UNITED STAlES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) Premanufacture Notice Numbers: 

) 

) 

) CONTAINS NO 

) CBI 

) 

Trinity Manufacturing Inc. ) P-12-0539 

P-13-0107 

) P-13-OI09 

) 

) 

) 

) 

Consent Order and Determinations Supporting Consent Order 
11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms of the Order 

III. Contents of PMN 

IV. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

II. Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal 

Pending 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 Order 

VII. Effect of Consent Order 

Attachment A - Defmitions 

Attachment B - Notice of Transfer of Consent Order 
111 

PREAMBLE 

I. INTRODUCTION 

Under the authority of § 5(e) of the Toxic Substances Control Act ("TSCA") (15 U.S.C . 

. 2604( e)), the Environmental Protection Agency ("EPA" or "the Agency") issues the attached 

Order, regarding premanufacture notices ("PMNs") and associated chemical substances (the 

"PMN substances"): 

P-12-0539: Alkanes, CZI-34 - branched and linear, chIoro (CASRN: 139-2825-28-3); 

P-13-0107: Alkanes, Cll-30 - branched and linear, chIoro (CASRN: 1401947-24-0); and 

P-13-0109 Alkanes, CZ4-Z8, chIoro (CASRN: 1402738-52-6) 

submitted by Trinity Manufacturing Inc. ("the Company"), to take effect upon expiration of the 

PMN review periods, respectively. The Company submitted the PMN s to EPA pursuant to § 

5(a)(l) ofTSCA and 40 CFR Part 720. 

Under § 15 of TSCA, it is unlawful for any person to fail or refuse to comply with any 

provision of § 5 or any order 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 sei=e 

pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 of 

TSCA, such as this one, are subject to the § 12(b) export notice requirement. 

II. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for these PMN substances requires the Company to: 

(a) submit to EPA certain phased fate and toxicity testing before exceeding certain production 

volume limits; 
IV 

(b) not manufacture any of the PMN substances with greater than I weight percent ("wt%") of 

chlorinated ("CI") paraffins with an alkyl chain:S 20; and 

(c) maintain certain records. 

III. CONTENTS OF PMN 

By signing this Order, the Company represents that it has carefully reviewed this document and 

hereby agrees that no information herein is claimed as confidential business information ("CBI") 

by the Company (per § 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2). EPA will 

make this document available for public viewing. 

CBI Claims (Bracketed in the Preamble and Order): 

No CBI claims. 

Specific Chemical Identitv, Uses and Production Volume: 

PMN Chemical Identity Uses Maximum 12-

Month 

Production 

Volume (kg) 

P-12-0539 Alkanes, C21-34 - branched and • Extreme pressure additive 2,500,000 

linear, chloro (CASRN: 139- for lubricants 

2825-28-3) • Flame retardant for rubber 

P-13-0107 Alkanes, C22-30 - branched and • Flame retardant for rubber 500,000 

linear, chloro (CASRN: 

1401947-24-0) 

P-13-0109 Alkanes, C24-28, chloro • Extreme pressure lubricant 1,000,000 

(CASRN: 1402738-52-6) in metal working fluids 

• Flame retardant/plasticizer 

in polymers/plastics 

Test Data Submitted with PMNs: None 
v 

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK 

The following are EPA's predictions regarding the probable human and environmental 

toxicity, human exposure, and environmental release of the PMN substances, based on the 

information currently available to the Agency. 

Persistent, Bioaccumulative, and Toxic Concerns: 

When released to the environment, very long chain chlorinated paraffins ("vLCCPs" - alkyl 

chain length of 21 or more) are expected to rapidly partition to particulates and sediments where 

they are anticipated to persist in the environment with half-lives of months or greater. If they do 

degrade over time, these substances are expected to form shorter chain halogenated chemicals. 

Based on the complex starting mixtures, lack of data on biological and abiotic reactions, and 

potential degradation products, there is high uncertainty regarding the fate and transport of these 

substances. Nevertheless, by analogy to medium chain chlorinated paraffins (MCCPs - alkyl 

chain length of 14 to 17), EPA expects vLCCPs and possible degradation products to be 

potentially highly persistent, potentially bioaccumulative, and potentially toxic: Transport and 

magnification across trophic levels ;nay also result in toxicity to higher organisms, including 

fish, higher predators, and potentially humans. 

Within the vLCCPs category, EPA expects the shorter carbon chain range of these substances 

(C21-C24) and lower chlorinated substances (degree chlorinated less than 50%) to present the 

greatest potential for risk, as they may be the most bioaccumulative, mobile in the environment, 

and toxic. As stated above, the Agency has concerns about the potential for the PMN substances 

to degrade to shorter chain chlorinated compounds; however, EPA also has concerns about 

potential impurities or small fractions ofMCCPs and/or long-chain chlorinated paraffins 
VI 

("LCCPs" - alkyl chain lengths of 18 to 20) that may be present as impurities. EPA has 

determined that each of the PMN substances will contain less than I wt% MCCPslLCCPs (P-12-

0539 originally contained more than I wt% MCCPs and LCCPs, but the Company amended this 

PMN to reduce the level of impurities). This fraction of MCCPslLCCPs may present a 

comparable or greater potential risk compared to the vLCCP fraction, even though there are 

limited amounts of the MCCPILCCP congeners present in the PMN substances. 

Human Health Effects Sunnnarv: 

The Company did not provide any information on the toxicity ofvLCCPs in humans. Acute oral 

toxicity data in animals show that vLCCPs are of very low acute toxicity. Studies in animals 

have shown that some vLCCPs may have the potential to cause slight skin irritation and 

sensitization, but no eye irritation potentiaL The liver is the main target organ of vLCCPs in 

repeated-dose studies in experimental animals. Inflannnatory and necrotic changes of the liver 

were observed in rats exposed to a vLCCP (C20•30, 43 wt% Cl) at dose levels of 100 milligrams 

per kilograin ofhodyweight per day (mglkg-bw/day) and above. For another vLCCP (C20-26, 70 

wt% Cl), effects in the liver occurred at a very high dose level of 3,750 mg/kg-bw/day; the NoObserved-Adverse-Effect-Level ("NOAEL") was 900 mg/kg-bw/day. 

An increased incidence of malignant lymphoma in male mice was reported at the highest dose of 

5,000 mglkg-bw/day when tested using a vLCCP (C23, 43 wt% Cl) in carcinogenicity studies in 

male and female rats and mice. Malignant lymphoma is one of the more variable tumors in mice 

and has a viral origin in many cases. In addition, data on the analogous short-chain chlorinated 

paraffins ("SCCPs") have shown no increase in the incidence of malignant lymphoma in a 
V11 

carcinogenicity study of SCCPs. Therefore, EPA concludes that the increased incidence of 

malignant lymphoma in male mice was not test-article related. Based on the foregoing 

information, along with the lack of in vitro and in vivo genotoxicity of vLCCPs, the Agency 

concludes that vLCCPs are not expected to pose a carcinogenic hazard to humans. 

Several prenatal developmental toxicity studies with vLCCPs have been conducted in rats and 

rabbits. No signs of maternal toxicity were reported in rats at doses as high as 5,000 mglkgbw/day. A maternal toxicity Lowest-Observed-Adverse-Effect-Level ("LOAEL") was reported 

in rabbits at 500 mglkg-bw/day, but it was limited to mirior signs of clinical toxicity. No signs of . 

developmental toxicity were reported in any ofthe available studies, with NOAELs for 

developmental toxicity of 5,000 mglkg-bw/day in rats and> 1,000 mglkg-bw/day in rabbits. 

Environmental Effects Summary: 

Most of the data on test substances analogous to vLCCPs have reported difficulties when 

evaluating aquatic toxicity in the water column. The difficulties included: 1) solubilizing the test 

substances in solution, 2) measuring the test substance in solution, and 3) characterizing the 

effect levels for the studies. Based on estimated physical-chemical properties(e.g., water 

solubility, logarithmic octanol-water partition coefficient, etc.), the Agency expects that all of.the 

PMN substances will not occur in dissolved form in the water column, rather the Agency expects 

the PMN substances to be present in the water column when exposures occur by adsorption to 

suspended solids or sediments. 

EPA expects that exposure and uptake for all of the PMN substances will be very limited from 
Vlll 

the aqueous phase. However, as noted above, toxicity to aquatic organisms within the water 

column is expected to occur only from exposure to suspended solids or sediments. In addition, 

EPA anticipates that adverse effects may occur, under limited situations, e.g, spills, from 

physical exposure to slicks at the surface and/or small and large suspended droplets. 

Due to the absence of data on chronic toxicity to aquatic organisms, sediment-dwelling 

organisms, and terrestrial plants these endpoints were assessed using experimental data from 

MCCPs (Cl4-17, 52 wt% Cl). The MCCP data were used in this PMN evaluation to fill data needs 

for the vLCCPs as a conservative approach for characterizing the potential hazard(s) of the PMN 

substances. 

The available experimental studies on vLCCPs indicate that the acute toxicity to aquatic 

organisms is No Effects at Saturation (NES) - that is, all of the PMN substances are not expected 

to cause acute toxicity to aquatic organisms up to their solubility limit. 

Aquatic Acute concentration of concern ("CoC") = NES (weight of evidence based on 

results of studies on the following vLCCP substances: C>20 40-42 wt% CI; C>20 48-54 wt% 

For chronic toxicity to aquatic organisms ("Ch V"), the Agency used analog data from an MCCP 

for invertebrate toxicity which reported a ChV ofl3 f!g/L. Based on OPPT Guidancel

, the ChV 

is divided by an assessment factor of 10 to derive the CoC of 1.3 f!glL or 1.3 ppb. 

1 US EPA, 2012 "Sustainable Futures & P2 Framework Manual." EPA-748-B12-00l, Available at: 

http://www.epa.gov/oppt/sf/pubs/sf-p2-manual.htrnl . 
IX 

Aquatic Chronic CoC = 1.3 ppb (read-across based on results of a study on the following 

MCCP substance: CI4-17 52 wt% CI) 

No acute or chronic sediment-invertebrate toxicity data were submitted for the PMN substances, 

and the Agency was unable to locate toxicity data for these endpoints. Therefore, an MCCP 

analog (C14-17, 52 wt% CI) was used to derive acute and chronic CoCs. The reported Geometric 

mean of the Maximum Allowable Toxicant Concentration ("GMATC") of 187 mglkg dry weight 

(dw) (sediment) by Thompson et al. (2002) was used as the principal study for deriving the 

CoCs. Based on OPPT Guidance2

, the GMATC is first multiplied by an acute to chronic ratio of 

10 for invertebrates to yield 1,870 mglkg dw sediment and subsequently divided by an 

assessment factor of5 to yield an acute CoC of 374 mglkg dw (sediment). The GMATC is 

divided an assessment factor of 10 to yield a chronic CoC of 18.7 mglkg dw (sediment). 

Sediment Invertebrate Acute CoC = 374 mglkg dw (sediment; read-across based on results 

of a study on the following MCCP substance: C14-17, 52 wt% CI) 

Sediment Invertebrate Chronic CoC = 18.7 mglkg dw (sediment; read-across based on 

results of a study on the following MCCP substance CI4-17, 52 wt% CI) 

No acute or chronic terrestrial-invertebrate toxicity data were submitted for the PMN substances, 

and the Agency was unable to locate toxicity data for these endpoints. Therefore, an MCCP 

analog (C14-I7, 52 wt% Cl) was used to derive acute and chronic CoCs for these endpoints, based 

on a reported GMATC of 149 mglkg dw (sediment). Based on OPPT Guidance3

, the GMATC is 
x 

first multiplied by an acute to chronic ratio of 10 for invertebrates to yield 1,490 mg/kg dw 

(sediment) and subsequently divided by an assessment factor of 5 to yield an acute CoC of 298 

mg/kg dw (sediment). The GMA TC is divided an assessment factor of 10 to yield a chronic CoC 

of 14.9 mg/kg dw (sediment). 

Terrestrial Invertebrate Acute CoC = 298 mglkg dw (sediment; read-across based on 

results of a study on the following MCCP substance: C14-17, 52 wt% CI) 

Terrestrial Invertebrate Chronic CoC = 15 mg/kg dw (sediment; read-across based on 

results of a study on the following MCCP substance: Cl4-17, 52 wt% CI) 

Exposure and Environmental Release Summary: 

P-12-0539: 

Use 2-

Manufacture Process 

Use I-Metal Compounding 

working of Rubber 

Products 

# Sites 1 6 73 5 

Workers 3 4 48 48 

(#/site) 

Exposure 125 120 120 250 

(days/year) 

Dermal Exposure Up to 1,800 Up to 1,800 Up to 2,900 1,800 

(mg/day) 

Inhalation negligible negligible Up to 5.3 (mist) Up to 15 

Exposure 

(mg/day) 
Xl 

Releases 1 120 247 250 

(days/year) 

Release to Water Up to 400 Up to 52 25 Up to 111 

(kg/day) 14 typical 

P-13-0 I 07 - import only: 

ProcessinglUse - Compounding of 

Rubber Products 

# Sites 4 

Workers 48 

(#/site) 

Exposure 250 

(days/year) 

Dermal Exposure Up to 130 

(mg/day) 

" 

Inhalation Exposure 15 

(mg/day) 

Releases 300 

(days/year) 

. 

Release to Water 20.5 

(kg/day) 

P-13-0109: 

Processing for Use 2 -

Use I-Metal Compoundin Manufacture Metal 

working working g of Rubber 

Products 

# Sites I 6 29 5 
Xll 

Processing for Use 2-

Use 1-Metal Componndin Manufacture Metal 

working working gofRubber 

Products 

Workers 9 4 1,392 240 

(#/site) 

Exposure 50 120 247 250 

(days/year) 

Dennal Exposure Up to 1,800 Up to 1,800 Up to 2,900 1,800 

(mg/day) 

Inhalation Exposure negligible negligible Up to 2.1 (mist) Up to 15 

(mg/day) 

Releases I 1 247 250 

(days/year) 

Release to Water Up to 400 67 25 Up to 340 

(kg/day) 14.8 typical 

The substances meet the following New Chemicals Exposure Based Criteria: 

P-12-0539 Annual Releases to Surface 56,000 kg/yr 

Water After Treatment 

Fish Ingestion Dose 0.0042 mg/kg/day 

Groundwater Dose 0.0039 mg/kg/day 

Total Releases After 550,000 kg/yr 

Treatment 

P-13-0107 Annual Releases to Surface 2,460 kg/yr 

Water After Treatment 

Total Releases After 30,200 kg/yr 

Treatment 

P-13-0109 Annual Releases to Surface 6,572 kg/year 

Water After Treatment 

Total Releases After 242,000 kg/year 

Treatment 
X111 

Risk(s) to Workers: 

Based on the expected limited absorption of all the PMN substances, all margins of exposure 

(MOEs) were above the benchmark value of30. EPA did not identify any unreasonable risks to 

workers from vLCCPs. of Limiting MCCPs/LCCPs total impurities to 1 wt% or less, EPA did 

not identify unreasonable risks to workers from these impurities. 

Risk(s) to General Public: 

EPA did not identify unreasonable risks to the general public from environmental releases of 

vLCCPs. 

Risk(s) to Consumers: 

EPA did not identify unreasonable risks to consumers from vLCCPs as there were no consumer 

uses identified in the PMNs. 

v. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 

(a) EPA is unable to determine the potential for adverse environmental effects from exposures 

of aquatic organisms to the PMN substances, potential impurities, and potential degradants. 

Therefore, EPA concludes, pursuant to §5(e)(I)(A)(i) of TSCA, that the information available to 

the Agency is insufficient to permit a reasoned evaluation of the potential adverse environmental 

effects of the PMN substances. 
XlV 

(b) In light of the potential risks of adverse environmental effects posed by the uncontrolled 

manufacture, import, processing, distribution in commerce, use, and disposal of the PMN 

substances, EPA has concluded, pursuant to § 5( e)(1 )(A)(ii)(I) of TSCA, that uncontrolled 

manufacture, import, processing, distribution in commerce, use, and disposal of the PMN 

substances may present an uureasonable risk of injury to the environment. 

(c) In light of the estimated production volume and environmental releases of the PMN 

substances, EPA has further concluded, pursuant to § 5(e)(1)(A)(ii)(II) ofTSCA, that the PMN 

substances will be produced in substantial quantities and may reasonably be anticipated to enter 

the environment in substantial quantities, and there may be significant (or substantial) human 

exposures to the PMN substances. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 

ENVIRONMENTAL EFFECTS 

Triggered Testing. The Order prohibits the Company from exceeding specified 

production volumes during various phases unless the Company submits the information 

described in the Testing section of this Order in accordance with the conditions specified in the 

Testing section. 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CONTAINS NO 

CBI 

CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

(a) Scope. The requirements of this Order apply to all commercial mannfacturing, processing, 

distribution in commerce, use, and disposal of the chemical substances: 

P-12-0539: Alkanes, C21.34 - branched and linear, chloro (CASRN: 139-2825-28-3); 

P-13-0107: Alkanes, C22.30 - branched and linear, chloro (CASRN: 1401947-24-0); and 

P-13-109 Alkanes, C24.28, chloro (CASRN: 1402738-52-6) 

("the PMN substances") in the United States by Trinity Manufacturing, Inc. ("the Company"), 

except to the extent that those activities are exempted by paragraph (b). 

(b) Exemptions. Manufacturing, processing, distribution in cormnerce, use and disposal of the 

PMN substances is exempt from tIle requirements of this Order (except the requirements in the 

Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the 

Internet Address (URL) • http://www.epa.gov 

Recycled/Recyclable· Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper 
2 

extent that (1) these activities are conducted in full compliance with all applicable requirements of 

the follov",\Ii.'lg exenlptions, and (2) such ,:::Glnplian.ce is docurnented by appropriate ~l'ecordkeeping as 

reauired in the RecordkeCDing section of this Order. '- .< '-' 

(l) Export. Until the COmpfu'1Y begins commerciallllfu""lufacture of a PMN substance 

subject to this Order for use in the United States, the requirements of this Order do not apply to 

manufacture, processing or distribution in connnerce of that PMN substance or substances solely 

for export in accordance with TSCA §§12(a) and 12(b), 40 CFR 720.3(s) and 40 CFR Part 707. 

However, once the Company begins to manufacture that PMN substance or substances for use in 

the United States, no further activity by the Company involving the PMN substance is exempt as 

"solely for export" even if some amount of that PMN substance or substances isfare later 

exported. At that point, the requirements of this Order apply to all activities associated with that 

PMN substance or substances while in the territory of the United States. Prior to leaving U.S. 

territory, even those quantities or batches of that PMN substance or 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. 

(2) Research & Development ("R&D"). The requirements of this Order do not apply to 

manufacturing, processing, distribution in connnerce, use and disposal of the PMN substances in 

small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 

720.3(cc), and 40 CFR 720.36. The requirements of this Order also do not apply to 

manufacturing, processing, distribution in commerce, use and disposal of the PMN substances 

when manufactLl'"ed solely for non-commercial research and development per TSCA §5(i) fu'1d ~o 

CFR 720.30(1). 
-2-

(3) Byproducts. The requirements of this Order do not apply to the PMN substances when 

they are produced, without separate commercial intent, only as a "byproduct" as defmed at 40 CFR 

no.3( d) and in compliance with 40 CFR nO.30(g). 

(4) No Separate Commercial Purpose. 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 

nO.30(h), with no commercial purpose separate from the substance, mixture, or article of which it 

is a part. 

(5) Imported Articles. The requirements of this Order do not apply to the PMN substances 

when they are imported as part of an "article" as defmed at 40 CFR nO.3( c) and in compliance 

with 40 CFR720.22(b)(I). 

(c) Automatic Sunset. If the Company has obtained for a PMN substance subject to this Order a 

Test Market Exemption ("TME") under TSCA §5(h)(1) and 40 CFR nO.38 or a Low Volume 

Exemption ("L VE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)( 4) 

and 40 CFR n3.50( c)(1) and (2) respectively, any such exemption is automatically rendered null 

and void as of the effective date of this Consent Order. 

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

PROHmITION 

The Company is prohibited from manufacturing, importing, processing, distributing in 

commerce, using, or disposing of the PMN substances in the United States, for any nonexempt 
- 3 -

commercial purpose, pending the development of information necessary for a reasoned evaluation 

of the environmental effects of the substances, and the completion of EPA's review of, and 

regulatory action based on, that information, except in accordance with the conditions described in 

this Order. 

TESTING 

(a) Section 8ee) Reporting. Reports of information on a PMN substance which reasonably 

supports the conclusion that a PMN substance presents 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 

appropriate PMN identification mnnber for this substance and contain a statement that the 

substance is subject to this Consent Order. Additional information regarding section 8( e) reporting 

requirements can be found at www.epa.gov/oppt/tsca8e. 

(b) Notice of Study Scheduling. The Company shall notify, in writing, the EPA Monitoring 

Assistance and Media Programs Division (2227 A), Office of Enforcement and Compliance 

Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N. W., 

Washington, D.C. 20460, of the following 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, whichever is later: 

(I) 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 -

(4) The appropriate PMN identification number for each substance and a statement that the 

substance is subject to this Consent Order. 

(c) Good Laboratory Practice Standards and Test Protocols. Each study performed to address the 

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

("GLP") Standards at 40 CFR Part 792 and using methodologies generally accepted in the relevant 

scientific community at the time the study is initiated. Before starting to conduct any study, the 

Company must submit written test protocols to EPA for review. Protocols must be submitted as a 

support document for the PMN, using the procedures set out in 40 CFR 720040. EPA will respond 

to the Company within 4 weeks of receiving the written protocols. EPA review of a test protocol 

does not mean pre-acceptance of test results. 

(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or 

importing the PMN substances after a certain date (calculated from the first notice of 

commencement) and/or aggregate manufacture and import volumes for different phases ("the 

production limit") that considers all of the PMN substances, unless the Comp~ny conducts the 

following studies and submits all final study reports and underlying "raw data", as defmed in 40 

CFR Part 792, in accordance with the conditions specified in this Testing section. 

Phase Production Limit Study and Guideline Substances 

1 1,200,000 kg Analysis for chain length P-12-0539, P-13-0107, and P-13-

cumulative, aggregate and wt"/o Cl (for example 0109 

production volume by GCIMS HPLCIMS) 

or and present EPA with a 

9 months, whichever certificate of analysis, 

comes earlier certificate of compliance 
- 5 -

Phase Production Limit Studv and Guideline Substances 

with GLP standards, and 

all "raw data" for 

congener analysis. 

2a 4 years, 4 months An inherent • Three chlorinated linear C21 

or biodegradation study- paraffin fractions to represent 

14,100,000 kg, highly modified SCAS each of the 40%, 55%, and> 

cumulative, aggregate (OPPTS 70% chlorine by weight. 

production volume, 835.3210/835.5045 or • Three chlorinated C26 linear 

whichever comes OECD 302A) or Zahn paraffin fractions to represent 

earlier Wellens (OPPTS each of the 40%,55%, and> 

835.3200 or OECD 302B) 70% chlorine by weight. 

- with analytical • Three chlorinated linear 

procedures capable of paraffin fractions, whose chain 

measuring individual length represents the central 

congeners and degradation tendency of the congener 

products over time. distribution of the vLCCP 

product as identified in Phase I 

testing, to represent each of the 

40 wt"1o, 55 wt"1o, and> 70 

wt% chlorine by weight. 

2b 12 years, 8 months Bioaccumulation in • Three chlorinated linear C21 

or Sediment-dwelling paraffin fractions to represent 

59,100,000 kg Benthic Oligochaetes each of the 40%, 55%, and> 

cumulative, aggregate (OECD 315) 70% chlorine by weight. 

production volume, • Three chlorinated C26 linear 

whichever comes paraffm fractions to represent 

earlier each of the 40%, 55%, and> 

70% chlorine by weight. 

• Three chlorinated linear 

paraffin fractions, whose phain 

length represents the central 

tendency of the congener 

distribution of the vLCCP 

product as identified in Phase I 

testing, to represent each of the 

40 wt%, 55 wt%, and> 70 

wt% chlorine by weight. 

2b 12 years, 8 months Aerobic and anaerobic • Three chlorinated linear C21 

or 59,100,000 kg soil metabolism studies paraffin fractions to represent 

cumulative, aggregate (OECD 307) with each of the 40%, 55%, and> 

production volume, analytical procedures 70% chlorine by weight. 

whichever comes capable of measuring • Three chlorinated C26 linear 
- 6 -

Phase Production Limit Studv and Guideline Substances 

earlier individual congeners and paraffin fractions to represent 

degradation products over each of the 40%,55%, and> 

time. 70% chlorine by weight. 

• Three chlorinated linear 

paraffin fractions, whose chain 

length represents the central 

tendency of the congener 

distribution ofthe vLCCP 

product as identified in Phase 1 

testing, to represent each of the 

40 wt%, 55 wt%, and> 70 

wt% chlorine by weight. 

3 15 years, 5 months or Sediment-Water • For any of the parent 

78,400,000 kg Chironomid Life-Cycle substances in Phase 2b testing 

cumulative, aggregate Toxicity Test Using that are absorbed by the 

production volume, Spiked Water or Spiked Benthic Oligochaetes 

whichever comes Sediment (OECD 233) 

earlier 

OR4 

Sediment-Water 

Lumbriculus Toxicity Test 

Using Spiked Sediment 

(OECD 225) 

3 15 years, 5 months or Bioaccumulation in • For any of the degradation 

78,400,000 kg Sediment-dwelling prod!lcts in Phase 2a or 2b that 

cumulative, aggregate Benthic Oligochaetes are identified to potentially 

production volume, (OECD 315) present an unreasonable risk or 

whichever comes to further degrade to generate a 

earlier substance of potential concern 

4 16 years, 5 months or Sediment-Water • For any ofthe degradation 

86,100,000 kg Chironomid Life-Cycle substances in Phase 3 testing 

cumulative, aggregate Toxicity Test Using that are absorbed by the 

production volume, Spiked Water or Spiked Benthic Oligochaetes 

whichever comes Sediment (OECD 233) 

earlier 

OR5 

4 If the degradation half-life ofthe test substance is 28 days or shorter from Phase 2, OECD 225 is an acceptable 

guideline; otherwise, OECD 233, a whole lifecyde test, must be conducted. 

51d. 
- 7 -

Phase Productiou Limit Studv aud Guideline Substances 

Sediment-Water . 

Lumbriculus Toxicity Test 

Using Spiked Sediment 

(OECD225) 

EPA will evaluate the results of the Bioaccumulation in Sediment-dwelling Benthic Oligochaetes 

study (OECD 315) in Phases 2b and 3 to determine if a Bioaccumulation in Terrestrial 

Oligochaetes (OECD 317) study is warranted for any ofthe parent or degradation products. If, 

based on the results of testing conducted under the Consent Order, EPA determines that the PMN 

substances or any degradation products will or may pose an unreasonable risk to human health or 

the environment, EPA may specify in a written notice to the Company that the Company undertake 

certain actions concerning further testing, manufacture, import, processing, distribution, use and/or 

disposal of the PMN substances to mitigate exposures to or to better characterize the risks 

presented by the PMN substances or its degradation products. 

(e) Test Reports. The Company shall: (1) conduct each study 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 the final report of each study (with an additional sanitized copy, if 

confidential business information is involved) and all underlying data ("the report and data") to 

EPA prior to exceeding the applicable production limit. The final report and data must be 

submitted as a support document for the PMN, using the procedures set out in 40 CFR 720040. 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 "Test 

Report" subparagraphs in the applicable test guidelines. However, for purposes of this Consent 
- 8 -

Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear 

that the submission of such information is mandatory. 

EPA will require the submission of raw data such as slides and laboratory notebooks only 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. 

(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 unnecessary to conduct that study. 

(g) Equivocal Data. If EPA fmds 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 relief 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 

specified in paragraphs (b), (c), and (e) (except that the study may be submitted after reaching the 

applicable production limit). The testing requirements may be modified, as necessary to permit a 

reasoned evaluation of the risks presented by the PMN substances, only by mutual consent of EPA 

and the Company. 

(h) EPA Determination of Invalid Data. 

(1) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA's receipt of a 

test report and data, the Company receives written notice that EPA fmds 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. 
-9-

(2) The Company may continue to manufacture and import the PMN substances beyond 

the applicable production limits only if so notified, in writing, by EPA in response to the 

Company's compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii). 

(i) If there is sufficient time to reconduct the study in compliance with paragraphs 

(b), (c), and (e) before exceeding the applicable production limit specified in paragraph (d), the 

Company may reconduct the study. If there is insufficient time to reconduct the study in 

compliance with paragraphs (b), (c), and (e) before exceeding a production limit specified in 

paragraph (d), the Company may exceed that production limit (the applicable limit associated with 

the particular test), but must otherwise comply with paragraphs (b), (c), and (e), and shall submit 

the report and data to EPA within a reasonable period of time, all as specified by EPA in the notice 

described in subparagraph (h)(1). EPA will respond to the Company, in writing, within 6 weeks of 

receiving the Company's report and data. 

(ii) The Company may, within 4 weeks of receiving from EPA the notice described 

in subparagraph (h)(I), 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. 

(I) Except as described in subparagraph (i)(2), if the Company becomes aware that 

circumstances clearly beyond the control of the Company or laboratory will prevent, or.have 

prevented, development of scientifically valid data under the conditions specified in paragraphs ( c) 

and (e), the Company remains prohibited from further manufacture and import of the PMN 

substances beyond the applicable production limit. 
- 10-

(2) The Company may submitto EPA, within 2 weeks of first becoming aware of such 

circumstances, a written statement explaining why circumstances clearly beyond the control of the 

Company or laboratory will cause or have caused development of scientifically invalid data. EPA 

will notify the Company of its response, in writing, within 4 weeks of receiving the Company's 

report. EPA's written response may either: 

(i) allow the Company to continue to manufacture 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 

compliance with paragraphs (b), (c), and (e), if there is sufficient time to conduct or reconduct the 

sh).dy and submit the report and data to EPA before exceeding the production limit specified in 

paragraph (d). If there is insufficient time for the Company to comply with paragraphs (b), (c), 

and (e) before exceeding the production limit specified in paragraph (d), the Company may exceed 

. the production limit, but must otherwise comply with paragraphs (b), (c), and (e), and shall submit 

the report and data to EPA within a reasonable period of time, all as specified by EPA in the notice 

described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks of 

receiving the Company's report and data, as to whether the Company may continue to manufacture 

and import beyond the applicable production limit. 

G) Unreasonable Risk. 

EPA may notify the Company in writing that EPA fmds 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 ormay present an unreasonable risk of injury to human health or the environment. 

EPA's notice may specify that the Company undertake certain actions concerning further testing, 
- 11 -

manufacture, import, processing, distribution, useandlor disposal of the PMN substances to 

mitigate exposures to or to better characterize the risks presented by the PMN substances. Within 

2 weeks from receipt of such a notice, the Company must cease all manufacture, import, 

processing, distribution, use and disposal of the PMN substances, unless either: 

(1) within 2 weeks from receipt of the EPA notice, the Company complies with 

such requirements as the notice specifies; or 

(2) within 4 weeks from receipt of the EPA notice, the Company submits to EPA a 

written report refuting EPA's finding andlor the appropriateness of any additional requirements 

imposed by EPA. The Company may continue to manufacture, import, process, distribute, use and 

dispose of the PMN substances in accordance with the terms of this Order pending EPA's response 

to the Company's written report. EPA will respond to the Company, in writing, within 4 weeks of 

receiving the Company's report. Within 2 weeks of receipt of EPA's written response, the 

Company shall comply with any requirements imposed by EPA's response or cease all 

manufacture, import, processing, distribution, use and disposal of the PMN substances. 

(k) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing 

section, the Company must continue to obey all the terms of this Consent Order until otherwise 

notified in writing by EPA. The Company may, based upon submitted test data or other relevant 

information, petition EPA to modify or revoke provisions of this Consent Order pursuant to Part 

VI. of this Consent Order. 
- 12 -

RISK NOTIFICATION· 

(a) If as a result of the test data required under the terms of this Order, the Company becomes 

aware that the PMN substances may present a risk of injury to the environment (or is so notified by 

EPA), the Company must incorporate this new information, and any information on methods for 

protecting against such risk, into a Material Safety Data Sheet ("MSDS"), as described in 40 CFR 

section 721. 72( c), within 90 days from the time the Company becomes aware of the new 

information. If the PMN substances is not being manufactured, imported, processed, or used in the 

Company's workplace, the Company must add the new information to an MSDS before the PMN 

substances is reintroduced into the workplace. 

(b) The Company must ensure that persons who will receive the PMN substances from the 

Company, or who have received the PMN substances from the Company within 5 years from the 

date the Company becomes aware of the new information described in paragraph (a) of this 

section, are provided an MSDS containing the information required under paragraph (a) within 90 

days from the time the Company becomes aware of the new information. 

MANUFACTURING 

(a)(1) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import 

of the PMN substances by any other person. 

(2) Sunset Following SNUR. Subparagraph (a)(l) shall expire 75 days after promulgation 

of a [mal significant new use rule ("SNUR") governing the PMN substances under section 5(a)(2) 
- 13-

of TSCA unless the Company is notified on or before 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 in writing that all Federal Court actions involving the 

SNUR have been resolved and the validity of the SNUR affirmed. 

(3) Notice of SNUR. When EPA promulgates a [mal SNUR for the PMN substances and 

subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify 

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

of the existence of the SNUR. 

(b) The Company shall not manufacture the PMN substances with the amount of chlorinated 

paraffins with an alkyl chain ::; 20 to exceed more than 1 % of that PMN substance by weight. 

III. RECORDKEEPING 

(a) Records. The Company shall maintain the following records until 5 years after the Gate they 

are created and shall make them available for inspection and copying by EPA in accordance with 

section 11 of TSCA: 

(1) Exemptions. Records documenting that the PMN substances did in fact qualify for any 

one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records 

must satisfy all the statutory and regulatory recordkeeping requirements applicable to the 

exemption being claimed by the Company. Any amounts or batches of the PMN substances 

eligible for the export only exemption in Section I, Paragraph (b)(l) of this Order are exempt from 
- 14 -

all the requirements 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)(I)(B) and 12(b), respectively. Any amounts or batches of the PMN substances 

eligible for the research and development exemption in Section I, Paragraph (b )(2) of this Order 

are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 

5 years from the date of their creation, the records required by 40 CFR nO.78(b). For any 

amounts or batches of the PMN substances claimed to be eligible for any other exemption 

described in Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating 

qualification for that exemption as well as the 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 

address, if different) of all persons outside the site of manufacture or import to whom the 

Company directly sells or transfers the PMN substances, the date of each sale or transfer, and the 

quantity of the substances sold or transferred on such date; 

(4) Records documenting the address of all sites of manufacture, import, processing, and 

use; 

(5) Records documenting compliance with any applicable manufacturing, processing, use, 

and distribution restrictions in the Manufacturing and Distribution sections of this Order, including 

distributees' written agreement to comply with the Distribution section of this Order; 

(6) Copies of any Transfer Documents and notices required by the Successor Liability 

section of this Order, if applicable; and, 
- 15 -

(7) The Company shall keep a copy of this Order at each of its sites where the PMN 

substances is manufactured or 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 

Company's customers. 

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 

1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this "collection of 

information" unless this Order displays a currently valid control number from the Office of 

Management and Budget ("OMB"), and EPAso informs the Company. The "collection of 

information" required in this TSCA §5( e) Consent Order has been approved under currently valid 

OMB Control Number 2070-0012. 

IV. REOUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA's Request for Information. Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA 

may occasionally conduct on-site compliance inspections of Company facilities and conveyances 

associated with the PMN substances. To facilitate such inspections, EPA personnel may contact 

the Company in advance to request information pertinent to the scheduling and conduct of such 

inspections. Such requests may be written or oral. The types of information that EPA may request 

include, but are not limited to, the following: 

(1) Expected dates and times when the PMN substances will be in production within the 

subsequent 12 months; 
(2) Current workshift schedules for workers who are involved in activities associated with 

the PMN substances and may reasonably be exposed to the PMN substances; 

(3) Current job titles or categories for workers who are involved in activities associated 

with the PMN substances and may reasonably be exposed to the PMN substances; 

(4) Existing exposure monitoring data for workers who are involved in activities 

associated with the PMN substances and may reasonably be exposed to the PMN substances; 

(5) Records required by the Recordkeeping section of this Order; and/or, 

, (6) Any other information reasonably related to determining compliance with this Order or 

conducting an inspection for that purpose. 

(b) Company's Response. The Company shall respond to such requests within a reasonable 

period of time, but in no event later than 30 days after. receiving EPA's request. When requested 

in writing by EPA, the Company's response shall be in writing. To the extent the information is 

known to or reasonably ascertainable by 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 ("CEI") that the 

Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with § 14 of 

TSCA and 40 CFR Part 2. 
- 17 -

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

(a) Scope: This section 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 a PMN substance 

or substances subject to this Order, including the right to manufacture that PMN substance, to 

another person outside the Company (the "Successor in Interest"). 

(b) Relation of Transfer Date to Notice of Commencement ("NOC"). 

(1) Before NOC. If the transfer from the Company to the Successor inlnterest is effective 

before EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN 

substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a 

new PMN to EPA and comply fully with Section 5(a)(1) of TSCA and 40 CFRpart 720 before 

commencing manufacture or import of the PMN substance. 

(2) After NOC. If the transfer from the Coiupany 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 a new PMN to EPA. 

(c) DefInitions. The following defInitions apply to this Successor Liability section ofthe Order: 

(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 substance, 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 Company in the PMN substance, such as a licensee who has acquired a limited 

license to the patent or manufacturing rights associated with the PMN substance. A Successor in 
- 18 -

Interest must be incorporated, licensed, or doing business in the United States in accordance with 

40 CFR nO.22(a)(3) and 40 CFR nO.3(z). 

(2) "Transfer Document" means the legal instrument(s) used to convey the interests in the 

PMN substance, including the right to manufacture the PMN substance, from the Company to the 

Successor in Interest. 

(d) Notices. 

(I) Notice to Successor in Interest. 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 

Order and the "Notice of Transfer" document which is incorporated by reference as Attachment B 

to this Order. 

(2) Notice to EPA. Within 10 business days of the effective date of the transfer, the 

Company shall, by registered mail, submit the fully executed Notice of Transfer document to: 

U.S. 'Enviromnental Protection Agency, New Chemicals Management Branch (7405), 1200 

Pennsylvania Avenue, N.W., Washington, D.C. 20460. 

(3) Transfer Document. Copies of the Transfer Document must be maintained by the 

Successor in Interest at its principal place of business, and at all sites where the PMN substance is 

manufactured or imported. Copies of the Transfer Document must also be made available for 

inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must 

contain provisions which expressly transfer liability for the PMN substance under the terms of this 

Order from the Company to the Successor in Interest. 
- 19 -

(e) Liability. 

(1) The Company shall be liable for compliance with the requirements of this Order until 

the effective date of the transfer described above. 

(2) The Successor in Interest shall be liable for compliance with the requirements of this 

Order effective as of the date of transfer. 

(3) Nothing in this section shall be construed to prohibit the Agency from taking 

enforcement action against the Company after the effective date of the transfer for actions taken, or 

omissions made, during the time in which the Company manufactured, processed, used, distributed 

in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order. 

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

of this Consent Order requires the Company to submit test data to EPA at a specified production 

volume ("test trigger"), the aggregate volume of the PMN substancesmanufactured and imported 

by the Company up to the date of transfer shall count towards the test trigger applicable to the 

Successor in Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Company may petition EPA at any time, based upon new information on the human 

health or environmental effects of, or human exposure to or environmental release of, the PMN 

substances, 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 information EPA determined 

to be necessary to evaluate those exposures and risks are described in the preamble to this Order. 

However, in determining whether to amend or revoke this Order, EPA will consider all relevant 
- 20-

information available at the time the Agency makes that determination, including, where 

appropriate, any reassessment of the test data or other information that supports the findings in this 

Order, an examination of new test data or 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 (lnd 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 substances. 

In addition, the Company may petition EPA at any time to make other modifications to the 

language of this Order. EPA will issue such a modification if EPA determines that the 

modification is useful, appropriate, and consistent with the structure and intent of this Order as 

issued. 
- 21 -

VII. EFFECT OF CONSENT ORDER 

(a) Waiver. By consenting to the entry of this Order, the Company waives its rights to file 

objections to this Order pursuant to section 5(e)(I)(C) of TSCA, to receive service of this Order no 

later than 45 days before the end of the review period pursuant to section 5( e)(1 )(B) of TSCA, and 

to challenge the validity of this Order in any subsequent action. Consenting to the entry of this 

Order, and agreeing to be bound by its terms, do not constitute an admission by the Company as to 

the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver 

does not affect.any other rights that the Company may have under TSCA. 

(b) CEl Brackets. By signing this Order, the Company represents that it has carefully reviewed 

this document and hereby agrees that no information herein is claimed as confidential by the 

Company (per section 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2). EPA will 

make this document available for public viewing. 

~ec%'~'- Maria J. Doa, F,mrector 

Chemical Control Division 

Office of Pollution Prevention and Toxics 

-=st £::~~~.. ;' Name: Vic Perr~ Title: Chief Operating Officer 

Company: Trinity Manufacturing Inc. 
ATTACHMENT A 

DEFINITIONS 

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

 “Chemical name” means the scientific designation of a chemical substance in accordance 

with the nomenclature system developed by the Chemical Abstracts Service’s rules of 

nomenclature, or a name which will clearly identify a chemical substance for the purpose of 

conducting a hazard evaluation. 

 “Chemical protective clothing” means items of clothing that provide a protective barrier to 

prevent dermal contact with chemical substances of concern. Examples can include, but are not 

limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. 

 “Company” means the person or persons subject to this Order. 

 “Commercial use” means the use of a chemical substance or any mixture containing the 

chemical substance in a commercial enterprise providing saleable goods or a service to consumers 

(e.g., a commercial dry cleaning establishment or painting 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 any product 

containing the chemical substance in or around a permanent or temporary household or residence, 

during recreation, or for any personal use or enjoyment. 

 “Consumer product” means a chemical substance that is directly, or as part of a mixture, 

sold or made available to consumers for their use in or around a permanent or temporary 

household or residence, in or around a school, or in recreation. 

 “Container” means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage 

tank, or the like that contains a hazardous chemical. For purposes of this section, pipes or piping 

systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be 

containers. 

 “Contract Manufacturer” means a person, outside the Company, who is authorized to 

manufacture and import the PMN substance under the conditions specified in Part II. of this 

Consent Order and in the Consent Order for Contract Manufacturer. 

 “Identity” means any chemical or common name used to identify a chemical substance or a 

mixture containing that substance. 
2 

 “Immediate use.” A chemical substance is for the “immediate use” of a person if it is under 

the control of, and used only by, the person who transferred it from a labeled container and will 

only be used by that person within the work shift in which it is transferred from the labeled 

container. 

 “Impervious.” Chemical protective clothing is “impervious” to a chemical substance if the 

substance causes no chemical or mechanical degradation, permeation, or penetration of the 

chemical protective clothing under the 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 concentration, 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 

substance.

 “NIOSH” means the National Institute for Occupational Safety and Health of the U.S. 

Department 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 significant 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 substances or 

mixtures are manufactured, imported, or processed. 

 “PMN substance” means the chemical substance 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, 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 of physical state or concentration, through all intended operations of 

processing, including the cleaning of equipment. 

 “Scientifically invalid” means any significant departure from the EPA-reviewed protocol or 

the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency 

review that prevents a reasoned evaluation of the health or environmental effects of the PMN 

substance. 
3 

 “Scientifically equivocal data” means data which, although developed in apparent 

conformity with the Good Laboratory Practice Standards and EPA-reviewed protocols, are 

inconclusive, internally 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 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 of physical 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 OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

___________________________ _________________ 

Company (Transferor) PMN Number 

1. Transfer of Manufacture Rights. Effective on _______________, the Company did sell or 

otherwise transfer to ________________________________, (“Successor in Interest”) the rights 

and liabilities associated with manufacture of the above-referenced chemical substance, which was 

the subject of 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 

Substances Control Act (“TSCA,” 15 U.S.C. §2604(e)). 

2. Assumption of Liability. The Successor in Interest hereby 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, or doing business in the United States in accordance with 40 CFR 

720.22(a)(3). 

3. Confidential Business Information. The Successor in Interest hereby: 

___ reasserts, 

___ relinquishes, or 

___ modifies 

all Confidential Business Information (“CBI”) 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 be deemed to apply to all such claims. Where “modifies” is 

indicated, such modification shall be explained in detail in an attachment to this Notice of 

Transfer. Information which has been previously disclosed to the public (e.g., a chemical identity 

that was not claimed as CBI by the original submitter) would not subsequently be eligible for 

confidential treatment under this Notice of Transfer.
NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

 (continued) 

___________________________________ _____________________ 

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 Authorized Official 

___________________________________ 

Address 

___________________________________ 

City, State, Zip Code 
NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

(continued)

___________________________________ 

Successor’s Technical Contact

___________________________________ 

Address 

___________________________________ 

City, State, Zip Code 

___________________________________ 

Phone