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:

) ) ) ) ) 3M Company ) P-13-305 ) ) ) ) )

_________________________________________________________________ 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 and Risk

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 (defin ed by statute to include impor t), Processing, Distribution in Commerce, Use, and Disposal Pending Su bmission and 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 Orderiii



## PREAMBLE

I. INTRODUCTION Under the authority of § 5(e) of the Toxic Substances Control Act (“TSCA”) (15 U.S.C. 2604(e)), the Environmental Protection Agency (“EP A” or “the Agency”) issues the attached Order, regarding premanufacture notice (“ PMN”) P-13-305 for the chemical substance [ (“the PMN substance”) submitted by 3M Company (“the Company”), to ta ke 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 s ubstance requires the Company to: (a) provide personal protective equipment to its workers to prevent dermal exposure; (b) provide respirators to its work ers to prevent i nhalation exposure; (c) label containers of the PM N substance and provide Material Safety Data Sheets (“MSDSs”) and worker training in accordance with the provisions of the Hazard Communication Program section;iv

(d) use the PMN substance only as a chemi cal intermediate. Any chemical substance manufactured using the PMN substance may contai n residuals of the PMN substance at levels no greater than [ (e) recover and convert, capture (des troy), recycle, or reuse the subs tance at an overall efficiency of [ when the PMN substance is used as an intermediate in accordance with the provisions of the Use section; (f) not use the PMN substance in consumer products; (g) distribute the PMN substance only to a pers on who agrees to follow the same restrictions (except the testing requirements); (h) provide risk notific ation in accordance with the provision s of the Risk Notification section;

and (i) maintain certain records.v

III. CONTENTS OF PMN By signing this Order, the Compa ny represents that it has carefu lly reviewed this document and agrees that all information here in that is claimed as confiden tial by the Company 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.

Confidential Business Information Claims (Bracketed in the Preamble and Order) : Chemical identity, production volume, use, exposure and release information Chemical Identity: Specific: [ Generic: Fluorinated acid alkylester

Use: Specific: [

Generic: Intermediate

Maximum 12-Month Production Volume: [ Test Data Submitted with PMN: physical/chemical propertie s and 4-hour range-finding inhalation toxicity study in rats

IV. EPA’S ASSESSMENT OF EXPOSURE AND RISK The following are EPA’s predictions regard ing the probable human and environmental toxicity, human exposure and environmental re lease of the PMN substance, based on the information currently available to the Agency.

Human Health Effects Summary:

EPA has concerns that these PMN substances will persist in the environment, couldvi

bioaccumulate, and be toxic (“PBT”) to humans, other mammals, and birds. EPA’s concerns are based on data on the PMN substances, analogy to ] chemicals, and to perfluorooctanoic acid (“PFOA”) and perfluor ooctane sulfonate (“PFOS”) which are both currently under review by EPA for PBT concer ns. Some [ ], PFOA, and PFOS are expected to persist for years in the environment. Biodegradati on and photolysis tests of some analogous substances indicate litt le or no biodegradation or p hotolysis of perfluoroalkyl compounds. Bioaccumulation concerns are base d on the measured presence of certain perfluoroalkyl compounds, in cluding PFOA, in wildlife and in human blood samples. There is concern for neurotoxicity from potential acute exposures and in worker exposures based on the submitted acute inhala tion study where signs consistent with neurotoxicity including tremors and seizures were seen at 3000 ppm but not at 300 ppm. There are additional concerns based on an analog Perf luorobutanoic Acid (PFBA) for thyroid, liver, and developmental toxicity. There are concerns that potential releases to water could be toxic to the general population. For this scenar io, data on an analog, [

are use d. [ was tested in a repeateddose 28-day oral toxicity study in rats (OCSPP 870.3050) conducted by 3M. The dose levels for the 28-day toxicity study were 0, 6, 30 and 150 m g. The test substance was administered daily for 28 days by oral gavage to SPF-bred Sprague Dawley rats. One control group and four treated groups (including a positive control group) were tested, each consisting of 10 males and 10 females. An extra 10 animals per sex per dose gr oup were allowed 21 days of recovery. Pupillary reflex testing at the end of the treatment period showed a delayed (but pr esent) bilateral pupillary reflex for all examined males at 30 mg, A NO AEL of 150 mg/kg BW/day was established forvii

females. A systemic NOAEL of 6 mg/kg/day was established for males based on the presence of hypertrophy/hyperplasia of the follicular epithel ium of the thyroid glands, increased liver weights and lower c holesterol levels. Toxicity studies on PFOA and PFOS indicate developmental, reproductive and systemic toxicity in various species. Cancer may also be of concern. These factors, taken together, raise concerns for potential adverse chronic effects in humans and wildlife. Fo r additional information about PFOA, consult the EPA docket number , EPA-HQ -OPPT-2003-13. Additional information about PFOA, and other perfluorinated substanc es may also be found in the Administrative Record for PFOS, PFOA, and Telome rs and Related Chemicals (AR-226). Administrative Record (AR-226) is not currently available online, but copies can be requested on CD-ROM from the EPA Docket office by callin g 202/566-0280, or sending an email request to oppt.ncic@epa.gov.

The data on the PMN substances and other data indicate a different and less toxic profile for the PMN substances than for PFOA and PFOS. However, based on: 1) the persistence of the PMN substance, 2) the toxicity data on the PMN s ubstance and its analogs, and 3) the possibility that this substance may be used as a substitu te for a use of PFOA, EPA believes that more

information is needed on the to xicity of the PMN substance. Environmental Effects Summary: EPA expects the water soluble PMN substan ce to hydrolyse to the highly persistent perfluoro C x carboxylic acid in the environment. For exam ple, methyl trifluoroacetate hydrolyzes in less than 1 minute. In addition, the de gradation products may be bioaccumulative or biopersistent based on some related substances. No short-term ecotoxico logical concerns were raised for the PMN substance. As stated prev iously, the analog PFOA is persistent in theviii

environment and has a long bioretention time in vari ous species. It has been detected in a number of species of wildlife, including marine mammals. It is toxic to mammalian and other species. The presence in the environment and toxico logical properties of PFOA continue to be investigated. Occupational Exposure: EPA expects dermal exposure to workers to be negligible because this Consent Order requires that workers use impervious gloves when dermal exposure is likely. Inhalation exposure to workers is expected to reach 440 mg/day ove r 4 days during sampling of the liquid product. General population exposures: The lifetime average daily dose (LADD) estimated by EPA is 2.59 x 10 -5 mg/kg/day to the general population via drinking water. The LADD via fish ingestion is 1.10 x 10 -6 mg/kg/day

Environmental releases:

The surface water concentration is estimated to be 387 ppb during processing/use. There are some minimal releases to air that are possibl e but it is expected that most wastes will be

incinerated. EPA requires in this Consent Order that the substance be recovered, recycled, reused, or destroyed at levels achieving 99% efficiency and/or destruction.

Risk to Workers: Because workers are exposed for relatively short periods of time, risk to workers is assessed by comparison to the Neurotoxicity NOAEL of 300 ppm (175 mg/kg-BW/day) from the Acute (4-hr) Inhalation Toxic ity Study in Rats using the PMN Substance (Range-Finding).ix

An acceptable Margin of Exposure (MOE) is ≥ 300 (adjusted using PFBA half-life data). An unacceptable MOE of 32 is predicted for the worst case worker inhalation scenario (vapor from sampling liquid product). (NOAEL dose: 175 mg/kg-BW/day x 100% NOAEL route absorption factor) 

# ÷ (worker dose: 440 mg/day x 100% exposure route absorption factor ÷ 80 kg BW for male adult)

Workers should wear gloves that have been proven to be impervious to the PMN and respiratory protection adequate (fold factor of 9) to bring the MOE up to the acceptable level of

300. Risk to General Public:

Because releases to surface water occur 16 da ys per year risk to the general population will be determined by comparison to a Repeat Do se 28-day Oral Toxicity Study in Rats (OCSPP 870.3050) conducted by [ For general population and consumer risk calculations, typically the ADD (Average Daily Dose) is used to calcul ate the MOE when the endpoint is either reproductive toxicity, immunotoxicity, neurotoxicity, or systemic toxicity because these endpoints result from chronic exposures. The ADD can be estimated from the Lifetime Average Daily Dose (LADD) by multiplying the LADD by 75/40 (1.8 75) to adjust for the differences in Averaging Times (ADD (non-cancer) = 40 yr and LADD (cancer) = 75 yrs). The worst case MOE for the general population via drinking water = 123,457 = (NOAEL dose: 6 mg/kg-BW/day) x 100% NOAEL route absorption factor) 

# ÷ LADD: 2.59 x 10 -5 mg/kg/day x 1.875 x 100% exposure route absorption factorx

The worst case MOE for the general popul ation via fish ingestion = 2,857,143 = (NOAEL dose: 6 mg/kg-BW/day) x 100% NOAEL route absorption factor) 

# ÷ LADD: 1.10 x 10 -6 mg/kg/day x 1.875 x 100% exposure route absorption factor

There is no risk predicted to the general popu lation from either drinking water or fish ingestion because the acceptabl e MOE adjusted for the PFBA ha lf-life data is 300 or more.

Risk to Consumers: The PMN substance is to be prohibited in consumer products. Thus, consumer exposures and risk are not expected.

Risk to the Environment: The acute concentration of concern (COC) of 6,500 ppb will not be exceeded during the 16 days that surface water releases occur, however the chronic COC of 220 ppb will be exceeded. However, the potential for chronic risk to aquatic organisms exists only if the surface

water concentration exceeds the chronic COC fo r 20 consecutive days per year or more. The 20- day criterion is based on partial life-cycle testing with fish and Daphnids. Because releases occur less than 20 consecutive days per y ear there is low concern for chr onic risk to aquatic organisms.

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 fo r human health and environmental effects from exposure to the PMN substance. EPA therefore c oncludes, 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 and environmental effects of the PMN substance.xi

(b) In light of the potential risk of human health and e nvironmental effects posed by the uncontrolled manufacture (defined by statute to include import), pro cessing, distribution in commerce, use, and disposal of the PMN s ubstance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture (defined by statute to include import), processing, distribution in commer ce, use, and disposal of the PMN substance may present an unreasonable risk of injury to hum an health and the environment.

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND ENVIRONMENTAL EFFECTS Pended Testing. The Order does not require submission of the follo wing testing at any specified time or production volume. However, the Orde r’s restrictions on ma nufacture (defined by statute to include import), pro cessing, distribution in commerce , and use of the PMN substance will remain in effect until the Order is modifi ed or revoked by EPA based on submission of that

or other relevant information.

Test Guidelines Metabolism and pharmacokinetics test OCSPP 870.7485 Subacute inhalation toxicity : 28-day study OECD 412

## 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 dis posal of the chemical substance ] (P-13-305)(“the PMN subs tance”) in the United States by 3M Company (“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 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 complian ce is documented by appropr iate recordkeeping as required in the Recordkeepi ng section of this Order.

(1) Export . Until the Company begins commercial manufacture of the PMN substance for use in the United States, the requirements of this Order do not apply to ma nufacture, processing or

distribution in commerce of the PMN substan ce solely for export in accordance with TSCA- 2 -

§§12(a) and 12(b), 40 CFR 720.3(s) a nd 40 CFR Part 707. However, once the Company begins to

manufacture the PMN substance for use in the United States, no further activity by the Company involving the PMN substance is ex empt as “solely for export” even if some amount of the PMN substance is later exported. At th at point, the requirements of th is Order apply to all activities

associated with the PMN substance while in the te rritory of the United States. Prior to leaving U.S. territory, even those quanti ties or batches of the PMN substa nce that are destined for export are subject to terms of the Order, and count towa rds 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 a pply to manufacturing, processing, distribution in commer ce, use and disposal of the PM N substance when manufactured solely for non-commercial research and de velopment per TSCA §5(i) and 40 CFR 720.30(i). (3) Byproducts . The requirements of this Order do not apply to the PMN substance when it is produced, without separate commercial inte nt, 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, pursuant to any of the exemptions in 40 CFR 720.30(h), with no commercial purpose separate from the substa nce, mixture, or article of which it is a part. (5) Imported Articles . The requirements of this Order do not apply to the PMN substance when it is imported as part of an “article” as defined at 40 CF R 720.3(c) and in compliance with 40 CFR 720.22(b)(1).- 3 -

(c) 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 Exemp tion (“LoREX”) under TSCA §5(h)(4) and 40 CFR 723.50(c)(1) and (2) respectively, any such exempti on is automatically re ndered 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, pe nding the development of information necessary

for a reasoned evaluation of the human health and environmental effects of the substance, and the completion of EPA’s review of, and regulator y action based on, that information, except in

accordance with the conditions described in this Order.

TESTING (a) Section 8(e) Reporting. Reports of information on the PMN substance which reasonably supports the conclusion that the PMN substance presents a substantial risk of injury to health or the environment and which is required to be reporte d under TSCA section 8(e) shall reference the appropriate PMN identification number for this substance and contain a statement that the- 4 -

substance is subject to this Cons ent Order. Additional informati on 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 number for each substance and a statement that the substance is subject to this Consent Order.

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- 5 -

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 conduc ted according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and using methodol ogies generally accepted in the relevant scientific community at the time the study is initiated. Before starting to conduct any study that will use a modified version of a published test guideline, the Company must submit written test protocols to EPA for review (submission of written test protocols is optional for tests that are to be conducted using unmodified published 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 pr otocols. EPA review of a test protocol does not mean pre-acceptance of test results. (d) Unreasonable Risk.- 6 -

EPA may notify the Company in writing that EP A finds that the data generated by a study are scientifically valid and unequivo cal and indicate that, despite the terms of this Order, the PMN substance will or may present an unreasonable risk of injury to human health or the environment. EPA’s notice may specify that the Company undert ake certain actions con cerning further testing, manufacture (defined by statute to include import), processing, distri bution, use and/or disposal of the PMN substance to mitigate exposures to or to better characterize the risks presented by the PMN substance. Within 2 weeks from receipt of such a notice, the Company must cease all manufacture (defined by statute to include import), processing, distri bution, 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 (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 th e PMN substance in accordance with the terms of this Order pending EPA’s response to the Compa ny’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.

PROTECTION IN THE WORKPLACE- 7 -

(a) Establishment of Program. During manufacturing, processing, and use of the PMN substance at any site controlled by the Co mpany (including any associated packaging and storage and during any cleaning or maintenance of equipment asso ciated with the PMN substance), the Company must establish a program whereby: (1) General Dermal Protection. Each person who is reasonably likely to be dermally exposed in the work area to the PMN substan ce through direct handling of the substance or through contact with equipment on which the subs tance may exist, or because the substance

becomes airborne in a form liste d in subparagraph (a)(5) of this section, is provided with, and is required to wear, personal protect ive equipment that provides a ba rrier to prevent dermal exposure to the substance in the specific work area where it is selected for use. Each such item of personal protective equipment must be se lected and used in accordance with Occupational Safety and Health Administration (“OSHA”) dermal protection requirement s at 29 CFR 1910.132, 1910.133,

and 1910.138. (2) Specific Dermal Protective Equipment. The dermal protective equipment required by subparagraph (a)(1) of this sec tion must include, but is not limited to, impervious gloves. (3) Demonstration of Imperviousness. The Company is able to demonstrate that each item of chemical protective clothing selected, including gloves, provi des an impervious barrier to prevent dermal exposure during normal and expected duration and conditions of exposure within the work area by any one or a combination of the following: (i) Permeation Testing. Testing the material used to make the chemical protective clothing and the construction of the clothing to establish that the protective clothing will be impervious for the expected dura tion and conditions of exposure. The testing must subject the chemical protective clothing to the expected conditions of exposur e, including the likely- 8 -

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 fo r Testing and Materials (“ASTM”) F739 “Standard Test Method for Permea tion of Liquids and Ga ses through Protective Clothing Materials under Conditions of Continuous Contact.” Resu lts shall be reported as the cumulative permeation rate as a function of tim e, and shall be documented in accordance with ASTM F739 using the format specified in ASTM F1194-99(2010) “Standard Guide for Documenting the Results of Chemical Permeatio n Testing of Materials Used in 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

substance. (ii) Manufacturer’s Specifications. Evaluating the speci fications from the manufacturer or supplier of the chemical prot ective clothing, or of the material used in construction of the clothing, to establish that the chemical protective clothing will be impervious to the PMN substance alone and in likely combinati on with other chemical s ubstances in the work

area. (4) Respiratory Protection. Each person who is reasonabl y likely to be exposed by

inhalation in the work area to the PMN substance in the form listed in subparagraph (a)(5) of this section is provided with and is required to wear, at a mini mum, a National Institute for Occupational Safety and Health (“NIOSH”)-certified respirator with an Applied Protection Factor (“APF”) of 10, from the respirators listed in subp aragraph (a)(6) of this s ection, and the respirator

is used in accordance with OSHA and NIOSH re spiratory 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 program under the OSHA requirements in 29 CFR 1910.134.- 9 -

(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), (ii) Gas/vapor (all substa nces in the gas form), or (iii) Combination Gas/Vapor and Particul ate (gas and liquid/solid physical states are both present; a good example is paint spray mi st, which contains both liquid droplets and vapor). (6) Authorized Respirators. The following NIOSH-certified respirators meet the minimum requirements for subparagraph (a)(4) of this section: (i) Any NIOSH-certified powered air-purifyi ng respirator with a hood or helmet and with appropriate gas/vapor (acid gas, organic vapor, or substance sp ecific) cartridges. (ii) Any NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. (b) De Minimis Concentrations . The requirements of this secti on do not apply to quantities of the PMN substance that are (1) present in the work area only as a mixture and (2) at a concentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or volume if the PMN

substance is identified as a potential carcinogen in paragraph (f) of the Hazard Communication Program section of this Order). This exemption is not available if the Company has reason to believe that, during intended activities, the PMN substance in the mixture may be reconcentrated above the 1.0 or 0.1 percent level, whichever ap plies. If this Order contains New Chemical Exposure Limits provisions or Release to Wate r provisions that, respectively, specify a NCEL concentration (“TWA”) or in-stream concentratio n (“N”) less than the de minimis concentration specified here, then this de minimis ex emption does not apply to those provisions.- 10 -

RISK NOTIFICATION (a) If the Company becomes aware that the PMN s ubstance may present a risk of injury to health or the environment (or is so notified by EP A), the Company must incorporate this new information, and any information on methods for pr otecting 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 aware of the new information. If the PMN substance is not being manufactured (defined by statute to include import), processed, or used in the Company’s workplace, the Company must add the new informa tion 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 c ontaining the information require d under paragraph (a) within 90 days from the time the Company beco mes aware of the new information.

HAZARD COMMUNICATION PROGRAM (a) Written Hazard Communication Program. The Company shall develop and implement a written hazard communication program for the PMN substance in each workplace. The written program will, at a minimum, describe how the requ irements of this section for labels, MSDSs, and other forms of warning material will be satisfie d. The Company must make the written hazard- 11 -

communication program available, upon request, to all employees, contractor employees, and their designated representatives. The Company ma y rely on an existing hazard communication program, including an existing program esta blished under the OSHA Hazard Communication Standard (29 CFR 1910.1200), to comply with this paragraph provided that the existing hazard communication program satisfies the requirements of this section. The written program shall include the following: (1) A list of chemical substances known to be present in the work area which are subject to a TSCA section 5(e) consent order signed by the Co mpany or to a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E. The list must be maintained in each work area where the PMN substance is known to be present and must us e the identity provided on the MSDS for the substance required under paragraph (c) of this sec tion. The list may be compiled for the workplace or for individual work areas. If the Company is required either by a nother Order issued under section 5(e) of TSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, to maintain a list of substances, the lists shall be combined with the list under this subparagraph. (2) The methods the Company will use to info rm employees of the hazards of non-routine tasks involving the PMN substance (e.g., cleaning of reactor vessels), and the hazards associated

with the PMN substance contained in unlabeled pipes in their work area. (3) The methods the Company will use to info rm contractors of the presence of the PMN substance in the Company’s workpl ace and of the provisions of th is Order if employees of the contractor work in the Company’ s workplace and are reasonably li kely to be exposed to the PMN substance while in the Company’s workplace.

(b) Labeling.- 12 -

(1) The Company shall ensure that each c ontainer of the substance in the workplace is

labeled in accordance with this subparagraph (b)(1). (i) The label shall, at a minimum, contain the following information: (A) A statement of the health hazar ds(s) and precautionary measure(s), if any, identified either in paragr aph (f) of this section or by th e Company, for the PMN substance. (B) The identity by which the PMN substance may be commonly recognized. (C) A statement of exposure a nd precautionary measure(s), if any, identified either in paragraph (f) of this s ection, or by the Company, for the PMN substance. (ii) The Company may use signs, placards, process sheets, batch tickets, operating procedures, or other such written ma terials in lieu of affixing labels to individual stationary process containers, as long as the alternative method identif ies the containers to wh ich it is applicable and conveys information specified by subparagraph (b)(1 )(i) of this section. Any written materials must be readily accessible to the employees in their work areas throughout each work shift. (iii) The Company need not label por table containers into which the PMN

substance is transferred from la beled containers, and which are intended only for the immediate use of the employee who performs the transfer. (iv) The Company shall not remove or de face an existing label on containers of the PMN substance obtained from persons outside th e Company unless the container is immediately re-labeled with the information specified in subparagraph (b)(1)(i) of this section. (2) The Company shall ensure that each c ontainer of the substance leaving its workplace

for distribution in commerce is labeled in accordance with this subparagraph (b)(2). (i) The label shall, at a minimum, contain the following information:- 13 -

(A) The information prescribed in s ubparagraph (b)(1)(i) of this section. (B) The name and address of the ma nufacturer or a responsible party who can provide additional informati on on the substance for hazard evaluation and any appropriate emergency procedures. (ii) The label shall not c onflict with the requirements of the Hazardous Materials Transportation Act (18 U.S.C. 1801 et. seq.) and re gulations issued under that Act by the Department of Transportation. (3) The label, or alternative forms of warn ing, shall be legible and prominently displayed. (4) The label, or alternative forms of warn ing, shall be printed in English; however, the information may be repeated in other languages. (5) If the label or alternative form of warni ng is to be applied to a mixture containing the PMN substance in combination with any other subs tance that is either s ubject to another TSCA section 5(e) Order applicable to the Company, or subject to a TSCA sec tion 5(a)(2) SNUR at 40 CFR Part 721, subpart E, or defined as a “hazardous chemical” under the OSHA Hazard Communication Standard (29 CF R 1900.1200), the Company may pres cribe on the label, MSDS,

or alternative form of warning, the measures to control work er exposure or environmental release which the Company determines provide the greatest degree of protection. However, should these control measures differ from the applicable measur es required under this Order, the Company must seek a determination of equivalency for such alternative control meas ures pursuant to 40 CFR 721.30 before prescribing them unde r this subparagraph (b)(5). (6) If the Company becomes aware of a ny significant new information regarding the hazards of the PMN substance or ways to protect against the hazards, this new information must be

added to the label within 3 months from th e time the Company becomes aware of the new- 14 -

information. If the PMN substance is not bei ng manufactured (defined by statute to include import), processed, or used in the Company’ s workplace, the Company must add the new

information to the label before the PMN subs tance is reintroduced into the workplace.

(c) Material Safety Data Sheets. (1) The Company must obtain or develop an MSDS for the PMN substance. (2) The MSDS shall contain, at a minimum, the following information: (i) The identity used on the container label of the PMN substance under this section, and, if not claimed confidential, the ch emical and common name of the PMN substance.

If the chemical and common names are claimed c onfidential, a generic ch emical name must be

used. (ii) Physical and chemical characteristic s of the substance kn own to the Company, (e.g., vapor pressure, flash point). (iii) The physical hazards of the s ubstance known to the Company, including the potential for fire, expl osion, and reactivity. (iv) The potential human and environmenta l hazards as specified in paragraph (f)

of this section. (v) Signs and symptoms of exposure, and any medical conditions which are expected to be aggravated by exposure to the PMN substance known to the Company. (vi) The primary routes of exposure to the PMN substance. (vii) Precautionary measur es to control worker exposure and/or environmental release required by this Order, or alternative control measures which EPA has determined under 40 CFR 721.30 provide substantially the same degree of protection as the identif ied control measures.- 15 -

The MSDS must identify any New Chemical Expos ure Limits specified in paragraph (b) of the New Chemical Exposure Limit section of this Orde r and must contain the information specified in the graduated respirator table in paragraph (e)(2 ) of the New Chemical Exposure Limit section. (viii) Any generally applicable precauti ons for safe handling and use of the PMN substance which are known to the Company, incl uding appropriate hygienic practices, protective measures during repair and maintenance of contam inated equipment, and procedures for response to spills and leaks. (ix) Any generally applicable control measures which are known to the Company, such as appropriate engineering controls, work practices, or personal protective equipment. (x) Emergency first aid pro cedures known to the Company. (xi) The date of preparation of the MSDS or of its last revision. (xii) The name, address, and telepho ne number of the Company or another responsible party who can provide additional in formation on the chemical substance and any appropriate emergency procedures. (3) If no relevant information is found or known for any given category on the MSDS, the Company must mark the MSDS to indicate th at no applicable information was found. (4) Where multiple mixtures containing the PMN substance have similar compositions (i.e., the chemical ingredients are essentially th e same, but the specific composition varies from mixture to mixture) and similar hazards, the Comp any may prepare one MSDS to apply to all of these multiple mixtures. (5) If the Company becomes aware of a ny significant new information regarding the hazards of the PMN substance or ways to protect against the hazards, this new information must be

added to the MSDS within 3 months from th e time the Company becomes aware of the new- 16 -

information. If the PMN substance is not bei ng manufactured (defined by statute to include import), processed, or used in the Company’ s workplace, the Company must add the new information to the MSDS before the PMN substance is reintroduced into the workplace. (6) The Company must ensure that pers ons receiving the PMN substance from the Company are provided an a ppropriate MSDS with their initial sh ipment and with the first shipment after an MSDS is revised. The Company may either provide the MSDS with the shipped containers or send it to the person pr ior to or at the time of shipment. (7) The Company must maintain a copy of th e MSDS in its workplace, and must ensure that it is readily accessible during each work shift to employees when they are in their work areas. (8) The MSDS may be kept in any form, including as operating procedures, and may be designed to cover groups of substa nces in a work area where it may be more appropriate to address the potential hazards of a process rather than indi vidual substances. However, in all cases, the required information must be provided for th e PMN substance and must be readily accessible during each work shift to employees wh en they are in their work areas. (9) The MSDS must be printed in English; however, the information may be repeated in other languages.

(d) Employee Information and Training. The Company must ensure that employees are provided with information and training on the PMN substance. This info rmation and training must be provided at the time of each employee’s initia l assignment to a work area containing the PMN

substance and whenever the PMN substance is in troduced into the employee’s work area for the

first time. (1) The information provided to employ ees under this paragraph shall include:- 17 -

(i) The requirements of this section. (ii) Any operations in the work area where the PMN substance is present. (iii) The location and availability of the written hazard communication program required under paragraph (a) of this section, including the lis t of substances required by subparagraph (a)(1) of this se ction and MSDSs required by para graph (c) of this section. (2) The training provided to employees shall include: (i) Methods and observations that may be us ed to detect the presence or release of the PMN substance in or from an employee’s wo rk area (such as exposure monitoring conducted by the Company, continuous monitoring devices, visual appearance, or odor of the substance when being released). (ii) The potential human health and envi ronmental hazards of the PMN substance as specified in paragraph (f) of this section. (iii) The measures employees can take to protect themselves and the environment from the PMN substance, including specific proc edures the Company has implemented to protect employees and the environment from exposure to the PMN substance, including appropriate work practices, emergency procedures, personal protective equipment, e ngineering controls, and other measures to control worker exposure and/or envi ronmental release required under this Order, or

alternative control measures which EPA has determined under 40 CFR 721.30 provide the same degree of protection as the specified control measures. (iv) The requirements of the hazard communication program developed by the Company under this section, including an explan ation of the labeling system and the MSDS required by this section and guidance on obtaini ng and using appropriate hazard information.- 18 -

(e) De Minimis Concentrations . The requirements of this Ha zard Communication section do not apply to quantities of the PMN substance that ar e (1) present in the work area only as a mixture and (2) at a concentration not to exceed 1.0 perc ent by weight or volume (0.1 percent by weight or

volume if the PMN substance is id entified as a potential carcinogen in paragraph (f) of the Hazard Communication Program section of this Order). This exemption is not available if the Company has reason to believe that, duri ng intended activities, the PMN s ubstance in the mixture may be

reconcentrated above the 1.0 or 0.1 percent level, whichever applies. If this Order contains (1) New Chemical Exposure Limits provisions that specify a NCEL concentration less than the de minimis concentration specified here, or (2) Rel ease to Water provisions that prohibit release to water or specify in-stream concentration (“N”) less than the de minimis concentration specified here, then this de minimis exempti on does not apply to those provisions.

(f) Human Health, Environmental Hazard, Exposure, and Precautionary Statements. The following human health and environmental hazard and precautionary statements shall appear on each label as specified in paragraph (b) and the MSDS as specified in paragraph (c) of this section: (1) Human health hazard statements. This substance may cause: (i) Central Nervouse System (CNS) De pression: Signs/symptoms may include headache, dizziness, drowsiness, incoordination, nausea, slowed reaction time, slurred speech, giddiness, and unconsciousness. (ii) Liver Effects: Signs/symptoms ma y include loss of appetite, weight loss, fatigue, weakness, abdominal tenderness and jaundice.”- 19 -

(iii) Endocrine Effects: Signs/symptoms may include disruption of gonadal, thyroid, adrenal, or pancreatic function; changes in horm one production; alterations in circulating hormone levels; and/or changes in ti ssue response to hormones. (2) Human hazard precautionary statem ents. When using this substance: (i) Avoid skin contact. (ii) Avoid breathing dust/fum e/gas/mist/vapors/spray. (iii) Do not ingest. (iv) Wear respiratory protection. (v) Wear protective gloves. (3) The human and environmental hazard and precautionary statement on the label prepared pursuant to paragraph (b ) of this section must be foll owed by the statement: “See the

MSDS for details.” (g) Existing Hazard Communication Program. The Company need not take additional actions if existing programs and procedures satisfy the requirements of this section.

MANUFACTURING (a)(1) Prohibition. The Company shall not cause, encourage, or suggest the manufacture (defined by statute to include import) of th e PMN substance by any other person. (2) Sunset Following SNUR. Subparagraph (a)(1) shall ex pire 75 days after promulgation of a final significant new use rule (“SNUR”) governing the PMN substan ce under section 5(a)(2) of TSCA unless the Company is notified on or befo re that day of an action in a Federal Court seeking judicial review of the SNUR. If the Company is so no tified, subparagraph (a)(1) shall not- 20 -

expire until EPA notifies the Company in writin g that all Federal Court actions involving the

SNUR have been resolved and th e 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 su bparagraph (a)(2), the Company shall notify each person whom it causes, encourages or suggests to manufacture (defined by statute to include import) the PMN substance of the existence of the SNUR.

USE (a) The Company shall onl y use the PMN substance: (1) As an intermediate where any chemical substance manufactured using the PMN substance may contain residuals of the PMN s ubstance at levels no greater than [ (2) In non-consumer products; and (3) By recovering and conve rting, capturing (destroying), recycling, or reusing the substance at an overall efficiency of [ when the PMN substance is used as an intermediate. Since the PMN substance is inseparable from an impurity, reference to the PMN substance inherently includes the inseparable impurity. Calc ulations for mass balance and recovery of the

PMN substance for reuse or destruction will be based on the total amount charged and recovered presuming 100% pure PMN substance.

DISTRIBUTION (a) Export Notice Requirement . No later than the date of dist ribution, the Compa ny shall notify in writing any person to whom it dist ributes the PMN substance that, due to the issuance of this- 21 -

Consent Order under section 5(e) of TSCA, the PMN substance is 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 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 confiden tial, the generic chemical identity.

(b) Distribution Requirements. Except after the PMN has been completely reacted or as provided in paragraph (c), the Company shall distribute th e PMN substance outside the Company, other than for disposal, only to a person who has agreed in writing prior to the da te of distribution, to: (1) Notify in writing any person to whom it di stributes 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 notification requirements of TSCA section 12(b) and 40 CF R Part 707 Subpart D. Such notice shall contain, in the form in which it ap pears 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 substance to any other person, other than for disposal, until after the PMN substance has been completely reacted. (3) Comply with the same requirements and restrictions, if any, re quired of the Company in the Protection in the Workplace section of this Order. (4) Comply with the same requirements and restrictions, if any, re quired of the Company in the Hazard Communication Progr am section of this Order. (5) Only use the PMN substance: (i) As an intermediate;- 22 -

(ii) In non-consumer products; and (iii) By recovering and conve rting, capturing (destroying), recycling, or reusing the

substance at an overall efficien cy of of the product.

(c) Temporary Transport and Storage. Notwithstanding paragra ph (b), the Company may distribute the PMN substance outside the Company for temporary transport and storage in sealed containers provided the followi ng three conditions are met: (1) Subsequent to any such exempt temporary transport or storage of sealed containers, the PMN substance may be distributed only to the Company or a person who has given the Company the written agreement re quired by paragraph (b). (2) Any human exposure or environmental release resulting from opening the sealed containers and removing or washing out the PMN substance may occur only while the PMN substance is in the possession and control of th e Company or a person who has given the Company the written agreement re quired by paragraph (b). (3) The sealed containers must be labele d in accordance with pa ragraph (b)(2) of the Hazard Communication Program s ection of this Order.

(d) Recipient Non-Compliance. If, at any time after commenci ng distribution in commerce of the PMN substance, the Company obtains knowledge that a recipient of the substance has failed to comply with any of the conditions specified in pa ragraph (b) of this Dist ribution section or, after subparagraph (b)(2) expires in a ccordance with subparagraph (e)(1), has engaged in a significant new use of the PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a significant new use notice to EPA, the Compa ny shall cease supplying the substance to that- 23 -

recipient, unless the Company is able to document each of the following: (1) That the Company has, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any of the conditions specified in paragraph (b) of this Distribution section, or has e ngaged in a significant new use of the PMN substance without submitting a significant new use notice to EPA. (2) That, within 15 working days of notif ying 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 section and will comply with those terms,

or is aware of the terms of th e significant new use rule for the PMN substance and will not engage in a significant new use without submitti ng a significant new use notice to EPA. (3) If, after receiving a stat ement of assurance from a r ecipient under subparagraph (d)(2) of this Distribution section, the Company obtains know ledge that the recipient has failed to comply with any of the conditions specified in paragraph (b) of this Distri bution section, or has engaged in a significant new use of the PMN substance without submitting a significant new use notice to EPA, the Company shall cease supplying the PMN subs tance to that recipien t, shall notify EPA of the failure to comply, and sha ll resume supplying the PMN substa nce to that recipient only upon written notification from the Agency.

(e) Sunset Following SNUR. (1) Subparagraph (b)(2) of this Distribution section shall expire 75 days after promulgation of a fi nal SNUR for the PMN substance under section 5(a)(2) of TSCA, unless the Company is notified on or before that day of an action in a Federal Court seeking judicial review of the SNUR. If the Compa ny is so notified, subpara graph (b)(2) of this Distribution section shall not expire until EPA not ifies the Company in writing that all Federal- 24 -

Court actions involving the SNUR have been re solved and the validity of the SNUR affirmed. (2) When EPA promulgates a final SNUR for th e PMN substance and subparagraph (b)(2) of this Distribution section expires in a ccordance with subparagraph (e)(1), the Company shall notify each person to whom it distributes the PMN substance of the existence of the SNUR. Such notification must be in writing and must speci fically include all limitations contained in the SNUR which are defined as significant new uses, and which would invoke significant new use notification to EPA

for the PMN substance. Such notice must also reference the publication of the SNUR for this PMN substance in either the Federal Register or the Code of Federal Regulations. After promulgation of a SNUR and expiration of subpara graph (b)(2), such notice may substitute for the written agreement required in the introductory clau se of paragraph (b); so that, if the Company provides such notice to the persons to whom it di stributes the PMN substance, then the Company is not required to obtain from such persons the written agreement specified in paragraph (b).

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 only exemp tion in Section I, Paragraph (b)(1) of this Order are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the- 25 -

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 exempti on in Section I, Paragra ph (b)(2) of this Order are exempt from all the requirements in this Reco rdkeeping section, if the Company maintains, for 5 years from the date of their creation, th e records required 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 this Order, the Company shall keep records demonstrating qualification for that exemption as well as the reco rds specified in paragra phs (2) and (3) below, but is exempt from the other recordkeeping re quirements in this Recordkeeping section; (2) Records documenting the manufacture (defin ed by statute to include import) volume of the PMN substance and the corresponding dates of manufacture (defined by statute to include import); (3) Records documenting the names and addresses (including shipment destination address, if different) of all pers ons outside the site of manufacture (defined by statute to include import) to whom the Company directly sells or tr ansfers the PMN substance, the date of each sale 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) Records documenting establishment and im plementation of a program for the use of any applicable personal protectiv e equipment required pursuant to the Protection in the Workplace section of this Order; (6) Records documenting the determinations required by the Protection in the Workplace

section of this Order that chem ical protective clothing is impe rvious to the PMN substance;- 26 -

(7) Records documenting establishment and implementation of the hazard communication program required by the Hazard Communicati on Program section of this Order; (8) Copies of labels required under the Hazard Communication Program section of this Order; (9) Copies of Material Safety Data Sheets required by the Hazard Communication Program section of this Order; (10) Records documenting compliance with any applicable manufacturing, use, and

distribution restrictions in the Manufacturing, Use, and Distribu tion sections of this Order, including distributees’ written agreement to comply with the Distribution se ction of this Order; (11) Copies of any Transfer Documents a nd notices required by the Successor Liability section of this Order, if applicable; and, (12) The Company shall keep a copy of this Order at each of its sites where the PMN substance is manufactured (defined by statute to include import).

(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 cu rrently valid control number from the Office of Management and Budget (“OMB”), and EPA so informs the Company. The “collection of- 27 -

information” required in this TSCA §5(e) Consen t 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 facilit ate 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 include, but are not limite d 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 w ho are involved in activities associated with the PMN substance and may reasonably 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; (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.- 28 -

(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 by the Compa ny 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”). (1) Before NOC. If the transfer from the Company to the Successor in Interest is effective

before EPA receives a notice of commencement of manufacture or import (“NOC”) for the PMN substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a new PMN to EPA and comply fully with Section 5(a)(1) of TSCA and 40 CFR part 720 before commencing manufacture (defined by statute to include import) of the PMN substance.- 29 -

(2) After NOC. If the transfer from the Company to the Successor in Interest is effective after EPA receives a NOC, the Successo r 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, thr ough a transfer document signed by the Company, as transferor, and the Successor in Interest, as transferee. The te rm 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) and 40 CFR 720.3(z). (2) “Transfer Document” means the legal instru ment(s) used to convey the interests in the PMN substance, including the right to manufacture the PMN substance, from the Company to the

Successor in Interest.

(d) Notices. (1) Notice to Successor in Interest. On or before the 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.- 30 -

(2) Notice to EPA. Within 10 business days of the e ffective date of the transfer, the Company shall, by registered mail, submit the fully executed Notice of Transfer document to:

The written notice should be submitted to EPA as follows:

Postal Mail Address U.S. Environmental Protection Agency New Chemicals Management Branch (7405M) 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460

Courier Delivery Address U.S. Environmental Protection Agency New Chemicals Management Branch (7405M) 1201 Constitution Avenue, N.W. Washington, D.C. 20004 (3) Transfer Document. Copies of the Transfer Docu ment must be maintained by the Successor in Interest at its principal place of busin ess, and at all sites where the PMN substance is manufactured (defined by statute to include import). Copies of th e Transfer Document must also be made available for inspection pursuant to Sect ion 11 of TSCA, must stat e the effective date of transfer, and must contain provi sions which expressly transfer liability for the PMN substance

under the terms of this Order from the Company to the Successor in Interest.

(e) Liability.- 31 -

(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. (3) Nothing in this section shall be c onstrued to prohibit the Agency from taking enforcement action against the Company after the eff ective date of the transf er for actions taken, or omissions made, during the time in which the Comp any manufactured, processed, used, distributed in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order.

VI. MODIFICATION AND REVO CATION OF CONSENT ORDER The Company may petition EPA at any time, based upon new information on the human health or environmental effects of, or human e xposure to or environmental release 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 PMN substance and the information EPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend or 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 the test data or other information that supports the findings in this Order, an examination of new test data or othe r 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 expos ure or substantial enviro nmental release in the- 32 -

absence of data sufficient to permit a reasoned eval uation of the health or environmental effects of

the PMN substance. In addition, the Company may petition EPA at a ny 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 structur e and intent of this Order as

issued.- 33 -

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 e nd of the review period pursuant to section 5(e)(1)(B ) of TSCA, and to challenge the validity of this Order in any s ubsequent action. Consenti ng 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 underlying the Agency’s de terminations in this proceeding. This waiver does not affect any other rights th at 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, Ph.D., 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 (defined by statut e to include import) the PMN substance under the conditions specified in Part II. of this Consent Order and in the Consent Order for Contract Manufacturer. “Identity” means any chemical or common name used to identify a 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 manufactured (defined by stat ute to include import) 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 significant de parture from the EPA-reviewed protocol or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency review that prevents a reasoned evaluation of the health or en vironmental 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-reviewed 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 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”) 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.ii

NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER (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 Codeiii

NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER (continued)

___________________________________ Successor’s Technical Contact

___________________________________ Address

___________________________________ City, State, Zip Code

___________________________________ Phone