UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE

PENDING DEVELOPMENT OF INFORMATION

 In the matter of: ) Premanufacture Notice Number:

)

)

)

)

)

 [ ] ) P04-132

)

)

)

)

) 

______________________________________________________________________________

 Consent Order and Determinations Supporting Consent Order

______________________________________________________________________________

EPA SANITIZED Page 1 of 38
ii

TABLE OF CONTENTS

Preamble

I. Introduction

II. Summary of Terms of the Order

III. Contents of PMN 

IV. EPA's Assessment of Risk

V. EPA's Conclusions of Law

VI. Information Required to Evaluate Human Health Effects

Consent Order

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

Pending Submission and Evaluation of Information

II. Record-keeping

III. Successor Liability Upon Transfer of Consent Order

IV. Modification and Revocation of Consent Order

V. Effect of Consent Order

Attachment A - Definitions

Attachment B - Notice of Transfer of Consent Order

EPA SANITIZED Page 2 of 38
iii

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") P04-132 submitted by [ ] ("the

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

PMN to EPA pursuant to section 5(a)(1) of TSCA 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: 

(1) Provide workers with personal protective equipment to prevent dermal exposure;

(2) Label the PMN substance and provide Material Safety Data Sheets (MSDS) and worker training

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

(3) Not use the PMN substance other than as described in the PMN, as an [ ] and/or as an [ 

 ];

(4) Distribute the PMN substance only to a person who agrees to follow the same restrictions and to

not further distribute the PMN substance until it has been completely reacted; and

(5) Maintain certain records.

EPA SANITIZED Page 3 of 38
iv

III. CONTENTS OF PMN

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

chemical identity, use, production volume, processing information, other information.

Chemical Identity

Specific: [ ]

Generic: Ethylhexyl Oxetane

Use

Specific: [

 ]

Generic: additive for industrial applications

Maximum 12-Month Production Volume: [ ] kg/yr

Test Data Submitted with PMN: 

- Glove permeation test data for the both the Polyvinyl Alcohol and the Silvershield/4H materials

indicated that potentially exposed workers could be provided with Polyvinyl Alcohol gloves with

a thickness of no less than 31.3 mils or Silvershield/4H sleeves with a thickness of no less than 2.7

mils for up to 8 hours

- Negative in Salmonella and E coli

- Negative for chromosome aberrations and CHL cells

- Acute oral study in rats - no deaths or signs of toxicity at 2000 mg/kg

- Acute dermal study in rats - no deaths or signs of toxicity at 2000 mg/kg

- 28-day oral study in rats (20, 100, 500 mg/kg) - increased weights and hypertrophy of the

centrilobular hepatocytes, slight hypertrophy of the follicular cells of the thyroid at 500 mg/kg;

NOAEL = 100 mg/kg

- minimal eye irritant

- strong dermal irritant

- not a dermal sensitizer, Magnusson and Kligman

ECOTOX: Predicted (P) and measured (M) toxicity values in mg/L (ppm) are:

fish (M) 96-h LC30 = 3.5 measured (M) static (S), nominal (N), hardness (H) 67

fish (RT) 96-h LC50 = 2.1 M SR24,M H100

fish (RT) 96-h LC50 = 3.5 M S,M H100

EPA SANITIZED Page 4 of 38
v

daphnid 48-h LC50 = 1.7 M S,M H250

algal 72-h EC50 (cells/mL (c)) = 0.690 M S,M H15

algal 72-h EC50 (area under growth curve(a)) = 0.690 M S,M H15

algal 72-h EC50 (growth rate (r)) = 1.0 M S,M H15

algal ChV EC10 c = 0.460 M S,M H15

algal ChV EC10 a = 0.540 M S,M H15

algal ChV r = 0.610 M S,M H15

IV. EPA'S ASSESSMENT OF RISK

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

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

Human Health Effects 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. 

Toxicological Endpoints of Concern and Basis for Concern: In a 28-day oral toxicity study on the

PMN substance (OECD guideline 407), rats were given the chemical by oral gavage at 0, 20, 100,

or 500 mg/kg/day. A no-observable adverse-effect level (NOAEL) of 100 mg/kg/day was concluded

based on liver and thyroid abnormalities at a higher dose level.

Occupational Exposure: During use of the PMN substance, EPA expects dermal exposure of up to

4,300 mg/day resulting in a Margin of Exposure (MOE) of 8 via dermal exposure.

EPA SANITIZED Page 5 of 38
vi

Occupational Exposure Summary:

Process Use 1 Use 2 

# Sites [ ] [ ] [ ]

Total # of Workers with

Exposure

[ ] [ ] [ ]

Days/year Exposure [ ] [ ] [ ]

Dermal Exposure (mg/day) 1,700 4,300 880.00

Inhalation Exposure 

(mg/day) (worst-case)

0.19 31 1.3 

Environmental Effects Summary:

If the PMN substance were to be used other than as described in the PMN, i.e., as an [ ]

and/or as an [ ], there could be the potential for significant risk to the aquatic environment. For

example, when the PMN was assessed for use as a [ ], the concentration of concern of 20 ppb

in aquatic environments was predicted to be exceeded for greater than 20 days per year and surface

water concentrations were predicted to reach up to 995 ppb.

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 environmental toxicity and liver and thyroid

effects from dermal exposure 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 environmental and human health effects of the PMN substance.

B. In light of the potential risk of systemic toxicity to humans and aquatic toxicity posed by the

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

EPA SANITIZED Page 6 of 38
PMN substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled

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

substance may present an unreasonable risk of injury to human health and the environment.

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 

ENVIRONMENTAL EFFECTS

Pending Testing. The Modified Order does not require submission of the following

information at any specified time or production volume. However, the Order’s restrictions on

manufacturing, 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 the following data or other relevant information.

If the Company wishes to manufacture the PMN differently than required by the Consent

Order, the Company should conduct and submit the following tests: 

- A 90-day oral toxicity study in rodents (OPPTS 870.3100)

- Fish early-life stage toxicity test (rainbow trout) (OPPTS 850.1400/OECD 210)

- Daphnid chronic toxicity test (OPPTS 1300/OECD 202)

EPA SANITIZED Page 7 of 38
1

CONSENT ORDER

I. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION 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 [ 

 ] (P04-132) ("the PMN substance") in

the United States, for any nonexempt commercial purpose, pending the development of information

necessary for a reasoned evaluation of the environmental and human health effects of the substance,

and 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. Any information on the PMN substance which reasonably

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

or the environment required to be reported under EPA's section 8(e) policy statement at 43 Federal

EPA SANITIZED Page 8 of 38
2

Register 11110 (March 16, 1978), shall reference the appropriate PMN identification number for this

substance and shall 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).

(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

(including studies identified in section VI. of the Preamble), 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 (including studies identified in section VI. of the Preamble) 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 such study, the Company must obtain approval of test protocols from EPA by

EPA SANITIZED Page 9 of 38
3

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

written protocols. Published test guidelines provide general guidance for development of test

protocols, but are not themselves acceptable protocols. Approval of the test protocol does not mean

pre-acceptance of test results. 

(d) 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 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 (d)(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 (d)(1), 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,

EPA SANITIZED Page 10 of 38
4

import, processing, distribution, use and disposal of the PMN substance.

PROTECTION IN THE WORKPLACE

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

any site controlled by the Company, the Company must establish a program whereby:

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

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

with equipment on which the substance may exist is provided with, and is required to wear, personal

protective equipment that provides a barrier to prevent dermal exposure to the substance in the specific

work area where it is selected for use. Each such item of personal protective equipment must be

selected and used in accordance with 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)(1) 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 by the following

testing 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. 

(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

EPA SANITIZED Page 11 of 38
5

shall be 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 recorded as a cumulative permeation rate as a function of time, and shall be

documented in accordance with ASTM F739 using the format specified in ASTM F1194-89 "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 during which they are exposed to the PMN substance. Data on the glove

testing conducted to date appears on page iv of the Preamble to this Order.

(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 reconcentrated above the 1.0 or 0.1 percent

level, whichever is applicable.

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,

EPA SANITIZED Page 12 of 38
6

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 5(a)(2) SNUR at 40 CFR Part 721, subpart E, to maintain a list of substances, the lists

shall be combined with the list under this subparagraph.

(2) The methods the Company will use to inform employees of the hazards of non-routine

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

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

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

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

EPA SANITIZED Page 13 of 38
7

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:

(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.

(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.

EPA SANITIZED Page 14 of 38
8

(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)(1)(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,

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

EPA SANITIZED Page 15 of 38
9

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.

(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

EPA SANITIZED Page 16 of 38
10

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

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

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

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

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

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

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

spills and leaks. 

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

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

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

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

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

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

emergency procedures.

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

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

(4) Where multiple mixtures containing the PMN substance have similar compositions (i.e.,

the chemical ingredients are essentially the same, but the specific composition varies from mixture to

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

mixtures. 

EPA SANITIZED Page 17 of 38
11

(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

EPA SANITIZED Page 18 of 38
12

the time of each employee's initial assignment to a work area containing the PMN substance and

whenever the PMN substance is introduced into the employee's work area for the first time.

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

(i) The requirements of this section.

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

(iii) The location and availability 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

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. 

EPA SANITIZED Page 19 of 38
13

(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. If the 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) systemic effects

(ii) aquatic toxicity effects

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

(i) avoid skin contact.

EPA SANITIZED Page 20 of 38
14

(ii) use skin protection.

(3) The human 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

(a)(1) The Company shall not cause, encourage, or suggest the manufacture or import of the PMN

substance by any other person. 

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

final significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2) of TSCA

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

review of the SNUR. If the Company is so notified, subparagraph (a)(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 of SNUR. When EPA promulgates a final SNUR for the PMN substance and

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

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

existence of the SNUR.

USE

(a) The Company shall not use the PMN substance other than as described in the PMN, i.e., as an [ ]

and/or as an [ ].

DISTRIBUTION

EPA SANITIZED Page 21 of 38
15

(a) Distribution Requirements. Except as provided in paragraph (b), the Company shall distribute the

PMN substance outside the Company, other than for disposal, only to a person who has agreed in

writing prior to the date of distribution, to:

(1) Not further distribute the PMN substance to any other person, other than 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.

(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

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

Order) provided the following two conditions are met:

(1) Subsequent to any such exempt temporary transport or storage of sealed containers, the

PMN substance may be distributed only to 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).

EPA SANITIZED Page 22 of 38
16

(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) 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 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.

EPA SANITIZED Page 23 of 38
17

(d) Sunset Following SNUR. (1) Paragraph (a)(1) 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)(1) 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 accordance with subparagraph (d)(1), the Company shall notify each

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

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

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

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

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

SNUR and expiration of subparagraph (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).

TESTING

(a) Section 8(e) Reporting. Any 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

required to be reported under EPA's section 8(e) policy statement at 43 Federal Register 11110 (March

16, 1978), shall reference the appropriate PMN identification number for this substance and shall

EPA SANITIZED Page 24 of 38
18

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).

(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

(including studies identified in section VI. of the Preamble), 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 (including studies identified in section VI. of the Preamble) 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 such 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

EPA SANITIZED Page 25 of 38
19

written protocols. Published test guidelines provide general guidance for development of test

protocols, but are not themselves acceptable protocols. Approval of the test protocol does not mean

pre-acceptance of test results. 

(d) 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 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 (d)(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 (d)(1), 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.

EPA SANITIZED Page 26 of 38
20

II. 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 of TSCA:

(1) Records documenting the 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;

(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;

EPA SANITIZED Page 27 of 38
21

(8) Records documenting compliance with any applicable manufacturing 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) Copies of any Transfer Documents and notices required by the Successor Liability section

of this Order, if applicable; and

(10) 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.

III. 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

EPA SANITIZED Page 28 of 38
22

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

commencing manufacture or import of the PMN substance.

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

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

EPA SANITIZED Page 29 of 38
23

(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.

(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

EPA SANITIZED Page 30 of 38
24

("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.

IV. MODIFICATION AND REVOCATION OF CONSENT ORDER

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

of, or human exposure to, the PMN substance, to modify or revoke substantive provisions of this

Order. The exposures and risks identified by EPA during its review of the PMN substance and the

information EPA determined to be necessary to evaluate those exposures and risks are described in the

preamble to this Order. However, in determining whether to amend or revoke this Order, EPA will

consider all relevant information available at the time the Agency makes that determination, including,

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

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

information.

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

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

in significant or substantial human exposure or substantial environmental release in the absence of

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

substance.

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.

EPA SANITIZED Page 31 of 38
25

V. 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)(1)(C) of TSCA, to receive service of this Order no later than 45

days before the end of the review period pursuant to section 5(e)(1)(B) of TSCA, 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, 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 Jim Willis, Director

Chemical Control Division

Office of Pollution Prevention and Toxics

 

 

 _______ 

Date Name:

 

Title:

Company: [ ]

EPA SANITIZED Page 32 of 38
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. 

"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.

EPA SANITIZED Page 33 of 38
2

"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. 

"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.

EPA SANITIZED Page 34 of 38
3

"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.

EPA SANITIZED Page 35 of 38
ATTACHMENT B

NOTICE OF TRANSFER 

OF

TOXIC SUBSTANCES CONTROL ACT

SECTION 5(e) CONSENT ORDER

___________________________ P04-132

Company (Transferor) 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

EPA SANITIZED Page 36 of 38
SECTION 5(e) CONSENT ORDER

NOTICE OF TRANSFER (cont.)

___________________________________ P04-132

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

TOXIC SUBSTANCES CONTROL ACT

SECTION 5(e) CONSENT ORDER

EPA SANITIZED Page 37 of 38
NOTICE OF TRANSFER (cont.)

___________________________________

Successor's Technical Contact 

___________________________________

Address

___________________________________

City, State, Zip Code

___________________________________

Phone

EPA SANITIZED Page 38 of 38