Consent Order - Risk-Based Human Health (w/ NCELs) UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF POLLUTION PREVENTION AND TOXICS REGULATION OF A NEW CHEMICAL SUBSTANCE PENDING DEVELOPMENT OF INFORMATION In the matter of: ) Premanufacture Notice ) Number: ) ) ) ) ) ) ) ) ) ) ) ) Consent Order and Determinations Supporting Consent Order TABLE OF CONTENTS Preamble I. Introduction II. Summary of Terms of the Order III. Contents of PMN IV. EPA's Assessment of Risk V. EPA's Conclusions of Law VI. Information Required to Evaluate Human Health Effects Consent Order I. Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation of Information II. Recordkeeping 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 of Transfer of Consent Order I. INTRODUCTION Under the authority of  5(e) of the Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e)), the Environmental Protection Agency ("EPA" or "the Agency") issues the attached Order, regarding premanufacture notice ("PMN") P-_____________ submitted by ________________________ ("the Company"), to take effect upon expiration of the PMN review period. The Company submitted the PMN to EPA pursuant to section 5(a)(1) of TSCA and 40 CFR Part 720. Under  15 of TSCA, it is unlawful for any person to fail or refuse to comply with any provision of  5 or any order issued under  5. Violators may be subject to various penalties and to both criminal and civil liability pursuant to  16, and to specific enforcement and seizure pursuant to  17. II. SUMMARY OF TERMS OF THE ORDER The Consent Order for this PMN substance requires the Company to: () submit to EPA certain toxicity testing at least 14 weeks before manufacturing or importing a total of kilograms of the PMN substance; () provide its workers personal protective equipment to prevent dermal exposure; () provide its workers respirators to prevent inhalation exposure; () as an alternative to using respirators, maintain workplace airborne concentrations of the PMN substance at or below a specified New Chemical Exposure Limit ("NCEL") of _________, verified by actual monitoring data (A sampling and anlytical method must be developed by the Company, verified by an independent third- party laboratory, and submitted to EPA); () label the PMN substance and provide Material Safety Data Sheets (MSDS) and worker training in accordance with the provisions of the Hazard Communication Program section; () not manufacture the PMN substance ; () not process the PMN substance ; () not use the PMN substance ; () distribute the PMN substance only to a person who agrees to follow the same restrictions (except the testing requirements) and to not further distribute the PMN substance until it has been completely reacted; () distribute the PMN substance only ; () dispose of the PMN substance only by ; () comply with the Release to Water provisions; () maintain certain records. III. CONTENTS OF PMN Confidential Business Information Claims (Bracketed in the Preamble and Order): Chemical Identity: Specific: Generic: Use: Specific: Generic: Maximum 12-Month Production Volume: Test Data Submitted with PMN: IV. EPA'S ASSESSMENT OF RISK The following are EPA's predictions regarding the probable toxicity, human exposure and environmental release of the PMN substance, based on the information currently available to the Agency. Human Health Effects Summary: Concerns: Basis: Absorption: New Chemical Exposure Limit: ____ as an 8-hour time-weighted average. Exposure Summary: Manufacture Process Use Consumer # Sites # Persons/site # Days/Year Amt. Dermal Exp. Amt. Inhal. Exp. Amt. Drinking Water Exp. Environmental Effects Summary: Environmental Release Summary: V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis of the Consent Order: A. EPA is unable to determine the potential for________________ _________________________________________________________________ from exposure to the PMN substance. EPA therefore concludes, pursuant to  5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation of the human health effects of the PMN substance. B. In light of the potential risk of______________________ ______________________________________________________ posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance, and the Agency's conclusion that issuing the Order will not result in any significant loss of benefits to society, EPA has concluded, pursuant to  5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to human health. C. In light of the estimated production volume of, and human exposure to, the PMN substance, EPA has further concluded, pursuant to  5(e)(1)(A)(ii)(II) of TSCA, that the PMN substance will be produced in substantial quantities and there may be significant or substantial human exposure to the substance. VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS The Order prohibits the Company from exceeding a specified production volume unless the Company submits the information described in the Testing section of this Order in accordance with the conditions specified in the Testing section. The following additional information would be required to evaluate the following effects which may be caused by the PMN substance: Information Effects Guidelines The Order does not require submission of the above information at any specified time or production volume. However, the Order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information. CONSENT ORDER I. TERMS OF MANUFACTURE, IMPORT, PROCESSING, DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION ("the Company") is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing of the chemical substance ("the PMN substance") in the United States, for any nonexempt commercial purpose, pending the development of information necessary for a reasoned evaluation of the _________________ ____________________________________________________________ effects of the substance, and the completion of EPA's review of, and regulatory action based on, that information, except under the following conditions: TESTING (a) Any information on the PMN substance which reasonably supports the conclusion that the PMN substance presents a substantial risk of injury to health or the environment required to be reported under EPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978) as amended at 52 Federal Register 20083 (May 29, 1987), shall reference the appropriate PMN identification number for this substance and shall contain a statement that the substance is subject to this Consent Order. Additional information regarding section 8(e) reporting requirements can be found in the reporting guide referenced at 56 Federal Register 28458 (June 20, 1991). (b) The Company shall notify, in writing, the EPA Laboratory Data Integrity Branch (2225A), Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 20460, of the following information within 10 days of scheduling any study required to be performed pursuant to this Order, or within 15 days after the effective date of this Order, whichever is later: 1. The date when the study is scheduled to commence; 2. The name and address of the laboratory which will conduct the study; and 3. The name and telephone number of a person at the Company or the laboratory whom EPA may contact regarding the study. 4. The appropriate PMN identification number for each substance and a statement that the substance is subject to this Consent Order. (c) Each study required to be performed pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and using methodologies generally accepted at the time the study is initiated. Before starting to conduct any such study, the Company must obtain approval of test protocols from EPA by submitting written protocols. EPA will respond to the Company within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (d) (e.g., 40 CFR 797 or 798) provide general guidance for development of test protocols, but are not themselves acceptable protocols. (d) The Company is prohibited from manufacturing or importing the PMN substance beyond the following aggregate manufacture and import volumes ("the production limits"), unless the Company conducts the following studies on the PMN substance and submits all final reports and underlying data in accordance with the conditions specified in this Testing section: Production Limit Study Guideline (e) The Company shall: (1) conduct each study in good faith, with due care, and in a scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of each study; and (3) submit, in triplicate (with an additional sanitized copy, if confidential business information is involved), the final report of each study and all underlying data ("the report and data") to EPA no later than 14 weeks prior to exceeding the applicable production limit. The final report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting", "Data and Reporting", and "Test Report" subparagraphs in the applicable test guidelines. However, for purposes of this Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the submission of such information is mandatory. EPA will require the submission of raw data such as slides and laboratory notebooks only if EPA finds, on the basis of professional judgment, that an adequate evaluation of the study cannot take place in the absence of these items. (f) The Company is not required to conduct a study specified in paragraph (d) of this Testing section if notified in writing by EPA that it is unnecessary to conduct that study. (g) If EPA finds that the data generated by a study are scientifically equivocal, the Company may continue to manufacture and import the PMN substance beyond the applicable production limit. To seek relief from any other restrictions of this Order, the Company may make a second attempt to obtain unequivocal data by reconducting the study 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 PMN substance, only by mutual consent of EPA and the Company. (h)(1) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA's receipt of a test report and data, the Company receives written notice that EPA finds that the data generated by a study are scientifically invalid, the Company is prohibited from further manufacture and import of the PMN substance beyond the applicable production limit. (2) The Company may continue to manufacture and import the PMN substance beyond the applicable production limit only if so notified, in writing, by EPA in response to the Company's compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) The Company may reconduct the study in compliance with paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), 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 EPA within a reasonable period of time, all as specified by EPA in the notice described in subparagraph (h)(1). EPA will respond to the Company, in writing, within 6 weeks of receiving the Company's report and data. (ii) The Company may, within 4 weeks of receiving from EPA the notice described in subparagraph (h)(1), submit to EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 weeks of receiving the Company's report. (i)(1) Except as described in subparagraph (i)(2), if the Company becomes aware that circumstances clearly beyond the control of the Company or laboratory will prevent, or have prevented, development of scientifically valid data under the conditions specified in paragraphs (c) and (e), the Company remains prohibited from further manufacture and import of the PMN substance beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks of first 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 of scientifically invalid data. EPA will notify the Company of its response, in writing, within 4 weeks of receiving the Company's report. EPA's written response may either: (i) allow the Company to continue to manufacture and import the PMN substance beyond the applicable production limit, or (ii) require the Company to continue to conduct, or to reconduct, the study in compliance with paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to conduct or reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), 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 EPA within a reasonable period of time, all as specified by EPA in the notice described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks of receiving the Company's report and data, as to whether the Company may continue to manufacture and import beyond the applicable production limit. (j)(1) EPA may notify the Company in writing that EPA finds that the data generated by a study are scientifically valid and unequivocal and indicate that, despite the terms of this Order, the PMN substance will or may present an unreasonable risk of injury to human health or the environment. EPA's notice may specify that the Company undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal of the PMN substance to mitigate exposures to or to better characterize the risks presented by the PMN substance. Within 2 weeks from receipt of such a notice, the Company must cease all manufacture, import, processing, distribution, use and disposal of the PMN substance, unless either: (2) within 2 weeks from receipt of the notice described in subparagraph (j)(1), the Company complies with such requirements as EPA's notice specifies; or (3) within 4 weeks from receipt of the notice described in subparagraph (j)(1), the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of any additional requirements imposed by EPA. The Company may continue to manufacture, import, process, distribute, use and dispose of the PMN substance in accordance with the terms of this Order pending EPA's response to the Company's written report. EPA will respond to the Company, in writing, within 4 weeks of receiving the Company's report. Within 2 weeks of receipt of EPA's written response, the Company shall comply with any requirements imposed by EPA's response or cease all manufacture, import, processing, distribution, use and disposal of the PMN substance. (k) Regardless of the satisfaction of any other conditions in this Testing section, the Company must continue to obey all the terms of this Consent Order until otherwise notified in writing by EPA. The Company may, based upon submitted test data or other relevant information, petition EPA to modify or revoke provisions of this Consent Order pursuant to Part IV. of this Consent Order. PROTECTION IN THE WORKPLACE (a) During manufacturing, processing, and use of the PMN substance at any site controlled by the Company, the Company must establish a program whereby: (1) Each person who is reasonably likely to be dermally exposed in the work area to the PMN substance through direct handling of the substance or through contact with equipment on which the substance may exist, or because the substance becomes airborne in a form listed in subparagraph (a)(6) of this section, is provided with, and is required to wear, personal protective equipment that provides a barrier to prevent dermal exposure to the substance in the specific work area where it is selected for use. Each such item of personal protective equipment must be selected and used in accordance with 29 CFR 1910.132 and 29 CFR 1910.133. (2) In addition to the personal protective equipment described in subparagraph (a)(1) of this section, the following items are required: (i) Gloves. (ii) Full body chemical protective clothing. (iii) Chemical goggles or equivalent eye protection. (iv) Clothing which covers any other exposed areas of the arms, legs and torso. Clothing provided under this subparagraph (a)(2)(iv) need not be tested or evaluated under the requirements of subparagraph (a)(3). (3) The Company is able to demonstrate that each item of chemical protective clothing selected, including gloves, provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions of exposure within the work area by any one or a combination of the following: (i) Testing the material used to make the chemical protective clothing and the construction of the clothing to establish that the protective clothing will be impervious for the expected duration and conditions of exposure. The testing must subject the chemical protective clothing to the expected conditions of exposure, including the likely combinations of chemical substances to which the clothing may be exposed in the work area. Permeation testing shall be conducted according to the American Society for Testing and Materials (ASTM) F739 "Standard Test Method for Resistance of Protective Clothing materials to Permeation by Liquids or Gases." Results shall be recorded as a cumulative permeation rate as a function of time, and shall be documented in accordance with ASTM F739 using the format specified in ASTM F1194- 89 "Guide for Documenting the Results of Chemical Permeation Testing on Protective Clothing Materials." Gloves may not be used for a time period longer than they are actually tested and must be replaced at the end of each work shift. (ii) Evaluating the specifications from the manufacturer or supplier of the chemical protective clothing, or of the material used in construction of the clothing, to establish that the chemical protective clothing will be impervious to the PMN substance alone and in likely combination with other chemical substances in the work area. (4) Each person who is reasonably likely to be exposed by inhalation in the work area to the PMN substance in the form listed in subparagraph (a)(6) of this section, is provided with, and is required to wear, at a minimum, a NIOSH-approved respirator from one of the categories listed in subparagraph (a)(5) of this section, and the respirator is used in accordance with 29 CFR 1910.134 and 42 CFR Part 84. (5) The following NIOSH-approved respirators meet the minimum requirements for subparagraph (a)(4) of this section: (i) Category 19C Type C supplied-air respirator operated in pressure demand or other positive pressure mode and equipped with a full facepiece. (ii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting facepiece. (iii) Category 19C Type C supplied-air respirator operated in pressure demand or continuous mode and equipped with a hood or helmet or tight-fitting facepiece. (iv) Category 21C air-purifying respirator equipped with a full facepiece and high efficiency particulate filters. (v) Category 21C powered air-purifying respirator equipped with a tight-fitting facepiece and high efficiency particulate filters. (vi) Category 21C powered air-purifying respirator equipped with a loose-fitting hood or helmet and high efficiency particulate filters. (vii) Category 21C air-purifying respirator equipped with a high efficiency particulate filter including disposable respirators. (viii) Category 23C air-purifying respirator equipped with a full facepiece and combination cartridges approved for paints, lacquers, and enamels. (Approval label may preclude use for some paints, lacquers, or enamels.) (ix) Category 23C powered air-purifying respirator equipped with a tight-fitting facepiece and combination cartridges approved for paints, lacquers, and enamels. (Approval label may preclude use for some paints, lacquers, or enamels.) (x) Category 23C powered air-purifying respirator equipped with a loose-fitting hood or helmet and combination cartridges approved for paints, lacquers, and enamels. (Approval label may preclude use for some paints, lacquers, or enamels.) (xi) Category 23 powered air-purifying respirator equipped with combination cartridges approved for paints, lacquers, and enamels, including disposable respirators. (Approval label may preclude use for some paints, lacquers, or enamels.) (xii) Category 23C air-purifying respirator equipped with a full facepiece and organic gas/vapor cartridges. (xiii) Category 23C air-purifying respirator equipped with a tight-fitting facepiece and organic gas/vapor cartridges. (xiv) Category 23C powered air-purifying respirator equipped with a loose-fitting hood or helmet and organic gas/vapor cartridges. (xv) Category 23C air-purifying respirator equipped with organic gas/vapor cartridges, including disposable respirators. (6) The following forms of airborne chemical substances are listed for subparagraphs (a)(1) and (4) of this section: (i) Dust. (ii) Mist. (iii) Fume. (iv) Smoke. (v) Vapor. (vi) Gas. (b) If the PMN substance is present in the work area only as a mixture, the Company is exempt from the provisions of this protection in the workplace section if the concentration of the PMN substance in the mixture does not exceed 1.0 percent by weight or volume, or 0.1 percent by weight or volume if paragraph (g) of the Hazard Communication Program section of this Order identifies cancer as a potential human health hazard of the PMN substance. This exemption does not apply if the Company has reason to believe that during intended use or processing in the work area, the PMN substance in the mixture may be reconcentrated above the 1.0 or 0.1 percent level, whichever is applicable. NEW CHEMICAL EXPOSURE LIMIT (a) ALTERNATIVE TO REQUIREMENTS OF RESPIRATOR SECTION (1) EPA recommends and encourages the use of pollution prevention, source reduction, engineering controls and work practices, rather than respirators, as a means of controlling inhalation exposures whenever practicable. (2) Whenever a person is reasonably likely to be exposed to the PMN substance by inhalation, as an alternative to compliance with the respirator requirements in the Protection in the Workplace section of this Order, the Company may comply with the requirements of this New Chemical Exposure Limit section. However, before the Company may deviate from the respirator requirements in the Protection in the Workplace section of this Order, the Company must: (i) submit to EPA a copy of the Company's sampling and analytical method for the PMN substance, verified in accordance with subsection (c)(3) of this 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 Limit section by persons who are reasonably likely to be exposed to the PMN substance by inhalation. (3) After appropriate respiratory protection has been selected at a workplace based on the results of actual 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 of this Order (unless it is the same as required by this New Chemical Exposure Limit section). (b) EXPOSURE LIMIT (1) General. The following new chemical exposure limit (NCEL) for the PMN substance is an interim level determined by EPA based on the limited information available to the Agency at the time of development of this Order. The NCEL for the PMN substance is as follows: (i) Time-weighted average (TWA) limit. The Company shall ensure that no person is exposed to an airborne concentration of the PMN substance in excess of ______ as an 8-hour time-weighted average, without using a respirator in accordance with subsection (e) of this New Chemical Exposure Limit section. (ii) Short-term exposure limit (STEL). The Company shall ensure that no person is exposed to an airborne concentration of the PMN substance in excess of ______ as averaged over any 15 minute period, without using a respirator in accordance with subsection (e) of this New Chemical Exposure Limit section. (2) Automatic Sunset. If, subsequent to the effective date of this Order, the Occupational Safety and Health Administration (OSHA) promulgates, pursuant to 6 of the Occupational Safety and Health Act, 29 U.S.C. 655, a final chemical-specific permissible exposure limit (PEL) specifically applicable to this PMN substance and the OSHA PEL is not challenged in court within 60 days of its promulgation, then any respirator requirements in the Protection in the Workplace section of this Order and any requirements of this New Chemical Exposure Limit section applicable to workers and situations subject to the OSHA PEL shall automatically become null and void. (c) PERFORMANCE-CRITERIA FOR SAMPLING AND ANALYTICAL METHOD (1) Applicability. For initial development and validation of the sampling and analytical method for the PMN substance, all the requirements of this subsection (c) apply. For subsequent monitoring conducted pursuant to subsection (d) of this New Chemical Exposure Limit section, only the following requirements apply: (c)(4)(i), (4)(ii), (4)(iv)(B), (4)(v)(B), (8), and (9). Any deviation from the requirements of this subsection (c) must be approved in writing by EPA. (2) Submission of Verified Method and Certification Statement. The Company shall submit to EPA a copy of a validated sampling and analytical method for the PMN substance 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 of both the Company and the Laboratory, certifying the truth and accuracy of the independent laboratory verification conducted pursuant to subsection (c)(3). (3) Verification of Analytical Method by Independent Third- Party Laboratory. (i) Verification. The Company shall have an independent reference laboratory ("Laboratory") verify the validity of the analytical method for the PMN substance, in accordance with the other requirements in this subsection (c)(3). It is the Company's responsibility to ensure that the Laboratory complies with all the requirements specified in this subsection (c)(3). (ii) Independent Reference Laboratory. The independent reference laboratory must be a separate and distinct person (as defined at 40 CFR 720.3(x)) from the Company and from any other person who may have developed the method for the Company. (iii) Accreditation. The Laboratory must be 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 of the analytical method for the PMN substance must comply with TSCA Good Laboratory Practice Standards (GLPS) at 40 CFR Part 792. [Certain provisions of the TSCA GLPS applicable to toxicity testing in laboratory animals, such as 40 CFR 792.43 ("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 section where 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 program approved in advance in writing by EPA. (v) Analysis of Duplicate Samples. The Company shall collect six duplicate samples (a total of 12) at the TWA concentration. The samples shall be taken either from a controlled environment (e.g., a sealed chamber or "glove box") which closely resembles the actual workplace conditions or, for solids and liquids with very low vapor pressure, by injecting the PMN substance onto a sample collection device. The duplicate samples shall be collected on identical collection media, at the same time, and under the same conditions. One set of six samples shall immediately be analyzed by the Company, the other set of six samples shall be analyzed by the Laboratory using the method developed by or for the Company. (vi) Sample Storage Study. If the results of the analysis of duplicate samples pursuant to paragraph (c)(3)(v) do not satisfy the requirements in paragraph (c)(3)(vii), the Company must perform a sample storage study as follows: (I) Triplicate Samples. The Company shall collect six triplicate samples (a total of 18) at the TWA concentration. The samples shall be taken either from a controlled environment (e.g., a sealed chamber or "glove box") which closely resembles the actual workplace conditions or, for solids and liquids with very low vapor pressure, by injecting the PMN substance onto a sample collection device. The triplicate samples shall be collected on identical collection media, at the same time, and under the same conditions. One set of six samples shall immediately be analyzed by the Company. (II) Analysis After Sample Storage. A sample storage evaluation shall be performed with the two remaining sets of six samples. One set of six samples shall be analyzed by the Laboratory using the method developed by or for the Company, and the other shall be analyzed by the Company on the same day as the Laboratory analyzes its six samples. Specialized storage conditions for the samples including extraction conditions, time from sampling to extraction, time from collection or extraction (if applicable) to analysis and storage conditions must be specified in the method description. (vii) Comparison of Results. The difference between the results of the two sets of six samples analyzed by the Laboratory and the Company as required in either paragraph (c)(3)(v) or (c)(3)(vi)(II) shall be evaluated using a two-sample t-test with unequal variances, and the two sides of the critical regions shall not exceed a 5% significance level. (See Attachment B - Statistical Analysis of NCELs Analytical Method Verification Results.) The average of each set of six samples must be within 10% of the true value. If the average of each set of six samples is not within 10% of the true value, then the sample storage time between collection and analysis must be reduced until the average of each set of six samples is within 10% of the 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 PMN substance ranging from one half the NCEL to twice the NCEL. (ii) NCEL quantitation limits. The analytical method should be capable of reliably quantifying the PMN substance across the full range of reasonably likely exposures. At a minimum, the analytical method must be capable of reliably quantifying from a lower quantitation limit ("LQL") of one half the NCEL to an upper quantitation limit ("UQL") of at least twice 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 comply with paragraph (e)(4)(i). (iii) Lower quantitation limit signal-to-noise ratio. The analytical method shall be capable of quantifying the PMN to a concentration of one half the NCEL with a signal that is at least five times the baseline noise level. Baseline noise must be amplified to a measurable level when possible, even if the required amplification is beyond that used in routine analysis of samples. (If baseline noise cannot be obtained, another reference must be selected. This may be a peak considered to be noise caused by the reagent matrix.) The sampling preparation method must be specified and the detection limit for the 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 of five (5) calibration standards with a linear correlation of 0.95 -- these five (5) calibration standards must consist of one standard at each of the following concentrations: one half the NCEL (0.5 x NCEL); between one half and one times the NCEL (0.5 x NCEL <> 1 x NCEL); one times the NCEL (1 x NCEL); between one and two times the NCEL (1 x NCEL <> 2 x NCEL), and twice the NCEL (2 x NCEL). (B) During each week of both 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% of the initial calibration value. If not, then the initial calibration must be repeated, and any samples associated with that outlying calibration check must be reanalyzed. (v) Calculated percent recovery. (A) For method development and validation, the Company must calculate the percent of the PMN substance recovered by the analytical method from a sample containing a known quantity of the PMN substance. The sample shall be taken either from a controlled environment (e.g., a sealed chamber or "glove box") which closely resembles the actual workplace conditions or, for solids and liquids with very low vapor pressure, by injecting the PMN substance onto a sample collection device. (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 PMN substance 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 or vapor 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 of the capacity must be provided in the form of breakthrough 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 PMN substance in the effluent stream is equal to 5% of the concentration of the influent stream, or when 20% of the PMN substance is detected in the backup section of the sampler. (vii) Sampling device desorption efficiency. Where applicable, the desorption efficiency must be evaluated for the air sampling device. A minimum of six air samples spiked with the PMN substance at at least the NCEL concentration must be prepared. A recovery of at least 75% must be obtained for each of the six samples. (5) Precision. The estimate of the coefficient of variation of each set of six samples from the controlled atmosphere test (spiked at 1.0 NCEL, per paragraphs (c)(3)(v) or (vi)) must be less than 0.105, including allowance of 0.05 for error due to sampling. (6) Interpretation of Accuracy and Precision Data. (i) If a single matrix spike recovery is less than 75% recovery or greater than 125% or the estimated precision is greater than 0.105, then the Company must re-prepare the matrix spike, re- sample, and reanalyze all samples associated with such matrix spike or triplicate samples. (ii) For percent 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 if measurements fall below the NCEL. For example, if the observed level is 30 mg/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. If the 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 re-validates the method to confirm that the requirements for accuracy and precision in paragraphs (c)(4) and (5) are met. Examples of possible changes include but are not limited to: introduction of a new chemical substance to the workplace which may interfere with the analysis of the new chemical; introduction of light to the workplace which may interfere with a light-sensitive PMN substance; or introduction of water/increased humidity to the workplace which could react with the PMN substance and cause difficulties in collection and analysis. (9) Comparability. 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 EPA receipt of the sampling and analytical method pursuant to this subsection (c) do not ensure that the method will produce valid monitoring data. The Company is ultimately responsible for ensuring the validity of its monitoring data. (d) MONITORING POTENTIAL EXPOSURE (1) General. (i) Action level. The "action level" is defined as an airborne concentration of the PMN substance, calculated as an 8- hour time-weighted average, equal to one half the NCEL TWA specified in subparagraph (b)(1). (The action level may be exceeded without penalty; its purpose pertains solely to determination of the requisite monitoring frequency.) (ii) Representative exposure groups. Whenever monitoring is required by this New Chemical Exposure Limit section, the Company shall take representative samples of what the potential exposure of each person who is reasonably likely to be exposed to airborne concentrations of the PMN substance would be if respirators were not worn. The Company shall do so by sampling the breathing zone air of at least one person that represents, and does not underestimate, the potential exposure of every person performing the same or substantially similar operations in each work shift, in each job classification, in each work area (hereinafter identified as an "exposure group") where inhalation exposure to the PMN substance is reasonably likely to occur. The exposure of each person need not be itself directly sampled if that exposure is represented by sampling the exposure of another person in the same exposure group. (iii) Good laboratory practice standards. Determinations of potential inhalation exposure shall be made according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and the sampling and analytical method developed pursuant to subsection (c) of this New Chemical Exposure Limit section. [Certain provisions of the TSCA GLPS applicable to toxicity testing in laboratory animals, such as 40 CFR 792.43 ("Test system care 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 where monitoring samples are analyzed by a laboratory accredited by either: (A) the American Industrial Hygiene Association (AIHA) Industrial Hygiene Laboratory Accreditation Program (IHLAP); or (B) another comparable program approved in advance in writing by EPA. (iv) Representative 8-hour TWA airborne concentrations shall be determined on the basis of samples representing the full shift exposure for each exposure group. (v) Determinations of compliance with the STEL shall be made from 15 minute breathing zone samples measured at operations where there is reason to believe that the maximum short-term exposures will occur, such as during, but not limited to, the following operations: __________. (2) Initial monitoring. Before the Company may deviate from the respirator requirements of the Protection in the Workplace section, the Company shall conduct initial monitoring to accurately determine the airborne concentration of the PMN substance for each exposure group in which persons are reasonably likely to be exposed to the PMN substance. (3) Periodic 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 6 months. If the PMN substance is not manufactured, processed, or used at all during a given 6 month calendar period, the Company is not required to conduct monitoring until manufacture, processing, or use of the PMN substance is resumed. However, cessation of manufacturing, processing and use of the PMN substance for less than the 6 month period does not constitute grounds for postponement of the 6 month deadline to conduct monitoring. (ii) If any 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 PMN substance 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 PMN substance is resumed. However, cessation of manufacturing, processing and use of the PMN substance for less than the 3 month period does not constitute grounds for postponement of the 3 month deadline to conduct monitoring. (iii) The Company may alter the monitoring schedule from every 3 months to every 6 months for any exposure group for whom two consecutive measurements taken at least 7 days apart indicate that the potential exposure has decreased to the TWA or below, but is at or above the action level. Where the PMN substance is manufactured, processed, or used in batches of duration less than 7 days, the 2 consecutive measurements may be taken at least 24 hours apart, provided that the measurements accurately reflect the highest peak exposures and variability in exposure. (4) Termination of monitoring. (i) If representative 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 for that exposure group, except when additional monitoring is required by paragraph (d)(5) of this New Chemical Exposure Limit section. Where the PMN substance is manufactured, processed, or used in batches of duration less than 7 days, the 2 consecutive measurements may be taken at least 24 hours apart, provided that the measurements accurately reflect the highest peak exposures and variability in exposure. (5) Additional monitoring. (i) For a previously monitored exposure group, the Company shall, within 7 days of any of the events listed below in this paragraph (d)(5)(i), conduct the initial monitoring followed by any periodic or additional monitoring required by subsection (d) of this New Chemical Exposure Limit section: (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 occur that may reasonably cause new or additional exposures to the PMN substance; and (c) whenever else the Company has any reason to suspect a change that may reasonably result in new or additional exposures to the PMN substance. (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 occur before 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 professional judgment of a qualified expert. (6) Notification of monitoring results. (i) Within 15 working 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 in writing either individually or by posting the information in an appropriate and accessible location. (ii) Whenever the NCEL is exceeded, the written notification required by the preceding paragraph shall describe the action being taken by the Company to reduce inhalation exposure to or below the NCEL, or shall refer to a document available to the person which states the actions to be taken to reduce exposure. (7) Exemption based on objective data. Where the Company has documented and reliable objective data demonstrating that, even under worst-case conditions, employee exposure to the PMN substance 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 Recordkeeping") 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 PMN substance and must be obtained under conditions closely resembling the types of materials, processes, control methods, work practices, and environmental conditions in the Company's current workplace operations with the PMN substance. Examples of objective data that may be used to demonstrate that employee exposure will not exceed the action level, even under worst case conditions, include information on the physical and chemical properties of the PMN substance, 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) of this New Chemical Exposure Limit section and the measured airborne concentration of the PMN substance for any person who is reasonably likely to be exposed to the PMN substance by inhalation exceeds the NCEL, the Company shall provide those persons the respirators specified in this subsection (e), rather than the respirator(s) identified in the Protection in the Workplace section of this Order, and shall ensure that the respirators are used in accordance with 29 CFR 1910.134 and 42 CFR Part 84. When the Company has not yet actually measured the airborne concentration of the PMN substance 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 of Appropriate Respiratory Protection. 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 PMN 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). [Note - The following table for particulate exposure is provided here for purposes of illustration. The other tables at the end of this New Chemical Exposure Limit section may be inserted depending on the physical form of the PMN substance.] PARTICULATE EXPOSURE: Measured Concentration of PMN Substance Required Respiratory Protection ó NCEL No respirator required. ó (10 x NCEL) Category 21 C air-purifying respirator equipped with a high efficiency particulate filter, including disposables, or Category 19C Type C supplied- air respirator. ó (25 x NCEL) Category 21 C powered air- purifying respirator equipped with a loose fitting hood or helmet and high efficiency particulate filters. Category 19 C Type C supplied- air respirator operated in continuous flow mode, and equipped with a hood or helmet. ó (50 x NCEL) Category 21 C air-purifying respirator equipped with a full facepiece and high efficiency particulate filters. Category 21 C powered air- purifying respirator equipped with a tight-fitting facepiece and high efficiency particulate filters. Category 19 C Type C supplied- air respirator operated in continuous flow mode, and equipped with a tight-fitting facepiece. ó (2000 x NCEL) Category 19 C Type C supplied- air respirator operated in pressure demand or other positive pressure mode, and equipped with a full facepiece. > (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 a pressure demand or other positive pressure mode. (3) Reductions in Respiratory Protection. After appropriate respiratory protection has been selected based on the results of actual monitoring conducted at a workplace in accordance with subsection (d) of this New Chemical Exposure Limit section, the Company shall not, at that workplace, use the respiratory protection required by the Protection in the Workplace section of this Order (unless it is the same as required by this New Chemical Exposure Limit section). Before the Company may make any reduction in any respiratory protection selected 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 PMN substance is manufactured, processed, or used in batches of duration less than 7 days, the 2 consecutive measurements may be taken at least 24 hours apart, provided that the measurements accurately reflect the highest peak exposures and variability in exposure. (4) Special Situations. (i) Measurements Outside Quantitation Limits. When a value less than the lower quantitation limit ("LQL") of the analytical method (as described in paragraph (c)(4)(ii)) is measured, the Company shall estimate potential exposure using generally established and accepted statistical methods. If the 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 19C supplied- air respirator listed in this subsection (e). Any reductions in this respiratory protection must comply with paragraph (e)(3). The Company may submit an improved analytical method provided that it complies fully with subsection (c) of this New Chemical Exposure Limit section, including the 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 exposed persons 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 professional judgment of a qualified expert. (f) NCEL RECORDKEEPING (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 EPA in accordance with section 11 of TSCA: (i) A copy of the sampling and analytical methods used and continuing evidence of their accuracy over time as required by section (c); (ii) Records documenting compliance with the analytical method verification requirements 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 CFR Part 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 not comply with TSCA GLPS, such records shall include the written accreditation from the AIHA or the written approval from EPA. (iv) Records documenting all monitoring dates, duration, and results of each sample taken; (v) Records documenting the name, address, work shift, job classification, and work area of the person monitored and of all other persons whose exposures the monitoring is intended to represent; (vi) Any conditions that might have affected the monitoring results; (vii) Notification of monitoring results required by paragraph (d)(8); (viii) Records documenting any changes in the production, process, control equipment, personnel or work practices that may reasonably cause new or additional exposures to the PMN substance; (ix) Records documenting any spills, leaks, ruptures or other breakdowns that may cause new or additional exposure; (x) The type of respiratory protective devices worn by the monitored person, if any; (xi) Records documenting any actions taken to mitigate exposures to the PMN substance; (xii) Records documenting reliance on the objective data exemption in paragraph (d)(7), including: (A) the source of the data, (B) protocols and results of any relevant testing or analysis, (C) a description of the operation exempted and how the data demonstrate that employee exposures will not exceed the action level, (D) other data relevant to the operations, materials and employee exposures covered by the exemption. PAINT SPRAY MIST EXPOSURE: Measured Concentration of PMN Substance Required Respiratory Protection ó NCEL No respirator required. ó (10 x NCEL) Category 23 C air-purifying respirator equipped with combination cartridges approved for paints, lacquers and enamels2, including disposables, or Category 19C Type C supplied-air respirator. ó (25 x NCEL) Category 23 C powered air- purifying respirator equipped with a loose fitting hood or helmet and combination cartridges approved for paints, lacquers and enamels2. Category 19 C Type C supplied- air respirator operated in continuous flow mode, and equipped with a hood or helmet. ó (50 x NCEL) Category 23 C air-purifying respirator equipped with a full facepiece and combination cartridges approved for paints, lacquers and enamels2. Category 23 C powered air- purifying respirator equipped with a tight-fitting facepiece and combination cartridges approved for paints, lacquers and enamels2. Category 19 C Type C supplied- air respirator operated in continuous flow mode, and equipped with a tight-fitting facepiece. ó (2000 x NCEL) Category 19 C Type C supplied- air respirator operated in pressure demand or other positive pressure mode, and equipped with a full facepiece. > (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 a pressure demand or other positive pressure mode. 2 Approval label may preclude use for some paints, lacquers or enamels. ORGANIC VAPOR EXPOSURE The following table shall be used until data on cartridge performance is submitted to, and approved in writing by, EPA. Measured Concentration of PMN Substance Required Respiratory Protection ó NCEL ó (25 x NCEL) No respirator required. Category 19 C Type C supplied- air respirator operated in continuous flow mode, and equipped with a hood or helmet. ó (50 x NCEL) Category 19 C Type C supplied- air respirator operated in continuous flow mode, and equipped with a tight-fitting facepiece. ó (2000 x NCEL) Category 19 C Type C supplied- air respirator operated in pressure demand or other positive pressure mode, and equipped with a full facepiece. > (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 a pressure demand or other positive pressure mode. ORGANIC VAPOR EXPOSURE The following table shall be used only after data on cartridge performance is submitted to, and approved in writing by, EPA. Measured Concentration of PMN Substance Required Respiratory Protection ó NCEL No respirator required. ó (10 x NCEL) Category 23 C air-purifying respirator equipped with organic gas/vapor cartridges, including disposables, or Category 19C Type C supplied- air respirator. ó (25 x NCEL) Category 23 C powered air- purifying respirator equipped with a loose fitting hood or helmet and organic gas/vapor cartridges. Category 19 C Type C supplied- air respirator operated in continuous flow mode, and equipped with a hood or helmet. ó (50 x NCEL) Category 23 C air-purifying respirator equipped with a full facepiece and organic gas/vapor cartridges. Category 23 C powered air- purifying respirator equipped with a tight-fitting facepiece and organic gas/vapor cartridges. Category 19 C Type C supplied- air respirator operated in continuous flow mode, and equipped with a tight-fitting facepiece. ó (2000 x NCEL) Category 19 C Type C supplied- air respirator operated in pressure demand or other positive pressure mode, and equipped with a full facepiece. > (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 a pressure demand or other positive pressure mode. HAZARD COMMUNICATION PROGRAM (a) Written hazard communication program. The Company shall develop and implement a written hazard communication program for the PMN substance in each workplace. The written program will, at a minimum, describe how the requirements of this section for labels, MSDSs, and other forms of warning material will be satisfied. The Company must make the written hazard communication program available, upon request, to all employees, contractor employees, and their designated representatives. The Company may rely on an existing hazard communication program, including an existing program established under the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1910.1200), to comply with this paragraph provided that the existing hazard communication program satisfies the requirements of this section. The written program shall include the following: (1) A list of chemical substances known to be present in the work area which are subject to a TSCA section 5(e) consent order signed by the Company or to a TSCA section 5(a)(2) SNUR at 40 C.F.R. Part 721, subpart E. The list must be maintained in each work area where the PMN substance is known to be present and must use the identity provided on the MSDS for the substance required under paragraph (c) of this section. The list may be compiled for the workplace or for individual work areas. If the Company is required either by another Order issued under section 5(e) of TSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, to maintain a list of substances, the lists shall be combined with the list under this subparagraph. (2) The methods the Company will use to inform employees of the hazards of non-routine tasks involving the PMN substance (e.g., cleaning of reactor vessels), and the hazards associated with the PMN substance contained in unlabeled pipes in their work area. (3) The methods the Company will use to inform contractors of the presence of the PMN substance in the Company's workplace and of the provisions of this Order if employees of the contractor work in the Company's workplace and are reasonably likely to be exposed to the PMN substance while in the Company's workplace. (b) Labeling. (1) The Company shall ensure that each container of the substance in the workplace is labeled in accordance with this subparagraph (b)(1). (i) The label shall, at a minimum, contain the following information: (A) A statement of the health hazards(s) and precautionary measure(s), if any, identified in paragraph (g) of this section or by the Company, for the PMN substance. (B) The identity by which the PMN substance may be commonly recognized. (C) A statement of the environmental hazard(s) and precautionary measure(s), if any, identified in paragraph (g) of this section, or by the Company, for the PMN substance. (D) A statement of exposure and precautionary measure(s), if any, identified in paragraph (g) of this section, or by the Company, for the PMN substance. (ii) The Company may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu of affixing labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys information specified by subparagraph (b)(1)(i) of this section. Any written materials must be readily accessible to the employees in their work areas throughout each work shift. (iii) The Company need not label portable containers into which the PMN substance is transferred from labeled containers, and which are intended only for the immediate use of the employee who performs the transfer. (iv) The Company shall not remove or deface an existing label on containers of the PMN substance obtained from persons outside the Company unless the container is immediately relabeled with the information specified in subparagraph (b)(1)(i) of this section. (2) The Company shall ensure that each container of the substance leaving its workplace for distribution in commerce is labeled in accordance with this subparagraph (b)(2). (i) The label shall, at a minimum, contain the following information: (A) The information prescribed in subparagraph (b)(1)(i) of this section. (B) The name and address of the manufacturer or a responsible party who can provide additional information on the substance for hazard evaluation and any appropriate emergency procedures. (ii) The label shall not conflict with the requirements of the Hazardous Materials Transportation Act (18 U.S.C. 1801 et. seq.) and regulations issued under that Act by the Department of Transportation. (3) The label, or alternative forms of warning, shall be legible and prominently displayed. (4) The label, or alternative forms of warning, shall be printed in English; however, the information may be repeated in other languages. (5) If the label or alternative form of warning is to be applied to a mixture containing the PMN substance in combination with any other substance that is either subject to another TSCA section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, or defined as a "hazardous chemical" under the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS, or alternative form of warning, the measures to control worker exposure or environmental release which the Company determines provide the greatest degree of protection. However, should these control measures differ from the applicable measures required under this Order, the Company must seek a determination of equivalency for such alternative control measures pursuant to 40 CFR 721.30 before prescribing them under this subparagraph (b)(5). (c) Material Safety Data Sheets. (1) The Company must obtain or develop an MSDS for the PMN substance. (2) The MSDS shall contain, at a minimum, the following information: (i) The identity used on the container label of the PMN substance under this section, and, if not claimed confidential, the chemical and common name of the PMN substance. If the chemical and common name are claimed confidential, a generic chemical name must be used. (ii) Physical and chemical characteristics of the substance known to the Company, (e.g., vapor pressure, flash point). (iii) The physical hazards of the substance known to the Company, including the potential for fire, explosion, and reactivity. (iv) The potential human and environmental hazards as specified in paragraph (g) of this section. (v) Signs and symptoms of exposure, and any medical conditions which are expected to be aggravated by exposure to the PMN substance known to the Company. (vi) The primary routes of exposure to the PMN substance. (vii) Precautionary measures to control worker exposure and/or environmental release required by this Order, or alternative control measures which EPA has determined under 40 CFR 721.30 provide substantially the same degree of protection as the identified control measures. The MSDS must identify any New Chemical Exposure Limits specified in paragraph C. of the New Chemical Exposure Limit section of this Order and must contain the information specified in the graduated respirator table in paragraph D.(2) of the New Chemical Exposure Limit section. (viii) Any generally applicable precautions for safe handling and use of the PMN substance which are known to the Company, including appropriate hygienic practices, protective measures during repair and maintenance of contaminated equipment, and procedures for response to spills and leaks. (ix) Any generally applicable control measures which are known to the Company, such as appropriate engineering controls, work practices, or personal protective equipment. (x) Emergency first aid procedures known to the Company. (xi) The date of preparation of the MSDS or of its last revision. (xii) The name, address, and telephone number of the Company or another responsible party who can provide additional information on the chemical substance and any appropriate emergency procedures. (3) If no relevant information is found or known for any given category on the MSDS, the Company must mark the MSDS to indicate that no applicable information was found. (4) Where multiple mixtures containing the PMN substance have similar compositions (i.e., the chemical ingredients are essentially the same, but the specific composition varies from mixture to mixture) and similar hazards, the Company may prepare one MSDS to apply to all of these multiple mixtures. (5) If the Company becomes aware of any significant new information regarding the hazards of the PMN substance or ways to protect against the hazards, this new information must be added to the MSDS within 3 months from the time the Company becomes aware of the new information. If the PMN substance is not being manufactured, imported, processed, or used in the Company's workplace, the Company must add the new information to the MSDS before the PMN substance is reintroduced into the workplace. (6) The Company must ensure that persons receiving the PMN substance from the Company are provided an appropriate MSDS with their initial shipment and with the first shipment after an MSDS is revised. The Company may either provide the MSDS with the shipped containers or send it to the person prior to or at the time of shipment. (7) The Company must maintain a copy of the MSDS in its workplace, and must ensure that it is readily accessible during each work shift to employees when they are in their work areas. (8) The MSDS may be kept in any form, including as operating procedures, and may be designed to cover groups of substances in a work area where it may be more appropriate to address the potential hazards of a process rather than individual substances. However, in all cases, the required information must be provided for the PMN substance and must be readily accessible during each work shift to employees when they are in their work areas. (9) The MSDS must be printed in English; however, the information may be repeated in other languages. (d) Employee information and training. The Company must ensure that employees are provided with information and training on the PMN substance. This information and training must be provided at the time of each employee's initial assignment to a work area containing the PMN substance and whenever the PMN substance is introduced into the employee's work area for the first time. (1) The information provided to employees under this paragraph shall include: (i) The requirements of this section. (ii) Any operations in the work area where the PMN substance is present. (iii) The location and availability of the written hazard communication program required under paragraph (a) of this section, including the list of substances required by subparagraph (a)(1) of this section and MSDSs required by paragraph (c) of this section. (2) The training provided to employees shall include: (i) Methods and observations that may be used to detect the presence or release of the PMN substance in or from an employee's work area (such as monitoring conducted by the Company, continuous monitoring devices, visual appearance, or odor of the substance when being released). (ii) The potential human health and environmental hazards of the PMN substance as specified in paragraph (g) of this section. (iii) The measures employees can take to protect themselves and the environment from the PMN substance, including specific procedures the Company has implemented to protect employees and the environment from exposure to the PMN substance, including appropriate work practices, emergency procedures, personal protective equipment, engineering controls, and other measures to control worker exposure and/or environmental release required under this Order, or alternative control measures which EPA has determined under 40 CFR 721.30 provide the same degree of protection as the specified control measures. (iv) The requirements of the hazard communication program developed by the Company under this section, including an explanation of the labeling system and the MSDS required by this section and guidance on obtaining and using appropriate hazard information. (e) Low concentrations in mixtures. If the PMN substance is present in the work area only as a mixture, the Company is exempt from the provisions of this section if the concentration of the PMN substance in the mixture does not exceed 1.0 percent by weight or volume, or 0.1 percent by weight or volume if paragraph (g) of this section identifies cancer as a potential human health hazard of the PMN substance. However, this exemption does not apply if the Company has reason to believe that during intended use or processing in the work area, the PMN substance in the mixture may be reconcentrated above the 1.0 or 0.1 percent level, whichever is applicable. (f) Existing hazard communication program. The Company need not take additional actions if existing programs and procedures satisfy the requirements of this section. (g) Human health, environmental hazard, exposure, and precautionary statements. The following human health and environmental hazard and precautionary statements shall appear on each label as specified in paragraph (b) and the MSDS as specified in paragraph (c) of this section: (1) Human health hazard statements. This substance may cause: (i) skin irritation. (ii) respiratory complications. (iii) central nervous system effects. (iv) internal organ effects. (v) birth defects. (vi) reproductive effects. (vii) cancer. (viii) immune system effects. (ix) developmental effects. (2) Human hazard precautionary statements. When using this substance: (i) avoid skin contact. (ii) avoid breathing the substance. (iii) avoid ingestion. (iv) use respiratory protection, or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of _____. (v) use skin protection. (3) Environmental hazard statements. This substance may be: (i) toxic to fish. (ii) toxic to aquatic organisms. (4) Environmental hazard precautionary statements. Notice to users: (i) disposal restrictions apply. (ii) spill clean-up restrictions apply. (iii) do not release to water. (5) Each human and environmental hazard and precautionary statement on the label prepared pursuant to paragraph (b) of this section must be followed by the statement: "See the MSDS for details." MANUFACTURING (a)(1) The Company shall not cause, encourage, or suggest the manufacture or import of the PMN substance by any other person. (2) Subparagraph (a)(1) shall expire 75 days after promulgation of a final significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2) of TSCA unless the Company is notified on or before that day of an action in a Federal Court seeking judicial review of the SNUR. If the Company is so notified, subparagraph (a)(1) shall not expire until EPA notifies the Company in writing that all Federal Court actions involving the SNUR have been resolved and the validity of the SNUR affirmed. (3) When EPA promulgates a final SNUR for the PMN substance and subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Company shall notify each person whom it causes, encourages or suggests to manufacture or import the PMN substance of the existence of the SNUR. (b) The Company shall not manufacture the PMN substance: (1) In non-enclosed processes; (2) In the United States; (3) Beyond an aggregate manufacture and importation volume of ; (4) Beyond an annual manufacture and importation volume of ; (5) In the form of a powder; (6) In the form of a solid; (7) In the form of a liquid; (8) In the form of a gas; (9) Other: . PROCESSING (a) The Company shall not process the PMN substance: (1) In non-enclosed processes; (2) Beyond the site of manufacture or import; (3) In the form of a powder; (4) In the form of a solid; (5) In the form of a liquid; (6) In the form of a gas; (7) Other: . USE (a) The Company shall not use the PMN substance: (1) In non-enclosed processes; (2) Beyond the site of manufacture or import; (3) Other than as an intermediate; (4) Other than as a site-limited intermediate; (5) As an intermediate where the concentration of the PMN substance in the product intended for distribution in commerce exceeds percent; (6) Other than as described in the PMN; (7) For non-industrial applications; (8) For commercial applications; (9) For non-commercial applications; (10) In consumer products; (11) In the form of a powder; (12) In the form of a solid; (13) In the form of a liquid; (14) In the form of a gas; (15) Involving an application method that generates a vapor, mist, or aerosol; (16) Involving an application method that generates a dust; (17) Other: . DISTRIBUTION (a) Except as provided in paragraph (b), the Company shall distribute the PMN substance 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 PMN substance to any other person, including for disposal, until after the PMN substance has been completely reacted (cured) or _________. (2) Comply with the same requirements and restrictions, if any, required of the Company in the Protection in the Workplace and the New Chemical Exposure Limit sections of this Order, or _______. (3) Comply with the same requirements and restrictions, if any, required of the Company in the Hazard Communication Program section of this Order, or______. (4) Comply with the same environmental release restrictions, if any, required of the Company in the Disposal and Release to Water sections of this Order, or _______. (5) Not process the PMN substance: (i) In non-enclosed processes; (ii) At a site not in that person's control; (iii) Except as described in the PMN; (iv) In the form of a powder; (v) In the form of a solid; (vi) In the form of a liquid; (vii) In the form of a gas; (viii) Other: . (6) Not use the PMN substance: (i) At a site not under the person's control; (ii) In non-enclosed processes; (iii) Other than as an intermediate; (iv) Other than as a site-limited intermediate; (v) As an intermediate where the concentration of the PMN substance in the product intended for distribution in commerce exceeds percent; (vi) Other than as described in the PMN; (vii) For non-industrial applications; (viii) For commercial use; (ix) For non-commercial use; (x) In consumer products; (xi) In the form of a powder; (xii) In the form of a solid; (xiii) In the form of a liquid; (xiv) In the form of a gas; (xv) Involving an application method that generates a vapor, mist, or aerosol; (xvi) Involving an application method that generates a dust. (xvii) Other: . (b) Notwithstanding paragraph (a), the Company may distribute the PMN substance outside the Company for temporary transport and storage in sealed containers (labelled in accordance with paragraph (b)(2) of the Hazard Communication Program section of this Order) provided that any human exposure or environmental release resulting from opening the container and removing or washing out the PMN substance may occur only while the PMN substance is in the possession and control of the Company or a person authorized to receive the PMN substance from the Company pursuant to this Distribution section of this Order. (c) If, at any time after commencing distribution in commerce of the PMN substance, the Company obtains knowledge that a recipient of the substance has failed to comply with any of the conditions specified in paragraph (a) of this Distribution section or, after paragraph (a)(1) expires in accordance with subparagraph (d)(1), has engaged in a significant new use of the PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a significant new use notice to EPA, the Company shall cease supplying the substance to that recipient, unless the Company is able to document each of the following: (1) That the Company has, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any of the conditions specified in paragraph (a) of this Distribution section, or has engaged in a significant new use of the PMN substance without submitting a significant new use notice to EPA. (2) That, within 15 working days of notifying the recipient of the noncompliance, the Company received from the recipient, in writing, a statement of assurance that the recipient is aware of the terms of paragraph (a) of this Distribution section and will comply with those terms, or is aware of the terms of the significant new use rule for the PMN substance and will not engage in a significant new use without submitting a significant new use notice to EPA. (3) If, after receiving a statement of assurance from a recipient under subparagraph (c)(2) of this Distribution section, the Company obtains knowledge that the recipient has failed to comply with any of the conditions specified in paragraph (a) of this Distribution section, or has engaged in a significant new use of the PMN substance without submitting a significant new use notice to EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA of the failure to comply, and shall resume supplying the PMN substance to that recipient only upon written notification from the Agency. (d)(1) Paragraph (a)(1) of this Distribution section shall expire 75 days after promulgation of a final SNUR for the PMN substance under section 5(a)(2) of TSCA, unless the Company is notified on or before that day of an action in a Federal Court seeking judicial review of the SNUR. If the Company is so notified, paragraph (a)(1) of this Distribution section shall not expire until EPA notifies the Company in writing that all Federal Court actions involving the SNUR have been resolved and the validity of the SNUR affirmed. (2) When EPA promulgates a final SNUR for the PMN substance and paragraph (a)(1) of this Distribution section expires in accordance with subparagraph (d)(1), the Company shall notify each person to whom it distributes the PMN substance of the existence of the SNUR. Such notification must be in writing and must specifically include all limitations contained in the SNUR which are defined as significant new uses, and which would invoke significant new use notification to EPA for the PMN substance. Such notice must also reference the publication of the SNUR for this PMN substance in either the Federal Register or the Code of Federal Regulations. After promulgation of a SNUR and expiration of subparagraph (a)(1), such notice may substitute for the written agreement required in the introductory clause of paragraph (a); so that, if the Company provides such notice to the persons to whom it distributes the PMN substance, then the Company is not required to obtain from such persons the written agreement specified in paragraph (a). DISPOSAL (a) The Company shall dispose of the PMN substance and any waste stream containing the PMN substance only as follows. This provision does not supersede or preempt any applicable federal, state, and local laws and regulations. (1) The PMN substance must be disposed of only by: (i) incineration; (ii) landfill; (iii) deep well injection; (iv) other: (2) Waste streams from manufacture must be disposed of only by: (i) incineration; (ii) landfill; (iii) deep well injection; (iv) other: (3) Waste streams from processing must be disposed of only by: (i) incineration; (ii) landfill; (iii) deep well injection; (iv) other: (4) Waste streams from use must be disposed of only by: (i) incineration; (ii) landfill; (iii) deep well injection; (iv) other: (5) The Company shall not dispose of or release the PMN substance into the environment. RELEASE TO WATER (a) The Company is prohibited from any predictable or purposeful release of the PMN substance or any waste stream containing the PMN substance from (manufacturing/processing/use): (1) Into the waters of the United States; (2) Into the waters of the United States without application of one or more of the following specified treatment technologies either by the discharger or, in the case of a release through publicly-owned treatment works, by a combination of treatment by the discharger and the publicly-owned treatment works: (i) Chemical precipitation and settling; (ii) Biological treatment (activated sludge or equivalent) plus clarification; (iii) Stream stripping; (iv) Resin or activated carbon adsorption; (v) Chemical destruction or conversion; (vi) Primary wastewater treatment; (3) Into the waters of the United States without primary wastewater treatment, and secondary wastewater treatment as defined in 40 CFR Part 133. (4)(i) Into the waters of the United States if the quotient from the formula: number of kilograms/day/ site released ----------------------------- x 1000 = N parts per billion receiving stream flow (million liters/day) exceeds , when calculated using the methods described in 40 CFR 721.91. However, 40 CFR 721.91(a)(4) does not apply. Instead, if the waste stream containing the PMN substance will be treated using , then the amount of PMN substance reasonably likely to be removed from the waste stream by such treatment may be subtracted in calculating the number of kilograms released. No more than percent removal efficiency may be attributed to such treatment. (ii) In lieu of calculating the quotient in subparagraph (4)(i), monitoring or alternative calculations may be used to predict the surface water concentration expected to result from the intended release of the substance, if the monitoring procedures or calculations have been approved for such purpose by EPA. EPA will review and act on a written request to approve monitoring procedures or alternative calculations within 90 days after such a request is received. The Agency will inform the Company of the disposition of such requests in writing and, where a request is denied, will explain the reasons therefore. II. RECORDKEEPING (a) The Company shall maintain the following records until 5 years after the date they are created and shall make them available for inspection and copying by EPA in accordance with section 11 of TSCA: A. RECORDS (1) Records documenting the manufacture and importation volume of the PMN substance and the corresponding dates of manufacture and import; (2) Records documenting the names and addresses (including shipment destination address, if different) of all persons outside the site of manufacture or import to whom the Company directly sells or transfers the PMN substance, the date of each sale or transfer, and the quantity of the substance sold or transferred on such date; (3) Records documenting establishment and implementation of a program for the use of any applicable personal protective equipment required pursuant to the Protection in the Workplace section of this Order; (4) Records documenting the determinations required by the Protection in the Workplace section of this Order that chemical protective clothing is impervious to the PMN substance; (5) Records required by paragraph F. of the New Chemical Exposure Limits section of this Order, if applicable; (6) Records documenting establishment and implementation of the hazard communication program required by the Hazard Communication Program section of this Order; (7) Copies of labels required under the Hazard Communication Program section of this Order; (8) Copies of material safety data sheets required by the Hazard Communication Program section of this Order; (9) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections of this Order, including distributees' written agreement to comply with the Distribution section of this Order; (10) Records documenting compliance with any applicable disposal requirements under the Disposal section of this Order, including method of disposal, location of disposal sites, dates of disposal, and volume of PMN substance disposed. Where the estimated disposal volume is not known to the Company and is not reasonably ascertainable by the Company, the Company must maintain other records which demonstrate establishment and implementation of a program that ensures compliance with any applicable disposal requirements; (11) Records documenting establishment and implementation of procedures that ensure compliance with any applicable water discharge limitation in the Release to Water section of this Order; (12) Copies of any Transfer Documents and notices required by the Successor Liability section of this Order, if applicable; and (13) The Company shall keep a copy of this Order at each of its sites where the PMN substance is manufactured of imported. B. APPLICABILITY The provisions of this Recordkeeping Section are applicable only to activities of the Company and its Contract Manufacturer, if applicable, and not to activities of the Company's customers. III. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by which the Company's rights and obligations under this Order may be transferred when the Company transfers its interests in the PMN substance, including the right to manufacture the PMN substance, to another person outside the Company (the "Successor in Interest"). (b) Relation of Transfer Date to Notice of Commencement ("NOC"). (1) Before NOC. If the transfer from the Company to the Successor in Interest is effective before EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a new PMN to EPA and comply fully with Section 5(a)(1) of TSCA and 40 CFR part 720 before commencing manufacture or import of the PMN substance. (2) After NOC. If the transfer from the Company to the Successor in Interest is effective after EPA receives a NOC, the Successor in Interest shall comply with the terms of this Order and is not required to submit a new PMN to EPA. (c) Definitions. The following definitions apply to this Successor Liability section of the Order: (1) "Successor in Interest" means a person outside the Company who has acquired the Company's full interest in the rights to manufacture the PMN substance, including all ownership rights and legal liabilities, through a transfer document signed by the Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest of the Company in the PMN substance, such as a licensee who has acquired a limited license to the patent or manufacturing rights associated with the PMN substance. A Successor in Interest must be incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(3). (2) "Transfer Document" means the legal instrument(s) used to convey the interests in the PMN substance, including the right to manufacture the PMN substance, from the Company to the Successor in Interest. (d) Notices. (1) Notice to Successor in Interest. On or before the effective date of the transfer, the Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent Order and the "Notice of Transfer" document which is incorporated by reference as Attachment C to this Order. (2) Notice to EPA. Within 10 business days of the effective date of the transfer, the Company shall, by registered mail, submit the fully executed Notice of Transfer document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405), 401 M Street, S.W., Washington, D.C. 20460. (3) Transfer Document. Copies of the Transfer Document must be maintained by the Successor in Interest at its principal place of business, and at all sites where the PMN substance is manufactured or imported. Copies of the Transfer Document must also be made available for inspection pursuant to Section 11 of TSCA, must state the effective date and time of transfer, and must contain provisions which expressly transfer liability for the PMN substance under the terms of this Order from the Company to the Successor in Interest. (e) Liability. (1) The Company shall be liable for compliance with the requirements of this Order until the effective date and time of the transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements of this Order effective as of the date and time of transfer. (3) Nothing in this section shall be construed to prohibit the Agency from taking enforcement action against the Company after the effective date of the transfer for actions taken, or omissions made, during the time in which the Company manufactured, processed, used, distributed in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order. (f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing section of this Consent Order requires the Company to submit test data to EPA at a specified production volume ("test trigger"), the aggregate volume of the PMN substance manufactured and imported by the Company up to the date of transfer shall count towards the test trigger applicable to the Successor in Interest. IV. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company may petition EPA at any time, based upon new information on the health effects of, or human exposure to, the PMN substance, to modify or revoke substantive provisions of this Order. The exposures and risks identified by EPA during its review of the PMN substance and the information EPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend or revoke this Order, EPA will consider all relevant information available at the time the Agency makes that determination, including, where appropriate, any reassessment of the test data or other information that supports the findings in this Order, an examination of new test data or other information or analysis, and any other relevant information. EPA will issue a modification or revocation if EPA determines that the activities proposed therein will not present an unreasonable risk of injury to health or the environment and will not result in significant or substantial human exposure or substantial environmental release in the absence of data sufficient to permit a reasoned evaluation of the health or environmental effects of the PMN substance. In addition, the Company may petition EPA at any time to make other modifications to the language of this Order. EPA will issue such a modification if EPA determines that the modification is useful, appropriate, and consistent with the structure and intent of this Order as issued. V. EFFECT OF CONSENT ORDER By consenting to the entry of this Order, the Company waives its rights to file objections to this Order pursuant to section 5(e)(1)(C) of TSCA, to receive service of this Order no later than 45 days before the end of the review period pursuant to section 5(e)(1)(B) of TSCA, and to challenge the validity of this Order in any subsequent action. Consenting to the entry of this Order, and agreeing to be bound by its terms, does not constitute an admission by the Company as to, the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any other rights that the Company may have under TSCA. Date Charles M. Auer, Director Chemical Control Division Office of Pollution Prevention and Toxics Date Name: Title: Company: ATTACHMENT A DEFINITIONS [Note: The attached Order may not contain some of the terms defined below.] "Chemical name" means the scientific designation of a chemical substance in accordance with the nomenclature system developed by the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service's rules of nomenclature, or a name which will clearly identify a chemical substance for the purpose of conducting a hazard evaluation. "Chemical protective clothing" means items of clothing that provide a protective barrier to prevent dermal contact with chemical substances of concern. Examples can include, but are not limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. "Company" means the person or persons subject to this Order. "Commercial use" means the use of a chemical substance or any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment or painting contractor). "Common name" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other than by its chemical name. "Consumer" means a private individual who uses a chemical substance or any product containing the chemical substance in or around a permanent or temporary household or residence, during recreation, or for any personal use or enjoyment. "Consumer product" means a chemical substance that is directly, or as part of a mixture, sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in recreation. "Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical. For purposes of this section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "Contract Manufacturer" means a person, outside the Company, who is authorized to manufacture and import the PMN substance under the conditions specified in Part II. of this Consent Order and in the Consent Order for Contract Manufacturer. "Identity" means any chemical or common name used to identify a chemical substance or a mixture containing that substance. "Immediate use." A chemical substance is for the "immediate use" of a person if it is under the control of, and used only by, the person who transferred it from a labeled container and will only be used by that person within the work shift in which it is transferred from the labelled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance if the substance causes no chemical or mechanical degradation, permeation, or penetration of the chemical protective clothing under the conditions of, and the duration of, exposure. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless of physical state or concentration, through all intended operations of manufacture, including the cleaning of equipment. "MSDS" means material safety data sheet, the written listing of data for the chemical substance. "NIOSH" means the National Institute for Occupational Safety and Health of the U.S. Department of Health and Human Services. "Non-enclosed process" means any equipment system (such as an open-top reactor, storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact of the bulk chemical substance and the workplace air may occur. "Non-industrial use" means use other than at a facility where chemical substances or mixtures are manufactured, imported, or processed. "PMN substance" means the chemical substance described in the Premanufacture notice submitted by the Company relevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the body to prevent contact with, and exposure to, an identified chemical substance or substances in the work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types of respirators. Barrier creams are not included in this definition. "Process stream" means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless of physical state or concentration, through all intended operations of processing, including the cleaning of equipment. "Scientifically invalid" means any significant departure from the EPA-approved protocol or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency approval that prevents a reasoned evaluation of the health or environmental effects of the PMN substance. "Scientifically equivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk of injury to human health or the environment of the PMN substance. "Sealed container" means a closed container that is physically and chemically suitable for long-term containment of the PMN substance, and from which there will be no human exposure to, nor environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless of physical state or concentration, through all intended operations of industrial, commercial, or consumer use. "Waters of the United States" has the meaning set forth in 40 CFR 122.2. "Work area" means a room or defined space in a workplace where the PMN substance is manufactured, processed, or used and where employees are present. "Workplace" means an establishment at one geographic location containing one or more work areas. 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 of the data measured by two laboratories.  Compute mean squares _ Si2 = (Xij - Xi)2/(ni - 1), i=1, 2  Form the ratio _ _ T = (X1 - X2)/(W1 + W2)1/2  Compute degrees of freedom f = (W1 + W2)2/[W12/(n1 - 1) + W22/(n2 - 1)] where, W1 = S12/n1, i = 1, 2 _ X1 = Average of the results from the company laboratory _ X2 = Average of the results from the independent laboratory n1 = Number of samples analyzed by the company laboratory n2 = Number of samples analyzed by the independent laboratory. Then compare the absolute value of T to the 97.5 percentile point of a t distribution with f degrees of freedom. If the absolute value exceeds the 97.5 percentile point, the results measured by two laboratories are significantly different at 95% level. Otherwise, they are not significantly different. In general, f may not be a integer. Use interpolation to obtain the 97.5 percentile point of a t distribution with f degrees of freedom. EXAMPLES -- The following examples (based on simulated data) illustrate the method: Example 1 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 n1 = 6 X2 = 100.40 n2 = 6 S11 = 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 of freedom, the 97.5 percentile point will be approximately 2.530 which is greater than the absolute value of T, 2.467. Hence, the means of two data sets are not significantly different at the 5% level. However, if this problem had been 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 _ _ X1 = 95.37 n1 = 6 X2 = 104.37 n2 = 6 S11 = 65.59 W1 = 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 freedom the 97.5 percentile point will be approximately 2.282 which is less than the absolute value of T, 2.290. Hence, the means of two data sets are significantly different at the 5% level. ATTACHMENT C NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER ___________________________ _________________ Company (Transferor) PMN Number 1. Transfer of Manufacture Rights. Effective on _______________, the Company did sell or otherwise transfer to ________________________________, ("Successor in Interest") the rights and liabilities associated with manufacture of the above- referenced chemical substance, which was the subject of a premanufacture notice (PMN) and is governed by a Consent Order issued by the U.S. Environmental Protection Agency (EPA) under the authority of 5(e) of the Toxic Substances Control Act (TSCA, 15 U.S.C. 2604(e)). 2. Assumption of Liability. The Successor in Interest hereby certifies that, as of the effective date of transfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal of the PMN substance, shall be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(3). 3. Confidential Business Information. The Successor in Interest hereby: ___ reasserts, ___ relinquishes, or ___ modifies all Confidential Business Information (CBI) claims made by the Company, pursuant to Section 14 of TSCA and 40 CFR part 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is indicated, such modification shall be explained in detail in an attachment to this Notice of Transfer. TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER NOTICE OF TRANSFER (continued) ___________________________________ _____________________ Company (Transferor) PMN Number ___________________________________ _____________________ Signature of Authorized Official Date ____________________________________ Printed Name of Authorized Official ___________________________________ Title of Authorized Official ___________________________________ Successor in Interest ___________________________________ _____________________ Signature of Authorized Official Date ___________________________________ Printed Name of Authorized Official ___________________________________ Title of Authorized Official ___________________________________ Address ___________________________________ City, State, Zip Code ___________________________________ Successor's Technical Contact ___________________________________ Address ___________________________________ City, State, Zip Code ___________________________________ Phone