UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF POLLUTION PR EVENTION AND TOXICS

REGULATION OF A NEW CHEMICAL SUBSTANCE

PENDING DEVELOPMENT OF INFORMATION

In the matter of : ) Premanufacture Notice Number:

) ) ) ) ) P13-0292 ) [ ) ) ) ) )

_________________________________________________________________ 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 Exposure

V. EPA’s Conclusions of Law VI. Information Required to Evaluate Hu man Health and Environmental Effects

Consent Order I. Scope of Applicability and Exemptions II. Terms of Manufacture (Including Import), Processing, Distribution in Commerce, Use, and Disposal Pending Submission an d Evaluation 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 Order

Attachment C – Draft Basis for Prot ocol Developmentiii



## PREAMBLE

I. INTRODUCTION Under the authority of § 5(e) of the Toxic S ubstances Control Act (“TSCA”) (15 U.S.C. 2604(e)), the Environmental Protection Agency (“EP A” or “the Agency”) issues the attached Order, regarding premanufacture notice (“PM N”) P-13-0292 for the chemical substance [ (“the PMN substance”) submitted by [ (“the Company”), to take effect upon expiration of the PMN review period. The Company submitted the PMN to EPA pursuant to § 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 issu ed under § 5. Violators may be subject to various penalties and

to both criminal and civil liabil ity pursuant to § 16, and to specific enforcement and seizure pursuant to § 17. In addition, chemical substanc es 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 this PMN substance requires the Company to maintain certain

records and submit to EPA certain toxicity and other testing.iv

III. CONTENTS OF PMN By signing this Order, the Company represen ts that it has carefully reviewed this document and agrees that all info rmation herein that is claime d 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 docum ent available for public viewing, EPA will remove only the information contai ned within the brackets.

Confidential Business Information Claims (Bracketed in the Preamble and Order) : Chemical identity, company name and representative, pr ecursor substance name, composition, chemical identity information, production volume, use, exposure scenarios. Chemical Identity: [ Generic: Organophosphorus polymer

Use : [ Generic: Additive for polymers Maximum 12-Month Production Volume: [ kg

Test Data Submitted with PMN: Bacterial Reverse Mutation Test Acute Oral toxicity in Rats In vitro skin corrosivity test In vitro skin irritation Ocular irritation test Acute Daphnia toxicity

IV. EPA’S ASSESSMENT OF EXPOSURE Using available exposure information from the public literature (i.e., measured values for [ in house dust in homes), a nd certain assumptions fo r mouthing behavior by young children, EPA is concerned that there might be a potential exposure to the general population. However, there is uncerta inty about the risk from this sc enario due to the absence ofv

hazard data on the PMN substance itself and information on the ability for the PMN substance to migrate or leach out of [ Consumer exposure is possible if the PMN migrates from the [ or decomposes to form dust particles that can be inhaled or ingested. Anal ogous chemicals, including Tris(2-c hloroethyl)phosphate (TCEP) and Tris(1,3-dichloro-2 propyl) phosphate (TDCPP), can be found in household dust, and are widespread in the environment. Assuming simila r use patterns over time, the PMN substance may be expected to display similar exposure patterns.

V. EPA’S CONCLUSIONS OF LAW The following findings constitute th e basis of the Consent Order: (a) EPA is unable to determine the potential for human health effects of the PMN substance from exposure of humans to the PMN substan ce. EPA therefore conc ludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information available to the Agen cy is insufficient to permit a

reasoned evaluation of the human hea lth effects of the PMN substance. (b) In light of the estimated production volume and human exposure to the PMN substance, EPA further concluded, pursuant to § 5(e)(1)(A)( ii)(II) of TSCA, that the PMN substance will be produced in substantial quantities, will be pr esent in consumer products, and there may be significant (or substantial) human exposure to the substance.vi

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH

AND ENVIRONMENTAL EFFECTS Triggered Testing. The Order prohibits the Company from exceeding a specified production volume unless the Company submits the information described in the Testing section

of this Order in accordance with the cond itions specified in the Testing section.

## 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 of th e chemical substance (P-13-0292) (“the PMN substance”) in the United States by [ (“the Co mpany”), 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 is exempt from the requirements of this Order (except the requirements in the Recordkeeping and Successor Liability Upon Transf er 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 Reco rdkeeping section of this Order.

(1) Export . Until the Company begins commerci al manufacture of the PMN substance 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 solely for export in accordance with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company- 2 -

begins to manufacture the PMN substance for use in the United States, no further activity by the Company involving the PMN substan ce is exempt as “solely for export” even if some amount of the PMN substance is later exported. At that po int, the requirements of this Order apply to all

activities associated with the PMN substance while in the territory of the United States. Prior to leaving U.S. territory, even thos e quantities or batches of the PM N substance 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. (2) Research & Development (“R&D”) . The requirements of this Order do not apply to manufacturing, processing, distribu tion in commerce, use and disposal of the PMN substance in small quantities solely for rese arch and development in accord ance with TSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CFR 720.36. The requirements of this Order also do not apply to manufacturing, processing, distribution in commer ce, use and disposal of the PMN substance when manufactured solely for non-commercial research and development per 40 CFR 720.30(i) and TSCA §5(i). (3) Byproducts . The requirements of this Order do not apply to the PMN substance when it is 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). (4) No Separate Commercial Purpose . The requirements of this Order do not apply to the PMN substance when it is manufactured, pur suant to any of the exemptions in 40 CFR 720.30(h), with no commercial purpose separate from the substance, mixture, or article of which it is a part. (5) Imported Articles . The requirements of this Order do not apply to the PMN- 3 -

substance when it is imported as part of an “article” as defined at 40 CFR 720.3(c) and in compliance with 40 CFR 720.22(b)(1).

(b) Automatic Sunset . If the Company has obtained for the PMN substance 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 (I NCLUDING IMPORT), PROCESSING, DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION

PROHIBITION The Company is prohibited from manufacturing (defined by statute to include import), processing, distributing in commer ce, using, or disposing of th e PMN substance in the United States, for any nonexempt commercial purpose, pending the development of information necessary for a reasoned evalua tion of the human health and environmental effects of the substance, and the completion of EPA’s revi ew of, and regulatory action based on, that information, except in accordance with the conditions describe d in this Order.

.- 4 -

TESTING (a) Section 8(e) Reporting. Reports of information on th e PMN substance which reasonably supports the conclusion that the PMN substance presen ts a substantial risk of injury to health or the environment and which is required to be re ported under TSCA section 8(e) shall reference the appropriate PMN identification number for th is substance and contain a statement that the substance is subject to this Consent Order. Additional info rmation regarding section 8(e) reporting requirements can be found at www.epa.gov/oppt/tsca8e

.

(b) Notice of Study Scheduling. The Company shall notify, in writing, the EPA Monitoring Assistance and Media Programs Division (2227A ), Office of Enforcement and Compliance Assurance, U.S. Environmental Protecti on Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, of the following inform ation within 10 days of scheduling any study required to be performed pursuant to this Order, or within 15 days after the effective date of this Order, whichever is later: (1) The date when the study is scheduled to commence; (2) The name and address of the labor atory which will conduct the study; (3) The name and telephone number of a pers on at the Company or the laboratory whom EPA may contact regard ing the study; and, (4) The appropriate PMN identification numbe r for each substance and a statement that the substance is subject to this Consent Order.- 5 -

The written notice should be submitted to EPA as follows:

Postal Mail Address U.S. Environmental Protection Agency GLP Section Chief – Pesticides, Water and Toxics Branch Monitoring Assistance and Me dia Programs Division (2227A) Office of Enforcement and Compliance Assurance 1200 Pennsylvania Avenue, N.W. Washington, DC 20460

Courier Delivery Address U.S. Environmental Protection Agency GLP Section Chief – Pesticides, Water and Toxics Branch Monitoring Assistance and Me dia Programs Division (2227A) Office of Enforcement and Compliance Assurance

Room 7117B 1200 Pennsylvania Avenue, N.W. Washington, DC 20004

(c) Good Laboratory Practice St andards and Test Protocols. Each study performed to address

the risks identified in this Order must be conducted according to TSCA Good Laboratory

Practice Standards at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific community at the time the study is initiated. Before starting to conduct any- 6 -

study that will use a modified version of a published test guideline, the Company must submit written test protocols to EPA for review (submissi on of written test protocols is optional for tests that are to be conducted using unmodified publis hed test guidelines). Protocols must be submitted as a support document for the PMN, using the procedures set out in 40 CFR 720.40. EPA will respond to the Company within 4 weeks of receiving the written protocols. EPA review of a test protocol does not mean pre-acceptance of test results.

(d) Triggered Testing Requirements. The Company is prohibited from manufacturing (defined by statute to include import) the PMN substance af ter a certain date and/ or aggregate domestic manufacture volume (“the production limit”), unless the Company conducts the following

studies on the PMN substance and submits all final re ports and underlying data in accordance with the conditions specifie d in this Testing section.

Production Limit Study Guideline [ kg Repeated dose 28-day oral OPPTS Test Guidelines 870.3050, or years months t oxicity study in rodents whichever comes later Mouse erythrocyte OPPTS Test Guidelines 870.5395, micronucleus test Hydrolysis OECD Method 111 [ kg or -Migration into simulated Develop protocols based on the [ years, saliva; head ove r heels, US Consumer Product Safety months, -Migration into simulated Commission protocols # 3, 4, whichever comes later, swea t; filter paper/skin, and 5 as directed by EPA and (Attachment C) - Mechanical removal of chemicals from articles to suspended particulates in the air, vapor phase air, or settled dust.- 7 -

(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in a scientifically valid manner; (2) promptly fu rnish to EPA the results of any interim phase of each study; and (3) submit the final report of ea ch study (with an additional sanitized copy, if

confidential business information is involved) and all underlying da ta (“the report and data”) to EPA prior to exceeding the applicable production limit. The final report and data must be submitted as a support document for the PMN, using the procedures set out in 40 CFR 720.40. The final report shall contain th e contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applic able “Reporting,” “Data and Reporting,” and “Test Report” subparagraphs in th e applicable test guidelines. However, for purposes of this Consent Order, the word “should” in those subparagr aphs shall be interpreted to mean “shall” to

make clear that the submission of such info rmation is mandatory. EPA will require the

submission of raw data such as slides and laborat ory notebooks only if EPA finds, on the basis of professional judgment, that an adequate evaluati on of the study cannot take place in the absence

of these items.

(f) Testing Waivers. The Company is not required to c onduct a study specified in paragraph (d) of this Testing section if notif ied in writing by EPA that it is unnecessary to conduct that study.

(g) Equivocal Data. If EPA finds that the data generate d by a study are scientifically equivocal, the Company may continue to manufacture (def ined by statute to include import) the PMN substance beyond the applicable pro duction limit. To seek relief from any other restrictions of this Order, the Company may make a second at tempt to obtain unequivocal data by reconducting- 8 -

the study under the conditions specif ied in paragraphs (b), (c), a nd (e) (except that the study may be submitted after reaching the applicable produ ction limit). The testing requirements may be modified, as necessary to permit a reasoned evaluation of the risks presented by the PMN substance, only by mutual consent of EPA and the Company.

(h) 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 Comp any is prohibited from further manufacture (defined by statute to include import) of th e PMN substance beyond the applicable production

limit. (2) The Company may continue to manufacture (defined by st atute to include import) the PMN substance beyond the applicable production lim it only if so notified, in writing, by EPA in response to the Company’s compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) If there is sufficient time to reconduc t the study in compliance with paragraphs (b), (c), and (e) before exceeding the production limit specified in paragraph (d), the Company may reconduct the study. If there is insufficien t time to reconduct the study in compliance with paragraphs (b), (c), and (e) before exceeding th e production limit specified in paragraph (d), the Company may exceed the production limit, but must otherwise comply with paragraphs (b), (c), and (e), and shall submit the repo rt and data to EPA within a r easonable period of time, all as- 9 -

specified by EPA in the notice described in subparagraph (h)(1). EPA will respond to the Company, in writing, within 6 weeks of receiving the Company’s report and data. (ii) The Company may, within 4 we eks of receiving from EPA the notice described in subparagraph (h)(1), submit to EP A a written report refu ting EPA’s finding. EPA will respond to the Company, in writing, within 4 weeks of receiving the Company’s report.

(i) Company Determination of Invalid Data. (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 da ta under the conditions specified in paragraphs (c) and (e), the Company remain s prohibited from further manufacture (defined by statute to include import) of the PMN substance beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks of first becoming aware of such circumstances, a written statement explaining why circumstances clearly beyond the control of the Company or laboratory will cause or have caused development of scientifically invalid data. EPA will notify the Company of its response, in writing, within 4 weeks of receiving the Company’s report. EPA’s wr itten response may either: (i) allow the Company to continue to ma nufacture (defined by statute to include import) the PMN substance beyond the applicable production limit, or (ii) require the Company to continue to conduct, or to reconduct, the study in compliance with paragraphs (b), (c), and (e), if there is sufficient time to conduct or reconduct the study and submit the report and data to EPA before exceeding the production limit specified- 10 -

in paragraph (d). If there is insufficient time for the Company to comply with paragraphs (b), (c), and (e) before exceeding th e production limit specified in pa ragraph (d), the Company may exceed the production limit, but must otherwise comp ly with paragraphs (b), (c), and (e), and shall submit the report and data to EPA within a reasonable period of tim e, all as specified by EPA in the notice described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks of receivi ng the Company’s report and data , as to whether the Company may continue to manufacture (defined by stat ute to include import) beyond the applicable production limit.

(j) Unreasonable Risk. EPA may notify the Company in writing that EPA finds that the data generated by a study are scientifically valid and unequivocal and indicate that, despite the te rms of this Order, the PMN substance will or may present an unreasona ble risk of injury to human health or the environment. EPA’s notice may specify that th e Company undertake certain actions concerning further testing, manufacture (defined by statute to include import), processing, distribution, use and/or disposal of the PMN substance to mitigate e xposures to or to better characterize the risks presented by the PMN substance. Within 2 weeks from receipt of such a notice, the Company must cease all manufacture (defined by statute to include import), processing, distribution, use and disposal of the PMN substance, unless either: (1) within 2 weeks from receipt of th e EPA notice, the Company complies with such requirements as th e notice specifies; or- 11 -

(2) within 4 weeks from receipt of the EPA notice, the Company submits to EPA a written report refuting EPA’s finding and/or the appropriateness of any additional requirements imposed by EPA. The Company may continue to manufacture (defined by statute to include import), process, distribute, use and dispose of the PMN substan ce in accordance with the terms of this Order pending EPA’s response to the Comp any’s written report. EPA will respond to the Company, in writing, within 4 weeks of receiving the Company’s report. Within 2 weeks of receipt of EPA’s written response, the Company sh all comply with any requirements imposed by EPA’s response or cease all manufacture (defin ed by statute to include import), processing, distribution, use and disposal of the PMN substance.

(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 notified in writing by EPA. The Company may, based upon submitted test data or other relevant information, petition EPA to modify or revoke provi sions of this Consent Order pursuant to Part

VI. of this Consent Order.

RISK NOTIFICATION (a) If as a result of the test data required under the terms of this Or der, the Company becomes aware that the PMN substance may present a risk of injury to health or the environment (or is so notified by EPA), the Company must incorporate this new information, and any information on methods for protecting against such risk, into a Material Safety Data Sheet (“MSDS”), as described in 40 CFR section 721.72(c), within 90 days from the time the Company becomes- 12 -

aware of the new information. If the PMN s ubstance is not being manufactured (defined by statute to include import), processed, or used in the Company’s workplace, the Company must

add the new information to an MSDS before the PMN substance is reintroduced into the workplace.

(b) The Company must ensure that persons who will receive the PMN substance from the Company, or who have received the PMN substan ce from the Company within 5 years from the date the Company becomes aware of the new info rmation described in paragraph (a) of this section, are provided an MSDS containing the information requi red under paragraph (a) within 90 days from the time the Company becomes aware of the new information.

MANUFACTURING (a)(1) Prohibition. The Company shall not cause, enc ourage, or suggest the manufacture (defined by statute to include import) of the PMN substance by any other person. (2) Sunset Following SNUR. Subparagraph (a)(1) sh all expire 75 days after promulgation of a final significant new use rule (“SNUR”) governing the PMN substance under section 5(a)(2) of TSCA unless th e Company is notified on or before that day of an action in a Federal Court seeking judicial review of the SN UR. If the Company is so notified, subparagraph (a)(1) shall not expire until EPA notifies the Comp any 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 substance and subparagraph (a)(1) expires in accordance with subparagraph (a )(2), the Company shall notify- 13 -

each person whom it causes, encourages or suggests to manufacture or import the PMN

substance of the existence of the SNUR.

III. RECORDKEEPING (a) Records. The Company shall maintain the followi ng 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 substance did in fact qualify for any one or more of the exemptions described in Secti on I, Paragraph (b) of this Order. Such records must satisfy all the statutory and regulatory recordkeeping re quirements applicable to the exemption being claimed by the Company. Any amounts or batches of the PMN substance eligible for the Export exemption in Section I, Paragraph (b)(1) of this Order are exempt from all the requirements in this Recor dkeeping section, if the Company ma intains, for 5 years from the date of their creation, copies of the export label and expor t notice to EPA, required by TSCA sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches of the PMN substance eligible for the Research and Development exem ption in Section I, Pa ragraph (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, the records requ ired by 40 CFR 720.78(b). For any amounts or batches of the PMN substance claimed to be eligible for any other exemption described in Section I, Paragraph (b) of th is Order, the Company shall keep records demonstrating qualification for that exemption as well as the records specified in paragraphs (2)- 14 -

and (3) below, but is exempt from the other r ecordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture (def ined by statute to include import) volume

of the PMN substance and the corres ponding dates of manufacture and import; (3) Records documenting the names and addresses (including shipment destination address, if different) of all pe rsons outside the site of manufacture or import to whom the Company directly sells or transfers the PMN substa nce, the date of each sa le or transfer, and the quantity of the substance sold or transferred on such date; (4) Records documenting the address of all si tes of manufacture (d efined by statute to include import), processing, and use; (5) Copies of Material Safe ty Data Sheets required by the Risk Notification section of this Order; (6) Copies of any Transfer Documents a nd notices required by th e Successor Liability section of this Order, if applicable; and, (7) The Company shall keep a copy of this Order at each of its sites where the PMN substance is manufactured (defined by stat ute to include import) , processed, or used.

(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.- 15 -

(c) OMB Control Number. Under the Paperwork Reduction Ac t and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Co mpany is not required to respond to this “collection of information” unless this Order disp lays 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 TS CA §5(e) Consent Order has been approved under currently valid OMB Control Number 2070-0012.

IV. REQUESTS FOR PRE-IN SPECTION 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 inspec tions of Company facilities and conveyances

associated with the PMN substance. To fac ilitate such inspections, EPA personnel may contact the Company in advance to request information pertinent to the schedul ing and conduct of such inspections. Such requests may be written or oral. The types of information that EPA may request include, but are not limited to, the following: (1) Expected dates and times when the PM N substance will be in production within the subsequent 12 months; (2) Current workshift schedules for workers who are involved in activities associated with the PMN substance and may reasonabl y be exposed to the PMN substance; (3) Current job titles or categories for worker s who are involved in activities associated with the PMN substance and may reasonabl y be exposed to the PMN substance; (4) Existing exposure monitoring data fo r workers who are involved in activities associated with the PMN substance and may r easonably be exposed to the PMN substance;- 16 -

(5) Records required by the Recordkeep ing section of this Order; and/or (6) Any other information reasonably related 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 request. When requested in writing by EPA, the Company’s response shall be in writing. To the extent the information is known to or reasonably ascertainable to the Comp any at the time of the request, the Company’s response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers to all of EPA’s requests.

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

TSCA and 40 CFR Part 2.

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by which the Co mpany’s rights and obligations under this Order may be transferred when the Company transfers its interests in the PMN substance, including the right to manufacture the PMN substance, to another person outside the Company (the “Successor in Interest”).

(b) Relation of Transfer Date to Notice of Commencement (“NOC”).- 17 -

(1) Before NOC. If the transfer from the Company to the Successor in Interest is

effective before EPA receives a notice of comm encement of manufacture or import (“NOC”) for the PMN substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a new PMN to EPA and comply full y with Section 5(a)(1 ) of TSCA and 40 CFR part 720 before commencing manufacture or import of the PMN substance. (2) After NOC. If the transfer from the Company to the Successor in Interest is effective after EPA receives a NOC, the Succe ssor in Interest shall comply with the terms of this Order and shall not be required to submit a new PMN to EPA.

(c) Definitions. The following definitions apply to this Successor Liability sect ion of the Order: (1) “Successor in Interest” means a pers on outside the Company who has acquired the Company’s full interest in the rights to manufact ure the PMN substance, including all ownership rights and legal liabilities, th rough a transfer document signed by the Company, as transferor, and the Successor in Interest, as transferee. Th e term excludes persons who acquire less than the full interest of the Company in the PMN substance, such as a licensee who has acquired a limited license to the patent or manuf acturing rights associated with th e PMN substance. A Successor in 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 inst rument(s) used to c onvey the interests in the PMN substance, including the right to manuf acture the PMN substance, from the Company

to the Successor in Interest.- 18 -

(d) Notices. (1) Notice to Successor in Interest. On or before the effectiv e date of the transfer, the Company shall provide to the Successor in Intere st, by registered mail, a copy of the Consent

Order and the “Notice of Transfer” document whic h is incorporated by reference as Attachment

B to this Order. (2) Notice to EPA. Within 10 business days of the e ffective date of the transfer, the Company shall, by registered mail, submit the fu lly executed Notice of Transfer document to: U.S. Environmental Protection Agency, Ne w Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies of the Transfer Docu ment must be maintained by the Successor in Interest at its principal place of bus iness, and at all sites where the PMN substance is manufactured or imported. Copies of the Transf er Document must also be made available for inspection pursuant to Section 11 of TSCA, must state the effectiv e date of transfer, and must contain provisions which expressly transfer li ability for the PMN substance under the terms of this Order from the Company to the Successor in Interest.

(e) Liability. (1) The Company shall be liable for complian ce 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 transfer.- 19 -

(3) Nothing in this section shall be c onstrued to prohibit the Agency from taking enforcement action against the Company after the e ffective date of the tran sfer for actions taken, or omissions made, during the time in whic h the Company manufactured, processed, used, distributed in commerce, or disposed of the PMN substance pursuant to the terms of this Consent

Order.

(f) Obligations to Submit Test Data under Consent Order. If paragraph (d ) of the Testing

section of this Consent Order re quires the Company to submit test data to EPA at a specified production volume (“test trigger”), the aggreg ate volume of the PMN substance manufactured and imported by the Company up to the date of tr ansfer shall count towards the test trigger applicable to the Successor in Interest.- 20 -

VI. MODIFICATION AND REVO CATION OF CONSENT ORDER The Company may petition EPA at any time, based upon new information on the health or environmental effects of, or human exposur e to, or environmental releases of the PMN substance, to modify or revoke substantive provi sions of this Order. The exposures and risks identified by EPA during its review of the PM N substance and the information EPA determined to be necessary to evaluate thos e exposures and risks are described in the preamble to this Order. However, in determining whether to amend or re voke this Order, EPA will consider all relevant information available at the time the Agency makes that determination, including, where appropriate, any reassessment of th e test data or other information that supports the findings in this Order, an examination of new test data or other information or analysis, and any other

relevant information.

EPA will issue a modification or revocation if EPA determines that the activities proposed therein will not present an unreasonable risk of injury to health or the environment and will not result in significant or substantial human exposure or substantia l environmental release in the absence of data sufficient to permit a reas oned evaluation of the health or environmental

effects of the PMN substance. In addition, the Company may petition EPA at any time to make other modifications to the language of this Order. EPA will issue su ch a modification if EPA determines that the modification is useful, appropriate, and consistent with the structur e and intent of this Order as

issued.- 21 -

VII. EFFECT OF CONSENT ORDER (a) Waiver. By consenting to the entry of this Orde r, 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 ac tion. Consenting to the entry of this Order, and agreeing to be bound by its terms, do not constitute an admission by the Company as to the facts or conclusions underl ying the Agency’s determinations in this proceeding. This waiver does not affect any other rights that the Company may have under

TSCA.

(b) CBI Brackets. By signing this Order, the Company re presents that it has carefully reviewed this document and hereby agrees that all informati on herein that is claime d 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 informa tion that is not bracket ed is not claimed as

confidential. To make this document availabl e for public viewing, EPA will remove only the

information contained within the brackets.

_________________ _____________________________________ Date Maria J. Doa, PhD, Director Chemical Control Division Office of Pollution Prevention and Toxics

_________________ _____________________________________ Date Name: [ ] Title: [ ] Company: [ATTACHMENT A

DEFINITIONS

[Note: The attached Order may not cont ain some of the terms defined below.]

“Chemical name” means the sc ientific designation of a chem ical substance in accordance with the nomenclature system developed by the Chemical Abstracts Service’s rules of nomenclature, or a name which will clearly iden tify 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, j ackets, and pants. “Company” means the person or persons subject to this Order.

“Commercial use” means the use of a chemi cal substance or any mixture containing the chemical substance in a commercial enterprise pr oviding saleable goods or a service to consumers (e.g., a commercial dry cleaning estab lishment or painting contractor). “Common name” means any designation or identi fication such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other than by its chemical name. “Consumer” means a private individual who uses a chemical substance or any product containing the chemical substance in or around a permanent or temporary household or residence, during recreation, or for any personal use or enjoyment. “Consumer product” means a chemical substance th at is directly, or as part of a mixture, sold or made available to consumers for thei r use in or around a permanent or temporary household or residence, in or around a school, or in recreation. “Container” means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical . For purposes of this section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. “Contract Manufacturer” means a person, out side the Company, who is authorized to manufacture and import the PMN substance under th e 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 chem ical substance or a mixture containing that substance.2

“Immediate use.” A chemical substance is for the “immediate use” of a person if it is under the control of, and used only by, the person who tr ansferred it from a labeled container and will only be used by that person within the work shift in which it is transferred from the labeled container. “Impervious.” Chemical protective clothing is “impervious” to a chemical substance if the substance causes no chemical or mechanical degradation, permeation, or penetration of the chemical protective clothing under the condi tions of, and the duration of, exposure. “Manufacturing stream” means all reasonably an ticipated transfer, flow, or disposal of a chemical substance, regardless of physical stat e or concentration, throug h all intended operations of manufacture, including the cleaning of equipment. “MSDS” means material safety data sheet, the written listing of data for the chemical substance.

“NIOSH” means the National In stitute for Occupational Safety and Health of the U.S. Department of Health and Human Services. “Non-enclosed process” means any equipment sy stem (such as an open-top reactor, storage tank, or mixing vessel) in which a chemical subs tance is manufactured, processed, or otherwise used where significant direct contact of the bul k chemical substance and the workplace air may occur. “Non-industrial use” means use other than at a facility where chemical substances or mixtures are manufacture d, imported, or processed.

“PMN substance” means the chemical substa nce described in the Premanufacture notice submitted by the Company relevant to this Order. “Personal protective equipment” means any ch emical protective clothi ng or device placed on the body to prevent contact wi th, and exposure to, an identif ied chemical substance or substances in the work area. Examples incl ude, 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 anticipate d transfer, flow, or disposal of a chemical substance, regardless of physical state or con centration, through all in tended operations of processing, including the cleaning of equipment. “Scientifically invalid” means any significan t departure from the EPA-approved protocol or the Good Laboratory Practice Sta ndards at 40 CFR Part 792 without prior or subsequent Agency approval that prevents a reasoned evaluation of the health or e nvironmental effects of the PMN substance.3

“Scientifically equivocal data” means da ta which, although deve loped in apparent conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsis tent, or otherwise insufficient to permit a reasoned evaluation of the potential risk of injury to human health or the environment of the PMN substance.

“Sealed container” means a closed container th at 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 s ubstance during transport and storage.

“Use stream” means all reasonabl y anticipated transfer, flow, or disposal of a chemical substance, regardless of physical state or con centration, through all in tended 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 th e above-referenced chemical substance, which was the subject of a premanufacture notice (“PMN”) a nd 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 (“TS CA,” 15 U.S.C. §2604(e)).

2. Assumption of Liability. The Successor in Interest hereby certi fies 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, shall be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in th e 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”) cl aims made by the Company, pursuant to Section 14 of TSCA and 40 CFR part 2, for the PMN substanc e(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 su bmitter) would not subsequently be eligible for confidential 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 Authori zed Official Date

___________________________________ Printed Name of Authorized Official

___________________________________ Title of Authorized Official

___________________________________ Successor in Interest

___________________________________ _____________________ Signature of Authori zed Official Date

___________________________________ Printed Name of Aut horized 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 Contact

___________________________________ Address

___________________________________ City, State, Zip Code

___________________________________ Phone4

Attachment C - Basis for Protocol Development