lJ\{W~JrfLtUNVIRONMENTAL PROTEC'110N AGENCY 

EPA SAI'IIJp~ICE OF POLLUTION PREVENTION AND TOXIes 

sw,; J11)~ULATION OF A NEW CHEMICAL SIJBSTANCE 

\~.' 

- PEl'..'DING DEVELOPMENT OF lNFORMATlON . \./\ . c..'2i 

In the matter of: ) 

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) 

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) 

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Premanufacture Notice Number: 

) P06-0702 

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) 

) 

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Consent Order and Determinations Supporting Consent Order 

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TABLE OF CONTE:N"TS 

Preamble 

L Introduction 

, 

If. .' Sumwary ofTenns of the Order 

III. Contents ofPMN 

N. EPA's Assessment of Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate HUIlJ1i.n Health Effects 

Consent Order 

1. Scope of Applicability and Exemptions 

II. Tenns of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal 

Pending Submission and Evaluation of Information 

III. Rerordkeeping 

N. Requests for Pre-Inspection Information 

V. Suecessor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Statistical Analysis ofNCELs Analytical Method Verification Results 

Attachment C - Notice of Transfer of Consent Order 

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II1 

PREAMBLE 

I. INTRODUCTION 

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

2604( QJ), the Environmcntal Protection Agency ("EPA" or "thc Agency") issues the attached 

Order, regarding premanufacture notice ("PMN") P-06-0702 for the chemical substance 

. (the "PMN substance") submitted by 

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

period. The Company submitted the PMN to EPA pursuant to section 5(a)(I) ofTSCA and 40 

CPR Part 720. 

Under § 15 ofTSCA, it is unlawful for any person to fail or refuse· to eomply 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 subj ect to an Order issued under § 5 of 

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

II. SUMMARY OF TERM') OF THE ORDER 

The Consent Order for this PMN substance require!; the Company to: 

(1) submit to EPA certain toxicity testing at least 14 weeks beforc manufacturing or 

importing a total . kilograms of the PMN substance; 

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

(3) provide its workers respirators to prevent inhalation exposure; 

(4) as an alternative to using respirators, maintain workplace airborne concentrations of 

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IV 

the PMN substance at or below a specified New Chemical Exposure Limit ("NCEL") of 

OJ 4 mg/mJ verified by actual exposure monitoring data (To pursue this option, a sampling and 

analytical method must be developed by the Company, verified by an independent third-party 

laboratory, and submitted to EPA,); 

(5) label the PMN substance and provide Material Safety Data Sheets (MSDS) and 

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

section; 

(6) distribute the PMN substaneconlyto 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; 

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

(8) maintain certain records. 

III. CONTEl'Il'S OF PMN 

Confidential Business Information Claims C$m9ktlt<JcI in the Preamble and Order): 

Company identity, chemical identity, planf site, use, production volume. 

Chemical Identitv: 

Specific: 

Generic: Substituted aliphatic amine 

Specific: . 

Generic: Polymer curative 

Maximum 12-MonthProduction Volume: 

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Test Data Slll)!nitted During the Review of the PMN: 

Glove Penneability)3tudy with J-..1}30X style 9-912 gloves = impervious for 110 minutes 

Acute Aguatic Toxicity Testing Acute toxicity studies with daphnia, algae, and fish, as well as 

a fish toxicity stUdy with mitigation by humic acid were submitted on the P1vfN substance. 

Results of the studies showed that daphnia Was the most sensitive species. Based on these 

studies, a concern concentration was established by EPA at 1 part per billion PMN substance in 

surface water. 

IV. EPA'S ASSESSl\:lENT OF RISK 

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

human exposure and environmental release of the P1v1N substance, based on the information 

qurrently available to the Agency. 

Human Health Effects Summary: 

Absorption: GI tract 60% 

Lung 100% 

Skin 80% 

Toxicological Endpoints of Concern: Chronic liver toxicity~ acute oral toxicity and corrosion to 

membranes, dermal toxicity, inhalation toxicity, dermal and eye irritation. 

Basis: By analogy to test data on 

Environmental Effects Summary: Environmental toxicity estimates are based on acute toxicity 

testing on the PMN substance. Environmental risk estimates are based on estimated releases to 

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VI 

surface water during processing and use operations. During processing, EPA's Concentration of 

Concern (COC) of1 part per billion is predicted to be exceeded 112 out of 115 days per year 

(Surface Water Concentration: 76 ppb). During use, the COC is predicted to be exceeded 51 out 

of 55 days per year (Surface Water Concentration: 235 ppb). 

Exposure and Environmental Relcase Summary: 

Manufacture Process Use 

I # Sites . 

Workers 

! I (#/site) v 

• Exposure 

I (days/year) 

Dermal Exposure negligible (mg/day) 

I Inhalation Exposure 

i (mg/day) I 

negligible 

'"~-""" ---~--------

Drinking Water NA NA NA Exposure (mg/-day) , 

-

Releases (days/year) NA 

Release to Water NA (kg/day) 

Risk to Workers: Predicte-d dennal and inhalation occupational exposures far excee-d acceptable 

levels and indicate unacceptable Margins of Exposures (MOE's). Specifically, PMN exposures 

are expccte-d to excee-d acceptable levels by 30-fold for inhalation exposure (during application 

coating) and by far larger factors for dermal exposure (during drum loading/unloading). 

NlOSH Assigned Protection Factor ("APF"): 50 

New Chemical. Exposure Limit = 0.14 mg/m3 

as an 8-hour time-weighted average ("TWA"). 

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V. EPA'S CONCI,USIO:-JS OF LAW 

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

(a) EPA is unable to determine the potential for human health effects, such a~ chronic liver 

toxicity, acute oral toxicity, dermal toxicity, inhalation toxicity, dermal and eye irritation from 

exposure to the PMN substance. Further, EPA is unable to determine the potential fur toxicity to 

aquatic organisms from environmental release of the PM-1\[ substance. EPA therefore concludes, 

pursuant to § 5( e )(1 )(A)(i) ofTSCA, that the infoitnation availab Ie 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 acute oral toxicity, dennal toxicity, inhalation toxicity, dermal 

and eye irritation and toxicity to aquatic organisms posed by the uncontrolled manufacture, 

import, processing, distribution in commerce, use, and disposal 0 f the PMN substance, EPA has 

concluded, pursuant to § 5(e)(1)(A)(ii)(l) ofTSCA, that uncontrolled manufiletore, import, 

processing, distribution in commercc, use, and disposal oflbe PMN substance may present an 

unreasonable risk of injury to human health and the environment 

VI. INFORMATION REQUIRED TO EVALUATE HEALTH AND ENVIRON1\IENT AL 

EFFECTS 

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

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

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

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

environmental effects which may be caused by the PMN substance: 

Information 

. Dapbnid Chrome Toxicity Test 

FishEarly Lifestage Toxicity Test 

Guidelines 

OPPTS 850.1300 

OPPTS 850.1400 

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. 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D,C, 20460 

CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

OFFICE OF 

PREVENTION, PESTICIDES AND 

rOXIG SUBSTANCES 

(a) Scope. The requirements of this Order apply to all commercial manufacturing, processing, 

distribution in commerce, use and disposal of the chemical substance 

(p-06-0702)("the PMN substance") in the United StateS by 

("the Company"), except to the extent that those activities are 

exempted by paragraph (b). 

(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal of lhe 

PMN substance is exempt from the requirements of this Order (except lhe requirements in lhe 

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

extent that (1) lhese 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 oflhis Order. 

(1) CompletelY Rea,;ted (Cured). The requirements of this Order do not apply to quantities 

of the PMN substance after they have been completely reacted (cured), 

lnleme! Address (uRL}. hrtp://v.'VfN:epa.gov 

Re.cyc!edIRocyclable 6 Printed wiLl) Vegetable on Based 1:1Y.s on -;00% Poslcor.surner, Process Chlorine Free Recycled Paper 

EPA SANITIZED Page 9 of 74
(2) De Minimis Concen.!!:ations. The requirements of this Order do not apply to quantities 

of the PMN substfu'ce 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 

thePMN substance is ideutified as a potential carcinogen in paragraph (f) of the Hazard 

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

has reason to believe that, during intended activities, the PrvfN substanec in the mixture may be 

reconcentrated above the 1.0 or 0.1 percent level, whichever applies. Ifhis 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 ·ofthe PMN substance for 

use in the United States, the requirements of this Order do not apply to manufacture, pfoeessing or 

distribution in commerce of the PMN substance solely for export in aetordanee with TSCA § 12(a) 

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

manufueture the PMN substance for use in the United States, no further aetivity by the Company 

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

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

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

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

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

Testing section of this Order. 

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(4) ResearCl1 & Devel9pment ("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 of the 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 whcn 

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

720.3(d) and in compliance with 40 CFR720.30(g). 

(6) No Stmarate Commercial Purpose.· The requirements of this Order do not apply to the 

PMN substance when it is manufactured, pursuant to any of the exemptions in 40 CFR 720.30(h), 

with no commercial purpose separate from the substance, mixture, or article of which it is a pari. 

(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 CPR nO.3( c) and in Compliance with 40 

CFR n0.22(b)(1). 

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

Exemption ("TME") under TSCA §5(h)(1) and 40 CPR 720.38 or a Low Volume Exemption 

("LVE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(hX 4) and 40 CFR 

723.50C c)(1) and (2) respectively, any such exemption is automatically rendered null and void as 

of the effective date of this Consent Order. 

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II. TERJ'WS OFMANUI<'ACTURE, IMPORT, I'ROCESSING, 

DISTRIBLTION IN COMMERCE, USE. AND DISI'OSAL 

I'ENDli'lG 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 ofEP A's 

review of, and regulatory action based on, that information, except in accordance with the 

conditions described in this Order. 

TESTING 

(a) SectiqI] 8(e) Reporting, Any information on the PMN substance which reasonably supports 

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

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

Register 11110 .(March 16, 1978) as amended at 52 Federal Register 20083 (May 29, 1987), shall 

reference the appropriate PMN identification number for this substance and shall contain a 

statement that the substance is subject to this Consent Order, Additional information regarding 

seetion B( e) reporting requirements can be found in the reporting guide referenced at 56 Federal 

Registtl,r28458 (June 20, 1991), 

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

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

Protec.:tion Agency, 1200 Pennsylvania Avenue, N. W.,Washington, D.C. 20460, of the following 

information within 10 days of scheduling any study required to be performed pursuant to this 

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

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

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

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

EPA may contact regarding the study; and, 

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

substance is subject to this Consent Order. 

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

pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards 

at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific 

cormnunity at the time the study is initiated. Before starting to conduct any such study, the 

Company must obtain approval of test protocols from EPA by SUbmitting written protocols. EPA 

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

guidelines specified in paragraph (d) provide general guidance for development oftest protocols, 

but are not themselves acceptable protocols. Approval of the test protocol does not mean preacceptance oftest results. 

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

importing the PMN &'ubstance beyond the following aggregate manufacture and import volume 

("the production limit"), unless the Company conduct~ the following studies on the PMN 

substance and submits an final reports and underlying data in accordance with the conditions 

specified in this Testing section. 

Production Limit 

Primary Skin Irritation 

Primary Eye Irritation 

28-Day Repeated Dose (rats/gavage) 

Guideline 

OECD404 

OECD405 

OECD407 

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

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

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

information is involved), the final report of each study and allllnderlying data ("the report and 

data") to EPA no later than 14 weeks prior to exceeding the applicable production Ihnit. The final 

report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted 

to EPA in accordance with the applicable "Reporting," "Data and Reporting," and "Test Report" 

subparagraphs in the applicable test guidelines. However, for purposes of this Consent Order, the 

word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the 

submission of such information is mandatory. EPA will not require the submission of raw data 

such as slides and laboratory notebooks unless if EPA fmds, on the basis of professional judgment, 

that an adequate evaluation of the study cannot take place in the absence of these items. 

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(f) Testing Waiv~rs. The Company is not required to conduct a study specified in paragraph (d) of 

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

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

the Companymay continue to manufacture and import the PMN substance beyond the applicable 

production limit. To seck relief from allY other restrictions of this Order, the Company may make 

a second attempt to obtain unequivocal data by reeonducting the study under the conditions 

specified in paragraphs (b), (c), and (e)(I) and (2). The testing requirements may be modified, as 

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

mutual consent ofEP A and the Company. 

(h) EPA Determination of Invalid Data. 

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

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

a study are seientifically invalid, the Company is prohibited from further manufacture and import 

of the PMN substance beyond the applicable production limit. 

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

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

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

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

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

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

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

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

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

by EPA in the notice des(,Tibed in subparagraph (h)(1). EPA will respond to the Company, in 

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

(ii) The·Corripanymay, within 4 weeks of receiving from EPA the notice described 

in subparagraph (h)(l), submit to EPA a written report refutingEPA's finding. EPA will respond 

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

(i) Company Determination of Invalid Data. 

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

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

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

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

substance beyond the applicable production limit. 

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

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

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

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

report. EPA's written response may either: 

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

beyond the applicable production limit, or 

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

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

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

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

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

Company may exceed the productiori limit and shall submit the report and data in triplicate to EPA 

within a reasonable period of time, all a~ specified by EPA in the notice desLTibed in subparagraph 

(i)(2). EPA will respond to the Company, in writing, within 6 weeks of receiving the Company's 

report and data, as to whether the Company may continue to manufacture and import beyond the 

applicable production limit. 

G) Unreasonable Risk. . 

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

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

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

enviroument. EPA's notice may specify that the Company undertake certain actions conceruing 

further testing, manufacture, import, pr~cessing, distribution, use and! or disposal of the PMN 

substance to mitigate exposures to or to better characterize the risks presented by the PM:\[ 

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

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

either: 

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(2) within 2 weeks from receipt of the notice described in subparagraph 0)(1), the 

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

(3) within 4 weeks from receipt of the noticedescribed in subparagraph 0)(1), the 

Company submits to EPA a written report refuting EPA's finding andlor the appropriateness of 

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

import, process, distribute, use and dispose of the PMN substance in accordance with the terms of 

this Order pending EPA's response to the Company's written report .. EPA will respond to the 

Company, in writing,within 4 weeks of receiving the Company's report. Within 2 weeks of 

reeeiptofEPA's written response, the Company shall comply with any requirements imposed by 

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

PMN substance. 

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

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

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

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

VI. of this Consent Order. 

PROTECTION IN THE WORKPLl\CE 

(a) Establishment of Program. During manufacturing, proeessing, 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: 

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(1) General Derrn,u Protection. Each person who is reasonably likely to be dennally 

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, or because the substance 

becomes airborne in a fonn listed in subparagraph (a)(5) of this section, 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 seIectcq and used in accordance with Occupational Safety and 

Health Administration ("OSHA") dennal protection requirements at 29 CFR 1910.132, 1910.133, 

and 1910.138. 

(2) Specific Dennal Protective Equipment The dermal personaIproteetive equipment 

required by subparagraph (aX!) of this section must include, but is not limited to, the following 

items; 

(i) Ansell NEOX style 9-912 gloves. 

(ii) Full body chemical protective clothing. 

(iii) Chemical goggles or equivalent eye protection. 

(iv) Clothing which covers any other exposed areas of the arms, legs and torso. 

(3) Demonstration of hnperlliQusness. 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 pemlcation testing, as follows: 

(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 

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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 Resistanee of Protective Clothing materials to 

Permeation by Liquids or .Gases." Results shall be recorded as a cumulative permeation rale as a 

function of time, and shall be documented in accordance with ASTM F739 using the format 

specified in ASTM Fl194-99 "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 PM:l\ substance. (Permeation testing on Ansell NEOX style 9-912 gloves showed· 

the gloves to be impervious to the PMN substance for 110 minutes.} 

(4) Respiratory Protection. Each person who is reasonably likely to be exposed by 

inhalation in the work area to the PMN substance in the form listed in subparagraph (a)(5) of this 

section, is provided with, and is required to wear, at ~minimum, aN ational Institute for 

Oeeupational Safety and Health (''NIOSH'').eertified respirator with an Applied Protection Factor 

("APF") of 50, from the respirators listed in subparagraph (a)( 6) of this section, and the respirator 

is used in accordance with OSHA and NIOSH respiratory protection requirements at 29 CFR 

1910.134 and 42 CFR Part 84. All respirators must be issued, used, and maintained aeeording to 

an appropriate respiratory protection program under the OSHA requirements in 29 CFR 1910.134. 

(5) phYsical States, The following physical states of airborne chemical substances are 

listed for subparagraphs (a)(l) and (4) of this section: 

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(i) Combination GaslVapor and Particulate (gas and liquid/solid physical states are 

both present; a good example is paint spray mist, which contains both liquid droplets and vapor). 

(6) Authorized R~spimtors. The following NIOSH-eertified respirators meet the minimum 

requirements for subparagraph (a)(4) of this section: 

(i) Combination GaslPartieulate, APF of 50 

(I) NIOSH-certified airpuri:£ying, tight-fitting full-face respirator equipped with the 

appropriate combination cartridges. Cartridges should be tested and approved for the gas/vapor 

substance (I.e., organic vapor, acid gas, or substance-specific cartridge) and should include a . 

particulate filter (.:'J100 if oil aerosols arc ahsent, RIOO, or PlOO). 

(II) NIOSH-certified powered air-purifYing respirator equipped '>'Iith a tightfitting facepiece (full-fuce) and the appropriate combination cartridges. Cartridges should be 

tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific 

cartridges) and should include HEP A filters. 

(III) NIOSH-certified supplied-air respirator operated in pressure demand or 

continuous flow mode and equipped with a tight-fitting face piece (full-face). 

NEW CHEMICAL EXPOSURE LIMIT 

(a) A1t~ative to Requirements of Respirator Sec~on. 

(1 ) EPA recOlurnends and encourages the use of pollution prevention, source reduction, 

engineering controls and work practices, rather than respirators, as a means of controlling 

inhalation exposures whenever practicable. 

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(2) Whenever a person is reasonably likely to be exposed to the PMN substance by 

inhalation, as an alternative to compliance with the respirator requirements in the Prote('iion in the 

Workplace section of this Order ~ the Company may comply "lith the requirements of this New 

Chemical Exposure Limit section. However, before the Company may deviate from the respirator 

requirements in the Protection in the Workplace section of this Order, the COmpany must: 

(i) submit to EPA a copy of the Company's sampling and analytical method for the 

PMN substance, verified in accordance with subsection (cX3) of this New Chemical Exposure 

Limit section; 

(il) obtain exposure monitoring results in accordanee with this New Chemical 

Exposure Limit section; and 

(iii) based on those exposure monitoring results, select, provide, and ensure use if 

necessary of the appropriate respiratory protection specified in paragraph (e)(2) of this New 

C'hernicaI Exposure Limit section by persons who are reasonably likely to be exposed to the PMN 

substance by inhalation. 

(3) After appropriate respiratory protection has been selected at a workplace based on the 

results of actual exposure monitoring conducted in accordance with this New Chemical Exposure 

Limit section, the Company shall not, at that workplace, use the respiratory protection required in 

the Protection in the Workplaee section of this Order (unless it is the same as required by.this New 

Chemical Exposure Limit se<-iion). 

EPA SANITIZED Page 22 of 74
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(b) Exposure Limit. 

(I) GeneraL The following new chemical exposure limit ("NCEL'') for the PMN 

substance is an interim level determined by EPA based on the limited information available to the 

Agency at the time of development of this Order. The NCEL for the PMN substance is as follows: 

(i) Time-Weighted A vcrr~~:rW A") Limit. 1be Company shall ensure that no . 

person is exposed to an airborne concentration of the PMN substanCe in excess of 0.14 mg/m3 (the 

NCEL) as an 8-hour time-weighted average, without using a respirator in accOrdance with 

subsection (e) of this New Chemical Exposure Limit section . 

. (Ii) Non-8:Hom;: Work-shifts. For non-8-hourwork-shifts, the NCEL forlhal 

work-shift (NCELn) shall be detennined by the following equation: NCELn = NCEL x (8/n) x 

[(24-n)!16], where n = the nUmber of hours in the actual work-shift. 

(2) Automatic Sunset. If, subsequent to the effective date of this Order, OSHA 

promulgates, pursuant to §6 of the Occupational Safety and Health Act, 29 U.S.c. 655, a final 

chemical-specific permissible exposure limit ("PEL") specifically applicable to this PMN 

substance and the OSHA PEL is not challenged in court within 60 days of its promulgation, then 

any respirator requirements in thc Protection in the Workplace section ofthis Order and any 

requirements of this New Chemical Exposure Limit section applicable to workers and situations 

subject to the OSHA PEL shall automatically become nuIl and void. However, the requirements of 

this Consent Order are not negated by any pre-existing OSHA PEL applicable to the PMN 

. substance. 

EPA SANITIZED Page 23 of 74
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(c) performanc_e-Cgteri~fi?!:_fulmpli.illLand i\.llalytiCal Metho_th 

(1) Applieabi lity, For initial development and validation of the sampling and analytical 

method for the PMN substance, all the requirements of this subsection (e) apply. For subsequent 

exposure monitoring conducted pursuant to subsection (d) of this New Chemical Exposure Limit 

section, only the following requirements apply; (c)(4)(i), (4)(ii), (4)(iv)(B), (4)(v)(B), (8), (9), and 

(10). Any deviation from the requirements of tllis subsection (c) must be approved in writing by 

EPA. 

(2) Submission of Verified Method and Certification Statement. The Company shall 

submit to EPA a copy of a validated sampling and analytical method for the PMN substance wmch 

satisfies the criteria specified in this subsection (c). The method description shall expressly state 

how the method compares with each quantitative requirement specified in this subsection (c). The 

submission must include a written statement, signed by authorized officials of both the Company 

and the Laboratory, certifying the truth and aceuracy of the independent laboratory verification 

conducted pursuant to subsection (c)(3), To asslst EPA in identifying the document, it shall state 

in a conspicuous, underlined subject-line at the top of the first page: ''NCEL Sampling and 

Analvtical M~thod for PMN # P06-0702," 

(3) Verification of Analytical Method by Independent Third-Party LaboratgIY, 

(i) Yerification. 'The Company shall have an independent reference laboratory 

("Laboratory") verifY the validity ofthe analytical method for the PMN substance, in accordance 

with the other requirements in this subsection (c)(3), It is the Company's responsibility to ensure 

that the Laboratory complies with all the requirements specified in this subsection (c)(3), 

EPA SANITIZED Page 24 of 74
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(ii) lndependent Reference LaboratQTh The independent reference laboratory must 

be a separate and distinct person (as defined at 40 CPR 720.3(x» from the Company and from any 

other person who may have developed the method for the Company. 

(iii) Accreditation. The Laboratory must be aecredited by a fonnally recognized 

government or private laboratory accreditation program for chemical testing and/or analysis. 

(iv) Good Laboratory Practice Standards. The Laboratory verification of the 

analytical method for the PMN substance must comply with TSCA Good Laboratory Practice 

Standards ("GLPS") at 40 CPR Part 792. [

] However, compliance with TSCA GLPS is not 

required under this New Chemical ExposUre Limit section where the analytical method is verified 

by a laboratory accredited by either: (A) the American Industrial Hygiene Association ("AlHA") 

lndustrial Hygiene Laboratory Accreditation Program ("llILAP"); or (B) another comparable 

program approved in advance in writing by EPA. 

(v) Analysis ofDllPlicat~ Samples. Ibe Company shall collect six duplicate 

samples (a total of 12) at the TWA concentration. The samples shall be taken either from a 

. controlled environment (e.g., a sealed chamber or "glove box") which closely resembles the actual 

workplace conditions or, for solids and liquids with very low vapor pressure, by injecting the PMN 

substance onto a sample collection device. The duplicate samples shall be collected on identical 

collection media, at the same time, and under the same conditions. One set of six samples shall 

immediately be analyzed by the Company, the other set of six samples shall be analyzed by the 

EPA SANITIZED Page 25 of 74
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Laboratory using the method developed by or for the Company, 

(vi) Sampl~~tQJ:'age i';tudy. If the results of the analysis of duplicate samples 

pursuant to paragraph (c )(3)( v) do not satisfy the requirements in paragraph (c)(3 )(vii), the 

Company must perform a sample storage study as follows: 

(I) Triplicate Samples. The Company shall collect six triplicate samples (a 

total of 18) at the TWA concentration. The samples shall be taken either from a controlled 

environment (e.g., a sealed chamber or "glove box") which closely resembles the actual work;place 

conditions or, for solids and liquids with very low vapor pressure, by injecting the PMN substance 

onto a sample collection device. The triplicate samples shall be collected 011 identical collection 

media, at the same time, and under the same conditions. One set of six samples shall immediately 

be analyzed by the· Company. 

(II) Analysis After Sample Storage, A sample storage evalUation shall be 

performed with the two remaining sets of six samples. One set of six samples shall be analyzed by 

the Laboratory using the method developed by or for the Company, and the other shall be analyzed 

by the Company on the same day as the Laboratory analyzes its six samples, Specialized storage 

conditions for the samples including extraction conditions, time from sampling to extraction, time 

from collection or extraction (if applicable) to analysis and storage conditions must be specified in 

the method description . 

. (vii) ComparisongfRe,mlt"" The difference between the results of the two sets of 

six samples analyzed by the Laboratory and the Company as required in either paragraph (c )(3) (v) 

or (c)(3)(vi)(1I) shall be evaluated using a two-sample Hest with unequal variances, and the two 

sides of the critical regions shall not exceed a 5% significance leveL (See Attachment B -

EPA SANITIZED Page 26 of 74
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Statistical Analysis ofNCELs Amilytical Method Verification Results.) The arithmetic mean of 

each set of six samples must be within 10% of the overall arithmetic mean of the two sets of 

sample measurements. If the arithmetic mean of each set of six samples is not within 10% of the 

overall arithmetic mean, then the sample storage time between collection and analysis must be 

reduced until the average of each set of six samples is within 10% of the overall arithmetic mean. 

(4) Accuracy. The sampling and analytical method must clearly demonstrate the 

following: 

(i) GeneraL The sampling and analytical method, and all exposure monitoring data 

relied on by the Company, shall be accurate to within ±25% at a 95% confidence level for 

concentrations of the PMN substance ranging from one half the NCEL to twice the NCEL 

(ii) NCEL Quantitation Limits .. The analytical method should be capable of 

reliably quantifYing the PMN substance across the full range of reasonably likely exposures. At a 

minimum, the analytieal method must be capable of reliably quanti fying. from a lovver quantitation 

limit ("LQL") of one half the NCEL to an upper quantitation limit ("UQL") of at least twice the 

NCEL. If the Company obtains an exposure monitoring sample that is more than 10% above the 

actual UQL oftheanalytieal method, the Company must comply with paragraph (e)(4)(i). 

(iii) Lower Quantitation Limit Signal-To-Noise Ratio. The analytical method shall 

be capable of quantifYing the PMN to a concentration of oue half the NCEL with a signal that is at 

least five times the baseline noise level. Baseline noise must be amplified to a measurable level 

when possible, even if the required amplification is beyond that used in routine analysis of 

samples. (If baseline noise cannot be obtained, another reference must be selected. This maybe a 

peak considered to be noise caused by the reagent matrix.) The sampling preparation method must 

EPA SANITIZED Page 27 of 74
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be specified and the detection limit for the analytical procedure must be reported as mass per 

injection for chromatographic techniques. 

(iv) Instnlment Calibrll.tiollo 

(1) Initial Calibration. For method development and validation (but not 

subsequent exposure monitoring), the initial calibration shall at a minimum consist of five (5) 

'. . 

calibration staildards with a linear correlation of 0.95 -- these five (5) calibration standards must 

consist of one standard at each of the following concentrations: one half the NCEL (0.5 x NCEL); 

between one half and one times the NCEL (0.5 x NCEL < > 1 x NCEL); one times the NCEL (1 x 

NCEL); between one and two times the NCEL (1 x NCEL < > 2 x NCEL), and twice the NCEL (2 

x NCEL). 

(II) Continuing Calibration. During each week of both method 

development/validation and subsequent exposure monitoring, the Company shall conduct both an 

initial instrument calibration and a continuing calibration. The Company shall perform at least one 

continuing calibration sample at the NCEL concentration, and at least one additional calibration 

sample per every 10 samples analyzed. The continuing calibration sample shall fall within ± 25% 

of the initial calibration value. If not, then the initial calibration must be repeated, and any samples 

associated with that outlying calibration check must be re-analyzed. 

(v) Calculated Percent Recovery. 

(1) Initial CalculaJion. For method development and validation, the 

Company must calculate the percent of the PMN substance recovered by the analYtical method 

from a sample contaiuing a known quantity of the PMN substance. The sample shall be taken 

either from a controlled environment (e.g., a sealed chamber or "glove box") which closely 

EPA SANITIZED Page 28 of 74
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resembles the actual workplace conditions or, for solids and liquids with velY low vapor pressure, 

by injecting the PMN substance onto a sample collection device. (Such a sample is referred to as a 

"matrix spike'). The calculated percent recovery for each matrix spike shall be greater than or 

equal to 75% and less than or equal to 125%. Spike eoncentrations for the PMN substance must be 

included in the sampling and analytical method submitted te EPA. 

(II) SUlJseguent Calculation. During each subsequent exposure monitoring 

episode or campaign, at least 1 matrix spike, prepared by injecting the PMN substance onte a . 

sample collection device, shall be analyzed. (This matrix spike must be prepared at the NCEL 

concentration.) 

(vi) Sampling DeviceCapacity. The capacity of the sampling device must be 

tested and results reported to show under a kno\','Il and well-defined set of conditions that the 

device is capable of collecting the new chemical in solid, liquid or vapor phase with minimal loss. 

The sampling device's capacity (air voluille and collected analyte mass) must be specified. For 

methods that use adsorbent tubes as the eolleetion medium, evidence of the capacity must be 

provided in the form ofbreaklhrough testing. This testing must be doric at a concentration twice 

the NCEL and under conditions similar te those expected rothe workplace. Breakthrough is 

defined to have occurred when the concentration of the PMN ollbstance in the effluent stream is 

equal to 5% of the concentration of the influent stream, or when 20% of the PMN substance is 

detected in the backup section of the sampler. 

(vii) Sampling Deyice Des~tion Efficiency. ""'here applicable, the desorption 

efficiency must be evaluated for the air sampling device. A miuirnum of six air samples spiked 

with the PMN' substance at least the NCEL concentration must be prepared. A recovery of at least 

EPA SANITIZED Page 29 of 74
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75% must be obtained for each of the six samples. 

(5) l'.recision. The estimate of the coetIicient of variation of each set of six samples from 

the controlled atmosphere test (spiked at LO NCEL, per paragraphs (c)(3)(v) or (vi» must be less 

than 0.105, including allowance of 0.05 for error due to sampling. 

(6) Interpretation of Accuracy and Precision Data. 

(i) If a single matrix spike recovery is less than 75% recovery or greater than 125% 

or the estimated precision is greater than 0.105, then the Company must re-prepare the matrix 

spike, re-sample, and re-analyze all samples associated with such matrix spike or triplicate 

samples. 

(ii) For percent recoveries less than 90% but greater than 75%, correction fur low 

recovery is required. Correct for recovery first by dividing the observed amo1ill( by the proportion 

recovered before deteimining if measurements fall below the NCEL. For example, if the observed 

level is 30 mg/m} and the percent recovery is 75%, use the value 30 mg/m3 /(0. 75) = 40 mg/m3 

when determining whether the levels are below the exposure limit. 

(7) Representativeness. All sample conditions used to develop the methodology sha1l 

mimic the actual workplace environment expected to be monitored. CAlnditions such as the 

temperature, hmnidity, lighting, and presence of other chemicals, etc. must mimic the conditions in 

the workplace to be monitored. 

(8) C'hanges Affecting Validity,. lfthe workplace environment changes from the initial 

conditions described in the veri fled sampling and analytical method in a way reasonably likely to 

invalidate the accuracy of the method, then the Company must c{)mply with the respirator 

requirements in the Protection in the Workplace section of this Order, unless the Company reEPA SANITIZED Page 30 of 74
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validates the method to confirm that the requirements for accuracy and precision in paragraphs 

. (c)(4) and (5) are met. Examples ofpos;;ible changes include but are npt limited to: introduction 

of a new chemical substance to the workplace which may interfere with the analysis of the new 

chemical; introduction of light to the workplace which may interlbre with a light-sensitive PMN 

substance; or introduction ofwateriincreased humidity to the workplacewhich could react with the 

P:r:.1N substance and cause difficulties in collection and analysis. 

(9) Comparability. All data and results shall be reported in the same uriits of measurement 

as the NCEL. 

(10) Responsibilitv for Method Validity, The independent laboratory verification and EPA 

receipt of the sampling and analytical method pursuant to this subsection (c) do not ensure that the 

method will produce valid exposure monitoring data. The Company is ultimately responsible for 

ensuring the validity of its exposure monitoring data. 

(d) Monitoring Potential Exposurc, 

(1) General, 

(i) Action Level. The "action level" is defined as an airbome concentration ofthe 

PMN substance, calculated as an 8-hour time-weighted average, equal to one half the NCEL TWA 

specified in subparagraph (b)(I). For non-8-hour work shifts, the action level is equal to one half 

the NCELn. (The NCELn is described in subparagraph (b Xl )(ii).) The Company may. cxceed the 

action level without penalty. The propose of the action level is solely to detennine the requisite 

monitoring frequency. 

EPA SANITIZED Page 31 of 74
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(ii) Representative Exposure GrOJllli,. Whenever exposure monitoring is required 

by this New Chemical Exposure Limit section, the Company shall take representativ~ samples of 

what the potential exposure of each person who is reasonably likely to be exposed to airborne 

concentrations of the PMN substance would be if respirators were not worn. The Company shall 

do so by sampling the breathing zone air of at least one person that represents, and does not 

lUlderestimate, the potential exposure of every person performing the same or substantially similar 

operations in each work shift, in each job classification, in each work area (hereinafter identified as 

an "exposure group") where inhalation exposure to the PMN substance is reasonably likely to 

OCcur. The exposure of each person need not be itself directly sampled ifthaf exposure is 

represented by sampling the exposure of another person in the same exposure group. 

(iii) Good Labor,ato!,), Practice Standard~ Determinations of potential inhalation 

exposure shall be made according to TSCA Good Laboratory Practice Standards at 40 CPR Part 

792 and the sampling and analytical method developed pursuant to subsection (c) of this New 

Chemical Exposure Limit section. [Certain provisions of the TSCA GLPS applicable to toxicity 

testing in laboratory animals, such as 40 CFR 792.43 ("Test system care flicilities"), 792.45 ("Test 

system supply facilities") and 7 92.90 ("Animal and other test systeni care"), are clearly 

inapplicable to the NCEL requirements.] However, compliance with TSCA GLPS is not required 

where exposure monitoring samples are analyzed by a laboratory accredited by either: (A) the 

American Industrial Hygiene Association ("AIHA") Industrial Hygiene Laboratory Accreditation 

Program ("IHLAP"); or (B) another comparable program approved in advance in writing by EPA. 

EPA SANITIZED Page 32 of 74
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(iv) !'llllShift EXpgSUT_'< SamjJI~s, R«presentative 8-hour TWA airborne 

concentrations shall be determined on the basis of samples representing the full shift exposure for 

each exposure group. 

(2) lPitial Mo_nltoring. Before the Company may deviate from the respirator requirements 

of the Protection in the Workplace section, the Company shall conduct initial exposure monitoring' 

to accurately determine the airborne concentration of the PMN substance for each exposure group 

in which persons are reasonably likely to be exposed to the PMN substance. 

(3) Periodic Monitorin& 

(i) If any r«presentative samples taken during the initial exposure monitoring reveal 

an airborne concentration at or above the action level but at or below the TWA, the Company shall 

r«peat the exposure monitoring for that exposure group at least every 6 months. If the pM'-J 

substance is not manufactured, processed, or used at all during a given 6 month calendar period, 

the Company is not required to conduct exposure monitoring until manufacture, processing, or use 

of the P.MN substance is resumed. However, cessation of manufacturing, processing and use of 

the PMN substance for less than the 6 month period does not constitute grounds for postponement 

of the 6 month deadline to conduct exposure monitoring. 

Oi) If any representative samples taken during the initial exposure monitoring 

reveal an airborne concentration above the TWA, the Company shall repeat the exposure 

monitoring for that exposure group at least every 3 months. If the PMN substance is not 

manufactured, processed, or used at all during a given 3 month calendar period, the Company is 

not required to conduct exposure monitoring until manufacture, processing, or use of the PMN 

substance is resumed. However, cessation of manufacturing, processing and use of the PMN 

EPA SANITIZED Page 33 of 74
, . 

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substance for less than the:3 month period does not constitute grounds for postponement of the 3 

month deadline to conduct exposure monitoring. 

(iii) 1110 Company may alter the exposure monitoring schedule from every 3 

months to every 6 months for any exposure group for whom two cousecutive measurements taken 

at least 7 days apart indicate that the potential exposure has decreased to the 1WA or below, but is 

at or above the action level. Where the PMN substance is manufactured, processed, or used in . 

batches of duration less than 7 days, the 2 consecutive measurements may be taken at least 24 

hours apart, provided that the measurements accurately reflect the highest peak exposures and 

variability in exposure. 

(4) Termination ofMonltorin& 

(i) If representative samples taken during the initial exposure monitoring reveal an 

airborne concentration below the action level, the Company may' discontinue monitoring for that 

exposure group, except when additional exposure monitoring is required by paragraph (d)(5) of 

this Kew Chemical Exposure Limit section. 

(ii) If representative samples taken d~g the periodic monitoring reveal that an 

airborne concentration, as indicated by at least 2 consecutive measurements taken at least 7 days 

apart, are below the action level, the Company may diseontinue the monitoring for that exposure. 

group, exeept when additional monitoring is required by paragraph (d)(5) ofthis New Chemical 

Exposure Limit section. Where the PMN substance is manufactured, processed, or uscd in batches 

of duration less than 7 days, the 2 conseeutive measurements may be taken at least 24 hours apart, 

provided that the measurements accurately reflect the highest peak exposures and variability in 

exposure. 

EPA SANITIZED Page 34 of 74
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(5) Additional Monitoring, 

(i) For a previously monitored exposure group, the Company shall, within 7 days 

of any of the events listed below in this paragraph (d)(5)(i), conduc1 the initial exposure 

monitoring followed by any periodie or additional exposure monitoring required by subsection (d) 

of this New Chemieal Exposure Limit section: 

(l) change in the production volume, process, eontrol equipment, personnel 

Or work practices that may reasonably eause new or additional exposures to the PMN substance; 

(11) spills, leaks, ruptures or other breakdowns occur that may reasonably 

cause new or additional exposures to the PMN substance; and, 

(III) whenever else the Company has any reason to suspect a change that 

may reasonably result in new Of additional exposures to the PMN substance. 

(li) In no event is the additional exposure monitoring requirement in paragraph 

(d)( 5)(i) intended to delay implementation of any necessary cleanup or other remedial action. 

During any cleanup ot remedial operations that may occur before commencing additional exposure 

monitoring, the Company shall enaure that potentially exposed persons use at least the respiratory 

protection specified in subsection (e) for the measured airborne concentration, or more protective 

respiratory equipment deemed appropriate by the best professional judgment of a qualified expert. 

(6) Notification of Monitoring Re~ults. 

(i) Within 15 working days after receipt of the results of any exposure monitoring 

required by this Order, the Company shaH notifY each person whose exposure is represented by 

that monitoring. The notice shall identifY the NCEL, the exposure monitoring results, and any 

corresponding respiratory protection required by subsection (e). Affected persons shall be notified 

EPA SANITIZED Page 35 of 74
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in writing either individually or by posting the information in an appropriate and accessible 

location. 

(ii) Whenever the NCEL is exceeded, the written notification required by the 

preceding paragraph shall describe the action being taken by the Company to reduce inhalation 

exposure to or below the NCEL, or shall refer to a document available to the person which states 

the actions to be taken to reduce exposure. 

(7) Exemption based on Objective Data. Where the Company has documented and 

reliable objective data demonstrating that, even under worst-case conditions, employee exposure to 

the P:MN substance \\-ill not exceed the action Icvel (defined in paragraph (d)(l lei»~ under the 

expected handling procedures and conditions for a specific "exposure group" (defined in paragraph 

(d)(l)(ii», then that exposure group is exempt from this New Chemical Exposure Limit section , . . 

(except paragraph (d)(5) "Additional Monitoring" and subsection (f) "NCEL Record-keeping") 

and the respirator requirements in the Protection in the Workplace section of this Order. Any ~uch 

objective data must accurately characterize actual employee exposures to the P:MN substance and 

must be obtained under conditions closely resembling the types of materials, processes, control 

methods, work practices, and environmental conditions in the Company's current workplace 

operations with the P:MN substance. Examples of objective data that may be used to demonstrate 

that employee exposure will not exceed the action level, even under worst case conditions, include 

information on the physical and chemical properties of the P:MN substance, industry-wide studies, 

and/or laboratory test results. 

EPA SANITIZED Page 36 of 74
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(e) Respiratory Protectiolb 

(1) General. Whenever the Company has conducted exposure monitoring at a worlcplace 

in accordance with subsection (d) of this New Chemical Exposure Limit section and the measured 

airborne concentration of the PMN substance for any person who is reasonably likely to be 

exposed to the PMN substance by inhalation exceeds the NCEL, the Company shall provide those 

persons the respirators specified in this subsection (e) (rather than the respirator(s) identified in the 

Protection in the Workplace scction of this Order), and shall em.ure that the re~;pirators are used 

(including training, fit testing, and maintenance) in accordance with OSHA and NIOSH respiratory 

protection tequirements at 29 CFR 1910.134 and 42 CPR Part 84. When the Company has not yet 

measured the airborne concentration of the PMN substance at a workplace in accordance with this 

New Chemical Exposure Limit section, thc Company shall comply with the respirator 

requirements in the Protcction in the Worlcplace section of this Order at that workplace. 

(2) Selection of Appropriate Respiratory Protection, After the Company has conduGied 

exposure monitoring in accordance with subsection (d) of this New Chemical Exposure Limit 

section, the Company shall select, provide, and ensure that persons who are reasonably likely to be 

exposed to the PMN substance by inhalation use, at a minimum, the respiratory protection which 

corresponds in the following table to the measured airborne concentration (or a more protective 

respirator which corresponds to a concentration higher than measured). 

EPA SANITIZED Page 37 of 74
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NCELs RESPIRATOR TABLES 

Measured Concentrations of PMN Substance and 

Corresponding Acceptable Respiratory Protection 

COMBINATION PARTIC'ULATE AND GAS/V APOR RESPIRATOR TABLE 

Measured 

Concentration 

of PMN Substance 

::; NCEL 

::; 10 x NCEL 

::;25 x NCEL 

Required Respiratory Protection 

~ No respiratory protection is required. 

I[Dqta on Cartridge Service Life Testing has been Reviewed and Approved 

by EPA: 

~ NIOSH-ccrtified air-purifYing, tight-fitting full facepiece respirator 

equipped with the appropriate combination cartridges. Cartridges should be 

tested and approved for the gas/vapor substance (i.e., organic vapor, acid . 

gas, or substance-specific cartridges) and should include a particulate filter 

(NIOO if oil aerosols are absent, RlOO, or PlOO). 

~ NIOSH-ccrtified powered air-purifying respirator equipped With a loose 

fitting hood or helmet and the appropriate combination cartridges. 

Cartridges should be tested and approved for the gas/vapor substance (i.e., 

organic vapor, acid gas, or substance-specific cartridges) and should include 

HEPA filters. 

If No Cartridge Service Life Testing is Available: 

~ NI OSH -certified supplied-air respirator operated in pressure demaud or 

If Data on CartridgeService Life Test/nil has been Reviewed and Approyeq 

bvEPA;. 

~ NIOSH-ccrtified air-purifying, tight-fitting full-face respirator equipped 

with the appropriate combination cartridges. Cartridges should be tested 

and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or 

substance-specific cartridges) and should include a particulate filter (NIOO if 

oil aerosols are absent, R 100, or PI 00). 

~ NIOSH-ccrtified powered air-purifYing respirator equipped with a loose 

fitting hood or helmet and the appropriate combination cartridges. 

EPA SANITIZED Page 38 of 74
~50xNCEL 

~2000xNCEL 

> 2000 x NCEL 

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Cartridges should be tested and approved for the gas/vapor substance (i.e., 

organic vapor, acid gas, or substance-specific cartridges) and should include 

HEP A filters. 

[[No Cartridge Jktyice Life resting is Available~ 

I(Data on Cartridge Service Life Testinghas been Reviewed aJ.ldA12lZ!Pveci. 

hlP4~ 

I- NIOSH-certified air-purifYing, tight-fitting fulHace respirator equipped 

with the appropriate combination cartridges. Cartridges should be tested 

and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or 

substance-specific cartridges) and should include a particulate filter (NIOO if 

oil aerosols are absent, Rl 00, or PI 00). 

If No Cartridge Service Life Testing is Available: 

~ NIOSH-certified supplied-air respirator operated in pressnre demand or 

other positive pressure mode and eqllipped with a tight-fitting full facepieee. 

I- Any self-contained respirator equipped with a'full facepiece and 

operated in a pressure demand or other positive pressure mode. 

I- Any supplied-air respirator equipped with a full facepiece operated in a 

pressure demand or other positive pressnre mode in combination with an 

auxiliary seli;contained breathing apparatus operated in a p'ressnre demand 

or other positive pressnre mode. 

(3) Reductions in Respiratorv Protection. After appropriate respiratory protection has been' 

selected based on thc results of actual exposure monitoring conducted at a workplace in 

accordance with subsection (d) of this New Chemical Exposure Limit section, the Company shall 

not, at that workplace, use the respiratory protection required by the Protection in the Workplace 

section of this Order (unless it is the same as required by this New Chemical Exposure Limit 

section). Before the Company may make any reduction in any respiratory protection selected 

EPA SANITIZED Page 39 of 74
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pursuant to this New Chemical Exposure Limit section, the Company must verify, by 2 

consecutive measurements taken at least 7 days apart, that the new respiratory protection is 

appropriate in accordance with paragraph (e)(2). \'v'here the PMN substance is manufactured, 

processed, or used in batches of duration less than 7 days, the 2 consecutive measurements may be 

taken at least 24 hours apart, provided that the measurements aceurately reflect the highest peak 

exposures and variability in exposure. 

(4) Special Situations. 

(i) MeasllrCI)"leqts Outside Quantitation Limits. When a value less than the lower 

quantitation limit ("LQL") of the analytical method (as described in paragraph (c)(4)(ii» is 

measured, the Company shall estimate potential exposure using generall y established and accepted 

statistical methods. If the C..ompany obtains an exposure monitoring sample that is rriore than 10% 

above the actual upper quantitation limit ("UQL") of the analytical method, the Company must 

ensure that its workers wear at least a NIOSH-certified supplied-air respirator operated in pressure 

demand or other positive pressure mode and eqnipped with a tight-fitting full fucepiece. Any 

reductions in this respiratory protection must comply with paragraph (e)(3). The Company may 

submit an impro~ed analytieal method provided that it complies fully with subsection (c) of this 

New Chemical Exposure Limit seetion, including the verification required by subsection (c)(3). 

(ii) Cleanu1J and RemedialActions. During any special cleanup or other remedial 

actions that may occur before commencing additional exposure monitoring (as discussed in 

paragraph (d)(5)(ii», the Company shall ensure that potentially exposed persons usc at least the 

respiratory protection specified above in this subsection (e) for the measured airborne 

concentration, or more protective respiratory equipment deemed appropriate by the best 

EPA SANITIZED Page 40 of 74
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professional judgment of a qual ified expert. 

(t)NCEL~Recordkeeping . 

. (1) Whenevcr the Company elects to comply with this New Chemical Exposure Limit 

section rather than the respirator requirements in the Protection in the Workplace section of this 

Order, the Company shall maintain the following records unti130 years after the date they are 

created, and shall make them available for inspection and copying by EP A in accordance with 

section 11 ofTSCA: 

". (i) A copy ofthe sampling and analytical methods used and continuing evidence of 

their accuracy over time as required by section (c); 

(ii) Records documenting compliance with the analytical method verification 

requirements ofsuhsection (c)(3), including copies ofthe signed certification staternent and the 

verificatioll results obtained by both laboratories; 

(iii) Records documenting either compliance with the Good Laboratory Practice 

Standards at 40 CFR Part 792, or use of a laboratory accredited by the American Industrial 

Hygiene Association ("AIHA") or another comparable program appro ved in advance in writing by 

EPA. Where the Company elects to not comply with TSCA GLPS, such records shall include the 

written accreditation from the AIHA or the written approval from EPA. 

(iv) Records documenting all exposure monitoring dates, duration, and w>ults of 

each sample taken; 

EPA SANITIZED Page 41 of 74
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(v) Records documenting the name, address, work shift, job classification, and 

work area of the person monitored and of all other persons whose exposures the monitorirg is 

intended to represent; 

(vi) Any conditions that might have affected the monitoring results; 

(vii) Notification of exposure monitoring results required by paragraph (dX6); 

(viii) Records documenting any changes in the production, process, control . 

equipment, personnel or work practices that may reasonably cause new or additional exposures to 

the PMN substance; 

(ix) Records documenting any spills, leaks, ruptures or other breakdowns that may 

canse new or additional exposure; 

substance; 

(x) The type of respiratory protective devices worn by the monitored person, if any; 

(xi) Records documenting any actions taken to mitigate exposures to the PMN 

(xii) Records documenting reliance on the objective data exemption in paragraph 

(d)(7), including: (A) the source of the data, (B) protocols and results of any relevant testing or 

analysis, (C) a description of the operation exempted and how the data demonstrate that employee 

exposures will not exceed the action level, (0) other data relevant to the operations, materials and 

employee exposures covered by the exemption. 

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 'WTItten 

EPA SANITIZED Page 42 of 74
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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 \>ntten hazard 

communication program available, upon request, to all employees, contractor employees, and their 

designated representatives. Tne Company may rely on an existing hazard communication 

program, including an existing program established under the OSHA Hazard Communication 

Standard (29 CFR 1910.1200), to comply 'With this paragraph provided that the exi;Jting 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 ( e) 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 See) ofTSCA, or by a TSeA section 5( a)(2) SNUR at 40 CFR Part 721, subpart E, to 

maintain a list of substances, the lislq shall be combined with the list under this subparagraph. 

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

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

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

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

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

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

EPA SANITIZED Page 43 of 74
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substance while in the Company's workplace. 

(b) Labeling. 

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

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

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

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

any, identified in paragraph (1) of this section or by the Company, for the PMN substance. 

(1I) The identity by which the PMN substance may be commonly 

recognized .. 

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

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

substance. 

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

identified in paragraph (1) 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 matetials in lieu of affixing labels to individual stationary process 

containers, as long as the altemative method identifies the containers to which it is applicable and 

conveys information specified by subparagraph (b )(1 )(i) of this seetion. Any written materials 

must be readily accessible to the employees in their work areas throughout each work shift. 

EPA SANITIZED Page 44 of 74
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(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-Iabeled with the information' specified in subparagraph (b)(1)(i) oHms section. 

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

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

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

(I) The information prescribed in subparagraph (b )(1 )(i) of tbis section. 

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

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

emergency procedures. 

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

Transportation Act (lSU.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 waruing, shall be printed in English; however, the 

infOImation may be repeated in other languages. 

(5) If the label or alternative form ofwaming is to be applied to a mixture containing the 

PMN substance in combination with any other substance iliat 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 

EPA SANITIZED Page 45 of 74
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CFR Part 721, subpart E, or definen as a "hazardous chemical" under the OSHA Hazard 

Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS, 

Of alternative form of warning, the measures to eontrol worker .exposure Of envirorunental release 

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

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

seck 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 siguificant new information regarding the 

hazards of the Pl\1N substance or ways to protect against the hazards, this new information must be 

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

information. If the PMl'\[ substance is not being manUfactured, imported, processed, or used in the 

Company's workplace, the Compaoy must add the new infonnation to the label befure the PMN 

substance is reintroduced into the workplace. 

( c) Material Safety Data Sheets. . 

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

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

(1) Thc identity used on the container label of the PMN substance under this 

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

If the chemical and common name is claimed eonfidential, a generic chenaical name must be used. 

(ii) Physical aod chemical characteristics of the substance knowu to the Company, 

(c.g., vapor pressurc, flash point). 

EPA SANITIZED Page 46 of 74
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(iii) The physical hazards of the substance known to the Company, including the 

potential for fire, explosion, and reactivity. 

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

of this section. 

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

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

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

(vii) Precautionary measures to control worker exposure andlor environmental 

release required by this Order, oraltetnative control measures which EPA has determined under 40 

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

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

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

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

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

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

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

to spills and leaks. 

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

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

(x) Emergency [ust 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 

EPA SANITIZED Page 47 of 74
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responsible party who can provide additional infomlation 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 muliiple mixtures containing the PMN substance have similar compositions 

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

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

these multiple mixtures. 

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

hazards of the PMN substance or·ways to protcct 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 

infurmation. 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 PJI,fN 

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 

EPA SANITIZED Page 48 of 74
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the potential hazards of a process rather than individual substances. However, in all cases, the 

required information must be provided for the PMN substance and must be readily accessible 

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

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

other languages. 

(d) Employee Information_and Training, The Company must ensure that employees are provided 

with information and training on the PMN substance. This information and training must be 

provided at ilie 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 

flrst time . 

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

(i) The requirements of this section: 

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

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

required under paragraph (a) of this section, including the list ofsubstanees required by 

subparagraph (a)(1) of this section and MSDSs required by paragraph (c) of this section. 

(2) The traiuing 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 condncted 

by the Company, continuous monitoring devices, visual appearance, or odor of the substance when 

being released). 

EPA SANITIZED Page 49 of 74
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(ii) The potential human health and enviroumental hazards of the PMN substance 

as specified in paragraph (f) 0 f this section. 

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

from the PMN substance, including specific procedures the Company has implemented to protect 

employees and the environment from exposure to the PMN substance, including appropriate work 

practices, emergency procedures, personal protective equipmetlt, 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 urider 40 CPR 721.30 provide the same 

degree of pro teet ion 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. 

(1) Human Health, Environmental Hazard, R'<posure, 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 (e) of this section: 

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

(i) skin irritation. 

(ii) respiratory complications. 

EPA SANITIZED Page 50 of 74
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(iii) internal organ effects. 

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

(i) avoid skin contact. 

(ii) avoid breathing the substance. 

(iii) avoid ingestion. 

(iv) use respiratory protection, or maintain workplace airborne concentrations at or 

below an 8-hour time-weighted average of 0.14 mg/m'. 

(v) use skin protection. 

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

(i) toxic to fish. 

(ii) toxic to aquatic organisms. 

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

(1) 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 SNVR. Subparagraph (a)(l) shall expire 75 days after promulgation 

of a final significant new use rule ("S1'. uRn) governing the PMN substance under section 5( a)(2) 

EPA SANITIZED Page 51 of 74
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ofTSCA unless the Company is notified on or before that day of an action in a Federal Court 

seeking judicial review of the S"NG~. If the Company is so notified, subparagraph (a)(l) shall not 

expire until EPA notifies the Company in writing thaI all Federal Court aetions involving the 

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

(3) Notice of SNUR. 'V\'hen EPA promulgates a fmal SNUR for the PMN substance and 

subparagraph (a)(I) 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 SNlJR. 

DISTRIBUTION 

(a) Export Notice Requirement. Prior to 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 sec;tion 5( e) ofTSCA, the PMN substance 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 specifie chemical identity of the PMN substance, or (B) if the 

;;pecific chemical identity is confidential, the generic chemical identity. 

(b) Distribution Requirements. Except after the PMN has been completely reacted or cured, or as 

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

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

EPA SANITIZED Page 52 of 74
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to: 

(1) Not further distribute the PJI,1N substance to any other person, other than for disposal, 

until after the P)I.1N substance has been completely reacted (cured) 

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

in the. Protection in the Workplace and the New ChemieaI EXPO;UfC Limit sections of this Order. 

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

.in the Hazard Communication Program section of tlris Order. 

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

Company in the Disposal and Release to Water sections ofthis Order. 

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

distribute the P)I.1N substance out~ide 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: 

(I) Subsequent to any sueh exempt temporary transport or storage of sealed containers, the 

Pl\1N substance may be distributed only to the Company or a person who has given the Company 

the written agreementreqllired by paragraph (a). 

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

containers and removing or Waslrillg out the P)I.1N substance may occur onl y while the Pl'vtN 

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

the written agreement required by paragraph (a). 

EPA SANITIZED Page 53 of 74
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(d) Recipient Non:~ol!lpliance. If, at any time after commencing distribution in commerce of the 

P~1N substance, the Company obtains knowledge that a recipient of the substance has failed to 

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

paragraph (a)(l) expireS in accmdancewith subparagraph (d)(l), has engaged in a significant new 

use of the p~ substance (as defined in 40 CFR Part 721, Subpart E) wilhout submitting a 

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

recipient, unless the Company isableto docliment each of the following: 

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

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

Distribution section, or has engaged in a significant new use ofthe PMN substance without 

submitting a significant new use notice to EPA. 

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

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

aware of the terms of paragraph (a) of this Distribution section and will comply with those terms, . 

or is aware of the terms of the significant new use rule for the PMN substance and will not engage 

in a significant new use without submitting a significant new use notice to EPA. 

(3) If, after receiving a statement of assurance from a recipient under subparagraph (c)(2) 

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

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

a significant new use of the PMN substance without submitting a significant new use notice to 

EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA of 

the failure to comply, and shall resume supplying the PJ'vIN substance to that recipient only upon 

EPA SANITIZED Page 54 of 74
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written notification from the Agency. 

(e)~unsetfolloJ'iing SNUR, (1) Paragraph (a)(l) of this Distribution section shall expire 75 days 

after promulgation of a final SNUR for the PlvrN 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. lfthe Company is so notified, paragraph (a)(l) of this Distribution section 

shall not expire until EPA notifies the Company in writing that all.F ederal Court actions involving 

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

(2) When EPA promulgates a final SNUR for the PlvfN substance and paragraph (a)(I) of 

this Distribution section expires in accordance with subparagraph (d)(l), the Company shall notify 

each person to whom it distributes the PMN substance of the existence ofthe·SNuR. Such 

notifieation must be in writing and must specifically include all limitations contained in the Sl\TUR 

which are defined as significant new uses, and which would in voke significant new use 

notification to EPA for the PMN substance. Such notice must also reference the publication of the 

SNUR for this PMN substance in either the Federal Register or the Code of Federal Regulations. 

After promulgation of a Sl\TUR and expiration of subparagraph (a)(I), such notiecmay substitute 

for the written agreement required in the introductory clause of paragraph (a); so that, if the 

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

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

(a). 

EPA SANITIZED Page 55 of 74
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(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 of the P:MN substance, or any 

waste stream from manufacturing/processing/use containing the PMN substance: 

(1) Into the waters of the United States. 

m. ru;CORDKl<~EPING 

(a) Reco!9l1., The Company shall maintain the following records until 5 years after the date they 

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

section 11 ofTSCA: 

(I) Exemptio~. Records documenting that the PMN substance did in fact qualifY for any 

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

must satisfY all the statutory and regulatory recordkeepingrequirements applicable to the 

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

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

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

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

sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches ofthePMN 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 

EPA SANITIZED Page 56 of 74
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amounts or batches of the PfvlN substance claimed to be eligtble for any other exemption described 

in Section r, Paragraph (b) of this Order, the Company shall keep records demonstrating 

qualification fur that exemption as well as the records specified in paragraphs (2) and (3) below, 

but is exempt from the other recordkeeping requirements in this Recordkeeping section; 

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

and the corresponding dates of manufacture and import; 

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

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

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

the substance sold or transferred on such date; 

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

use; 

(5) Records documenting establishmentand implementation of a program for the use of 

any applicable personal protective equipment required pursuant to the Protection in the Workplace 

section ofthls Order; 

(6) Records documenting the determinations required by the Protection in the Wod-place 

section ofthls Order that chemical protective clothing is impervious to the PMN substance; 

(7) Records required by paragraph (t). of the New Chemical Exposure Limits section of 

this Order, if applicable; 

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

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

(9) Copies oflabels required under the Hazard Communication Program section of this 

EPA SANITIZED Page 57 of 74
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Order; 

(1O) Copies of Material Safety Data Sheets required by the Hazard Conunurucation 

Program section of this Order; 

(11) Records documenting compliance ',vith any applicable manufacturing, processing, 

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

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

(12) 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 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; 

(13) 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; 

(14) Copies of any Transfer Docmnents and notices required by the Successor Liability 

section of this Order, if applicable; and 

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

substance is manufactured or imported. 

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

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

EPA SANITIZED Page 58 of 74
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Company's customers. 

(c) OMB Control N1J1l1jJer. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 

1320, particularly 5 CFR 1320.5(b), the Company is 110t required to respond to this "collection of 

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

Management and Budget ("OMB"), and EPA so infonns the Company. The "collection of 

information" required in this TSCA §5(c) Consent Order has been approved under currently valid 

OMB Control Number 2070-0012. 

IV. REOUESTS FOR PRE-INSPECTION INFORMATiON 

(a) EPA's Request for Informatio:q. Pursuant to seetion 11 ofTSCA and 40 CFR 720,122, EPA 

may occasionally conduct on-si te compliance inspections of Company facilities and conveyd.llccs 

associated with the PMN substance. To faciHtate such inspectionS, EPA personnel fi:iay contact tile 

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

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

include, but are not limited to, the following: 

(i) Expeeted dates and times wheo the PMN substance will be in production within the 

subsequeot 12 months; 

(ii) Current workshift schedules tor workers who are involved in aetivities associated with 

the PMN substanee and may reasonably be exposed to thePMN 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 PMl'< substance; 

EPA SANITIZED Page 59 of 74
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(iv) Existing exposure monitoring data for workers who are involved in activities 

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

(h) Companv's Response .. The Company shall respond to such requc&1:s 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 to the Company at the tillle of the request, the Company's 

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

. to all of EPA's requests. 

(e) Confidential Business Jnfonnaiion. Any Confidential Business Information ("CBI") that the 

Company submits to EPA pursuant to paragraph (h) shall be protected hi. 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"). 

EPA SANITIZED Page 60 of 74
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(b) Relation of Transfer Date to Notice of Commencement ("NOG"1 

(!) ):le{ore N9C. If the transfer from the Company to the Successor in Interest is effective 

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

substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a 

new PMN to EPA and comply fully with Section 5(a)(1) ofTSCA and 40 CFRpart 720 before 

commencing manufacture or import ofthe 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 defmitions 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 thefuJJ 

interest of the Company in the PMN substance, such as a licensec 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 acccrdance with 

40 CFR 720.22(a)(3). 

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

P!l1N substance, including the right to manufacture the PMN substance, from the Compaoy to the 

EPA SANITIZED Page 61 of 74
- 54-

Successor in Interest. 

(d) Notices. 

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

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

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

to this Order. 

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

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

U.S. Environmental Protection Agency, New Chemicals Branch (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 of business, and at all sites where the PMN substance is 

manufactured or imported. Copies ofthc Transfer Document must also be made available fur 

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

contain provisions which expressly transfer liability for the PMNsubstanceunder the terms of this 

Order from the Company to the Suecessor in Interest. . 

( e) Liability, 

(1) The Company shall be liabl e 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 

EPA SANITIZED Page 62 of 74
- 55-

Order effective as of the date of transfer. 

(3) Nothing in this section shall be construed to prohibit the Agency from taking 

enforcement action" against the Company after the effective date of the transfer fo~ actions taken, or 

omissions made, during the time in which the Company manufdctured, processed, used, distributed 

in commerce, or disposed of the PMN substance pursuant to the temas of this Consent Order. 

(f) Obligationsto :;!ublllit Test Data unde;r Cgnsent Order. If paragraph (d) of the Testing section 

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

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

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

Successor in Interest 

EPA SANITIZED Page 63 of 74
- 56-

VI. MODIFICATION At'lD REVOCATION OF CONSENT ORDER 

. The Company may petition EPAat any time, based upon new information on the health 

effects of, or human exposure to, the PMN substance, to modifY orrevoke 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 evaJuate those exposures and risks arc 

described in the preamble to this Order. However, in detennining whether to amend or revoke this 

Order, EPA will consider all relevant information available at the time the Agency makes that 

detennination, 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 infurmation . 

. EPA will issue a modifi cation or revocation if EPA detennines 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 ill the 

absence of data sufficient to pennit 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 iiEP A determines that the 

modification is useful, appropriate, and consistent with the strut-we and intent of this Order as 

issued. 

EPA SANITIZED Page 64 of 74
- 57-

VII, EFFECT 01<" CONSENT ORDER 

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

this Order pursuant to section 5(e)(l)(C) ofTSCA, to receive service of this Order no later than 45 

days before the end of the review period pursuant to section 5(e)(1)(B) of TSCA, and to challenge 

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

agreeing to be bound by its terms, does not constitute an admission by the Company as to the facts 

or conclusions underlying the Agency's determinations in this proceeding. This waiver does not 

affect any other rights that the Company may have under T 

Title: 

Company: 

EPA SANITIZED Page 65 of 74
ATTACHME1W A 

DEFINITIONS 

{Note: The attached Order may not contain some a/the terms defined below.] 

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

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

Chemistry or the Chemical Abstract~ 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 clotlring" means items of clothiIig that provide a protective barrier to 

. prevent dermal contact ,vith chemical substances of concem. 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 establisInnent 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, 

s.old.or. made available to consumers for their use in or aronnd 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 cht:mical. 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 Manufac:turer" means a person, outside the Company, who is authorized to 

manufacture and import the PJ\,1N substance under the conditions specified in Part 11. of this 

Consent Order and in the Consent Order for Contract :Vlanufacturer. 

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

mixture containing that substance. 

EPA SANITIZED Page 66 of 74
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. 

"Impervious." Chemical protective clothing is "impervious" to a chemical substance if the 

substance causes no chemical or mechamcal 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 ofa 

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

of manufacture, including the cleaning of equipment. 

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

substance. . 

"NIOSH" means the National Institute for Occupational Safety and Health of the U.S. 

Department of Health and Human Services. 

"Non-enclosed process" means any equipment system (such as an open-top reactor, storage 

tank, or mixing vessel) in which a cherliical substance is manufactured, processed, or otherwise 

used where significant direct contact of the bulk chemieal 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 Prernanufacture notice 

subrliitted by the Company relevant to this Order. 

"Personal protective equipment" means any chemical protective clbthing ordevice 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, cherliieal protective 

clothing, aprons, hoods, cherliic.a1 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 

substancc, 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 Pt,1N 

substance. 

EPA SANITIZED Page 67 of 74
3 

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

confonnity with the Good Laboratory Practice Standards and EP A-approved protocols, are 

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

the potential risk of injury to human healthm the environment of the PMN substance. 

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

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

or 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 aU intended operations of 

industrial, commercial, or consumer use. 

"Waters of the United States" has the meaning set forth in 40 CJ?R 122.2. 

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

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

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

work areas. 

EPA SANITIZED Page 68 of 74
ATTACHMENT B 

STATISTICMJ ANALYSIS OF NCELs ANALYTICAL METHOD 

VERIFICATION RESULTS 

This Attachment describes the statistical teclmique (with examples) for comparing lhe 

analytical results obtained by two laboratories pursuant to paragraph (c)(3)(vii) of the New 

Chemical Exposure Limit section of this Order. 

STATISTICAL TECHNIQUE 

To obtain two-sample t test with unequal variances, perfonn lhe following operations: 

• Compute means of the data measured by two laboratories. 

• Compute mean squares 

2 .- 2 . Sj = L:(Xij - Xi) I(ni -1), 1=1, 2 

• Fonn the ratio 

• Compute degrees of freedom 

where, 

-

Xl Average of the results from the company laboratory 

-

X2 Average oflhe results from the independent laboratory 

nl = Number of samples analyzed by the company laboratory 

n2 = Number of samples analyzed by the independent laboratory. 

EPA SANITIZED Page 69 of 74
2 

Then compare the absolute value ofT to the 97.5 percentile point of a t distribution with f 

degrees of freedom. If the absolute value exceeds the 97.5 percentile point, the results measured 

by two laboratories are significantly different at 95% level. Otherwise, they are not significantly 

different. In general, f may not be an integer. Use interpolation to obtain the 97.5 percentile point 

of a t distribution with f degrees of freedom .. 

EXAMPLES -. The following examples (based on simulated data) illustrate the method: 

Example 1 

Xl = 83.30 nl =6 

Data Set 1 

80.56 

100.01 

86.04 

52.61 

84.85 

95.75 

Absolute value ofT = 2.467 

X2 = 100.40 

sl = 9.26 

f= 5.33 

97.11 

102.13 

99.83 

97.83 

105.44 

100.D4 

The t table shows that the 97.5 percentile point is 2.571 and 2.447 for 5 and 6 degrees of 

freedom, respectively. For 5.33 degrees of freedom, the 97.5 percentile point will be 

approximately 2.530 which is greater than the absolute value ofT, 2.467. Hence, the means of 

two data sets are not significantly differeJ;lt at the 5% level. 

However, if this problem had been treated as an ordinary two-sample 1 test, the means 

would be significantly different at the 5% level becauBe the absolute ofT is greater than 2.228, the 

97.5 percentile point for the t distribution with 10 degrees of freedom. 

Example 2 

82.87 

101.85 

87.44 

99.68 

101.15 

99.21 

. Dajll. Set 2 

108.05 

96.51 

100,04 

104.33 

110.32 

107.00 

EPA SANITIZED Page 70 of 74
3 

.. -

Xl =9537 nl 6 

si = 27.25 

Absolute value ofT 2.290 f=8.54 

The t table shows that for 8 and 9 degrees of freedom the 97.5 percentile point is 2.306 and 

2.262, respectively. For 8.54 degrees of freedom the 97.5 percentile point will be approximately 

2.282 which is less than the absolute value ofT, 2.290. Hence, the means of two data sets are 

significantly different at the 5% level. 

EPA SANITIZED Page 71 of 74
Company (Transferor) 

ATTACHMENT C 

NOTICE OF TRA.NSFER 

OF 

TOXIC SUBSTA..NCES COl'il'ROL ACT 

SECTION See) CONSENT ORDER 

PMNNumber 

1. Transfer ofMaQufacture Rights. Effective on __ .~. __ ....-J the Company did sell or 

otherwise transfer to _ .~ ____ . __ .... ~_.. ; ("Sue<;essor in Interest") the rights 

arid 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 ("EP An) 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 Suecessor in Interest. Successor in Interest also certifies that it is 

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

720.22(a)(3) . 

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

_ reasserts, 

__ relinquishes, or 

modifies 

all Confidential Business Infonnation ("CBr') 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 CBr by the original submitter) would not subsequently be eligible for 

confidential treatment under this Notice of Transfer . 

EPA SANITIZED Page 72 of 74
Company (Transferor) 

2 

TOXIC SUBSTANCES CO~TROL ACT 

SECTIO~ See) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

PMNNumber 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Interest 

Signature of Authorized Official Date 

Title of Authorized Official 

City, State, Zip Code 

EPA SANITIZED Page 73 of 74
, 

3 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

-.~~.-=---= 

City, State, Zip Code 

Phone 

EPA SANITIZED Page 74 of 74