance is reintroduced into the workplace. 

(c) Material Safety Data Sheets. 

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

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

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

section, and, if not claimed confidential, the chemical and common name of the PMN substance. 

If the chemical and common names 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 (f) 

of this section. 

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

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

(vi) The primary routes of exposure to the PMN 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 40 
- 15-

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

The MSDS must identify any New Chemical Exposure Limits specified in paragraph (b) of the 

New Chemical Exposure Limit section of this Order and must contain the information specified in 

the graduated respirator table in paragraph (e)(2) of the New Chemical Exposure Limit section. 

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

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) If no 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 PMN 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 PMN substance or ways to protect against the hazards, this new information must be 
- 16-

added to the MSDS within 3 months from the time the Company becomes aware of the new 

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

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

substance is reintroduced into the workplace. 

(6) The Company must ensure that persons receiving the PMN substance from the 

Company are provided an appropriate MSDS with their initial shipment and with the first shipment 

after an MSDS is revised. The 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 form, 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 PMN 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 information may be repeated in 

other languages. 

(d) Employee Information and Training. The Company must ensure that employees are provided 

with information and training on the PMN substance. This information and training must be 

provided at the time of each employee's initial assignment to a work area containing the PMN 

substance and whenever the PMN substance is introduced into the employee's work area for the 

first time. 
- 17-

( 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 PMN 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 PMN substance in or from an employee's work area (such as exposure monitoring conducted 

by the Company, continuous monitoring devices, visual appearance, or odor of the substance when 

being released). 

(ii) The potential human health and environmental hazards of the PMN substance 

as specified in paragraph (f) ofthis section. 

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

from the PMN substance, including specific procedures the Company has implemented to protect 

employees and the environment from exposure to the PMN 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. 

(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 obtaining and using appropriate hazard information. 
- 18 -

(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) ofthis section: 

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

(i) developmental effects. 

(2) Human hazard precautionary statements. When using this substance: 

(i) avoid breathing the substance. 

(iii) avoid ingestion. 

(3) Environmental hazard statements. This substance may be: 

(i) toxic to fish. 

(ii) toxic to aquatic organisms. 

(4) Environmental hazard precautionary statements. Notice to users: 

(i) do not release to water. 

(5) The human and environmental 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." 
- 19-

MANUFACTURING 

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

of the PMN 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 ("SNUR") governing the PMN substance under section 5(a)(2) 

of TSCA 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)(l) 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 PMN substance and 

subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Company shall notify each 

person whom it causes, encourages or suggests to manufacture or import the PMN substance of the 

existence of the SNUR. 

USE 

(a) The Company shall not use the PMN substance other than as a site-limited intermediate. 

DISTRIBUTION 

(a) Export Notice Requirement. No later than the date of distribution, the Company shall notify in 

writing any person to whom it distributes the PMN substance that, due to the issuance of this 

Consent Order under section 5( e) of TSCA, the PMN substance is subject to the export notification 

requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in 

the form in which it appears in this Consent Order, the following information: (1) the PMN 
-20-

number, and (2) either (A) the specific chemical identity of the PMN substance, or (B) ifthe 

specific chemical identity is confidential, the generic chemical identity. 

(b) Distribution Requirements. (i) Except after the PMN has been completely reacted or as 

provided in paragraph (c), the Company shall distribute the PMN 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) Notify in writing any person to whom it distributes the PMN substance that, due to the 

issuance of this Consent Order under section 5(e) ofTSCA, the PMN substance is subject to the 

export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such 

notice shall contain, in the form in which it appears in this Consent Order, the following 

information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN 

substance, or (B) if the specific chemical identity is confidential, the generic chemical identity. 

(2) Not further distribute the PMN substance to any other person, other than for disposal, 

until after the PMN substance has been completely reacted (cured). 

(3) Comply with the same requirements and restrictions, required of the Company in the 

Hazard Communication Program section of this Order. 

(4) Comply with the same environmental release restrictions, required of the Company in 

the Release to Water sections of this Order. 

(5) Not use the PMN substance other than as a site-limited intermediate. 

(ii) Disposal Exemption. Except for the §12(b) export notice requirement in paragraph 

(b )(i)(1) above, the distribution requirements in (b )(i) do not apply when the Company distributes 

the PMN substance for disposal only. 
-21 -

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

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

containers (labeled 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 

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

the written agreement required by paragraph (b). 

(2) Any human exposure or environmental release resulting from opening the sealed 

containers and removing or washing out the PMN substance may occur only while the PMN 

substance is in the possession and control of the Company or a person who has given the Company 

the written agreement required by paragraph (b). 

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

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

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

paragraph (b)(2) expires in accordance with subparagraph (e)(l), has engaged in a significant new 

use ofthe PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a 

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

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

(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 (b) of this 

Distribution section, or has engaged in a significant new use of the PMN substance without 
-22-

submitting a significant new use notice to EPA. 

(2) That, within 15 working days of notifying the recipient of the noncompliance, the 

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

aware ofthe terms of paragraph (b) ofthis Distribution section and will comply with those terms, 

or is aware of the terms of the significant new use rule for the PMN substance and will not engage 

in a significant new use without submitting a significant new use notice to EPA. 

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

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

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

a significant new use ofthe PMN substance without submitting a significant new use notice to 

EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA of 

the failure to comply, and shall resume supplying the PMN substance to that recipient only upon 

written notification from the Agency. 

(e) Sunset Following SNUR. (1) Paragraph (b)(2) of this Distribution section shall expire 75 

days after promulgation of a final SNUR for the PMN 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 (b )(2) 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 affirmed. 

(2) When EPA promulgates a final SNUR for the PMN substance and paragraph (b )(2) of this 

Distribution section expires in accordance with subparagraph (e)(l), the Company shall notify each 

person to whom it distributes the PMN substance of the existence of the SNUR. Such notification 
-23-

must be in writing and must specifically include all limitations contained in the SNUR which are 

defined as significant new uses, and which would invoke significant new use notification to EPA 

for the PMN substance. Such notice must also reference the publication of the SNUR for this 

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

promulgation of a SNUR and expiration of subparagraph (b )(2), such notice may substitute for the 

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

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

is not required to obtain from such persons the written agreement specified in paragraph (b). 

RELEASE TO WATER 

(a) This provision does not supersede or preempt any applicable federal, state, and local laws and 

regulations. (Those other laws may be more stringent than the requirements below.) The 

Company is prohibited from any predictable or purposeful release of the PMN substance, or any 

waste stream from manufacturing, processing, or use containing the PMN substance into the 

waters of the United States. 

III. RECORDKEEPING 

(a) Records. The Company shall maintain the following records until 5 years after the date they 

are created and shall make them available for inspection and copying by EPA in accordance with 

section 11 ofTSCA: 

(1) Exemptions. Records documenting that the PMN 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 
-24-

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

eligible for the export only 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)(l)(B) and 12(b), respectively. Any amounts or batches ofthe PMN 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 720.78(b). For any 

amounts or batches of the PMN 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 for that exemption as well as the records specified in paragraphs (2) and (3) below, 

but is exempt from the other recordkeeping requirements in this Recordkeeping section; 

(2) Records documenting the manufacture and importation volume of the PMN substance 

and the corresponding dates of manufacture and import; 

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

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

directly sells or transfers the PMN 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 manufacture, import, processing, and 

use; 

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

program required by the Hazard Communication Program section of this Order; 
-25-

(6) Copies of labels required under the Hazard Communication Program section of this 

Order; 

(7) Copies of Material Safety Data Sheets required by the Hazard Communication 

Program section of this Order; 

(8) Records documenting compliance with any applicable manufacturing, use, and 

distribution restrictions in the Manufacturing, Use, and Distribution sections of this Order, 

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

(9) Records documenting establishment and implementation of procedures that ensure 

compliance with any applicable water discharge limitation in the Release to Water section of this 

Order; 

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

section of this Order, if applicable; and, 

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

substance is manufactured or imported. 

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

of the Company and its Contract Manufacturer, if applicable, and not to activities of the 

Company's customers. 

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 

1320, particularly 5 CFR 1320.5(b ), the Company is not required to respond to this "collection 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 
-26-

information" required in this TSCA §5(e) Consent Order has been approved under currently valid 

OMB Control Number 2070-0012. 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA's Request for Information. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA 

may occasionally conduct on-site compliance inspections of Company facilities and conveyances 

associated with the PMN substance. To facilitate such inspections, EPA personnel may contact the 

Company in advance to request information pertinent to the scheduling and conduct of such 

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

include, but are not limited to, the following: 

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

subsequent 12 months; 

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

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

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

with the PMN substance and may reasonably be exposed to the PMN substance; 

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

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

(v) Records required by the Recordkeeping section of this Order; and/or, 

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

or conducting an inspection for that purpose. 
-27-

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

period 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 by 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 ofEPA's requests. 

(c) Confidential Business Information. Any Confidential Business Information ("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 PMN 

substance, including the right to manufacture the PMN substance, to another person outside the 

Company (the "Successor in Interest"). 

(b) Relation of Transfer Date to Notice of Commencement ("NOC"). 

(1) Before NOC. If the transfer from the Company to the Successor in Interest is effective 

before EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN 

substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a 

new PMN to EPA and comply fully with Section 5(a)(1) ofTSCA and 40 CFR part 720 before 

commencing manufacture or import of the PMN substance. 
-28-

(2) After NOC. If the transfer from the Company to the Successor in Interest is effective 

after EPA receives a NOC, the Successor in Interest shall comply with the terms of this Order and 

shall not be required to submit a new PMN to EPA. 

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

(1) "Successor in Interest" means a person outside the Company who has acquired the 

Company's full interest in the rights to manufacture the PMN substance, including all ownership 

rights and legal liabilities, through a transfer document signed by the Company, as transferor, and 

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

interest of the Company in the PMN substance, such as a licensee who has acquired a limited 

license to the patent or manufacturing rights associated with the PMN substance. A Successor in 

Interest must be incorporated, licensed, or doing business in the United States in accordance with 

40 CFR 720.22(a)(3) and 40 CFR 720.3(z). 

(2) "Transfer Document" means the legal instrument(s) used to convey the interests in the 

PMN substance, including the right to manufacture the PMN substance, from the Company to the 

Successor in Interest. 

(d) 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" document which is incorporated by reference as Attachment B 

to this Order. 
-29-

(2) Notice to EPA. Within 10 business days of the effective date ofthe 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 ofbusiness, and at all sites where the PMN 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 PMN substance under the terms of this 

Order from the Company to the Successor in Interest. 

(e) Liability. 

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

the effective date ofthe 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. 

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

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

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

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

(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing section 

of this Consent Order requires the Company to submit test data to EPA at a specified production 
-30-

volume ("test trigger"), the aggregate volume of the PMN substance manufactured and imported 

by the Company up to the date of transfer shall count towards the test trigger applicable to the 

Successor in Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Company may petition EPA at any time, based upon new information on the human 

health or environmental effects of, or human exposure to or environmental release of, the PMN 

substance, to modify or revoke substantive provisions of this Order. The exposures and risks 

identified by EPA during its review of the PMN substance and the information EPA determined to 

be necessary to evaluate those exposures and risks are described in the preamble to this Order. 

However, in determining whether to amend or revoke this Order, EPA will consider all relevant 

information available at the time the Agency makes that determination, 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 

information. 

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

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

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

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

the PMN substance and its cation. 

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

language of this Order. EPA will issue such a modification if EPA determines that the 
- 31 -

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

issued. 
-32-

VII. EFFECT OF CONSENT ORDER 

(a) Waiver. By consenting to the entry of this Order, the Company waives its rights to file 

objections to this Order pursuant to section 5(e)(l)(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)(l)(B) ofTSCA, 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 under TSCA. 

(b) CBI Brackets. By signing this Order, the Company represents that it has carefully reviewed 

this document and hereby agrees that all information herein that is claimed as confidential by the 

Company (per section 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) is correctly 

identified within brackets and that any information that is not bracketed is not claimed as 

confidential. To make this document available for public viewing, EPA will remove only the 

information contained within the brackets. 

Date 1 

• 

Jim Wil s, i tor 

Chemic I ntrol Division 

ollution Prevention and Toxics 

Name: ..,-;,...-YA.--y Jf.-eAr,. e.c..c 

Title: .1 ~. 1/1 c.~ ,Orui~ -.-+-

Company: c . ,.., k • 

r~J' rc - ,/,..;,..~ c ""·- •c.JI..I (.,IJ"' r"'t-. 
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 Chemical Abstracts Service's rules of 

nomenclature, or a name which will clearly identify a chemical substance for the purpose of 

conducting a hazard evaluation. 

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

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

trade name, brand name, or generic chemical name used to identify a chemical substance other 

than by its chemical name. 

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

tank, or the like that contains a hazardous chemical. For purposes of this 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 PMN 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 identify a chemical substance or a 

mixture containing that substance. 

"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. 

"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. 

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

mixtures are manufactured, imported, or processed. 
2 

"PMN 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 cleaning 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 PMN 

substance. 

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

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

inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of 

the potential risk of injury to human health or the environment of the PMN substance. 

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

long-term containment of the PMN substance, and from which there will be no human exposure to, 

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

"Use stream" means all reasonably anticipated transfer, flow, or disposal 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 PMN 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. 
Company {Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

PMNNumber 

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

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

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

the subject of a premanufacture notice ("PMN") and is governed by a Consent Order issued by the 

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

720.22(a)(3). 

3. Confidential Business Information. The Successor in Interest hereby: 

reasserts, 

_ relinquishes, or 

modifies 

all Confidential Business Information ("CBI") claims made by the Company, pursuant to Section 

14 ofTSCA and 40 CFR part 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is 

indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is 

indicated, such modification shall be explained in detail in an attachment to this Notice of 

Transfer. Information which has been previously disclosed to the public (e.g., a chemical identity 

that was not claimed as CBI by the original submitter) would not subsequently be eligible for 

confidential treatment under this Notice of Transfer. 
2 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

Company (Transferor) 

Signature of Authorized Official 

NOTICE OF TRANSFER 

(continued) 

PMNNumber 

Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Interest 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Address 

City, State, Zip Code 
3 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone