UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OF NEW CHEMICAL SUBSTANCES
PENDING DEVELOPMENT OF INFORMATION

In the matter of: ) Premanufacture Notice Numbe r: ) ) ) ) ) ) [ ] ) P

- 10

- 115 through 126 ) ) ) ) ) ) )

Consent Order and Determinations Supporting Consent Order

_______________________________________________________________________TABLE OF CONTENTS

I. Introduction Preamble

II. Summary of Terms of the Order
III. Co ntents of PMN
IV. EPA’s Assessment of Risk
V. EPA’s Conclusions of Law
VI. Information Re quired to Evaluate Human Health and Environmental Effects

I. Scope of Applicability and Exemptions Consent Order

II. Terms of Manufacture, Import, Processing, Distri bution in Commerce, Use, and Disposal
P ending Submission 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 Or der
VII. Effect of Consent Order
Attachment A

- Definitions
Attachment B

- Notice of Transfer of Consent Order
Attachment C

- Consent Order for Processoriii 

## PREAMBLE

I Under the authority of § 5(e) of the Toxic Substance Control Act (“TSCA” ) (15 U.S.C. INTRODUCTION

2604(e)), the Environmental Protection Agency (“EPA” or “the Agency”) issues the attached Order, regarding premanufacture notices (“PMNs”) P

- 10

- 0115 through P

- 10

- 0126 for the chem i cal
substances described in the notices as carbon nanofibers (“CNFs”) ( the “PMN substances”), su bmitted by [ ] (“the Company”), to take effect upon expiration of the PMN review period. The Company submitted the PMN s to EPA pursuant to section 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 pr ovision of § 5 or any order issued under § 5. Violators may be subject to various penalties and to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizur e pu r suant to § 17. In addition, chemical substance s subject to an Order issued under § 5 of TSCA, such as this one, are subject to the § 12(b) export notice requirement.

II.
The Consent Order for th ese PMN substances r equires the Company to: SUMMARY OF TERMS OF THE ORDER

(1) submit to EPA certain exposure and physical

- chemical property testing within a specified time period and certain toxicity testing a t least 14 weeks before manufacturing or importing a total of [ ] of the PMN substance s ; (2) provide its workers personal protective equipment to prevent dermal exposure; (3) provide its workers respirators to prevent inhalation exposure;iv (4) comply with the Release to Water Provisions ; (5) use the PMN substances only as e lectrical and the rmal conductivity additive s, m echanical rei nforce ment additives, e nergy storage additive s, and c hemical intermediate s; (6) limit the processing and use of the PMN substances to industrial settings; (7) provide the U.S. EPA with a 1 g sample of the P MN mat erials upon request by EPA; (8) distribute the PMN substances only to a person who agrees to follow the same restrictions a pplicable to the company (except the testing requirements) and to not further distribute the PMN
substances until after they have bee n (i) co m pletely reacted (cured); (ii) incorporated or embedded into a polymer matrix that itself has been completely reacted (cured); (iii) embedded in a perm anent solid polymer , metal, glass, or ceramic form ; or (iv) incorporated into an article as d e fi n ed at 40 CFR 720.3(c); and (9) maintain certain records.
III. By signing this Order, the Company represents that it has carefully reviewed this doc u ment and hereby agrees that all information herein that is claimed as confidential by the C o m pany (per section 14 of TSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) is correctly ide n tified within brackets and that any information that is not bracketed is not claimed as confide n tial. To make this document available for public viewing, EPA wi ll remove only the information contained within
the brackets. CONTENTS OF PMN

Confidential Business Information Claims (Bracketed in the Preamble and Order ) Company, p roduction v olume , and process information :

Chemical Identity: Specific identity:v

Gen eric: Carbon Nanofibers

S pecific : Electrical conductivity additive in thermoplastics and thermo sets, m echanical reinforc ement additive i n thermoplastics and thermosets, e nergy storage additive , and c hemical intermed i Use :

ate

.vi
Forms: The notice described three forms of the PMN sub stances as p owdered , l iquid polymer
form with a concentration of the PMN substances up to [ ] (“liquid polymer form”) , and s olid polymer form with a concentration of the PMN substances up to [ ] (“solid polymer form”) . The notice also described “pre

- p reg forms” of the PMN substances. For purposes of this order the pre

preg form described as “ agglomerates coated with polymeric substances ” is considered a po w dered
form , and the pre

- preg form described as “ uncured pre

- impregnated composite fibers ” is con si dered a liquid pol y mer form.

Maximum 12

- Month Production Volume
P

- 10

- 115

– [ ] :

P

- 10

- 116

– [ ]
P

- 10

- 117

– [ ]
P

- 10

- 118

– [ ]
P

- 10

- 119

– [ ]
P

- 10

- 120

– [ ]
P

- 10

- 121

– [ ]
P

- 10

- 122

– [ ]
P

- 10

- 123

– [ ]
P

- 10

- 124

– [ ]
P

- 10

- 125

– [ ]
P

- 10

- 126

– [ ]
T est Data Submitted with the PMN s :
- Nonevii

T he following are EPA’s predictions regarding the probable toxicity , human exposure and
environmental release of the PMN subst ance s , based on the information currently available to the Agency. IV . EPA’S ASSESSMENT OF RISK

Absorption is expected to be poor via all routes for the PMN substances , based on test data
for chemicals with similar molecular structures and chemicals with similar physical/chemical
prope r ties

. Data on the PMN substances and other analogous substances indicate the potential for generation of increased amounts of respirable or absorbable particles during proces s ing and use of
nanoscale materials

. M uch more e valuation is needed to determine the toxicity of nanoscale mat erials for all routes of exposure

. There are concerns for lung effects , based on the EPA Respirable, Poorly Soluble Particulates chemical category. See www.epa.gov/oppt/newchems/pubs/cat02.htm #Respirable

. B ased on test data for analogous
che m icals there are concerns for pulmonary toxicity, fibrosis, carcinogeni city , mutagenicity , and immunotoxicity of the PMN substance s
. There are also data suggesting that pulmonary depos i tion
of some nano sca le materials , including carbon nanotubes in the agglomerated form , may induce cardiovascular toxicity when these nano scale materials are inhaled. The major health concerns are for potential pulmonary toxicity, fibrosis and cancer to workers exposed via in hal a tion. Based on the uncertainty of the characterization and exposure of nanoscale materials in general , there may
be additional potential for translocation across the dermis and effects on ta r get organs

. Human Health Effects Summary:viii

Environmental effect studies have not been conducted specifically on CNFs, but based on chemical structure and physical

- chemical properties, EPA is assessing CNFs to behave sim i larly in the environment to carbon nanotubes ( “ CNT ” ). T oxicity from CNT exposures has been r e ported in many aquatic species at concentr a tions much higher than any estimated solubi lity limits. Even though CNT are not appreciably w a ter soluble as manufactured, aqueous CNT suspensions can be easily made through reaction with strong acids, ozone, o r dispersing agents. Recent laboratory r esearch show s that CNT combine with dissolved organic matter to form stable aqueous su s pensions.
No studies on CNT are available in which a broad range of production methods, sources, purific ation, functionalizatio n, etc. were investigated. EPA expect s that some fraction of the CNT , if r eleased into the environment, will eventually b e come suspended in water. Sublethal effects have been noted for single

- walled carbon nan o tubes ( “ SWCNT ” ) in fish at levels as low as 1 00 ppb. Noted effects included respiratory stress, ventilation rate , gill mucus secretion , gill da m age , and aggressive behaviors. Liver cell injuries were also readily apparent at these exposure le v els and suggest the possibility of liver tumor formation o ver longer exposure periods. This r e sponse is also
notable because effects were seen in cells closes t to blood vessels, suggesting tran s port of respired
or in gested SWCNT via the blood stream. Some effects in the gut lumen were also observed at these expos ure levels. Further studies need to be conducted before EPA can determine a concentr ation of concern. Such studies must measure a c tual concentrations of carbon nanotubes and control for the effects of contaminants, solvents, and physical factors such as bl ockage of gills or inte stines. Before such testing is conducted, advanced fate testing would be necessary to asce r tain what substance is likely to present the highest environmentally relevant concentr a tions. Environmental Effects Summary:ix
TABLE 1.
- Exposure and Environmental Releas e Summary for the P
- 10
- 0115

– P
- 10
- 012 0 :

Manufacture Proc essing for Ele c trical Condu c tivity Additive for Compo s ites Proc essing for Mechanical Rei n forcement

for Comp os ites Proc essing and Use for Cruc ible ha n dling for Heat Trea t ment of Carbon Nan o fibers ( inte r mediate) Use as an I ntermediate

(mil l ing)

# Sites [ ] [ ] [ ] [ ] (same as manufactu ring) [ ] (same as manufactu ring) Workers (#/site) [ ] [ ] [ ] [ ] [ ]

Exposure (days/year) [ ] [ ] [ ] [ ] [ ]
Dermal Exposure (mg/day) [ ] to solid pa rti culate [ ] to liquid [ ] to solid pa r ticulate [ ] to liquid [ ] to solid pa r ticulate [ ] to liquid [ ] to solid pa r ticulate [ ] to solid pa r ticulate
Inhalation Exposure (mg/day) [ ] mg/day worst case [ ] mg/day worst case [ ] mg/ day worst case [ ] mg/day worst case [ ] mg/day worst case Drinking Water E xposure (mg/day) [ ] mg/kg/day acute dose rate (“ADR”) 0.0004 mg/kg/day Lifetime average dose rate (“LADD”) [ ] mg/kg/day ADR 0.000016 mg/kg/day LADD [ ] mg/kg/day A DR 0.000016 mg/kg/day LADD [ ] mg/kg/day ADR 0.0004 mg/kg/day LADD [ ] mg/kg/day ADR 0.0004 mg/kg/day LADD
Releases (days/year) [ ] [ ] [ ] [ ] [ ]

Surface Water Co ncentration (ppb) [ ] worst case [ ] [ ] [ ] worst case [ ]x

TABLE 1 (continued)
. - Exposure and Environmental Release Summary for the P
- 10
- 0115

– P
- 10
- 0120 :
Use s as an Electr ical Condu c tivity Additive and m echanical Rei nforcement for

Composites (thermoplastics and

so l id therm o sets) Use as an Electrical Co n duct ivity Additive for Co m posites (liquid the rmosets) Use as a M echanical Rei nforcement for

Compo s ites (thermosets) Use as an Add itive for Ba t tery Ele c trodes

# Sites [ ] [ ] [ ] [ ] (same as manufactu r ing) Workers (#/site) Not assessed [ ] [ ] [ ]

Exposure (days/year) Not expected [ ] [ ] [ ]

Dermal Exposure (mg/day) Not expected [ ] to liquid [ ] to liquid [ ] to solid pa rticulate [ 880 ] to liquid Inhalation Exp o sure (mg/day) Not expected Negligible Negligible [ ] mg/day worst case exp osure Drinking Water E xposure (mg/day) Not expected [ ] mg/kg/day ADR 0.000012 mg/kg/day LADD [ ] mg/kg/day ADR 0.000012 mg/kg/day LADD [ ] mg/kg/day ADR 0.0004 mg/kg/day LADD
Releases (days/year) Not expected [ ] [ ] [ ]xi
TABLE 2
. - Exposure a nd Environmental Release Summary for the P
- 10
- 0121

– P
- 10
- 0126 :

Manufacture Proc essing and u se as a Cruc ible ha n dling for Heat Trea t ment of Ca r bon Nanofibers (intermediate use) Proc essing as an Electr i cal Conducti v ity Additive for Compo s ites Proc essing as a Mechanical Rei n forcement

for Comp os ites Electrical Conductivity Additive for Composites (thermopla stics and so l id thermosets)

# Sites [ ] [ ] (same as manufacture) [ ] [ ] [ ]
Workers (#/site) [ ] [ ] [ ] [ ] Not assessed

Exposure (days/year) [ ] [ ] [ ] [ ] Not expected
Dermal Exposure (mg/day) [ ] to solid pa rticulate [ ] to liquid [ ] to solid pa r ticulate [ ] to solid pa r ticulate [ ] to liquid [ ] to solid pa r ticulate [ ] to liquid Not expected

Inhalation Exposure (mg/da y) [ ] mg/day worst case [ ] mg/day worst case [ ] mg/day worst case [ ] mg/day worst case Not expected
Drinking Water E xposure (mg/day) [ ] mg/kg/day ADR [ ] mg/kg/day LADD [ ] mg/kg/day ADR [ ] mg/kg/day LADD [ ] mg /kg/day ADR [ ] mg/kg/day LADD [ ] mg/kg/day ADR [ ] mg/kg/day LADD Not expected

Releases (days/year) [ ] [ ] [ ] [ ] Not expectedxii
TABLE 2 (continued).
- Exposure and Environmental Release Summary for the P
- 10
- 0121

– P
- 10
- 0126 :
U se 2b: Electrical Conductivity Add itive for Composites (liquid thermosets) Use 3a: Mechanical Reinforcement for Composites (thermoplastics ) Use 3b: M echa n ical Rei nforcement for

Compo s ites (thermosets) Use 4: Add i tive for Battery Ele ctrodes

# Sites [ ] [ ] [ ] [ ]
Workers (#/site) [ ] Not assessed [ ] [ ]

Exposure (days/year) [ ] Not expected [ ] [ ]

Dermal Exposure (mg/day) [ ] to liquid Not expected [ ] to liquid [ ] to solid pa rticulate [ ] to liquid Inhalation Exp o sure (mg/day) Negligi ble to li quids Not expected Negligible to li q uids [ ] mg/day worst case exp osure Drinking Water E xposure (mg/day) [ ] mg/kg/day ADR [ ] mg/kg/day LADD Not expected [ ] mg/kg/day ADR [ ] mg/kg/day LADD [ ] mg/kg/day ADR [ ] mg/kg /day LADD

Releases (days/year) [ ] Not expected [ ] [ ]

Risk to Workers: The PMN substances may present a risk to workers exposed to the PMN su bstances and associated byproducts via inhalation. In the table s above , the worst case worker inh alati on value is [ ] during manufacturing , but other inhalation exposures may occur during
proces s ing and use

. T here is a concern for pulmonary toxicity, fibrosis and cancer and a potentialxiii for cardiovascular effects to workers exposed to the PMN substances and assoc i ated byproducts
via the inhalation route. To mitigate potential health effects via inhalation , the Order requires a ppropriate respiratory protection. EPA believes the PMN substances as manufa c tured present a low risk to workers expo sed to the PMN substances itself dermally, but does not have sufficient info rmation to evaluate the risks when the PMN substances are handled

. To mit i gate potential health effects via dermal exposure, the Order requires dermal pr o tection.

Risk to genera l population : T here is potential for exposure to the PMN substances of the general population and the environment from landfill releases , fugitive, and stack air emissions . Human ingestion may result from landfill or direct water releases. Direct water releases are restricted by
the Order.

The following findings constitute the basis of the Consent Order: V. EPA’S CONCLUSIONS OF LAW

( a ) EPA is unable to determine the potential for effects to human health and the environment from exposure to the PMN substance s . EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned evalu a tion of the
human health and environmental effects of the PMN substance s
.

(b) In light of th e potential risk to human health and the environment posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN su bstance s , EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufa c-xiv ture, import, processing, distribution in commerce, use, and disposal of the PMN substances may present an unreasonable risk of injury to human health and the environment

.

VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS Triggered Testing. Th e Order prohibits the Company from manufacturing the PMN substances beyond specified time period s and production volume s , unless the Company submits the info rm a tion described in the Testing section of t his Order in accordance with the conditions specified in the Testing section. T he Order’s restrictions on manufacture, import, processing, distribution in

commerce, use, release to water, and disposal of the PMN substance s will remain in effect u n til the Order is modified or revoked by EPA based on submission of that or other relevant info r mation. EPA encourages the Company to develop additional environmental and health effects testing in
coordination with other manufacturers of carbon nanotubes

. This can be done under the in

- depth portion of EPA’s Nanoscale Materials Stewardship Program or through independent testing. EPA
is willing to facilitate th e process in coordination with other ongoing environmental and health e ffects testing for the PMN substances nationally and internationally.

## CONSENT ORDER

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

- 10

- 0115, P

- 10

- 0116, P

- 10

- 011 7 , P

- 10

- 011 8 , P

- 10

- 011 9 , P

- 10

- 01 20 , P

- 10

- 01 21 , P

- 10

- 01 22 , P

- 10

- 01 23 , P

- 10

- 01 24 , P

- 10

- 01 25 , P

- 10

- 01 26 , generically described as carbon nanofibers (“CNFs ”) and specifically described by the physical

- chemistry properties in the Notice ( the “PMN substance s ” ) by [ ] (“the Company”), except to the extent that those activ ities are exempted by par a graph (b).

(b) Exemptions

extent that (1) these activities are conducted in full compliance with all applicab le requirements of the following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required in the Recordkeeping section of this Order. . Manufacturing, processing, distribution in commerce, use and disposal of the
PMN substance s are exempt from the requirements of this Order (except the requirements in the Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the2 (1) Completely Reacted , C ured , or Embedded

( 2 ) . The requirements of this Order do not a pp ly to quantities of the PMN substance s that are used solely for the uses authorized in par a graph ( b ) of the Manufacturing section and paragraph s (a) and (b) of the Processing/Use section of this
Order , after those quantities have been (i) completely reacte d (cured) ; (ii) incorporated or embe dded into a polymer matrix that itself has been reacted (cured) ; (iii) embedded in a perm a nent solid polymer , metal, glass, or ceramic form that is not intended to undergo further processing e x cept for
mechanical process ing ; or (iv) incorporated into an article as defined at 40 CFR 720.3(c)

. Export

( 3 ) . Until the Company begins commercial manufacture of the PMN substance s for use in the United States, the requirements of this Order do not apply to manufacture, proces sing
or distribution in commerce of the PMN substance s solely for export in accordance w ith TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to
manufacture the PMN substances for use in the United States, no furth er activit ies by the Company involving the PMN substances are exempt as “solely for export” even if some amount s of the PMN
substances are later exported. At that point, the requirements of this Order apply to all activities
associated with the PMN substa nces while in the territory of the United States. Prior to leaving U.S. territory, even those quantities or batches of the PMN substances that are destined for export are subject to terms of the Order, and count towards any production volume test triggers in the Testing section of this Order. Research & Development ( “ R&D ” ) . The requirements of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal of the PMN substances in small quantities solely for researc h and development in accordance with TSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CFR 720.36.3 ( 4 ) Byproducts

( 5 ) . The requirements of this Order do not apply to the PMN substances when they are produced, without separate commercial intent, only as “byproduct s ” a s defined at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). No Separate Commercial Purpose

(c) . The requirements of this Order do not apply to the
PMN substances when they are manufactured, pursuant to any of the exemptions in 40 CFR 720.30(h) , with no commercial purpose separate from the substance , mixture, or article of which they are a part.
Automatic Sunset . If the Company has obtained for the PMN substance s T est Market Exem ption s ( “ TME ” ) under TSCA §5(h)(1) and 40 CFR 720.38 or Low Volume Exemption s ( “ LVE ” ) or Low Release and Exposure Exemption s ( “ LoRE x” ) under TSCA §5(h)(4) and 40 CFR 723.50(c)(1) and (2) respectively, any such exemption is automatically rendered null and void as
of the effective date of this Consent Order

.

II. TE RMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION

The Company is prohibited from manufacturing, importing, processing, distributing in commerce, using, or dispo sing of the PMN substances in the United States, for any nonexempt commercial purpose, pending the development of information necessary for a reasoned evaluation
of the human health and environmental effects of the substances , and the completion of EPA’s r eview of, and regulatory action based on, that information, except in accordance with the conditions
described in this Order. PROHIBITION4

(a) TESTING Section 8(e) Reporting. Reports of information on the PMN substances which reasonably su pports the conclusion that the PMN substances present a substantial risk of injury to health or the environment and which is required to be reported under TSCA section 8(e) shall reference the a ppropriate PMN identification number for th e substances and contain a statement that the su b stan ces are subject to this Consent Order. Additional information regarding section 8(e) repor t ing r equir e ments can be found at www.epa.gov/oppt/tsca8e

.

(b) Notice of Study Scheduling. For toxicologi cal testing, t he Company shall notify, in writing, the EPA Laboratory Data Integrity Branch (2225A), Office of Enforcement and Compliance A ssurance, U.S. Enviro n mental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, of the follow ing information 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, whic h e ver is later (1) The date when the study is scheduled to commence;

:

(2) The name and address of the laboratory which will conduct the study; (3) The name and telephone number of a person at the Company or the laboratory whom EPA may contact regarding the study; and (4) The appropriate PMN identification number for the substance s and a st atement that the
substance s are subject to this Consent Order.5 (c) Good Laboratory Practice Standards and Test Protocols. Each study required to be performed pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific comm unity at the time the study is initiated. Before starting to conduct any such study, the Company must obtain approval of test protocols from EPA by submitting wr itten protocols. EPA will r espond to the Company within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (d) provide general guidance for development of test protocols, but are not themselves acceptable protoco ls. Approval of the test protocol does not mean pre

- acceptance of
test results.

(d) Triggered Testing Requirements.

( 1 ) The Company is prohibited from manufacturing or impor ting the PMN substances beyond the following time periods or aggregate manufactu re and import
volume s of all PMN substances combined ( collectively “the production limit”) , unless the Co m p any conducts the following tests on the PMN substances and/ or associated byproducts (as ident i fied from the workplace exposure monitoring and charact erization testing ) and submits all final reports and underlying data in accordance with the conditions specified in this Testing se c tion. Exposure and Toxicity Tests

. The production limit for these tests shall be calculated star ting two years after expiration of the PMN review period

. TABLE 3.

– Required Exposure and Toxicity Test s : Production Limit Test [ ] Guideline Workplace exposure monito ring and characterization tes ting (including byproducts) as well as quantification and characteriza tion of substances6 that may be released during exposures typical during the use phase , such as handling, tearing and cutting the PMN substances

. This should be conducted considering aggr egate exposures to all PMN substances, but with chara c te riz a tion of th e exposures to i ndividual su b stances/particles. [ ] or [ ] kg , whichever comes first. Using a representative PMN su b stance in the group P

- 10

- 0115, P

- 10

- 0116, P

- 10

- 0117, P

- 10

- 0118, P

- 10

- 0119, and P

10

- 01 20: a 90

- day inhalation toxicity test , with a post

exposure observ a tion period of up to 3 months , bronchoa l veolar la v age fluid (BALF) analysis, aggreg ation/agglomeration state, shape, size/size particle distribution and surface pro perties of materials as
administered, agg regation/ agglomeration state, shape, size/size particle distribution and surface properties of m aterials of the delivered mater ials after administration, d etermination of cardiovasc u lar toxicity , heart histopatho l ogy, and data on pulmonary depos ition

. OPPTS 870

. 3465

[ ] or [ ] kg , whic h ever comes first. Using a representative PMN su b stance in the group P

- 10

- 0121, P

- 10

- 0122, P

- 10

- 0123, P

- 10

- 0124, P

- 10

- 0125, and P

10

- 0126: a 90

- d ay inhalation toxi c ity test , with a post

exposure observ a tion period of up to 3 months , bronchoa l veolar la v age fluid (BALF) analysis, aggreg ation/agglomeration state, OPPTS 870

. 34657 shape, size/size particle distribution and surface pro perties of materials as

admini stered, aggregation/ agglomeration state, shape, size/size particle distribution and surface properties of m aterials of the delivered mater ials after administration, d etermination o f cardiovasc u lar toxicity , heart histopatho l ogy, and data on pulmonary depos ition

.
(2) Material Characterization and Physical

- Chemical Properties

.

**•** Within 1 year following a notice of commencement , by means of transmission electron m icroscopy (“TEM”) , scanning electron microscopy ( “ SEM ” ) , scanning transmission ele ctronic microscopy (“STEM”) plus X

- ray analys is [ T he Company must submit the following material characterization data on the PMN substances (including data summ a ries and
proc edures )

. Description of the physical

- chemical properties of the material tested and mat e rial
characterization tests should take into consideration the characterizations identified in the Gui dance Manual for Sponsors of the OECD Sponsorship Programme for t he Testing of Manufa c tured
Nanomaterials.

] , or other means acceptable to the Agency, the Company shall attempt to establish whether the chemical structure of their carbon nanofibers are stacked cups or bowls, scrolled sheets, ribbons, or a n other structure.

**•** Within 1 year following a notice of commencement, the Company shall conduct dustiness
studies utilizing DIN 15051 on PMN substances P

- 10

- 0119 and P

- 10

- 012 5.8

**•** Within 1 year following a notice of commencement, the Company shall measure or identify
the fo l lowing properties on PMN substances, P

- 10

- 0119, P

- 10

- 0121, P

- 10

- 0122, P

- 10

- 0123, P

- 10

- 0124, P

- 10

- 0125, and P

- 10

- 0126 :

TABLE 4.

– Required Propertie
Charac teristic or Property s : Guideline or method
Determine the nature of the fiber ends

– open, closed or both (in which case the Company
shall ide n tify the distribution of the fiber ends ) SEM, TEM , and/or STEM

Number of overlapping “walls” or layers from
the edge of the fiber to the core SEM, TEM, and/or STEM

Ring size/connectivity

- 5,6 and/or 7 or other SEM, TEM, and/or STEM Alignment of long “z” axis

- straight, bent, bucked, branched, hel i cal, or othe r SEM, TEM, and/or STEM

Presence, nature, and densit y of any ring d eformities Dry p article size of agglomerates via particle

count SEM, TEM, and/or STEM

Inside diameter of fiber (where no overlap of
the walls or layers occurs) SEM, TEM, and/or STEM

**•** Within 1 year following a notice of commencement, t he C ompany shall provide d etails about the catalyst(s) used including particle size and shape of the catalyst utilized in the9
manufacture of each PMN substance for P

- 10

- 0115 and P

- 10

- 0118. The company shall a lso pr o vide residual catalyst information (parti cle size, composition, nature of residue) on

su b stances P

- 10

- 0115, P

- 10

- 118, P

- 10

- 0124, P

- 10

- 0125, P

- 10

- 0126.

**•** Within 1 year following a notice of commencement, the Company shall provide details on the reasonably ascertainable chemical compositions (chemic al identity and percent of the substances in the encapsulation) of the substances encapsulating the PMN substances i ncluding thermosets, thermoresins, elastomers, glasses, me t als, and ceramics. ( e ) Test Reports.

word “should” in those subparagraphs sha ll be interpreted to mean “shall” to make clear that the submission of such information is mandatory. EPA will not require the submission of raw data such as slides and laboratory notebooks unless if EPA finds, on the basis of professional judgment,
that an adequate evaluation of the study cannot take place in the absence of these items. The Company shall: (1) conduct each stud y in good faith, with due care, and in a scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of each study; and (3) submit, in triplicate (with an additional sanitized copy, if confidential business i nformation is invo lved), the final report of each study and all underlying data (“the report and data”) to EPA no later than 14 weeks prior to exceeding the applicable production limit. The final report shall contain the contents specified in 40 CFR 792.185. Underlying da ta shall be submitted to EPA in accordance with the applicable “Reporting”, “Data and Reporting”, and “Test Report” subparagraphs in the applicable test guidelines. However, for purposes of this Consent Order, the

( f

) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) of this Testing section if notified in writing by EPA that it is unne cessary to conduct that study.10 ( g ) Equivocal Data. If EPA finds that the data generated by a study are scientifically equivocal, the Company may continue to manufacture and import the PMN substances beyond the applicable production limit. To seek reli ef from any other restrictions of this Order, the Company may make a second attempt to obtain unequivocal data by reconducting the study under the conditions spec ified in paragraphs (b), (c), and ( e )(1) and (2). The testing requirements may be modified, a s ne cessary to permit a reasoned evaluation of the risks presented by the PMN substance s , only by m utual consent of EPA and the Company.

( h) EPA Determination of Invalid Data. (1) Except as described in subparagraph ( h )(2) of this Section , if, within 6 weeks of EPA’s receipt of a test report and data, the Company receives written notice that EPA finds that the data generated by a study are scientifically invalid, the Company is prohibited from further manufacture and import of the PMN substances beyond the applicable production limit. (2) The Company may continue to manufacture and import the PMN substances beyond the applicable production limit only if so notified, in writing, by EPA in response to the Co m p any’s compliance with 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 the production limit as required by subparagraph ( e )(3)
of this Section , the Company shall comply with subparagraph ( e )(3) of this Section . If there is i nsufficient time for the Company to comply with subparagraph ( f )(3) of this Section , the Com pany may exceed the production limit and shall submit the report and data in triplicate to EPA within a reasonable period of time, all as specified by EPA in the notice described in subparagraph ( h )(1) of11
this Section . EPA will respond to the Company, in writing, within 6 weeks of receiving the Co mpany’s report and data. (ii) The Company may, within 4 weeks of receiving from EPA the notice described in subparagraph ( h )(1) of this Section , submit to EPA a written report refuting EPA’s finding.
EPA will respond to the Company, in writing, within 4 weeks of receiving the Company’s report.

( i ) Company Determination of Invalid Data. (1) Except as described in subparagraph ( i )(2) of this Section , if the Company becomes aware that circumstances clearly bey ond the control of the Company or laboratory will prevent, or have prevented, development of scientifically valid data under the conditions specified in par agraphs (c) and ( e ), the Company remains prohibited from further manufacture and import of the
PMN s ubstances beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks of first becoming aware of such ci rcumstances, a written statement explaining why circumstances clearly beyond the control of the Company or laboratory wil l cause or have caused development of scientifically invalid data. EPA will notify the Company of its response, in writing, within 4 weeks of receiving the Company’s report. EPA’s written response may either: (i) allow the Company to continue to manufac ture and import the PMN substances beyond the applicable production limit, or (ii) require the Company to continue to conduct, or to reconduct, the study in co mpliance with paragraphs (b), (c), and ( e )(1) and (2). If there is sufficient time to conduct o r

reco n duct the study and submit the report and data to EPA at least 14 weeks before exceeding the
pr o duction limit as required by subparagraph ( e )(3) of this Section , the Company shall comply12 with subparagraph ( e )(3) of this Section . If there is insuffic ient time for the Company to comply with subparagraph ( e )(3) of this Section , the Company may exceed the production limit and shall

su b mit the report and data in triplicate to EPA within a reasonable period of time, all as specified by EPA in the notice de scribed in subparagraph ( i )(2) of this Section . EPA will respond to the
Co m pany, in writing, within 6 weeks of receiving the Company’s report and data, as to whether the Company may continue to manufacture and import beyond the applicable production limit

.

( j ) Unreasonable Risk. (1) EPA may notify the Company in writing that EPA finds that the data generated by a study are scientifically valid and unequivocal and indicate that, despite the terms of this Order, the
PMN substances will or may present an unreasonable risk of injury to human health or the env ironment. EPA’s notice may specify that the Company undertake certain actions concerning fu rther testing, manufacture, import, processing, distribution, use and/or disposal of the PMN su bstances to mi tigate exposures to or to better characterize the risks presented by the PMN su b stan ces . Within 2 weeks from receipt of such a notice, the Company must cease all manufacture, i mport, processing, distribution, use and disposal of the PMN substance s , unless either: (2) within 2 weeks from receipt of the notice described in subparagraph ( j )(1) of this Se ction , 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) of this Se ction , the Company submits to EPA a written report refuting EPA’s finding and/or the appropriat eness of any additional requirements imposed by EPA. The Company may continue to manufa cture, import, process, distribute, use and dispose of t he PMN substances in accordance with the terms of this Order pending EPA’s response to the Company’s written report. EPA will respond to13 the Company, in writing, within 4 weeks of receiving the Company’s report. Within 2 weeks of receipt of EPA’s written response, the Company shall comply with any requirements imposed by EPA’s response or cease all manufacture, import, processing, distribution, use and disposal of the
PMN substance s
.

( k ) Other Requirements. Regardless of the satisfaction of any other c onditions in this Testing se ction, the Company must continue to obey all the terms of this Consent Order until otherwise not ified in writing by EPA. The Company may, based upon submitted test data or other relevant i nformation, petition EPA to modify or r evoke provisions of this Consent Order pursuant to Part VI
of this Consent Order.

(a) PROTECTION IN THE WORKPLACE Establishment of Program.

(1) The Company shall determine and implement the minimum dermal and respiratory
p ersonal protective equipment requirements for the different forms of the PMN substance s accor ding to the following table: During manufacturing, processing, and use of the PMN substances at any site controlled by the Company (including any associated packaging and storage and during any cleaning or maintenance of equipment associated with the PMN substance s ), the Company must establish a program whereby:14
Table 5.
- Applicable Protective Requirements for Different Forms of the PMN Su b stance s

( 2 ) General Dermal Protection. Physical Forms

E ach person who is reasonably likely to be dermally e xposed in the work area to the PMN substances through direct ha n dling of the substance s or through

con tact with equipment on which the substances may exist, is required to wear, at a minimum, pe rsonal protective equipment that provides a barrier to prevent dermal exp o sure to the substance s , as specified in the minimum dermal protection column of T able 5 , i n the sp e cific work area where the
substance s are selected for use. Each such item of personal protective equipment must be selected
and used in a c cordance with OSHA dermal protection requirements at 29 CFR 1910.132, Maximum c oncentr ation of the PMN su bstances Minimum Dermal Protection
Powdered Minimum Respir a t ory Protection [ ] Full general and sp ecific dermal protection required in paragraphs ( a ) (2) and ( a ) (3). Respiratory protection required in paragraph ( a ) (5)

. Liquid polymer form Less than or equal to [ ] Full general and sp ecific dermal protection required in paragraphs ( a ) (2) and ( a ) (3). None required pr o vi ded there is no ge n er ation of vapor, mist, or aerosol in a non

enclosed process and the con centration of the PMN su b stances is less than or equal to , otherwise respir a tory protection r e quired in paragraph ( a ) (5) Solid polymer form Less than or equal to [ ] If there is no gener ation of dust and the concentration of the PMN substance s are less than or equal to , none required. Othe rwise, full general and specific dermal prote ction required in par agraphs (a) (2) and ( a ) (3). If there is no gener ation of dust in a non

enclosed process and the concentration of the PMN su b stance s is less than or equal to , none require d. Ot herwise, respiratory protection required in paragraph ( a ) (5).15 1910.133, and 1910.138. ( 3 ) Specific Dermal P rotective Equipment

(i) Gloves impervious to the PMN substance s
. . When required by T able 5 , t he dermal pe rsonal protective equipment must include, but is not limited to, the fo l lowing items :

(ii) F ull body clothing impervious to th e PMN substance s
. ( 4 ) Demonstration of Imperviousness.

(i) The Company must be able to demonstrate that
each item of chemical protective clothing selected, including gloves, provides an impervious ba r r ier to pr e vent dermal exposure during normal and expected duration and conditions of exposure within the work area by any one or a combination of the following:
Permeation T e sting

. Testing the material used to make the chemical protective clothing and the construction of the clothing to establish that th e protective clothing will be impe rvious for the expected duration and conditions of exposure. The testing must subject the chemical
pr o tective clothing to the expected conditions of exposure, including the likely combinations of
chemical substance s to wh ich the clothing may be exposed in the work area. T esting may be co nducted a c cording to the American Society for Testing and Materials ( “ ASTM ” ) F739 “Standard Test Method for Resistance of Protective Clothing materials to Permeation by Liquids or Gases.” Results shall be recorded as a cumulative permeation rate as a function of time, and shall be doc umented in accordance with ASTM F739 using the format specified in ASTM F1194

- 89 “Guide for Documenting the Results of Chemical Permeation Testing on Protecti ve Clothing Materials.” Testing may also be conducted according to the ASTM F1671

- 07 “Standard Test Method for R esistance of Materials Used in Protective Clothing to Penetration by Blood

- Borne Pathogens Using
Phi

- X174 Bacteriophage Penetration as a Test System”

. 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 during16 which they are exposed to the PMN substance s
. (i i ) Manufacturer’s Specifications

( 5 ) . Evaluating the specificatio ns from the manufa cturer or supplier of the chemical protective clothing, or of the material used in construction of the clothing, to establish that the chemical protective clothing will be impervious to the PMN su bstances alone and in likely combination w ith other chemical substances in the work area. Respiratory Protection.

( 6 ) When required by T able 5 , each person who is reasonably likely to be exposed by inhalation in the work area to the PMN substance s is provided with, and is r equired to wear, at a minimum, a NIOSH

- certified respirator from the respirators listed in subpar agraph (a)( 6 ) of this se c tion, and the respirator is used in accordance with the Occupational Safety
and Health Administr a tion (“ OSHA ”) and NIOSH respiratory protection require ments at 29 CFR
1910.134 and 42 CFR Part 84. “Reasonably likely to be exposed by inhalation” includes, but is not limited to, any worker in the work area during activities (including a reasonable time p e riod following any such activities) involving handl ing quantities of the non

- exempt PMN su b stances by manufacturing, cleaning, harvesting, cutting, loading, and unloading, and maintaining machines in
or on enclosed areas. All respirators must be issued, used, and maintained according to an appr opriate res piratory protection program under the OSHA requirements in 29 CFR 1910.134. Authorized Respirators. meet the minimum requirements for subparagraph (a)( 5 ) of this section: NIOSH

- certified air

purifying, ti ght

- fitting full

- face respirator equipped with N

- 100 , P

- 100, or R

- 100 filter with an APF of 50 or greater

. The following NIOSH

- certified respirators

MANUFACTURING17 (a)(1) Prohibition.

(2) The Company shall not cause, encourage, or suggest the manufacture or import
of the PMN substances by any other person. Sunset Following SNUR.

(3) Subparagraph (a)(1) of this Section shall expire 75 days after promulgation of a final significant new use rule (“SNUR”) governing the PMN substances under section 5(a)(2) of TSCA unless the Company is notified on or before that day of an action in a Federal Court seeking judicial review of the SNUR. If the Company is so notified, subparagraph (a)(1) shall not expire until EPA notifies the Company in writing that all Federal Court actions i nvolving the SNUR have b een resolved and the validity of the SNUR affirmed.
Notice of SNUR. When EPA promulgates a final SNUR for the PMN substances and su bparagraph (a)(1) of this Section expires in accordance with subparagraph (a)(2) of this Section , the Company sha ll notify each person whom it causes, encourages or suggests to manufacture or i mport the PMN substances of the existence of the SNUR.

( b ) (1) The Company shall not m anufacture or import the PMN substance s for use other than as an : (i) Electrical and thermal conductivity additive in en capsulated thermoplastics, ther mosets,
ela s tomers, glass, metals, and ceramics; (ii) Mechanical reinforcement additive in encapsulated thermoplastics, thermoset s, elasto m ers, glass, metals, and ceramics; (iii) Energy storage additive; or (iv) Chemical intermediate. ( 2 ) The Company shall not use the PMN substance for non

- industrial applications

.

(c ) Sample. The Company shall provide to EPA a 1 gram sample of each of the PMN substance s18 as specified by EPA in a future written reques t along with a copy of the MSDSs for the su b stance s
.

(a) The Company shall not process or use the PMN substance s other than as : PROCESSING AND USE

( 1 ) Electrical and thermal conductivity additive in encapsulat ed thermoplastics, therm osets, ela s tomers, glass, metals, and ceramics; ( 2 ) Mechanical reinforcement additive in encapsulated thermoplastics, thermosets, ela s t omers, glass, metals, and ceramics; ( 3 ) Energy storage additive; or ( 4 ) Chemical intermediate.

(b) The Company shall not use the PMN substance for non

- industrial applications

.

(a) DISTRIBUTION Export Notice Requirement

. No later than the date of distribution, the Company shall notify in writing an y person to whom it distributes the PMN substances (a Distributee) that, due to the iss uance of this Consent Order under section 5(e) of TSCA, the PMN substances are subject to the e xport notification requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D. Such n otice shall contain, in the form in which they appear in the Consent Order, the following info rm a tion: (1) the PMN number ( s ) and (2) either (A) the specific chemical identity( ies ) of the chem ical substances, or (B) if the specific chemica l identity( ies ) are confidential, the generic chemical
ide n tit ( ies )

.19 (b) Types of Distributees . This Distribution section authorizes the Company to distribute the PMN substances to three types of Distributees: (1) Distributees who will further distri bute the PMN substances only when the PMN substances are in a n exempted or mitigated state, as defined in paragraph (c); (2) Distributees who will further distribute the PMN substances in a non

exempted and unmitigated state after the attached Consent Orde r for Processor expires , 75 days after promulgation of a final SNUR governing all of the PMN substances ; and (3) Distributees
who will further distribute the PMN substances in a non

- exempted and unmitigated state before the
attached Consent Order for Proce ssor expires , 75 days after promulgation of a final SNUR gover ning all of the PMN substances . The distribution requirements for the first two Distributees are identical and are stated in paragraph (e) below. The third type of Distributee must sign the a ttached Consent Order for Processor, as specified in paragraph (f) below.

(c) (1) Mitigated and Exempted States of the PMN Substances

. Exempted State of the PMN Substances

.

(i) completely reacted (cured) ; As described in Section I of this Order Scope o f Applicability and Exemption s paragraph (b) (1) , the provisions of this Order d o not apply to quant ities of the PMN substances after they have been :

(ii) incorporated or embedded into a polymer matrix that i t self has been reacted (cured) ; (iii) embedd ed in a permanent solid polymer, metal, glass, or ceramic form that is not i ntended to undergo further processing except for mechanical processing; or (iv) incorporated into an article as defined at 40 CFR 720.3(c)

.

(2) Mitigated States of the PMN Su bstances

. F or purposes of further distribution, t he PMN20
substances shall be considered to be in a “mitigated state” when the PMN su b stances are: (i) incorporated or embedded in a solid polymer form with a concentration of the PMN
substances equal to or b elow [ ]

.

(d) Temporary Transport and Storage.

(1) Subsequent to any such temporary transport or storage of sealed containers, the PMN substances may be distributed only to the Company or to a Distributee compliant with par a graph (e) or (f). Notwithstanding paragraphs (e) and (f) in this Distribution section, the Company may distribute the PMN substances outside the Company for temporary transport and storage in sealed containers provided the following two conditions are met:

(2) Any human exposure or environmental release resulting from opening the sealed co ntainers and removing or washing out the PMN substances may occur only while the PMN su bstances are in the possession and control of the Company or a Distributee compliant with par agraph (e) or (f).

(e) Distribution Requirements in the Absence of Processor Order

(1) Notify in writing any person to whom it distributes the PMN substances that, due to the
issuance of this Consent Order under section 5(e) of TSCA, the PMN substances are subject to the . Except when the PMN su bstances are in a exempted or mitigated state as described in paragraph (c) above, or as provided in the Temporary Transport and Storage paragraph (d) above, or for Distributees who sign Processor Orders as described in paragraph (f) below, the Company shall distribute the PMN substances ou tside the Company, other than for disposal, only to a Distributee who has agreed in writing prior to the date of distribution, to:21 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 appears in this Consent Order, the following info rm a tion: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN su bstances , or (B) if the specific chemical identity is confidential, the generic chemical identity. ( 2 ) Not further distribute the PMN substances , to any other person, other than for disposal,
until after the PMN substance s are in an exempted or mitigated state as de fined in subpar a graph (c)
of this Section

. Thus, further distribution for processing and use may occur once the PMN su bstance s are in an exempted or mitigated state. ( 3 ) Comply with the same requirements and restrictions required of the Company in the Protection in the Workplace s ection. ( 4 ) Not process or use the PMN substances other than as : (i) Electrical and thermal conductivity additive in encapsulated thermoplastics, therm osets, elastomers , glass, metals, and c e ramic s; (ii) Mechanical reinforcement additive in en capsulated thermoplastics, thermosets, ela stomers, glass, metals,. and ceramics; (iii) Energy storage additive; and (iv) Chemical intermediate. (5) Limit us e of the PMN substance s to industrial applications

. ( 6 ) Comply with the same environme ntal release restrictions required of the Company in the
Release to Water Section of the Order.

(f) Consent Order for Processor

.22 (1) If the Company distributes the PMN substances to Distributees who will further di stribute the PMN substances in a non
- exempted and unmitigated state before the attached Co n sent Order for Processor expires , 75 days after promulgation of a final SNUR governing all of the PMN substances, the Company shall distribute the PMN substances outside the Company, other than for disposal, only to a Distributee who has signed the Consent Order for Processor in Attac h ment C to this Order (a “Processor”). (2) The Company shall obtain from each such Processor a signed copy of the Consent O rder for Processor and submit th is copy to E PA along with the name, address, and telephone nu mber of a responsible official of the Processor. The Processor or Company must receive a fully ex ecuted copy of the Consent Order for Processor from EPA before the Processor may begin to pr oc ess any of the PMN substances.

(g) Sunset following SNUR

. (1) If the Company distributes the PMN substances to Distributees who will further di stribute the PMN substances in a non

- exempted and an unmitigated state before the attached Co nsent Order for Processor expires , 75 days after promulgation of a final SNUR governing all of the PMN substances, the Company shall distribute the PMN substances, other than for disposal, only to processors who have signed the attached Consent Order for Processor in accordance with par agr aph (f) of this Distribution section. After the attached Consent Order for Processor expires 75 days after promulgation of a final SNUR governing all of the PMN substances, the Company shall distribute the PMN substances only to Distributees who comply wi th the requirements specified in paragraph (e) of this Distribution section. (2) Paragraphs (e) and (f) of this Distribution section shall expire 75 days after promulg a-23 tion of a final SNUR for the PMN substances under section 5(a)(2) of TSCA, unless the Company is notified on or before that day of an action in a Federal Court seeking judicial review of the SNUR. If the Company is so notified, paragraphs (e)(2) and (f) of this Distribution section shall not expire until EPA notifies the Company in writin g 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 substances and paragraph (e) of this Distribution section expires in accordance with subparagr aph (g)(2), the Company shall notify
each Distributee to whom it distributes the PMN substances of the existence of the SNUR. Such notification must be in writing and must specifically include all limitations contained in the SNUR which are defined as sig nificant new uses, and which would require significant new use notific ation to EPA for the PMN substances. Such notice must also reference the publication of the SNUR
for these PMN substances in either the Federal Register or the Code of Federal Regul a tio ns. After promulgation of a SNUR and expiration of paragraphs (e)(2) and (f), such notice may subst i tute for the written agreement required in the introductory clause of paragraph (f); so that, if the Co mpany provides such notice to the Distributee, then the Company is not required to obtain from such Distributee the written agreement specified in paragraph (e). However, even absent such written agreement, the Company remains obligated to comply with the “Recipient Non

- Compliance” pa ragraph (h) below.

(h ) Recipient Non

- Compliance. If, at any time after commencing distribution in commerce of the PMN substances, the Company obtains knowledge that a recipient (including a Processor) of the PMN substances has failed to comply with any of the applicable cond itions specified in paragraphs (e) or (f) of this Distribution section or, after paragraphs (e) or (f) expires in accordance with par a-24 graph (g)(2), has engaged in a significant new use of the PMN substances (as defined in 40 CFR Part 721, Subpart E) withou t submitting a significant new use notice to EPA, the Company shall cease supplying the substances to that recipient, unless the Company is able to document each of the following: (1) That the Company has, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any of the applicable conditions specified in paragraphs (e) or (f) of this Distribution section, or has engaged in a significant new use of the PMN substances without submitting a significant new use no tice to EPA. (2) That, within 15 working days of notifying the recipient of the noncompliance, the Company received from the recipient, in writing, a statement of assurance that the recipient is aware of the applicable terms of paragraphs (e) or (f) of th is Distribution section and will comply with those terms, or is aware of the terms of the significant new use rule for the PMN substances and will not engage in a significant new use without submitting a significant new use notice to
EPA. (3) If, after re ceiving a statement of assurance from a recipient under subparagraph (h)(2) of this Distribution section, the Company obtains knowledge that the recipient has failed to comply with any of the applicable conditions specified in paragraphs (e) or (f) of this Distribution section, or has engaged in a significant new use of the PMN substances without submitting a significant new use notice to EPA, the Company shall cease supplying the PMN substances to that recipient, shall notify EPA of the failure to comply, and shall resume supplying the PMN substances to that recipient only upon written notification from the Agency.25

This provision does not supersede or preempt any applicable federal, state, and local laws and re gulations. (Those other law s may be more stringent than the requirements below.) The Co m pany is prohibited from any predictable or purposeful release of the PMN substance s , or any waste stream from processing and use containing the PMN substances into the waters of the United State s
. RELEASE TO WATER

III. (a) RECORDKEEPING
Records.

(1) After the effective date of this Order and, consistent with any other requirements u nder TSCA, the Company shall maintain the following records until 5 years after the date they are
created and shall make them availab le for inspection and copying by EPA in accordance with se ction 11 of TSCA: Exemptions . Records documenting that the PMN substances did in fact qualify for any one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such re cords must satisfy all the statutory and regulatory recordkeeping requirements applicable to the exem ption being claimed by the Company. Any amounts or batches of the PMN substances eligible for the Export exemption in Section I, Paragraph (b)( 2 ) of this Order, are exempt from all the requir ements in this Recordkeeping section, if the Company maintains, for 5 years from the date of their creation, copies of the export label and export notice to EPA, required by TSCA sections 12(a)(1)(B) and 12(b), respecti vely. Any amounts or batches of the PMN substances eligible for the Research and Development exemption in Section I, Paragraph (b)( 3 ) of this Order, are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the date of their creation, the records required by 40 CFR 720.78(b). For any amounts or
batches of the PMN substances claimed to be eligible for any other exemption described in Section26 I, Paragraph (b) of this Order, the Company shall keep records demonstrating qualification for that exemption as well as the records specified in paragraphs (2) and (3) below, but is exempt from the other recordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture and importation volume of the PMN substances and the corresponding dates of manufacture and import; (3) Records documenting the names and addresses (including shipment destination a ddress, if different) of all persons outside the site of manufacture or import to whom th e Company directly sells or transfers the PMN substance s , the date of each sale or transfer, and the quantity of
the substances sold or transferred on such date; (4) Records documenting the address es of all sites of manufacture, import, processing, and

use ; (5) Records documenting establishment and implementation of a program for the use of any applicable personal protective equipment required pursuant to the Protection in the Workplace
section of this Order ; (6) Records documenting the determinations req uired by the Protection in the Workplace section of this Order that chemical protective clothing is impervious to the PMN substance s ; (7) Records documenting compliance with any applicable manufacturing, processing, and
distribution restrictions in the M anufacturing, Processing and Use , and Distribution sections of this Order, including distributees’ written agreement to comply with the Distribution section of this
O r der;

(8) Copies of any Transfer Documents and notices required by the Successor Liabi lity section of this Order, if applicable; and27 (9) The Company shall keep a copy of this Order at each of its sites where t he PMN su bstances are manufactured of imported.

(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities of the Company and its Contract Manufacturer, if applicable, and not to activities of the Co m p any’s customers.

(c) OMB Control Number. 1320, particularly 5 CFR 1320 .5(b), the Company is not required to respond to this “collection of information” unless this Order displays a currently valid control number from the Office of Ma nagement and Budget ( “ OMB ” ), and EPA so informs the Company. The “collection of info rm a tion” required in this TSCA §5(e) Consent Orders has been approved under currently valid
OMB Control Number 2070
- 0012. Under the Paperwork Reduction Act and its regulations at 5 CFR Part

IV. REQUESTS FOR PRE
- INSPECTION INFORMATION (a) EPA’s Request for Information

(i) Expected dates and times when the PMN substances will be in production within the subsequent 12 months; . Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA
may oc c asionally conduct on

- site compliance inspections of Company facilities and conveyances
associated with the PMN substance s . To facilitate such inspections, EPA personnel may contact the Company in advance to request information pertinent to the schedul ing and conduct of such inspections. Such requests may be written or oral. The types of information that EPA may request may include, but are not limited to, the following:28 (ii) Current workshift schedules for workers who are involved in activities associated with
the PMN substances and may reasonably be exposed to the PMN substance s ; (iii) Current job titles or categories for workers who are invol ved in activities associated
with the PMN substances and may reasonably be exposed to the PMN substance s ; (iv) Existing exposure monitoring data for workers who are involved in activities assoc i a ted with the PMN substances and may reasonably be exposed to the PMN substance s ; (v) Records required by the Recordkeeping section of this Order; and/or (vi) Any other information reasonably related to determining compliance with this Order or conducting an inspection for that purpose.

(b) Company’s Response . The Company shall respond to such requests within a reasonable period of time, but in no event later than 30 days after receiving EPA’s request. When requested in wri ting by EPA, the Company’s response shall be in writing. To the extent the information is kn own to or reasonably ascertainable to the Company 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 Information ( “ 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 ORDER29 (a) Scope. This secti on sets forth the procedures by which the Company’s rights and obligations under this Order may be transferred when the Company transfers its interests in the PMN su bstance s , including the right to manufacture the PMN substance s , to another person outside the Company (the “Successor in Interest”).

(b) (1) Relation of Transfer Date to Notice of Commencement (“NOC”).
Before NOC.

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

(c) Definitions. (1) “Successor in Interest” means a person outside the Company who has acquired the Company’s full interest in the rights to manufacture the PMN su bstance s , including all ownership rights and legal liabilities, through a transfer document signed by the Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest of the Compan y in the PMN substance s , such as a licensee who has acquired a limited l icense to the patent or manufacturing rights associated with the PMN substance s . A Successor in Interest must be incorporated, licensed, or doing business in the United States in acco rdance with The following definitions apply to this Successor Liability section of the Order:30 40 CFR 720.22(a)(3). (2) “Transfer Document” means the legal instrument(s) used to convey the interests in the
PMN substance s , including the right to manufacture the PMN substance s , from the Company to
the Successor in Interest.

(d) (1) Notices.
Notice to Successor in Interest.

(2) On or before the effective date of the transfer, the Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent O rder and the “Notice of Transfer” document which is incorporated by reference as Attachment B to
this Order.
Notice to EPA.

(3) Within 10 business days of the effective date of the transfer, the Co mpany shall, by registered mail, submit the fully executed Notice of Transfer document to: U.S. E nvironmental Protection A gency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460.
Transfer Document. Copies of the Transfer Document must be maintained by the Su ccessor in Interest at its principal place of business, and at all sites where the PMN substances are manufactured or imported. Copies of the Transfer Document must also be made available for i nspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must co ntain provisions which expressly transfer lia bility for the PMN substances under the terms of this Order from the Company to the Successor in Interest.

(e) Liability.31 (1) The Company shall be liable for compliance with the requirements of this Order until
the effective date of the transfer descri bed 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 construed to prohibit the Agency from taking enforc ement action against the Company after the effective date of the transfer for actions taken, or omi ssions made, during the time in which the Company manufactured, processed, used, distributed in commerce, or disposed of the PMN substances pursuant to the terms of this Consent Order.

(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing section of this Consent Order requires the Company to submit test data to EPA at a specified production volume (“test trigger”), the aggregate volume of the PMN substances manufactured and imported by the Company up to the date of transfer shall count towards the test trigger applicable to the
Successor in Interest.

VI. The Company may petition EPA at any t ime, based upon new information on the health e fMODIFICATION AND REVOCATION OF CONSENT ORDER32 fects of, or human exposure to, the PMN substance s , to modify or revoke substantive provisions of this Order. The exposures and risks identified by EPA during its review of the PMN substances
and the informa tion EPA determined to be necessary to evaluate those exposures and risks are d escribed in the preamble to this Order. However, in determining whether to amend or revoke this Order, EPA will consider all relevant information available at the time the Agen cy makes that d etermination, 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 other information or analysis, and any other relevant information

. EPA will issue a modification or revocation if EPA determines that the activities proposed therein will not present an unreasonable risk of injury to health or the environment and will not result in significant or substantial human exposure or substantia l environmental release in the a bsence of data sufficient to permit a reasoned evaluation of the health or environmental effects of
the PMN substance s
. In addition, the Company may petition EPA at any time to make other modifications to the language of thi s Order. EPA will issue such a modification if EPA determines that the modification is useful, appropriate, and consistent with the structure and intent of this Order as i ssued.33

(a) VII . EFFECT OF CONSENT ORDER
Waiver.

(b) By consenting to the entry of this Order, the Company waives its rights to file obje ctions to this Order pursuant to section 5(e)(1)(C) of TSCA, to receive service of this Order no later than 45 days before the end of the review period pursuant to section 5(e)(1)(B) of TSCA, and to
challen ge the validity of this Order in any subsequent action. Consenting to the entry of this O rder, 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 determinations in th is proceeding. This waiver does not affect any other rights that the Company may have under TSCA.
CBI Brackets

. By signing this Order, the Company represents that it has carefully reviewed this document and hereby agrees that all information herein that is claimed as confidential by the
Co m pany (per section 14 of TSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) is correctly
ident i fied within brackets and that any information that is not bracketed is not claimed as confide ntial. To make this docum ent available for public viewing, EPA will remove only the information

co n tained within the brackets

.

_________________ ________________________________ Date Jim Willis, Director Chemical Control Division Office of Pollution Prevention and Toxics

___________________ ________________________________ Date Name: [ ] T itle: [ ] C ompany: [ ]ATTACHMENT A
DEFINITIONS [Note: The attached Order may not contain som e of the terms defined below.] “Chemical name” means the scientific designation of a chemical substance in accordance with the nomenclature system developed by the International Union of Pure and Applied Chemi stry or the Chemical Abstracts Service’s rule s of nomenclature, or a name which will clearly ide n t ify 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 chemi cal substance of concern. Examples can include, but are not limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. “Company” means the person or persons subject to this Order.
“Commercial use” means the use of a chem ical substance or any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment or painting contractor). “Common name” means any designation or i dentification 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 co nta ining the chemical substance in or around a permanent or temporary household or residence, du ring recreation, or for any personal use or enjoyment. “Consumer product” means a chemical substance that is directly, or as part of a mixture, sold or made avai lable to consumers for their use in or around a permanent or temporary hous ehold 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 c ontains 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, outside the Company, who is authorized to manufacture and import the PMN substances under the conditions specified in Part II. of this Co nsent Order and in the Consent Order for Contract Manufacturer. “Identity” means any chemical or common name used to identify a chemical sub stance 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 transferred it from a labeled container and will only be used by t hat person within the work shift in which it is transferred from the labeled co ntainer. “Impervious.” Chemical protective clothing is “impervious” to a chemical substance if the substance causes no chemical or mechanical degradation, permeation, or pen etration of the chem ical protective clothing under the conditions of, and the duration of, exposure. “Manufacturing stream” means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless of physical state or concentrati on, through all intended operations of manufacture, including the cleaning of equipment. “MSDS” means material safety data sheet, the written listing of data for the chemical su bstance. “NIOSH” means the National Institute for Occupational Safety and H ealth of the U.S. D epartment of Health and Human Services.
“Non

- enclosed process” means any equipment system (such as an open

- top reactor, storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where s ignificant direct contact of the bulk chemical substance and the workplace air may occur. “Non

- industrial use” means use other than at a facility where chemical substance s or mi xtures are manufactured, imported, or processed.
“PMN substance s ” means the chemical substance s described in the Premanufacture notice submitted by the Company relevant to this Order. “Personal protective equipment” means any chemical protective clothing or device placed on the body to prevent contact with, and exposure to, a n identified chemical substance or substance 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. B arrier creams are not included in this definition. “Process stream” means all reasonably anticipated transfer, flow, or disposal of a chemical substance, regardless of physical state or concentration, through all intended operations of pr oces s ing, includ ing the cleaning of equipment. “Scientifically invalid” means any significant departure from the EPA

- approved protocol or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency approval that prevents a reasoned evalu ation of the health or environmental effects of the PMN substance.3

“Scientifically equivocal data” means data which, although developed in apparent confo r mity with the Good Laboratory Practice Standards and EPA

- approved protocols, are inconclusive, inte rnally inconsistent, 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 that is physically and chemically suitable for long

- term containment of the PMN substance, and from which there will be neither human exp osure to, nor environmental release of, the PMN substances during transport and storage. “Use stream” means all reasonably anticipated transfer, flow, or disposa l of a chemical substance, regardless of physical state or concentration, through all intended operations of indu strial, 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 d efined space in a workplace where the PMN substances is manufactured, processed, or used and where employees are present. “Workplace” means an establishment at one geographic location containing one or more work areas.ATTACHMENT B
NOTICE OF TRANSFER O F TOXIC SUBSTANCE CONTROL ACT SECTION 5(e) CONSENT ORDER

___________________________ _________________ Company (Transferor) PMN Number
1. Transfer of Manufacture Rights. Eff ective on _______________, the Company did sell or ot herwise transfer to ________________________________, (“Successor in Interest”) the rights and liabilities associated with manufacture of the above

- referenced chemical substance s , which was the subject o f a premanufacture notice ( “ PMN ” ) and is governed by a Consent Order issued by the U.S. Environmental Protection Agency ( “ EPA ” ) under the authority of §5(e) of the Toxic Su bstance Control Act (TSCA, 15 U.S.C. §2604(e)).
2. Assumption of Liability.

incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(a)(3). The S uccessor in Interest hereby certifies that, as of the effective date of transfer, all actions or omissions governed by the applicable Consent Order limiting manufa cture, processing, use, distribution in commerce and disposal of the PMN substances , shall be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is

3. Confidential Business Information. ___ reasserts, The Successo r in Interest hereby: ___ 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 “relinquishe s” is indicated, that designation shall be deemed to apply to all such claims. Where “modifies” is ind icated, such modification shall be explained in detail in an attachment to this Notice of Transfer. Information which has been previously disclosed to t he public (e.g., a chemical identity that was not claimed as CBI by the original submitter) would not subsequently be eligible for confidential treatment under this Notice of Transfer.2

TOXIC SUBSTANCE CONTROL ACT SECTION 5(e) CONSENT ORDER
NOTICE OF TRANSFER (cont inued )

__________________________________ _____________________ Company (Transferor) PMN Number

___________________________________ _____________________ Signature of Authorized Official Date

____________________________________ Printed Name of Authorized Official

___________________________________ Title of Authorized Official

___________________________________ Successor in Interest

___________________________________ _____________________ Signature of Authorized Official Date

___________________________________ Printed Name of Authorized Official

___________________________________ Title of Aut horized Official

___________________________________ Address

___________________________________ City, State, Zip Code3

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

__________________________________ Successor’s Technical Contact

___________________________________ Address

___________________________________ City, State, Zip Code

___________________________________ Phon e