.. TSCA NON-CONFIDENTIAL 

BUSINESS INFORMATION 

DOCUMENT DESCRIPTION DOCUMENT CONTROL NUMBER DATE RECEIVED 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY ,~}OJ t \ 

OFFICE OF POLLUTION PREVENTION AND TOXICS ~_.·'/( 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) Premanufacture Notice Number: 

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111111111111111111111111111111111111111111111111111111111111111111111111111 

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s o o 9 0 0 0 0 2 4 0 ) I S 

P07-327 and P07-328 

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__________________ r\J __!.(J1 

Consent Order and Determinations Supporting Consent Order 

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11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms of the Order 

III. Contents of PMN 

IV. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions ofLaw 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

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

Pending Submission and Evaluation oflnformation 

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 ofTransfer of Consent Order 
111 

PREAMBLE 

I. INTRODUCTION 

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

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

Order, regarding premanufacture notices ("PMNs") P07-327 and P07-328 for the chemical 

substances: [ ]- (P07-

327) and [ 

] (P07-328) (the "PMN substances") submitted by [ ] ("the Company"), to take 

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

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

Under § 15 of TSCA, it is unlawful for any person to fail or refuse to comply with any 

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

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

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

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

II. SUMMARY OF TERMS OF THE ORDER 

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

- Submit to EPA certain toxicity testing at least 14 weeks before manufacturing or importing a 

total of 

] kilograms of the PMN substances, combined. 

-Label containers of the PMN substance, P07-327, and provide Material Safety Data Sheets 

(MSDSs) and worker training in accordance with the provisions of the Hazard Communication 

Program section for P07-327; 

- Comply with the Release to Water provisions; and 

-Maintain certain records. 

III. CONTENTS OF PMN 

Confidential Business Information Claims (Bracketed in the Preamble and Order): Company 

name, chemical identity, production volume, import, processing and use information, other 

information. 

Chemical Identity: 

Specific: 

P07-327: [ 

P07-328: [ 

Generic: 

P07-327: Substituted phenol 

P07-328: Substituted phenol 

Use: 

Specific: 

] 
P07-327: [ 

P07-328: [ 

Generic: 

P07-327: Antioxidant 

P07-328: Antioxidant 

v 

Maximum 12-Month Production Volume: P07-327: [ 

kilograms/year. 

] . 

]. 

] kilograms/year; P07-328: [ ] 

Test Data Submitted with PMN: P07-327- Rat acute oral toxicity study OECD 425: LDO = 2.0 

glkg with no toxic signs. 

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. 

Human Health Exposure Summary 

For P07-327 and P07-328, dermal exposure to the PMN substance is estimated to be 

greater than 250 workers for over 100 days per year. 

Environmental Effects Summary: 

Based on Quantitative Structural Activity Relationship ("QSAR") analysis derived from 

test data on structurally similar phenols, EPA expects toxicity to aquatic organisms to occur at a 

concentration of 1 part per billion PMN substance in surface waters for P07-327 (See 

www.epa.gov/oppt/newchems/chemcat.htm). 
VI 

Exposure and Environmental Release Summary: 

P07-327 P07-327 P07-327 P07-327 P08-328 P08-328 

Processing 1 Processing 2 Use 1 Use 2 Processing Use 

[ [ I [ [ I [ [ 

I I 

I 

I 

#of Sites [ ] [ ] [ ] [ ] [ ] [ ] 

Total# of [ ] [ ] [ ] [ ] [ ] [ ] 

Workers 

Exposure [ ] [ ] [ ] [ ] [ ] [ ] 

(days/year) 

Dermal 3100 [ ] 3100 [ ] 52 [ ] 87 [ ] [ ] [ ] 

Exposure 11 [ ] 18 [ ] 

(mg/day) 

Inhalation 1.6 150 N/A Negligble Negilgible Negligible 

Exposure 

(mg/day) 

Release to None None None None None Negligible 

Water 

(kg/day) 

Surface Not N/A NIA N/A NIA NIA 

Water applicable 

Concen- (N/A) 

tration 

Days N/A N/A N/A NIA N/A NIA 

Exceeding 

Concern 

Level 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 
Vll 

(a) EPA is unable to determine the potential for human health effects from exposure of humans 

to P07-327 and P07-328 and EPA is also unable to determine the potential for environmental 

toxicity from exposure of aquatic organisms to P07 -327. EPA therefore concludes, pursuant to § 

5(e)(l)(A)(i) ofTSCA, that the information available to the Agency is insufficient to permit a 

reasoned evaluation of the human health and environmental effects of the PMN substances. 

(b) In light of the potential risk of aquatic toxicity posed by the uncontrolled manufacture, 

import, processing, distribution in commerce, use, and disposal ofthe P07-327, 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 the environment. 

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

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

will be produced in substantial quantities and there may be significant (or substantial) human 

exposure to the substances. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 

ENVIRONMENTAL EFFECTS 

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

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

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

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

following effects which may be caused by the PMN substance P07-327: 

Algal toxicity, Tiers I and II (OPPTS 850.5400) 

Fish early-life stage toxicity test (rainbow trout) (OPPTS 850.1400) 

Daphnid chronic toxicity test (OPPTS 850.1300) 

The Order does not require submission of the above pended testing on P07-327 at any specified 

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

processing, distribution in commerce, use, and disposal of the P07-327 will remain in effect until 

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

information. 
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 ofthe chemical substances P07-327: [ 

] and 

P07-328: [ 

("the PMN substances") in the United States by [ ]("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 
2 

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

recordkeeping as required in the Recordkeeping section of this Order. 

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

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

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

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

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

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

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

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

reconcentrated above the 1.0 or 0.1 percent level, whichever applies. 

(3) Export Only. 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 40 CFR 720.3(s). However, once the Company begins to 

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

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

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

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

U.S. territory, even those quantities or batches of the PMN substance that are destined for export 
3 

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

Testing section ofthis Order. 

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

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

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

720.3(cc), and 40 CFR 720.36. 

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

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

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

(6) 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 in 40 CFR 

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

it is a part. 

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

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

("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 ofthis Consent Order. 
4 

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

PROHIBITION 

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

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

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

evaluation of the 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, which is required to be reported under EPA's section 8(e) policy statement at 

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

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

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

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

reporting guide referenced at 56 Federal Register 28458 (June 20, 1991 ). 
5 

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

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

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

of the following information within 1 0 days of scheduling any study required to be performed 

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

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

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

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

EPA may contact regarding the study; and 

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

the substance is subject to this Consent Order. 

(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be 

performed pursuant to this Order must be conducted according to TSCA Good Laboratory 

Practice Standards at 40 CFR Part 792 and using methodologies generally accepted in the 

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

study, the Company must obtain approval of test protocols from EPA by submitting written 

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

protocols. Published test guidelines specified in paragraph (d) provide general guidance for 

development of test protocols, but are not themselves acceptable protocols. EPA approval of a 

test protocol does not mean pre-acceptance of test results. 
6 

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

importing the PMN substances beyond the following aggregate manufacture and import volumes 

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

P07-327 and submits all final reports and underlying data in accordance with the conditions 

specified in this Testing section. 

Production Limit 

] kilograms 

Study/Guideline 

Mouse lymphoma assay (mammalian cell gene mutation test), in 

vitro (Test Guideline OPPTS 870.5300) 

Repeated Dose 28-day oral toxicity in rodents. Should include a 

neurotoxicity battery as described in OPPTS 870.6200 (Test 

Guildeline OPPTS 870.3050 or OECD 407). 

(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and 

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

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

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

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

limit. The final report shall contain the contents specified in 40 CFR 792.185. Underlying data 

shall be submitted to EPA in accordance with the applicable "Reporting", "Data and Reporting", 

and "Test Report" subparagraphs in the applicable test guidelines. However, for purposes of this 

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

make clear that the submission of such information is mandatory. EPA will require the 

submission of raw data such as slides and laboratory notebooks only if EPA finds, on the basis of 
7 

professional judgment, that an adequate evaluation of the study cannot take place in the absence 

of these items. 

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

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

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

the Company may continue to 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 )(1) and (2). The testing requirements may be modified, as 

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

mutual consent of EPA and the Company. 

(h) EPA Determination oflnvalid Data. 

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

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

by a study are scientifically invalid, the Company is prohibited from further manufacture and 

import of the PMN substance beyond the applicable production limit. 

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

the applicable production limit only if so notified, in writing, by EPA in response to the 

Company's compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii). 
8 

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

and (e)(l) and (2). If there is sufficient time to reconduct the study and submit the report and 

data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph 

(e)(3), the Company shall comply with subparagraph (e)(3). If there is insufficient time for the 

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

shall submit the report and data in triplicate to EPA within a reasonable period of time, all as 

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

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

(ii) The Company may, within 4 weeks of receiving from EPA the notice 

described in subparagraph (h)(l ), submit to EPA a written report refuting EPA's finding. EPA 

will respond to the Company, in writing, within 4 weeks of receiving the Company's report. 

(i) Company Determination of Invalid Data. 

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

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

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

(c) and (e), the Company remains prohibited from further manufacture and import of the PMN 

substance beyond the applicable production limit. 

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

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

the Company or laboratory will cause or have caused development of scientifically invalid data. 
9 

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

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

(i) allow the Company to continue to manufacture and import the PMN substance 

beyond the applicable production limit, or 

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

compliance with paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to conduct or 

reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the 

production limit as required by subparagraph (e)(3), the Company shall comply with 

subparagraph (e)(3). If there is insufficient time for the Company to comply with subparagraph 

( e )(3 ), the Company may exceed the production limit and shall submit the report and data in 

triplicate to EPA within a reasonable period of time, all as specified by EPA in the notice 

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

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

manufacture and import beyond the applicable production limit. 

G) Unreasonable Risk. 

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

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

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

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

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

substance to mitigate exposures to or to better characterize the risks presented by the PMN 
10 

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

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

either: 

(A) within 2 weeks from receipt of the notice described in subparagraph G)(l), the 

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

(B) within 4 weeks from receipt of the notice described in subparagraph (j)(l), the 

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

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

import, process, distribute, use and dispose 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 of EPA's written response, the Company shall comply with any requirements imposed by 

EPA's response or cease all manufacture, import, processing, distribution, use and disposal of the 

PMN substance. 

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

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

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

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

IV. of this Consent Order. 
11 

HAZARD COMMUNICATION PROGRAM 

[The provisions of this section apply only to P07-327] 

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

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

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

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

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

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

communication program, including an existing program established under the Occupational 

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

1910.1200), to comply with this paragraph provided that the existing hazard communication 

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

following: 

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

to a TSCA section 5(e) consent order signed by the Company or to a TSCA section 5(a)(2) 

SNUR at 40 C.F.R. Part 721, subpart E. The list must be maintained in each work area where the 

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

substance required under paragraph (c) of this section. The list may be compiled for the 

workplace or for individual work areas. If the Company is required either by another Order 

issued under section 5(e) ofTSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, 

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

subparagraph. 
12 

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

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

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

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

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

substance while in the Company's workplace. 

(b) Labeling. 

(1) The Company shall ensure that each container of the substance in the workplace is 

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

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

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

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

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

recognized. 

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

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

substance. 

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

identified in paragraph (f) of this section, or by the Company, for the PMN substance. 
13 

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

procedures, or other such written materials in lieu of affixing labels to individual stationary 

process containers, as long as the alternative method identifies the containers to which it is 

applicable and conveys information specified by subparagraph (b)(l)(i) ofthis section. Any 

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

work shift. 

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

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

use of the employee who performs the transfer. 

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

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

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

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

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

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

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

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

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

emergency procedures. 

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

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

Department of Transportation. 
14 

(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 other substance that is either subject to another TSCA 

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

CFR Part 721, subpart E, or defined as a "hazardous chemical" under the Occupational Safety 

and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the 

Company may prescribe on the label, MSDS, or alternative form of warning, the measures to 

control worker exposure or environmental release which the Company determines provide the 

greatest degree of protection. However, should these control measures differ from the applicable 

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

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

subparagraph (b)(5). 

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

hazards of the PMN substance or ways to protect against the hazards, this new information must 

be 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. 
15 

(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 name are claimed confidential, a generic chemical name must be 

used. 

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

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

(iii) The physical hazards of the substance known to the Company, including the 

potential for fire, explosion, and reactivity. 

(iv) The potential human and environmental hazards as specified in paragraph (f) 

of this section. 

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

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

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

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

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

40 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 
16 

measures during repair and maintenance of contaminated equipment, and procedures for response 

to spills and leaks. 

(ix) Any generally applicable control measures which are known to the Company, 

such as appropriate engineering controls, work practices, or personal protective equipment. 

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

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

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

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

appropriate emergency procedures. 

(3) If no relevant information is found or known for any given category on the MSDS, 

the Company must mark the MSDS to indicate that no applicable information was found. 

(4) Where multiple mixtures containing the PMN substance have similar compositions 

(i.e., the chemical ingredients are essentially the same, but the specific composition varies from 

mixture to mixture) and similar hazards, the Company may prepare one MSDS to apply to all of 

these multiple mixtures. 

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

hazards of the PMN substance or ways to protect against the hazards, this new information must 

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

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

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

PMN substance is reintroduced into the workplace. 
17 

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

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

shipment after an MSDS is revised. The Company may either provide the MSDS with the 

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

(7) The Company must maintain a copy of the MSDS in its workplace, and must ensure 

that it is readily accessible during each work shift to employees when they are in their work 

areas. 

(8) The MSDS may be kept in any form, including as operating procedures, and may be 

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

address the potential hazards of a process rather than individual substances. However, in all 

cases, the required information must be provided for the PMN substance and must be readily 

accessible during each work shift to employees when they are in their work areas. 

(9) The MSDS must be printed in English; however, the information may be repeated in 

other languages. 

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

provided with information and training on the PMN substance. This information and training 

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

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

for the first time. 

(1) The information provided to employees under this paragraph shall include: 

(i) The requirements of this section. 
18 

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

existing programs and procedures satisfy the requirements of this section. 

(f) Environmental Hazard and Precautionary Statements for P07-327. The following 

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) Environmental hazard statements. This substance may be: 

(i) toxic to fish. 

(ii) toxic to aquatic organisms. 

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

(i) do not release to water. 

(3) The 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." 

MANUFACTURING 

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

import of the PMN substance by any other person. 

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

promulgation of a final significant new use rule ("SNUR") governing the PMN substance under 

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

Federal Court seeking judicial review of the SNUR. If the Company is so notified, subparagraph 
20 

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

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

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

subparagraph (1) expires in accordance with subparagraph (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. 

DISTRIBUTION 

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

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

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

distribution, to: 

(1) Not further distribute the PMN substance to any other person, including for disposal, 

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

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

in the Hazard Communication Program section of this Order. 

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

Company in the Release to Water section ofthis Order. 

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

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

containers (lab~led in accordance with paragraph (b)(2) ofthe Hazard Communication Program 

section of this Order) provided the following two conditions are met: 
21 

(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 (a). 

(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 (a). 

(c) 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 (a) of this Distribution section or, 

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

significant new use of the PMN substance (as defined in 40 CFR Part 721, Subpart E) without 

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

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

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

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

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 (a) of this Distribution section and will comply with those terms, 
22 

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 (c)(2) 

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

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

engaged in a significant new use of the 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. 

(d) Sunset Following SNUR. (1) Paragraph (a)(l) ofthis Distribution section shall expire 75 

days after promulgation of a final SNUR for the PMN substance under section 5(a)(2) ofTSCA, 

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

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

section shall not expire until EPA notifies the Company in writing that all Federal Court actions 

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

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

this Distribution section expires in accordance with subparagraph (d)(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 
23 

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 ( a)(l ), such notice 

may substitute for the written agreement required in the introductory clause of paragraph (a); so 

that, ifthe Company provides such notice to the persons to whom it distributes the PMN 

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

specified in paragraph (a). 

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, P07-

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

the waters of the United States. 

III. RECORDKEEPING 

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

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

section 11 ofTSCA: 

(1) Exemptions. Records documenting that the PMN substance did in fact qualify for any 

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

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

exemption being claimed by the Company. Any amounts or batches of the PMN substance 
24 

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

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

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

sections 12(a)(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)(4) of this 

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

maintains, for 5 years from the date of their creation, the records required by 40 CFR 720.78(b). 

For any amounts or batches of the PMN substance claimed to be eligible for any other exemption 

described in Section I, Paragraph (b) of this Order, the Company shall keep records 

demonstrating qualification for that exemption as well as the records specified in paragraphs (2) 

and (3) below, but is exempt from the other recordkeeping requirements in this Recordkeeping 

section; 

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

substance and the corresponding dates of manufacture and import; 

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

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

Company directly sells or transfers the PMN substance, the date of each sale or transfer, and the 

quantity of the substance sold or transferred on such date; 

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

use; 

( 5) Records documenting establishment and implementation of the hazard 

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

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

Order; 

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

Program section of this Order; 

(8) Records documenting compliance with any applicable manufacturing, processing, 

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

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

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

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

Order; 

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

section of this Order, if applicable; and 

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

substance is manufactured of imported. 

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

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

Company's customers. 

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

Part 1320, particularly 5 CFR 1320.5(b ), the Company is not required to respond to this 

"collection of information" unless this Order displays a currently valid control number from the 
26 

Office ofManagement and Budget ("OMB"), and EPA so informs the Company. The 

"collection of information" required in this TSCA §5(e) Consent Orders has been approved 

under currently valid OMB Control Number 2070-0012. 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

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

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

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

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

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

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

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

subsequent 12 months; 

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

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

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

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

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

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

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

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

or conducting an inspection for that purpose. 
27 

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

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

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

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

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

answers to all ofEPA's requests. 

(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the 

Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with § 14 of 

TSCA and 40 CFR Part 2. 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

(a) Scope. This section sets forth the procedures by which the Company's rights and obligations 

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

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

Company (the "Successor in Interest"). 

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

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

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

the PMN substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest 
28 

must submit a new PMN to EPA and comply fully with Section 5(a)(l) ofTSCA 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 

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). 

(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 
29 

Order and the "Notice of Transfer" document which is incorporated by reference as Attachment 

C to this Order. 

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

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

U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania 

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

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

Successor in Interest at its principal place ofbusiness, and at all sites where the PMN substance 

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

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

contain provisions which expressly transfer liability for the PMN substance under the terms of 

this Order from the Company to the Successor in Interest. 

(e) Liability. 

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

the effective date 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, 
30 

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

Order. 

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

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

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

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

Successor in Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

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

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

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

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

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

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

information available at the time the Agency makes that determination, including, where 

appropriate, any reassessment of the test data or other information that supports the findings in 

this Order, an examination of new test data or other information or analysis, and any other 

relevant information. 

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

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

will not result in significant or substantial human exposure or substantial environmental release 
31 

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 if EPA determines that the 

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

issued. 
32 

VII. EFFECT OF CONSENT ORDER 

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

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

than 45 days before the end of the review period pursuant to section 5(e)(l)(B) ofTSCA, and to 

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

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

to the facts or conclusions underlying the Agency's determinations in this proceeding. This 

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

Date 

Date 

Jim Willis, Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 

Name: 

Title: 

Company: 
ATTACHMENT A 

DEFINITIONS 

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

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

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

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

clearly 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 labelled 

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 

mr 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-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. 
3 

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

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

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

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

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

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

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

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

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

industrial, commercial, or consumer use. 

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

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

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

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

work areas. 
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

PMNNumber 

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

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

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

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

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

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

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

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

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

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

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

720.22(a)(3). 

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

reasserts, 

_ relinquishes, or 

modifies 

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

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

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

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

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

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

eligible for confidential treatment under this Notice of Transfer. 
2 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

Company (Transferor) 

Signature of Authorized Official 

NOTICE OF TRANSFER 

(continued) 

PMNNumber 

Date 

Printed N arne 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 
TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone