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: 

) 

) 

) 

) 

) 

. ) P-12-548 

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) 

) 

) 

) 

Consent Order and Determinations Supporting Consent Order 
TABLE OF CONTENTS 

Preamble 

I. Introduction 

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

Pending Submission and Evaluation ofinformation 

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 
PREAMBLE 

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-12-548 for the chemical substance,-

PMN substance") submitted 

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

the PMN to EPA pursuant to § 5(a)(l) ofTSCA and 40 CPR 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 ofTSCA, 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 before manufacturing or importing a total 

kilograms of the PMN substance; 

(b) submit to EPA any data developed to comply with REACH (Regulation, Evaluation, 

./tuthorization, ru'ld Res1Tiction of Chemicals in the European Union); 

(c) provide personal protective equ.ipr.n_ent to its workers to prevent dermal exposure; 
(d) label containers ofthe PMN substance and provide Material Safety Data Sheets ("MSDSs") 

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

section; 

(e) not manufacture, process, or use the PMN substance other than as 

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

(except the testing requirements); 

(g) 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): Company 

Name, Chemical Identity, Production Volume, Use, and Manufacturing and Processing 

Information. 

Chemical Identity: 

Generic: Aryl-substituted alkane 

Specific: 

Generic: Dielectric Fluid. 
Test Data Submitted with PMN: 

Bacterial gene mutation assay (Ames)- Negative. 

Chromosomal aberration test- Negative. 

Rat inhalation LC50 > 1mg/L but <5 mg/L; 

Skin sensitization in the mouse local lymph node assay (up to 25% active ingredient)- Negative. 

Rat 28-day oral study (analogue) No Observed Effect Level (NOEL)= 50 mg/kg, liver toxicity at 

~250mg/kg; 

Rat 28-day oral study (analogue) NOEL= 15 mg/kg, liver toxicity at ~150 mglkg; 

rat oral combined protocol (OECD 422) NOEL= 30 mg/kg (parental animals), liver toxicity at 

higher doses; reproductive toxicity NOEL= I 00 mg/kg (highest dose tested); developmental 

toxicity NOEL= 10 mg/kg. 

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, based on the 

information currently available to the Agency. 

Persistent, Bioaccumulative, and Toxic Concern: 

EPA identified human health and environmental concerns because the PMN substance may be a 

persistent, bioaccumulative, and toxic (PBT) chemical, based on physical/chemical properties of 

the PJVIN substance, as described in the New Chemicals.Program's PBT category (64 FR 60194, 

November 4, 1999)(FRL-6097-7). EPA estimates that the PMN substance will persist in the 
environment for more than two months and estimates a bioaccumulation factor of greater than or 

equal to 1,000. 

Human Health Effects Summary: 

Absorption: The PMN substance is expected to be absorbed dermally and by inhalation. 

Toxicological Endpoints of Concern: Developmental toxicity and liver toxicity. 

Basis: Submitted test data. 

Environmental Effects Summary: 

Based on EcoSAR analysis for neutral organic chemicals the PMN substance may be toxic to 

aquatic organisms at concentrations as low as 8 ppb. 

See www.epa.gov/opptintr/newcherns/pubs/chemcat.htrn 

Exposure and Environmental Release Summary: 

Manufacture Use 

#Sites 

Workers 

Exposure 

880 880 

Inhalation Exposure 0.027 0.017 
I Drinking Wate~ none <lmg/yr 

none < 1 ppb 

Concentration 

Days Exceeding none none 

Concern Level 

Risk to Workers: There is a potential risk to workers from dermal exposure to the PMN substance 

as these potential exposures result in a margin of exposure of only 33 from the NOEL of 30 

mg!kg/day. 

Risk to General Public and the Environment: Because the PMN substance may be a PBT substance 

with both human health and environmental effects, potential releases of the PMN substance may 

result in risks to the environment and general public. 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 

(a) EPA is tmable to deter-mine the potential for effects from exposure of humans and aquatic 

organisms to the PMN substance. EPA therefore concludes, pursuant to§ 5(e)(l)(A)(i) ofTSCA, 

that L\e inf.•mnation available to the Agency is insufficient to permit a reasoned evaluation of the 

human health and environ1nental effects of the P}.;IN substance. 
(b) In light of the potential risk to human health and the environment 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. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 

ENVIRONMENTAL EFFECTS 

triggered Testing. The Order prohlbits 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. 
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 sulJst:m<:e 

(P-12-548 )("the PMN substance") in the United States 

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

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

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. 

(I) 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 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 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 
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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 

are subject to tenus of the Order, and count towards any production volume test triggers in the 

Testing section of this Order. 

(2) 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 TSCA §5(i) and 40 .CPR 720.30(i). 

(3) Bvvroducts. 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). 

(4) No Separate Commercial Pumose. The requirements of this 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. 

(5) 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 )(l ). 

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

Exemption ("TME") under TSCA §5(h)(l) and 40 CPR 720.38 or a Low Volume Exemption 
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("L VE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)( 4) and 40 CFR 

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

of the effective date of this Consent Order. 

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

PROHffiiTION 

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 human health and 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 substantial risk 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. 
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(b) Notice of Study Scheduling. The Company shall notifY, in writing, the EPA Monitoring 

Assistance and Media Programs Division (2227A), 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 

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 performed to address the 

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

Standards at 40 CPR 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 that 

will use a modified version of a published test guideline, the Company must submit written test 

protocols to EPA for review (submission of written test protocols is optional for tests that are to be 

conducted using unmodified published test guidelines). Protocols must be submitted as a support 

document for the PMN, using the procedures set out in 40 CPR 720.40. EPA will respond to the 

Company within 4 weeks of receiving the written protocols. EPA review of a test protocol does 

not mean pre-acceptance 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 aggregate production volumes ("the 

production limits"), 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. 

a 14-day dermal toxicity test 

a bioaccumulation in sedimentdwelling benthic oligochaetes test 

a sediment and soil adsorption/ 

desorption mobility in soils 

Production Limit Test Guideline 

(OPPTS 870.3200 or 

OECD 410) 

(OECD 315) 

(OPPTS 835.1220) 

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

confidential business information is involved) and all underlying 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 information is mandatory. EPA will require the submission of raw 
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data such as slides and laboratory notebooks only ifEP A finds, on the basis of professional 

judgment, that an adequate evaluation of the study cannot take place in the absence of these ite111s. 

(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) (except that the· stu4y may be submitted after reaching the 

applicable production limit) .. 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 fmds 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). 
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(i) If there is sufficienttime to reconduct the study in compliance with paragraphs 

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

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

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

Company may exceed the producticm 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)(!}. 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)(!), 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 frrst becoming ay.'are 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: 
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(i) allow the Company to continue to manufacture and import 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), and (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 

and import beyond the applicable production limit. 

G) Unreasonable Risk. 

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 will or may present an unreasonable risk of injury to human health or the enviromuent. 

EPA's notice may specify that the Company undertake certain actions concerning further testing, 

manufacture, import, processing, distribution, use and/or disposal ofthe 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 EMN substance, unless either: 
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(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 of the 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, import, process, distribute, use and 

dispose of the 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 

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 t=s 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. 

(l) The Company is required to submit all final reports and the underlying data of any testing 

developed to comply with REACH (Regulation, Evaluation, Authorization, and Restriction of 

Chemicals in the European Union) no later than 90 days after submission of the testing to the 

European Uuion. 
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PROTECTION IN THE WORKPLACE 

(a) Establishment of Program. During manufacturing, processing, and use of the PMN substance 

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

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

must establish a program whereby: 

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

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

through contact with equipment on which the substance may exist, is provided with, and is 

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

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

protective equipment must be selected and used in accordance with Occupational Safety and 

Health Administration ("OSHA") dermal protection requirements at 29 CPR 1910.132, 1910.133, 

and 1910.138. 

(2) Specific Dermal Protective Equipment. The dermal protective equipment required by 

subparagraph (a)(l) of this section must include, but is not limited to, the following item: 

Gloves. 

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

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

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

the work area by any one or a combination of the following: 

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

clothing .and the construction of the clothing to establish thatthe protective .. clothing will be 

impervious for the expected duration and conditions of exposure. The testing must subject the 
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chemical protective clothing to the expected conditions of exposure, including the likely 

combinations of chemical substances to which the clothing may be exposed in the work area. 

Permeation testing shall be conducted according to the American Society for Testing and Materials 

("ASTM") F739 "Standard Test Method for Permeation of Liquids and Gases through Protective 

Clothing Materials under Conditions of Continuous Contact." Results shall be reported as the 

cumulative permeation rate as a function of time, and shall be documented in accordance with 

ASTM F739 using the format specified in ASTM F1194-99(2010) "Standard Guide for 

Documenting the Results of Chemical Permeation Testing of Materials Used in Protective 

Clothing Materials." 'Gloves may not be used for a time period longer than they are actually tested 

and must be replaced at the end of each work shift during which they are exposed to the PMN 

substance. 

(ii) Manufacturer's Specifications. Evaluating the specifications from the 

manufacturer or supplier of the chemical protective clothing, or of the material used in 

construction of the clothing, to establish that the chemical protective clothing will be impervious to 

the PMN substance alone and in likely combination with other chemical substances in the work 

area. 

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- ofwarning.material will be satisfied. The Company must make the written hazard 

communication program available, upon request, to all employees, contractor employees, and their 
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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 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 S(e) consent order signed by the Company or to a TSCA section 5(a)(2) SNUR at 

40 CFR 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 sectimi. 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 S(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. 
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(1) The Company shall ensure that each container of the substance in the workplace is 

labeled in accordance with this subparagraph (b )(1 ). 

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

(A) A statement of the health hazards(s) and precautionary 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 of the enviromnental 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 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 )(1 )(i) of this section. Any written materials 

must be readily accessible to the employees in their work areas throughout each work shift. 

(iii) The Company need not label portable containers into which the 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 

. BMN substance obtained from persons outside the Company unless the container is immediately 

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

(A) The information prescribed in subparagraph (b )(I )(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 of warning, shall be legible and prominently displayed. 

(4) The label, or alternative forms 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 othersubstance 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 defmed as a "hazardous chemical" under the OSHA Hazard 

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

or·a]ternative 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). 
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(6) Ifthe 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, 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 nartles 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. 
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(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 

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 Compa:hy, 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.toprotecLagainsUhe hazards, this new information must be 

added to the MSDS within 3 months from the time the Company becomes aware of the new 
- 17-

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 

· firsUirne •. 

(I) The information provided to employees under this paragraph shall include: 
- 18-

(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) of this 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 .. 
- 19-

(e) De 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 

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 (l) 

New Chemical Exposure Limits provisions that specifY a NCEL concentration less than the de 

minimis concentration specified here, or (2) Release to Water provisions that prohibit release to 

water or specifY in-stream concentration ("N") less than the de minimis concentration specified 

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

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

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

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

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

(i) internal organ effects. 

(ii) developmental effects. 

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

(i) avoid skin contact. 

(ii) use skin protection. 

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

(i) toxic to aquatic organisms. 
-20-

( 4) 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." 

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

existing programs and procedures satisfy the requirements of this section. 

MANUFACTURING 

(a)(!) 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)(!) 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 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 or import the PMN substance of the 

existence of the SNUR. 

(b) The Company shall not manufacture, process, or use the PMN substance other than as a 
- 21 -

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) ofTSCA, the PMN substance is subject to the export notification 

requirements ofTSCA section 12(b) and 40 CPR 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. 

(b) Distribution Requirements. Except 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 of TSCA section 12(b) and 40 CPR 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) Comply with the same requirements and restrictions, if any, required of the Company 

in the Protection in the Workplace section of this Order. 

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

.. in the Hazard Communication Program section of this Order. 

( 4) Not further distribute the PMN substance to any other person, other than for disposal. 
-22-

(5) Not process or use the PMN substance: other than as 

(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 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 

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). 

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

Hazard Communication Program section of this Order. 

(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 

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 CPR Part 721, Subpart E) without subniitting.a 

significant new use notice to EPA, the Company shall cease supplying ii'le substance to that 
-23-

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

(I) 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 

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 of the terms of paragraph (b) of this 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) 

ofthis 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 of the 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. (!) Subparagraph (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 Cmnpanyjs.so .notified, subparagraph (b )(2) of this 

Distribution section shall not expire until EPA notifies the Company in writing that all Federal 
-24-

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

(2) When EPA promulgates a fmal SNUR for the PMN substance and subparagraph (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 

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, if the 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). 

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 

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 are exempt from 

all the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the 
-25-

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) of this Order 

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

5 years from the date oftheir 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 a program for the use of 

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

section of this Order; 

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

section of this Order that chemical protective clothing is impervious to the PMN.·substance; 
-26-

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

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

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

Order; 

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

Program section of this Order; 

(1 0) 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; 

(11) Copies of any Transfer 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 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 CPR Part 

1320, particularly 5 CPR 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 
-27-

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 II 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; 

(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) Currentjob 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 determining compliance with this Order or 

conducting an inspection for that purpose. 
-28-

(b) Company's Response. The Company shall respond to such requests withln 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 of EPA'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.and4G CFRpart 720 before 

commencing manufacture or import of the PMN substance. 
-29-

(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. ' · · · 
- 30-

(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 

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

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

Successor in Interest at its principal place of business, and at all sites where the 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, aiJ.d 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 of the transfer described above. 

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

Order effective as of the date of transfer. 

(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 terms of this Consent Order. 

(f) Obligations to Submit Test Data under Cons.ent 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 
- 31 -

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 environm,ental 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 

:1ppropriate, 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 ifEP A 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. 

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 ifEP A.determines that the 
-32-

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

issued. 
-33-

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 adinission 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. 

fLo Ap?u'J dDJ3 

Date 

Date {f~ol:j 

Maria J. Doa, Ph.D , irector 

Chemical Control Division 

Office of Pollution Prevention and Toxics 
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. 

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

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

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

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

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

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

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

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

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

than by its chemical name. 

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

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

during recreation, or for any personal use or enjoyment. 

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

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

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

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

tank, or the like that contains a hazardous chemical. For purposes 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. · 
2 

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

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

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

container. 

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

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

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

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

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

of manufacture, including the cleaning of equipment 

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

substance. 

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

Department of Health and Human Services. 

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

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

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

occur. 

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

mixtures are manufactured, imported, or processed. 

"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-reviewed protocol or 

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

review that prevents a reasoned evaluation of the health or environrnental.effects of the PMN 

substance. 
3 

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

conformity with the Good Laboratory Practice Standards and EPA-reviewed 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 onegeographic location containing one or more 

work areas. 
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(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 §S(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. 
NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

(continued) 

Company (Transferor) PMNNumber 

Signature of Authorized Official 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 
Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone