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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES REGULATION OF A NEW CHEMICAL SUBSTANCE PENDING DEVELOPMENT OF INFORMATION

In the matter of: Premanufacture Notice Number: ' J ,\ ")

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R.T. Vanderbilt P-02-285**!.,;~~·~'"'**

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Consent Ordetand Determinations Supporting Consent Order ,-..p


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# ' ' TABLE OF CONTENTS

Preamble I. Introduction II. Summary ofTerms ofthe Order III. Contents ofPMN IV. EPA's Assessment ofRisk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health Effects
Consent Order I. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation II. Recordkeeping III. Successor Liability Upon Transfer ofConsent Order IV. Modification and Revocation ofConsent Order V. Effect ofConsent Order
Attachment A

- Definitions Attachment B- Notice ofTransfer ofConsent Order

# ' 1. iii I. INTRODUCTION Underthe authority of§ 5(e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e)), the Environmental ProtectionAgency ("EPA" or "the Agency") issues the attached Order, regardingpremanufacture notice ("PMN") P-02-285 submitted by R.T. Vanderbilt Company, Incorporated ("the Company"), to take effect upon expiration ofthe PMN review period. The Company submittedthe PMN to EPA pursuant to section 5(a)(1) ofTSCA and 40 CFRPart 720. Under § 15 ofTSCA, it is unlawful for any person to fail orrefuse to comply with any provision of§ 5 or any order issued under§ 5. Violators may be subject to various penalties and to both criminal and civil liabilitypursuant to § 16, and to specific enforcement and seizure pursuant to§ 17. In addition, chemical substances subject to an Order issued under§ 5 ofTSCA, 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 manufacture and process the PMN substance with an average aspect ratio no greater than 5 and no more than15% ofthe PMN substance shall have an aspectratio greater than 1 0. The Companymust periodically analyze representative samples to determine compliance with the aspect ratio requirement and maintainrelevant records to show compliance. The Company may only manufacture to import the PMN substance as described above, unless the Company submits appropriate testing ofthe PMN substance.


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# ' 1 iv III. CONTENTS OF PMN Confidential Business Information Claims (Bracketed in the Preamble and Order): production volume, processing, and other information. Chemical Identity: Silane, trimethoxy[3-oxiranylmethoxy]propyl-, reaction products with wollasonite. Use: Functional filler for polymer systems. Maximum 12-Month Production Volume: [• 

### kg Test Data Submitted with PMN: Particle Size Data

- The particles are nominal 10 micron length with a median diameter of2.8 micron, making the average aspect ratio less than 5.

IV. EPA'S ASSESSMENT OF RISK The following are EPA's predictions regarding the probable toxicity andhuman exposure ofthe PMN substance, based onthe information currently available to the Agency. Human Health Effects Summary: A. Absorption: Absorption is nil all routes. B. Health Effects: EPA expects the PMN substance to cause lung toxicity ifinhaledbased
onlung overload for poorly soluble particulates (see www.epa.gov/oppt/newchems/chemcat.htm). EPA also has a marginal concern for carcinogenicitybased on test data on the starting material, wollastonite. According to the IARC chapter on wollastonite, "there is limited evidence for the carcinogenicity ofwollastonite to experimental animals. There is inadequate evidence for the carcinogenicity ofwollastonite to animals (IARC (42): 145 -158."v C. Exposure Estimates: Manufacturing ( ;) -In the absence ofprotective equipment, workers will be exposed via inhalation to 150 mg/day ofthe PMN substance in particulate form: days/year. Use(< ;)

- In the absence ofprotective equipment, workers will be exposed via inhalation to up to 45 mg/day ofthe PMN substance in mist form days peryear. Further, the Company provided additional information pertaining to the particle size. EPA's assessment ofthis data indicated that the PMN substance has an average aspectratio no greater than 5, and not more than 15% ofthe PMN substance has an aspect ratio greaterthan 10. Ifthis particle size profile is maintained, respiratoryprotection is unnecessary.

V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis ofthe Consent Order: A. EPA is unable to determine the potential for lung toxicity from exposure to the PMN substance. EPA therefore concludes, pursuantto§ 5(e)(l)(A)(I) ofTSCA, that the information available to the Agencyis insufficient to permit a reasoned evaluation ofthe human health effects ofthe PMN substance. B. In light ofthe potential risk oflung toxicityposed bythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance, and the Agency's conclusion that issuing the Order will not result in any significant loss ofbenefits to society, EPAhas concluded, pursuant to§ 5(e)(l)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance may present an unreasonable risk ofinjury to human health.

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VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH EFFECTS

Before EPA will allow the Companyto manufacture the PMN substance at variance with the aspect ratio restrictions ofthe attached Consent Order, the following information would be required to evaluate the human health effects:

1. 90-day Subchronic Inhalation Toxicity with a 60 day holdingperiod. 2. Carcinogenicity Study Guidelines OPPTS 870.3465
OPPTS 870.4200 These tests should be conducted on the PMN substance with an average aspect ratio ofgreater than 5 and more than 15% ofthe PMN substance with an aspect ratio ofgreater than 10. The Order does not require submission ofthe above information at any specified time orproduction volume. However, the Order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance will remain in effect until the Orderis modified orrevokedbyEPA based on submission ofthat or other relevant information.

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Ill, UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

CONSENT ORDER OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES

I. TERMS OF MANUFACTURE. IMPORT, PROCESSING. DISTRIBUTION IN COMMERCE. USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION R.T. Vanderbilt Company, Inc. ("the Company") is prohibited from manufacturing, importing, processing, distributingin commerce, using, ordisposing ofthe chemical substance Silane, trimethoxy[3-oxiranylmethoxy]propyl-, reactionproducts with wollasonite (p-02- 295)("the PMN substance") in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe human health effects ofthe substance, and the completion ofEPA's review of, and regulatory action based on, that information, except under the following conditions: ASPECT RATIO (a) The Company shall manufacture andprocess the PMN substance with an average aspect ratio ofno greaterthan 5 and no more than 15% ofthe PMN substance shall have an aspect ratio greater than 1 0.


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## .,, 2 (b) The Company shall analyze the aspect ratio ofthe PMN substance produced at each ·manufacturing facility both (1) at the time ofinitial commencement ofnon-exempt commercial manufacture at, orimport from, that facility, and (2) at least annually thereafter during every year in which the PMN substance is manufactured at, orimported from, that facility. Forexample, if the PMN substance is initially imported from one foreign manufacturing facility and later manufactured in the United States at one domestic facility, the aspect ratio must bemeasured at commencement ofimport, at least every year ofimport thereafter, at the commencement of domestic manufacture, and at least every year ofmanufacture thereafter. Aspect ratio from production at anynew facilities must be analyzed at commencement and annually thereafter.

MANUFACTURING (a)(l) The Company shall not cause, encourage, or suggest the manufacture orimport ofthe PMN substance by any otherperson. (2) Subparagraph (a)(I) shall expire 75 days afterpromulgation ofa final significant
new use rule ("SNUR") governing the PMN substance under section 5(a)(2) ofTSCAunless the Company is notified on orbefore that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Company is so notified, subparagraph (a)(l) shall not expire until EPA notifies the Company in writing that all Federal Court actions involving the SNUR have been resolved and the validity ofthe SNUR affirmed. (3) When EPA promulgates a final SNUR for the PMN substance and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify each person whom it causes, encourages or suggests to manufacture or import the PMN substance ofthe

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1/1, 3 existence ofthe SNUR. Such notification mustbe in writing and must specifically include all limitations contained inthe 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 thepublication ofthe SNUR for this PMN substance in either the Federal Register or the Code ofFederal Regulations.

II. RECORDKEEPING (a)The Company shall maintain the following records until5 years after the date they are created and shall make them available for inspection and copyingby EPA in accordance with section 11 ofTSCA: A. RECORDS (1) Records documenting compliance with the requirements in the Aspect Ratio section ofthis Order, includingthe results from analyzing representative samples ofthe PMN substance; (2) Records documenting the aggregate manufacture and import volume ofthe PMN substance and the corresponding dates ofmanufacture or import; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture or import to whom the Company directly sells or transfers the PMN substance, the date ofeach sale ortransfer, and the quantity ofthe substance sold ortransferred on such date; (4) Records documenting compliance with any applicable manufacturingrestrictions in the Manufacturing section ofthis Order;

# •• 4 (5) Copies ofany TransferDocuments and notices required bythe SuccessorLiability section ofthis Order, ifapplicable; and (6) The Company shall keep a copy ofthis Order at each ofits sites where the PMN is manufactured, imported, processed orused. B. APPLICABILITY The provisions ofthis Recordkeeping Section are applicable only to the activities ofthe Company and not to activities ofthe Company's customers.

III. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER
(a) Scope. This section sets forth theprocedures by which the Company's rights and obligations underthis Order maybe transferred when the Company transfers its interests in the PMN substance, including the right to manufacture the PMN substance, to anotherperson outside the Company (the "Successor in Interest").
(b) Relation ofTransferDate to Notice ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from the Company to the Successorin Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN substance from the Companypursuant to 40 CFR 720.102, the Successor in Interest must submit
a new PMN to EPA and comply fully with Section 5(a)(l) ofTSCA and40 CFRpart 720 before commencing manufacture or import ofthe PMN substance.



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., 5 (2) AfterNOC. Ifthe transfer from the Company to the Successor in Interest is effective afterEPAreceives a NOC, the Successorin Interest shall comply with the terms ofthis Order and is not required to submit a new PMN to EPA.
(c) Definitions. The following definitions apply to this SuccessorLiability section ofthe Order: (1) "Successor inInterest" means a person outside the Company who has acquired the Company's full interest in the rights to manufacture the PMN substance, including all ownership rights and legal liabilities, through a transfer document signed bythe Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe Company in the PMN substance, such as a licensee who has acquired a limited license to the patent ormanufacturing rights associated with the PMN substance. A Successorin Interest mustbe incorporated, licensed, ordoing business in the United States in accordance with 40 CFR 720.22(3). (2) "Transfer Document" means the legal instrument(s) used to convey the interests in the PMN substance, including the right to manufacture the PMN substance, from the Company to the Successor in Interest.
(d) Notices. (1) Notice to Successorin Interest. On orbefore the effective date ofthe transfer, the Company shall provide to the Successor in Interest, byregistered mail, a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated by reference as Attachment C to this Order.


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## • 6 (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the Company shall, byregistered mail, submit the fully executed Notice ofTransfer document to: U.S. Environmental ProtectionAgency, New Chemicals Branch (7405), 401 M Street, S.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Document must be maintained bythe Successor in Interest at its principal place ofbusiness, and at all sites where the PMN substance is manufactured orimported. Copies ofthe Transfer Document must also bemade available for inspectionpursuant to Section 11 ofTSCA, must state the effective date and time oftransfer, and must containprovisions which expresslytransfer liability for the PMN substance under the terms ofthis Order from the Company to the Successorin Interest.
(e) Liability. (1) The Company shall be liable for compliance with the requirements ofthis Order until the effective date and time ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date and time oftransfer. (3) Nothing in this section shall be construed to prohibit the Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken, oromissions made, during the time in which the Companymanufactured, processed, used, distributed in commerce, or disposed ofthe PMN substance pursuant to the terms ofthis Consent Order.



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# • 7 (f) Obligations to Submit Test Data under Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Orderrequires the Company to submit test data to EPA at a specifiedproduction volume ("test trigger"), the aggregate volume ofthe PMN substance manufactured and imported bythe Company up to the date oftransfer shall count towards the test trigger applicable to the Successor inInterest.

IV. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company maypetition EPA at any time, based upon new information on the environmental effects or environmental release ofthe PMN substance, tomodify orrevoke substantive provisions ofthis Order. The exposures and risks identifiedbyEPA during its review ofthe PMN substance and the information EPA determined to benecessary to evaluate those exposures and risks are described inthe preamble to this Order. However, in determining whetherto amend orrevoke this Order, EPA will consider all relevant information available at the time the Agencymakes that determination, including, where appropriate, anyreassessment of the test data or other information that supports the findings in this Order, an examination ofnew test data orother information or analysis, and any other relevant information. EPA will issue a modification orrevocation ifEPA determines that the activities proposed therein will not present anumeasonable risk ofinjury to health orthe environment and will not result in significant or substantial human exposure or substantial environmental release in the absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects ofthe PMN substance.



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# •• 8 In addition, the Company may petition EPA at any time to make other modifications to the language ofthis Order. ·EPA will issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.



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9 IV. EFFECT OF CONSENT ORDER Byconsenting to the entry ofthis Order, the Company waives its rights to file objections to this Orderpursuant to section 5(e)(l)(C) ofTSCA, to receive service ofthis Orderno later than 45 days before the end ofthe reviewperiodpursuant to section 5( e)(1)(B) ofTSCA, and to challenge the validity ofthis Order, ormodifications made thereto, in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound byits terms, does not constitute
an admission bythe Company as to the facts orconclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any otherrights that the Company mayhave under TSCA.

Date , Acting Director Chemical Control Division Office ofPollution Prevention and Toxics

Company: R.T. Vanderbilt

## • ATTACHMENT A DEFINITIONS [Note: The attached Order may not contain some ofthe terms defined below.] "Aspect ratio" means the length ofa particle ofthe PMN substance dividedbyits width. "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed bythe International Union ofPure andApplied Chemistry orthe Chemical Abstracts Service's rules ofnomenclature, or a name which will clearly identify a chemical substance for the purpose ofconducting a hazard evaluation. "Company" means the person orpersons subject to this Order. "Commercial use" means the use ofa chemical substance or any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment orpainting contractor). "Commonname" means any designation oridentification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other than byits chemical name. "Consumer" means a private individual who uses a chemical substance or anyproduct containing the chemical substance in or around apermanent ortemporary household or residence, during recreation, or for anypersonal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, oras part ofa mixture, sold or made available to consumers for theiruse in or around apermanent ortemporary household orresidence, in or around a school, or in recreation.

"Contract Manufacturer" means a person, outside the Company, who is authorized to manufacture and import the PMN substance under the conditions specified in Part II. ofthis Consent Order andin the Consent Order for Contract Manufacturer. "Identity" means any chemical or common name used to identify a chemical substance or a mixture containing that substance. "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is under the control of, and used only by, the person who transferred it from a labeled container and will only be used bythatperson within the work shift in which it is transferred from the labelled container.



## !£2 "Manufacturing stream" means all reasonably anticipated transfer, flow, ordisposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment.·
. "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance as required under § 721.72(c). "Non-enclosedprocess" means any equipment system (such as an open-top reactor, storage 

### tank, ormixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe bulk chemical substance and the workplace airmay occur. "Non-industrial use" means use otherthan at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the Premanufacture notice submittedbythe Companyrelevant to this Order. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofprocessing, including the cleaning ofequipment. "Scientifically invalid" means any significant departure from the EPA-approvedprotocol orthe Good Laboratory Practice Standards at 40 CFR Part 792 withoutprioror subsequent Agency approval that prevents a reasoned evaluation ofthe health orenvironmental effects ofthe PMN substance. "Scientifically equivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approvedprotocols, are inconclusive, internally inconsistent, orotherwise insufficient to permit a reasoned evaluation of the potential risk ofinjury to human health orthe environment ofthe PMN substance. "Sealed container" means a closed container that is physically and chemically suitable for longterm containment ofthe PMN substance, and from which there will be no human exposure to, nor environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, orconsumer use. "Waters ofthe 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.


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l 3 "Workplace" means an establishment at one geographic location containing one ormore work areas.



### 7 fuCompany (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER

PMNNumber
1. Transfer ofManufacture Rights. Effective on , the Company did sell or otherwise transfer to , ("Successor in Interest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substance, which was the subject ofa premanufacture notice (PMN) and is governed by a Consent Order issuedby the U.S. Environmental Protection Agency (EPA) under the authority of§5(e) ofthe Toxic Substances Control Act (TSCA, 15 U.S.C. §2604(e)).
2. Assumption ofLiability. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the responsibility ofthe Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(3).
3. Confidential Business Information. The Successor in Interest hereby: reasserts,

_ relinquishes, or modifies all Confidential Business Information (CBI) claims made bythe Company, pursuant to Section 14 ofTSCA and 40 CFRpart 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is indicated, such modification shall be explained in detail in an attachment to this Notice of Transfer.



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TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER

Company (Transferor)
Signature ofAuthorized Official NOTICE OF TRANSFER (continued)

PMNNumber

Date
PrintedName ofAuthorized Official
Title ofAuthorized Official

Successorin Interest
Signature ofAuthorized Official Date
Printed Name ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip Code

# ' I. 3 TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER NOTICE OF TRANSFER (continued)

Successor's Technical Contact
Address City, State, Zip Code
Phone