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UNITED STATES ENVJRONMENTAL PROTECTION AGENCY '' 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMA T10N 

In the matter of: ) ' Premanufacture Notice Number: 

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Consent Order and Determinations Supporting Consent Order 
11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

ll. Summary of Terms of the Order 

Ill. Contents of PMN 

IV. EPA's Assessment of Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

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

Pending Submission and Evaluation of Information 

Ill. Record-keeping 

IV. Successor Liability Upon Transfer of Consent Order 

V. Modification and Revocation of Consent Order 

VI. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Notice of Transfer of Consent Order 
111 

I. INTRODUCTION 

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

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

regarding premanufacture notice ("PMN") P-04-80 submitted by [ ] ("the 

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

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: 

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

] kilograms of the PMN substance; 

(2) provide personal protective equipment to its workers to prevent dermal exposure; 

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

worker training in accordance with the provisions of the Hazard Communication Program section; 

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

the testing requirements) and to not further distribute the PMN substance until it has been completely 

reacted; 
IV 

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

( 6) maintain certain records. 

III. CONTENTS OF PMN 

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

chemical identity, production volume, manufacturing and processing information, and other information. 

Chemical Identity: 

Specific: [ 

Generic: Halogen-substituted oxetane 

Use: 

Monomer for use in the production of reactive polymers for surface coating materials and other 

polymer intermediates. 

Maximum 12-Month Production Volume: [ 

Test Data Submitted with PMN: none 

] kg/yr 

IV. EPA'S ASSESSMENT OF RISK 

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

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

Human Health Summary: 

Absorption: EPA expects 20 percent absorption of the PMN chemical via skin, 100 percent via the 

lungs and 60 percent via the GI tract. 
v 

Toxicological Endpoints of Concern and Basis for Concerns: 

Toxicological endpoints of concern include male reproductive effects and systemic effects. 

EPA analysis of data on one analogue of oxetane concluded a no-observable-adverse-effect level 

(NOAEL) of 100 mg/kg/day in a 28-day oral toxicity study based on liver and thyroid abnormalities at 

higher dose levels. EPA analysis of data on another oxetane analogue concluded a NOAEL of 200 

mg/kg/day in a 28-oral toxicity study based on increases in liver and kidney weights and adverse effects 

on male reproductive organs, in particular, atrophy of seminiferous tubules in testes and decrease in 

sperm in epididymus lumen at higher dose levels. 

EPA does not consider the intact PMN substance to be analogous to [ 

]. 

Risk to Occupational Workers: 

EPA expects up to 17 50 mg/day dermal exposure during use of the PMN substance, resulting 

in a Margin of Exposure (MOE) of 22, indicating a high risk to workers via dermal exposure. 

Environmental Effects Summary: 

EPA calculates the aquatic Concentration of Concern (CoC) to be 5 parts per billion (ppb) 

based on a Structure Activity Relationship (SAR) analysis for oxetanes (see 

www.epa.gov/oppt/newchems/chemcat.htm). The PMN parent material is also predicted to be a 

persistent, bioaccumulative and toxic (PBT) chemical. EPA models predicted the log Kow to be 4.9 

and the fish bioconcentration factor (BCF) to be 3.0. Under certain conditions, the PMN substance 

may breakdown to produce [ 

on related [ ] compounds. 

]. EPA is in the process of evaluating testing 
VI 

Exposure and Environmental Release Summary: 

Manufacture of monomer Use of monomer to produce 

polymer 

#Sites [ ] [ ] 

Workers with dermal exposure [ ] [ ] 

(#/site) 

Exposure [ ] [ ] 

(days/year) 

Dermal Exposure up to 1,750 up to 1,750 

(mg/day) 

Drinking Water Exposure (mg/day) Not expected Not expected 

Release to Water Not expected Not expected 

(kg/day) 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 

A. EPA is unable to determine the potential for human health and environmental effects from exposure 

of humans and aquatic organisms to the PMN substance. EPA therefore concludes, pursuant to § 

5( e )(1 )(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned 

evaluation of the human health and environmental effects of the PMN substance. 

B. 1n light of the potential risk of human health and environmental effects posed by the uncontrolled 

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

and the Agency's conclusion that issuing the Order will not result in any significant loss of benefits to 

society, EPA has concluded, pursuant to§ 5(e)(l)(A)(ii)(l) 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. 
Vll 

C. In light of the estimated production volume of, and human exposure to, the PMN substance, EPA 

has further concluded, pursuant to § 5( e)( 1 )(A)(ii)(II) of TSCA, that the PMN substance will be 

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

substantial quantities, and there may be significant (or substantial) human exposure to the substance. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 

ENVIRONMENTAL EFFECTS 

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

volume unless the Company submits the information described in the Testing section of this Order in 

accordance with the conditions specified in the Testing section. 

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

environmental toxicity and persistent, bioaccumulative, and toxic characteristics which may be 

associated with the PMN substance: 

1) Algal toxicity test (OPPTS 850.5400); 2) Aquatic invertebrate acute toxicity test (OPPTS 

850.10 10); 3) Fish acute toxicity test (OPPTS 850.1075); 4) PBT testing: log Kow test (OECD 

117). If the log Kow test results in an Agency bioaccumulation rating of B2 or greater, then the fish 

bioconcentration factor (BCF) test (OPPTS 850.1730) should be conducted. If the tested fish BCF is 

greater than 1000 and results in an Agency B2 rating or greater, then the 90-day sub-chronic rat-oral 

toxicity test (OPPTS 870.31 00) should be conducted. 

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

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

in commerce, use, and disposal of the PMN substance 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 of the chemical substance [ 

] (P-04-80)("the PMN substance") 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 of the following exemptions, 

and (2) such compliance is documented by appropriate recordkeeping as required in the 

Recordkeeping section of this Order. 
2 

(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. 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 

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

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

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

exported. At that point, the requirements of this Order apply to all activities associated with the PMN 

substance while in the territory of the United States. Prior to leaving U.S. territory, even those 

quantities or batches of the PMN substance that are destined for export are subject to terms of the 

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

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

manufacturing, processing, distribution in commerce, use and disposal of the PMN substance in small 
3 

quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 720.3(cc), I 

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 (LYE) 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, 

DISTRIDUTION IN COMMERCE. USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

] ("the Company") is prohibited from manufacturing, importing, 

processing, distributing in commerce, using, or disposing of the chemical substance [ 

] (P04-80) ("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 
4 

the completion of EPA's review of, and regulatory action based on, that information, except under the 

following conditions: 

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) as amended at 52 Federal Register 20083 (May 29, 1987), 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 68 Federal Register 33129 (June 3, 

2003). 

(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 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 ~;tudy; and 

3. The name and telephone number of a person at the Company or the laboratory whom EPA 

may contact regarding the study. 
5 

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

A 

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

development of test protocols, but are not themselves acceptable protocols. 

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

PMN substance beyond an aggregate manufacture and import volume of [ , ] kilograms ("the 

production limit"), unless the Company conducts a combined repeated dose study with a 

reproductive/developmental toxicity screening in rats by gavage (Test Guideline OPPTS 

870.3650/0ECD 422) 1 on the PMN substance and submits all final reports and underlying data in 

accordance with the conditions specified in this Testing section. 

(e) Te~lt Reports. The Company shull: (1) conduct ouch study in good fnith, with due cure, und in u 

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 

1 Study should be modified to include pre-dosing for a full sperm cycle (70 days). 
6 

than 14 weeks prior to exceeding the applicable production limit. The final report shall contain the 

contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with 

the applicable "Reporting", "Data and Reporting", and "Test Report" subparagraphs in the applicable 

test guidelines. However, for purposes of this Consent Order, the word "should" in those 

subparagraphs shall be interpreted to mean "shall" to make clear that the submission of such information 

is mandatory. EPA will require the submission of raw data such as slides and laboratory notebooks 

only if EPA finds, on the basis of professional judgment, that an adequate evaluation of the study cannot 

take place in the absence of these items. 

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

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

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

Company may continue to manufacture and import the PMN substance beyond the applicable 

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

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

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

permit a reasoned evaluation of the risks presented by the PMN substance, only by mutual consent of 

EPA and the Company. 

(h) EPA Determination of Invalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 

weeks of EPA's receipt of a test report and data, the Company receives written notice that EPA finds 
7 

that the data generated by a study are scientifically invalid, the Company is prohibited from further 

manufacture and import of the PMN substance beyond the applicable production limit. 

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

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

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

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

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

at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), 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)( 1 ). 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. 
.. 

9 

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

mitigate exposures to or to better characterize the risks presented by the PMN substance. Within 2 

weeks from receipt of such a notice, the Company must cease all manufacture, import, processing, 

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

(2) within 2 weeks from receipt of the notice described in subparagraph U)( 1 ), the Company 

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

(3) within 4 weeks from receipt of the notice described in subparagraph U)(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. 
10 

PROTECTION IN THE WORKPLACE 

(a) During manufacturing, processing, and use of the PMN substance at any site controlled by the 

Company, the Company must establish a program whereby:· 

(1) 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 29 CFR 1910.132 and 29 CFR 1910.133. 

(2) Specific Dermal Protective Equipment. In addition to the personal protective equipment 

described in subparagraph (a)(l) of this section, the following items are required: 

(i) Gloves. 

(ii) Chemical goggles or equivalent eye protection 

(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) Imperviousness Testing. Testing the material used to make the chemical protective 

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

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

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

substances to which the clothing may be exposed in the work area. Permeation testing shall be 
11 

conducted according to the American Society for Testing and Materials (ASTM) F739 "Standard Test 

Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases." Results 

shall be 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 F 1194-89 "Guide for Documenting 

the Results of Chemical Permeation Testing on Protective Clothing Materials." Gloves may not be used 

for a time period longer than they are actually tested and must be replaced at the end of each work 

shift. 

(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. 

(b) Low Concentrations in Mixtures. If the PMN substance is present in the work area only as a 

mixture, the Company is exempt from the provisions of this Protection in the Workplace section if the 

concentration of the PMN substance in the mixture does not exceed 1.0 percent by weight or volume, 

or 0.1 percent by weight or volume if paragraph (g) of the Hazard Communication Program section of 

this Order identifies cancer as a potential human health hazard of the PMN substance. This exemption 

does not apply if the Company has reason to believe that during intended use or processing in the work 

area, the PMN substance in the mixture may be concentrated above the 1.0 or 0.1 percent level, 

whichever is applicable. 
12 

HAZARD COMMUNICATION PROGRAM 

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

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

at a minimum, describe how the requirements of this section for labels, MSDSs, and other forms of 

warning material will be satisfied. The Company must make the written hazard communication program 

available, upon request, to all employees, contractor employees, and their designated representatives. 

The Company may rely on an existing hazard communication 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) of TSCA or by a 

TSCA section ~(u)(2) SNtJR ut 40 CFR Purt 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. 
13 

(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)( I). 

(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 in paragraph (g) 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 environmental hazard(s) and precautionary measure(s), 

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

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

paragraph (g) 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. 
14 

(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 

relabeled with the information specified in subparagraph (b)(l)(i) of this section. 

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

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

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

(A) The information prescribed in subparagraph (b )(1 )(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 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, 
15 

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). 

(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 (g) 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. 
16 

(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 

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. 
17 

(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. 

(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 
18 

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 infm'mation provided to employees under this paragraph shall include: 

(i) The requirements of this section. 

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

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

under paragraph (a) of this section, including the list of substances required by subparagraph (a)( 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 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 (g) 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 me1.unues 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. 
19 

(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. 

(e) Low Concentrations in Mixtures. Ifthe PMN substance is present in the work area only as a 

mixture, the Company is exempt from the provisions of this section if the concentration of the PMN 

substance in the mixture does not exceed 1.0 percent by weight or volume, or 0.1 percent by weight or 

volume if paragraph (g) of this section identifies cancer as a potential human health hazard of the PMN 

substance. However, this exemption does not apply if the Company has reason to believe that during 

intended use or processing in the work area, the PMN substance in the mixture may be reconcentrated 

above the 1.0 or 0.1 percent level, whichever is applicable. 

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

programs and procedures satisfy the requirements of this section. 

(g) 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) male reproductive effects 

(ii) systemic effects 

(2) Human hazard precautionary statements. When using this substance: 
(i) avoid skin contact. 

(ii) use skin protection. 

20 

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

(i) toxic to fish. 

(ii) toxic to aquatic organisms. 

(iii) persistent, bioaccumulative and toxic. 

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

(i) do not release to water. 

(5) The human and environmental hazard and precautionary statement contained on a label prepared 

pursuant to paragraph (b) of this section must be followed by the statement: "See the MSDS for 

details." 

MANUFACTURING 

(a)(l) 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)(l) 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. 
21 

(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. 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. 

DISTRIBUTION 

(a) Distribution Requirements. Except 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. 

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

in the Release to Water section of this Order. 
22 

(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 

(labelled in accordance with paragraph (b )(2) of the Hazard Communication Program section of this 

Order) provided that any human exposure or environmental release resulting from opening the container 

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 authorized to receive the PMN substance from the 

Company pursuant to this Distribution section of this Order. 

(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)(l) expires in accordance with subparagraph (d)(l), has engaged in a significant new use of the 

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

notice to EPA, the Company shall cease supplying the substance to that recipient, unless the Company 

is able to document each of the following: 

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

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

section, or has engaged in a significant new use of the 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, or is aware of the terms 
23 

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) of this Distribution section shall expire 75 days 

after promulgation of a final SNUR for 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, 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)( 1) of this 

Distribution section expires in uccordance with subparagraph (d)( 1 ), the Company shull notify euch 

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 
24 

either the Federal Register or the Code of Federal Regulations. After promulgation of a SNUR and 

expiration of subparagraph (a)( 1 ), such notice may substitute for the written agreement required in the 

introductory clause of paragraph (a); so that, if the Company provides such notice to the persons to 

whom it distributes the PMN substance, then the Company is not required to obtain from such persons 

the written agreement specified in paragraph (a). 

RELEASE TO WATER 

(a) The Company is prohibited from any predictable or purposeful release of the PMN substance, or 

any waste stream from manufacturing, processing, or use of the PMN substance 

into the waters of the United States. 

III. RECORD-KEEPING 

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) Records documenting the aggregate manufacture and importation volume of the PMN 

substance and the corresponding dates of manufacture and import; 

(2) 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; 
25 

(3) 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; 

(4) 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; 

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

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

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

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

section of this Order; 

(8) Records documenting compliance with any applicable manufacturing and distribution 

restrictions in the Manufacturing and Distribution sections 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, imported, processed or used. 

(b) Applicability. The provisions of this Record-keeping Section are applicable only to activities of the 

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

customers. 
26 

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

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

information" unless this Order displays a currently valid control number from the Office of Management 

and Budget (OMB), and EPA so informs the Company. The "collection of information" required in this 

TSCA 5(e) Consent Order has been approved under currently valid OMB Control Number 2070-

0012. 

IV. 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)(l) ofTSCA and 40 CFR part 720 before 

commencing manufacture or import of the PMN substance. 
27 

(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 is not 

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(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 Order 

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

Order. 
28 

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

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

Protection Agency, New Chemicals Branch (7405M), 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 and time 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 and time 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 and time 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. 
29 

(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. 

V. MODIFICATION AND REVOCATION OF CONSENT ORDER 

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

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

modify or revoke substantive provisions of this Order. The exposures and risks identified by EPA 

during its review of the PMN substance and the information EPA determined to be necessary to 

evaluate those exposures and risks are described in the preamble to this Order. However, in 

determining whether to amend or revoke this Order, EPA will consider all relevant information available 

at the time the Agency makes that determination, including, where appropriate, any reassessment of the 

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

other information or analysis, and any other relevant information. 

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

therein will not present un unrensonuble risk of injury to health or the environment and will ntlt 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 if EPA determines that the 
30 

modification is useful, appropriate, and consistent with the structure and intent of this Order as issued. 
VI. 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) of TSCA, and to 

challenge the validity of this Order, or modifications made thereto, in any subsequent action. 

Consenting to the entry of this Order, and agreeing to be bound by its terms, does 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 

Office of 

_L !_.// 

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 

"Immediatb 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 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-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 longterm 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 5(e) CONSENT ORDER 

P04-80 

PMN Number 

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(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 of 

TSCA 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. 
TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER (cont.) 

P04-80 

Company (Transferor) PMN Number 

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