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: 

) 

) 

CONTAINS NO ) 

) 

CB · 7)~oly ~ 

) 

) P-13-0568 

) 

) 

) 

) 

) 

Consent Order and Determinations Supporting Consent Order 
ii 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary ofTerms of the Order 

III. Contents ofPMN 

IV. EPA's Assessment of Risk 

V. EPA's Conclusions ofLaw 

VI. Information Required to Evaluate Environmental Effects 

Co€ent rd r "? ,'\ T~ ~ OO 

I. Scope o1i\pp lc bility and Exemptions 

II. Terms of Manufacture, Processing, Distribution in Commerce, Use, and Disposal Pending 

Submission and Evaluation of Information 

III. Reoordkeeping 

IV. Successor Liability Upon Transfer of Consent Order 

V. Modification and Revocation of Consent Order 

VI. Effect of Consent Order 

Attaclunent A - Definitions 

Attachment B - Notice of Transfer of Consent Order 
iii 

PREAMBLE 

I. INTRODUCTION 

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

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

Order, regarding premanufacture notice C'PMN") P-13-0568 for the chemical substance 

("the PMN substance") submitted by ("the 

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

the PMN to EPA pursuant to § 5(a)(l) of TSCA 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 Ol'der issued under§ 5 ofTSCA, such as 

this one, are subject to the§ 12(b) export notice requirement. 

II. SUMMARY OF TERMS OF TH.E ORDER 

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

(a) label the PMN substance and provide Material Safety Data Sheets ("MSDS") and worker 

training in accordance with the provisions ofthe Hazard Communication Program section; 
(b) not use the PMN substance other than as 

applications 

iv 

enhanced oil recovery 

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

to not further distribute the PMN substance until it has been partitioned into oil or petroleum 

streams following use as ] enhanced oil recovery applications; 

(d) comply with the Release to Water provisions; and 

(e) 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 (Bruck~.::ted in the Prcnmhlu nut! Order): 

Chemical identity, Company Name, Production Volume, Uses, Processing information 
v 

Generic: benzenesulfonic acid, dimethyl-, alkyl derivatives, sodium salt 

] enhanced oil recovery applications 

Test Data Submitted with the PMN: 

• Biotic Degradation (Modified Sturm Test) Evaluation, In An Aqueous Medium, of the 

"Ultimate" Biodegradability on an analog 

• Salmonella-E. Coli/Mammalian Microsome Reverse Mutation Assay 

• Determination ofKoc Coefficient Following OBCD Guideline 121 

• FTIR spectrum of the PMN substance 

• Acute Dermal Toxicity Study in Rabbits 

• Skin Sensitization Study in Guinea Pigs 

IV. EPA4

S ASSESSMENT OF RISK 

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

releases of the PMN substance, based on the infonnation currently available to the Agency. 

Environmental Effects Summary: 

Based on test data on the chemical substance itself, EPA identified the following concentrations of 

concern: 

Chronic (20 days of exceedance or greater): 4 part per billion ("ppb") 

Acute (less than 20 days of exceedance): 84 ppb 

Human Health Effects Summary: 
vi 

Absorption is poor from the skin, moderate from the GI tract, and good from the lung (analog). 

Concern for surfactant effects on the lung; corrosion to eye, mucous membranes and lung based on 

surfactant properties of the compounds and analogues. Rabbit dennal study indicated potential for 

skin irritation. 

Environmental Re1ease Summarv: 

During the initial review of the PMN that applied genetic engineering scenarios published by EPA 

relevant to the notified usc, EPA assessed the following releases and exposures of the PMN 

substance. 

#Sites 

Workers 

(#/site) 

Exposure 

(days/year) 

Dermal Exposure 

(mglday) 

Inhalation Exposure 

(mglday) · 

Drinking Water 

Exposure (mg/day) 

Releases 

(days/year) 

Manufacture Processing/Use 

.. 
vii 

Release to Water 

(kg/day) 

- • 

Surface Water Up to. Up to. 

Concentration (ppb) 

Days .Exceeding 1 50 

Concern Level 

As part of this Consent Order, the Company has agreed to limit any predictable or purposeful 

release of the PMN substance, or any waste stream from manufacturin?, processing, and use 

containing the PMN substance, into the waters of the United States that would result in surface 

water concentrations exceeding 4 parts per billion ("ppb"), when calculated using the methods 

described in 40 CFR 721.91. Except for quantities of the PMN substance that have partitioned into 

oil or petroleum streams following use as ] enhanced oil recovery 

applications, the Company shall distribute the PMN substance outside the Company only to a 

person who h~s agreed in writing prior to the date of distribution, to, among other requirements, to 

also abide by this water release trigger and shall maintain such agreements on file for inspection by 

the Agency. 

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 ecological toxicity and enviromnental fate from 

human health and env1ronmental release of the .PMN substance. EPA therefore concludes, 
viii 

pursuant to§ S(e)(l)(A)(i) ofTSCA, that the infonnation available to the Agency is insufficient to 

pennit a reasoned evaluation of the environmental effects of the PMN substance. 

(b) In light of the potential risk of ecological tox.icity and human health posed by the uncontrolled 

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

has concluded, pursuant to§ 5(e)(1){A)(ii)(I) ofTSCA, that uncontrolled manufacture processing, 

distribution in commerce, use, and disposal of the PMN substance may present an unreasonable 

risk of injury to the environment. . 

VI. INFORMATION REQUIRED TO EVALUATE 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 

OFfiCE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

(a) Scope. The requirements of this Order apply to all commercial manufacturing, processing, 

distribution in commerce, use and disposal of the chemical substance 

("the PMN substance") in the United States by the ("the C9mpany"), except to 

the extent that those activities are exempted by paragraph (b). 

(b) Exemptions. Manufacturing, processing, distribution in commerce, usc 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 nll applicable requirements of 

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

required in the Recordkceping section of this Order. 

(1) Export. Until the Company begins commercial manufacture ofthe PMN substance for 

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

Internet Address (URL) • ht1p:llwww epa gov 

Recycled/Recyclable • Printed w11h Vegetable Oil eased Inks on 100% Postc:onsumer. Process Chlorine Froe Recycled Paper 
• 2 

c11stribution ill commerce of the PMN substance solely for export .in accordance with TSCA 

§§ 12(a) and 12(b ), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to 

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

involving the PMN substance is exempt as "solely for exp01i'' even if some amount ofthe 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. tcnitory, even those quantities or batches of the PMN substance that are destined for expolt 

are subject to terms of the Order, and cow1t towards any pTOduction volume test triggers in the 

Testing section of this Order. 

(2) Researcn & 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 re..o;;earch and development in accordance with TSCA §5(h)(3), 40 CFR 

720.3(cc), and 40 CFR 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 TSCA §5(i) and 40 

CFR 720.30(i). 

(3) 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 CFR 

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

(4) No Separate Commercial Purpose. The requirements of this Order do not apply to the 

PMN substance when it is manufactured, pursuant to any of the exemptions in40 CFR 720.30(h), 

with no commercial purpose separate fi:om the substance, mixture, or article of which it is a part. 
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(5) lmported 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 CFR 720.3(c) and in compliance with 40 

CPR 720.22(b)(l). 

(6) Partitioned. The requirements ofthis Order do not apply to quantities of the PMN 

substance that have partitioned into oil or petroleum streams following use as 

- ] enhanced oil recovery applications. 

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

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

("LVE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)(4) and 40 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, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

PROHIBITION 

The Company is prohibited from manufacturing, 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 

environmental effects of the substance, and the completion of EPA's review of, and regulatory 

action based on, that information, except in accordance with the conditions described in this Order. 

TESTING 

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

supports the conclusion that the PMN substance presents a substantial1isk of injury to health or the 

environment and which is required to be reported under TSCA section 8(e) 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 at www.epa.gov/oppt/tsca8e. 

(b) Notice of Study Scheduling. The Company shall notify, in writing, the EPA Monitoring 

Assistance and Media Programs Division (2227 A), 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 10 days of scheduling any study 
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required to be perform~ purs~ant to this Ord~, 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 an~ address of the laboratory which will conduct the study; 

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

may contact regard~g the study; and, 

( 4.) The appropriate PMN identification number· for each substance and a statement that the 

substance i~ subject to this Consent Order. 

(c) Good Laboratory Practice Standards and Test Protocols. Each studyperfonned to address the 

risks identified in this Order must be conducted according to TSCA Good Laboratory Praptice 

Standards at 40 CPR Part 792 and using method9logies generally accepted in the relevant 

.scientific community at the time the study is initiated. Before starting to conduct any study that 

will use a modified version of a puljlished test gui_deline, the CoiQpany tnilst submit written test 

protocols to EPA for review (~ubmission of written test protocols is optional for-tests that are to be 

cond~cted llsing unmodified published test gUidelines). Protocols must be submitted as a support 

. . document for the P~, using ~e procedures set out in 40 CFR 720.40. EPA will_ respond to the . . , . 

Company within 4 weeks of receiving the wri~en proto~ls .. EP.A reViC:W of a te~t protocol do·es 

not mean pre-acceptance oftest'results. 

(d) Triggered Testing Requirements. · The Company is prohibited from manufacturing the PMN 

su~stance at volumes greater 
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the Notice of Commencement (''the production limit"), unless the Company conducts the 

following studies on the PMN substance and submits all final reports and underlying data in 

accordance with the conditions specified in this Testing section. 

Production Limit 

Fish early life stage test 

Daphnid chronic toxicity 

test 

Test Guideline 

OPPTS 850 . .1400 

OPPTS 850.1300 

(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 the firial report of each study (with an additional sanitized copy, if 

confidential business infonnation is involved) and alltmderlying data ("the report and data") to 

EPA prior to exceeding the applicable production limit. The final report and data must be 

submitted as a support document for the PMN, using the procedures set out in 40 CFR 720.40. 

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 infonnation is mandatory. EPA will require. the submission of raw 

data such as slides and laboratory notebooks only ifEPA finds, on the basis of professional 

judgment, that an adequate evaluation of the study cannot take place in the absence of these items. 
- 7 -

(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 manufacturethe 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) (except that the study may be submitted after reaching the applicable 

production limit). The testing requirements may be modified, as necessary to penn it a reasoned 

evaluation ofthc 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 !eceipt of a 

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

a study are scientifically inva1id, the:: Company is prohibited from further manufacture of the PMN 

substance beyond the applicable production limit. 

(2) The Company may continue to manufacture 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) If there is sufficient time to reconduct the study in compliance with paragraphs 

(b), (c), and (e) before exceeding the production limit specified in paragraph (d), the Company 
- s -

may reconduct the study. If there is insufficient time to reconduct the study in compliance with 

paragraphs (b), (c), and (c) before exceeding the production limit specified in paragraph (d), the 

Company may exceed the production limit, but must otherwise comply with paragraphs (b), (c), 

and (e), and shall submit the report and data to EPA within a reasonable period of time, all as 

specified by EPA in the notice described in subparagraph (h)( I). 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 Wl'itten report refuting EPA's finding. EPA will respond 

to the Company~ in writing, within 4 weeks ofreceiving the Company's report. 

(i) Company DetelJllination ofinvalid 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 fi·om further manufacture 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: 
- 9 .. 

(i) allow the Company to continue to manufacture the PMN 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), ~d (e), if there is sufficient time to conduct or reconduct the 

study and submit the report and data to EPA before exceeding the production limit specified in 

paragraph (d). If there is insufficient time for the Company to comply with paragraphs (b), (c), 

and (e) before exceeding the production limit specified in paragraph (d), the Company may exceed 

the production limit, but must otherwise comply with paragraphs (b), (c), and (e), and shall submit 

the report and data 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 

beyond the applicable production limit. 

(j) Unrea~onable Risk. EPA may notify the Company in writing that EPA fmds that the data 

generated by a study are scientifically valid and unequivocal and indicate that, despite the te1ms of 

this Order, the PM:N substance wit! 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, 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, processing, distribution, use and disposal of the PMN substance, unless either: 
~ 10 -

(1) within 2 weeks from receipt of the EPA notice, the Company complies with such requirements 

as the notice specifies; or 

(2) within 4 weeks from receipt ofthe EPA notice, 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, 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 ofEPA's written response, the 

Company shall comply with any requirements imposed by EPA's response or cease all 

manufactw·e, processing, distribution, use and disposal of the PMN substance. 

(k) .Pther 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. 

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 
- 11 -

communication program available, upon request, to all employees, contractor employees, and their 

designated representatives. The Company may rely on an existing hazard communication 

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

Standard (29 CFR 191 0.1200), to comply with this paragraph provided that the existing hazard 

communication program satisfies the requirements oftl1is section. The written program shall 

include the following: 

(I) A list of chemical substance 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 CPR Part 721, subpart E. The list must be maintained in each work area where the PMN 

substance is known to be present and must usc the identity provided on the MSDS for the 

substance required under paragraph (c) of this section. The list may he 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 substance, 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. 
.. 12 -

(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: 

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

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

(B) The identity by which the PMN substance may be commonly 

recognized. 

(C) A statement ofU1e environmental hazard(s) and precautionary 

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

PMN substance. 

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

identified either in paragraph (f) of this 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 af~xing 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 u·ansfer. 
- 13 -

(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 immediat~ly 

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). 

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

(A) The information prescribed in subparagraph (b)(l)(i) of this section. 

(B) 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 ofwa:ming, shall be legible and prominently displayed. 

(4) The label, or alternative fonns of warning, 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 

CPR 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 measw-es to control worker exposure or environmental release 
- 14 -

which the Company detennines 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 

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, 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) Matetial 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, gene1ic chemical names 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. 
- 15 -

(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 conh·ol worker exposure and/or environmental 

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

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

measures duri~g repair and maintenance of contaminated equipment, and procedures for response 

to spills and leaks. 

(ix) Any generally applicable control measures which arc 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 infonn.ation 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> tbQ 

Company must mark the MSDS to indicate that no applicable infonnation was found. 
- 16 -

(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 

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

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

Company's workplace, the Company must add the new infonnation 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 tlle 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 substance in a work area where it may be more appropriate to address 

the potential hazards of a process ra'ther than individual substance. 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 wllen they are in their work areas. 
- 17 -

(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. 

(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 oflhc written hazard communication program 

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

subparagraph (a)(]) 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 (t) of this section. 
- 16 -

(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 fi·om exposw·e to the PMN substance, including appropriate work 

pradices, 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 obtainjng and using appropriate hazard information. 

(e) D~ Minimis Concentrations. The requirements of this Hazard Communication section 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 

)Jas 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. 
- 19 -

(() Hun:tan Health, Envir_onmental.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: 

(l) Environmental hazard statements. These substance may be: 

(i) toxic to fish. 

(ii) toxic to aquatic organisms. 

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

(i) disposal restrictions apply. 

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

(i) skin irritation. 

(ii) serious eye damage. 

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

(i) avoid skin contact. 

(ii) avoid breathing the substance. 

(iii) avoid ingestion. 

(iv) 1.1se skin protection. 

(5) The human health, 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." 
- 20 -

MANUFACTURING 

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

PMN substance by any other person. 

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

of a final significant new use rule ("SNUR") governing 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, 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 affinned. 

(3) Notice of SNUR. When EPA promulgates a final SNUR for the PMN substance and 

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

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

existence of the SNUR. 

(b) The Company shall not manufacture the PMN substance other for use than as 

- ] enhanced oil recovery applications. 

PROCESSING 

(a) The Company shall not process the PMN substance other for use than as 

- enhanced oil recovery applications. 
- 21 -

!}.§I 

(a) The Company shall not usc the PMN substance other than as 

enhanced oil recovery applications. 

DISTRIDUTJOI'j 

(a) Exp.9rt _Notice Requirement. No later than the date of distribution, the Company shall notify in 

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

Consent Order under section 5(c) ofTSCA, the PMN substance is subject to the export notification 

req11ircments ofTSCA section 12(b) and 40 CFR Part 707 Subprut 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 ofthe PMN substance, or (B) if the 

specific chemical identity js confidential, the generic chemical identity. 

(b) Distribution Requirements. (i) Except for quantities of the PMN substance that have 

partitioned into oil or petroleum streams following use as enhanced 

oil recovery applications or as provided in paragraph (c), the Company shall distribute the PMN 

substance outside the Company 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 
- 22 -

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, 

except for quantities of the PMN substance that have partitioned into oil or petroleum streams 

following use as enhanced oil recovery applications. 

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

in the Hazard Communication Program section of this Order. 

(4) Comply with the same environmental release restrictions, if any, required of the 

Company in the Disposal and Release to Water sections of this Order. 

(5) Not use the PMN substance other than as described in the PMN; 

(c) Jem);!Or.M.)' Transport and Storage. Notwithstanding paragraph (b), the Company may 

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

containers" (defined for the purposes of this Order to exclude tank trucks, tractor trailers, train 

cars or other delivery vehicles with attached tanks) provided the following three 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 
- 23 -

Hubst<tnc~ is in the ro11scssion and control of the Comp11ny or a person who h:t<: given the Company 

the written agreement rtXJuired by paragraph (b). 

(3) The sealed containers must be labeled in accordance with paragraph (b)(2) ofthe 

Hazard Communication Program section of this Order. 

(d) Hccipicnt_Non~Compliance. 

(1) It~ at any time afier commencing distribution in commerce of the P.MN substance, 1'11e 

Company obtains knowledge that a recipient or transporter of the substance has failed to comply 

with any of the conditions spt:·cified in paragraph (b) of this Distribution section or, after 

suhp:u·agraph (b )(2) expires in accordance with subparagraph ( e)(l ), has engaged in a significant 

new use of the 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: 

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

rccipie~1t 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 l'MN substance without 

submitting significant new use notices to EPA. 

(b) That, within 15 working days ofnotit)rlltg the recipient ofthe noncompliance, the 

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

aware of the tem1s of paragraph (b) ofthis Distribution section and will comply with those tenns, 

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

in significant new uses without submitting significant new use notices to EPA. 
- 24 -

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

(d)(l)(b) 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 si!,rnificant new uses ofthe PMN substance without submitting a significant new usc 

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. 

(2) If, at any time after commencing distribution in commerce of the PMN 

substance, EPA obtains knowledge (such as through a TSCA Section 11 inspection or subpoena), 

that a recipient of the substance has failed to comply with any of the conditions specified in 

paragraph (b) of the Distribution section or, after subparagraph (b)(2) expires in accordance with 

subparagraph (e)(l), has engaged in a significant new use of the PMN substance (as defmed in 40 

CFR Part 721, Subpart E) without submitting a significant new use notice to EPA, EPA may notify 

the Company in writing tha~, despite the terms of this Order, EPA finds that the distribution in 

commerce ofthe PMN substance will or may present an unreasonable risk of injury to human 

health or the environment. EPA's notice may specify that the Company unde1take certain actions 

concerning further testing, manufacture·, processing, distribution, usc and/or disposal of the PMN 

substance to mitigate exposures 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, 

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

(a) within 2 weeks from receipt of the EPA notice, the Company complies with such requirements 

as the notice specifies; or 
- 25 -

(b) within 4 weeks from receipt ofthe EPA notice, the Comp<my ~ub.mits to EPA a written 

report refuting EPA's finding and/or the appropriateness of any additional actions imposed by 

EPA. The 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 notice or revised response or, cease all 

manufacture, processing, distdbution, use and disposal of the PMN substance. 

(e) Sunset Following SNUR. (1) Subparagraphs (b)(2) and (d)(2) of this Distribution section 

shall expire 75 days after promulgation of a final SNLJRs for the PMN substance under section 

)(a)(2) ofTSCA, unless the Company is notified on or before that day of an action inn Federal 

Court seekingjudicial review of the SNUR. Ifthe Company is so notified, subparagraph (b)(2) 

aud (d)(2) of this Distribution section shall not expire until EPA notifies the Company in writing 

that aJI Federal Court actions involving the SNUR have been resolved and the validity of the 

SNUR affirmed. 

(2) When EPA promulgates a flnal SNUR for the PMN substance and subparagraphs (b )(2) and 

(d)(2) of this Distribution section expires in accordance with subparagraph (e)( I), the Company 

shall notify each person to whom it distributes the PMN substance of the existence ofthe SNURs. 

Such notification must be in writing and must specifically include all limitations contained in the 

SNURs which arc defined as sjgnificant 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 

SNURs for this PMN substance in either the Federal Register or the Code ofFcdcral Regulations. 

After promulgation of SNURs and expiration ofsubparahrraphs (b)(2) and (d)(2), such notices 
- 26 -

may substitute for the written agreements required in the introductory clause of paragraph (b); so 

that, if the Company provides such notices to the persons to whom it distributes the PMN 

substance, then the Company is not required to obtain from such persons the written agreements 

specified in paragraph (b). 

RELEASE TO WATER 

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, and use containing the PMN substance: 

(l)(a) Into the waters of the United States if the quotient from the formula: 

number of kilograms/day/site released 

---------------------------··---------- x 1000 = N parts per billion 

receiving stream flow (million liters/day) 

exceeds 4 parts per billion ("ppb"), when calculated using the methods described in 40 CFR 

721.91. However, 40 CFR 721.9l(a)(4) does not apply. Instead, ifthe waste stream containing 

the PMN substance will be treated using biological treatment (activated sludge or equivalent) plus 

clarification, then the amount ofPMN substance reasonably likely to be removed from the waste 

stream by such treatment may be subtracted in q1lculating the number of kilograms released. No 

more than 90 percent removal efficiency may be attributed to such treatment. 

(b) In lieu of calculating the quotient in subparagraph (l)(a), monitoring or alternative calculations 

may be used to predict the surface water concentration expected to result from the intended release 
- 27 ~ 

of the .'Jubstancc, if the monitoring proc(~dun'!S or calr:ulations have been approved for such pnrpor;c 

by EPA. EPA will review and act on a written request to approve monitoring procedures or 

alternative calculations within 90 days after such a r(,'qUCSt is received. The Agency will infonn 

lhc Company of the disposition of such requests in writing and, where a request is denied, will 

explain the reasons therefore. 

Ill. RECOR'DKF.EPING: 

(a) Recor:~~ The Company shall maintain the following records until 5 years after the date they 

arc 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 

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)(l) of this Order arc exempt fi'om 

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 of the PMN substance 

eligible for the research and development exemption in Section I, Paragraph (b)(2) ofthis Order 

are exempt from all the rcqujrements in this Rccordkeeping section, if the Company maintains, for 

5 years from the date of their creation, the records required by 40 CPR 720. 78(b) . .For any 
- 28 -

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 volume of the PMN substance and the 

corresponding dates of manufacture; 

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

address, if different) of all persons outside the site of manufacture 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 transfen-ed on such date; 

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

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

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

(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, processing, ·use, 

and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections of 

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

Order; 
- 29 -

(9) RGcords documenting compliance with any applicable dispos~l requirements under the 

Disposal section of this Order, including method of disposal, location of disposal sites, dates of 

disposal, and volume ofPMN substance disposed. Where the estimated disposal volume is not 

known to the Company and is not reasonably ascertainable by the Company, the Company must 

maintain other records which demonstrate establishment and implementation of a program U1at 

ensures compliance with any applicable disposal requirements; 

(10) Records documenting establishment and implementation ofprocedures that ensure 

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

Order; 

( 11) Copies of any Trans fer Documents and notices required by the Successor Liability 

section of this Order, if applicable; and, 

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

substance is manufactured. 

(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 

Companys 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 
- 3 0 -

Management and Budget ("OMB"), and EPA so informs the Company. The "collection of 

infonnation" 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 CPR 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: 

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

subsequent 12 months; 

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

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

(3) 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; 

(4) 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; 

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

(6) Any other information reasonably related to detennining compliance with this Order or 

conducting an inspection for that purpose. 
- 31 -

(b) 5;0JnP..!l.!1Y'.s Response. The Company shall respond to such requests within a reasonable 

period of time, but in 110 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 of EPA's requests. 

(c) ~on.tidential Business lnfotmation. 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) .S.9..ope. 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 ofTr!l!lsH"r 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 

st1bstance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit 
- 32 -

new PMN to EPA and comply fully with Section 5(a)(l) of TSCA and 40 CFR part 720 before 

commencing manufacture or import of the PMN substance. 

(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 ;md 

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 transfer documents 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 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 tlie Successor in Interest, by registered mail, a copy of the Consent 
- 33 -

Order and the "Notice ofTrallSfcr" document which is incorporated by reference as Attachment B 

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 Management Branch (7405), 1200 

PeJU1sylvania Avenue, N.W., Washington, D.C. 20460. 

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

Successor in Interest at its pr.incipal place ofbusiness, and at all sites where the PMN substance is 

manufactured. Copies of the Transfer Docmnent must also be made available for inspection 

pursuant to Section J 1 ofTSCA, must state the effective date oftransfer, 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. 

(l) The Company shall be liable for compliance with the requirc1nents of this Order until 

the effective date of the transfer described above. 

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

Order effective as of the date oftransfer. 

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

action against the Company after the effective date of the 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 tetms of this Consent Order. 
- 3.; 

-
- 35 -

VI. M.QPJF~CA OON ANJ.U?.EVQ_!::A T(Q~ OF _C{)j~T~}.!~ . .T ORDJi:~ 

(a) Petition~. 

(1) The Company may petition EPA at any time, based upon -new infom1at.ion on the 

environmental effects or environmental release of the PMN substance, to modify or revoke 

substantive provisions of this Order. 

(2) The exposures and risks identified by EPA during its review of the PMN substance and 

the information EPA determined to be necessruy to evaluate those exposures and risks arc 

described in the preamble to this Order. However, in determining whether to amend or revok~ this 

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

determination, including, where appropriate, any rcns1;essment 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. 

(3) 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 pennit a reasoned evaluation of the health or environmental 

effects of the PMN substance. 

( 4) 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 

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

issued. 
- 36 -

(b) Modification or .Revocation by EPA. Based on study' results describing in the paragraph (d) of 

the Testing Section or if EPA becomes aware of information that the terms ofthe Consent Order 

are not being adherecfto by downstrt'l8lll users as described in paragraph (d)(2) of the Distribution 

Section, EPA may mo.dify or revoke this Consent Order by following procedures set out in these 

paragraphs. 
- 37 -

(a) Waiver. By consentin3 to the cnt1y of this Order, the Company waives its rights to file 

objections to this Order pursuant to section 5(e)(l)(C) of1'SCA, to receive service of this Order no 

later than 45 days before the end of the review period pursuant to section 5(c){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 conch.1sions underlying the Agency's determinations in this proceeding. This waiver 

does not affect any other rights that the Company may have under TSCA. 

(b) Q13.1 Bra9.kcts.!. 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 Patt 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. 

JJ/ lo I'L-l ~- j_ V Date 

JJevucJ_~-- Maria J. Do a: ~D. Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 
ATI'ACJIMENT 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, arc not considered to be 

containers. 

''Contract Manufacturer" means a person, outside the Company, who is authorized to 

manufacture 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. fTOm a labeled container and will 

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

container. 

"Manufacture" means to produce or manufacture in tlhe United States or import into the 

customs territory of the United States. 

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

chemical substance, regard1ess ofphysica1 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. 
2 

".Non··industrial useH means use other than at a facility where chemical substances or 

mixtures are manufactured or processed. 

"P.MN substance" means the chemical substance described in the Prcmanufacture notice 

submitted by the Company relevant to this Order. 

"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-Rpproved 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 cJosed container that is physically and chemically suitable for 

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

nor environmental release of, the l)MN substance during transport and storage. 

"Use stream" means all reasonably anticipated transfer, t1ow, or disposal of a chemical 

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

industtial, commercial, or consumer usc. 

"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 <rreas. 
Company (Transferor) 

A TI ACHMENT B 

NOTICE Of' TRk"fSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

PMNNumber 

1. Transfer ofManuf.f!9ture Rights~ Effective on , the Company did sell or 

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

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

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

U.S. EnvironmentaJ 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 cettifies 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 respons.ibility 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. Confid~@i..~U?.JJ.siness lufonnation. 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. Infonnation 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. 
Company (Transferor) 

2 

TOXIC SUBSTANCES CONTROL ACT 

SECfiON S(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

PMNNurnber 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Autho.rized 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 

S.ECTION S(e) CONSENT ORDER 

NOTICE OF TRANS.FER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone