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: ) ) ) ) ) [ ] ) P

- 09

- 198/199 ) ) ) ) )

_________________________________________________________________ Consent Order and Determinations Supporting Consent Order

_________________________________________________________________ii

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. Scope of Applicability and Exempti ons

II. Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation of Information

III. Recordkeeping

IV. Requests for Pre

- Inspection Information

V. S u ccessor Liability Upon Transfer of Consen t 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 Contro l Act ( “ TSCA ” ) (15 U.S.C. 2604(e)), the Environmental Protection Agency ( “ EPA ” or “ the Agency ” ) issues the attached Order, regarding premanufacture notice s ( “ PMN s ” ) P

- 09

- 198

- 199 for the chemical substances,

multi

- wall carbon nanotubes, MWCNTs, (“the PMN su bstances ” ) submitted by [ ] ( “ the Company ” ), to take effect upon expiration of the PMN review period. The Company submitted the PMN to EPA pursuant to § 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. In addition, chem ical 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 ORDER

The Consent Order for th e s e PMN substance s requires the Company to:

1 ) Submit certain test data before either exceeding the sp ecified production volume or a specified time period ;

2 ) Submit certain physical

- chemical data ;

3 ) Submit a 1 gram sample of the PMN substances with the MSDS to EPA upon request ; 4) Require workers to use impervi ous gloves and chemical protective clothing when dermally exposed to the PMN substance;iv 5) Require workers to use a full

- face NIOSH

- approved respirator with an N

- 100 cartridge while exposed to the PMN substance by inhalation in the work area; 6) Imp ort, process, and use the PMN substances only as [ ]; 7) Not manufacture the PMN substance in the United States (import only);

8 ) Not release the PMN substance to water during processing and use; 9) Distribute the PMN substances only to a person who agrees to follow the same restrictions (except the testing requirements); and,

10 ) M aintain certain records.

III. CONTENTS OF PMN By signing this Order, the Company represents that it has carefully reviewed this document and agrees that all information herein that is claimed as confidential by the Company 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

infor mation contained within the brackets. Confidential Business Information Claims (Bracketed in the Preamble and Order) : Name of authorized official, company’s name and address, PV, trade name, physical

- chemical properties, precursor substances, process info rmation, personal protection, impurities, use, environmental releases, material characterization data.

Chemical Identit y : multi

- wall carbon nanotubes.

Use:

Specific : [ ]v

Generic: a dditive for reinforcement.

Maximum 12

- Month Production Volume: [ ] kg/yr

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 s , based on the information currently availab le to the Agency. Human Health Effects Summary: Absorption is expected to be poor via all routes based on test data for chemicals with similar molecular structures and chemicals with similar physical/chemical properties described in the EPA Respirable, Poo rly Soluble Particulates chemical category. See www.epa.gov/oppt/newchems/pubs/cat02.htm#Respirable

. Toxicological Endpoints of Concern:

- Irritation to the eye, skin, and mucous membranes (including the respiratory tract);

- Lung effects from poorly s oluble high molecular weight particles;

- Possible lung effects, based on data for analogous substances;

- Potential for lung cancer from respirable particles or agglomerates; and

- Possible immunotoxic effects. Exposures/Releases: The exposures a nd releases evaluated in the risk assessment include the following:vi

Manufacture Processes Use Gen Pop

# Sites Imported [ ]

Workers (#/site) None None [ ] Exposure (days/year) 240 240

Dermal Exposure (mg/day) [ ] (workers) Uncertain

Drinking Water Exposure (mg/day) Uncertain

Releases (days/year) 240

Release to Air (kg/day) 1.24

Total Environmental releases estimate summary: [ ]

Risk to Workers: The PMN substances may present a risk to workers exposed to t he PMN

substances via inhalation. Risk to general population: A qualitative evaluation of the releases estimated indicates that there is some potential for exposure to the general population. Human inhalation, ingestion and dermal exposure may result fro m the water, landfill, incineration and fugitive air releases.

E nvironmental Risk: Risk from environmental exposure is low based on no water releases.

V. EPA ’ S CONCLUSIONS OF LAW The following findings constitute the basis of the Consent Order:vii (a) EP A is unable to determine the potential for human health effects from exposure to the PMN

substances. 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 s

. (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, pursuan t 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 EFFE CTS Triggered Testing. The Order prohibits the Company from exceeding a specified production time or production volume unless the Company submits the information described in the Testing section of this Order in accordance with the conditions specified i n the Testing

section. The Order’s restrictions on manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of that or other r elevant information. EPA encourages the Company to develop additional health effects testing in coordination with other manufacturers of carbon nanotubes. EPA is willing to facilitate the process in coordination with other ongoing health effects testing f or the PMN substances nationally and internationally. In addition, this Order requires that the Company provide EPA with a 1 g sample of theviii PMN materials and MSDS, upon request.

## CONSENT ORDER

I. SCOPE OF APPLICABILITY AND EXEMPTIONS (a) Scope . The requirements of this Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal , in the United States, of the following chemical

substance s , multi

- wall nanotubes, MWCNTs ( “the PMN substance s ”) , submitted by [ ] (“the Company”), except to the extent that those activities are exempted by paragraph (b).

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

PMN substance s is exempt from the requirements of this Order (except the requirements in the Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the extent that (1) these activities are conducted in full compliance with all applicable requirements of the following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required in the Recordkeeping section of this Order. (1) Completely Reacted (Cured). If quantities of the PMN substance (A) are used solely for the purpose authorized in paragraph b(i) under the Ma nufacturing section and paragraph (a) of the Processing/Use section of this Order; and (B) those quantities have been (i) completely reacted (cured); (ii) embedded or incorporated into a polymer matrix that itself has been reacted (cured); (iii) or embedde d in a permanent solid polymer form that is not intended to undergo further processing, except mechanical processing; then the requirements of this Order do not apply.- 2

- ( 2 ) Export . Until the Company begins 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 with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, onc e the Company begins to

manufacture the PMN substance s for use in the United States, no further activity by the Company involving the PMN substance s are exempt as “solely for export” even if some amount of the PMN

substance s are later exported. At that po int, 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 expor t 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 substa nce s when they are produced, without separate commercial intent, only as a “byproduct” as defined at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). ( 5 ) No Separate Commercial Purpose . The requirements of this Order do not apply to the

PMN subst ance 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, mixture, or article of which of which they are a part.- 3

- (c) Automatic Sunset . If the Company has obtained for the PMN substance s a Test 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 (“LoREX”) 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 Company is 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 evaluat ion

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 with the conditions described in

this Order.

TESTING (a) Section 8(e) Reporting. Any informa tion on the PMN substances which reasonably supports the conclusion that the PMN substances present 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 (Ma rch 16, 1978), 68 Federal Register 33129 (June 3, 2003), and 70 Federal Register 2162 (January 12, 2005), shall reference the appropriate PMN identification numbers for- 4

- these substances and shall contain a statement that the substances 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 Company shall notify, in writing, the E PA 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 following information within 10 days of scheduling any study r equired 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; (3) The name and telephone number of a person at the Company or the laboratory whom EPA may contact regarding the study; and (4) The appropriate PMN identification numbers for the substances and a statement that the substances 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 Standards at 40 CFR Part 792 and using methodologies generally acc epted in the relevant scientific community at the time the study is initiated. Before starting to conduct any such study, the Company must obtain approval of test protocols from EPA by submitting written protocols. EPA will respond to the Company within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (d) provide general guidance for development of test protocols,- 5

- but are not themselves acceptable protocols. Approval of the test protocol does not mean pre

acce ptance of test results.

(d) Triggered Testing Requirements. ( 1 ) Tests. The Company is prohibited from manufacturing or importing the PMN

substance s beyond the following aggregate manufacture and import volume of t he PMN

substances or beyond the followi ng time limit (“the production /time limits”) , unless the Company

conducts the following test on the PMN substances and submits all final reports and underlying data in accordance with the conditions specified in this Testing section. The production/time l imit shall be calculated starting from the date two years after expiration of the review period.

Production/Time Limit Test Guideline [ ] year(s) and [ Submit test data for the 90

- day OPPTS 870

- 3465 month(s) or inhalati on toxicity test [ ] kg, with a post

- exposure observation whichever comes first period of up to 3 months; bronchoalveolar lavage fluid (BALF) analysis; aggregation/agglomeration state, shape, particle si ze distribution and surface properties of material as

- manufactured (dry) and as

- administered; aggregation/agglomeration state, shape, particle size distribution and surface properties of materials of the delivered materials after administration; determination of cardiovascular toxicity, heart histopathology, and data on pulmonary deposition. (2) Physical/Chem i cal Properties. If the Company owns or controls any site in the United

States where t he PMN substances are processed or used, the Company must submit the following data within 6 months after expiration of the PMN review period.- 6

- a) Ring size/connectivity are 5, 6, &/or 7 member rings present or any larger ring systems b) Hexagonal arra y orientation i.e. armchair, zig

- zag, chiral with chiral angle measured c) Alignment of long axis any branching, buckling, or bending on any of the tubes (even if only a small amount) d) Deformities any deformities observed (e.g. bumps, gaps, etc. in the tubes) e) Dry particle size distribution must be on the dry substances as originally imported &/or manufactured, not on the substances first dispersed in a solvent then dried. Particle size distribution to be by count method, not by weight or vol ume method f) Dustiness (EN 15051 method) Description of the physical

- chemical properties of the material tested should take into consideration the characterizations identified in the Guidance Manual for Sponsors of OECD Sponsorship Programme for the Testing of Manufactured Nanomaterials.

(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in a scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of each study; and (3) s ubmit, 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 produ ction 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 gu idelines. However, for purposes of this Consent Order, the word “should” in those subparagraphs shall be interpreted to mean “shall” to make clear that the- 7

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

such as slides 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.

(f) Testing Waivers. 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) Equivocal Data. If EPA finds that the data generated by a study are scientifically equivocal, the Company may continue to manufacture and import the PMN substances 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

sp ecified 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 substances, only by mutual consent of EPA and the Company.

(h) EPA Determination 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 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 substances beyond the applicable production limit. (2) The Company may continue to manufacture and import the PMN substances beyond the applicable production limit only if so notified, in writin g, by EPA in response to the Company’s compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii).- 8

- (i) The Company may reconduct the study in compliance with paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to recon duct 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 wit h subparagraph (f)(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 th e 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 respo nd to the Company, in writing, within 4 weeks of receiving the Company’s report.

(i) Company Determination of Invalid Data. (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 substances beyond the a pplicable 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 :- 9

- (i) allow the Company to continue to manufacture and import the PM N substance s 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 w riting, 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) Unreasonable Risk. (1) EPA may notify the Company in writing that EPA finds t hat the data generated by a study are scientifically valid and unequivocal and indicate that, despite the terms of this Order, the PMN substances will or may present an unreasonable risk of injury to human health or the environment. EPA’s notice may speci fy that the Company undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal of the PMN substances to mitigate exposures to or to better characterize the risks presented by the PMN

substances. Within 2 weeks from receipt of such a notice, the Company must cease all manufacture, import, processing, distribution, use and disposal of the PMN substances, unless

either:- 10

- ( 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

an y additional requirements imposed by EPA. The Company may continue to manufacture, import, process, distribute, use and dispose of the PMN substances in accordance with the terms of this Order pending EPA’s response to the Company’s written report. EPA w ill 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, proce ssing, distribution, use and disposal of the

PMN substances.

(k) Other Requirements. 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

no tified in writing by EPA. The Company may, based upon submitted test data or other relevant information, petition EPA to modify or revoke provisions of this Consent Order pursuant to Part

VI of this Consent Order.

PROTECTI O N IN THE WORKPLACE (a) Establishment of Program. During manufacturing, processing, and use of the PMN substances at any site controlled by the Company (including any associated packaging and storage and during any cleaning or maintenance of equipment associated w ith the PMN substances), the Company must establish a program whereby:- 11

- (1) General Dermal Protection. Each person who is reasonably likely to be dermally exposed in the work area to the PMN substances through direct handling of the substances or through contact with equipment on which the substances may exist, or because the substances become airborne in a form listed in subparagraph (a)(5) of this section, is provided with, and is required to wear, personal protective equipment that provides a barrier to prevent dermal exposure to the substances 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 accordance with OSHA dermal protection requirements at 29 CFR 1910 .132, 1910.133, and 1910.138. (2) Specific Dermal Protective Equipment. The dermal personal protective equipment required by subparagraph (a)(1) of this section must include, but is not limited to, the following

items: (i) Gloves impervious to the PMN s ubstances (ii) Full body clothing impervious to the PMN substances (3) Demonstration of Imperviousness. The Company is able to demonstrate that each item of chemical protective clothing selected, including gloves, provides an impervious barrier to

preve nt 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 the material used to make the chemical protective clothing and the con struction 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 li kely 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- 12

- (“ASTM”) F739 “Standard Test Method for Resistance of Protect ive 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 Documen ting the Results of Chemical Permeation Testing on Protective Clothing Materials.” Gloves may not be used for a time period longer than they are actually tested and must be replaced at the end of each work shift during which they are exposed to the PMN su bstances. (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 substances alone and in likely combination with other chemical substances 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 substances 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, and maintained according to an appropriate respiratory protection p rogram 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)- 13

- (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.

MANUFACTURING (a)(1) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import of the PMN substances 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 substances 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, s ubparagraph (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) Notice of SNUR. When EPA promulgates a final SNUR for the PMN su bstances 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 substances of

the existence of the SNUR. 6) (b) Prohibited Uses. Th e Company shall not: (i) import the PMN substances for use other than as [ ];

(ii) manufacture the substance in the United States. (c) The Company shall provide to EPA a 1 gram sample of the PMN substances as specified by EPA in a future request, al ong with a copy of the MSDS for the substances.- 14

-

PROCESSING AND USE The Company shall not process or use the PMN substances other than as [ ].

DISTRIBUTION (a) Export Notice Requirement. No later than the date of distribution, the Company shall noti fy in writing any person to whom it distributes the PMN substances that, due to the issuance of this Consent Order under section 5(e) of TSCA, the PMN substances are subject to the export notification requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in the form in which they appear in the Consent Order, the following information: (1) the PMN numbers and (2) either (A) the specific chemical identities of the chemical substances, or (B) if the specific chemical ide ntities are confidential, the generic chemical

identities.

(b)(i) Distribution Requirements. Except after the PMN substances have been (i) completely reacted (cured); (ii) embedded or incorporated into a polymer matrix that itself has been reacted (cu red); (iii) or embedded in a permanent solid polymer form that is not intended to undergo further processing, except mechanical processing, the Company shall distribute the PMN substances outside the Company, other than for disposal, only to a person who h as agreed in writing prior to the date of distribution, to: (1) Notify in writing any person to whom it distributes the PMN substance that, due to the issuance of this Consent Order under section 5(e) of TSCA, the PMN substance is subject to the

export no tification requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D. Such- 15

- notice shall contain, in the form in which it appears in this Consent Order, the following information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN substance, or (B) if the specific chemical identity is confidential, the generic chemical identity. (2) Not further distribute the PMN substances to any other person, other than for disposal,

until after the PMN substances have been (i) comple tely reacted (cured); (ii) embedded or incorporated into a polymer matrix that itself has been reacted (cured); (iii) or embedded in a permanent solid polymer form that is not intended to undergo further processing, except mechanical processing

. (3) Compl y with the same requirements and restrictions required of the Company in the Protection in the Workplace section. (4) Not process or use the PMN substances other than for: [ ]; (5) Comply with the same environmental release restrictions r equired of the Company in

the Release to Water Section of the Order. (ii) Disposal Exemption . Except for the §12(b), export notice requirement in paragraph (b)(i)(1) above, the distribution requirements in (b)(i) do not apply when the Company distributes the PMN substance for disposal only.

(c) Temporary Transport and Storage. Notwithstanding paragraph (b), the Company may distribute the PMN substances outside the Company for temporary transport and storage in sealed containers provided the following t wo conditions are met: (1) Subsequent to any such exempt temporary transport or storage of sealed containers, the PMN substances may be distributed only to the Company or a person who has given the Company the written agreement required by paragraph (b).- 16

- (2) Any human exposure or environmental release resulting from opening the sealed containers and removing or washing out the PMN substances may occur only while the PMN substances are in the possession and control of the Company or a person who has given the Company the written agreement required by paragraph (b).

(d) Recipient Non

- Compliance. If, at any time after commencing distribution in commerce of the PMN substances, the Company obtains knowledge that a recipient of the substances have failed to

c omply with any of the conditions specified in paragraph (b) of this Distribution section or, after paragraph (a)(1) expires in accordance with subparagraph (e)(1), has engaged in a significant new use of the PMN substances (as defined in 40 CFR Part 721, S ubpart E) without submitting a significant new use notice to EPA, the Company shall cease supplying the substances to that recipient, unless the Company is able to document each of the following: (1) That the Company has, within 5 working days, notified t he recipient in writing that the recipient has failed to comply with any of the conditions specified in paragraph (b) of this Distribution section, or has engaged in a significant new use of the PMN substances without submitting a significant new use notic e 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 (b) of this Distribution sectio n and will comply with those terms, or is aware of the terms of the significant new use rule for the PMN substances 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 (d)(2) of this Distribution section, the Company obtains knowledge that the recipient has failed to comply- 17

- with any of the conditions specified in paragraph (a) of this Distribution section, or has engaged in a significant new use of the PMN substances without submitting a significant new use notice to EPA, the Company shall cease supplying the PMN substances to that recipient, shall notify EPA of the failure to comply, and shall resume supplying the PMN substa nces to that recipient only upon written notification from the Agency.

(e) Sunset Following SNUR . (1) Subparagraph (b)(i)(2) of this Distribution section shall expire 75 days after promulgation of a final SNUR for the PMN substances 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 (b)(i)(2) of this Distribution section shall not expire until EPA notifies th e 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 substances and paragraph (b)(i)(2) of this Distribution section expires in accordance with subparagraph (e)(1), the Company shall notify each person to whom it distributes the PMN substances of the existence of the SNUR. Such notification must be in writing and must specifically include all limitations contained in the SNUR

whic h are defined as significant new uses, and which would invoke significant new use notification to EPA for the PMN substances. Such notice must also reference the publication of

the SNUR for th e PMN substances in either the Federal Register or the Code of Federal Regulations. After promulgation of a SNUR and expiration of subparagraph (b)(i)(2), such notice may substitute for the written agreement required in the introductory clause of paragraph (b); so that, if the Company provides such notice to the pers ons to whom it distributes the PMN substances, then the Company is not required to obtain from such persons the written agreement- 18

- specified in paragraph (b).

RELEASE TO WATER The Company is prohibited from any predictable or purposeful release of the PMN substances, or any waste stream from processing and use containing the PMN substances, into the waters of the

United States.

III. RECORDKEEPING (a) Records. The Company shall maintain the following records until 5 years after the date they

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

section 11 of TSCA : (1) Exemptions

. Records documenting that the PMN substances did in fact qualify for any one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records must satisfy all the statutory and regulatory recordkeeping requirements applicable to the exemption being claimed by the Company. Any amounts or batches of the PMN substances eligible for the Export exemption in Section I, Paragraph (b)(2) of this Order, are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the date of their creation, 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 substances eligible for the Research and Development exemption in Section I, Paragraph (b)(3) of this Order, are exempt from all the requirements in this Recordkeeping section, if the Com pany maintains, for 5 years from the date of their creation, the records required by 40 CFR 720.78(b). For any amounts or batches of the PMN substances claimed to be eligible for any other exemption- 19

- described in Section I, Paragraph (b) of this Order, the Company 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 substances and the corresponding dates of manufacture and import; ( 3 ) Records documenting the names and addresses (including shipment destination address, if different) of all persons outside the site of manu facture or import to whom the Company directly sells or transfers the PMN substances, the date of each sale or transfer, and the quantity of the substances sold or transferred on such date; ( 4 ) Records documenting the addresses of all sites of manufacture , import, processing, and

use; ( 5 ) 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; ( 6 ) Records docum enting the determinations required by the Protection in the Workplace section of this Order that chemical protective clothing is impervious to the PMN substances; ( 7 ) Records documenting compliance with any applicable manufacturing, processing, use,

and d istribution restrictions in the Manufacturing, Processing, and Use, and Distribution sections of this Order, including distributees’ written agreement to comply with the Distribution section of this Order; ( 8 ) Records documenting compliance with the Relea se To Water section of this Order; (9) Copies of any Transfer Documents and notices required by the Successor Liability section of this Order, if applicable; and,- 20

- (10) The Company shall keep a copy of this Order at each of its sites where the PMN

substan ces are 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.

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this “collection of information” unless this Order displays a currently valid control number from the Office of Management and Budget (“OMB”), and EPA so informs the Company. 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

- INSP ECTION INFORMATION (a) EPA ’ s Request for Information

. Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA may occasionally conduct on

- site compliance inspections of Company facilities and conveyances

associated with the PMN substances. To facilitate such inspections, EPA personnel may contact the Company 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 ar e not limited to, the following:- 21

- (i) Expected dates and times when the PMN substances will be in production within the subsequent 12 months; (ii) Current workshift schedules for workers who are involved in activities associated with

the PMN substances an d may reasonably be exposed to the PMN substances; (iii) Current job titles or categories for workers who are involved in activities associated with the PMN substances and may reasonably be exposed to the PMN substances; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substances and may reasonably be exposed to the PMN substances; (v) Records required by the Recordkeeping section of this Order; and/or , (vi) Any other information reasonably relate d to determining compliance with this Order or conducting an inspection for that purpose.

(b) Company ’ s Response

. The Company shall respond to such requests within a reasonable period of time, but in no event later than 30 days after receiving EPA’s req uest. When requested in writing by EPA, the Company’s response shall be in writing. To the extent the information is known to or reasonably ascertainable to the Company at the time of the request, the Company’s response shall demonstrate a good faith effo rt to provide reasonably accurate and detailed answers to all of EPA’s requests.

(c) Confidential Business Information

. Any Confidential Business Information (“CBI”) that the Company submits to EPA pursuant to paragraph (b) shall be protected in accorda nce with §14 of

TSCA and 40 CFR Part 2.- 22

- V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by which the Company’s rights and obligations under this Order may be transferred when the Company transfers its interests in the PMN substances, including the right to manufacture the PMN substances, 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 tr ansfer 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 substances from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit

new P MNs 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 substances. (2) After NOC. If the transfer from the Company to the Successor in Interest is effective

after EPA receives a NOC , the Successor in Interest shall comply with the terms of this Order and shall not be required to submit new PMNs to EPA.

(c) Definitions. The following definitions apply to this Successor Liability section of the Order: (1) “ Successor in Interest ” me ans a person outside the Company who has acquired the Company’s full interest in the rights to manufacture the PMN substances, including all ownership rights and legal liabilities, through a transfer document signed by the Company, as transferor, and

the S uccessor in Interest, as transferee. The term excludes persons who acquire less than the full interest of the Company in the PMN substances, such as a licensee who has acquired a limited license to the patent or manufacturing rights associated with the PM N substances. A Successor in- 23

- 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 substances, including the right to manufacture the PMN substances, 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 Inte rest, 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 sh all, by registered mail, submit the fully executed Notice of Transfer document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies of the Transfer D ocument must be maintained by the Successor in Interest at its principal place of business, and at all sites where the PMN substances are manufactured or imported. Copies of the Transfer Document must also be made available for inspection pursuant to Sect ion 11 of TSCA, must state the effective date of transfer, and must contain provisions which expressly transfer liability for the PMN substances under the terms of this Order from the Company to the Successor in Interest.

(e) Liability.- 24

- (1) The Company shall be liable for compliance with the requirements of this Order until

the effective date of the transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements of this

Order effective as of the date of trans fer. (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 substances 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 substances manufactured and imported by the Company up to the date of transfer shall count towards the test trigger applicable to the

Suc cessor in Interest.

VI. 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 substances, to modify or revoke substantive provisions

of th is Order. The exposures and risks identified by EPA during its review of the PMN substances and the information EPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whet her 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- 25

- 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 substanc es. 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 i ntent of this Order as

issued.- 26

- VII. 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, do not constitute an admi ssion 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. By signing this Order, the Company represents that it has ca refully reviewed this document and hereby agrees that all information herein that is claimed as confidential by the Company (per section 14 of TSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) is correctly identified within brackets and that any informat ion that is not bracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained within

the brackets.

_________________ _____________________________________ Date Jim Willis, Di rector 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 Chemical Abstracts Service’s rules of nomenclature, or a name which will clearly identi fy 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 n ame, 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 perma nent 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 s ection, 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 subs tance 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 mixt ure containing that substance.2

“ Immedi ate 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 transfer red from the labeled 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 con ditions 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, includi ng 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 an d 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 s ubmitted 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 ” mean s 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 substa nce.3

“ 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 rea soned 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 concentra tion, 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

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 an d 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 O rder 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(a)(3).

3. Confidential Business Information. The Successor in Interest hereby:

___ reasserts, ___ relinquishes, or ___ modifies all Confidential Business Information ( “ CBI ” ) claims made by the Com pany, 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 ex plained 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 confident ial treatment under this Notice of Transfer.2

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 Code3

TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER

NOTICE OF TRANSFER (continued)

___________________________________ Successor’s Technical C ontact

___________________________________ Address

___________________________________ City, State, Zip Code

___________________________________ Phone