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 Number: 

) 

) 

) 

) 

) 

[ l ) Pll-0483, Pll-0487, Pll-0527, Pll-0528, 

) Pll-0529, Pll-0530, Pll-0532, Pll-0533, 

) and Pll-0534 

) 

) 

) 

EPA SANITIZED 

) 

) 

) 

Consent Order, Consent Order for Contract Manufacturer, 

and Determinations Supporting Consent Orders 
11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Sunnnary of Terms of the Order 

III. Contents ofPMNs 

IV. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health and Enviromnental 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 

Attaclnnent A - Definitions 

Attaclnnent B- Notice of Transfer of Consent Order 

Attaclnnent C - Consent Order for Contract Manufacturer 

Attaclnnent D- Key Elements of Biodegradation Testing ofFluorotelomer based Chemicals 
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 ("PMN s") P 11-0483, P 11-0487, P 11-0527, 

Pll-0528, Pll-0529, Pll-0530, P11-0532, P11-0533, and Pll-0534 ("the PMN 

substances") submitted by [ l 

("the Companies"), to take effect upon expiration of the PMN review period. The Companies 

submitted the PMNs to EPA pursuant to§ 5(a)(1) ofTSCA and 40 CFR Part 720. 

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

provision of§ 5 or any order issued under § 5. Violators may be subject to various penalties and 

to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure 

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 the PMN substances requires the Companies to: 

(I) Record and report [ ] impurities of the 

starting [ ] raw materials; 
IV 

(2) Not exceed the maximum established levels of [ 

] impl}rities; 

(3) Submit to EPA the results of certain triggered tests on the PMN substance P 11-0483 

and triggered fate test data on the PMN substance P11-0530 before manufacturing or 

importing an aggregate of [ ] kilograms (kg) (Tier 1 ), [ ] years [ ] months after the 

Company signed this Consent Order (Tier 2), [ ] kg (Tier 3) and, [ ] kg 

(Tier 4) of the PMN substances Pl1-0487, Pll-0530, Pll-0533, and Pll-0534 combined; 

(4) Limit the annual production volume for the PMN substances, P11-0487, Pll-0530, 

Pll-0533, and Pll-0534 to [ ] kg each; 

(5) Use the PMN substances P11-0483, Pll-0527, Pll-0528, P11-0529, and Pll-0532 as 

chemical intermediates as described in the PMNs (to manufacture Pll-0487, Pll-0530, 

Pll-0533, and Pll-0534) and to manufacture [ 

]; 

(6) Use the chemical substances Pll-0487, Pll-0530, Pll-0533 andPll-0534 only 

as surfactants for [ J applications as described in the PMN s; 

(7) Not use the PMN substances in any consumer spray applications; 

(8) Distribute the PMN substances only to a person that agrees to follow the same 

restrictions (except for testing requirements listed in the Testing section of the Consent 

Order); 

(9) Comply with the Release to water provisions; 

(10) Incinerate all waste containing any of the PMN substances from manufacturing and 

processing (except for the PMN materials/waste that will be recycled and reused in 
v 

manufacturing of the PMN substances or products made from the PMN substances) in 

an incinerator with combustion temperature of minimum 1 000 degrees C and residence 

time of minimum 2 seconds; and 

(11) Maintain certain records. 

A Consent Order for Contract Manufacturers is attached (Attachment C) to extend these 

requirements to the identified Contract Manufacturers. The Contract Manufacturers must keep 

records of quantities manufactured, but the Companies must submit to EPA all information 

required in the Consent Order. 

III. CONTENTS OF PMN 

By signing this Order, the Companies represent that they have carefully reviewed this 

document and agree that all information herein that is claimed as confidential by the Companies 

is correctly identified within brackets and that any information that is not bracketed is not 

claimed as confidential. To make this document available for public viewing, EPA will remove 

only the information contained within the brackets. 

Confidential Business Information Claims (Bracketed in the Preamble and Order): 

Companies' identities; chemical identities; impurities; synonyms; production volumes; specific 

use; operation descriptions, including exposure and release estimates; and physical/chemical 

properties. 

Chemical Identity: 
Specific: 

P-11-0483- [ 

P-11-0487 - [ 

], 

P-11-0527 - [ 

], 

P-11-0528 - [ 

], 

P-11-0529- [ 

l 

P-11-0530 - [ 

P-11-0532- [ 

], 

P-11-0533 - [ 

], and 

P-11-0534 - [ 

Generic: 

P-11-0483, alkyl thiol; 

P-11-0487, alkyl polyamide; 

P-11-0527, substituted fluoroalkane; 

P-11-0528, fluorinated thio1; 

], 

], 

P-11-0529, fluorinated monomer; 

P-11-0530, fluoropolyacrylamide; 

P-11-0532, polyfluoroalkyl amine; . 

P-11-0533, non-ionic fluorosurfactant; and 

P-11-0534, anionic fluorosurfactant. 

VI 

]. 
Use: 

Specific: 

P-11-0483- [ 

P-11-0487- [ 

P-11-0527- [ 

P-11-0528 - [ 

P-11-0529 - [ 

P-11 -0530 - [ 

P-11-0532 - [ 

P-11- 0533 and P-11-0534- [ 

]. 

Vll 

]. 

]. 

]. 

]. 

l 

]. 

]. 

Generic: P11-0487, P11-0530, P11-0533 and P11-0534- surfactants 

P11-0483, P11-0527, Pl1-0528, .P11-0529, and P11-0532- chemical intermediates 

Maximum 12-Month Production Volume: (kg/year) 

P-11-0483-[ ] 

P-11-0487- [ ] 

P-11- 0527- [ ] 

P-11-0528-[ ] 

P-11- 0529- [ ] 

P-11- 0530- [ ] 

p -11- 0532- [ ] 

P-11- 0533 - [ ] 

P-11- 0534 - [ ] 

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK 

Based on the properties of the PMN substances and test data on analogous perfluorinated 

chemicals and potential perfluorinated degradation products such as perfluorooctanoic acid 
Vlll 

(PFOA), perftnOlOOctanesulfonate (PFOS), perfluorohexane sulfonate (PFHS), and 

1H,1H,2H,2H-perfluoroocanesulfonic acid, EPA has identified human health and ecotoxicity 

concerns. 

Human Health Effects Sununary: 

Based on the analysis of the available test data for surfactant properties of analogous 

substances and the degradation products of the PMN substances (Pll- 0483, Pll-0487, 

Pll-0527, Pll-0528, Pll-0529, Pll-0530, Pll-0532, Pll-0533, and Pll-0534), EPA has 

human health concerns for irritation to skin, eyes, lungs, mucous membranes, and lung toxicity 

if inhaled. Toxicity studies on PFOA and PFOS indicate liver toxicity, blood toxicity, male 

reproductive toxicity, inununosuppression, and oncogenicity. These factors, taken together, raise 

concerns for potential adverse chronic effects in humans and wildlife. 

Ecotoxicity and Environmental Effects Summary: All PMN substances subject to this Order, 

Pll- 0483, Pll-0487, Pll-0527, Pll-0528, Pll-0529, Pll-0530, Pll-0532, Pll-0533, 

Pll-0534 and/or degradation products have been identified as having a potential concern for 

ecotoxicity. Based on EcoSAR analysis of test data on analogous substances, EPA predicts 

toxicity to aquatic organisms may occur at concentrations that exceed the identified 

concentrations of concern (COC). Based on data for analogous perfluorinated chemicals, 

perfluorooctanoic acid (PFOA), perfluorooctanesulfonate (PFOS), and perfluorohexane 

sulfonate (PFHS), EPA has determined that the PMN substances and their degradation products 

will persist in the environment, could bioaccumulate or biomagnify, and could be toxic to 

people, wild mammals, and birds ("PBT"). The presumed perfluorinated degradants for the 

PMN substances include perfluorohexanoic acid (PFHxA). Biodegradationand.photolysis tests 
ix 

of analogous substances to PFOA and PFOS indicate little or no biodegradation or photolysis of 

perfluoroalkyl compounds. 

Bioaccumulation concerns are based on concerns raised by tbe measured presence of certain 

perfluoroalkyl compounds witb longer carbon chain length, including PFOA, PFOS, and PFHS 

in wildlife and in human blood samples. Potential risks to the environment are controlled by tbe 

Disposal and Release to Water restrictions are detailed in tbe Consent Order. 

Exposure and Environmental Release Summaries: 

Manufacturing will take place at the following [ 

[ 

l 

Waste to tbe environment from manufacturing [ 

PMN substances) will be incinerated. Processing [ 

and inhalation exposures are [ 

]. 

Environmental releases during use [ 

dispersive use are from disposal of [ 

disposal to POTW orto .surfacecwater of [ 

] sites: 

] and processing (tbat contain tbe 

] will take place at [ 

]. Occupational dermal 

]. Use as [ 

] which is considered 

], and from 
X 

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 human health and environmental effects from 

exposure to the PMN substances and their potential degradation products. EPA therefore 

concludes, pursuant to§ 5(e)(l)(A)(i) ofTSCA, that the information available to the Agency is 

insufficient to permit a reasoned evaluation of the human health and environmental effects of the 

PMN substances and potential degradation products. 

(b) In light of the potential risK of human health and 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) ofTSCA, that uncontrolled 

manufacture, 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. 

(c) Irt light of the estimated production volume of, and human exposure to, the PMN substances 

and potential degradation products, EPA has further concluded, pursuant to § 5( e)(l )(A)(ii)(II) of 

TSCA, 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 exposure to the substances and potential degradation products. 
XI 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH 

AND ENVIRONMENTAL EFFECTS 

Triggered Testing. The Order prohlbits the Companies from exceeding the specified 

production volumes unless the Companies submit the information described in the Testing 

section of this Order for P!!-0483 and Pll-0530 in accordance with the conditions specified in 

the Testing section. 

In addition, the Companies shall not manufacture or cause, encourage or suggest that a [ ] 

manufacturer manufacture the PMN substances unless a routine testing of the [ 

] starting raw material for [ ] 

impurities by the Companies or as evidenced by a Certificate of Analysis from the raw material 

supplier, meets the established purity level as specified in Table I and Table 2 ofthls Order. 

Further, the Companies or the raw material supplier will annually test the [ l 

starting raw material for [ ], including establishlng calibration curves where the level 

of quantification desired is [ ]. 

If, at any point, the PMN substances [ ] that are related to the 

PMN substances regulated under this Consent Order but are regulated separately through a [ 

] are withdrawn by the Companies from PMN review, Pll-0487, 

Pll-0530, Pll-0533, and Pll-0534 will be subject to all testing (triggered) required in the [ 

]. In addition, Pll-0530 will be subject to all tests required 

for P ll-0483 in the case of [ ] withdrawal. The testing triggers will be 

calculated at the time of the withdrawal, starting from the. beginningofthe.manufacturing. 
Xll 

Pended Testing. 

The following pended testing on the PMN substances P11-0487, P11-0527, 

Pll-0528, Pll-0529, Pll-0532, P11-0533, and Pll-0534, would be necessary to evaluate the 

environmental effects: 

All the triggered tests listed in the Testing section of this Consent Order for Pll-0483 

and P11-0530 plus aerobic and anaerobic transformation in soil tests (OECD 307), 

phototransformation of chemicals (Draft OECD Guideline on soil surfaces-2 soils, Jan. 

2002), simulation test-aerobic sewage treatment (activated sludge units) (OECD 303A), 

and aerobic and anaerobic transformation in aquatic sediment systems (OECD 308). 

P 11-0530 will have the following tests pended: phototransformation of chemicals (Draft 

OECD Guideline on soil surfaces-2 soils, Jan. 2002), simulation test-aerobic sewage 

treatment (activated sludge units) (OECD 303A), and aerobic and anaerobic 

transforniation in aquatic sediment systems (OECD 308). 

No consumer spray application of any of the PMN substances (P11-0487, 

P11-0530, P11-0533, and P11-0534) is allowed until the following tests of all PMN compounds 

for health effects are conducted by the Companies, submitted to and evaluated by EPA, and the 

use in consumer spray application is approved by EPA: acute inhalation test, OPPTS 870.1300, 

and a 90-day inhalation study, OPPTS 870.3465, with a post-exposure observation period of up 

to 3 months and bronchoalveolar lavage fluid (BALF) analysis. EPA has determined that the test 

results could allow the Agency to consider consumer spray application of the PMN substances. 
Xlll 

The Order does not require submission of the above pended testing at any specified time 

or production volume. However, the Order's restrictions on manufacture, import, processing, 

distribution in commerce, use, and disposal of the PMN substance will remain in effect until the 

Order is modified or revoked by EPA based on submission of that or other relevant information. 

EPA expects that protocols would be submitted prior to any additional toxicological or 

ecological testing. Due to the limited water solubility of some of these substances and 

consequent analytical difficulties, some modification of the protocols may be necessary. These 

and other modifications will be agreed upon between EPA and the Companies. 
CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

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

processing, distribution in commerce, use and disposal of the following chemical substances; 

P-11-0483 - [ 

P-11-0487 - ( 

P-11-0530 - ( 

], P-11-0527 - [ 

], P-11-0528- [ 

], P-11-0529- [ 

], P-11-0532 - [ 

], P-11-0533 - [ 

], and P-11-0534- [ 

], 

], 

], 
-2-

submitted by [ ] ("the Companies"), to 

take effect upon expiration of the PMN review period, except to the extent that those activities 

are exempted by paragraph (b). 

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

PMN substances 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 the 

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

of the following exemptions, and (2) such compliance is documented by appropriate 

recordkeeping as required in the Recordkeeping section of this Order. 

(!) Export. Until the Companies begin commercial manufacture of the PMN substances 

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

processing or distribution in commerce of the PMN substances solely for export in accordance 

with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the 

Companies begin to manufacture the PMN substances for use in the United States, no further 

activity by the Companies involving the PMN substances is exempt as "solely for export" even if 

some amount of the PMN substances is later exported. At this point, the requirements of this 

Order apply to all activities associated with the PMN substances while in the territory of the 

United States. Prior to leaving U.S. territory, even those quantities or batches ofthe PMN 

substances that are destined for export are subject to the 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 commerce, use and disposal of the PMN substances in 

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

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 manufactured solely for non-commercial research and development per 40 CFR 720.30(i) 

and TSCA §5(i). 

(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 720.3( d) and in compliance with 40 CFR 720.30(g). 

( 4) No Separate Connnercial 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 

720.30(h), with no commercial purpose separate from the substances, mixture, or article of 

which it is a part. 

(5) Imported Articles. The requirements ofthis Order do not apply to the PMN 

substances when they are imported as part of an "article" as defined at 40 CFR 720.3( c) and in 

compliance with 40 CFR 720.22(b)(l). 

(c) Automatic Sunset. If the Companies have obtained for the PMN substances a Test Market 

Exemption ("TME") under TSCA §5(h)(l) and 40 CFR 720.38 or a Low Volume Exemption 

("LYE") or Low Release and Exposure Exemption ("LoREX") 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. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION OF INFORMATION 
-4-

PROHIBITION 

The Comp~ies are prohibited from manufacturing the PMN substances in the United 

States, for any non-exempt 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 ofEPA's review of, and regulatory action based on, that 

information, except in accordance with the conditions described in this Order. 

CHEMICAL SYNTHESIS AND COMPOSITION 

(a) Restrictions. The Companies shall not manufacture or cause, encourage or suggest that a [ 

J manufacturer manufacture the PMN substances unless testing of the [ 

] starting raw material by the Companies or as evidenced by a Certificate of Analysis 

from the raw material supplier, meets the established purity level as specified in Table 1 and 

Table 2 of this Order. If, a product that contained [ ] products was 

processed or manufactured in the equipment at the facility where the PMN substances are to be 

made, the Companies shall test the Initially Isolated Formulations of the PMN substances for the 

analytes specified in Table 3 of this Order to confirm that cross-contamination from the 

manufacture of the product with [ J has not occurred. Testing shall be 

conducted upon initial commencement of manufacture and at least annually thereafter, until one 

year after the date of the last manufacture or processing of a product that contains [ ] 

products at that facility. No testing ofinitially Isolated Formulations of the PMN substimces will 

be required if [ ] have not been previously manufactured or processed or 
- 5-

were not manufactured or processed at the facility withln one year of manufacturing or 

processing of the PMN substances. The Companies shall submit all test protocols to EPA for 

approval prior to initiating testing. Protocols should be submitted to the OPPT Document 

Control Office (7407M), 1200 Pennsylvania Ave, N.W., Washlngton, DC 20460; Attention: 

Program Manager, New Chemicals Program, Chemical Control Division. EPA will respond to 

the Companies withln [ J of receiving the written protocols. Absent a response from EPA 

within the [ ] window, the Companies are permitted to rely on its protocols until an 

EPA response is received. The Companies shall record the levels of impurities [ 

] associated with the PMN substances manufactured 

by the Companies and/or the Contract Manufacturer, as specified below. The Companies shall 

record analytes present in the [ ], at each manufacturing facility using tills raw 

material (as shown in Table l). Further, the Companies will also annually record the analyte [ 

] present in the [ ] starting raw material (as shown in 

Table 2). The Companies shall make its best effort to minimize these impurities. If any new 

manufacturing facilities are added, or the manufacturing process is significantly altered, then the 

PMN substances must be tested at commencement of these actions and annually thereafter. 

(b) Reporting. The Companies shall test representative samples of the Initially Isolated 

Formulations of the PMN substances manufactured or imported by the Companies and/or the 

Contract Manufacturer to determine compliance with the requirements in paragraph (a). The 

Companies shall test the Initially Isolated Formulations of the PMN substances at each 

manufacturing facility both (1) at the initial commencement of non-exempt manufacture of the 

PMN substances at that facility, and (2) at least annually thereafter during every year in which 
-6-

the PMN substances are manufactured at that facility or imported. If any new manufacturing 

facility is added, or if the process of manufacture of the PMN substances or any intermediate 

thereof is significantly altered, then the Initially Isolated Formulation of the PMN substances 

must be tested at commencement of these actions and annually thereafter, as set forth above. If 

the PMN substances are imported, the Companies shall obtain from the foreign manufacturer 

written documentation to certify that representative samples ofthe imported form of the PMN 

substances have been tested, consistent with the requirements of this paragraph (b) and 

determined to comply with the requirements of paragraph (a). 

The Companies shall report the above testing to EPA at initial commencement of 

manufacture or import and again if any new manufacturing facility is added or if the process of 

manufacture of the PMN substances or any intermediate thereof is significantly altered. the 

Companies shall continue to report these impurity levels to EPA annually. This is consistent 

with the current annual reporting cycle [ 

]. In addition to the reporting for the Initially Isolated Formulations of the PMN 

substances itself, the Companies shall, for the [ ] starting raw material, annually 

report (1) the average values and the range of values, including outlying data, for the routine 

testing for the analytes specified in Table 1, and (2) the results of the annual testing for the 

analyte specified in Table 2. 

TABLE 1: Chemicals to be Routinely Tested in [ ] Starting Raw Material 

Analyte CAS Number Limit in[] 

[] [ l []minimum 

[] [ l [J 

[] [ l 
- 7-

TABLE 2: Chemicals to be Tested at least Annually in [ ] Starting Raw Material 

Analyte Limit in[] 

[] 

TABLE 3: Chemicals to be Tested in the Initially Isolated Formulations of the PMN Substance 

Estimated Maximum in Initially 

Analyte CAS Number Isolated Formulations of the PMN 

Substance 

[] [ l [] [] [ l 

[] [ l [] 

TESTING 

(a) Section 8(e) Reporting. Reports of information on the PMN substances which reasonably 

supports the conclusion that the PMN substances presents a substantial risk of injury to health or 

the enviromnent and which is required to be reported under TSCA section 8( e) shall reference 

the appropriate PMN identification numbers for these substances and contain a statement that the 

substances are 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 Companies shall notify, in writing, the EPA Monitoring 

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

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

Washington, D.C. 20460, of the following information within 10 days of scheduling any study 
- 8-

required to be performed pursuant to this Order, or within 15 days after the effective date of this 

Order, whichever is later: 

(1) The date when the study is scheduled to commence; 

(2) The name and address ofthe laboratory which will conduct the study; 

(3) The name and telephone number of the persons at the Companies or the laboratory 

whom EPA may contact regarding the study; and, 

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

the substances are subject to this Consent Order. 

(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be 

performed pursuant to the triggered testing requirements of 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 community at the time the study is 

initiated. Before starting to conduct any toxicity study, the Companies must obtain approval of 

test protocols from EPA by submitting written: protocols. Protocols must be submitted to the 

OPPT Document Control Office (7407M), 1200 Pennsylvania Ave. N. W., Washington, DC 

20460; Attention: Program Manager, New Chemicals Program, Chemical Control Division. 

EPA will respond to the Companies within [] of receiving the written protocols. Absent a 

response from EPA within the [] window, the Companies are permitted to rely on its protocol 

until an EPA response is received. Published test gnidelines specified in paragraph (d) provide 

general guidance for development of test protocols, but are not themselves acceptable protocols. 

EPA approval of a test protocol does not mean pre-acceptance of test results. 
- 9-

(d) Triggered Testing Requirements. The Companies are prohibited from manufacturing or 

importing the PMN substances beyond the following time allowances or aggregate manufacture 

and import volumes ("the production limits"), unless the Companies either: 

(1) conducts the following studies on the PMN substances and submits all final reports 

and underlying data in accordance with the conditions specified in this Testing section, or 

(2) submits other relevant information (including test data conducted using alternate 

guidelines) to meet these requirements and EPA determines that this other information satisfies 

the testing requirements. 

The following triggered testing on the PMN substance P11-0483 (Tiers 1, 3, and 4) and Tier 2 

and Tier 4 triggered fate tests on the PMN substance P11-0530 will be required in the Consent 

Order 14 weeks before manufacturing or importing an aggregate of [ ] kilograms (Tier 1 ), 

[] years []months (Tier 2), []kilograms (Tier 3), and []kilograms (Tier 4) of 

the PMN substances [ J combined. 

Tier 1 tests (for Pll-0483 chemical substance) [ ] kg 

Pharmacokinetics study in rats and mice 

Combined repeated dose toxicity study 

with developmental/reproduction screening 

test, oral route, species to be determined 

by the results of the pharmacokinetics 

studies with modifications. 

Tier 2 tests (for P11-0530 chemical substance) 

Soil biodegradation study 

(OPPTS 870.7485) 

(OPPTS 870.3650 modified, 

OECD421 modified) 

[] years [] months after the date the 

Company signed this Consent Order 

(OECD 307) 
Tier 3 (for Pll-0483 chemical substance) [ 

Fish 96-hr LC50 

Flow-through method, analytical 

measurement of test substance, 

mean, measured test concentrations. 

Acute Daphnia 

Flow-through method, analytical 

measurement of test substance, 

mean, measured test concentrations. 

Algae 

Static method, analytical measurement 

of test substance, mean, measured test 

concentrations. 

Tier 4 test [ l kg 

- 10-

Triggered testing (for Pll-0483 chemical substance) 

l kg 

Avian Reproduction in bobwhite quail or mallard ducks 

(OPPTS 850.1075) 

(OPPTS 850.1010) 

(OPPTS 850.5400) 

for PMN compound. (OPPTS 850.2300, OECD 206) 

Triggered testing for Pll-0530 chemical substance 

Hydrolysis as a function of pH and temperature (OPPTS 835.2130, OECD 111) 

UV visible light absorption (OPPTS 830.7050) 

Direct Photolysis, if wavelengths greater than 

290 nm are absorbed in the previous test 

(OPPTS 835.2210) 

Indirect Photolysis Screening Test 

Anaerobic biodegradability of 

organic compounds in digested sludge 

Degradation test 

(OPPTS 835.05270) 

(OECD 311/835.3420) 

(Modified Semi Continuous Activated Sludge, 

SCAS, OPPTS Guideline 835.5045 or OECD 302A, 

or modified Zahn-Wellens method, OECD 302B, 

with analysis for degradation products - see EPA 

general guidance presented in Attachment D, Key · 
- 11 -

Elements of Biodegradation Testing of 

Fluorotelomer Based Chemicals. The Companies 

must analyze for the C6 and C7 possible degradants 

specified in Table 4 below) 

Table 4. Potential PBT Enviromnental Metabolites/degradants to be analyzed. 

Analyte CAS Number 

[] [] 

[] [ l 

[] [ l 

[] [ l 

[] [ l 

[] [ l 

[] [ l 

[] [ l 

(e) Test Reports. The Companies 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, in triplicate (with an additional sanitized copy, if 

confidential business information is involved), the final report of each study and all underlying 

data ("the report and data") to EPA prior to exceeding the production limit. The fmal 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 ofthis Consent Order, 

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

the submission of such inforination is mandatory. EPA will require the submission ohaw data · 
- 12-

such as slides aud laboratory notebooks only ifEP A fmds, on the basis of professional judgment, 

that au adequate evaluation of the study carmot take place in the absence of these items. 

(f) Testing Waivers. The Companies are 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 because for example, alternative information would satisfy the requirements. 

(g) Equivocal Data. If EPA finds that the data generated by a study are scientifically equivocal, 

the Companies may continue to manufacture aud import the PMN substances beyond the 

applicable production limit. To seek relief from any other restrictions of this Order, the 

Companies may make a second attempt to obtain unequivocal data by reconducting the study 

under the conditions specified in paragraphs (b), (c), aud (e)(l) aud (e)(2). 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 ofEP A aud the Companies. 

(h) EPA Determination of Invalid Data. 

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

test report aud data, the Companies receive written notice that EPA finds that the data generated 

by a study are scientifically invalid, the Companies are prohibited from further manufacture aud 

import of the PMN substances beyond the applicable production limit. 

(2) The Companies may continue to manufacture aud import the PMN substances 

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

Companies' compliance with either .of the following subparagraphs (h)(2)(i) or (h)(2)(ii). 
- 13-

(i) The Companies may reconduct the study in compliance with paragraphs (b), 

(c), and ( e)(l) and (2). If there is sufficient time to reconduct the study and submit tbe report and 

data to EPA before exceeding tbe production limits as required by subparagraph ( e )(3), the 

Companies shall comply witb subparagraph (e)(3). Iftbere is insufficient time for the 

Companies to comply with subparagraph ( e )(3), the Companies 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 tbe notice described in subparagraph (h)(l ). EPA will respond to tbe 

Companies, in writing, witbin 6 weeks of receiving the Companies' report and data. 

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

described in subparagraph (h)( I), submit to EPA a written report refuting EPA's fmding. EPA 

will respond to the Companies, in writing, witbin 4 weeks of receiving the Companies' report. 

(i) Company Determination of Invalid Data. 

(1) Except as described in subparagraph (i)(2), if the Companies become aware that 

circumstances clearly beyond tbe control of tbe Companies or laboratory will prevent, or have 

prevented, development of scientifically valid data under tbe conditions specified in paragraphs 

(c) and (e), the Companies remain prohibited from further manufacture and import of the PMN 

substances beyond the applicable production limit. 

(2) tbe Companies may submit to EPA, within 2 weeks of first becoming aware of such 

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

the Companies or laboratory will cause or have caused development of scientifically invalid data. 

EPA will notify the Companies of its response, in writing, within 4 weeks of receiving tbe 

Companies' report. EPA's written response may eitber: 
- 14-

(i) allow the Companies to continue to manufacture and import the PMN 

substances beyond the applicable production limit, or 

(ii) require the Companies to continue to conduct, or to reconduct, the study in 

compliance with paragraphs (b), (c), and (e)(l) and (2). If there is sufficient time to conduct or 

reconduct the study and submit the report and data to EPA before exceeding the production 

limits, as required by subparagraph ( e )(3), the Companies shall comply with subparagraph ( e )(3). 

If there is insufficient time for the Companies to comply with subparagraph (e)(3), the 

Companies 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 (i)(2). EPA will respond to the Companies, in writing, within 6 weeks of receiving 

the Companies' report and data, as to whether the Companies may continue to manufacture and 

import beyond the applicable production limit. 

G) Unreasonable Risk. 

(I) EPA may notify the Companies 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 

enviroument. EPA's notice may specify that the Companies 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. Within 2 weeks from receipt of such a notice, the Companies must cease all 

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

either: 
- 15 -

(A) within 2 weeks from receipt of the notice described in subparagraph (j)(l ), 

the Companies comply with such requirements as EPA's notice specifies; or 

(B) within 4 weeks from receipt of the notice described in subparagraph (j)(l), 

the Companies submit to EPA a written report refuting EPA's finding and/or the appropriateness 

of any additional requirements imposed by EPA. The Companies 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 Companies' written report. EPA will respond to the 

Companies, in writing, within 4 weeks of receiving the Companies' report. Withln 2 weeks of 

receipt of EPA's written response, the Companies 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 tills Testing 

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

notified in writing by EPA. The Companies 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. 

MANUFACTURING 

(a)(l) Prohlbition. The Companies shall not cause, encourage, or suggest the manufacture or 

import of the PMN substances by any other person, except as described in paragraph (b). 
- 16-

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

promulgation of a final significant new use rule ("SNUR") governing the PMN substances under 

section 5(a)(2) ofTSCA unless the Companies are notified on or before that day of an action in a 

Federal Court seeking judicial review of the SNUR. If the Companies are so notified, 

subparagraph (a)(l) shall not expire until EPA notifies the Companies 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 final SNUR for the PMN substances 

and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Companies shall 

notifY each person whom it causes, encourages or suggests to manufacture or import 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 significant new 

uses, and which would invoke significant new use notification to EPA for the PMN substances. 

Such notice must also reference the publication of the SNUR for the PMN substances in either 

the Federal Register or the Code of Federal Regulations. 

(4) Subparagraph (a)(2) shall not negate the effects of any fully executed Consent Order 

for Contract Manufacturer entered into under paragraph (b )(2). 

(b) Contract Manufacturer. Notwithstanding paragraph (a), the Companies may cause the 

Contract Manufacturer( s) identified in the PMN and listed in the Preamble of this Order to 

manufacture or import the PMN substances according to the following conditions (after this 

Order has been signed, the Companies may petition EPA pursuant to Section VI of this Order to 

. include additional Contract Manufacturers): 
- 17-

(1) The Contact Manufacturer must be under contract to the Companies to manufacture 

or import the PMN substances solely for the Companies. The contract must specify the identity 

of the PMN substances, the total quantities to be manufactured, and the basic technology to be 

used for manufacturing. 

(2) The Companies shall obtain from each Contract Manufacturer a signed copy of the 

Consent Order for Contract Manufacturer (attached to this Order as Attachment C) and submit 

the copy to EPA along with the name, address, and telephone number of a responsible official of 

the Contract Manufacturer. The Consent Order should be submitted to the OPPT Document 

Control Office (7407M), 1200 Pennsylvania Ave. N.W., Washington, DC 20460; Attention: 

Program Manager, New Chemicals Program, Chemical Control Division. The Contract 

Manufacturer or Company must receive a fully executed copy of the Consent Order for the 

Contract Manufacturer from EPA before the Contract Manufacturer may begin manufacture or 

import. 

(3) If at any time, the Companies learn that the Contract Manufacturer has failed to 

comply with any of the conditions specified in the Consent Order for Contract Manufacturer, the 

Companies shall immediately cease to cause the Contract Manufacturer to manufacture or import 

the PMN substances, unless the Contract Manufacturer is in compliance with a SNUR for the 

PMN substances, or unless the Companies are able to document each of the following: 

(i) That the Companies have, within 5 working days, notified the Contract 

Manufacturer in writing that the Contract Manufacturer has failed to comply with the conditions 

specified in the Consent Order for Contract Manufacturer. 

(ii) That, within 15 working days of notifying the Contract Manufacturer of the 

noncompliance, the Companies received from the Contract Manufacturer, in writing, a statement 
- 18 -

of assurance that the Contract Manufacturer is aware of the terms of the Consent Order for 

Contract Manufacturer and will comply with those terms. 

(iii) If, after receiving a statement of assurance from the Contract Manufacturer 

under subparagraph (B) of this Section, the Companies have notice or knowledge that the 

Contract Manufacturer has failed to comply with any of the conditions specified in the Consent 

Order for Contract Manufacturer, the Companies shall immediately cease to cause the Contract 

Manufacturer to manufacture or import the PMN substances, shall notify EPA of the failure to 

comply, and shall resume causing the Contract Manufacturer to manufacture or import the PMN 

substances only upon written notification from the Agency. 

c) The Companies and their Contract Manufacturer( s) shall not manufacture the PMN 

substances Pll-0487, Pll-0530, Pll-0533, and Pll-0534 beyond an annual manufacture and 

importation volume of [ ] each. 

The Companies shall: 

(a) use the PMN substances Pll-0483, Pll-0527, Pll-0528, Pll-0529, and Pll-0532 as 

[ ] described in the PMNs (to manufacture Pll-0487, Pll-0530, 

Pll-0533, and Pll-0534) and to manufacture [ 

]. 

(b) use the PMN substances Pll-0487, Pll-0530, Pll-0533, andPll- 0534 only as surfactants 

for [ ] applications under the scenarios described in the PMNs; and 
- 19-

(c) not use the PMN substances Pll-0487, Pll-0530, Pll-0533, and Pll- 0534 for 

consumer spray applications. 

DISTRIBUTION 

(a) Export Notice Requirement. No later than the date of distribution, the Compauies shall 

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) ofTSCA, the PMN substances is subject to the export 

notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice 

shall contain, in the form in which it appears in this Consent Order, the following information: 

(1) the PMN number, and (2) either (A) the specific chemical identity ofthe PMN substances, or 

(B) if the specific chemical identity is confidential, the generic chemical identity. 

(b) Distribution Requirements. Except as provided in paragraph (c), the Companies shall 

distribute the PMN substances outside the Compauies, other than for disposal, only to a person 

who has agreed in writing prior to the date of distribution, to: 

(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 is subject to 

the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. 

Such notice shall contain, in the form in which it appears in this Consent Order, the following 

information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN 

substances, or (B) if the specific chemical identity is confidential, the generic chemical identity. 

(2) Comply with the same environmental release restrictions, required of the Compauies 
-20-

in the Disposal and Release to Water sections of this Order. 

(3) Use the PMN substances Pll-0483, Pll-0527, Pll-0528, Pll-0529, and Pll-0532 

only as chemical intermediates described in the PMNs and to [ 

]; 

(4) Use the PMN substances Pll-0487, Pll-0530, Pll-0533, and Pll- 0534 only as 

surfactants for [ ] applications under the scenarios described in the 

PMNs; and 

(5) Not use the PMN substances Pll-048'7, Pll-0530, Pll-0533, and Pll-0534 for 

consumer spray applications. 

(c) Temporary Transport and Storage. Notwithstanding paragraph (b), the Companies may 

distribute the PMN substances outside the Companies for temporary transport and storage in 

sealed containers provided the following three conditions are met: 

(1) Subsequent to any such exempt temporary transport or storage of sealed containers, 

the PMN substances may be distributed only to the Companies or a person who has given the 

Companies the written agreement required by paragraph (b). 

(2) Any human exposure or enviromnental release resulting from opening the sealed 

containers and removing or washing out the PMN substances may occur only while the PMN 

substances is in the possession and control of the Companies or a person who has given the 

Companies the written agreement required by paragraph (b). 

(3) A statement of the health hazards( s) and precautionary measure( s ), if any, identified 

by the Companies for the PMN substance; the identity by which the PMN substance may be 

commonly recognized; a statement of the enviromnental hazard(s) and precautionary measure(s), 
- 21 -

if any, identified by the Companies for the PMN substance; a statement of exposure and 

precautionary measure(s), if any, identified by the Companies for the PMN substance; and the 

name and address of the manufacturer or a responsible party who can provide additional 

information on the substance for hazard evaluation and any appropriate emergency procedures. 

The label shall not conflict with the requirements of the Hazardous Materials Transportation Act 

(18 U.S.C. 1801 et. seq.) and regulations issued under that Act by the Department of 

Transportation. 

(d) Recipient Non-Compliance. If, at any time after commencing distribution in commerce of 

the PMN substances, the Companies obtain knowledge that a recipient of the substances has 

failed to comply with any of the conditions specified in paragraph (b) of this Distribution section 

or, after paragraph (b )(2) expires in accordance with subparagraph ( e )(l ), has engaged in a 

significant new use of the PMN substances (as defined in 40 CFR Part 721, Subpart E) without 

submitting a significant new use notice to EPA, the Companies shall cease supplying the 

· substances to that recipient, unless the Companies are able to document each of the following: 

(l) That the Companies have, within 5 working days, notified the recipient in writing 

that the recipient has failed to comply with any of the conditions specified in paragraph (b) of 

this Distribution section, or has engaged in a significant new use of the PMN substances without 

submitting a significant new use notice to EPA. 

(2) That, within 15 working days of notifying the recipient of the noncompliance, the 

Companies received from the recipient, in writing, a statement of assurance that the recipient is 

aware of the terms of paragraph (b) of this Distribution section and will comply with those terms, 
-22-

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 receiving a statement of assurance from a recipient under subparagraph 

(d)(2) of this Distribution section, the Companies obtain knowledge that the recipient has failed 

to comply with any of the conditions specified in paragraph (b) 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 Companies 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. 

(e) Sunset Following SNUR. (1) Paragraph (b)(2) of this Distribution section shall expire 75 

days after promulgation of a fmal SNUR for the PMN substances under section 5(a)(2) ofTSCA, 

unless the Companies are notified on or before that day of an action in a Federal Court seeking 

judicial review of the SNUR. If the Companies are so notified, paragraph (b )(2) of this 

Distribution section shall not expire until EPA notifies the Companies in writing that all Federal 

Court actions involving the SNUR have been resolved and the validity of the SNUR affirmed. 

(2) When EPA promulgates a final SNUR for the PMN substances and paragraph (b)(2) of this 

Distribution section expires in accordance with subparagraph ( e )(I), the Companies shall notify 

each person 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 significant new uses, and which would invoke significant new use 

notification 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 
-23-

Regulations. After promulgation of a SNUR and expiration of subparagraph (b )(2), such notice 

may substitute for the written agreement required in the introductory clause of paragraph (b); so 

that, if the Companies provide such notice to the persons to whom it distributes the PMN 

substances, then the Companies are not required to obtain from such persons the written 

agreement specified in paragraph (b). 

DISPOSAL 

The Companies shall dispose of the PMN substances and any waste containing the PMN 

substances from manufacturing and processing only as follows: incinerate the waste in 

an incinerator operating at the temperature of at least I 000 degrees C and a residence 

time of minimum of2 seconds. Any tank or vessel washings, residues from transport 

vessels or tanks, and similar materials that are captured and retained in the normal 

course of manufacturing and processing for re-use in manufacturing of the PMN 

substances or products made from the PMN substances are exempt from this method of 

disposal. 

This provision does not supersede or preempt any applicable federal, state, and local laws 

and regulations if those laws are more stringent than the requirements below. 

RELEASE TO WATER 

This provision does not supersede or preempt any applicable federal, state, and local laws and 

regulations. (Those other laws may be more stringent than the requirements below.) 
-24-

the Companies are prohibited from any predictable or purposeful release of the PMN substances, 

or any manufacturing or processing waste streams containing any of the PMN substances to the 

waters of the United States, except [ 

]. 

RISK NOTIFICATION 

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

aware that the PMN substances may present a risk of injury to human health or the environment 

(or is so notified by EPA), the Companies must incorporate this new information, and any 

information on methods for protecting against such risk, into a Material Safety Data Sheet 

("MSDS ") for the PMN substances, as described in 40 CFR section 721. 72( c), within 90 days 

from the time the Companies become aware of the new information. If the PMN substances are 

not being manufactured, imported, processed, or used in the Companies' workplace, the 

Companies must add the new information to an MSDS before the PMN substances are 

reintroduced into the workplace. 

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

Companies (including any Contract Manufacturer( s) (as described in paragraph (b) of the 

Manufacturing section of this Order), or who have received the PMN substances .from the 

Companies within 5 years from the date the Companies become aware of the new information 
-25-

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 Companies become aware of the 

new information. 

III. RECORDKEEPING 

(a) Records. The Compauies shall maintain the following records until 5 years after the date 

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

with section 11 ofTSCA: 

(I) 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 Companies. 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 all the requirements in this Recordkeeping section, if the Companies maintain, 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)(l)(B) and !2(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 Companies 

maintain, 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 Section I, Paragraph (b) of this Order, the Compauies shall keep records 

demonstrating qualification for that exemption as well as the records specified in paragraphs (3) 
-26-

and ( 4) below, but is exempt from the other recordkeeping requirements in this Recordkeeping 

section; 

(2) Records documenting compliance with the Chemical Synthesis and Composition; 

(3) Records documenting the manufacture and importation volume of the PMN 

substances and the corresponding dates of manufacture and import; 

( 4) 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 

Companies directly sell or transfers the PMN substances, the date of each sale or transfer, and 

the quantity of the substances sold or transferred on such date; 

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

use; 

( 6) Records documenting compliance with any applicable manufacturing, processing, 

use, disposal and distribution restrictions in the Manufacturing, Processing, Use, and Distribution 

sections of this Order, including distributees' written agreement to comply with the Distribution 

section of this Order; 

(7) Records documenting compliance with any applicable disposal requirements under 

the Disposal section of this Order, including method of disposal, location of disposal sites, dates 

of disposal, and volume ofPMN substances disposed. Where the estimated disposal volume is 

not known to the Companies and is not reasonably ascertainable by the Companies, the 

Companies must maintain other records which demonstrate establishment and implementation of 

a program that ensures compliance with any applicable disposal requirements; 
-27-

(8) Records documenting establishment and implementaiion of procedures that ensure 

compliance with any applicable water discharge limitation in the Release to Water section of this 

Order; 

(9) Copies of any Transfer documents and notices required by the Successor Liability 

section of this Order, if applicable; and, 

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

substances is manufactured, imported, processed, or used. 

(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities 

of the Companies and its Contract Manufacturer, if applicable, and not to activities of the 

Companies' 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 Companies are 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 EPA so informs the Companies. The 

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

currently valid OMB Control Number 2070-0012. 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA's Reguest for Information. Pursuant to section 11 ofTSCA 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 Companies 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: 

(l) 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 that 

are collected during the manufacture or processing of 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 Companies shall respond to such requests within a reasonable 

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

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

known to or reasonably ascertainable by the Companies at the time of the request, the 

Companies' response shall demonstrate a good faith effort to provide reasonably accurate and 

detailed answers to all ofEPA's requests. 
-29-

(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the 

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

TSCA and 40 CFR Part 2. 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

(a) Scope. This section sets forth the procedures by which the Companies" rights and 

obligations under this Order may be transferred when the Companies transfer its interests in the 

PMN substances, including the right to manufacture the PMN substances, to another person 

outside the Companies (the "Successor in Interest"). 

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

(1) Before NOC. If the transfer from the Companies to the Successor in Interest is 

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

the PMN substances from the Companies pursuant to 40 CFR 720.102, the Successor in Interest 

must submit a new PMN to EPA and comply fully with Section 5(a)(l) of TSCA and 40 CFR 

part 720 before commencing manufacture or import of the PMN substances. 

(2) After NOC. If the transfer from the Companies 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 of the Order: 
-30-

(1) "Successor in Interest" means a person outside the Companies Who has acquired the 

Companies' full interest in the rights to manufacture the PMN substances, including all 

ownership rights and legal liabilities, through a transfer document signed by the Companies, as 

transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire 

less than the full interest of the Companies in the PMN substances, such as a licensee who has 

acquired a limited license to the patent or manufacturing rights associated with the PMN 

substances. A Successor in Interest must be incorporated, licensed, or doing business in the 

United States in accordance with 40 CFR 720.22(a)(3) and 40 CFR 720.3(z). 

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

the PMN substances, including the right to manufacture the PMN substances, from the 

Companies to the Successor in Interest. 

(d) Notices. 

(1) Notice to Successor in Interest. On or before the effective date of the transfer, the 

Companies 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 

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

U.S. Enviromnental Protection Agency, New Chemicals 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 substances 
- 31 -

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

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

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

this Order from the Companies to the Successor in Interest. 

(e) Liability. 

(1) The Companies 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 Companies after the effective date of the transfer for actions 

taken, or omissions made, during the time in which the Companies 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 Companies 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 Companies up to the date of transfer shall count towards the test trigger 

applicable to the Successor in Interest. 
-32-

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Companies 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 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 and 

will not result in significant or substantial human exposure or substantial environmental release 

in the absence of data sufficient to permit a reasoned evaluation of the health or environmental 

effects of the PMN substances. 

In addition, the Companies 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. 
-33-

VII. EFFECT OF CONSENT ORDER 

(a) Waiver. By c;onsen(ing to the entry of this Order, the Companies waive their rights to file 

objections to this Order pursuant to section 5(e)(l)(C) ofTSCA, to receive service of this Order 

no later than 45 days before the end of the review peliod pursuant to section 5(e)(l)(B) ofTSCA, 

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 

Companies as to the facts or conclusions underlying the Agency's determinations in this 

proceeding. Tills waiver does not affect any other lights that the Companies may have under 

TSCA. 

(b) CBI Brackets. By signing this Order, the Companies represent that it have carefully 

reviewed this document and hereby agrees that all information herein that is claimed as 

confidential by the Companies (per section 14 of TSCA, 40 CFR Part 720 Subpart E, and 40 

CFR Part 2) is correctly identified within brackets and that any information that is not bracketed 

is not claimed as confidential. To make this document available for public viewing, EPA will 

remove only the information contained withln the brackets. 

l~) vlevtcLlbJ) 

Date 

i I I!-Jn I t.o/3 

Date 

Malia J. Doa, h D., Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 

Name: [ 

Title: [ 

Company: [ . ] 
Date Name: [ Title: [ 

Company: [' 

J 

J 

J 
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. 

"Company" means the person or persons subject to this Order. 

"Commercial use" means the use of a chemical substances or any mixture containing the 

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

conswners (e.g., a commercial dry cleaning establishment or painting contractor). 

"Common na_me" means any designation or identification such as code name, code 

number, trade name, bra11d name, or generic chemical name used to identify a chemical 

substance other than by its chemical J';lmn.e. :' Y. 

"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 pm·sonf!l 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, drmn, 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 Companies, 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. 

"Final Formulation of the PMN substance" means the formulated dispersion of the PMN '·-") 

substance in the form in which it is sojclto customers outside the Companies or transferred to a 

different business unit within the Comp<~nies. The tem1 does not include intermediate dilutions 

of the PMN substance that are intended only for use within the Companies for further dilution 

prior to sale. • 

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

a mixture containing that substance. 
A-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. 

•,'' 

. '·~, 

"Initially Isolated Fonnulation¥ofthe PMN substance" means a common intermediate 

PMN formulation, as it exists when fltst·produced and isolated after the polymer manufacturing 

process, that can be further processed or repackaged at the direction of the Companies to result 

ultimately in one or more final formulations ofthe PMN substance. 

"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. 

"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 substances and the 

workplace air may occur. 

"Non-industrial use" means use other than at a facility where chemical substances or 

mixtures are manufactured, imported, orprocessed. 

"PMN substance" mea.11s the c!jtlmical substance described in the Premanufacture notice 

submitted by the Companies relevant to this Order. 

"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-approved protocol, 

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

Agency approval that prevents a reasoned evaluation of the health or environmental effects of the 

PMN substance. 

"Scientifically equivocal data" means data which, although developed in apparent 

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

inconclusive, internally inconsistent, or otherwise insufficient to pem1it a reasoned evaluation of 

the potential risk of injury to human health or the environment of the PMN substance. 
A-3 

"Sealed container" means a closed container that is physically and chemically suitable for 

long-tem1 containment of the PMN substance, and from which there will be neither 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. 

"Workplace" means an establishment at one geographic location containing one or more 

work areas. 
Company (Transferor) 

, ATTACHMENT B 

NOTICE OF TRA.NSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

PMNNumber 

I. Transfer of Manufacture Rights. Effective on , the Companies did sell or 

otherwise transfer to , ("Successor in Interest") the rights 

and liabilities associated with manufacture of the above-referenced chemical substances, 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 Succe,,ssor in Interest hereby certifies that, as ofthe effective 

date of transfer, all actions or omissiorls governed by the applicable Consent Order limiting 

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

shall be the responsibility of the Successpdn Ipterest. Successor in Interest also certifies that it 

is incorporated, licensed, or doing busines1 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 Companies, pursuant to 

Sectionl4 ofTSCA and 40 CFR part 2, for the PMN substances(s). Where "reasserts" or 

"relinquishes" is indicated, that designation shall be deemed to apply to all such claims. Where 

"modifies" is indicated, such modifica!j'on shall be explained in detail in an attachment to this 

Notice of Transfer. Information whicqhas been previously disclosed to the public (e.g., a 

chemical identity that was not claimedas CBI by the original submitter) would not subsequently 

be eligible for confidential treatment under this Notice of Transfer. ,-·,<, 
B-2 

NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

(continued) 

Company (Transferor) PMNNumber 

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 
B-3 

NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone