# . DOES NOTCO)JTA**T~J**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF POLLUTION PREVENTION AND TOXICS REGULATION OF ANEW CHEMICAL SUBSTANCE PENDING DEVELOPMENT

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Inthematter of:

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### Premanufacture Notice ) Number: ) ) ) ) ) P-00-346 N 

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Consent Order and Determinations SupportingConsent Order

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# - 0\-iiTABLE OF CONTENTS

Preamble I. Introduction II. Summary of Terms of the Order III. Contents of PMN IV. EPA's Assessment of Exposure andRisk 

## v. EPA's Conclusions of Law VI. Information Required to Evaluate Human Health and Environmental Effects

Consent Order I. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation of Information II. Recordkeeping III. SuccessorLiabilityUpon Transfer of Consent Order IV. Modification and Revocation of Consent Order 

## v. Effect of Consent Order
AttachmentA - Definitions Attachment

### c - StatisticalAnalysis ofNCELs Analytical Method VerificationResults Attachment B - Notice of Transfer of Consent Order-iiiI. INTRODUCTION Under the authority of § 5(e) of the Toxic Substances Control Act ("TSCA") (15

## u.s.c. 2604(e)), the Environmental ProtectionAgency ("EPA" or "theAgency") issues the attached Order, regardingpremanufacture notice (11PMN11) P-00-346 submitted bythe**[~** ("the Company"), to take effectupon expiration of the PMN reviewperiod. The Company submittedthe PMN to EPA pursuant to section 5(a)(1) of TSCA and 40 CFR part 720. Under § 15 of TSCA, it isunlawful for anypersonto fail or refuse to complywith anyprovision of § 5 or any order issued under § 5. Violatorsmay be subjectto various penalties and to both criminal and civil liabilitypursuant to § 16, and to specific enforcement and seizurepursuant to § 17.

II. SUMMARY OF TERMS OF THE ORDER The Consent Order for this PMN substance requires the Company to: (1) submit to EPA certaintoxicity testing at least 14 weeks before either: (a) manufacturing or importing a total of [' kilograms of the PMN substance, or (b) months after commencement of non-exempt commercial manufacture or import of the PMN substance, whichever is later ; (2) providepersonal protective equipment to itsworkers to prevent dermal exposure;

### -iv- (3) lanel containers of the PMN substance and provideMaterial SafetyData Sheets (MSDSs) and worker training in accordance with the provisions of theHazard Communication Program section; (4) distribute the PMN substance, in accordance with the provisions of the Distribution section, only to a personwho has been notified of and agrees to the same restrictions (except the testingrequirements); (5) maintain certainrecords.

III. CONTENTS OF PMN Confidential Business Information Claims (Bracketed inthe Preamble and Order): Company Name, Chemical Identity, Production Volume, Use, Processing Information and Other Information. Chemical Identity: Specific:**[~** 

# . -**-~** -• ] Generic: Alkylatedphenol Use: Specific: Generic: Petroleum additive Maximum 12-Month ProductionVolume: kg Test Data SubmittedwithPMN: 28-Day Oral Study

- no deaths; signs of liver and thyroid effects. Acute Oral

- LD50 between 200 and 2000, lowtoxicity. Acute Dermal Toxicity

- all animals survived; no toxic signs observed. 

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### -v-



### . Skin Irritation study

- mildly irritating. Eye Irritation Study

- minimally irritating.
IV. EPA'S ASSESSMENT OF EXPOSQRE AND RISK The following are EPA's predictions regarding theprobable toxicity and human exposure of the PMN substance, based on the information currently available to theAgency.

Human Health Effects Summary: Based on submitted toxicity test data on the PMN substance and data on analogs, the PMN substancemay cause liver and thyroid toxicity to workers exposed via the dermal route.
Absorption: The PMN substance is expectedto be absorbed andjor react via all routes: skin(12%), lung (50%), and GI tract (50%).

Environmental Effects summary: No significant risk expected.

EXPosure Symmary:

Due to low vapor pressure of the PMN compound no inhalation exposure is expected during manufacturing, processing or use. The following table summarizes EPA estimates of Potential Dermal Dose Rates (PDRs) for workers.

### -viMFG/PROC/USE 

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# II Workers 

# I Days/yr IPDR (mg/day) WorkerActivities Manufacture Sampling/Analysis, 

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# II 1,300 to 3,800 Cleaning Filter, Drumming Lube Oil Additive Package Formulation Sampling/Analysis, 

# I
L 

# II Loading Lube Oil Formulation Unloading, Sampling/

# I**~** Analysis, Loading t 130 to 3,800

to 390
Motor Oil (Industrial and Commercial Vehicles) Changing oil in vehicles

Risk Estimates: 

# I
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# ---..I < 130 to 360

Ano observed adverse effects level (NOAEL) could not be clearly established in the submitted 28-Day Oral Toxicity study with respect to thyroid and liver effects in all treated groups. However, EPA has concluded that the lowest observable effect level (LOEL) is 15 mg/kg/day, the lowest tested dose for liver and thyroid effects. The LOEL is based on effects being seen in the lowest tested dose of 15mg/kgjday. Based on the LOEL of 15, the margin of exposure (MOE) is 2 for liver and thyroid effects, well belowtheMOE of 1000 that EPA considers acceptable when the MOE calculation is based on a LOEL. 

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### -viiV. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis of the Consent order: A. EPA is unable to determine the potential for liver and thyroid toxicity from exposure ofhumans to the PMN substance. EPA therefore concludes, pursuant to§ S(e)(1)(A)(i) of TSCA, that the information available to theAgency is insufficient to permit a reasoned evaluation of thehuman health effects of the PMN substance. B. In light of thepotential risk of human health effectsposed bythe uncontrolledmanufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance, and the Agency's conclusion that issuing the Order will not result in any significant loss of benefits to society, EPA has concluded, pursuant to§ S(e)(l)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injuryto human health. 

### c. In light of the estimatedproduction volume of, and human exposure to, the PMN substance, EPA has further concluded, pursuant to§ S(e)(l)(A)(ii)(II) of TSCA, that the PMN substance will beproduced in substantial quantities and there may be significant (or substantial) human exposure to the substance.-viiiVI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH EFFECTS The Orderprohibits the Company from exceeding a specified production volume unless the Company submits the information described inthe Testing section of this Order in accordancewith the conditions specified in the Testing section. However, the Order•s restrictions onmanufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effectuntil the Order ismodified or revoked by EPA based on submission of that or otherrelevant information.UNITEDSTATESENVIRONMENTALPROTECTIONAGENCY WASHINGTON,D.C. 20460

CONSENT ORDER OFFICEOF PREVENTION,PESTICIDESAND TOXICSUBSTANCES I. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE. USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION
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. ] ("the Company") is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing of the chemical substance [r (P-00- 346) ("the PMN substance") in the United States, for any nonexempt commercial purpose, pending the development of information necessary for a reasoned evaluation of the human health effects of the substance, and the completion of EPA's review of, and regulatory action based on, that information, except under the following conditions:

TESTING (a) Any information on the PMN substancewhich reasonably supports the conclusion that the PMN substance presents a substantial risk of injury tohealth or the environment required to be reportedunder EPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978) as amended at 52 Federal Register 20083 (May 29, 1987), shall reference the appropriate PMN identification number for this substance and shall contain a

InternetAddress{URL)• http://www.epa.gov Recycled/Recyclable•PrintedwHhVegetableOilBasedInkson**€~&cycled**Paper(Minimum25%Postconsumer)-2- statement that the substance is subject to this Consent Order. Additional informationregarding section 8(e) reporting requirements can be found in the reportingguide referenced at 56 Federal Register 28458 (June 20, 1991).
(b) The Company shall notify, inwriting, the EPA Laboratory Data IntegrityBranch (2225A), Office of Enforcement and Compliance Assurance, u.s. Environmental ProtectionAgency, 401 M street, s.w., Washington, D.C. 20460, of the following information within 10 days of schedulingany studyrequired to be performedpursuant 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 laboratorywhich will conduct the study; and 3. The name and telephone number of a person at the Company or the laboratorywhom EPA may contact regardingthe study. 4. The appropriate PMN identificationnumber for each substance and a statement that the substance is subject to this Consent Order.
(c) Each studyrequired to be performedpursuant to this Order mustbe conducted according toTSCA Good Laboratory Practice Standards at 40 CFR Part 792 and usingmethodologies generally accepted at the time the study is initiated. Before startingto



## tl-3- conduct any study, the Company must obtain approval of test protocols from EPA by submittingwrittenprotocols. EPA will respond to the Company within 4 weeks ofreceiving the written protocols. Published test guidelines specified inparagraph (d) (e.g., 40 CFR 797 or 798) provide general guidance for development of testprotocols, but are not themselves acceptable protocols.
(d) The Company is prohibited from manufacturing or importing the PMN substance beyond either: (1) an aggregate manufacture and import volume of [ ] kilograms, or (2) [ ] months after the commencement of non-exempt commercial manufacture or import of the PMN substance, whichever is later ("the production limits"), unless the Company conducts a 28-DayRepeated Dose Dermal Toxicity study according to OECD guideline 410 with emphasis on the thyroid (per OPPTS guideline 870.3465) on the PMN substance and submits all final reports and underlying data in accordance with the conditions specified inthis Testing section.
(e) The Company shall: (1) conduct each study in good faith, with due care, and in a scientificallyvalidmanner; (2) promptly furnish to EPA the results of any interimphase of each study; and (3) submit, in triplicate (with an additional sanitized copy, if confidential business information is involved), the final report of each study and all underlying data ("thereport and data") to EPA no later than 14 weeks priorto exceeding theapplicableproduction limit. The final report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting", "Data and Reporting", and "TestReport" subparagraphs in the applicable test guidelines. However, for purposes of this Consent Order, the word "should" in those subparagraphs shall be interpreted tomean "shall" tomake clear that the submission of such information is mandatory. EPA will require the submission ofraw data such as slides and laboratory notebooks only if EPA finds, on the basis ofprofessional judgment, that an adequate evaluation of the study cannot take place in the absence of these items.
(f) The Company is not required to conduct a study specified in paragraph (d) of this Testing section if notified inwriting by EPA that it is unnecessaryto conduct that study.
(g) If EPA finds that the data generatedby a study are scientifically equivocal, the Company may continue tomanufacture and import the PMN substancebeyond the applicableproduction limit. To seek relief from any otherrestrictions of this Order, the Company may make a second attempt to obtain unequivocal data by reconducting the studyunder the conditions specified in paragraphs (b), (c), and (e)(l) and (2). The testingrequirements may bemodified, as necessarytopermit a-5- reasoned evaluation of the risks presentedby the PMN substance, onlybymutual consent of EPA and the Company.

(h)(1) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA's receipt of a test report and data, the Company receives written notice that EPA finds that the data generatedby
a study are scientifically invalid, the Company isprohibited from further manufacture and import of the PMN substance beyond the applicable production limit. (2) The Company may continue tomanufacture and import the PMN substance beyond the applicableproduction limit only if so notified, inwriting, by EPA in response to the Company's compliancewith either of the following subparagraphs (h)(2)(i)

or (h) (2)(ii). (i) The Company may reconduct the study in compliance with paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding theproduction limit as required by subparagraph (e)(3), the Company shall complywith subparagraph (e)(3). If there is insufficient time for the Company to complywith subparagraph (e)(3), the Company may exceed the production limit and shall submit the report and data in triplicate to EPA within a reasonableperiod of time, all
as specified by EPA in the notice described in subparagraph (h)(1). EPA will respond tothe Company, inwriting, within 6 weeks of receiving the Company's report and data.



### IH-6- (ii) The Companymay, within 4 weeks of receiving from EPA the notice described in subparagraph (h)(1), submit to EPA a writtenreport refuting EPA's finding. EPA will respond to the Company, inwriting, within 4 weeks of receiving the Company's report. (i)(l) Except as described in subparagraph (i)(2), if the Company becomes aware that circumstances clearly beyond the control of the company or laboratorywill prevent, orhave prevented, development of scientificallyvalid data under the conditions specified in paragraphs (c) and (e), the Company remains prohibited from further manufacture and import of the PMN substance beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks of first becoming aware of such circumstances, a written statement explainingwhy circumstances clearlybeyond the control of the Company or laboratorywill cause orhave caused development of scientifically invalid data. EPA will notify the Company of its response, inwriting, within 4 weeks of receivingthe Company's report. EPA's writtenresponse may either: (i) allow the Company to continue tomanufacture and import the PMN substance beyond the applicable production limit,
or (ii) require the Company to continue to conduct, or to reconduct, the study in compliancewithparagraphs (b), (c), and (e)(l) and (2). If there is sufficienttime to conduct or reconduct the study and submit the report and data to EPA at



# ,,-7- least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall complywith subparagraph (e)(3). If there is insufficient time for the Company to comply with subparagraph (e)(3), the Company may exceed the production limit and shall submit the report and data intriplicate to EPA within a reasonableperiod of time, all as specifiedby EPA in the notice described in subparagraph (i)(2). EPA will respond to the Company, inwriting, within 6 weeks of receiving the Company's report and data, as to whether the Company may continue tomanufacture and import beyond the applicable production limit.

(j)(1) EPA may notify the Company inwriting that EPA finds that the data generated by a study are scientificallyvalid and unequivocal and indicate that, despite the terms of this Order, the PMN substancewill or may present an unreasonable risk of injury to human health or the environment. EPA's noticemay specifythat the Company undertake certain actions concerning further testing, manufacture, import, processing, distribution,

use andjor disposal of the PMN substance tomitigate 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, import, processing, distribution, use and disposal of the PMN substance, unless either:

### -a- (2) within 2 weeks from receipt of the notice described in subparagraph (j)(1), the Company complies with such requirements

as EPA's notice specifies; or (3) within 4 weeks from receipt of the notice described in subparagraph (j)(1), the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of any additional requirements imposedby EPA. The Company may continue tomanufacture, import, process, distribute, use and dispose of the PMN substance in accordance with the terms of this Order pending EPA's response to the Company's writtenreport. EPA will respond to the Company, inwriting, within 4 weeks of receiving the Company's report. Within 2 weeks of receipt of EPA's written response, the Company shall complywith any requirements imposed by EPA's response or cease all manufacture, import, processing, distribution, use and disposal of the PMN substance.
(k) Regardless of the satisfaction of any other conditions in this Testing section, the Company must continue to obey all the terms of this Consent Order until otherwise notified inwriting by EPA. The Company may, basedupon submitted test data or other relevant information, petition EPA tomodify or revoke provisions of this Consent Order pursuant to Part IV. of this Consent Order.



# ,,-9- PROTECTION ZH THE WORKPLACE (a) Duringmanufacturing, processing, and use of the PMN substance at any site controlledby the Company, the Company must establish a programwhereby: (1) Eachpersonwho is reasonably likelyto be dermally exposed in the work area to the PMN substance through direct handling of the substance or through contact with equipment on which the substancemay exist, is providedwith, and is required to wear, personal protective equipment that provides a barrierto prevent dermal exposure to the substance in the specific work
area where it is selected for use. Each such item ofpersonal protective equipmentmust be selected and used in accordance with 29 CFR 1910.132 and 29 CFR 1910.133. (2) The Company is able to demonstrate that each item of chemical protective clothing selected, including gloves, provides
an impervious barrierto preventdermal exposure during normal and expected duration and conditions of exposure within the work

area by any one or a combination of the following: (i) Testing the material used tomake the chemical protective clothing and the construction of the clothing to establishthat the protective clothingwill be impervious for the expected duration and conditions of exposure. The testingmust subject the chemical protectiveclothing to the expected conditions of exposure, includingthe likely combinations of chemical substances to which the clothingmay be exposed in the work area. Permeation testing shall be conducted according to


## II-10- theAmerican Society for Testing and Materials (ASTM) F739 "StandardTestMethod for Resistance of Protective Clothing Materials to Permeationby Liquids or Gases." Results shall be reported as the cumulativepermeationrate as a function of time, and shall be documented in accordance withASTM F739 usingthe format specified inASTM F1194-89 "Guide for Documentingthe Results of Chemical Permeation Testing on Protective Clothing Materials." Gloves may not be used for a time period longer than they are actually tested and must be replaced at the end of each workshift.(ii) Evaluating the specifications from the manufacturer or supplier of the chemical protective clothing, or of the material used in construction of the clothing, to establish that the chemical protective clothingwill be impervious to the PMN substance alone and in likely combination with other chemical substances in the work area.
(b) If the PMN substance is present in the work area only as a mixture, the Company is exempt from theprovisions of this Protection in theWorkplace section if the concentration of the PMN substance in the mixture does not exceed 1.0percent by weight or volume, or 0.1 percent byweight or volume ifparagraph (g) of the Hazard Communication Program section of this Order identifies cancer as a potential human healthhazard of the PMN substance. This exemption does not apply if the Company has
reason to believe that during intendeduse orprocessing in the-11- work area, the PMN substance in the mixture may be concentrated above the 1.0 or 0.1 percent level, whichever is applicable.

HAZARD COMMUNICATIOB PROGRAM (a) writtenhazard communicationprogram. The Company shall develop and implement a writtenhazard communicationprogram for the PMN substance in eachworkplace. The writtenprogramwill, at a minimum, describe how the requirements of this section for labels, MSDSs, and other forms ofwarning material will be satisfied. The Company must make thewrittenhazard communicationprogram available, upon request, to all employees, contractor employees, and their designated representatives. The Company may rely on an existinghazard communicationprogram, including an existingprogram established under the Occupational Safety and HealthAdministration (OSHA) Hazard Communication standard (29 CFR 1910.1200), to complywith this paragraph provided that the existinghazard communicationprogram satisfies the requirements of this section. The writtenprogram shall include the following: (1) Alist of chemical substancesknown to be present in the work area which are subject to a TSCA section 5(e) consent order signedby the Company or to a TSCA section 5(a)(2) SNUR at 40 C.F.R. Part 721, subpart E. The listmust bemaintained in eachwork area where the PMN substance isknown to be present and must use the identityprovided ontheMSDS for the substance required under paragraph (c) of this section. The listmay be compiled for theworkplace or for individual work areas. If the-12- Company is required either by another Order issuedunder section S(e) of TSCA orby a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, tomaintain a list of substances, the lists shall becombined with the listunder this subparagraph. (2) The methods the Company will use to inform employees of thehazards of non-routine tasks involving the PMN substance (e.g., cleaning of reactor vessels), and thehazards associated with the PMN substance contained inunlabeled.pipes in theirwork

area.(3) The methods the Company will use to informcontractors of the presence of the PMN substance in the Company's workplace and of the provisions of this Order if employees of the contractorwork in the Company's workplace and are reasonably likely to be exposed to the PMN substancewhile in the Company's workplace.
(b) Labeling. (1) The Company shall ensure that each container 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) Astatement of the healthhazards(s) and precautionarymeasure(s), if any, identified inparagraph (g) of this section or by the Company, for the PMN substance. (B) The identitybywhich the PMN substance may be commonly recognized.


## AI-13- (C) Astatement of the environmental hazard(s) andprecautionarymeasure(s), if any, identified inparagraph (g) of this section, orby the Company, for the PMN substance. (D) Astatement of exposure andprecautionary measure(s), if any, identified inparagraph (g) of this section,
or by the Company, for the PMN substance. (ii) The Company may use signs, placards, process sheets, batchtickets, operatingprocedures, or other such writtenmaterials in lieu of affixing labels to individual stationaryprocess containers, as long as the alternativemethod identifies the containers towhich it is applicable and conveys information specified by subparagraph (b) (1)(i) of this section. Any writtenmaterials must be readily accessible to the employees in theirwork areas throughout eachwork shift. (iii) The Company need not label portable containers intowhich the PMN substance is transferred from labeled containers, and which are intended only for the immediate use of the employeewho performs the transfer. (iv) The Company shall not remove or deface an existing label on containers of the PMN substance obtained from persons outside the Company unless the container is immediately relabeledwith the information specified in subparagraph (b)(l)(i) of this section. (2) The Company shallensure that each container of the substance leaving its workplace for distribution in commerce is labeled in accordance with this subparagraph (b)(2).-14- (i) The label shall, at a minimum, contain the following information: (A) The informationprescribed in subparagraph (b)(l)(i) of this section. (B) The name and address of themanufacturer or a responsiblepartywho canprovide additional information on the substance for hazard evaluation and any appropriate emergency procedures. (ii) The label shall not conflictwith the requirements of the HazardousMaterials TransportationAct (18 

### u.s.c. 1801 et. seq.) and regulations issuedunder that Act by the Department of Transportation. (3) The label, or alternative forms of warning, shall be legible and prominentlydisplayed. (4) The label, or alternative forms of warning, shall be printed in English; however, the informationmay be repeated in other languages. (5) If the label or alternative form ofwarning is to be applied to a mixture containing the PMN substance in combination with any other substance that is either subjectto another TSCA section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, or defined as a "hazardous chemical" under the Occupational Safety and HealthAdministration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS,
or alternative form of warning, themeasures to control worker exposure or environmental release which the Company determines-15- provide the greatest degree of protection. However, should these controlmeasures differ from the applicablemeasures required under this Order, the Company must seek a determination of equivalency for such alternative controlmeasures pursuant to 40 CFR 721.30 beforeprescribing themunder this subparagraph (b)(5).
(c) Material SafetyData Sheets. (1) The Company must obtain or develop anMSDS for the PMN substance. (2) The MSDS shall contain, at a minimum, the following information: (i) The identityused on the container label of the PMN substanceunder this section, and, if not claimed confidential, the chemical and common name of the PMN substance. If the chemical and common name are claimed confidential, a generic chemical name must be used. (ii) Physical and chemical characteristics of the substanceknown to the Company, (e.g., vapor pressure, flash point). (iii) The physical hazards of the substanceknown to the Company, includingthe potential for fire, explosion, and reactivity. (iv) The potential human hazards as specified in paragraph (g) of this section.-16- (v) signs and symptoms of exposure, and anymedical conditions which are expected to be aggravated by exposure to the PMN substanceknown to the Company. (vi) Theprimaryroutes of exposure to the PMN substance.(vii) Precautionarymeasures to controlworker exposure and/or environmental release requiredbythis Order, or alternative controlmeasures which EPA has determinedunder 40 CFR 721.30 provide substantiallythe same degree of protection as the identified control measures. (viii) Any generally applicableprecautions for safe handling and use of the PMN substancewhich areknown to the Company, including appropriate hygienic practices, protective
measures during repair and maintenance of contaminated equipment, andprocedures for response to spills and leaks. (ix) Any generally applicable control measures which
areknown to the Company, such as appropriate engineering controls, workpractices, orpersonalprotective equipment. (x) Emergency first aidprocedures known to the Company. (xi) The date of preparation of theMSDS or of its last revision. (xii) The name, address, and telephone number of the Company or another responsiblepartywho canprovide additional information on the chemical substance and any appropriate emergencyprocedures.-17- (3) If no relevant information is found orknown for any given category on theMSDS, the Company mustmark theMSDS to indicate that no applicable informationwas found. (4) Where multiplemixtures containing the PMN substance have similar compositions (i.e., the chemical ingredients are essentiallythe same, but the specific composition varies from mixturetomixture) and similarhazards, the Company may prepare
oneMSDS to apply to all of thesemultiplemixtures. (5) If the Company becomes aware of any significant new information regarding the hazards of the PMN substance orways to protect against the hazards, this new informationmust be added to theMSDS within 3 months from the time the Company becomes
aware of the new information. If the PMN substance is not being manufactured, imported, processed, or used inthe Company's workplace, the Company must add the new information to theMSDS before the PMN substance is reintroduced into the workplace. (6) The Company must ensure that persons receiving the PMN substance from the Company areprovided an appropriateMSDS with their initial shipment andwith the first shipment after anMSDS isrevised. The Company may eitherprovide theMSDS with the shipped containers or send itto the personprior to or at the time of shipment. (7) The Company mustmaintain a copy of theMSDS in its workplace, and must ensure that it is readily accessible during eachwork shift to employees when they are in their work areas. (8) The MSDS may be kept in any form, including as operatingprocedures, and may bedesigned to cover groups of-18- substances in a work area where itmay bemore appropriate to address the potential hazards of a process rather than individual substances. However, in all cases, the required informationmust beprovided for the PMN substance and must be readily accessible during eachwork shift to employees when they are in theirwork

areas. (9) TheMSDS must be printed in English; however, the informationmay be repeated in other languages. (d) Employee information and training. The Company must ensure that employees are providedwith information and training on the PMN substance. This information and trainingmust beprovided at the time of each employee's initial assignment to a work area containingthe PMN substance and whenever the PMN substance is introduced into the employee's work area for the first time. (1) The informationprovided to employees under this paragraph shall include: (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 communicationprogram requiredunderparagraph (a) of this section, including the list of substances required by subparagraph (a){1) of this section andMSDSs required by paragraph (c) of this section. {2) The trainingprovided to employees shall include: (i) Methods and observations thatmay be used to detect the presence or release of the PMN substance in or from an-19-'**employ~e•s** work area (such as monitoring conducted by the Company, continuous monitoring devices, visual appearance, or odor of the substancewhen beingreleased). (ii) The potential human health and environmental hazards of the PMN substance as specified inparagraph (g) of this section. (iii) The measures employees can take to protect themselves and the environment from the PMN substance, including specific procedures the Company has implemented to protect employees and the environment from exposure to the PMN substance, including appropriatework practices, emergencyprocedures, personal protective equipment, engineering controls, and other
measures to control worker exposure and/or environmental 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 programdeveloped by the Company under this section, including an explanation of the labeling system and theMSDS required bythis section and guidance on obtaining and using appropriate hazard information.
(e) Low concentrations in**mixtu~es.** If the PMN substance is present in the work area onlyas a mixture, the Company is exempt from the provisions of this section if the concentration of the PMN substance in the mixture does not exceed 1.0 percent by weight orvolume, or 0.1 percent byweight orvolume ifparagraph-20- (g) of this section identifies cancer as a potential human health hazard of the PMN substance. However, this exemption does not apply ifthe Company has**reaso~** to believe that during intended
use orprocessing inthework area, the PMN substance in the mixturemay be reconcentrated above the 1.0 or 0.1 percent level, whichever is applicable.
(f) Existinghazard communicationprogram. The Company need not take additional actions if existingprograms and procedures satisfythe requirements of this section.
(g) Human health. exposure. andprecautionary statements. The following human health hazard and precautionary statements shall appear on each label as specified inparagraph (b) and theMSDS
as specified inparagraph (c) of this section: (1) Human health hazard statements. This substancemay
cause: (i) internal organ effects. (2) Human hazard precautionary statements. When using this substance:(i) avoid skin contact. (ii) use skinprotection. (3) The human hazard andprecautionary statement contained
on a label preparedpursuant toparagraph (b) of this section must be followed by the statement: "See theMSDS for details."-21- KABUPACTQRING (a)(1) The Company shall not cause, encourage, or suggest the manufacture or import of the PMN substanceby any otherperson. (2) Subparagraph (a)(1) shall expire 75 days after promulgation of a final significantnew use rule ("SNUR11) governing the PMN substanceunder section 5(a)(2) ofTSCA unless the.Company is notified on orbefore that day of an action in a Federal Court seekingjudicial review of the SNUR. If the Company is so notified, subparagraph (a)(1) shall not expire until EPA notifies the Company inwriting that all Federal Court actions involving the SNUR have been resolved and the validity of the SNUR affirmed. (3) When EPA promulgates a final SNUR for the PMN substance and subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Company shall notify eachpersonwhom itcauses, encourages or suggests tomanufacture or import the PMN substance of the existence of the SNUR. Such notificationmust be in writing andmust specifically include all limitations contained in the SNUR which are defined as significantnew uses, and which would invoke significant new use notificationto EPA for the PMN substance. such noticemust also reference the publication of the SNUR for this PMN substance in eitherthe Federal Register or the Code of Federal Regulations.

DISTRIBtzTION (a) Except as provided inparagraph (b), the company shall distribute the PMN substance outside the Company, including for-22- disposal, only to a personwho has been notified of the restrictions and agrees priorto the date of distribution, to: (1) Comply with the same requirements and restrictions, if any, required of the Company inthe Protection intheWorkplace section of this Order. (2) Comply with the same requirements and restrictions, if any, required of the Company inthe Hazard Communication Program section of this Order.
(b) Notwithstandingparagraph (a), the Company may distribute the PMN substance outside the Company for temporary transport and storage in sealed containers (labelled in accordance with paragraph (b)(2) of the Hazard Communication Program section of this Order) provided that anyhuman exposure from opening the container and removing orwashing out the PMN substancemay occur onlywhile the PMN substance is in the possession and control of the Company or a person authorized to receive the PMN substance from the Company pursuant to this Distribution section of this Order.
(c) If, at any time after commencing distribution in commerce of the PMN substance, the Company obtainsknowledge that a**r~cipient** of the substancehas failed to complywith any of the conditions specified inparagraph (a) of this Distribution section or, after paragraph (a)(1) expires in accordancewith subparagraph (d)(1), has engaged in a significant new use of the PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a-23- signiffcant new use notice to EPA, the Company shall cease supplying the substance to that recipient, unless the Company is able to document each of the following: (1) That the Company has, within 5 working days, notified the recipient inwriting that the recipienthas failed to comply with any of the conditions specified inparagraph (a) of this Distribution section, orhas engaged in a significant new use of the PMN substancewithout submitting a significant new use notice to EPA. (2) That, within 15 working days of notifying the recipient ofthe noncompliance, the Company received from the recipient, in writing, a statement of assurance that the recipient is aware of the terms of paragraph (a) of this Distribution section and will complywith those terms, or is aware of the terms of the significant new use rule for the PMN substance and will not engage in a significant new use without submitting a significant
new use notice to EPA. (3) If, after receiving a statement of assurance from a recipient under subparagraph (c)(2) of this Distribution section, the Company obtains knowledge that the recipient has failed to comply with any of the conditions specified inparagraph (a) of this Distribution section, orhas engaged in a significant new
use of the PMN substancewithout submitting a significant new use notice to EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA of the failure to comply, and shall resume supplying the PMN substance to that recipient onlyupon written notification from theAgency.i.
-24- (d)(1) Paragraph (a)(1) of this Distribution section shall

expire 75 days afterpromulgation of a final SNUR for the PMN substanceunder section 5(a)(2) of TSCA, unless the Company is notified on orbefore that day of an action in a Federal Court seekingjudicial review of the SNUR. If the Company is so notified, paragraph (a)(1) of this Distribution section shall not expire until EPA notifies the Company inwriting that all Federal Court actions involving the SNUR have been resolved and the validity of the SNUR affirmed. (2} When EPA promulgates a final SNUR for the PMN substance andparagraph (a}(1} of this Distribution section expires in accordance with subparagraph (d)(1}, the Company shall notify each person towhom it distributes the PMN substance of the existence of the SNUR. Such notificationmust be inwriting and must specifically 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 noticemust also reference the publication of the SNUR for this PMN substance in either the Federal Register or the Code of Federal Regulations. Afterpromulgation of a SNUR and expiration of subparagraph (a}(1}, such noticemay substitute for the written agreement required in the introductory clause of paragraph (a}; so that, if the Company provides such notice to thepersons towhom it distributes the PMN substance, then the Company is not required to obtain from such persons the written agreement specified inparagraph (a).-25- II. RECORDKEEPING (a) The Company shallmaintain the following records until 5 years after the date they are created and shallmake them available for inspection and copying by EPA in accordance with section 11 of TSCA: A. RECOROS (1) Records documenting the aggregatemanufacture and importationvolume of the PMN substance and the corresponding dates of manufacture and import; (2) Records documenting the names and addresses (including shipment destination address, if different) of all persons outside the site of manufacture or import towhom the Company directly sells or transfers the PMN substance, the date of each sale or transfer, and the quantity of the substance sold or transferred on such date; (3) Records documenting that all persons outside the site of manufacture or import towhom the company directly sells or transfers the PMN substancehave been notified of the restrictions applicable to the PMN substancepursuant to the Protection in the Workplace and Hazard Communication Program sections of the Order; (4) Records documenting establishment and implementation of
a program for the use of any applicable personal protective equipment required pursuant to the Protection in the Workplace section of this Order;-26- (5) Records documenting the determinations required by the Protection in the Workplace section of this Order that chemical protective clothing is impervious to the PMN substance; (6) Records required byparagraph F. of the New Chemical Exposure Limits section of this Order, if applicable; (7) Records documenting establishment and implementation of thehazard communicationprogram required by the Hazard Communication 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 compliancewith any applicable manufacturing and distributionrestrictions in theManufacturing and Distribution sections of this Order; (11) Copies of any Transfer Documents and 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 ismanufactured, imported, processed or used. B. APPLICABILITY The provisions of this Recordkeeping Section are applicable only to activities of the Company and not to activities of the Company's customers.-27- III. SUCCESSOR LIABILITY QPON TBANSFER OF CONSENT OROER

(a) Scope. This section sets forth the procedures bywhich the Company's rights and obligations under this Order may be transferred when the Company transfers its interests in the PMN substance, including the right tomanufacture the PMN substance, to another person outside the Company (the 11Successor in Interest11) •
(b) Relation of Transfer Date to Notice of Commencement (11NQC11). (1) Before NQC. If the transfer from the Company to the Successor in Interest is effectivebefore EPA receives a notice of commencement of manufacture or import (11NOC11) for the PMN substance from the Company pursuant to 40 CFR 720.102, the Successor in Interestmust submit a new PMN to EPA and comply fully with Section S(a)(1) of TSCA and 40 CFR part 720 before commencingmanufacture or import of the PMN substance. (2) After NOC. If the transfer from the Company to the Successor in Interest is effective after EPA receives a NOC, the Successor in Interest shall complywith the terms of this Order and is not required to submit a new PMN to EPA.

(c) Definitions. The following definitions apply to this Successor Liability section of the Order: (1) 11Successor in Interest11 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-28- 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 of the Company inthe PMN substance, such as a licenseewho has acquired a limited license to thepatent or manufacturing rights associatedwith the PMN substance. A
successor in Interestmust be incorporated, licensed, or doing 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, includingthe right tomanufacture the PMN substance, from the Company to the
successor in Interest.
(d) Notices. (1) Notice to Successor in Interest. On orbefore the effective date of the transfer, the Company shallprovide to the Successor in Interest, by registeredmail, a copy of the Consent Order and the "Notice of Transfer" document which is incorporated byreference as Attachment

### c to this Order. (2) Notice to EPA. Within 10 business days of the effective date of the transfer, the Company shall, byregistered mail, submit the fully executedNotice of Transfer document to:
u.s. Environmental ProtectionAgency, New Chemicals Branch (7405), 401 MStreet, s.w., Washington, D.C. 20460. (3) Transfer Document. Copies of the Transfer Document must bemaintained by the Successor in Interest at itsprincipal-29- piace of business, and at all siteswhere the PMN substance is manufactured or imported. Copies of the Transfer Documentmust also bemade available for inspectionpursuant to Section 11 of TSCA, must state the effective date and time of transfer, and must containprovisions which expressly transfer liability for the PMN substanceunder the terms of this Order from the Company tothe Successor in Interest.
(e) Liability. (1) The company shall be liable for compliancewith the requirements of this Orderuntil the effective date and time 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 and time of transfer. (3) Nothing in this section shall be construed toprohibit theAgency from taking enforcement action against the Company after the effective date of the transfer for actions taken, or omissions made, during the time inwhich the Company manufactured, processed, used, distributed in commerce, or disposed of the PMN substancepursuant to the terms of this Consent Order.
(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing section of this Consent Order requires the Company to submit test data to EPA at a specified production volume ("test trigger"), the aggregate volume of the-30- PMN sunstancemanufactured and imported by the Company up to the date of transfer shall count towards the test trigger applicable to the Successor in Interest.

IV. MOPIFICATION

### AND REVOCATION OF CONSENT ORDER The Companymay petition EPA at any time, basedupon new information on the health or environmental effects of, human exposure to, or environmental release of, the PMN substance, to modify or revoke substantiveprovisions of this Order. The exposures and risks identifiedby EPA during itsreview of the PMN substance and the informationEPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determiningwhether to 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 of new test data or other information or analysis, and any other relevant information. EPA will issue a modification orrevocation if EPA determines that the activities proposed therein will notpresent
an unreasonable risk of injurytohealth or the environment and will not result in significant or substantial human exposure or substantial environmental release in the absence of data sufficient to permit a reasoned evaluation of the health or environmental effects of the PMN substance.-31- 

### Iri addition, the Company may petitionEPA at any time to make othermodifications tothe language of this Order. EPA will issue such a modification ifEPA determines that the modification isuseful, appropriate, and consistentwith the structure and intent of this Order as issued.-32- V. EFFECT OF CONSENT OROER By consentingto the entry of this Order, the Company waives its rights to file objections to this Orderpursuant to section S(e)(1)(C) of TSCA, to receive service of this Order no later than 45 days before the end of the reviewperiodpursuant to section S(e)(1)(B) of TSCA, and to challenge the validity of this Order, ormodifications made thereto, in any subsequent action. Consenting to the entry of this Order, and agreeing to be bound by its terms, does not constitute an admission by the Company as to the facts or conclusions underlying theAgency's determinations inthis proceeding. This waiver does not affect any other rights that the Company may have under TSCA.**~(1/8'(;** l Date tf1chemical Control D1vision Office of PollutionPrevention and Toxics

/. Name: t Title: Company:

### ATTACHMENT A DE:PIHITIOHS [Bote: The attached ordermay not contain some of the terms definedbelow.] "Chemical name" means the scientific designation of a chemical substance in accordancewiththe nomenclature system developed by the International Union of Pure andApplied Chemistryor the Chemical Abstracts Service's rules of nomenclature, or a name which will clearly identify a chemical substance for thepurpose of conducting a hazard evaluation. "Chemical protective clothing" means items of clothingthat provide a protectivebarrier toprevent dermal contactwith chemical substances of concern. Examples can include, but are not limited to: full bodyprotective clothing, boots, coveralls, gloves, jackets, andpants. "Company" means theperson orpersons subject to this Order. "Commercial use" means the use of a chemical substance or anymixture containingthe chemical substance in a commercial enterpriseproviding saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment orpainting contractor). "Common name" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other than by its chemical name. "Consumer" means a private individual who uses a chemical substance or anyproduct containing the chemical substance in or around a permanent or temporaryhousehold orresidence, during recreation, or for any personal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, or as part of a mixture, sold ormade available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or inrecreation. "Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storagetank, or the like that contains a hazardous chemical. Forpurposes of this section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "ContractManufacturer" means a person, outside the Company, who is authorized tomanufacture and import the PMN substanceunder the conditions specified in Part II. of this consent Order and in the Consent Order for ContractManufacturer.-2- "Identity" means any chemical or common name used to identify a chemical substance or a mixture containing that substance. "Immediateuse.'' Achemical substance is for the "immediate use" of a person if it is under the control of, and used onlyby, thepersonwho transferred it from a labeled container andwill onlybe used bythatpersonwithin the work shift inwhich it is transferred from the labelled container.

11Impervious.11 Chemical protective clothing is 11impervious11 to a chemical substance if the substance causes no chemical or mechanical degradation, permeation, orpenetration of the chemical protective clothingunder the conditions of, and the duration of, exposure. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless ofphysical state or concentration, through all intended operations of manufacture, includingthe cleaning of equipment. "MSDS" means material safetydata sheet, the written listing of data for the chemical substance as required under§ 721.72(c). ''NIOSH" means the National Institute for Occupational Safety and Health of the

### u.s. Department of Health and Human Services. "Non-enclosedprocess" means any equipment system (such as an open-top reactor, storagetank, ormixing vessel) inwhich a chemical substance ismanufactured, processed, or otherwiseused where significant direct contact of the bulk chemical substance and the workplace airmay occur. "Non-industrial use" means use other than at a facility where chemical substances ormixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the Premanufacture notice submittedbythe Company relevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the body toprevent contact with, and exposure to, an identified chemical substance or substances in the work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types of respirators. Barrier creams are not included in this definition.
"Process stream" means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless ofphysical-3- state or concentration, through all intended operations of processing, including the cleaning of equipment. "Scientifically invalid" means any significant departure from the EPA-approvedprotocol or the Good Laboratory Practice standards at 40 CFR Part 792 without prior or subsequentAgency approval that prevents a reasoned evaluation of the health or environmental effects of thePMN substance. "Scientificallyequivocal data" means data which, although developed in apparent conformitywith the Good Laboratory Practice standards and EPA-approvedprotocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk of injury tohuman health or the environment of the PMN substance. "Sealed container" means a closed containerthat is physically and chemically suitable for long-term containment of the PMN substance, and from which there will be no human exposure to, nor environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumer use. "Waters of the United States" has the meaning set forth in 40 CFR 122.2. "Work area" means a room or defined space in a workplace where the PMN substance is manufactured, processed, or used and where employees are present. "Workplace" means an establishment at one geographic location containing one or more work areas.ATTACHMENT B NOTICE OP TRANSPER OP TOXIC SUBSTANCES CONTROL ACT

SECTION S(e) CONSENT ORDER
Company (Transferor) PMN Number
1. Transfer ofManufacture Rights. Effective on

, the Company did sell or otherwise transfer to

-------- I ("Successor in Interestn) the r1ghts and liab1l1t1es associatedwith manufacture of the abovereferenced chemical substance, whichwas the subject of a premanufacture notice (PMN) and is governed by a Consent Order issued by the u.s. Environmental ProtectionAgency (EPA) under the authority of §5(e) of the Toxic Substances Control Act (TSCA, 15 u.s.c. §2604(e)).
2. Assumption of Liability. The Successor in Interesthereby certifies that, as of the effective date of transfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal of the PMN substance, shall be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, ordoing 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 by the Company, pursuant to Section 14 of TSCA and 40 CFR part 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is indicated, that designation shall bedeemed to apply to all such claims. Where "modifies" is indicated, suchmodification shall be explained indetail in an attachment to this Notice of Transfer.TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER NOTICE OF TRANSFER (continued)
Company (Transferor)
Signature ofAuthor1zed Off1c1al
PrintedName ofAuthor1zed Off1cial
Title ofAuthorized**Ofif~cial** 1''

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