UNITED STATES 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 Number: 

 ) 

 ) 

 ) 

 ) 

 ) 

 3M Company ) P-13-305 

 ) 

 ) 

 ) 

 ) 

 ) 

_________________________________________________________________ 

Consent Order and Determinations Supporting Consent Order 

_________________________________________________________________ 
ii 

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 (defined by statute to include 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 - Definitions 

Attachment B - Notice of Transfer of Consent Order 
iii 

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 notice (“PMN”) P-13-305 for the chemical substance 

[ (“the PMN substance”) 

submitted by 3M Company (“the Company”), to take effect upon expiration of the PMN review 

period. The Company submitted the PMN to EPA pursuant to § 5(a)(1) of TSCA and 40 CFR 

Part 720. 

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

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 this PMN substance requires the Company to: 

(a) provide personal protective equipment to its workers to prevent dermal exposure; 

(b) provide respirators to its workers to prevent inhalation exposure; 

(c) label containers of the PMN substance and provide Material Safety Data Sheets (“MSDSs”) 

and worker training in accordance with the provisions of the Hazard Communication Program 

section; 
iv 

(d) use the PMN substance only as a chemical intermediate. Any chemical substance 

manufactured using the PMN substance may contain residuals of the PMN substance at levels no 

greater than [ 

(e) recover and convert, capture (destroy), recycle, or reuse the substance at an overall efficiency 

of [ when the PMN substance is used as an intermediate in accordance with the provisions 

of the Use section; 

(f) not use the PMN substance in consumer products; 

(g) distribute the PMN substance only to a person who agrees to follow the same restrictions 

(except the testing requirements); 

 (h) provide risk notification in accordance with the provisions of the Risk Notification section; 

and 

 (i) maintain certain records. 
v 

III. CONTENTS OF PMN

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

agrees that all information herein that is claimed as confidential by the Company 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): 

Chemical identity, production volume, use, exposure and release information 

Chemical Identity: 

Specific: [

Generic: Fluorinated acid alkylester 

Use:

Specific: [

Generic: Intermediate 

Maximum 12-Month Production Volume: [

Test Data Submitted with PMN: physical/chemical properties and 4-hour range-finding 

inhalation toxicity study in rats 

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 substance, based on the 

information currently available to the Agency. 

Human Health Effects Summary:

EPA has concerns that these PMN substances will persist in the environment, could 
vi 

bioaccumulate, and be toxic (“PBT”) to humans, other mammals, and birds. EPA’s concerns are 

based on data on the PMN substances, analogy to ] chemicals, and to 

perfluorooctanoic acid (“PFOA”) and perfluorooctane sulfonate (“PFOS”) which are both 

currently under review by EPA for PBT concerns. Some [ ], PFOA, and PFOS are 

expected to persist for years in the environment. Biodegradation and photolysis tests of some 

analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl 

compounds. Bioaccumulation concerns are based on the measured presence of certain 

perfluoroalkyl compounds, including PFOA, in wildlife and in human blood samples. 

There is concern for neurotoxicity from potential acute exposures and in worker 

exposures based on the submitted acute inhalation study where signs consistent with 

neurotoxicity including tremors and seizures were seen at 3000 ppm but not at 300 ppm. There 

are additional concerns based on an analog Perfluorobutanoic Acid (PFBA) for thyroid, liver, 

and developmental toxicity. 

 There are concerns that potential releases to water could be toxic to the general 

population. For this scenario, data on an analog, [

 are used. [ was tested in a repeateddose 28-day oral toxicity study in rats (OCSPP 870.3050) conducted by 3M. The dose levels for 

the 28-day toxicity study were 0, 6, 30 and 150 mg. The test substance was administered daily 

for 28 days by oral gavage to SPF-bred Sprague Dawley rats. One control group and four treated 

groups (including a positive control group) were tested, each consisting of 10 males and 10 

females. An extra 10 animals per sex per dose group were allowed 21 days of recovery. Pupillary 

reflex testing at the end of the treatment period showed a delayed (but present) bilateral pupillary 

reflex for all examined males at 30 mg, A NOAEL of 150 mg/kg BW/day was established for 
vii 

females. A systemic NOAEL of 6 mg/kg/day was established for males based on the presence of 

hypertrophy/hyperplasia of the follicular epithelium of the thyroid glands, increased liver 

weights and lower cholesterol levels. 

 Toxicity studies on PFOA and PFOS indicate developmental, reproductive and systemic 

toxicity in various species. Cancer may also be of concern. These factors, taken together, raise 

concerns for potential adverse chronic effects in humans and wildlife. For additional information 

about PFOA, consult the EPA docket number, EPA-HQ -OPPT-2003-13. Additional information 

about PFOA, and other perfluorinated substances may also be found in the Administrative 

Record for PFOS, PFOA, and Telomers and Related Chemicals (AR-226). 

Administrative Record (AR-226) is not currently available online, but copies can be requested on 

CD-ROM from the EPA Docket office by calling 202/566-0280, or sending an email request to 

oppt.ncic@epa.gov. 

The data on the PMN substances and other data indicate a different and less toxic profile 

for the PMN substances than for PFOA and PFOS. However, based on: 1) the persistence of the 

PMN substance, 2) the toxicity data on the PMN substance and its analogs, and 3) the possibility 

that this substance may be used as a substitute for a use of PFOA, EPA believes that more 

information is needed on the toxicity of the PMN substance. 

Environmental Effects Summary:

EPA expects the water soluble PMN substance to hydrolyse to the highly persistent 

perfluoro Cx carboxylic acid in the environment. For example, methyl trifluoroacetate hydrolyzes 

in less than 1 minute. In addition, the degradation products may be bioaccumulative or 

biopersistent based on some related substances. No short-term ecotoxicological concerns were 

raised for the PMN substance. As stated previously, the analog PFOA is persistent in the 
viii 

environment and has a long bioretention time in various species. It has been detected in a number 

of species of wildlife, including marine mammals. It is toxic to mammalian and other species. 

The presence in the environment and toxicological properties of PFOA continue to be 

investigated. 

Occupational Exposure:

 EPA expects dermal exposure to workers to be negligible because this Consent Order 

requires that workers use impervious gloves when dermal exposure is likely. Inhalation exposure 

to workers is expected to reach 440 mg/day over 4 days during sampling of the liquid product. 

General population exposures:

 The lifetime average daily dose (LADD) estimated by EPA is 2.59 x 10-5 mg/kg/day to 

the general population via drinking water. The LADD via fish ingestion is 1.10 x 10-6 mg/kg/day 

Environmental releases:

 The surface water concentration is estimated to be 387 ppb during processing/use. There 

are some minimal releases to air that are possible but it is expected that most wastes will be 

incinerated. 

 EPA requires in this Consent Order that the substance be recovered, recycled, reused, or 

destroyed at levels achieving 99% efficiency and/or destruction. 

Risk to Workers:

Because workers are exposed for relatively short periods of time, risk to workers is 

assessed by comparison to the Neurotoxicity NOAEL of 300 ppm (175 mg/kg-BW/day) from the 

Acute (4-hr) Inhalation Toxicity Study in Rats using the PMN Substance (Range-Finding). 
ix 

 An acceptable Margin of Exposure (MOE) is ≥ 300 (adjusted using PFBA half-life data). 

An unacceptable MOE of 32 is predicted for the worst case worker inhalation scenario (vapor 

from sampling liquid product). 

(NOAEL dose: 175 mg/kg-BW/day x 

100% NOAEL route absorption factor) 

÷ (worker dose: 440 mg/day x 

100% exposure route absorption factor ÷ 

80 kg BW for male adult) 

 

Workers should wear gloves that have been proven to be impervious to the PMN and 

respiratory protection adequate (fold factor of 9) to bring the MOE up to the acceptable level of 

300. 

 Risk to General Public:

Because releases to surface water occur 16 days per year risk to the general population 

will be determined by comparison to a Repeat Dose 28-day Oral Toxicity Study in Rats (OCSPP 

870.3050) conducted by [

For general population and consumer risk calculations, typically the ADD (Average 

Daily Dose) is used to calculate the MOE when the endpoint is either reproductive toxicity, 

immunotoxicity, neurotoxicity, or systemic toxicity because these endpoints result from chronic 

exposures. The ADD can be estimated from the Lifetime Average Daily Dose (LADD) by 

multiplying the LADD by 75/40 (1.875) to adjust for the differences in Averaging Times 

(ADD (non-cancer) = 40 yr and LADD (cancer) = 75 yrs). 

The worst case MOE for the general population via drinking water = 123,457 = 

(NOAEL dose: 6 mg/kg-BW/day) x 

100% NOAEL route absorption factor) 

÷ 

LADD: 2.59 x 10-5 mg/kg/day x 1.875 x 100% 

exposure route absorption factor 
x 

The worst case MOE for the general population via fish ingestion = 2,857,143 = 

(NOAEL dose: 6 mg/kg-BW/day) x 

100% NOAEL route absorption factor) 

÷ 

LADD: 1.10 x 10-6 mg/kg/day x 1.875 x 100% 

exposure route absorption factor 

There is no risk predicted to the general population from either drinking water or fish 

ingestion because the acceptable MOE adjusted for the PFBA half-life data is 300 or more. 

Risk to Consumers:

The PMN substance is to be prohibited in consumer products. Thus, consumer exposures 

and risk are not expected. 

Risk to the Environment:

The acute concentration of concern (COC) of 6,500 ppb will not be exceeded during the 

16 days that surface water releases occur, however the chronic COC of 220 ppb will be 

exceeded. However, the potential for chronic risk to aquatic organisms exists only if the surface 

water concentration exceeds the chronic COC for 20 consecutive days per year or more. The 20-

day criterion is based on partial life-cycle testing with fish and Daphnids. Because releases occur 

less than 20 consecutive days per year there is low concern for chronic risk to aquatic organisms. 

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 substance. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, 

that the information available to the Agency is insufficient to permit a reasoned evaluation of the 

human health and environmental effects of the PMN substance. 
xi 

(b) In light of the potential risk of human health and environmental effects posed by the 

uncontrolled manufacture (defined by statute to include import), processing, distribution in 

commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 

5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture (defined by statute to include import), 

processing, distribution in commerce, use, and disposal of the PMN substance may present an 

unreasonable risk of injury to human health and the environment. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND

ENVIRONMENTAL EFFECTS

Pended Testing. The Order does not require submission of the following testing at any specified 

time or production volume. However, the Order’s restrictions on manufacture (defined by 

statute to include import), processing, distribution in commerce, and use 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. 

Test Guidelines

Metabolism and pharmacokinetics test OCSPP 870.7485 

Subacute inhalation toxicity: 28-day study OECD 412 
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 chemical substance 

] (P-13-305)(“the PMN substance”) in the United 

States by 3M Company (“the Company”), 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 substance is 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 (1) 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. 

(1) Export. Until the Company begins commercial manufacture of the PMN substance for 

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

distribution in commerce of the PMN substance solely for export in accordance with TSCA 
- 2 - 

§§12(a) and 12(b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to 

manufacture the PMN substance 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 the PMN 

substance is later exported. At that point, the requirements of this Order apply to all activities 

associated with the PMN substance while in the territory of the United States. Prior to leaving 

U.S. territory, even those quantities or batches of the PMN substance 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 commerce, use and disposal of the PMN substance 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 substance when manufactured 

solely for non-commercial research and development per TSCA §5(i) and 40 CFR 720.30(i). 

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

it is produced, without separate commercial intent, only as a “byproduct” as defined at 40 CFR 

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

(4) No Separate Commercial Purpose. The requirements of this Order do not apply to the 

PMN substance when it is manufactured, pursuant to any of the exemptions in 40 CFR 720.30(h), 

with no commercial purpose separate from the substance, mixture, or article of which it is a part. 

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

when it is imported as part of an “article” as defined at 40 CFR 720.3(c) and in compliance with 40 

CFR 720.22(b)(1). 
- 3 - 

(c) Automatic Sunset. If the Company has obtained for the PMN substance a Test Market 

Exemption (“TME”) under TSCA §5(h)(1) and 40 CFR 720.38 or a Low Volume Exemption 

(“LVE”) 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 (INCLUDING IMPORT), PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL

PENDING SUBMISSION AND EVALUATION

OF INFORMATION

PROHIBITION

The Company is prohibited from manufacturing (defined by statute to include import), 

processing, distributing in commerce, using, or disposing of the PMN substance in the United 

States, for any nonexempt commercial purpose, pending the development of information necessary 

for a reasoned evaluation of the human health and environmental effects of the substance, 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 8(e) Reporting. Reports of information on the PMN substance which reasonably 

supports the conclusion that the 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 number for this substance and contain a statement that the 
- 4 - 

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 (2227A), 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: 

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

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

(3) The name and telephone number of a person at the Company or the laboratory whom 

EPA may contact regarding the study; and, 

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

substance is subject to this Consent Order. 

The written notice should be submitted to EPA as follows: 

Postal Mail Address

U.S. Environmental Protection Agency 

GLP Section Chief – Pesticides, Water and Toxics Branch 

Monitoring Assistance and Media Programs Division (2227A) 

Office of Enforcement and Compliance Assurance 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 
- 5 - 

Courier Delivery Address

U.S. Environmental Protection Agency 

GLP Section Chief – Pesticides, Water and Toxics Branch 

Monitoring Assistance and Media Programs Division (2227A) 

Office of Enforcement and Compliance Assurance 

Room 7117B 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20004 

(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 

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 that 

will use a modified version of a published test guideline, the Company must submit written test 

protocols to EPA for review (submission of written test protocols is optional for tests that are to be 

conducted using unmodified published test guidelines). Protocols must be submitted as a support 

document for the PMN, using the procedures set out in 40 CFR 720.40. 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) Unreasonable Risk.
- 6 - 

EPA may notify the Company in writing that EPA finds that the data generated by a study 

are scientifically valid and unequivocal and indicate that, despite the terms of this Order, the PMN 

substance will or may 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, 

manufacture (defined by statute to include import), processing, distribution, use and/or disposal of 

the PMN substance to mitigate exposures to or to better characterize the risks presented by the 

PMN substance. Within 2 weeks from receipt of such a notice, the Company must cease all 

manufacture (defined by statute to include import), processing, distribution, use and disposal of the 

PMN substance, 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 and/or the appropriateness of any additional requirements 

imposed by EPA. The Company may continue to manufacture (defined by statute to include 

import), process, distribute, use and dispose of the PMN substance in accordance with the terms of 

this Order pending EPA’s response to the Company’s 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 (defined by statute to include import), processing, 

distribution, use and disposal of the PMN substance. 

PROTECTION IN THE WORKPLACE
- 7 - 

(a) Establishment of Program. During manufacturing, processing, and use of the PMN substance 

at any site controlled by the Company (including any associated packaging and storage and during 

any cleaning or maintenance of equipment associated with the PMN substance), the Company 

must establish a program whereby: 

(1) General Dermal Protection. Each person who is reasonably likely to be dermally 

exposed in the work area to the PMN substance through direct handling of the substance or 

through contact with equipment on which the substance may exist, or because the substance 

becomes airborne in a form listed in subparagraph (a)(5) of this section, is provided with, and is 

required to wear, personal protective equipment that provides a barrier to prevent dermal exposure 

to the substance in the specific work area where it is selected for use. Each such item of personal 

protective equipment must be selected and used in accordance with Occupational Safety and 

Health Administration (“OSHA”) dermal protection requirements at 29 CFR 1910.132, 1910.133, 

and 1910.138. 

 (2) Specific Dermal Protective Equipment. The dermal protective equipment required by 

subparagraph (a)(1) of this section must include, but is not limited to, impervious gloves. 

 (3) Demonstration of Imperviousness. The Company is able to demonstrate that each item 

of chemical protective clothing selected, including gloves, provides an impervious barrier to 

prevent dermal exposure during normal and expected duration and conditions of exposure within 

the work area by any one or a combination of the following: 

(i) Permeation Testing. Testing the material used to make the chemical protective 

clothing and the construction of the clothing to establish that the protective clothing will be 

impervious for the expected duration and conditions of exposure. The testing must subject the 

chemical protective clothing to the expected conditions of exposure, including the likely 
- 8 - 

combinations of chemical substances to which the clothing may be exposed in the work area. 

Permeation testing shall be conducted according to the American Society for Testing and Materials 

(“ASTM”) F739 “Standard Test Method for Permeation of Liquids and Gases through Protective 

Clothing Materials under Conditions of Continuous Contact.” Results shall be reported as the 

cumulative permeation rate as a function of time, and shall be documented in accordance with 

ASTM F739 using the format specified in ASTM F1194-99(2010) “Standard Guide for 

Documenting the Results of Chemical Permeation Testing of Materials Used in Protective 

Clothing Materials.” Gloves may not be used for a time period longer than they are actually tested 

and must be replaced at the end of each work shift during which they are exposed to the PMN 

substance. 

(ii) Manufacturer’s Specifications. Evaluating the specifications from the 

manufacturer or supplier of the chemical protective clothing, or of the material used in 

construction of the clothing, to establish that the chemical protective clothing will be impervious to 

the PMN substance alone and in likely combination with other chemical substances in the work 

area. 

(4) Respiratory Protection. Each person who is reasonably likely to be exposed by 

inhalation in the work area to the PMN substance in the form listed in subparagraph (a)(5) of this 

section is provided with and is required to wear, at a minimum, a National Institute for 

Occupational Safety and Health (“NIOSH”)-certified respirator with an Applied Protection Factor 

(“APF”) of 10, from the respirators listed in subparagraph (a)(6) of this section, and the respirator 

is used in accordance with OSHA and NIOSH respiratory protection requirements at 29 CFR 

1910.134 and 42 CFR Part 84. All respirators must be issued, used, and maintained according to 

an appropriate respiratory protection program under the OSHA requirements in 29 CFR 1910.134. 
- 9 - 

(5) Physical States. The following physical states of airborne chemical substances are 

listed for subparagraphs (a)(1) and (4) of this section: 

(i) Particulate (including solids or liquid droplets), 

(ii) Gas/vapor (all substances in the gas form), or 

(iii) Combination Gas/Vapor and Particulate (gas and liquid/solid physical states 

are both present; a good example is paint spray mist, which contains both liquid droplets and 

vapor). 

 (6) Authorized Respirators. The following NIOSH-certified respirators meet the 

minimum requirements for subparagraph (a)(4) of this section: 

(i) Any NIOSH-certified powered air-purifying respirator with a hood or helmet and 

with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges. 

(ii) Any NIOSH-certified continuous flow supplied-air respirator equipped with a 

loose fitting facepiece, hood, or helmet. 

 (b) De Minimis Concentrations. The requirements of this section do not apply to quantities of the 

PMN substance that are (1) present in the work area only as a mixture and (2) at a concentration 

not to exceed 1.0 percent by weight or volume (0.1 percent by weight or volume if the PMN 

substance is identified as a potential carcinogen in paragraph (f) of the Hazard Communication 

Program section of this Order). This exemption is not available if the Company has reason to 

believe that, during intended activities, the PMN substance in the mixture may be reconcentrated 

above the 1.0 or 0.1 percent level, whichever applies. If this Order contains New Chemical 

Exposure Limits provisions or Release to Water provisions that, respectively, specify a NCEL 

concentration (“TWA”) or in-stream concentration (“N”) less than the de minimis concentration 

specified here, then this de minimis exemption does not apply to those provisions. 
- 10 - 

RISK NOTIFICATION 

(a) If the Company becomes aware that the PMN substance may present a risk of injury to health 

or 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 substance is not being 

manufactured (defined by statute to include import), processed, or used in the Company’s 

workplace, the Company must add the new information to an MSDS before the PMN substance is 

reintroduced into the workplace. 

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

Company, or who have received the PMN substance 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. 

HAZARD COMMUNICATION PROGRAM

(a) Written Hazard Communication Program. The Company shall develop and implement a 

written hazard communication program for the PMN substance in each workplace. The written 

program will, at a minimum, describe how the requirements of this section for labels, MSDSs, and 

other forms of warning material will be satisfied. The Company must make the written hazard 
- 11 - 

communication program available, upon request, to all employees, contractor employees, and their 

designated representatives. The Company may rely on an existing hazard communication 

program, including an existing program established under the OSHA Hazard Communication 

Standard (29 CFR 1910.1200), to comply with this paragraph provided that the existing hazard 

communication program satisfies the requirements of this section. The written program shall 

include the following: 

(1) A list of chemical substances known to be present in the work area which are subject to 

a TSCA section 5(e) consent order signed by the Company or to a TSCA section 5(a)(2) SNUR at 

40 CFR Part 721, subpart E. The list must be maintained in each work area where the PMN 

substance is known to be present and must use the identity provided on the MSDS for the 

substance required under paragraph (c) of this section. The list may be compiled for the workplace 

or for individual work areas. If the Company is required either by another Order issued under 

section 5(e) of TSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, to 

maintain a list of substances, the lists shall be combined with the list under this subparagraph. 

(2) The methods the Company will use to inform employees of the hazards of non-routine 

tasks involving the PMN substance (e.g., cleaning of reactor vessels), and the hazards associated 

with the PMN substance contained in unlabeled pipes in their work area. 

(3) The methods the Company will use to inform contractors of the presence of the PMN 

substance in the Company’s workplace and of the provisions of this Order if employees of the 

contractor work in the Company’s workplace and are reasonably likely to be exposed to the PMN 

substance while in the Company’s workplace. 

(b) Labeling.
- 12 - 

(1) The Company shall ensure that each container of the substance in the workplace is 

labeled in accordance with this subparagraph (b)(1). 

(i) The label shall, at a minimum, contain the following information: 

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

any, identified either in paragraph (f) of this section or by the Company, for the PMN substance. 

(B) The identity by which the PMN substance may be commonly 

recognized. 

(C) A statement of exposure and precautionary measure(s), if any, 

identified either in paragraph (f) of this section, or by the Company, for the PMN substance. 

(ii) The Company may use signs, placards, process sheets, batch tickets, operating 

procedures, or other such written materials in lieu of affixing labels to individual stationary process 

containers, as long as the alternative method identifies the containers to which it is applicable and 

conveys information specified by subparagraph (b)(1)(i) of this section. Any written materials 

must be readily accessible to the employees in their work areas throughout each work shift. 

(iii) The Company need not label portable containers into which the PMN 

substance is transferred from labeled containers, and which are intended only for the immediate 

use of the employee who performs the transfer. 

(iv) The Company shall not remove or deface an existing label on containers of the 

PMN substance obtained from persons outside the Company unless the container is immediately 

re-labeled with the information specified in subparagraph (b)(1)(i) of this section. 

(2) The Company shall ensure that each container of the substance leaving its workplace 

for distribution in commerce is labeled in accordance with this subparagraph (b)(2). 

(i) The label shall, at a minimum, contain the following information: 
- 13 - 

(A) The information prescribed in subparagraph (b)(1)(i) of this section. 

(B) 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. 

(ii) 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. 

(3) The label, or alternative forms of warning, shall be legible and prominently displayed. 

(4) The label, or alternative forms of warning, shall be printed in English; however, the 

information may be repeated in other languages. 

(5) If the label or alternative form of warning is to be applied to a mixture containing the 

PMN substance in combination with any other substance that is either subject to another TSCA 

section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 

CFR Part 721, subpart E, or defined as a “hazardous chemical” under the OSHA Hazard 

Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS, 

or alternative form of warning, the measures to control worker exposure or environmental release 

which the Company determines provide the greatest degree of protection. However, should these 

control measures differ from the applicable measures required under this Order, the Company must 

seek a determination of equivalency for such alternative control measures pursuant to 40 CFR 

721.30 before prescribing them under this subparagraph (b)(5). 

(6) If the Company becomes aware of any significant new information regarding the 

hazards of the PMN substance or ways to protect against the hazards, this new information must be 

added to the label within 3 months from the time the Company becomes aware of the new 
- 14 - 

information. If the PMN substance is not being manufactured (defined by statute to include 

import), processed, or used in the Company’s workplace, the Company must add the new 

information to the label before the PMN substance is reintroduced into the workplace. 

(c) Material Safety Data Sheets.

(1) The Company must obtain or develop an MSDS for the PMN substance. 

(2) The MSDS shall contain, at a minimum, the following information: 

(i) The identity used on the container label of the PMN substance under this 

section, and, if not claimed confidential, the chemical and common name of the PMN substance. 

If the chemical and common names are claimed confidential, a generic chemical name must be 

used. 

(ii) Physical and chemical characteristics of the substance known to the Company, 

(e.g., vapor pressure, flash point). 

(iii) The physical hazards of the substance known to the Company, including the 

potential for fire, explosion, and reactivity. 

(iv) The potential human and environmental hazards as specified in paragraph (f) 

of this section. 

(v) Signs and symptoms of exposure, and any medical conditions which are 

expected to be aggravated by exposure to the PMN substance known to the Company. 

(vi) The primary routes of exposure to the PMN substance. 

(vii) Precautionary measures to control worker exposure and/or environmental 

release required by this Order, or alternative control measures which EPA has determined under 40 

CFR 721.30 provide substantially the same degree of protection as the identified control measures. 
- 15 - 

The MSDS must identify any New Chemical Exposure Limits specified in paragraph (b) of the 

New Chemical Exposure Limit section of this Order and must contain the information specified in 

the graduated respirator table in paragraph (e)(2) of the New Chemical Exposure Limit section. 

(viii) Any generally applicable precautions for safe handling and use of the PMN 

substance which are known to the Company, including appropriate hygienic practices, protective 

measures during repair and maintenance of contaminated equipment, and procedures for response 

to spills and leaks. 

(ix) Any generally applicable control measures which are known to the Company, 

such as appropriate engineering controls, work practices, or personal protective equipment. 

(x) Emergency first aid procedures known to the Company. 

(xi) The date of preparation of the MSDS or of its last revision. 

(xii) The name, address, and telephone number of the Company or another 

responsible party who can provide additional information on the chemical substance and any 

appropriate emergency procedures. 

(3) If no relevant information is found or known for any given category on the MSDS, the 

Company must mark the MSDS to indicate that no applicable information was found. 

(4) Where multiple mixtures containing the PMN substance have similar compositions 

(i.e., the chemical ingredients are essentially the same, but the specific composition varies from 

mixture to mixture) and similar hazards, the Company may prepare one MSDS to apply to all of 

these multiple mixtures. 

(5) If the Company becomes aware of any significant new information regarding the 

hazards of the PMN substance or ways to protect against the hazards, this new information must be 

added to the MSDS within 3 months from the time the Company becomes aware of the new 
- 16 - 

information. If the PMN substance is not being manufactured (defined by statute to include 

import), processed, or used in the Company’s workplace, the Company must add the new 

information to the MSDS before the PMN substance is reintroduced into the workplace. 

(6) The Company must ensure that persons receiving the PMN substance from the 

Company are provided an appropriate MSDS with their initial shipment and with the first shipment 

after an MSDS is revised. The Company may either provide the MSDS with the shipped 

containers or send it to the person prior to or at the time of shipment. 

(7) The Company must maintain a copy of the MSDS in its workplace, and must ensure 

that it is readily accessible during each work shift to employees when they are in their work areas. 

(8) The MSDS may be kept in any form, including as operating procedures, and may be 

designed to cover groups of substances in a work area where it may be more appropriate to address 

the potential hazards of a process rather than individual substances. However, in all cases, the 

required information must be provided for the PMN substance and must be readily accessible 

during each work shift to employees when they are in their work areas. 

(9) The MSDS must be printed in English; however, the information may be repeated in 

other languages. 

(d) Employee Information and Training. The Company must ensure that employees are provided 

with information and training on the PMN substance. This information and training must be 

provided at the time of each employee’s initial assignment to a work area containing the PMN 

substance and whenever the PMN substance is introduced into the employee’s work area for the 

first time. 

(1) The information provided to employees under this paragraph shall include: 
- 17 - 

(i) The requirements of this section. 

(ii) Any operations in the work area where the PMN substance is present. 

(iii) The location and availability of the written hazard communication program 

required under paragraph (a) of this section, including the list of substances required by 

subparagraph (a)(1) of this section and MSDSs required by paragraph (c) of this section. 

(2) The training provided to employees shall include: 

(i) Methods and observations that may be used to detect the presence or release of 

the PMN substance in or from an employee’s work area (such as exposure monitoring conducted 

by the Company, continuous monitoring devices, visual appearance, or odor of the substance when 

being released). 

(ii) The potential human health and environmental hazards of the PMN substance 

as specified in paragraph (f) of this section. 

(iii) The measures employees can take to protect themselves and the environment 

from the PMN substance, including specific procedures the Company has implemented to protect 

employees and the environment from exposure to the PMN substance, including appropriate work 

practices, emergency procedures, personal protective equipment, engineering controls, and other 

measures to control worker exposure and/or environmental release required under this Order, or 

alternative control measures which EPA has determined under 40 CFR 721.30 provide the same 

degree of protection as the specified control measures. 

(iv) The requirements of the hazard communication program developed by the 

Company under this section, including an explanation of the labeling system and the MSDS 

required by this section and guidance on obtaining and using appropriate hazard information. 
- 18 - 

(e) De Minimis Concentrations. The requirements of this Hazard Communication section do not 

apply to quantities of the PMN substance that are (1) present in the work area only as a mixture 

and (2) at a concentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or 

volume if the PMN substance is identified as a potential carcinogen in paragraph (f) of the Hazard 

Communication Program section of this Order). This exemption is not available if the Company 

has reason to believe that, during intended activities, the PMN substance in the mixture may be 

reconcentrated above the 1.0 or 0.1 percent level, whichever applies. If this Order contains (1) 

New Chemical Exposure Limits provisions that specify a NCEL concentration less than the de 

minimis concentration specified here, or (2) Release to Water provisions that prohibit release to 

water or specify in-stream concentration (“N”) less than the de minimis concentration specified 

here, then this de minimis exemption does not apply to those provisions. 

(f) Human Health, Environmental Hazard, Exposure, and Precautionary Statements. The 

following human health and environmental hazard and precautionary statements shall appear on 

each label as specified in paragraph (b) and the MSDS as specified in paragraph (c) of this section: 

(1) Human health hazard statements. This substance may cause: 

(i) Central Nervouse System (CNS) Depression: Signs/symptoms may include 

headache, dizziness, drowsiness, incoordination, nausea, slowed reaction time, slurred speech, 

giddiness, and unconsciousness. 

 (ii) Liver Effects: Signs/symptoms may include loss of appetite, weight loss, 

fatigue, weakness, abdominal tenderness and jaundice.” 
- 19 - 

 (iii) Endocrine Effects: Signs/symptoms may include disruption of gonadal, thyroid, 

adrenal, or pancreatic function; changes in hormone production; alterations in circulating hormone 

levels; and/or changes in tissue response to hormones. 

(2) Human hazard precautionary statements. When using this substance: 

(i) Avoid skin contact. 

(ii) Avoid breathing dust/fume/gas/mist/vapors/spray. 

(iii) Do not ingest. 

(iv) Wear respiratory protection. 

(v) Wear protective gloves. 

 (3) The human and environmental hazard and precautionary statement on the label 

prepared pursuant to paragraph (b) of this section must be followed by the statement: “See the 

MSDS for details.” 

(g) Existing Hazard Communication Program. The Company need not take additional actions if 

existing programs and procedures satisfy the requirements of this section. 

MANUFACTURING

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

by statute to include import) of the PMN substance by any other person. 

(2) Sunset Following SNUR. Subparagraph (a)(1) shall expire 75 days after promulgation 

of a final significant new use rule (“SNUR”) governing the PMN substance under section 5(a)(2) 

of TSCA unless the Company is notified on or before that day of an action in a Federal Court 

seeking judicial review of the SNUR. If the Company is so notified, subparagraph (a)(1) shall not 
- 20 - 

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 final SNUR for the PMN substance and 

subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Company shall notify each 

person whom it causes, encourages or suggests to manufacture (defined by statute to include 

import) the PMN substance of the existence of the SNUR. 

USE

(a) The Company shall only use the PMN substance: 

 (1) As an intermediate where any chemical substance manufactured using the PMN 

substance may contain residuals of the PMN substance at levels no greater than [ 

 (2) In non-consumer products; and 

 (3) By recovering and converting, capturing (destroying), recycling, or reusing the 

substance at an overall efficiency of [ when the PMN substance is used as an intermediate. 

Since the PMN substance is inseparable from an impurity, reference to the PMN substance 

inherently includes the inseparable impurity. Calculations for mass balance and recovery of the 

PMN substance for reuse or destruction will be based on the total amount charged and recovered 

presuming 100% pure PMN substance. 

DISTRIBUTION

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

writing any person to whom it distributes the PMN substance that, due to the issuance of this 
- 21 - 

Consent Order under section 5(e) of TSCA, the PMN substance is subject to the export notification 

requirements of TSCA 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 substance, or (B) if the 

specific chemical identity is confidential, the generic chemical identity. 

(b) Distribution Requirements. Except after the PMN has been completely reacted or as provided 

in paragraph (c), the Company shall distribute the PMN substance outside the Company, 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 substance that, due to the 

issuance of this Consent Order under section 5(e) of TSCA, the PMN substance is subject to the 

export notification requirements of TSCA 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 

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

(2) Not further distribute the PMN substance to any other person, other than for disposal, 

until after the PMN substance has been completely reacted. 

(3) Comply with the same requirements and restrictions, if any, required of the Company 

in the Protection in the Workplace section of this Order. 

(4) Comply with the same requirements and restrictions, if any, required of the Company 

in the Hazard Communication Program section of this Order. 

(5) Only use the PMN substance: 

(i) As an intermediate; 
- 22 - 

(ii) In non-consumer products; and 

(iii) By recovering and converting, capturing (destroying), recycling, or reusing the 

substance at an overall efficiency of of the product. 

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

distribute the PMN substance outside the Company 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 substance may be distributed only to the Company or a person who has given the Company 

the written agreement required by paragraph (b). 

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

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

substance is in the possession and control of the Company or a person who has given the Company 

the written agreement required by paragraph (b). 

(3) The sealed containers must be labeled in accordance with paragraph (b)(2) of the 

Hazard Communication Program section of this Order. 

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

PMN substance, the Company obtains knowledge that a recipient of the substance has failed to 

comply with any of the conditions specified in paragraph (b) of this Distribution section or, after 

subparagraph (b)(2) expires in accordance with subparagraph (e)(1), has engaged in a significant 

new use of the PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a 

significant new use notice to EPA, the Company shall cease supplying the substance to that 
- 23 - 

recipient, unless the Company is able to document each of the following: 

(1) That the Company has, within 5 working days, notified the recipient in writing that the 

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

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

submitting a significant new use notice to EPA. 

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

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

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

or is aware of the terms of the significant new use rule for the PMN substance and will not engage 

in a significant new use without submitting a significant new use notice to EPA. 

(3) If, after receiving a statement of assurance from a recipient under subparagraph (d)(2) 

of this Distribution section, the Company obtains 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 substance without submitting a significant new use notice to 

EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA of 

the failure to comply, and shall resume supplying the PMN substance to that recipient only upon 

written notification from the Agency. 

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

days after promulgation of a final SNUR for the PMN substance under section 5(a)(2) of TSCA, 

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

judicial review of the SNUR. If the Company is so notified, subparagraph (b)(2) of this 

Distribution section shall not expire until EPA notifies the Company in writing that all Federal 
- 24 - 

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

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

Distribution section expires in accordance with subparagraph (e)(1), the Company shall notify each 

person to whom it distributes the PMN substance 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 substance. Such notice must also reference the publication of the SNUR for this 

PMN substance in either the Federal Register or the Code of Federal 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 Company 

provides such notice to the persons to whom it distributes the PMN substance, then the Company 

is not required to obtain from such persons the written agreement specified in paragraph (b). 

III. RECORDKEEPING

(a) Records. The Company 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 of TSCA: 

(1) Exemptions. Records documenting that the PMN substance 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 substance 

eligible for the export only exemption in Section I, Paragraph (b)(1) of this Order are exempt from 

all the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the 
- 25 - 

date of their creation, copies of the export label and export notice to EPA, required by TSCA 

sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches of the PMN substance 

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 720.78(b). For any 

amounts or batches of the PMN substance 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 (defined by statute to include import) volume of 

the PMN substance and the corresponding dates of manufacture (defined by statute to include 

import); 

(3) Records documenting the names and addresses (including shipment destination 

address, if different) of all persons outside the site of manufacture (defined by statute to include 

import) to whom the Company directly sells or transfers the PMN substance, the date of each sale 

or transfer, and the quantity of the substance sold or transferred on such date; 

(4) Records documenting the address of all sites of manufacture (defined by statute to 

include import), processing, and use; 

(5) Records documenting establishment and implementation of a program for the use of 

any applicable personal protective equipment required pursuant to the Protection in the Workplace 

section of this Order; 

(6) Records documenting the determinations required by the Protection in the Workplace 

section of this Order that chemical protective clothing is impervious to the PMN substance; 
- 26 - 

 (7) Records documenting establishment and implementation of the hazard communication 

program required by the Hazard Communication Program section of this Order; 

(8) Copies of labels required under the Hazard Communication Program section of this 

Order; 

(9) Copies of Material Safety Data Sheets required by the Hazard Communication 

Program section of this Order; 

(10) Records documenting compliance with any applicable manufacturing, use, and 

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

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

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

section of this Order, if applicable; and, 

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

substance is manufactured (defined by statute to include import). 

(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 EPA so informs the Company. The “collection of 
- 27 - 

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 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 substance. 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 substance will be in production within the 

subsequent 12 months; 

(2) Current workshift schedules for workers who are involved in activities associated with 

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

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

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

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

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

(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. 
- 28 - 

(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 (“CBI”) that the 

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

TSCA and 40 CFR Part 2. 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT 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 the PMN 

substance, including the right to manufacture the 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 in Interest 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 CFR part 720 before 

commencing manufacture (defined by statute to include import) of the PMN substance. 
- 29 - 

(2) After NOC. If the transfer from the Company to the Successor in Interest is effective 

after EPA receives a NOC, the Successor in Interest shall 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: 

(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 

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

Successor in Interest. 

(d) Notices.

(1) 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. 
- 30 - 

(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: 

The written notice should be submitted to EPA as follows: 

Postal Mail Address

U.S. Environmental Protection Agency 

New Chemicals Management Branch (7405M) 

1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 

Courier Delivery Address

U.S. Environmental Protection Agency 

New Chemicals Management Branch (7405M) 

1201 Constitution Avenue, N.W. 

Washington, D.C. 20004 

 (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 (defined by statute to include import). 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. 

(e) Liability.
- 31 - 

(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. 

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 

substance, to modify or revoke substantive provisions of this Order. The exposures and risks 

identified by EPA during its review of the PMN substance 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 
- 32 - 

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

the PMN substance. 

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. 
- 33 - 

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)(1)(C) of TSCA, to receive service of this Order no 

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

to 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) CBI Brackets. By signing this Order, the Company represents that it has carefully reviewed 

this document and hereby agrees that all information herein that is claimed as confidential by the 

Company (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 within the brackets. 

_________________ _____________________________________ 

Date Maria J. Doa, Ph.D., Director 

 Chemical Control Division 

Office of Pollution Prevention and Toxics 

_________________ _____________________________________ 

Date Name: 

 Title: 

Company: 
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 (defined by statute to include 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 (defined by statute to include import) 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.
ii 

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 
iii 

NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

(continued)

___________________________________ 

Successor’s Technical Contact

___________________________________ 

Address 

___________________________________ 

City, State, Zip Code 

___________________________________ 

Phone