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UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY OFFICE OF POLLUTIONPREVENTIONANDTOXICS REGULATION OF ANEW CHEMICAL SUBSTANCE PENDING DEVELOPMENT OF INFORMATION ~

In the matter of: ) Premanufacture Notice Number:

Great Lakes Chemical Corporation ) ) ) ) ) ) ) ) ) ) ) ) P-04-244 

# IIIVIJINMIIIIIqII!JI'IiYildll~911,91111f~,11 llll,llllll Consent Order and Determinations Supporting Consent OrderTABLE OF CONTENTS

Preamble I . Introduction II . Summary ofTerms of the Order III . Contents of PMN IV. EPA's Assessment ofRisk V . EPA's Conclusions of Law VI . Information Required to Evaluate Human Health Effects

Consent Order I . Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation II . Record-keeping III . Successor Liability Upon Transfer of Consent Order IV. Modification and Revocation of Consent Order V . Effect of Consent Order Attachment A- Definitions Attachment B- Statistical Analysis of NCELs Analytical Method Verification Results Attachment C- Notice ofTransfer of Consent Order111 I . INTRODUCTION Under the authority of § 5(e) of the Toxic Substances Control Act ("TSCA") (15 U .S.C . 2604(e)), the Environmental Protection Agency ("EPA" or "theAgency") issues the attached Order, regarding premanufacture notice ("PMN") P-04-244 submitted by Great Lakes Chemical Corporation ("the Company"), to take effect upon expiration ofthe PMNreview period. The Company submitted the PMNto EPApursuant to section 5(a)(1) of TSCA and 40 CFRPart 720 . Under § 15 ofTSCA, it is unlawful for any person to fail or refuse to comply with any provision of § 5 or any order issued under § 5 . Violators may be subject to various penalties and to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5ofTSCA, such as this one, are subject to the § 12(b) export notice requirement. II . SUMMARY OF TERMS OF THE ORDER The Consent Order forthis PMNsubstance requires the Company to: (1 ) submit to EPA the following tiered toxicity testing at least 14weeks before manufacturing or importing the following production volumes ofthe PMNsubstance: Test Production Volume (Kilograms) I Cardiac Sensitization (protocol to be provided by the company) II Systemic/Developmental Toxicity (OECD422) in rats by the inhalation route but with a 10week dosing period prior to mating. (Depending on the results of this study, test III maybe required.)iv

III Reproductive Toxicity Test (OECD415) in rats by the inhalation route. IV Carcinogenicity (OPPTS 870.4200) in rats by the inhalation route. (2) provide its workers respirators to prevent inhalation exposure; (3) as an alternative to usingrespirators; maintain workplace airborne concentrations ofthe PMN substance at or below

a specified New

Chemical Exposure Limit ("NCEL") of 0 .5 mg/m3 verified by actual 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 .) ; (4) label the PMNsubstance and provide Material Safety Data Sheets (MSDS) and worker training in accordance withthe provisions ofthe Hazard Communication Programsection ; (5) not use the PMNsubstance other than as described in the PMN ; (6) distribute the PMNsubstance only to a person who agrees to followthe same restrictions (except the testing requirements) and to not further distribute the PMNsubstance until it has been completely reacted

; and (7) maintain certain records.v III . CONTENTS OF PMN Confidential Business Information Claims (Bracketed in the Preamble and Order) : -Production volume andprocessing information are claimed as confidential business information by the Company. This document does not contain certain proprietary information submitted to EPA in a Letter of Support by a customer of the Company that processes the PMNsubstance. Chemical Identity: Ethane, 2-bromo-l,l-difluoro, CAS # 359-07-9 . Use: Chemical Intermediate for a herbicide. Maximum12-M

onth Production Volume: ~ Test Data Subm

itted with PMN

: Rat oral LDo = 2,000mg/kg. Rat dermal LDo = 2,000mg/kg. Eye irritation (rabbits)-moderate. Skin irritation (rabbits)-no irritation.

IV . EPA'S ASSESSMENT OF RISK The following are EPA's estimations regarding the probable toxicity, human exposure and environmental release of the PMNsubstance, based on the information currently available to the Agency. Human Health Effects Summary . Absorption: EPAexpects 100%ofthe PMNsubstance to be absorbed via the skin, lungs, and GI tract.vi

Occupational Exposure Summary: Manufacture Processing/Use ** # Sites ** Workers * * (#/site) Exposure ** (days/year) Dermal Exposure None Expected ** (mg/day) Inhalation Exposure <380 mg/day ** (mg/day) ** Proprietary information fromthe processor/user. Risk to Occupational Workers. Based on acute data on the PMNsubstance, there is a potential risk ofeye irritation to manufacture and use workers exposed to the PMNsubstance. Based on analogue data on other alkyl halides, EPAis concerned that, in the absence ofprotective measures, inhalation and dermal exposure ofworkers to the PMNsubstance may cause eye irritation, skin sensitization, systemic toxicity, developmental toxicity, reproductive toxicity and cancer. Respiratory Assigned Protection Factor (APF) : 75 New Chemical Exposure Limit: 0 .5 mg/m3 as an 8-hour time-weighted average (TWA) . V . EPA'S CONCLUSIONS OF LAW The following findings constitute the basis of the Consent Order: A . EPAis unable to determine the potential for human health effects fromexposure to the PMN substance. EPAtherefore concludes, pursuant to § 5(e)(1)(A)(i) ofTSCA, that the information 

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available to the Agency is insufficient to permit a reasoned evaluation ofthe human health effects of the PMNsubstance. B . In light of the potential risk of human health effects posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMNsubstance, and the Agency's conclusion that issuing the Order will not result in any significant loss ofbenefits to society, EPAhas concluded, pursuant to § 5(e)(1)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to human health.

VI . INFORMATION REQUIREDTOEVALUATE HEALTH EFFECTS Triggered Testin~. The Orderprohibits the Company fromexceeding specified production volumes unless the Company submits the information described in the Testing section of this Order in accordance with the conditions specified in the Testing section.J~.~ED STqT~S' UNITED STATES ENVIRONMENTAL PROTECTION AGENCY



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' OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CONSENT ORDER I . TERMS OF MANUFACTURE IMPORT, PROCESSING, DISTRIBUTIONIN COMMERCE USE ANDDISPOSAL PENDING SUBMISSIONAND EVALUATION

OF INFOR

MATION The Great L.akes Chemical Corporation ("the Company") is prohibited. from . rnanufactuting, importing, processing, distributing in commerce, using, or disposing of'thc : chemical substance Ethane, 2-bromo-l .l-difluoro- ("the PMISf-substance") (P-04-244) in the United. States, for any nonexempt commercial purpose, pending the development of information necessary for a reasoned evaluation of the humanhealth effects of the, substance, sr_ ..d the completion of EPA's review of, and regulatory action based on, that information,, exceptunder tile following conditions: TESTING (a) Section 8(e) Reportin~ Any information on the PMNsubstance which reasonably supports the conclusion that the PMNsubstance 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 PMNidentification number for this substance and shall contain a 

# 9 internet Address (URL) ® http://www .epa.gov Recycled/Recyclable - Printed with Vegetable Oil Based Inks on 100%Postconsumer, Process Chlorine Free Recycled Paper-2-

statement that the substance is subject to this Consent Order. Additional information regarding section 8(e) reporting requirements can be found in the reporting guide referenced at 68 Federal Register 33129 (June 3, 2003) . . (b) Notice of Study Scheduling: The Company shall notify, in writing, the EPALaboratory Data Integrity Branch (2225A), Office ofEnforcement and Compliance Assurance, U .S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N .W ., Washington, D

.C. 20460, of the following information within 10 days of scheduling any studyrequired to be performed pursuant to this Order, or within 15 days afterthe effective date of this Order, whichever is later: 1 . The date when the study is scheduled to commence; 2 . The name and address ofthe laboratory which will conduct the study; and 3. The name and telephone number of a person at the Company or the laboratory whom EPAmay contact regarding the study. 4 . The appropriate PMNidentification 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 CFRPart 792 and using methodologies generally accepted at the time the study is initiated. Before starting to conduct any such study, the Company must obtain approval of test protocols fromEPAby submitting writtenprotocols. EPAwill respond to the Company within 4weeks ofreceiving the written protocols. Published test guidelines specified-3-

in paragraph (d) provi de general guidanc e for dev elopm ent of testprotocols, but are not themselves acceptable protocols. (d) Triggered Testing Requirements. The Company is prohibited frommanufacturing or importing the PMNsubstance beyond the following aggregate manufacture andimportvolumes ("the production limits"), unless the Company conducts the following studies on the P1VIN substance and submits all final reports and underlying data in accordance with the conditions specified in this Testing section. P roduction Limit Study Guideline 1 kilograms Cardiac Sensitization protocol to be provided by the Company Systemic/Developmental Toxicity OECD 422 in rats by the inhalation route but with a 10week dosing period prior to mating. kilograms Reproductive Toxicity OECD 415

in rats by the inhalation route. kilograms Carcinogenicity OPPTS 870 .4200 in rats by the inhalation route. (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 EPAthe results of any interimphase of each study

; and (3) submit, intriplicate (with an additional sanitized copy, if confidential business information is involved), the final report of each study and all underlying data ("the report and data") to EPAno later than 14weeks priorto exceeding the applicable production 

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limit. The final report shall contain the contents specified in 40 CFR792 .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 . EPAwill require the submission of raw

data such asslides and laboratory notebooks only if EPAfinds, on the basis of professionaljudgment, that an adequate evaluation ofthe study cannot take place in the absence of these items. (f) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) of this Testing section ifnotified in ting by EPAthat it is unnecessary to conduct that study . For example, based on the results of the systemic/developmental toxicity test, EPAwill determine whether the reproductive toxicity study is required. However, ifthe reproductive toxicity study is waived, the production volume limit for the carcinogenicity studywill accordingly become L_ l kilograms . (g) Equivocal Data. If EPAfinds that the data generated by a study are scientifically equivocal, the Company may continue to manufacture and import the PMNsubstance beyond the applicable production limit. To seek relief fromany otherrestrictions of this Order, the Company may make a second attempt to obtain unequivocal data by reconducting the study

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under the conditions specified in paragraphs (b), (c), and (e)(1) and (2) . The testing requirements may be modified, as necessary to permit a reasoned evaluation of the risks presented by the PMNsubstance, only by mutual consent ofEPAand the Company. (h) EPADetermination ofInvalid Data. (1) Except as described in subparagraph (h)(2), if, within 6weeks ofEPA's receipt of a test report and data, the Company receives written notice that EPAfinds that the data generated by a study are scientifically invalid, the Company is prohibited fromfurther manufacture and import ofthe PMNsubstance beyond the applicable production limit. (2) The Company may continue to manufacture and import the PMNsubstance beyond the applicable production limit only if so notified, in writing, by EPA in response to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii)

.

(i) The Company mayreconduct the study in compliance with paragraphs (b), (c), and (e)(1) and (2) . If there is sufficient time to reconduct the study and submit the report and data to EPAat least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3) . If there is insufficient time for the Company to comply with subparagraph (e)(3), the Company may exceed the production limit and shall submit the report and data in triplicate to EPAwithin a reasonable period oftime, all as specified by EPAin the notice described in subparagraph (h)(1) . EPAwill respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data.-6- (ii) The Company may, within 4weeks of receiving fromEPAthe notice described in subparagraph (h)(1), submit to EPAa written report refuting EPA's finding . EPA will respond to the Company, in writing, within 4weeks ofreceiving the Company's report . (i) Company Determination ofInvalid Data. (1) Except as described iii 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 ofscientifically valid data under the conditions specified in paragraphs (c) and (e), the Company remains prohibited fromfurther manufacture and import of the PMNsubstance beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks offirst becoming aware of such circumstances, a written statement explaining why circumstances clearly beyond the control of the Company or laboratory will cause or have caused development ofscientifically invalid data. EPAwill notify the Company ofits response, in writing, within 4weeks ofreceiving the Company's report . EPA's written response mayeither:

(i) allow

the Company to continue to manufacture and import the PMN substance beyond the applicable production limit, or

(ii) require the Company to continue to conduct, or to reconduct, the study in compliance with paragraphs (b), (c), and (e)(1) and (2) . Ifthere is sufficient time to conduct or reconduct the study and submit the report and data to EPAat least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3) . If there is insufficient time for the Company to comply with subparagraph (e)(3), the Company may exceed the production limit and shall submit the report and data in-7-

triplicate to EPAwithin a reasonable period oftime, all as specified by EPAin the notice described in subparagraph (i)(2) . EPAwill respond to the Company, in writing, within 6weeks of receiving the Company's report and data, as to whether the Company may continue to manufacture and import beyond the applicable production limit. (j) Unreasonable Risk. (1) EPAmay 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 PMNsubstance will or may present an unreasonable risk of injury to human health or the environment . EPA's notice may specify that the Company undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthe PMNsubstance to mitigate exposures to or to better characterize the risks presented by the PMNsubstance. Within 2 weeks fromreceipt of such a notice, the Company must cease all manufacture, import, processing, distribution, use and disposal of the PMN substance, unless either: (2) within 2weeks fromreceipt of the notice described in subparagraph (j)(1), the Company complies with such requirements as EPA's notice specifies; or (3) within 4weeks fromreceipt of the notice described iii subparagraph (j)(1), the Company submits,to EPAa writtenreport refuting EPA's finding and/or the appropriateness of any additional requirements imposed by EPA . The Company may continue to manufacture, import, process, distribute, use and dispose of the PMNsubstance in accordance withthe terms ofthis Order pending EPA's response to the Company's written report. EPAwill respond to the Company, in writing, within 4 weeks of receiving the Company's report . Within 2 weeks ofreceipt of EPA's written response, the Company shall comply with any requirements imposed by

EPA's response or cease all manufacture, import, processing, distribution, use and disposal of the PMNsubstance. (k) Other Requirements . Regardless ofthe satisfaction ofany other conditions in this Testing section, the Company must continue to obeyall the terms of this Consent Order until otherwise notified in writing by EPA . The Companymay, based upon submitted test data or other relevant information, petition EPA to modify or revoke provisions of this Consent Order pursuant to Part IV. of this Consent Order. PROTECTION INTHE WORKPLACE (a) During manufacturing, processing, and use of the PMNsubstance at any site controlled by the Company, the Companymust establish a program whereby: (1) Respiratory Protection. Each person who is reasonably likely to be exposed by inhalation in the work area to the PMNsubstance in the formlisted in subparagraph (a)(3) of this section, is provided with, and is required to wear, at a minimum, a NIOSH-approved respirator with an assigned protection factor (APF) of 75, fromone of the categories listed in subparagraph (a)(2) of this section, and the respirator is used in accordance with 29 CFR 1910.134 and 42 CFRPart 84. (2) Authorized Respirators. The following NIOSH-approved respirators meet the minimum

requirements for subparagraph (a)(1) ofthis section:-9- (i) NIOSH-certified supplied-air respirator operated in pressure demand or other positive pressure mode and equipped with a tight-fitting full facepiece with an assigned protection factor of 75. (3) Physical Form

. The following forms of airborne chemical substances are listed for subparagraphs (a)(1) of this section:

(i) Vapor. . (ii) Gas. (b) Low

Concentrations in Mixtures. Ifthe PMNsubstance is present in the work area only as a mixture, the Company is exempt fromthe provisions of this protection in the workplace section if the concentration of the PMNsubstance in the mixture does not exceed 1 .0 percent byweight or volume, or 0

.1 percent by weight or volume ifparagraph (g) of the Hazard Communication Programsection ofthis Order identifies cancer as a potential human health hazard ofthe PMN substance. This exemption does not apply if the Company has reason to believe that during intended use or processing in the work area, the PMNsubstance in the mixture may be reconcentrated above the 1 .0 or 0 .1 percent level, whichever is applicable. NEW CHEMICAL EXPOSURE LIMIT (a) Alternative to Requirements of'Respirator Section (1) EPArecommends and encourages the use ofpollution prevention, source reduction, engineering controls,and work practices, rather than respirators, as a means of controlling inhalation exposures whenever practicable.-10- (2) Whenever apersonis reasonably likely to be exposedto the PMNsubstance by inhalation, as an alternative to compliance with the respirator requirements in the Protection in the Workplace section ofthis Order, the Company may comply with the requirements of this New Chemical Exposure Limit section . However, before the Company may deviate fromthe respirator requirements in the Protection in the Workplace section of this Order, the Company must : (i) submit to EPA a copy ofthe Company's sampling and analytical method for the PMNsubstance, verified in accordance with subsection (c)(3) ofthis New Chemical Exposure Limit section;

(ii) obtain monitoring results in accordance with this New Chemical Exposure Limit section

; and (iii) based on those monitoring results, select, provide, and ensure use of the appropriate respiratory protection specified in paragraph (e)(2) of this New Chemical Exposure Limitsectionby persons whoare reasonably likely to be exposed to the PMNsubstance by inhalation. (3) After appropriate respiratory protection has been selected at a workplace based on the results of actual 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 Workplace section ofthis Order (unless it is the same as required by this New Chemical Exposure Limit section) .-11-

(b) Exposure Limit. (1) General . The following new chemical exposure limit (NCEL) for the PNIN substance is an interimlevel determined by EPAbased on the limited information available to the Agency at the time of development of this Order. The NCEL for the PNINsubstance is as follows: (i) Time-WeightedAverage (TWA) Limit. The . Company shall ensure that no person is exposed to an airborne concentration of the PNIN substance in excess of 0 .5 mg/m3 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-Hour Work-shifts. Fornon-8-hour work-shifts, the NCEL for that work-shift (NCELn) shall equal the 8-hour TWAin paragraph (i) x (8/n) x [(24-n)/16], where n

=the number ofhours in the actual work-shift. (2) Automatic Sunset . If, subsequent to the effective date ofthis Order, the Occupational Safety and Health Administration (OSHA) promulgates, pursuant to §6of the Occupational Safety and Health Act, 29 U .S .C . 655, a final chemical-specific permissible exposure limit (PEL) specifically applicable to this PNIN substance and the OSHA PEL is not challenged in court within 60days of its promulgation, then any respirator requirements in the Protection in the Workplace section of this Order and any requirements ofthis New Chemical Exposure Limit section applicable to workers and situations subject to the OSHA PEL shall automatically become null and void. However, the requirements ofthis Consent Order are not negated by any pre-existing OSHA PEL applicable to the PMNsubstance.-12-

(c) Performance-Criteria for Sampling and Analytical Method. (1) Applicability. For initial,development and validation of the sampling and analytical method for the PMNsubstance, all the requirements ofthis subsection (c) apply . For subsequent monitoring conductedpursuant to subsection (d) ofthis New Chemical Exposure Limit section, only the following requirements apply : (c)(4)(i), (4)(ii), (4)(iv)(B), (4)(v)(B), (8), and (9) . Any deviation fromthe requirements ofthis subsection (c) must be approved in writing by EPA . (2) Submission ofVerified Method and Certification Statement . The Company shall submit to EPAa copy of a validated sampling and analytical method for the PMNsubstance which 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 ofboth the Company and the Laboratory, certifying the truth and accuracy of the independent laboratory verification conducted pursuant to subsection (c)(3) . To assist EPAin identifying the document, it shall state in a conspicuous, underlined subject-line at the top: " NCEL Sampling and Analytical Method for PMN# ," after-which the correct PNIN number for this chemical substance shall be stated. (3) Verification ofAnalytical Method by Independent Third-Party LaboratorL . (i) Verification. The Company shall have an independent reference laboratory ("Laboratory") verify the validity of the analytical method for the PMNsubstance, 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)

.-13- (ii) Independent Reference Laboratory. The independent reference laboratory must be a separate and distinct person (as defined at 40 CFR720 .3(x)) fromthe Company and from any other person who mayhave developed the method for the Company . (iii) Accreditation. The Laboratory must be accredited by a formally recognized government or private laboratory accreditation program for chemical testing and/or analysis. (iv) Good Laboratory Practice Standards. The Laboratory verification ofthe analytical method forthe PMNsubstance must comply with TSCA Good Laboratory Practice Standards (GLPS) at 40 CFRPart 792. [Certain provisions ofthe TSCA GLPS applicable to toxicity testing in laboratory animals, such as 40 CFR792.43 ("Test system care facilities"), 792.45 ("Test system

supply facilities") and 792.90 ("Animal and other test system care"), are clearly inapplicable to the NCEL requirements .] However, compliance with TSCA GLPS is not required under this New Chemical Exposure Limit sectionwhere the analytical method is verified by a laboratory accredited by either: (A) the American Industrial Hygiene Association (AIHA) Industrial Hygiene Laboratory Accreditation Program(IHLAP) ; or (B) another comparable programapproved in advance in writing by EPA . (v) Analysis of Duplicate Samples. The Company shall collect six duplicate samples (a total of 12) at the TWAconcentration. The samples shall be taken either froma 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 PMNsubstance onto a sample collection device. The duplicate samples shall be collected on identical collection media, at the same time, and underthe same conditions. One set of six-14-

samples shall immediately be analyzed by the Company, the other set ofsix samples shall be analyzed by the Laboratory using the method developedby or for the Company . (vi) Sample Storage Study . If the results of the analysis of duplicate samples pursuant toparagraph (c)(3)(v) do not satisfy the requirements in paragraph (c)(3)(vii), the Company must performa sample storage study as follows: (I) Triplicate Samples. The Company shall collect six triplicate samples (a total of 18) at the TWAconcentration. The samples shall be taken either froma controlled environment (e.g., a sealed chamber or "glove box") which closelyresembles the actual workplace conditions or, for solids and liquids with very low vapor pressure, by injecting the PMNsubstance onto a sample collection device. The triplicate samples shall be collected on identical collection media, at the same time, and under the same conditions. One set ofsix samples shall immediately be analyzed by the Company.

(II) Analysis After Sample Storage. Asample storage evaluation shall be performed with the two remaining sets ofsix samples. One set ofsix samples shall be analyzed by the Laboratory using the method developedby 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 forthe samples including extraction conditions, time from sampling to extraction, time fromcollection or extraction (ifapplicable) to analysis and storage conditions must be specified in the method description.

(vii) Comparison ofResults. The difference between the results of the two sets ofsix samples analyzed by the Laboratory and the Company as required in either paragraph (c)(3)(v) or (c)(3)(vi)(11) shall be evaluated using atwo-sample t-test with unequal variances,-15-

and the twosides of the critical regions shall not exceed a 5% significance level . (See Attachment B - Statistical Analysis ofNCELs Analytical Method Verification Results.) The average of each set ofsix samples must be within 10%of the true value. If the average of each set ofsix samples is not within 10% ofthe true value, then the sample storage time between collection and analysis must be reduced until the average of each set ofsix samples is within 10% ofthe true value. (4) Accuracy. The sampling and analytical method must clearly demonstrate the following: (i) General . The sampling and analytical method, and all monitoring data relied on by the Company, shall be accurate to within +25% at a 95%

confidence level for concentrations of the PMNsubstance ranging fromone half the NCEL to twice the NCEL.

(ii) NCEL Quantitation Limits. The analytical method should be capable of reliably quantifying the PMNsubstance across the full range of reasonably likely exposures. At a minimum, the analytical method must be capable ofreliably quantifying froma lower quantitation limit ("LQL") of one half the NCEL to an upper quantitation limit ("UQL") of at leasttwice the NCEL. If the Company obtains a monitoring sample that is more than 10% above the actual UQL of the analytical method, the Company must complywith paragraph (e)(4)(i) . (iii) Lower Ouantitation Limit Sijznal-To-Noise Ratio The analytical method shall be capable of quantifying the PMNto a concentration of one halfthe 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-16-

analysis of samples. (Ifbaseline noise cannot be obtained, another reference must be selected. This may be apeak considered to be noise caused by the reagent matrix.) The sampling preparation method must be specified and the detection limit forthe analytical procedure must be reported as mass per injection for chromatographic techniques.

(iv) Instrument Calibration. (A) For method development and validation (but not subsequent monitoring), the initial calibration shall at a minimum consist offive (5) calibration standards with a linear correlation of 0 .95 -- these five (5) calibration standards must consist of one standard at each ofthe 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 andtwo times the NCEL (1 x NCEL < > 2 x NCEL), and twice the NCEL (2 x NCEL) . (B) During each week ofboth method development/validation and subsequent 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% ofthe 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. (A) For method development and validation, the Company must calculate the percent of the PMNsubstance recovered by the analytical method froma sample containing a known quantity ofthe PMNsubstance. The sample shall be taken either froma 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

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pressure, by injecting the PMNsubstance 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 concentrations for the PMN substance must be included in the sampling and analytical method submitted to EPA . (B) During each subsequent monitoring episode or campaign, at least 1 matrix spike, prepared by injecting the PMNsubstance onto a sample collection device, shall be analyzed. (This matrix spike must be prepared at the NCEL concentration.)

(vi) Sampling Device Capacity. The capacity of the sampling device must be tested and results reported to show under a known and well-defined set of conditions that the device is capable of collecting the new chemical in solid, liquid orvapor phase with minimal loss. The sampling device's capacity (air volume and collected analyte mass) must be specified. For methods that use adsorbent tubes as the collection medium, evidence ofthe capacity must be provided in the formofbreakthrough testing. This testing must be done at a concentration twice the NCEL and under conditions similar to those expected in the workplace. Breakthrough is defined to have occurred when the concentration of the PMNsubstance in the effluent streamis equal to 5%ofthe concentration of the influent stream, orwhen 20% of the PMNsubstance is detected in the backup section of the sampler.

(vii) Sampling Device Desorption Efficiency. Where applicable, the desorption efficiency must be evaluated for the air sampling device. Aminimum ofsix air samples spiked with the PMNsubstance at least the NCEL concentration must be prepared. Arecovery of at least 75%

mustbe obtained for each ofthe six samples.-18- (5) Precision. The estimate ofthe coefficient ofvariation of each set ofsix samples from the controlled atmosphere test (spiked at 1 .0 NCEL, perparagraphs (c)(3)(v) or (vi)) must be less than 0

.105, including allowance of 0 .05 for error due to sampling. (6) Interpretation ofAccuracv and Precision Data. (i) Ifa single matrix spike recovery is less than 75% recovery or greater than 125%or the estimated precision is greater than 0 .105, thenthe Company must re-prepare the matrix spike, re-sample, and re-analyze all samples associated with such matrix spike or triplicate samples.

(ii) Forpercent recoveries less than 90% but greater than 75%, correction for low recovery is required. Correct for recovery first by dividing the observed amount by the proportion recovered before determining ifmeasurements fall below the NCEL. For example, if the observed level is 30mg/m3 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 shall mimic the actual workplace environment expected to be monitored. Conditions such as the presence of other chemicals, lighting, humidity, etc. must mimic the conditions in the workplace to be monitored

. (8) Changes Affecting Validity. Ifthe workplace environment changes from the initial conditions described in the verified sampling and analytical method in a way reasonably likely to invalidate the accuracy of the method, then the Company must comply with the respirator requirements in the Protection in the Workplace section of this Order, unless the Company revalidates the method to confirm that the requirements for accuracy andprecision in paragraphs-19-

(c)(4) and (5) are met. Examples of possible changes include but are not limitedto: 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 interfere with a lightsensitive PMNsubstance; or introduction ofwater/increased humidity to the workplace which could react with the PMNsubstance and cause difficulties in collection and analysis. (9) ComparabiliW

. All data and results shall be reported in the same units of measurement as the NCEL. (10) Responsibility for Method Validity. The independent laboratory verification and EPAreceipt of the sampling and analytical method pursuant to this subsection (c) do not ensure that the method will produce validmonitoring data. The Company is ultimately responsible for ensuring the validity of its monitoring data. (d) Monitoring Potential Ex op sure. (1) General . (i) Action Level . The "action level" is defined as an airborne concentration of the PMNsubstance, calculated as an 8-hour time-weighted average, equal to one half the NCEL TWAspecified in subparagraph (b)(1) . (The action level may be exceeded without penalty; its purpose pertains solely to determination ofthe requisite monitoring frequency.)

(ii) Representative Exposure Groups. Whenever monitoring is required by this New Chemical Exposure Limit section, the Company shall take representative samples ofwhat the potential exposure of each person whois reasonably likely to be exposed to airborne concentrations of the PMNsubstance would be if respirators were notworn. The Company shall

### -20-

do so by sampling the breathing zone air of at least one person that represents, and does not underestimate, the potential exposure of every person performing the same or substantially similar operations in each work shift, in eachjob classification, in each work area (hereinafter identified as an "exposure group") where inhalation exposure to the PMNsubstance is reasonably likely to occur. The exposure of each person need notbe itself directly sampled if that exposure is represented by sampling the exposure ofanother person in the same exposure group. (iii) Good Laboratory Practice Standards. Determinations ofpotential inhalation exposure shall be made according to TSCA Good Laboratory Practice Standards at 40 CFRPart 792 and the sampling and analytical method developed pursuant to subsection (c) ofthis New Chemical Exposure Limit section . [Certain provisions of the TSCA GLPS applicable to toxicity testing in laboratory animals, such as 40 CFR792.43 ("Test systemcare facilities"), 792.45 ("Test system

supply facilities") and 792.90 ("Animal and othertest systemcare"), are clearly inapplicable to the NCEL "requirements.] However, compliance with TSCA GLPS is not required where monitoring samples are analyzed by a laboratory accredited by either : (A) the American Industrial Hygiene Association (AIHA) Industrial Hygiene LaboratoryAccreditation Program(IHLAP) ; or (B) another comparable program approved in advance in writing by EPA . (iv) Representative 8-hour TWAairborne concentrations shall be determined on the basis of samples representing the full shift exposure for each exposure group. (2) Initial Monitoring. Before the Company may deviate fromthe respirator requirements ofthe Protection in the Workplace section, the Company shall conduct initial-21-

monitoring to accurately determine the airborne concentration of the PMNsubstance for each exposure group in which persons are reasonably likely to be. exposed to the PMNsubstance. (3) Periodic Monitoring. (i) If any representative samples taken during the initial monitoring reveal an airborne concentration at or above the action level but at or below the TWA, the Company shall repeat the monitoring for that exposure group at least every 6months. If the PMNsubstance is not manufactured, processed, or used at all during a given 6month calendar period, the Company is not required to conduct monitoring until manufacture, processing, or use of the PMNsubstance is resumed. However, cessation of manufacturing, processing and use ofthe PMNsubstance for less than the 6month period does not constitute grounds for postponement of the 6 month deadline to conduct monitoring.

(ii) Ifany representative samples taken during the initial monitoring reveal an airborne concentration above the TWA, the Company shall repeat the monitoring for that exposure group at least every 3 months. If the PMNsubstance is not manufactured, processed, or used at all during a given 3 month calendar period, the Company is not required to conduct monitoring until manufacture, processing, or use of the PMNsubstance is resumed. However, cessation ofmanufacturing, processing and use ofthe PMNsubstance for less than the 3 month period does not constitute grounds for postponement ofthe 3 month deadline to conduct monitoring. (iii) The Company may alter the monitoring schedule fromevery 3 months to every 6months for any exposure group for whom two consecutive measurements taken at least 7 days apart indicate that the potential exposure has decreased to the TWAor below, but is at or-22-

above the action level . Where the PMNsubstance 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 ofMonitoring. (i) Ifrepresentative samples taken during the initial monitoring reveal an airborne concentration below the action level, the Company may discontinue monitoring for that exposure group, except when additional monitoring is required by paragraph (d)(5) of this New Chemical Exposure Limit section.

(ii) If representative samples taken during 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 discontinue the monitoring forthat exposure group, except when additional monitoring is required by paragraph (d)(5) of this New Chemical Exposure Limit section . Where the PMNsubstance 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 thehighest peak exposures and variability in exposure. (5) Additional Monitoring. (i) For a previously monitored exposure group, the Company shall, within 7 days of any ofthe events listed below in this paragraph (d)(5)(i), conduct the initial monitoring followed by anyperiodic or additional monitoring required by subsection (d) ofthis New Chemical Exposure Limit section:-23- (a) change in the production volume, process, control equipment, personnel or work practices that may reasonably cause new or additional exposures to the PMN substance; (b) spills, leaks, ruptures or other breakdowns occurthat may reasonably cause new

or additional exposures to the PMNsubstance; and

(c) whenever else the Companyhas any reason to suspect a change that may reasonably result in new or additional exposures to the PMNsubstance. (ii) In no event is the additional monitoring requirement in paragraph (d)(5)(i) intended to delay implementation of any necessary cleanup or other remedial action. During any such operations that may occurbefore commencing additional monitoring, the Company shall ensure 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 professionaljudgment of a qualified expert . (6) Notification of Monitoring Results. (i) Within 15working days after receipt of the results of any monitoring required by this Order, the Company shall notify each person whose exposure is represented by that monitoring. The notice shall identify the NCEL, the monitoring results, and any corresponding respiratory protection required by subsection (e) . Affected persons shall be notified inwriting 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-24-

exposure to or below

the NCEL, or shall refer to a document,available to the person which states the actions to be takento 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 PMNsubstance will not exceed the action level (defined in paragraph (d)(1)(i)) under the expected handling procedures and conditions for a specific "exposure group" (defined in. paragraph (d)(1)(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 such objective data must accurately characterize actual employee exposures to the PMNsubstance andmust 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 PMNsubstance. 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 andchemical properties of the PMNsubstance, industry-wide studies, and/or laboratory test results. (e) Respiratory Protection. (1) General . Whenever the Company has conducted monitoring at a workplace in accordance with subsection (d) ofthis New Chemical Exposure Limit section andthe measured airborne concentration ofthe PMNsubstance for any person whois reasonably likely to be exposedto the PMNsubstance by inhalation exceeds the NCEL, the Company shall providep. 33

### -25-

those persons the respirators specified in this subsection (e), rather than the respirator(s) identified in the Protection in the Workplace section of this Order, and shall ensure that the respirators are used in accordance with 29 CFR 1910.134 and 42 CFRPart 84. When the Company has not yet actually measured the airborne concentration of the PMNsubstance at a workplace in accordance with this New Chemical Exposure Limit section, the Company shall comply with the respirator requirements in the Protection in the Workplace section of this Order at that workplace. (2) Selection ofAppropriate RespiratoryProtection. After the Company has conducted 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 P1Vl .N substance by inhalation use at least the respiratory protection which corresponds in the following table to the actually measured airborne concentration (or a more protective respirator which corresponds to a concentration higher than actually measured) . GAS/VAPOR RESPIRATORTABLE Measured Concentration of PMNSubstance <_ NCEL <_ 10 x NCEL Reguired Respiratory Protection

~ No respiratory protection is required. IfData on Cartridge Service Life Testing has been Reviewed and Approved bv EPA:

~ NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with the appropriate gas/vapor cartridges (organic vapor, acid gas, or substance-specific) .-26- " NIOSH-certified powered air-purifying respirator equipped with a loose fitting hood or helmet and equipped with the appropriate gas/vapor cartridges (organic vapor, acid gas, or substance-specific) . _< 25 x NCEL IfData on Cartridge Service Life Testing has been Reviewed and

Approved by EPA

: " NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with the appropriate gas/vapor cartridges (organic vapor, acid gas, or substance-specific) . " NIOSH-certified powered air-purifying respirator equipped with a . loose-fitting hood or helmet and the appropriate gas/vapor cartridges (organic vapor, acid gas, or substance-specific) . 5 50x NCEL Data on Cartrid,

AppYoved by EPA

: " NIOSH-certified air-purifying, tight-fitting full-face respirator equippedwith the appropriate gas/vapor cartridges (organic vapor, acid gas, or substance-specific) . IfNo Cartridge Service Life Testing isAvailable: " NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow

mode and equipped with a tight-fitting full facepiece. S 2000x NCEL " NIOSH-certified, supplied-air respirator operated in pressure demand or

other positive pressure mode and equipped with a tight-fitting full facepiece.p. 36-27-

> 2000 x NCEL " Any self-contained respirator equipped with a full facepiece and

operated in a pressure demand or other positive pressure mode.

~ Any supplied-air respirator equipped with a full facepiece operated in a pressure demand or other positive pressure mode in combination with an auxiliary self-contained breathing apparatus operated in apressure demand or other positive pressure mode. (3) Reductions in Respiratory Protection. After appropriate respiratory protection has been selected based onthe results ofactual 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 bythis New Chemical Exposure Limit section) . Before the Company may make any reduction in any respiratory protection selected 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) . Where the PMNsubstance 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) Special Situations. (i) Measurements Outside Quantitation Limits. When avalue 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 generally established and-28-

accepted statistical methods. Ifthe Company obtains a monitoring sample that is more than 10% above the actual upper quantitation limit (UQL) of the analytical method, the Company must ensure that its workers wear at least a 19Csupplied-air respirator listed in this subsection (e) . Any reductions in this respiratoryprotection must comply with paragraph (e)(3) . The Companymay submit an improved analytical method provided that it complies fully with subsection (c) ofthis New Chemical Exposure Limit section, includingthe verification required by subsection (c)(3) .

(ii) Cleanup and Remedial Actions. During any special cleanup or other remedial actions that may occur before commencing additional monitoring (as discussed in paragraph (d)(5)(ii), the Company shall ensure that potentially exposedpersons use 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 professionaljudgment of a qualified expert. (f) NCEL Record-keeping. (1) Whenever 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 until 30 years after the date they are created, and shall make them available for inspection and copying by EPAin accordance with section 11 of TSCA

: (i) Acopy of the sampling and analytical methods used and continuing evidence oftheir accuracy over time as required by section (c) ;-29- (ii) Records documenting compliance with the analytical method verification requirements of subsection (c)(3), including copies of the signed certification statement and the verification results obtained by both laboratories;

(iii) Records documenting either compliance with the Good Laboratory Practice Standards at 40 CFRPart 792, or use of a laboratory accredited by the American Industrial Hygiene Association (AIHA) or another, comparable program approved in advance in writing by EPA . Where the Company elects to not comply with TSCA GLPS, such records shall include the written accreditation fromthe AIHAor the written approval fromEPA . (iv) Records documenting all monitoring dates, duration, and results ofeach sample taken

; (v) Records documenting the name, address, work shift, job classification, and work area of the person monitored and ofall other persons whose exposures the monitoring is intended to represent; .

(vi) Any conditions that might have affected the monitoring results; (vii) Notification ofmonitoring results required by paragraph (d)(8) ; (viii) Records documenting any changes in the production, process, control equipment, personnel or work practices that mayreasonably cause new or additional exposures to the PMNsubstance;

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

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

### -30- (xi) Records documenting any actions taken to mitigate exposures to the PMN substance; (xii) Records documentingreliance 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, (D) 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 communicationprogram for the PMNsubstance in each workplace. The written program will, at a minimum, describe how the requirements of this section for labels, MSDSs, and other forms ofwarning material will be satisfied. The Company must make the written hazard communication program available, upon request, to all employees, contractor employees, and their designated representatives. The Company mayrely on an existing hazard communication program, including an existing programestablished underthe Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1910.1200), to comply with this paragraph provided that the existing hazard communication programsatisfies the requirements ofthis section. The writtenprogramshall include the following: (1) Alist of chemical substances known to be present in'the work area which are subject to a TSCAsection 5(e) consent order signed by the Company or to a TSCAsection 5(a)(2)-31-

SNURat 40 C

.F.R. Part 721, subpart E. The list must be maintained in each work area where the PMNsubstance is knownto be present and must use the identity provided on the MSDS for the substance required under paragraph (c) ofthis section. The list may be compiled for the workplace or for individual work areas. Ifthe Company is required either by another Order issued under section 5(e) ofTSCA, or by a TSCA section 5(a)(2) SNURat 40 CFRPart 721, subpart E, to maintain a list ofsubstances, the lists shall be combined with the list under this subparagraph. (2) The methods the Company will use to informemployees of the hazards ofnonroutine tasks involving the PMNsubstance (e.g., cleaning ofreactor vessels), and the hazards associated with the PMNsubstance contained in unlabeled pipes in theirwork area. (3) The methods the Company will use to informcontractors ofthe presence of the PMNsubstance in the Company's workplace and ofthe provisions ofthis Order if employees of the contractor work in the Company's workplace and are reasonably likely to be exposed to the PMNsubstance while in the Company's workplace. (b) Labeling. (1) The Company shall ensure that each container ofthe substance in the workplace is labeled in accordance with this subparagraph (b)(1) .

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

(A) Astatement ofthe health hazards(s) and precautionary measure(s), if any, identified in paragraph (g) of this section or by the Company, for the PMNsubstance.

, (B) The identity bywhich the PMNsubstance may be commonly recognized.-32- (C) Astatement of the environmental hazard(s) and precautionary measure(s), if any, identified in paragraph (g) of this section, or by the Company, for the PMN substance. (D) Astatement of exposure and precautionary measure(s), ifany, identified in paragraph (g) of this section, or by the Company, forthe PMNsubstance.

(ii) The Company may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu of affixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys information specified by subparagraph (b)(1)(i) of this section . Any written materials must be readily accessible to the employees in theirwork areas throughout each work shift.

(iii) The Companyneed not label portable containers into which the P1V1N substance is transferred fromlabeled containers, and which are intended only for the immediate use of the employee whoperforms the transfer.

(iv) The Company shall not remove or deface an existing label on containers of the PMNsubstance obtained frompersons outside the Company unless the container is immediately re-labeledwith the information specified in subparagraph (b)(1)(i) of this section. (2) The, Company shall ensure that each container of the substance leaving its workplace for distribution in commerce is labeled in accordance with this subparagraph (b)(2) .

(i) The label shall, at a minimum, contain the following information: (A) The information prescribed in subparagraph (b)(1)(i) of this section.-33- 

### (B) The name and address of the manufacturer or a responsible party who can provide additional information on the substance for hazard evaluation and any appropriate emergency procedures.

(ii) The label shall not conflict with the requirements ofthe Hazardous Materials Transportation Act (18 U .S.C . 1801 et. seq.) and regulations issued under that Act by the Department ofTransportation. (3) The label, or alternative forms ofwarning, shall be legible and prominently displayed. (4) The label, or alternative forms ofwarning, shall be printed in English; however, the information may be repeated in other languages. (5) If the label or alternative formofwarning is to be applied to a mixture containing the PMNsubstance in combination with any other substance that is either subject to another TSCA section 5(e) Order applicable to the Company, or subject to a TSCAsection 5(a)(2) SNURat 40 CFRPart 721, subpart E, or defined as a "hazardous chemical" under the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS, or alternative form ofwarning, the measures to control worker exposure or environmental release which the Company determines provide the greatest degree ofprotection. However, should these control measures differ from the applicable measures required under this Order, the Company must seek a determination of equivalency for such alternative control measures pursuant to 40 CFR721 .30before prescribing themunder this subparagraph (b)(5) .-34-

(c) Material Safety Data Sheets . (1) The Companymust obtain or develop an MSDS for the PMNsubstance. (2) The MSDS shall contain, at aminimum, the following information: ' (i) The identity used on the container label of the PMNsubstance under this section, and, if not claimed confidential, the chemical and common name of the PMNsubstance. If the chemical and common name are claimed confidential, a generic chemical name must be used. (ii) Physical and chemical characteristics of the substance known to the Company, (e.g., vaporpressure, flashpoint) .

(iii) Thephysical hazards ofthe substance known to the Company, including the potential for fire, explosion; and reactivity.

(iv) The potential human and environmental hazards as specified in paragraph (g) of this section

. (v) Signs and symptoms ofexposure, and any medical conditions which are expected to be aggravated by exposure to the PMNsubstance known to the Company.

(vi) The primary routes ofexposure to the PMNsubstance. (vii) Precautionary measures to control worker exposure and/or environmental release required by this Order, or alternative control measures which EPAhas determined under 40 CFR 721 .30 provide substantially the same degree ofprotection as the identified control measures. The MSDS must identify any New Chemical Exposure Limits specified in paragraph (b) of the New

Chemical Exposure Limit section of this Order and must contain the information specified in the graduated respirator table in paragraph (e)(2) ofthe New~Chemical Exposure Limit section.-35- (viii) Any generally applicable precautions for safe handling and use ofthe PMN substance which are known to the Company, including appropriate hygienic practices, protective measures during repair andmaintenance of contaminated equipment, andprocedures for response to spills and leaks. .

(ix) Any generally applicable control measures which are known to the Company, such as appropriate engineering controls, work practices, or personal protective equipment. (x) Emergency first aid procedures known to the Company . (xi) The date of preparation of the MSDS or of its last revision. (xii) The name, address, and telephone number of the Company or another responsible party whocanprovide additional information onthe chemical substance and any appropriate emergencyprocedures. (3) If no relevant information is found or known for any given category on the MSDS, the Company must mark the MSDS to indicate that no applicable information was found. (4) Where multiple mixtures containing the PMNsubstance have similar compositions (i .e., the chemical ingredients are essentiallythe 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 information regarding the hazards of the PMNsubstance or ways to protect against the hazards, this new information must be addedto the MSDS within 3 months fromthe time the Company becomes aware of the new information. Ifthe PMNsubstance is not being manufactured, imported, processed, or used in-36-

the Company's workplace, the Companymust add the new information to the MSDS before the PMNsubstance is reintroduced into the workplace. (6) The Company must ensure that persons receiving the PMNsubstance 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 ofsubstances in a work area where it may be more appropriate to address the, potential hazards of a process rather than individual substances. However, in all cases, the required information must be provided for the PMNsubstance and must be readily accessible during each work shift to employees when they are in theirwork 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 PMNsubstance. This information and training must be provided at the time of each employee's initial assignment to a work area containing the PMNsubstance and whenever the PMNsubstance is introduced into the employee's work area for the first time.p. 47

### -37- (1) The information provided to employees under, this paragraph shall include: (i) The requirements ofthis section . (ii) Any operations in the work area where the PMNsubstance is present. (iii) The location and availability of the written hazard communicationprogram required under paragraph (a) of this section, including the list of substances required by subparagraph (a)(1) ofthis section and MSDSs required by paragraph (c) of this section. (2) The training provided to employees shall include: (i) Methods and observations that may be used to detect the presence or release ofthe PMNsubstance in or froman employee's work area (such as monitoring conductedby the Company, continuous monitoring devices, visual appearance, or odor of the substance when being released) .

(ii) The potential human health and environmental hazards of the PMN substance as specified in paragraph (g) ofthis section . (iii) The measures employees can take to protect themselves and the environment from the PMNsubstance, including specific procedures the Company has implemented to protect employees and the environment fromexposure to the PMNsubstance, including appropriate work practices, emergency procedures, personal protective equipment, engineering controls, and other measures to control worker exposure and/or environmental release required under this Order, or alternative control measures which EPAhas determined under 40 CFR 721 .30provide the same degree ofprotection as the specified control measures.

(iv) The requirements of the hazard communication program developedby the Company under this section, including an explanation of the labeling systemand the MSDS required by this section and guidance on obtaining and using appropriate hazard information .-38-

(e) Low

Concentrations in Mixtures. If the PMNsubstance is present in the work area only as a mixture, the Company is exempt fromthe provisions of this section if the concentration of the PMNsubstance in the mixture does not exceed 1 .0 percent by weight or volume, or 0 .1 percent by weight or volume ifparagraph (g) ofthis section identifies cancer as a potential human health hazard ofthe PMNsubstance. However; this exemption does not apply if the Company has reason to believe that during intended use or processing in the work area, the PMNsubstance in the mixture may be reconcentrated above the 1 .0 or 0 .1 percent level, whichever is applicable. (f) Existing Hazard Communication Program . The Company need not take additional actions if existing programs and procedures satisfy the requirements of this section . (g) Human Health, Environmental Hazard, Exposure, and Precautionary Statements. The following human health and environmental hazard and precautionary statements shall appear on each label as specified in paragraph (b) and the MSDS as specified in paragraph (c) of this section: (1) Human health hazard statements. This substance may cause: (i) internal organ effects. (ii) reproductive effects. (iii) cancer . (iv) developmental effects. (2) Human hazard precautionary statements. When using this substance:. (i) avoid breathing the substance. (ii) avoid ingestion.-39- (iii) use respiratory protection, or maintain workplace airborne concentrations at or below

an 8-hour time-weighted average of 0 .5 Mg/M3 (3) The human hazard andprecautionary statement on the label prepared pursuant to paragraph (b) ofthis section must be followed by the statement : "See the MSDS for details."

MANUFACTURING (a)(1) The Company shall not cause, encourage, or suggest the manufacture or import of the PMNsubstance by any other person. (2) Sunset Following SNUR . Subparagraph (a)(1) shall expire 75 days after promulgation of a final significant new use rule ("SNUR") governing the PMNsubstance under section 5(a)(2) ofTSCA unless the Company is notified on or before that day of an action in a Federal Court seekingjudicial review of the SNUR

. Ifthe Company is so notified, subparagraph (a)(1) shall not expire until EPAnotifies the Company inwriting that all Federal Court actions involving the SNUR have been resolved and the validity ofthe SNURaffirmed. (3) Notice of SNUR

. When EPApromulgates a final SNURfor the PMNsubstance and subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Company shall notify each person whom

it causes, encourages or suggests to manufacture or import the PMN substance of the existence of the SNUR . USE (a) The Company shall not use the PMNsubstance other than as a chemical intermediate for a herbicide.-40- DISTRIBUTION (a) Distribution Requirements. Except as provided in paragraph (b), the Company shall . distribute the PMNsubstance outside the Company, including for disposal, only to a person who has agreed in writing prior to the date of distribution, to: (1) Not further distribute the PMNsubstance to any other person, including for disposal, until after the PMNsubstance has been completely reacted (cured) . , (2) Complywith the same requirements andrestrictions, if any, required of the Company in the Protection in the Workplace and the New Chemical Exposure Limit sections of this Order. (3) Complywith the same requirements andrestrictions, if any, required ofthe Company in the Hazard Communication Program section ofthis Order. (4) Not use the PMNsubstance other than as a chemical intermediate for a herbicide. (b) Temporary Transport and Storage. Notwithstanding paragraph (a), the Companymay distribute the PMNsubstance outside the Company fortemporary transport and storage in sealed containers (labeled in accordance with paragraph (b)(2) of the Hazard Communication Program section of this Order) provided the following two conditions are met: (1) Subsequent to any such exempt temporary transport or storage of sealed containers, the PMNsubstance may be distributed only to the Company or a person who has given the Company the written agreement required by paragraph (a) . (2) Any human exposure or environmental release resulting fromopening the sealed containers and removing orwashing out the PMNsubstance may occur only while the PMN-41-

substance is in the possession andcontrol of the Company or aperson whohas given the Company the written agreement required by paragraph (a) . , (c) Recipient Non-Compliance. If, at any time after commencing distribution in commerce of the PMNsubstance, the Company obtains knowledge that a recipient ofthe substance has failed to comply with any ofthe conditions specified in paragraph (a) of this Distribution section or, after paragraph (a)(1) expires in accordance with subparagraph (d)(1), has engaged in a significant new

use of the PMNsubstance (as defined in 40 CFRPart 721, Subpart E) without submitting a significant new use notice to EPA, the Company shall cease supplying the substance to that recipient, unless the Company is able to document each ofthe following: (1) That the Company has, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any of the conditions specified in paragraph (a) ofthis Distribution section, or has engaged in a significant new use of the PMNsubstance without submitting a significant new use notice to EPA

. (2) That, within 15 working days ofnotifying the recipient of the noncompliance, the Company received fromthe recipient, inwriting, a statement of assurance that the recipient is aware ofthe terms ofparagraph (a) ofthis Distribution section and will comply with those terms, or is aware ofthe terms ofthe significant new use rule for the PMNsubstance 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 froma 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) ofthis Distribution section, or has engaged in a significant new use of the PMNsubstance without submitting a significant new-42-

use notice to EPA, the Company shall cease supplying the PNIN substance to that recipient, shall notify EPAof the failure to comply, and shall resume supplying the PMNsubstance to that recipient only upon written notification fromthe Agency. (d) Sunset Following SNUR . (1) Paragraph (a)(1) of this Distribution section shall expire 75 days after promulgation of a final SNURfor the PMNsubstance 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

. Ifthe Company is so notified, paragraph (a)(1) of this Distribution section shall not expire until EPAnotifies the Company in writing that all Federal Court actions involving the SNURhave been resolved and the validity ofthe SNURaffirmed. (2) When EPApromulgates a final SNURfor the PMNsubstance and paragraph (a)(1) of this Distribution section expires in accordance with subparagraph (d)(1), the Company shall notify each personto whom it distributes the PNINsubstance of the existence ofthe SNUR . Such notification must be in writing and must specifically include all limitations contained in the SNURwhich are defined as significant new uses, and which would invoke significant new use notification to EPAfor the PMNsubstance. Such notice must also reference thepublication of the SNURforthis PMNsubstance in either the Federal Register or the Code of Federal Regulations. After promulgation of a SNURand expiration of subparagraph (a)(1), such notice may substitute for the written agreement required in the introductory clause ofparagraph (a); so that, if the Companyprovides such notice to the persons to whom it distributes the PMN substance, then the Companyis not required to obtain fromsuch persons the written agreement specified in paragraph (a) .-43- Il . RECORD-KEEPING (a) Records. The Company shall maintain the following records until 5 years after the date they are created and shall make them available for inspection and copying by EPAin accordance with section 11 ofTSCA: (1) Records documenting the manufacture and importation volume of the PMN substance and the corresponding dates of manufacture and import ; (2) Records documenting volumes ofthe substance purchased in the United States by processors of the substance, names and addresses of suppliers and corresponding dates of purchase. (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site of manufacture or import to whom the Company directly sells or transfers the PMNsubstance, the date of each sale or transfer, and the quantity of the substance sold or transferred on such date; (5) Records required by paragraph F. ofthe New Chemical Exposure Limits section of this Order, ifapplicable; (6) Records documenting establishment and implementation ofthe hazard communicationprogram required by the Hazard Communication Programsection ofthis Order; (7) Copies oflabels required under the Hazard Communication Programsection of this Order; (8) Copies of material safety data sheets required by the Hazard Communication Programsection of this Order;-44- (9) Records documenting compliance with any applicable manufacturing, use, and distribution restrictions in the Manufacturing, Use, and Distribution sections of this Order, including distributees' written agreement to comply with the Distribution section of this Order; (10) Copies of any Transfer Documents and notices required by the Successor Liability section of this Order, if applicable; and (11) The Company shall keep a copy ofthis Order at each of its sites where the PMN substance is manufactured, imported, processed or used. (b) Applicability. The provisions of this Record-keeping Section are applicable only to activities of the Company and its Contract Manufacturer, if applicable, and not to activities of the Company's customers. (c) OMB Control Number . Underthe Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320 .5(b), the Company is notrequired to respond to this "collection of information" unless this Orderdisplays a currently valid control number from the Office of Management and Budget (OMB), and . EPAso informs the Company. The "collection of information" required in this TSCA 5(e) Consent Order has been approved under currently valid OMBControl Number 2070-0012 . III . SUCCESSORLIABILITY UPONTRANSFER 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-45-

substance, including the right to manufacture the PMNsubstance, to another person outside the Company (the "Successor in Interest") . (b) Relation ofTransfer Date to Notice of Commencement ("NOC",) . (1) Before NOC

. If the transfer fromthe Companyto the Successor in Interest is effective before EPAreceives a notice of commencement ofmanufacture or import ("NOC") for the PMNsubstance from the Companypursuant to 40 CFR720.102, the Successor in Interest must submit a new

PMNto EPA and comply fully with Section 5(a)(1) of TSCA and 40 CFR part 720 before commencing manufacture or import of the PMNsubstance. (2) After NOC

. Ifthe transfer fromthe Company to the Successor in Interest is effective after EPAreceives a NOC, the Successor in Interest shall comply with the terms ofthis Order and is not required to submit a new PMNto EPA

. (c) Definitions. The following definitions apply to this Successor Liability section of the Order: (1) "Successor in Interest" means aperson outside the Companywho has acquired the Company's full interest in the rights to manufacture the PMNsubstance, 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 termexcludes persons who acquire less than the full interest of the Company in the PMNsubstance, such as a licensee who has acquired a limited license to thepatent or manufacturing rights associated with the PMNsubstance. A Successor in Interest must be incorporated, licensed, or doing business in the United States in accordance with 40 CFR720 .22(3) .-46-

(2) "Transfer Document" means the legal instrument(s) used to convey the interests in the PMNsubstance, including the right to manufacture the PMNsubstance, fromthe Company to the Successor in Interest . (d) Notices. (1) Notice to Successor in Interest . On or before the effective date ofthe transfer, the Company shall provide to the Successor in Interest, by registered mail, .a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated by reference as Attachment Cto 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 ofTransfer document to: U .S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N

.W ., Washington, D

.C. 20460

. (3) Transfer Document . Copies of the Transfer Document must be maintained by the Successor in Interest at its principal place ofbusiness, and at all sites where the PMNsubstance is manufactured or imported. Copies ofthe Transfer Document must also be made available for inspection pursuant to Section 11 ofTSCA, must state the effective date and time oftransfer, and must contain provisions which expressly transfer liability for the PMNsubstance under the terms of this Order fromthe Company to the Successor in Interest. (e) Liability. (1) The Company shall be liable for compliance with the requirements ofthis Order until the effective date and time of the transfer described above.-47-

(2) The Successor in Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date andtime of transfer. (3) Nothing in this section shall be construed to prohibit the Agency from taking enforcement action against the Company after the effective date of the transfer for actions taken, or omissions made, during the time in which the Company manufactured, processed, used, distributed in commerce, or disposed of the PMNsubstance pursuant to the terms ofthis Consent Order. (f) Obligations to Submit Test Data under Consent Order. Ifparagraph (d) ofthe Testing section of this Consent Order requires the Company to submit test data to EPA at a specified production volume ("test trigger"), the aggregate volume ofthe PMNsubstance manufactured and imported by the Company up to the date of transfer shall counttowards the test trigger applicable to the Successor in Interest.

IV. MODIFICATIONAND REVOCATIONOF CONSENT ORDER The Company may petition EPA at any time, based upon new information on the health effects of, or human exposure to, the PMNsubstance, to modify or revoke substantive provisions ofthis Order. The exposures andrisks identified by EPA during its reviewofthe PMNsubstance and the information EPAdetermined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend or revoke this Order, EPAwill consider all relevant information available at the time the Agency makes that determination, including, where appropriate, any reassessment-48-

of the test data or other information that supports the findings in this Order, an examination of new test data or other information or analysis, and any other relevant information. EPAwill issue a modification or revocation if EPAdetermines that the activities proposed therein will notpresent an unreasonable risk of injury to health or the environment and will not result in significant or substantial human exposure or substantial environmental release in the absence of data sufficient to permit areasoned evaluation of the health or environmental effects ofthe PMNsubstance. In addition, the Company may petition EPA at any time to make other modifications to the language of this Order. EPAwill issue such a modification if EPAdetermines that the modification is useful, appropriate, and consistentwith the structure and intent ofthis Order as issued.-49- V . EFFECT OF CONSENT ORDER By consenting to the entry of this Order, the Company waives its rights to file objections to this Order pursuant to section 5(e)(1)(C) ofTSCA, to receive service ofthis Order no later than 45 days before the end of the review period pursuant to section 5(e)(1)(B) ofTSCA, and to challenge the validity of this Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound by its terms, does not constitute an admission by the Company as to, the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any other rights that the Company may have under TSCA .

Date Wardner G . Penberthy, Xcting Director Chemical Control Division Office of Pollution Prevention and Toxics



# 5 Date Company : Name:

# ~-/~

, t~(/ ~I117v Title:ATTACHMENT A DEFINITIONS [Note : The attached Order may not contain some ofthe terms defined below .] "Chemical name" means the scientific designation of a chemical substance in accordance with the nomenclature systemdeveloped by the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service's rules ofnomenclature, or a name which will clearly identify a chemical substance for thepurpose of conducting a hazard evaluation. "Chemical protective clothing" means items of clothing that provide aprotective barrier to prevent dermal contact with chemical substances of concern. Examples can include, but are not limited to: full body protective clothing, boots, coveralls, gloves,jackets, and pants. "Company" means the person or persons subject to this Order. "Commercial use" means the use of a chemical substance or any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment or painting contractor) . "Common name" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other than by its chemical name. "Consumer" means a private individual whouses a chemical substance or any product containing the chemical substance in or around apermanent or temporary household or residence, during recreation, or for any personal use or enjoyment. "Consumer product" means a chemical substance that is directly, or as part of a mixture, sold or made available to consumers fortheiruse in or around a permanent or temporary household or residence, in or around a school, or in recreation. , "Container" means anybag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical . Forpurposes of this section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "Contract Manufacturer" means a person, outside the Company, whois authorized to manufacture and import the PMNsubstance under the conditions specified in Part II . ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Identity" means any chemical or common name used to identify a chemical substance or a mixture containing that substance.

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"Immediate use." Achemical substance is for the "immediate use" of aperson if it is under the control of, and used only by, the person who transferred it froma labeled container and will only be used by that person within the work shift in which it is transferred fromthe labelled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance if the substance causes no chemical or mechanical degradation, permeation, or penetration of the chemical protective clothing under the conditions of, and the duration of, exposure. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning of equipment. "MSDS" means material safety data sheet, the written listing of data for the chemical substance. "NIOSH" means the National Institute for Occupational Safety and Health of the U .S. Department of Health and Human Services. "Non-enclosed process" means any equipment system(such as an open-top reactor, storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise usedwhere significant direct contact ofthe bulk chemical substance and the workplace air may occur. "Non-industrial use" means use otherthan at a facility where chemical substances or mixtures are manufactured, imported, or processed. "PMNsubstance" means the chemical substance described in the Premanufacture notice submitted by the Company relevant to this Order. _ Personal protective equipment" means any chemical protective clothing or device placed on the body to prevent contact with, and exposure to, an identified chemical substance or substances in the work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types of respirators. Barrier creams are not included in this definition. "Process stream" means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless of physical state or concentration, through all intended operations ofprocessing, including the cleaning of equipment. "Scientifically invalid" means any significant departure fromthe EPA-approved protocol or the Good Laboratory Practice Standards at 40 CFRPart 792 without prior or subsequent Agency approval that prevents a reasoned evaluation of the health or environmental effects of the PMNsubstance."Scientifically equivocal data" means data which, although developed in apparent

conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk of injury to human health or the environment of the PMNsubstance. "Sealed container" means a closed container that is physically and chemically suitable for long-termcontainment of the PMNsubstance, and from which there will be no human . exposure to, nor environmental release of, the PMNsubstance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumer use. "Waters ofthe United States" has the meaning set forth in 40 CFR 122.2. "Work area" means a roomor defined space in a workplace where the PMNsubstance is manufactured, processed, or used and where employees are present. "Workplace" means an establishment at one geographic location containing one or more work areas.ATTACHMENT B STATISTICAL ANALYSIS OF NCELs ANALYTICAL METHOD

VERIFICATION RESULTS This Attachment describes the statistical technique (with examples) for comparing the 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, perform the following operations: Compute means ofthe data measured by two laboratories. Compute mean squares Si2 = E(X

;j - X ;)2/(n; - 1), i=1, 2 Form the ratio T = (XI - X2)/(WI + Wz)vz Compute degrees of freedom f= (Wl +WZ)2/[WlZ/(nl - 1) +W22/(n2 - 1)] where, W,=S12/n,,i=1,2 X1=Average of the results fromthe company laboratory X2=Average of the results fromthe independent laboratory n, =Number of samples analyzed by the company laboratory n2= Number of samples analyzed by the independent laboratory.-2- Then compare the absolute value of T to the 97.5 percentile point ofat distribution with fdegrees 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 a integer. Use interpolation to obtain the 97.5 percentile point of a t distribution with fdegrees of freedom . EXAMPLES -- The following examples (based on simulated data) illustrate the method: Example 1 Data Set 1 Data Set 2 80.56 97.11 100 .01 102.13 86.04 99.83 52.61 97.83 84.85 105.44 95.75 100 .04 X1=83 .30 n,=6 X2=100 .40~ n2=6 S1' = 278.72 W1=46 .25 S22 = 9.26 W2 = 1 .54 Absolute value of T = 2.467 f= 5.33 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 offreedom, the 97.5 percentile point will be approximately 2.530which is greater than the absolutevalue ofT, 2.467. Hence, the means of two data sets are not significantly different at the 5% level . However, if this problem hadbeen treated as an ordinary two-sample t test, the means would be significantly different at the 5%level because the absolute of T is greater than 2 .228, the 97.5 percentile point for the t distribution with 10 degrees of freedom . Example 2 Data Set 1 Data Set 2 82.87 108.05 101 .85 96.51 87.44 100 .04 99.68 104.33 101 .15 110 .32 99.21 107.00-3- X1=95 .37 n1=6 X2 = 104.37 n2 =6 S1' = 65.59 Wl = 10.93 S22 = 27.25 W2 = 4 .54 Absolute value of T = 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 freedomthe 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 .ATTACHMENT C NOTICE OF TRANSFER

OF TOXICSUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER Company (Transferor) PMNNumber 1 . Transfer of Manufacture Rights. Effective on , the Company did sell or otherwise transfer to , ("Successor in Interest") the rights and liabilities associated with manufacture of the above-referenced chemical substance, which was the subject of apremanufacture notice (PMN) and is governed by a Consent Order issued by the U .S. Environmental Protection Agency (EPA) under the authority of §5(e) ofthe Toxic Substances Control Act (TSCA, 15 U .S .C. §2604(e)) . 2 . Assuamption 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 PMNsubstance, shall be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doingbusiness in the United States in accordance with 40 CFR 720 .22(3) . , 3 . Confidential Busin

ess Information. The Successor in Interest hereby: reasserts, relinquishes, or modifies all Confidential Business Information (CBI) claims made by the Company, pursuant to Section 14 ofTSCAand 40 CFRpart 2, for the PMNsubstance(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.-2- TOXICSUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER NOTICE OF TRANSFER (continued) Company (Transferor) PNIN Number Signature ofAuthorized Official Date Printed Name ofAuthorized Official Title ofAuthorized Official

Successor in Interest Signature ofAuthorized Official Date Printed Name ofAuthorized Official Title ofAuthorized Official Address City, State, Zip Code

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Successor's Technical Contact TOXICSUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER NOTICE OF TRANSFER (continued)

City, State, Zip Code Phonep. 70