ATTACHMENT C 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AN D TOXICS 

REGULATION OF NEW CHEMICAL SUBSTANCES 

PENDING DEVELOPMENT Of INFORMATION 

In the matter of: ) Premanufacture Notice Number: 

) 

) 

) 

) 

) 

[ ) P-11-0484 and P-11-0543 

) 

) 

) 

) 

) 

Consent Order for Contract Manufacturer 

EPA SANITIZED 
(a) Scope. [ 

with [ 

CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

J ("the Contract Manufacturer") has entered into a contract 

] ("the Companies") to manufacture (defined 

by statute to include import) exclusively for the Companies the following chemical substances: 

P-11-0484, [ 

] and P-11-0543 

] ("the PMN substances"). 

The requirements of this Order apply to all commercial manufacturing, processing, distribution 

in commerce, use and disposal of the PMN substances in the United States by the Contract 

Manufacturer, 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 substances is exempt from the requirements of this Order (except the requirements in the 

Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the 

extent that (1) these activities are conducted in full compliance with all applicable requirements 

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

recordkeeping as required in the Recordkeeping section of this Order. 

(1) Export. Until the Contract Manufacturer begins commercial manufac ture of the 

PMN substances for use in the United States, the requirements of this Order do not apply to 
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manufacture, processing or distribution in commerce of the PMN substances solely for expot1 in 

accordance with TSCA § 12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once 

the Contract Manufacturer begins to manufacture the PMN substances for use in the United 

States, no further activity by the Contract Manufacturer involving the PMN substances is exempt 

as "solely for export" even if some small amount of the PMN substances is later exported. /\t 

that point, the requirements of this Order apply to all activities associated vvith the PMN 

substances while in the territory of the United States. Prior to leaving U.S. ten·itory, even those 

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

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

Order. 

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

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

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

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 of the PMN substances 

when manufactured solely for non-commercial research and development per 40 CFR 720.30(i) 

and TSCA §S(i). 

(3) Byproducts. The requirements of this Order do not apply to the PMN substances 

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). 

(4) No Separate Commercial Purpose. The requirements of this Order do not apply to 

the PMN substances when it is manufactured, pursuant to any of the exemptions in 40 CrR 

720.30(11), with no commercial purpose separate from the substances, mixture, or article of 
.... - .) -

which it is a part. 

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

substances 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)(l ). 

(c) Automatic Sunset. If the Contract Manufacturer has obtained for the PMN substances a Test 

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

Exemption ("LYE'') or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)(4) 

and 40 CFR 723 .50(c)( I) and (2) respectively, any such exemption is automatically rendered null 

and void as of the effective date of this Consent Order. 

11. TERMS OF MANUFACTURE PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION OF INFORMATION 

PROHIBITION 

1\s a condition of manufacturing (defined by statute to include import) the PMN 

substances for the Companies, the Contract Manufacturer is prohibited from manufacturing, 

processing, distributing in commerce, using, or disposing of the PMN substances 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 

substances, and the completion of EP 1\ 's review of, and regulatory action based on, that 

information, except in accordance with the conditions described in this Order. 
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CHEMICAL SYNTHESIS AND COMPOSITION 

(b) Restrictions. The Contract Manufacturer shall not manufacture the PMN substances, unless 

testing of the [ ] starting raw material by the Companies or as evidenced 

by a Cet1ificate of Analysis from the raw material supplier. meets the established purity 

level as specified in Table I and Table 2 of this Order. 1 fa product that contained [ 

] products was processed or manufactured in the equipment at the facility 

where the PMN substances are to be made, the Companies shall test the Initially Isolated 

Formulations of the PMN substances for the analytes specified in Table 3 of this Order to 

confirm that cross-contamination from the manufacture of the product with l 

] has not occurred. Testing shall be conducted upon initial 

commencement of manufacture and at least annually thereafter, until one year after the date 

of the last manufacture or proces~ing of a product that contains [ ] products at 

that facili ty. No testing of Initially Isolated Formulations of the PMN substances will be 

required if[ ] have not been previously manufactured or processed or 

were not manufactured or processed at the facili ty within one year of manufacturing or 

processing of the PMN substances. The Companies shall submit all test protocols to EPA 

for approval prior to initiating testing. Protocols should be submitted to the OPPT 

Document Control Office (7407M), 1200 Pennsylvania 1\ve, N. W., Washington, DC 

20460: Attention: Program Manager, New Chemicals Program, Chemical Control Division. 

EPA will respond to the Companies within [ ] weeks of receiving the written protocols. 

Absent a response from EPA within the [ ] window, the Companies are permitted to 

rely on its protocols until an EPA response is received. The Companies shall record the 
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levels of impurities [ ] associated with the 

PMN substances manufactured by the Contract Manufacturer, as specified below. The 

Companies shall record analytes present in the [ ], at each manufacturing 

facility using this raw material (as shown in Table 1). f-urther, the Companies will also 

annually record the analyte [ ] present in the [ 

] starting rav.l material (as shown in Table 2). The Companies shall make 

its best effort to minimize these impurities. If any new manufacturing facilities are added, 

or the manufacturing process is significantly altered, then the PMN substances must be 

tested at commencement of these actions and annually thereafter. 

(b) Reporting. The Companies shall test representative samples of the Initially Isolated 

Formulations of the PMN substances manufactured (defined by statute to include import) by the 

Contract Manufacturer to determine compliance with the requirements in paragraph (a). The 

Companies shall test the Initially Isolated Formulations of the PMN substances at each 

manufacturing facility both (I) at the initial commencement of non-exempt manufacture of the 

PMN substances at that facility, and (2) at least annually thereafter during every year in which 

the PMN substance is manufactured at that facility. If any new manufacturing facility is added, 

or if the process of manufacture of the PMN substances or any intermediate thereof is 

significantly altered, then the Initially Isolated formulation of the PMN substances must be 

tested at commencement of these actions and annually thereafter, as set forth above. If the PMN 

substances are imported, the Companies shall obtain from the foreign manufacturer written 

documentation to certify that representative samples ofthe imported form of the PMN 

substances have been tested, consistent with the requirements of this paragraph (b) and 
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determined to comply with the requirements of paragraph (a). 

The Companies shall report the above testing to EPA at initial commencement of 

manufacture (defined by statute to include import) and again if any new manufacturing facility is 

added or if the process of manufacture of the PMN substances or any intermediate thereof is 

significantly altered. The Companies shall continue to report these impurity levels to EPA 

annual ly. This is consistent with the current annual reporting cycle [ 

]. In addition to the reporting for the 

Initially Isolated Formulations of the PMN substances itself, the Companies shall, for the [ 

] starting raw material, annually report (I) the average values and the 

range of values, including outlying data, for the routine testing for the analytes specified in Table 

I, and (2) the results of the annual testing for the analyte specified in Table 2. 

TABLE I: Chemicals to be Routinely Tested in [ ] Starting Raw Material 

Analyte CAS Number Limit in [ ] 

[ ] [ J [ ] minimum 

[ ] [ ] l 1 

[ ] [ J 

TABLE 2: Chemicals to be Tested at least Annually in [ j Starting Raw Material 

Analyte CAS. Number Limit in [ ] 

[ ] [ ] [ ] 
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TABLE 3: Chemicals to be Tested in the Initially Isolated Formulations of the PMN Substance 

Estimated Maximum in Initially 

Analyte CAS Number Iso,Iated Formulations of the PMN 

Substance 

[ ] [ ) [ · 1 (combined) [ ] [ ] 

[ ] [ ] [ ] 

MANUFACTURING 

(a)( I) Prohibition. The Contract Manufacturer shall not begin manufacture (defined by statute to 

include import) of the PMN substances until the Contract Manufacturer or the Companies 

receive a fully executed copy of the Consent Order for Contract Manufacture from EPA. 

(2) The Contract Manufacturer shall not cause, encourage, or suggest the manufacture 

(defined by statute to include import) of the PMN substances by any other person, except the 

Companies. 

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

promulgation of a final significant new use rule ("S 'UR") governing the PMN substances under 

section 5(a)(2) ofTSCA unless the Contract Manufacturer is notified on or before that day of an 

action in a Federal Court seeking judicial review of the SNUR. If the Contract Manufacturer is 

so notified, subparagraph (a)(2) shall not expire until EPA notifies the Contract Manufacturer in 

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

the SNUR affirmed. 
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(4) Notice ofSNUR. When EPA promulgates a final SNUR for the PMN substances 

and subparagraph (a)(2) expires in accordance with subparagraph (a)(3), the Contract 

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

(defined by statute to include import) the PMN substances 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 substances. Such notice must also reference the publication of 

the SNUR for the PMN substances in either the Federal Register or the Code of Federal 

Regulations. 

(c) The Companies and their Contract Manufacturer(s) shall not manufacture the 

PMN substances P-1 I -0484 and P-1 I -0543 exceeding: 

1 kilograms annually, respectively, while the Companies conduct 

the Tier I testing specified in their Consent Order for these PMN substances, and 

) kilograms annually, respectively, while the Companies conduct the ti er 2 

and 3 testing specified in their Consent Order for these PMN substances. 

The Contract Manufacturer shall: 

(a) Use the chemical substances PI 1-0484 and P 11-0543 only as surfactants for [ 

] applications as described in the PMNs; and 
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(b) Not use the PMN substances Pl l-0484 and Pll-0543 for consumer spray applications. 

DISTRIBUTION 

(a) The Contract Manufacturer shall distribute the PMN substances only to ''the Companies." 

(b) Export Notice Requirement. No later than the date of distribution, the Contract 

Manufacturer shall notify in writing any person to whom it distributes the PMN substances that, 

due to the issuance of this Consent Order under section S(e) ofTSCA, the PMN substances is 

subject to the export notification requirements ofTSCA 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: (I) the PMN number, and (2) either (A) the specific chemical identity of 

the PMN, or (B) if the specific chemical identity is confidential, the generic chemical identity. 

DISPOSAL 

(b) The Contract Manufacturer shall dispose of the PMN substances and any waste stream 

containing the PMN substances only as follows: all manufacturing and processing-related 

waste containing the PMN substances must be incinerated in an incinerator operating at the 

temperature of at least I 000 degrees C and a residence time of minimum of 2 seconds. Any 

tank or vessel washings, residues from transport vessels or tanks, and similar materials that are 
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captured and retained in the normal course of manufacturing and processing for re-use in 

manufacturing of the PMN substances or products made from the PMN substances are exempt 

from this method of disposal. 

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. 

RELEASE TO WATER 

This provision does not supersede or preempt any applicable federal, state, and local laws and 

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

The Contract manufacturer is prohibited from any predictable or purposeful release of the PMN 

substances, or any manufacturing/processing waste streams containing the PMN substances to 

the waters of the United States except [ 

). 

RISK NOTIFICATION 

(a) If as a result of the test data required under the terms of this Order. the Contract 

Manufacturer becomes aware that the PMN substances may present a risk of injury to human 

health or the environment (or is so notified by EPA), the Contract Manufacturer must incorporate 

this ne\v information, and any information on methods for protecting against such risk, into a 
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Material Safety Data Sheet ("MSDS") for the PMN substances, as described in 40 CFR section 

721.72(c), within 90 days from the time the Contract Manufacturer becomes aware ofthe new 

information. If the PMN substances is not being manufactured (defined by statute to include 

import), processed, or used in the Contract Manufacturer's workplace, the Contract Manufacturer 

must add the new infonnation to an MSDS before the PMN substances is reintroduced into the 

workplace. 

(b) The Contract Manufacturer must ensure that persons who will receive the PMN substances 

from the Contract Manufacturer, or who have received the PMN substances from the Contract 

Manufacturer within 5 years from the date the Contract Manufacturer becomes aware of the new 

information described in paragraph (a) of this section, are provided an MSDS containing the 

information required under paragraph (a) within 90 days from the time the Contract 

Manufactui·er becomes aware of the new information. 

III. RECORDKEEPING 

(a) Records. The Contract Manufacturer 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 II ofTSCA: 

(I) Exemptions. Records documenting that the PMN substances 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 Contract Manufacturer. Any amounts or batches of the PM 
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substances eligible for the export only exemption in Section I, Paragraph (b)( I) of this Order arc 

exempt from all the requirements in this Rccordkeeping section, if the Contract Manufacturer 

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 substances eligible for the research and development exemption in Section I, 

Paragraph (b )(2) of this Order are exempt from all the requirements in this Recordkeeping 

section, if the Contract Manufacturer 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 substances 

claimed to be eligible for any other exemption described in Section I, Paragraph (b) of this 

Order, the Contract Manufacturer shall keep records demonstrating qualification for that 

exemption as well as the records specified in paragraphs (3) and (4) below, but is exempt from 

the other recordkeeping requirements in this Recordkeeping section; 

(2) Records documenting compliance with the Chemical Synthesis and Composition, 

Manufacturing, and Distribution sections of this Order; 

(3) Records documenting the manufacture (defined by statute to include import) volume 

of the PMN substances and the corresponding dates of manufacture; 

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

address, if different) of all persons outside the site of manufacture (defined by statute to include 

import) to >vvhom the Contract Manufacturer directly sells or transfers the PMN substances, the 

date of each sale or transfer, and the quantity of the substances sold or transferred on such date; 

(5) Records documenting the address of all sites of tminufacture (defined by statute to 

include import); 
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(6) Records documenting compliance with any applicable manufacturing, processing, 

use, and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections 

of this Order; 

(7) 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 of PMN substances disposed; 

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

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

Order; and, 

(9) The Contract Manufacturer shall keep a copy of this Order at each of its sites where 

the PMN substances is manufactured (defined by statute to include import), processed, or used. 

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

of the Contract Manufacturer, and not to activities of the Contract Manufacturer'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 Contract Manufacturer 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 Contract 

Manufacturer. The "collection of information" required in this TSCA §5(e) Consent Order has 

been approved under currently valid OMB Control Number 2070-0012. 
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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 Contract Manufacturer facilities and 

conveyances associated with the PMN substances. To facilitate such inspections, EPA personnel 

may contact the Coptract Manufacturer 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: 

(!) Expected dates and times when the PMN substances will be in production within the 

subsequent 12 months; 

(2) CuiTent workshift schedules for workers who are involved in activities associated 

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

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

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

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

associated with the PMN substances and may reasonably be exposed to the PMN substances that 

are collected during the manufacture or processing of the PMN substances; 

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

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

or conducting an inspection for that purpose. 

(b) Contract Manufacturer's Response. The Contract Manufacturer 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 Contract Manufacturer"s response shall 
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be in writing. To the extent the information is known to or reasonably ascertainable by the 

Contract Manufacturer at the time of the request, the Contract Manufacturer's response shall 

demonstrate a good faith effort to provide reasonably accurate and detailed answers to all of 

EPA's requests. 

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

Contract Manufacturer submits to EPA pursuant to paragraph (b) shall be protected in 

accordance vvith § 14 ofTSCA and 40 CFR Part 2. 

V. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Contract Manufacturer may petition EPA at ahy time, based upon new information 

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

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

exposures and risks identified by EPA during its review of the PMN substances and the 

information EPA determined to be necessary to evaluate those exposures and risks arc 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 
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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 substances. 

In addition, the Contract Manufacturer 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. 
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VI. EFFECT OF CONSENT ORDER 

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

rights to ·file objections to this Order pursuant to section S(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 

S(e)(l)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. 

Consent,ing to the entry of this Order, and agreeing to be bound by its terms, do not constitute an 

admission by the Contract Manufacturer as to the facts or conclusions underlying the Agency's 

determinations in this proceeding. This waiver does not affect any other rights that the Contract 

Manufacturer may have under TSCA. 

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

carefully reviewed this document and hereby agrees that al1 information herein that is claimed as 

confidential by the Contract Manufacturer (per section 14 of TSCA, 40 CFR Part 720 Subpart E, 

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

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

EPA will remove only the information contained within the brackets. 

Date [ 

Maria 

~-~L---_ J. Doa, P . ., Director 

Chemical Contra Division 

Office of Pollution Prevention and Taxies 

_ _ ) ] Nan1e: t 

Title: [ 

Contract Manufacturei·: · 
ATTACHMENT 1 

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. 

"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 o'r 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" mean's a person, outside the Companies, who is authorized to 

manufacture (defined by statute to include import) the PMN substance under the conditions 

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

"Final Formulation of the PMN substance" means the formulated dispersion of the PMN 

substance in the form in which it is sold to customers outside the Companies or transferred to a 

different business unit within the Companies. The term does not include intermediate dilutions 

of the PMN substance that are intended only for use within the Companies for further dilution 

prior to sale. 

"Identity" means any chemical or common name used to identify a chemical substance or 

a mixture containing that substance. 
A-2 

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

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

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

container. 

"Initially Isolated Formulations of the PMN substance·· means a common intermediate 

PMN formulation, as it exists when first produced md isolated after the polymer manufacturing 

process, that can be further processed or repackaged at the direction of the Companies to result 

ultimately in one or more final formulations of the PMN substance. 

"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 materi al safety data sheet, the written listing of data for the chemical 

substances. 

"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 (defined by statute to include import) or processed. 

"PMN substance" means the chemical substance described in the ?remanufacture notice 

submitted by the Companies relevant to this Order. 

"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. 
A-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 neither 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, regardl ess 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. 

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

work areas. 
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] 
ATTACHMENT 1 

DEFINITIONS 

Note: The allached 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. 

·'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 v.rho 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 Companies, who is authorized to 

manufacture (defined by statute to include import) the PMN substance under the conditions 

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

"Final Formulation of the PMN substance" means the formulated dispersion of the PMN 

substance in the form in which it is sold to customers outside the Companies or transferred to a 

different business unit within the Companies. The term does not include intermediate dilutions 

of the PMN substance that are intended only for use within the Companies for further dilution 

prior to sale. 

" Identity" means any chemical or common name used to identify a chemical substance or 

a mixture containing that substance. 
A-2 

"Immediate usc." 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 \VOrk shift in which it is transferred from the labeled 

container. 

"Initially Isolated Formulations of the PMN substance" means a common intermediate 

PMN formulation, as it exists when first produced and isolated after the polymer manufacturing 

process, that can be further processed or repackaged at the direction of the Companies to result 

ultimately in one or more final formulations of the PMN substance. 

"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 

substances. 

"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 vvorkplace 

air may occur. 

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

mixtures are manufactured (defined by statute to include import) or processed. 

"PMN substance" means the chemical substance described in the Premanufacture notice 

submitted by the Companies relevant to this Order. 

·'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. 
A-3 

"Scaled 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 neither 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. 

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

work areas.