UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

I 

REGULATION OF A NEW CHEMICAL SUBSTANCE · .. ) 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) 

) 

) 

) 

) 

) 

3M Company ) 

) 

) 

) 

) 

) 

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(.) 

en 

Premanufacture Notice Number: 

P-09-0048 

11111111111111111111111111111111111111111111111/lllllllll !11111111111111111 

soogooo4757/c. 

Consent Order and Determinations Supporting Consent Order 

EPA SANITIZED @ qjr/vrt 

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11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms of the Order 

III. Contents of PMN 

IV. EPA's Assessment ofExposure and 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 

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

Disposal Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B- Notice of Transfer of Consent Order 

• 
111 

PREAMBLE 

I. INTRODUCTION 

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

U.S.C. 2604(e)), the Environmental Protection Agency ("EPA" or "the Agency") issues 

the attached Order, regarding premanufacture notice ("PMN") P-09-0048 for the 

chemical substance [ 

] ("the PMN substance") submitted by 3M 

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

The Company submitted the PMN to EPA pursuant to§ 5(a)(l) ofTSCA and 40 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 ofTSCA, such as this one, are subject to the§ 12(b) export notice 

requirement. 

II. SUMMARY OF TERMS OF THE ORDER 

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

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

(b) prevent the PMN substance from forming a powder during manufacturing, 

processing, or use; 
IV 

(c) not use the PMN substance involving an application method that generates a vapor, 

mist, aerosol or a dust, except within an enclosed or sealed reaction chamber; 

(d) 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; 

(e) use gloves impervious to the [ ] PMN particles contained in solution ( 

] particles are always in liquid during manufacturing and use); 

(f) not use the PMN substance except for the specific use "[ ] film coating 

additive"; 

(g) transport the PMN substance to processors and users using reusuable tote tanks 

cleaned not more than once per year; 

(h) dispose ofunreacted PMN substance in a RCRA-approved hazardous waste 

incinerator; 

(i) 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 or cured; 

(j) maintain certain records. 
v 

III. CONTENTS OF PMN 

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

Specific chemical identity, reactants, impurities, residuals, production volume, 

manufacturing and use information, particle size distribution of PMN substance 

suspended in water, air monitoring results, film leaching study, X-ray diffraction ofPMN 

substance suspended in water. 

Chemical Identity: 

Specific: [ 

Generic: surface modified ceramic particles 

Use: 

Specific: [ ] film coating additive 

Generic: film coating additive 

Maximum 12-Month Production Volume: [ 

Test Data Submitted with PMN: physical-chemical properties including specific gravity; 

solubility; particle size distribution ofPMN substance suspended in water; X-ray 

diffraction ofPMN substance suspended in water; air monitoring results of analog; 

thermogravimetric analysis characterization ofPMN substance; IR analysis ofPMN 

substance; and film leaching study. 
VI 

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK 

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

environmental toxicity, human exposure, and environmental release of the PMN 

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

Human Health Effects Summary: 

Absorption of the PMN chemical is expected to be poor via all routes because of the 

particle size (average [ ]). There are concerns for lung effects if inhaled, based on 

lung overload and potential for effects of [ ] particles. There is evidence that 

] poorly soluble, respirable particles can penetrate membranes in the 

respiratory tract and possibly in the GI tract. There may also be physical penetration 

through the skin. Tested [ ] particles have been shown to: (1) be inflammatory to 

the lungs, (2) cause lung fibrosis ofthe lung and lung cancer, and (3) induce systemic 

effects. There are also concerns for oncogenicity in the lungs if inhaled and if 

[ ] is bioavailable. In addition, there is a concern for skin allergies upon 

exposure to [ ]. The chemical is in the poorly soluble, respirable particles and 

] categories. Basis: 

See www.epa.gov/opptintr/newchems/pubs/chemcat.htm 

Environmental Effects Summary: 

Based on the SAR analysis of poorly soluble, respirable particles coated with an 

[ ] moiety the concern for ecotoxicity was low. The expected concentration 

of concern for the [ ] coating as manufactured and described in [ 

] is 55 parts per billion (ppb ). 

See www. epa. gov I opptintr/newchems/pubs/ chemcat.htm 
Vll 

Exposure and Environmental Release Summary: 

Manufacture Use 

#Sites [ ] [ ] 

Workers [ ] [ ] 

(#/site) 

Exposure 32 32 

(days/year) 

Dermal Exposure 1100 1100 

(mg/day) 

Inhalation Exposure Not expected Not expected 

(mg/day) 

Drinking Water Not expected Not expected 

Exposure (mg/day) 

Releases [ ] [ ] 

(days/year) 

Release to Water Not expected Not expected 

(kg/day) 

Release to Air [ ] of [ ] of 

(kg/day) incineration incineration 

product product 

Risk to the Environment 

The behavior of the [ ] particles in the environment from incineration releases 

is unclear. Based on no releases to water as described in the PMN during manufacturing 

and use, and limitations place on methods of disposal, the risk to the environment of the 

PMN substance is expected to be low. 
viii 

Risk to Workers: 

The PMN substance poses a risk oflung effects and/or systemic effects to workers if 

exposure occurs by the inhalation or dermal routes. The PMN states that during 

manufacturing and use, personal protective equipment and control technologies 

(including maintaining the PMN substance in a liquid or slurry formulation) will be used 

to prevent these exposures mitigating the potential risks. 

Risk to the General Public: 

The PMN substance poses a potential risk oflung effects and/or systemic effects to the 

general population if exposure occurs by the inhalation route, which would originate 

from releases of [ ] particles transformed by incineration, or from formation of 

powder (and subsequent releases to the environment) of the PMN substance in the 

workplace. The PMN states that during manufacturing and use, control technologies 

(including maintaining the PMN substance in a liquid or slurry formulation) and disposal 

of the PMN substances via incineration will be used to prevent these releases mitigating 

the potential risks. 

Risk to Consumers: 

Based on complete reaction of the PMN substance during use, EPA does not expect a risk 

to consumers. 
IX 

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 inflammation to the lungs, fibrosis ofthe 

lung, and lung cancer, or for systemic effects from exposure ofhumans and aquatic 

organisms to the PMN substance. EPA therefore concludes, pursuant to§ 5(e)(l)(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) In light of the potential risk of inflammation to the lungs, lung fibrosis of the lung, 

and lung cancer, or for systemic effects posed by the uncontrolled manufacture, import, 

processing, distribution in commerce, use, and disposal of the 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. 
X 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 

ENVIRONMENTAL EFFECTS 

Pended Testing. The following additional information would be required to 

evaluate the following effects which may be caused by the PMN substance: 

Tier Information Effects Guidelines 

1 90-day inhalation toxicity Lung OPPTS 870.3465 

study on PMN substance or OECD 413 

on rats with a postexposure observation 

period of up to sixty days, 

including bronchoalveolar 

lavage fluid ("BALF'') 

analysis. 

1 Determination of the Exposure 

removal efficiency of the 

PMN by the incinerator at 

the anticipated loading 

rate 

2 Full dissolution test using Exposure see OECD 

transformed PMN ENV /JM/MONO( 

substance following 2001)9 

incineration 

2 Particle size distribution, Exposure OPPTS 830.7520/ 

aspect ratio and crystalline ISO 13320-/ 

structure of transformed ASTM B822-02 

PMN substance following 

incineration 

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. Tier one studies may be conducted and evaluated 

before tier two testing, as they may obviate the need to conduct tier two studies. 
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-09-0048) ("the PMN substance") in the United States by 

3M Company ("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 
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Recordk~eping section of this Order. 

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

quantities of the PMN substance after they 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. If this Order contains New Chemical Exposure Limits 

provisions or Release to Water provisions that, respectively, specify a NCEL 

concentration ("TWA") or in-stream concentration ("N") less than the de minimis 

concentration specified here, then this de minimis exemption does not apply to those 

provisiOns. 

(3) Export. Until the Company begins commercial manufacture of the PMN 

substance for use in the United States, the requirements ofthis 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 
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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 quantities solely for research and development in accordance 

with TSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CFR 720.36. The requirements of this 

Order also do not apply to manufacturing, processing, distribution in commerce, use and 

disposal ofthe PMN substance when manufactured solely for non-commercial research 

and development per 40 CFR 720.30(i) and TSCA §5(i). 

(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 ofthis 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. 

(7) Imported Articles. The requirements of this Order do not apply to the PMN 

substance when it is imported as part of an "article" as defined at 40 CFR 720.3( c) and in 

compliance with 40 CFR 720.22(b )(I). 

(c) Automatic Sunset. If the Company has obtained for the PMN substance a Test 
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Market Exemption ("TME") under TSCA §5(h)(l) and 40 CFR 720.38 or a Low Volume 

Exemption ("L VE") or Low Release and Exposure Exemption ("LoREX") under TSCA 

§5(h)(4) and 40 CFR 723.50(c)(1) and (2) respectively, any such exemption is 

automatically rendered null and void as of the effective date of this Consent Order. 

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

PROHIBITION 

The Company is prohibited from manufacturing, importing, processing, 

distributing in commerce, using, or disposing of the PMN substance in the United States, 

for any nonexempt commercial purpose, pending the development of information 

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

substance, and the completion ofEPA's review of, and regulatory action based on, that 

information, except in accordance with the conditions described in this Order. 

TESTING 

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

reasonably supports the conclusion that the PMN substance presents a substantial risk of 

injury to health or the environment, which is required to be reported under EPA's section 

8(e) policy statement at 43 Federal Register 11110 (March 16, 1978), 68 Federal Register 

33129 (June 3, 2003), and 70 Federal Register 2162 (January 12, 2005), shall reference 

the appropriate PMN identification number for this substance and contain a statement that 
- 5 -

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 ). 

PROTECTION IN THE WORKPLACE 

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

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

storage and during any cleaning or maintenance of equipment associated with the PMN 

substance), the Company must establish a program whereby: 

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

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

substance or through contact with equipment on which the substance may exist is 

provided with, and is required to wear, personal protective equipment that provides a 

barrier to prevent dermal exposure to the substance in the specific work area where it is 

selected for use. Each such item of personal protective equipment must be selected and 

used in accordance with Occupational Safety and Health Administration ("OSHA") 

dermal protection requirements at 29 CFR 1910.132, 1910.133, and 1910.138. 

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

required by subparagraph (a)(1) ofthis section must include, but is not limited to, the 

following items: 

(i) Gloves impervious to the [ ] PMN particles contained in 

solution. 
- 6 -

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

item of chemical protective clothing selected, including gloves, provides an impervious 

barrier to prevent dermal exposure during normal and expected duration and conditions 

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

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

protective clothing and the construction of the clothing to establish 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 conducted according to the 

American Society for Testing and Materials ("ASTM") F739 "Standard Test Method for 

Resistance ofProtective 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 F1194-

99 "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. 

(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. 

.. 
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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 OSHA Hazard Communication Standard (29 CFR 

191 0.1200), to comply with this paragraph provided that the existing hazard 

communication program satisfies the requirements of this section. The written program 

shall include the following: 

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

subject to a TSCA section 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. 
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(2) The methods the Company will use to inform employees of the hazards of 

non-routine tasks involving the PMN substance (e.g., cleaning of reactor vessels), and the 

hazards associated with the PMN substance contained in unlabeled pipes in their work 

area. 

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

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

employees of the contractor work in the Company's workplace and are reasonably likely 

to be exposed to the PMN substance while in the Company's workplace. 

(b) Labeling. 

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

workplace is labeled in accordance with this subparagraph (b)(l). 

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

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

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

PMN substance. 

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

recognized. 

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

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

PMN substance. 
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(IV) A statement of exposure and precautionary measure(s), if 

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

substance. 

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

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

individual stationary process containers, as long as the alternative method identifies the 

containers to which it is applicable and conveys information specified by subparagraph 

(b)(l)(i) of this section. Any written materials must be readily accessible to the 

employees in their work areas throughout each work shift. 

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

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

immediate use of the employee who performs the transfer. 

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

containers of the PMN substance obtained from persons outside the Company unless the 

container is immediately re-labeled with the information specified in subparagraph 

(b)(l)(i) ofthis section. 

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

workplace for distribution in commerce is labeled in accordance with this subparagraph 

(b)(2). 

section. 

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

(I) The information prescribed in subparagraph (b)(l)(i) of this 
- 10-

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

party who can provide additional information on the substance for hazard evaluation and 

any appropriate emergency procedures. 

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

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

Act by the Department of Transportation. 

(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 OSHA Hazard Communication Standard (29 CFR 1900.1200), the 

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

measures to control worker exposure or environmental release which the Company 

determines provide the greatest degree of protection. However, should these control 

measures differ from the applicable measures required under this Order, the Company 

must seek a determination of equivalency for such alternative control measures pursuant 

to 40 CFR 721.30 before prescribing them under this subparagraph (b )(5). 

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

the hazards of the PMN substance or ways to protect against the hazards, this new 
- 11 -

information must be added to the label within 3 months from the time the Company 

becomes aware of the new information. If the PMN substance is not being manufactured, 

imported, processed, or used in the Company's workplace, the Company must add the 

new information to the label before the PMN substance is reintroduced into the 

workplace. 

(c) Material Safety Data Sheets. 

(1) The Company must obtain or develop an MSDS for the PMN substance. 

(2) The MSDS shall contain, at a minimum, the following information: 

(i) The identity used on the container label of the PMN substance under 

this section, and, if not claimed confidential, the chemical and common name of the PMN 

substance. If the chemical and common names are claimed confidential, a generic 

chemical name must be used. 

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

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

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

including the potential for fire, explosion, and reactivity. 

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

paragraph (f) ofthis 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. 
- 12-

(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. 
- 13-

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

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

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

area containing the PMN substance and whenever the PMN substance is introduced into 

the employee's work area for the first time. 

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

(i) The requirements of this section. 

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

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

program required under paragraph (a) of this section, including the list of substances 

required by subparagraph (a)(l) of this section and MSDSs required by paragraph (c) of 

this section. 

(2) The training provided to employees shall include: 

(i) Methods and observations that may be used to detect the presence or 

release of the PMN substance in or from an employee's work area (such as exposure 

monitoring conducted by the Company, continuous monitoring devices, visual 

appearance, or odor of the substance when being released). 

(ii) The potential human health and environmental hazards of the PMN 

substance as specified in paragraph (f) of this section. 

(iii) The measures employees can take to protect themselves and the 

environment from the PMN substance, including specific procedures the Company has 

implemented to protect employees and the environment from exposure to the PMN 

substance, including appropriate work practices, emergency procedures, personal 
- 15-

protective equipment, engineering controls, and other measures to control worker 

exposure and/or environmental release required under this Order, or alternative control 

measures which EPA has determined under 40 CFR 721.30 provide the same degree of 

protection as the specified control measures. 

(iv) The requirements of the hazard communication program developed 

by the Company under this section, including an explanation of the labeling system and 

the MSDS required by this section and guidance on obtaining and using appropriate 

hazard information. 

(e) Existing Hazard Communication Program. The Company need not take additional 

actions if existing programs and procedures satisfy the requirements of this section. 

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

following human health and environmental hazard and precautionary statements shall 

appear on each label as specified in paragraph (b) and the MSDS as specified in 

paragraph (c) ofthis section: 

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

(i) respiratory complications;. 

(ii) internal organ effects. 

(iii) cancer. 

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

(i) avoid skin contact. 

(ii) avoid breathing the substance. 
- 16-

(iii) use skin protection. 

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

(i) disposal restrictions apply. 

(ii) do not release to water. 

(5) The human and environmental hazard and precautionary statement on the 

label prepared pursuant to paragraph (b) of this section must be followed by the 

statement: "See the MSDS for details." 

MANUFACTURING 

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

or import of the PMN substance by any other person. 

(2) Sunset Following SNUR. Subparagraph (a)(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 ofthe SNUR. If the Company is so 

notified, subparagraph (a)(l) shall not expire until EPA notifies the Company in writing 

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

the SNUR affirmed. 

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

substance and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the 

Company shall notify each person whom it causes, encourages or suggests to 

manufacture or import the PMN substance of the existence of the SNUR. 

. ' 
- 17-

(b) The Company shall not manufacture the PMN substance: 

(1) In non-enclosed or unsealed processes when the PMN substance is in 

the form of a powder; 

(2) In non-enclosed or unsealed processes for an application method that 

generates a vapor, mist, aerosol or a dust. 

PROCESSING 

(a) The Company shall not process the PMN substance: 

(1) In non-enclosed or unsealed processes when the PMN substance is in 

the form of a powder; 

(2) In non-enclosed or unsealed processes for an application method that 

generates a vapor, mist, aerosol or a dust. 

(b) The Company shall transport the PMN substance to processors only using reusuable 

tote tanks cleaned not more than once per year. 

USE 

(a) The Company shall not use the PMN substance: 

(3) In non-enclosed or unsealed processes when the PMN substance is in 

the form of a powder; 

(4) In non-enclosed or unsealed processes for an application method that 

generates a vapor, mist, aerosol or a dust. 

(5) Other than as an"[ ] film coating additive." 
- 18-

(b) The Company shall transport the PMN substance to users only using reusuable tote 

tanks cleaned not more than once per year. 

DISTRIBUTION 

(a) Export Notice Requirement. No later than the date of distribution, the Company shall 

notify in writing any person to whom it distributes the PMN substance that, due to the 

issuance of this Consent Order under section 5( e) of TSCA, the PMN substance is subject 

to the export notification requirements of TSCA section 12(b) and 40 CFR Part 707 

Subpart D. Such notice shall contain, in the form in which it appears in this Consent 

Order, the following information: (1) the PMN number, and (2) either (A) the specific 

chemical identity of the PMN substance, or (B) ifthe specific chemical identity is 

confidential, the generic chemical identity. 

(b) Distribution Requirements. (i) Except after the PMN has been completely reacted as 

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

Company, other than for disposal, only to a person who has agreed in writing prior to the 

date of distribution, to: 

(1) Notify in writing any person to whom it distributes the PMN substance that, 

due to the issuance of this Consent Order under section 5( e) of TSCA, the PMN 

substance is subject to the export notification requirements ofTSCA section 12(b) and 40 

CPR Part 707 Subpart D. Such notice shall contain, in the form in which it appears in 

this Consent Order, the following information: (1) the PMN number, and (2) either (A) 

the specific chemical identity of the PMN substance, or (B) if the specific chemical 
- 19-

identity is confidential, the generic chemical identity. 

(2) Not further distribute the PMN substance to any other person, other than for 

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

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

Company in the Protection in the Workplace section of this Order. 

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

Company in the Hazard Communication Program section of this Order. 

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

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

(6) Not process the PMN substance: 

(i) In non-enclosed or unsealed processes when the PMN substance is in 

the form of a powder; 

(ii) In non-enclosed or unsealed processes for an application method that 

generates a vapor, mist, aerosol or a dust. 

(7) Not use the PMN substance: 

(i) In non-enclosed or unsealed processes when the PMN substance is in 

the form of a powder; 

(ii) In non-enclosed or unsealed processes for an application method that 

generates a vapor, mist, aerosol or a dust. 

(iii) Other than as an"[ ] film coating additive". 
-20-

(8) Shall transport the PMN substance only: 

(i) Using reusuable tote tanks cleaned not more than once per year. 

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

may distribute the PMN substance outside the Company for temporary transport and 

storage in sealed containers (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 the Company or a person who 

has given the Company the written agreement required by paragraph (b). 

(2) Any human exposure or environmental release resulting from opening the 

sealed containers and removing or washing out the PMN substance may occur only while 

the PMN substance is in the possession and control of the Company or a person who has 

given the Company the written agreement required by paragraph (b). 

(d) Recipient Non-Compliance. If, at any time after commencing distribution in 

commerce of the PMN substance, the Company obtains knowledge that a recipient of the 

substance has failed to comply with any of the conditions specified in paragraph (b) of 

this Distribution section or, after paragraph (b )(2) expires in accordance with 

subparagraph ( e )(1 ), has engaged in a significant new use of the PMN substance (as 

defined in 40 CPR 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: 
- 21 -

(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 (b) of this Distribution section, or has engaged in a significant new use of the 

PMN substance without submitting a significant new use notice to EPA. 

(2) That, within 15 working days of notifying the recipient of the noncompliance, 

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

recipient is aware of the terms of paragraph (b) of this Distribution section and will 

comply with those terms, or is aware of the terms of the significant new use rule for the 

PMN substance and will not engage in a significant new use without submitting a 

significant new use notice to EPA. 

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

subparagraph (d)(2) of this Distribution section, the Company obtains knowledge that the 

recipient has failed to comply with any ofthe conditions specified in paragraph (b) of this 

Distribution section, or has engaged in a significant new use of the PMN substance 

without submitting a significant new use notice to EPA, the Company shall cease 

supplying the PMN substance to that recipient, shall notify EPA ofthe failure to comply, 

and shall resume supplying the PMN substance to that recipient only upon written 

notification from the Agency. 

(e) Sunset Following SNUR. (1) Paragraph (b)(2) ofthis Distribution section shall 

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

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

Federal Court seeking judicial review of the SNUR. If the Company is so notified, 
-22-

paragraph (b )(2) 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 (b )(2) 

of this Distribution section expires in accordance with subparagraph (e)(l), the Company 

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

SNUR. Such notification must be in writing and must specifically include all limitations 

contained in the SNUR which are defined as significant new uses, and which would 

invoke significant new use notification to EPA for the PMN substance. Such notice must 

also reference the publication of the SNUR for this PMN substance in either the Federal 

Register or the Code ofF ederal Regulations. After promulgation of a SNUR and 

expiration of subparagraph (b )(2), such notice may substitute for the written agreement 

required in the introductory clause of paragraph (b); so that, if the Company provides 

such notice to the persons to whom it distributes the PMN substance, then the Company 

is not required to obtain from such persons the written agreement specified in paragraph 

(b). 

DISPOSAL 

(a) The Company shall dispose ofthe PMN substance and any waste stream containing 

the PMN substance only as follows. This provision does not supersede or preempt any 

applicable federal, state, and local laws and regulations if those laws are more stringent 

than the requirements below. 

. ' 
-23-

(1) The PMN substance must be disposed of only by incineration in a RCRAapproved hazardous waste incinerator. 

(2) Waste streams from manufacture must be disposed of only by incineration in 

a RCRA-approved hazardous waste incinerator. 

(3) Waste streams from processing must be disposed of only by incineration in a 

RCRA-approved hazardous waste incinerator. 

(4) Waste streams from use must be disposed of only by: 

(i) incineration in a RCRA-approved hazardous waste incinerator or 

(ii) Recycling via polymer reclamation. 

(5) The Company shall not dispose of or release the PMN substance into the 

environment. 

RELEASE TO WATER 

(a) This provision does not supersede or preempt any applicable federal, state, and local 

laws and regulations. (Those other laws may be more stringent than the requirements 

below.) The Company is prohibited from any predictable or purposeful release ofthe 

PMN substance, or any waste stream from manufacturing, processing, or use containing 

the PMN substance into the waters ofthe United States. 

III. RECORDKEEPING 

(a) Records. The Company shall maintain the following records until5 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: 
-24-

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

qualify for any one or more of the exemptions described in Section I, Paragraph (b) of 

this Order. Such records must satisfy all the statutory and regulatory recordkeeping 

requirements applicable to the exemption being claimed by the Company. Any amounts 

or batches of the PMN substance eligible for the export only exemption in Section I, 

Paragraph (b)(3) of this Order are exempt from all the requirements in this 

Recordkeeping section, if the Company maintains, for 5 years from the date of their 

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

12(a)(l)(B) and 12(b), respectively. Any amounts or batches of the PMN substance 

eligible for the research and development exemption in Section I, Paragraph (b)(4) of this 

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

Company maintains, for 5 years from the date of their creation, the records required by 

40 CFR 720.78(b). For any amounts or batches of the PMN substance claimed to be 

eligible for any other exemption described in Section I, Paragraph (b) ofthis Order, the 

Company shall keep records demonstrating qualification for that exemption as well as the 

records specified in paragraphs (2) and (3) below, but is exempt from the other 

recordkeeping requirements in this Recordkeeping section; 

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

substance and the corresponding dates of manufacture and import; 

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

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

to whom the Company directly sells or transfers the PMN substance, the date of each sale 

or transfer, and the quantity of the substance sold or transferred on such date; 
-25-

(4) Records documenting the address of all sites ofmanufacture, import, 

processing, and use; 

( 5) Records documenting establishment and implementation of a program for the 

use of any applicable personal protective equipment required pursuant to the Protection in 

the Workplace section of this Order; 

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

Workplace section of this Order that chemical protective clothing is impervious to the 

PMN substance; 

(7) Records documenting establishment and implementation of the hazard 

communication program required by the Hazard Communication Program section of this 

Order; 

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

ofthis Order; 

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

Communication Program section of this Order; 

(1 0) Records documenting compliance with any applicable manufacturing, 

processing, use, and distribution restrictions in the Manufacturing, Processing, Use, and 

Distribution sections of this Order, including distributees' written agreement to comply 

with the Distribution section of this Order; 

(11) Records documenting compliance with any applicable disposal requirements 

under the Disposal section of this Order, including method of disposal, location of 

disposal sites, dates of disposal, and volume ofPMN substance disposed. Where the 

estimated disposal volume is not known to the Company and is not reasonably 
-26-

ascertainable by the Company, the Company must maintain other records which 

demonstrate establishment and implementation of a program that ensures compliance 

with any applicable disposal requirements; 

(12) 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; 

(13) Copies of any Transfer Documents and notices required by the Successor 

Liability section of this Order, if applicable; and, 

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

PMN substance is manufactured or imported. 

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

activities ofthe Company and its Contract Manufacturer, if applicable, and not to 

activities of the Company's customers. 

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

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

this "collection of information" unless this Order displays a currently valid control 

number from the 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. 
-27-

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

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

720.122, EPA may occasionally conduct on-site compliance inspections of Company 

facilities and conveyances associated with the PMN substance. To facilitate such 

inspections, EPA personnel may contact the Company in advance to request information 

pertinent to the scheduling and conduct of such inspections. Such requests may be 

written or oral. The types of information that EPA may request include, but are not 

limited to, the following: 

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

within the subsequent 12 months; 

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

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

substance; 

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

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

substance; 

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

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

substance; 

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

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

this Order or conducting an inspection for that purpose. 
- 28-

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

reasonable period of time, but in no event later than 30 days after receiving EPA's 

request. When requested in writing by EPA, the Company's response shall be in writing. 

To the extent the information is known to or reasonably ascertainable by the Company at 

the time of the request, the Company's response shall demonstrate a good faith effort to 

provide reasonably accurate and detailed answers to all ofEPA's requests. 

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

that the Company submits to EPA pursuant to paragraph (b) shall be protected in 

accordance with § 14 of TSCA and 40 CFR Part 2. 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

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

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

in the PMN substance, including the right to manufacture the PMN substance, to another 

person outside the Company (the "Successor in Interest"). 

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

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

effective before EPA receives a notice of commencement of manufacture or import 

("NOC") for the PMN substance from the Company pursuant to 40 CFR 720.102, the 

Successor in Interest must submit a new PMN to EPA and comply fully with Section 
-29-

5(a)(l) ofTSCA and 40 CFR part 720 before commencing manufacture or import of the 

PMN substance. 

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

effective after EPA receives a NOC, the Successor in Interest shall comply with the terms 

of this Order and shall not be required to submit a new PMN to EPA. 

(c) Definitions. The following definitions apply to this Successor Liability section of the 

Order: 

(1) "Successor in Interest" means a person outside the Company who has 

acquired the Company's full interest in the rights to manufacture the PMN substance, 

including all ownership rights and legal liabilities, through a transfer document signed by 

the Company, as transferor, and the Successor in Interest, as transferee. The term 

excludes persons who acquire less than the full interest of the Company in the PMN 

substance, such as a licensee who has acquired a limited license to the patent or 

manufacturing rights associated with the PMN substance. A Successor in Interest must 

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

CFR 720.22(a)(3) and 40 CFR 720.3(z). 

(2) "Transfer Document" means the legal instrument(s) used to convey the 

interests in the PMN substance, including the right to manufacture the PMN substance, 

from the Company to the Successor in Interest. 
-30-

(d) Notices. 

(1) Notice to Successor in Interest. On or before the effective date of the transfer, 

the Company shall provide to the Successor in Interest, by registered mail, a copy of the 

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

as Attachment B to this Order. 

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

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

document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405), 

1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. 

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

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

substance is manufactured or imported. Copies of the Transfer Document must also be 

made available for inspection pursuant to Section 11 of TSCA, must state the effective 

date of transfer, and must contain provisions which expressly transfer liability for the 

PMN substance under the terms of this Order from the Company to the Successor in 

Interest. 

(e) Liability. 

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

Order until the effective date of the transfer described above. 

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

of this Order effective as of the date of transfer. 
- 31 -

(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) ofthe Testing 

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

specified production volume ("test trigger"), the aggregate volume of the PMN substance 

manufactured and imported by the Company up to the date of transfer shall count towards 

the test trigger applicable to the Successor in Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

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

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

of, the PMN substance, to modify or revoke substantive provisions of this Order. The 

exposures and risks identified by EPA during its review 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. 
-32-

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. 
- 33-

VII. EFFECT OF CONSENT ORDER 

(a) Waiver. By consenting to the entry of this Order, the Company waives its rights to 

file objections to this Order pursuant to section 5(e)(l)(C) ofTSCA, to receive service of 

this Order no later than 45 days before the end of the review period pursuant to section 

5(e)(l)(B) ofTSCA, and to challenge the validity of this Order in any subsequent action. 

Consenting to the entry of this Order, and agreeing to be bound by its terms, do not 

constitute an 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. 

(b) CBI Brackets. By signing this Order, the Company represents that it has carefully 

reviewed this document and hereby agrees that all information herein that is claimed as 

confidential by the Company (per section 14 ofTSCA, 40 CPR Part 720 Subpart E, and 

40 CPR Part 2) is correctly identified within brackets and that any information that is not 

bracketed is not claimed as confidential. To make this document available for public 

viewing, EPA will remove only the information contained 

Date 

• 

co 

Resource Division 

EHS & R Manager 

Company: 3M Company 
- 1 -

ATTACHMENT A 

DEFINITIONS 

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

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

accordance with the nomenclature system developed by the Chemical Abstracts Service's 

rules of nomenclature, or a name which will clearly identify a chemical substance for the 

purpose of conducting a hazard evaluation. 

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

barrier to prevent dermal contact with chemical substances of concern. Examples can 

include, but are not limited to: full body protective clothing, boots, coveralls, gloves, 

jackets, and pants. 

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

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

containing the chemical substance in a commercial enterprise providing saleable goods or 

a service to consumers (e.g., a commercial dry cleaning establishment or painting 

contractor). 

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

code number, trade name, brand name, or generic chemical name used to identify a 

chemical substance other than by its chemical name. 

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

product containing the chemical substance in or around a permanent or temporary 

household or residence, during recreation, or for any personal use or enjoyment. 

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

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

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

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

vessel, storage tank, or the like that contains a hazardous chemical. For purposes of this 

section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a 

vehicle, are not considered to be containers. 

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

authorized to manufacture and import the PMN substance under the conditions specified 

in Part II. of this Consent Order and in the Consent Order for Contract Manufacturer. 
- 2-

"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 labeled container. 

"Impervious." Chemical protective clothing is "impervious" to a chemical 

substance if the substance causes no chemical or mechanical degradation, permeation, or 

penetration of the chemical protective clothing under the conditions of, and the duration 

of, exposure. 

"Manufacturing stream" means all reasonably anticipated transfer, flow, or 

disposal of a chemical substance, regardless of physical state or concentration, through all 

intended operations of manufacture, including the cleaning of equipment. 

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

chemical substance. 

"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. 

"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 
- 3 -

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. 
3M Company 

Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

P09-0048 

PMNNumber 

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

sell or otherwise transfer to , ("Successor in 

Interest") the rights and liabilities associated with manufacture of the above-referenced 

chemical substance, which was the subject of a premanufacture notice ("PMN") and is 

governed by a Consent Order issued by the U.S. Environmental Protection Agency 

("EPA") under the authority of §5(e) of the Toxic Substances Control Act ("TSCA," 15 

U.S.C. §2604(e)). 

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

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

Order limiting manufacture, processing, use, distribution in commerce and disposal of the 

PMN substance, shall be the responsibility of the Successor in Interest. Successor in 

Interest also certifies that it is incorporated, licensed, or doing business in the United 

States in accordance with 40 CFR 720.22(a)(3). 

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

reasserts, 

_ relinquishes, or 

modifies 

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

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

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

Where "modifies" is indicated, such modification shall be explained in detail in an 

attachment to this Notice of Transfer. Information which has been previously disclosed 

to the public (e.g., a chemical identity that was not claimed as CBI by the original 

submitter) would not subsequently be eligible for confidential treatment under this Notice 

of Transfer. 
- 5 -

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

3M Company P09-0048 

Company (Transferor) PMNNumber 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Interest 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Address 

City, State, Zip Code 

,. . 

. . 
- 6-

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone 
• •