UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OF NEW CHEMICAL SUBSTANCES
PENDING DEVELOPMENT OF INFORMATION

In the matter of: ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) Premanufacture Notice Numbers:

[ P-08-0733/0734

Modified Consent Order and Determinations Supporting Consent Orderii

TABLE OF CONTENTS Preamble
I. Introduction
II. Summary of Terms of the Order
III. Contents of PMN
IV. EPA’s Assessment of Risk
V. EP A’s Conclusions of Law
VI. Information Required to Evaluate Human Health Effects

Consent Order
I. Scope of Applicability and Exemptions
II. Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evalua tion of Information
III. Recordkeeping
IV. Requests for Pre

- Inspection Information
V. Successor Liability Upon Transfer of Consent Order
VI. Modification and Revocation of Consent Order
VII. Effect of Consent Order Attachment A

- Definitions Attachment B

- Notice of Transfer of Consent Orderiii



## PREAMBLE

I . INTRODUCTION Under the authority of § 5(e) of the Toxic Substances Control Act (“TSCA”) (15 U.S.C. 2604(e)) ans section VI of the existing Consent Order , the Environmental Protection Agency (“EPA” or “t he Agency”) issues the attached Modified Consent Order, regarding premanufacture notice (“PMN”) P

- 08

- 0733/0734 for the chemical substances, multi walled carbon nanotubes, (“MWCNT” or the “PMN substances”) submitted by [ ] (“the Companies” or, where r eferred to individually, “the Company” ). The Companies submitted the PMNs to EPA pursuant to section 5(a)(1) of TSCA and 40 CFR Part 720. This is the second modification of a Consent Order original ly effective on February 13, 2009 and first modified effe ctive August 21, 2009. This second modification shall become effective on the date when fully executed by all three parties. The first modification add ed [ ] as a “Company” to the original Consent Order between the EPA and [ ]. [ ]. The firs t modifications was necessary to accommodate changes in market demand for different uses of the PMN substances, and so that [ ] can legally submit the Notice of Commencement (NOC) of non

- exempt commercial manufacture per 40 CFR 720.102. Both Companies are each liable for complying with the requirements of this Modified Consent Order
. Neither Company shall exceed the time limits in the Testing section of the Order unless the required study, reports and data have been submitted in satisfaction of the con ditions specified in the Testing section of the Order.
Th is second modification is necessary to (1) revise the deadline for delivery of the final report on the 90

- day subchronic study in rats currently underway, (3) amend the use of the PMNiv
substance, (3) clarify and expand the meaning of “completely reacted (cured)” in the Scope and Exemption section and in the Distribution section and (4) prohibit release of the PMN substances to surface waters

. Modifications (3) and (4) are a result of EPA ’s evolving po licy for nano materials

. Under § 15 of TSCA, it is unlawful for any person to fail or refuse to comply with any provision of § 5 or any order issued under § 5. Violators may be subject to various penalties and to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 of TSCA, such as this one, are subject to the § 12(b) export notice requirement.

II. SUMMARY OF TERMS OF THE ORDE R The Modified Consent Order for th ese PMN substances r equires the Compan ies to: (1) Deliver to EPA a 1 gram sample of each PMN substance , upon request , along with
cop ies of M aterial Safety Data Sheets (MSDS) ; (2) Submit to EPA the results of a 90

- day i nhalation toxicity study in rats with a post exposure observation period of up to 3 months , i nclud ing bronchoalveolar lavage fluid (“BALF”) analysis (OPPTS 870.3465 or OECD 413 ) , a determination of cardiovascular toxicity (clinically

- based blood/plasma pro tein analyses ), and histopathology of the heart at least 14 weeks before September 21 , 2011 ; ( 3 ) Within 6 months of commencing non

- exempt commercial manufacture of the PMN substance s , submit certain material characterization data; (4 ) Provide workers wit h impervious gloves and chemical protective clothing ;v
( 5 ) Provide workers with a NIOSH

– approved full

- face respirator with an N

- 100 cartridge while exposed by inhalation in the work area; ( 6 ) Use the PMN substance s only as : [ ] ; (7) Not manufactur e the PMN substance s in the United States ; ( 8 ) No t release the PMN substance to the waters of the United States ; (9) D istribute the PMN substance s only to a person who agree s to follow the same restrictions (except the testing requirements) ; and ( 10 ) M aintain certain records

.

III. CONTENTS OF PMN By signing this Order, the Compan ies represent that they have carefully reviewed this document and hereby agree that all information herein that is claimed as confidential by the Compan ies (per section 14 of TSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) is correctly identified within brackets and that any information that is not bracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the info rmation contained within the brackets. Confidential Business Information Claims (Bracketed in the Preamble and Order ) : Contact names , compan ies identit ies , impurities, production volume, uses , byproducts, trade identification name, MSDS, physical/chemical properties, worker exposure, environmental release, process information, test data in attachments. Chemical Identity: multi

- walled carbon nanotubesvi

Use : Specific: [ ]

Generic: (1) reinforcement for composites; open, non

- dispersive use, (2) conducti ve additive for composites; open, non

- dispersive use ; (3) conductive additive for batteries; contained use Maximum 12

- Month Production Volume : [ ] Test Data Submitted with PMN : Acute Oral Toxicity Studies of substances under PMN 08

- 733 and 734, Ac ute Inhalation Toxicity Studies for PMN

- 08

- 733 and 734, Bacterial Reverse Mutation Studies for PMN

- 08

- 733 and 734, Chromosomal Aberration Tests for PMN

- 08

- 733 and 734, Skin Sensitization Tests of PMN

- 08

- 733 and 734, Acute Dermal Irritation Studies of
PMN

- 08

- 733 and 734, Fish Acute Toxicity Test of PMN

- 08

- 733 and 734, Daphnia sp. Acute Immobilization Test of PMN

- 08

- 733 and 734, Alga Growth Inhibition of PMN

- 08

- 733, and Carcinogenicity Study of PMN

- 08

- 733.

IV . EPA’S ASSESSMENT OF RISK The follow ing are EPA’s predictions regarding the probable toxicity , human exposure and environmental release of the PMN substance s , based on the information currently available to the Agency. Human Health Effects Summary: Absorption: A bsorption of the PMN chemical s is expected to be poor via all routes of exposure based on structurally similar poorly soluble respirable particles

. Toxicological Endpoints:vii

- L ung overload from poorly soluble, respirable particles ;

- Possible mutagenic effects of MWCNT ;

- Possible immunot oxic effects of MWCNT ;

- Potential for lung cancer from respirable MWCNT nanoparticles or agglomerates. Basis: Based on the SAT Report, absorption of the PMN chemical s is expected to be poor via all routes based on the behavior of analogous substances. Ther e are concerns for lung effects if inhaled, based on lung overload of poorly soluble high molecular weight particles. PMNs 08

- 733 and 08

- 734 did not induce gene mutations in bacteria or chromosome mutations in mammalian cells in culture. Based on reviewe d data on similar materials, they may be weak inducers of aneuploidy, and inducers of DNA effects, both in mammalian cells in culture. There is potential for immunotoxic effects from P08

- 0733/0734. To the e xtent it they are respirable to the deep lung, t hese PMNs could cause adverse effects to the lung, including inflammation, cell damage, reduced bacterial clearance, and systemic immunotoxicity. Al though there were no other immunotoxicity data available for the substances, published data on analogous ma terials indicates that, in general, inhalation of particulates to the deep lung may lead to reduced alveolar macrophage phagocytosis and impaired clearance of inhaled bacteria. Such inhalation may also lead to pulmonary inflammation, which may damage cell s of the lung and exacerbate asthma symptoms. Carbon nanotube inhalation can also cause systemic and pulmonary immunotoxicity, inducing such ailments as granulomatous lung disease, asthma, exacerbation of asthma, and increased respiratory infecti ons.viii

Th ere is evidence that ultrafine particles penetrate membranes in the respiratory tract and possibly in the GI tract. If so, these particles can migrate to other organs such as the liver, kidney, and brain to produce potentially harmful effects. There may also be physical penetration through the skin. Tested CNTs have been shown to cause fibrosis of the lung and lung cancer, and induce systemic effects. Some recent data suggest cardiovascular effects also are possible from inhalation of carbon nanotubes

B ased on the submitter’s data, inhalation of respirable particles of P08

- 0 733/ 0 734 may lead to lung overload and associated problems, because these chemically inert and insoluble PMN substances of very high molecular weight exemplify materials known to caus e such effects. The results of another study submitted under P09

- 0 733 / 0 734 suggest that P08

- 0733 is weakly carcinogenic in hamsters.

Environmental Effects Summary: No significant effects expected

. A potential risk to the environment is considered low, b ased on low hazard due to low toxicity. Further, risk to aquatic organisms is considered to be low because of the extremely low solubility of carbon nanotubes in

water. While a predicted environmental concentration of the PMN substances cannot be calcula ted, the maximum concentration of any nanotubes released into the aqueous environment will likely be so low as to be negligible and would likely have no adverse effects on aquatic species. Exposure and Environmental Release Summary:ix

Scenario No. of Site s No. of Workers Inhalation (mg/day)

- Dermal (mg/day) Release to water

reinforcement for composites; open, non - dispersive use [] [] 1.6 NA NA

conductive additive for composites; open, non - dispersive use [] [] 0.53 NA NA

conductive additive for batte ries; contained use [ ] [] 0.54 NA NA

Risk to Workers: Based on available data, EPA concludes the PMN substance s may present a risk to workers exposed to the PMN substances via the inhalation route

. Risk to General Public: A qualitative evaluation of estimated releases indicates a low potential risk t o the general population from exposure to water, landfill , and/or incineration releases

.

V. EPA’S CONCLUSIONS OF LAW The following findings constitute the basis of the Consent Order: (A) EPA is unabl e to determine the potential for human health effects from exposure to the PMN substance s . 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 hum an health effects of the PMN substance s
.x
(B) In light of the potential risk to human health posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance s , 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 s may present an unreasonable risk of injury to human health.

VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS
T riggered Testing. The Order prohibits the Compan ies from exceeding a specified production time period or production volume unless the Compan ies submit the information described in the Testing section of this Order in accordance with the conditions specifi ed in the Testing section. The Order requires submission of the following triggered testing: Information Effects Guidelines
90

- day inhalation toxicity lung , heart OPPTS 870.3465 or OECD 413 study on rats with a post

- exposure observation period of up to 3 months , i nclud ing bronchoalveolar lavage fluid ( “ BALF ” ) analysis , a determination of cardiovascular toxicity (clinically

- based blood/plasma protein analyses), and histopathology of the heart

. Description of the physical

- chemical proper ties of the material tested should take into consideration the characterizations identified in most recent version of the Guidance Manual forxi
Sponsors of OECD Sponsorship Programme for the Testing of Manufactured Nanomaterials.
T he Order’s restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance s will remain in effect until the Order is modified or revoked by EPA based on submission of that or other relevant information.

EPA encourages the Compan ies to develop additional health effects testing in coordination with other multi

- walled carbon nanotube (MWCNT) manufacturers. This can be done under the in

depth portion of EPA’s Nanoscale Materials Stewardship Program or through independent testing

. EPA would be willing to facilitate th e process in coordination with other ongoing health effects testing for MWCNT nationally and internationally.

## CONSENT ORDER

I. SCOPE OF APPLICABILITY AND EXEMPTIONS (a) Scope . The requirements of this Order a pply to all commercial manufacturing, processing, distribution in commerce, use and disposal of the chemical substance s, multi

- walled carbon nanotubes (MWCNT), P

- 08

- 0733/0734 (“the PMN substance s ”) , in the United States by [ ] (“the Companies ”), except t o the extent that those activitie s are exempted by paragraph (b).

(b) Exemptions . Manufacturing, processing, distribution in commerce, use and disposal of the PMN substances are exempt from the requirements of this Order (except the requirements in the Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the extent that (1) these activities are conducted in full compliance with all applicable requirements of the following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required in the Recordkeeping section of this Order. (1) Completely Reacted (Cured) . The requirements of this Order do not apply to quantities of the PMN substances that have been completely reacted (cured); embedded or i ncorporated into a polymer matrix that has been reacted (cured); embedded, encapsulated or incorporated by the polymer binder into a permanent solid matrix (does not include slurries) that is not intended to undergo further processing, except mechanical

.2 ( 2 ) Export . Until the Compan ies begin commercial manufacture of the PMN substance s for use in the United States, the requirements of this Order do not apply to manufacture, processing or distribution in commerce of the PMN substance s solely for export in accordance w ith TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Compan ies begin to manufacture the PMN substance s for use in the United States, no further activit ies by the Compan ies involving the PMN substance s are exempt as “ solely for export” even if some amount s of the PMN substance s are later exported. At that point, the requirements of this Order apply to all activities associated with the PMN substance s while in the territory of the United States. Prior to leaving U.S. territory, even those quantities or batches of the PMN substance s that are destined for export are subject to terms of the Order, and count towards any production volume test triggers in the Testing section of this Order. ( 3 ) Research & Development ( “ R&D ” ) . The requirements of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal of the PMN substance s in small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CFR 720.36. ( 4 ) Byproducts . The requirements of this Order do not apply to the PMN substance s when they are produced, without separate commercial intent, only as “byproduct s ” as defined at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). ( 5 ) No Separate Commercial Purpose . The requirements of this Order do not apply to the PMN substance s when they are manufactured, pursuant to any of the exemptions in 40 CFR 720.30(h), with no commercial purpose separate from the substance s , mixture, or arti cle of which they are a part.3 (c) Automatic Sunset . If the Compan ies have obtained for the PMN substance s a T est Market Exemption ( “ TME ” ) under TSCA §5(h)(1) and 40 CFR 720.38 or a Low Volume Exemption ( “ LVE ” ) or Low Release and Exposure Exemption ( “ Lo RE x” ) under TSCA §5(h)(4) and 40 CFR 723.50(c)(1) and (2) respectively, any such exemption is automatically rendered null and void as of the effective date of this Consent Order

.

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE , AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION

PROHIBITION The Compan ies are prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing of the PMN substance s in the United States, for any nonexempt commercial purpose, pending the development of information necessary for a reasoned evaluation of the human health effects of the substance s , and the completion of EPA’s review of, and regulatory action based on, that information, except in accordance wit h the conditions described in this Order.

TESTING (a) Section 8(e) Reporting. Any information on the PMN substance s which reasonably supports the conclusion that the PMN substance s present a substantial risk of injury to health or the environment requi red 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 s for th ese substance s and shall con tain a4 statement that the substance s are 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) Notice of Study Scheduling. The Compan ies shall notify, in writing, the EPA Laboratory Data Integrity Branch (2225A), Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, of the fol lowing 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 a nd address of the laboratory which will conduct the study; (3) The name and telephone number of a person at the Compan ies or the laboratory whom EPA may contact regarding the study; and (4) The appropriate PMN identification number s for the substance s an d a statement that the substance s are subject to this Consent Order.

(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be performed pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Stan dards at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific community at the time the study is initiated. Before starting to conduct any such study, the Compan ies must obtain approval of test protocols from EPA by submit ting written protocols. EPA will respond to the Compan ies within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (d) provide general guidance for development of test protocols,5 but are not themselves acceptabl e protocols. Approval of the test protocol does not mean p re acceptance of test results.

(d) Triggered Testing Requirements. (1) 90

- day inhalation toxicity study

. The Compan ies are prohibited from manufacturing or importing the PMN substances after Se ptember 21, 2011, (“th e production limit”), unless the Compan ies conduct the following study on one of the PMN substance s and submit all final reports and underlying data in accordance with the conditions specified in this Testing section.

Production Limi t Study Guideline September 21 , 2011 90

- day inhalation toxicity OPPTS 8 70.3465 study on rats with a post

- exposure or OECD 413 observation period of up to 3 months , i nclud ing bronchoalveolar lavage fluid ( “ BALF ” ) analysis , a determination of cardiovascular toxicity (clinical ly

- based blood/plasma protein analyses), and histopathology of the heart.
If an appropriate adaptation of the 90

- day inhalation study for the evaluation of MWCNT is not developed within two years of the date the Compan ies sign this C onsent order or if the Compan ies commit to an appropriate program to test representative M WCNTs , e.g., under the in

- depth portion of the Nanoscale Materials Stewardship P rogram, the Compan ies may petition EPA, pursuant to Section V I of this Consent Order, to modify the above testing requirement. If a consortium of companies commit s to test a representative set of MWCNT for subchronic mammalian toxicity,
EPA will consider wa i ving the above requirement

.6 ( 2 ) Material Characterization

. If t he Compan ies own or control a n y site in the United States where the PMN substance s are processed or used, the Compan ies are prohibited from manufacturing or importing the PMN substance s beyond 6 months after commencing such processing or use of the PMN substance s in the Un ited States , unless the Compan ies submit the following material characterization data :

- Particle size distribution (that include both individual MWCNTs and their agglomerates) in the workplace, at sites control led by the Compan ies where the PMN substanc e s are processed or used

.

( e ) Test Reports. The Compan ies 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 t riplicate (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 time 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 guidelin es. However, for purposes of this Consent Order, the word “should” in those subparagraphs shall be interpreted to mean “shall” to make clear that the submission of such information is mandatory. EPA will not require the submission of raw data such as sli des and laboratory notebooks unless 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.7 ( f

) Testing Waivers. The Compan ies are not required to conduct a study spe cified in paragraph (d) of this Testing section if notified in writing by EPA that it is unnecessary to conduct that study.

( g ) Equivocal Data. If EPA finds that the data generated by a study are scientifically equivocal, the Compan ies may continue to m anufacture and import the PMN substance s beyond the applicable production limit. To seek relief from any other restrictions of this Order, the Compan ies may make a second attempt to obtain unequivocal data by reconducting the study under the conditions s pecified 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 s , only by mutual consent of EPA and the Compan ies

.

( h) EPA Determinat ion of Invalid Data. (1) Except as described in subparagraph ( h )(2), if, within 6 weeks of EPA’s receipt of a test report and data, the Compan ies receive written notice that EPA finds that the data generated by a study are scientifically invalid, the Comp an ies are prohibited from further manufacture and import of the PMN substance s beyond the applicable production time limit. (2) The Compan ies may continue to manufacture and import the PMN substance s beyond the applicable production limit only if so notif ied, in writing, by EPA in response to the Compan ies’ compliance with either of the following subparagraphs ( h )(2)(i) or ( h )(2)(ii). (i) The Compan ies may reconduct the study in compliance with paragraphs (b), (c), and ( e )(1) and (2). If there is suffici ent 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 Compan ies shall comply with subparagraph ( e )(3). If there is insufficient time for the8 Co mpan ies to comply with subparagraph ( f )(3), the Compan ies 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 Compan ies , in writing, within 6 weeks of receiving the Compan ies ’ report and data. (ii) The Compan ies may, within 4 weeks of receiving from EPA the notice described in subparagraph ( h )(1), submit to EPA a written report refuting E PA’s finding. EPA will respond to the Compan ies , in writing, within 4 weeks of receiving the Compan ies’ report.

( i ) Compan ies Determination of Invalid Data. (1) Except as described in subparagraph ( i )(2), if the Compan ies becomes aware that circumstan ces clearly beyond the control of the Compan ies or laboratory will prevent, or have prevented, development of scientifically valid data under the conditions specified in paragraphs (c) and ( e ), the Compan ies remain prohibited from further manufacture and i mport of the PMN substance s beyond the applicable production limit. (2) The Compan ies 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 Compa n ies or laboratory will cause or have caused development of scientifically invalid data. EPA will notify the Compan ies of its response, in writing, within 4 weeks of receiving the Compan ies’ report. EPA’s written response may either: (i) allow the Compa n ies to continue to manufacture and import the PMN substance s beyond the applicable production limit, or (ii) require the Compan ies 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 or9 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 Compan ies shall comply with subparagraph ( e )(3). If there is insuffici ent time for the Compan ies to comply with subparagraph ( e )(3), the Compan ies 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 Compan ies , in writing, within 6 weeks of receiving the Compan ies’ report and data, as to whether the Compan ies may continue to manufacture and import beyond the applicable production limit.

( j ) Unreasonable Ris k. (1) EPA may notify the Compan ies 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 s will or may present an unreasonable risk of in jury to human health or the environment. EPA’s notice may specify that the Compan ies undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal of the PMN substance s to mitigate exposures to or to better characterize the risks presented by the PMN substance s . Within 2 weeks from receipt of such a notice, the Compan ies must cease all manufacture, import, processing, distribution, use and disposal of the PMN substance s , unless either: (2) with in 2 weeks from receipt of the notice described in subparagraph ( j )(1), the Compan ies compl y with such requirements as EPA’s notice specifies; or (3) within 4 weeks from receipt of the notice described in subparagraph ( j )(1), the Compan ies submit to EPA a written report refuting EPA’s finding and/or the appropriateness of10 any additional requirements imposed by EPA. The Compan ies may continue to manufacture, import, process, distribute, use and dispose of the PMN substance s in accordance with the terms of this Order pending EPA’s response to the Compan ies’ written report. EPA will respond to the Compan ies , in writing, within 4 weeks of receiving the Compan ies’ report. Within 2 weeks of receipt of EPA’s written response, the Compan ies shall comply with an y requirements imposed by EPA’s response or cease all manufacture, import, processing, distribution, use and disposal of the PMN substance s
.

( k ) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing section, the Comp an ies must continue to obey all the terms of this Consent Order until otherwise notified in writing by EPA. The Compan ies may, based upon submitted test data or other relevant information, petition EPA to modify or revoke provisions of this Consent Order pursuant to Part VI of this Consent Order.

PROTECTION IN THE WORKPLACE (a) Establishment of Program. During manufacturing, processing, and use of the PMN substance s at any site controlled by the Compan ies (including any associated packaging and storage a nd during any cleaning or maintenance of equipment associated with the PMN substance s ), the Compan ies must establish a program whereby: (1) General Dermal Protection. Each person who is reasonably likely to be dermally exposed in the work area to the PMN substance s through direct handling of the substance s or through contact with equipment on which the substance s may exist, or because the substance s become airborne in a form listed in subparagraph (a)(5) of this section, is provided with, and is required t o wear,11 personal protective equipment that provides a barrier to prevent dermal exposure to the substance s in the specific work area where the substances are selected for use. Each such item of personal protective equipment must be selected and used in ac cordance with OSHA dermal protection requirements at 29 CFR 1910.132, 1910.133, and 1910.138. ( 2 ) Specific Dermal P rotective Equipment . The dermal personal protective equipment required by subparagraph (a)(1) of this section must include, but is not lim ited to, the following items : (i) Gloves impervious to the PMN substance s (ii) F ull body clothing impervious to the PMN substance s ( 3 ) Demonstration of Imperviousness. The Compan ies are able to demonstrate that each item of chemical protective clothi ng selected, including gloves, provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions of exposure within the work area by any one or a combination of the following: (i) Permeation Testing . Testing t he 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 protect ive 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 Ma terials ( “ 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 AST M 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 than12 they are actually tested and must be replaced at t he end of each work shift during which they are exposed to the PMN substance s
. (ii) Manufacturer’s Specifications . Evaluating the specifications from the manufacturer or supplier of the chemical protective clothing, or of the material used in construction of the clothing, to establish that the chemical protective clothing will be impervious to the PMN substance s alone and in likely combination with other chemical sub stances in the work

area. ( 4 ) Respiratory Protection. Each person who is reasonably likely to be exposed by inhalation in the work area to the PMN substance s in the form listed in subparagraph (a)(5) of this section, is provided with, and is required to wear, at a minimum, a NIOSH

- certified respirator from the respirators listed in subparagraph (a)(6) of this section, and the respirator is used in accordance with the Occupational Safety and Health Administration (“ OSHA ”) and NIOSH respiratory protection requirements at 29 CFR 1910.134 and 42 CFR Part 84. All respirators must be issued, used, a nd maintained according to an appropriate respiratory protection program under the OSHA requirements in 29 CFR 1910.134. ( 5 ) Physical States. The following physical states of airborne chemical substances are listed for subparagraphs (a)(1) and (4) of this section: (i) Particulate (including solids or liquid droplets)

. ( 6 ) Authorized Respirators. The following NIOSH

- certified respirators meet the minimum requirements for subparagraph (a)(4) of this section: NIOSH

- certified air

- purifying, tight

- fitting full

- face respirator equipped with N100 cartridges

.

MANUFACTURING13 (a)(1) Prohibition. The Compan ies shall not cause, encourage, or suggest the manufacture or import of the PMN substance s by any other person. (2) Sunset Following SNUR. Subparagraph (a) (1) shall expire 75 days after promulgation of a final significant new use rule (“SNUR”) governing the PMN substance s under section 5(a)(2) of TSCA unless the Compan ies are notified on or before that day of an action in a Federal Court seeking judicial rev iew of the SNUR. If the Compan ies are so notified, subparagraph (a)(1) shall not expire until EPA notifies the Compan ies in writing that all Federal Court actions involving the SNUR have been resolved and the validity of the SNUR affirmed. (3) Notic e of SNUR. When EPA promulgates a final SNUR for the PMN substance s and subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Compan ies shall notify each person whom it causes, encourages or suggests to manufacture or import the PMN subs tance s of the existence of the SNUR.

( b ) The Compan ies shall not : (1) M anufacture the PMN substance s in the United States (excluding import) (2) Import the PMN substance s for use other than as [ ].

(c) The C ompan ies shall provide to EPA a 1 gram s ample of each of the PMN substance s as specified by EPA in a future written request , along with a copy of MSDS for each of the PMN substance s
.

PROCESSING AND USE The Compan ies shall not process or use the PMN substance s other than as [ ].14

DISTRIBUT ION (a) Distribution Requirements

. Except after the PMN substances have been completely reacted (cured); embedded or incorporated into a polymer matrix that has been reacted (cured); embedded, encapsulated or incorporated by the polymer binder into a per manent solid matrix (does not include slurries) that is not intended to undergo further processing, except mechanical , the Compan ies shall distribute the PMN substance s outside the Compan ies , other than for disposal, only to a person who has agreed in writ ing prior to the date of distribution, to: (1 ) Not further distribute the PMN substance s to any other person, other than for disposal, until after the PMN substance s have been completely reacted (cured); embedded or incorporated into a polymer matrix that has been reacted (cured); embedded, encapsulated or incorporated by the polymer binder into a permanent solid matrix (does not include slurries) that is not intended to undergo further processing, except mechanical. (2) Comply with the same requirements and restrictions required of the Compan ies in the Protection in the Workplace section

. (3) Not process or use the PMN substance s other than as [ ]

.

(b) Temporary Transport and Storage. Notwithstanding paragraph (a), the Compan ies may distribute the PMN substance s outside the Compan ies for temporary transport and storage in sealed containers (labeled in accordance with paragraph (b)(2) of the Hazard Communication Program section of this Order) provided the following two conditions are met: (1) Subseq uent to any such exempt temporary transport or storage of sealed containers, the PMN substance s may be distributed only to the Compan ies or a person who has given the15 Compan ies the written agreement required by paragraph (a). (2) Any human exposure or envi ronmental release resulting from opening the sealed containers and removing or washing out the PMN substance s may occur only while the PMN substance s are in the possession and control of the Compan ies or a person who has given the Compan ies the written agr eement required by paragraph (a).

(c) Recipient Non

- Compliance. If, at any time after commencing distribution in commerce of the PMN substance s , the Compan ies obtain knowledge that a recipient of the substance s ha ve failed to comply with any of the cond itions 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 s (as defined in 40 CFR Part 721, Subpart E) without submitti ng a significant new use notice to EPA, the Compan ies shall cease supplying the substance s to that recipient, unless the Compan ies are able to document each of the following: (1) That the Compan ies have , within 5 working days, notified the recipient in wr iting 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 s without submitting a significant new use notice to EPA. (2) Tha t, within 15 working days of notifying the recipient of the noncompliance, the Compan ies 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 compl y with those terms, or is aware of the terms of the significant new use rule for the PMN substance s 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)16 of this Distribution section, the Compan ies obtain 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 n ew use of the PMN substance s without submitting a significant new use notice to EPA, the Compan ies shall cease supplying the PMN substance s to that recipient, shall notify EPA of the failure to comply, and shall resume supplying the PMN substance s to that recipient only upon written notification from the Agency.

(d) Sunset Following SNUR. (1) Paragraph (a)(1) of this Distribution section shall expire 75 days after promulgation of a final SNUR for the PMN substance s under section 5(a)(2) of TSCA, unless the Compan ies are notified on or before that day of an action in a Federal Court seeking judicial review of the SNUR. If the Compan ies are so notified, paragraph (a)(1) of this Distribution section shall not expire until EPA notifies the Compan ies in writ ing 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 s and paragraph (a)(1) of this Distribution section expires in accordance with subp aragraph (d)(1), the Compan ies shall notify each person to whom it distributes the PMN substance s 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 s ignificant new uses, and which would invoke significant new use notification to EPA for the PMN substance s . Such notice must also reference the publication of the SNUR for this PMN substance s in either the Federal Register or the Code of Federal Regulatio ns. 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 Compan ies provide such notice to the persons to whom it dist ributes the PMN17 substance s , then the Compan ies are not required to obtain from such persons the written agreement specified in paragraph (a).

RELEASE TO WATER This provision does not supercede or preempt any applicable federal, state, or local laws and re gulations. Those may be more stringent than the requirements below. The Compan ies are prohibited from any predictable or purposeful release of the PMN substances, or any waste stream from manufacturing, processing or use containing the PMN substances in to the waters of the United States.

III. RECORDKEEPING (a) Records. The Compan ies 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

sect ion 11 of TSCA: (1) Exemptions . Records documenting that the PMN substance s did in fact qualify for any one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records must satisfy all the statutory and regulatory recordke eping requirements applicable to the exemption being claimed by the Compan ies . Any amounts or batches of the PMN substance s eligible for the Export exemption in Section I, Paragraph (b)(3) of this Order, are exempt from all the requirements in this Record keeping section, if the Compan ies maintain, for 5 years from the date of their creation, copies of the export label and export notice to EPA, required by TSCA sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches of the PMN substance s eligi ble for the Research and Development exemption in Section I, Paragraph (b)( 3 ) of this Order,18 are exempt from all the requirements in this Recordkeeping section, if the Compan ies maintain, for 5 years from the date of their creation, the records required by 40 CFR 720.78(b). For any amounts or batches of the PMN substance s claimed to be eligible for any other exemption described in Section I, Paragraph (b) of this Order, the Compan ies shall keep records demonstrating qualification for that exemption as well as the records specified in paragraphs (2) and (3) below, but is exempt from the other recordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture and importation volume of the PMN substance s and the corresponding da tes of manufacture and import; (3) Records documenting the names and addresses (including shipment destination address, if different) of all persons outside the site of manufacture or import to whom the Compan ies directly sell or transfers the PMN substan ce s , the date of each sale or transfer, and the quantity of the substance s sold or transferred on such date; (4) Records documenting the address es of all sites of manufacture, import, processing, and

use; (5) Records documenting establishment and implemen tation of a program for the use of any applicable personal protective equipment required pursuant to the Protection in the Workplace section of this Order ; (6) Records documenting the determinations required by the Protection in the Workplace section of t his Order that chemical protective clothing is impervious to the PMN substance s ; (7) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing, Processing, Use, and Distribution s ections of this Order, including distributees’ written agreement to comply with the Distribution section of this19 Order; (8) Copies of any Transfer Documents and notices required by the Successor Liability section of this Order, if applicable; and (9) Th e Compan ies shall keep a copy of this Order at each of their sites where the PMN substance s are manufactured of imported. (b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities of the Compan ies and their Contra ct Manufacturer, if applicable, and not to activities of the Compan ies’ customers.

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Compan ies are not required to respond to this “collection of information” unless this Order displays a currently valid control number from the Office of Management and Budget ( “ OMB ” ), and EPA so informs the Compan ies . The “collection of information” required in this TSCA §5(e) Consent Orders has been approved under currently valid
OMB Control Number 2070

- 0012.

IV. REQUESTS FOR PRE

- INSPECTION INFORMATION (a) EPA’s Request for Information . Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA
may oc c asionally conduct on

- site compliance inspe ctions of the Compan ies ’ facilities and conveyances associated with the PMN substance s . To facilitate such inspections, EPA personnel may contact the Compan ies in advance to request information pertinent to the scheduling and conduct of such inspections. Such requests may be written or oral. The types of information that EPA may request may include, but are not limited to, the following:20 (i) Expected dates and times when the PMN substance s will be in production within the subsequent 12 months; (ii) Curre nt workshift schedules for workers who are involved in activities associated with the PMN substance s and may reasonably be exposed to the PMN substance s ; (iii) Current job titles or categories for workers who are involved in activities associated with the PMN substance s and may reasonably be exposed to the PMN substance s ; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substance s and may reasonably be exposed to the PMN substance s ; (v) Records requ ired by the Recordkeeping section of this Order; and/or (vi) Any other information reasonably related to determining compliance with this Order or conducting an inspection for that purpose.

(b) Compan ies’ Response . The Compan ies shall respond to such req uests within a reasonable period of time, but in no event later than 30 days after receiving EPA’s request. When requested in writing by EPA, the Compan ies’ response shall be in writing. To the extent the information is known to or reasonably ascertainabl e to the Compan ies at the time of the request, the Compan ies’ response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers to all of EPA’s requests.

(c) Confidential Business Information . Any Confidential Business I nformation ( “ CBI ” ) that the Compan ies submit to EPA pursuant to paragraph (b) shall be protected in accordance with §14 of TSCA and 40 CFR Part 2.21 V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures b y which the Compan ies’ rights and obligations under this Order may be transferred when the Compan ies transfer their i nterests in the PMN substance s , including the right to manufacture the PMN substance s , to another person outside the Compan ies (the “Succes sor in Interest”).

(b) Relation of Transfer Date to Notice of Commencement (“NOC”). (1) Before NOC. If the transfer from the Compan ies to the Successor in Interest is effective before EPA receives a notice of commencement of manufacture or import (“N OC”) for the PMN substance s from the Compan ies pursuant to 40 CFR 720.102, the Successor in Interest must submit new PMN s 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 s
. (2) After NOC. If the transfer from the Compan ies to the Successor in Interest is effective after EPA receives a NOC, the Successor in Interest shall comply with the terms of this Order and shall not be required to submit new PMN s to EPA.

(c) Defini tions. The following definitions apply to this Successor Liability section of the Order: (1) “Successor in Interest” means a person outside the Compan ies who has acquired a Compan y’s full interest in the rights to manufacture the PMN substance s , includin g all ownership rights and legal liabilities, through a transfer document signed by the Compan ies , as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest of the Compan ies in the PMN s ubstance s , such as a licensee who has acquired a limited license to the patent or manufacturing rights associated with the PMN substance s . A Successor in22 Interest must be incorporated, licensed, or doing business in the United States in accordance with
40 CFR 720.22(a)(3). (2) “Transfer Document” means the legal instrument(s) used to convey the interests in the PMN substance s , including the right to manufacture the PMN substance s , from the Compan ies to the Successor in Interest.

(d) Notices. (1) Notice to Successor in Interest. On or before the effective date of the transfer, the Compan ies 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 Compan ies shall, by registered mail, submit the fully executed Notice of Transfer document to: U.S. Environmental Protection Agency, New Chemicals Management Branch (7405 M ), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies of the Transfer Document must be maintained by the Successor in Interest at its principal place of business, and at all sites wher e the PMN substance s

are manufactured or imported. Copies of the Transfer Document must also be made available for inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must contain provisions which expressly transfer l iability for the PMN substance s under the terms of this Order from the Compan ies to the Successor in Interest.

(e) Liability.23 (1) The Compan ies shall be liable for compliance with the requirements of this Order until the effective date of the transfer d escribed above. (2) The Successor in Interest shall be liable for compliance with the requirements of this Order effective as of the date of transfer. (3) Nothing in this section shall be construed to prohibit the Agency from taking enforcement action ag ainst the Compan ies after the effective date of the transfer for actions taken, or omissions made, during the time in which the Compan ies manufactured, processed, used, distributed in commerce, or disposed of the PMN substance s pursuant to the terms of thi s Consent Order.

(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing section of this Consent Order requires the Compan ies to submit test data to EPA at a specified production volume (“test trigger”), the aggregate vo lume of the PMN substance s manufactured and imported by the Compan ies up to the date of transfer shall count towards the test trigger applicable to the Successor in Interest.24 VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Compan ies may petition EPA at any time, based upon new information on the health effects of, or human exposure to, the PMN substance s , to modify or revoke substantive provisions of this Order. The exposures and risks identified by EPA during its review of the PMN substance s and th e 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 in formation. 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 s ubstantial environmental release in the absence of data sufficient to permit a reasoned evaluation of the health or environmental effects of the PMN substance s
. In addition, the Compan ies may petition EPA at any time to make other modifications to the lang uage 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.

### 26
VII. EFFECT OF CONSENT ORDER (a) Waiver. By consenting to the entry of this Order, the Companies waive their rights to file objections to this Order pursuant to section 5(e)(I)(C) ofTSCA, to receive service ofthis Order no later than 45 days before the end of the review period pursuant to section 5(e)(l)(B) ofTSCA, and

to**challen~e** the validity of this Order in any subsequent action. Consenting to the entry of this

, Order, and agreeing to be bound by its terms, do not constitute an admission by the Companies as

. to, the facts or conclusions underlying the Agency's determinations in this proceeding. This

waiver does not affect aily other rights that the Companies may have under TSCA. (b) , CBl Brackets. By signing this Order, the Companies represent that the have carefully
reviewed this document and hereby agrees that all information herein that is claimed as confidential by the Companies (per section 14 of TSCA, 40 CFR Part 720 Subpart E, and 40 CFR
Part 2) is correctly identified within brackets and that any information that is not bracketed is not
claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained within ' the brackJ:!§';'

DateATTACHMENT A
DEFI NITIONS [Note: The attached Order may not contain some of the terms defined below.] “Chemical name” means the scientific designation of a chemical substance s in accordance with the nomenclature system developed by the International Union of Pure and Ap plied Chemistry or the Chemical Abstracts Service’s rules of nomenclature, or a name which will clearly identify a chemical substance s 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. “Companies” and “Company” mean 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 establis hment 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” mean s 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 chemic al 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, bo x, 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 contai ners. “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. “Iden tity” 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 under2 the control of, and used only by, the per son 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 dis posal 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 subst ance. “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 mixtu res 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 sh ields, 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 stat e 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 w ithout 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 apparent3 conformity with the Good Laborat ory 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 contai ner” 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 cont aining one or more work areas.ATTACHMENT B 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 s , 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 A ct (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, di stribution in commerce and disposal of the PMN substance s , shall be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(a)(3).
3. Confidential Business Information. The Successor in Interest hereby: ___ reasserts, ___ relinquishes, or ___ modifies all Confidential Business Information ( “ CBI ” ) claims made by the Company, pursuant to Section 14 of TSCA and 40 CFR p art 2, for the PMN substance(s). Where “reasserts” or “relinquishes” is indicated, that designation shall be deemed to apply to all such claims. Where “modifies” is indicated, such modification shall be explained in detail in an attachment to this Notice of Transfer. Information which has been previously disclosed to the public (e.g., a chemical identity that was not claimed as CBI by the original submitter) would not subsequently be eligible for confidential treatment under this Notice of Transfer.2

SECTION 5(e) CONSENT ORDER
NOTICE OF TRANSFER (cont)

__________________________________ _____________________ 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 Code3
SECTION 5(e) CONSENT O RDER
NOTICE OF TRANSFER (cont)

__________________________________ Successor’s Techn ical Contact

___________________________________ Address

___________________________________ City, State, Zip Code

___________________________________ Phone