EPA
SANITIZED
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF POLLUTION PREVENTION AND TOXICS

GH
9/1/2017
JW
9/1/2017

REGULATION OF A NEW CHEMICAL SUBSTANCE
PENDING DEVELOPMENT OF INFORMATION

In the matter of:

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Premanufacture Notice Number:

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Agfa Corporation

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P-17-0175

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Consent Order and Determinations Supporting Consent Order

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TABLE OF CONTENTS
Preamble
I.

Introduction

II.

Summary of Terms of the Consent Order

III.

Contents of PMN

IV.

EPA's Assessment of Exposure and Risk

V.

EPA's Determination

VI.

Information Required to Evaluate Human Health and Environmental Effects

Consent Order
I.

Scope of Applicability and Exemptions

II.

Terms of Manufacture, 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

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PREAMBLE
I. INTRODUCTION
This Consent Order is entered into voluntarily by the Environmental Protection Agency ("EPA'' or
"the Agency") and Agfa Corporation ("the Company"), regarding premanufacture notice ("PMN")
(P-17-0175) for the chemical substance Fluorinated propenoic poly alkyl ether ester ("the PMN
substance"). The Consent Order is issued under§ 5(e) of the Toxic Substances Control Act
("TSCA") (15 U.S.C. 2604(e)). The Company submitted the PMN to EPA pursuant to§
5(a)(1)(B) ofTSCA and 40 C.F.R. pt. 720.
Under § 15 of TSCA, it is unlawful for any person to fail or refuse to comply with any
provision of TSCA, any order issued under TSCA, or any consent order entered into under TSCA.
Violators may be subject to various penalties and to both criminal and civil liability pursuant to§
16 of TSCA, and to specific enforcement and seizure pursuant to § 17 of TSCA. 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 CONSENT ORDER
The Consent Order requires the Company to:
(a) refrain from manufacturing the PMN substance in the United States (i.e. Import Only);
(b) refrain from manufacturing the PMN substance beyond a maximum annual manufacture
(which includes import) volume of 60 kg.;
(c) refrain from using the PMN substance other than as described in the PMN as a leveling
agent for coatings applied to aluminum printing plates;

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(d) distribute the PMN substance only to a person who agrees to follow the same restrictions
(except the testing requirements) and to not further distribute the PMN substance until it has been
applied to aluminum printing plates; and,
(c) maintain certain records.

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III. CONTENTS OF PMN
By signing the Consent 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, that any information that is not bracketed is not claimed as
confidential, and that the Company has previously submitted any information so marked to EPA
under a claim of confidentiality in accordance with the requirements of TSCA and applicable
regulations. 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 the Consent Order):
Joint submitter identity, chemical identity, impurity and byproduct information.

Chemical Identity:
Trademark Reactant:
Pursuant to 40 C.F.R. 720.25(b)(3), this chemical is a Trade Mark Reactant and the CAS No. and
Identity are not known to the Trade Mark Reactant Supplier ("TMRS"). The TMRS here is the
Company and the entity possessing the chemical information is
(the "Joint Submitter"). The Company doesn't claim any information as CBI, but has no access to
the chemical identity, impurity and byproduct information claimed by the joint submitter.

Generic: Fluorinated propenoic poly alkyl ether ester
Use:
Leveling agent for coatings applied to aluminum printing plates

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Maximum 12-Month Production Volume: 60 kg/yr
Test Data Submitted with PMN: Ready Biodegradability, Bacterial Reverse Mutation, and
Bioconcentration Study.

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK
The following is EPA's assessment 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.

Persistent, Bioaccumulative, and Toxic Concern:
EPA identified human health and environmental concerns because the PMN substance may be a
persistent, bioaccumulative, and toxic (PBT) chemical, based on physical/chemical properties of
the PMN substances, as described in the New Chemicals Program's PBT category (64 FR 60194,
November 4, 1999)(FRL-6097-7). EPA estimates that the PMN substances will persist in the
environment for more than two months and estimates a bioaccumulation factor of greater than or
equal to 1,000.

Human Health Effects Summary:
Absorption: Absorption of the PMN substance is nil all routes based on physical /chemical
properties of high molecular weight polymers. However, there are potential degradant
perfluorohexanoic acid (PFHxA).
GI Tract: Absorption of PFHxA via the oral route is good based on toxicokinetics data.

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Lungs: Using an established Standard Operation Procedure (SOP), EPA expects good absorption
ofPFHxA via the lungs based on molecular weight(< 1000) and good solubility(> 1 g/L) by
analogy to PFOA which has a water solubility of9.5 g/L. No solubility data for PFHxA were
located.
Skin: PFHxA absorption through skin is likely to be poor to nil based on analogous data available
for perfluorosulfonic acid (PFOS) (below), with estimated absorption of<< 1%.

Toxicological Endpoints of Concern: For the potential incomplete incineration product, concerns
are liver toxicity, blood toxicity, and male reproductive toxicity.
Basis: Based on test data for the analog perfluorohexanoic acid (PFHxA).

Environmental Effects Summary:
Based on Structure Activity Relationships (SAR) nearest analog predictions for polynonionic
polymers with an average molecular weight greater than 1,000 g/mol. The PMN substance is low
hazard based on acute and chronic CoC of no effects at saturation. Ecotoxicity hazard concerns
are high for effects of the potential degradation products to terrestrial wild mammals and birds
based on data testing PFOS and PFOA in mammals. Hazards to aquatic organisms were not
identified as a concern for the intact PMN.
See https ://www .epa.gov/reviewing-new-chemicals-under-toxic-substances-control-acttsca/chemical-categories-used-review-new
Occupational Exposure Summary:
Processing: Coating for Optical Fibers, 1 unknown site, 24 d/yr, 56 workers
•

Inhalation exposures to dried plate coating are not expected.

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•

Dermal: Unloading Liquid Raw Material from Transport Containers (Bottles), Exposure to
Liquid at 30% concentration.
High End Potential Dose Rate: 530 mg/day over 24 days/yr

Use: Printing Plate Use, 800 unknown sites, 24 days/yr
•

Inhalation exposures to dried plate coating are not expected.

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Dermal exposures not expected because the PMN substance arrives in the dried coating;
EPA also assumes workers are not exposed to the spent developer solution.

Risk to Workers: Risk for systemic effects to unprotected workers who are exposed during the
Processing scenario for up to 4 hours per incident via the dermal route is not supported.

Risk to General Public: Risk for systemic effects from ingestion exposure to PFHxA released
from the intact is not supported. It is unlikely that the intact PMN substance will be degraded fast
and release PFHxA and expose the general population via ingestion of drinking water. Based on
the potential degradation pathways the likelihood of immediate general population exposure to
PFHxA is not high and might occur only after decades to centuries in the environment.

Risk to Consumers: No consumer use was identified.

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V. EPA'S DETERMINATION
Based on the foregoing:
(a) EPA is unable to determine whether the PMN substance will present an unreasonable risk to
health or the environment. Information available to EPA indicates that there is a potential for
human or environmental exposure to the PMN substance and that the PMN substance may have
potential incomplete incineration product, and cause liver toxicity, blood toxicity, and male
reproductive toxicity. Therefore, pursuant to§§ 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) ofTSCA,
EPA determines that uncontrolled manufacture, processing, distribution in commerce, use, or
disposal ofthe PMN substance may present an unreasonable risk of injury to health and the
environment and that the limitations imposed by the Consent Order are necessary to protect against
such risk.

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VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH
AND ENVIRONMENTAL EFFECTS

Pended Testing. The following additional information would be required to evaluate the
following effects which may be caused by the PMN substance:
Tier 1:
Characterization
A. Initial characterization of the PMN materials is required prior to any fate testing. The
characterization should include analysis for all starting materials/residuals/impurities. A
total fluorine analysis is also required to determine if there are other unknown
fluorochemicals present that may complicate the interpretation of fate test data.

B. Absorbance of light in the UVNIZ range (220-800 nm) is required to evaluate the potential
for direct photolysis. The UVNIZ absorbance spectra should be measured following the
OECD 101 or other appropriate test guideline.
Tier II:
Fate Testing
A. Different microbial populations and processes in different environments require testing in
each media to understand the environmental fate for the PMN substance. Fate testing
should be conducted following standard EPA and OECD protocols with appropriate
modifications and amendments for the PMN substance. Examples of standard protocol
modifications currently used for testing difficult to test and perfluoro chemical polymers
include, but are not limited to, identifying and quantify degradation products at the lowest

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possible levels, methods for dosing and extracting low solubility chemicals, analysis of
rates of formation and decline of multiple intermediates and end products, and additional

QAJQC requirements. In all fate tests, analysis of the individual chemicals present in
starting material and degradation products should be included in modified test protocols.
Test protocols should be submitted to EPA for review prior to test initiation.

B. If the UVNIZ absorption spectra test shows absorbance in the 220-800 nm range a direct
photolysis test (OECD 316- Photochemical Transformation in Water) or other measured
data sufficient to evaluate direct photolysis mechanisms, rates and pathways is needed.
Direct photolysis may be incorporated into indirect photolysis tests with appropriate
modifications of the indirect test protocols.

C. Indirect Photolysis testing is required determine if the PMN substance may degrade in
sunlight under environmental conditions. This testing should follow modified OCSPP
835.5270 Indirect Photolysis Screening Test or OCSPP 835.2410, Photodegradation in Soil
protocols, including sufficient QA/QC samples to allow evaluation of direct photolysis.

D. Inherent biodegradability testing is needed to determine if biodegradation in contact with
wastewater treatment microbial populations can occur, (OECD 302B Inherent
Biodegradability: Zahn-Wellens/EMPA test).

Tier III:
Potential Biodegradation Mechanisms and Pathways in Other Environmental Media

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In order to determine the potential biodegradation mechanisms and pathways in other
environmental media with different physical and chemical conditions and microbial populations in
those media additional testing is required. Data from the inherent biodegradation with sewage
microbes test may inform further testing but because soil, sludge, and sediment microbial
population can degrade chemicals by different mechanisms and at different rates, inherent
biodegradation test data is not sufficient to evaluate processes which may occur in these systems.
Additional tiered testing to evaluate biodegradation in aerobic and anaerobic soil and sediment,
and anaerobic sludge should be conducted regardless of the results ofthe initial testing.
This testing should include:
A. OECD 307 Aerobic and Anaerobic Transformation in Soil
B. OCSPP 835.3280 Part C: Mineralization and Transformation in Anaerobic Digester Sludge

C. OCSPP 835.4300 Aerobic Aquatic Metabolism
D. OCSPP 835.4400 Anaerobic Aquatic Metabolism

Bioaccumulation Testing
If degradation testing shows that products are formed which may be of concern for toxicity or
bioaccumulation they should be evaluated in additional testing:
A. OECD 305 Bioaccumulation in Fish: Aqueous and Dietary Exposure
B. OECD 315 Bioaccumulation in Sediment Dwelling Benthic Oligochaetes
C. OECD 317 Bioaccumulation in Terrestrial Oligochaetes
The Consent Order does not require submission of the above pended testing at any specified time
or production volume. However, the Consent Order's restrictions on manufacture and use of the

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PMN substance will remain in effect until the Consent Order is modified or revoked by EPA based
on submission of that or other relevant information.
NOTE: AnY request by EPA for the triggered and pended testing described in the Consent Order
was made based on EPA's consideration of available screening-level data, if any, as well as other
available information on appropriate testing for the PMN substance. Further, any such testing
request on the part of EPA that includes testing on vertebrates was made after consideration of
available toxicity information, computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models.

 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

CONSENT ORDER

I. SCOPE OF APPLICABILITY AND EXEMPTIONS
(a) Scope. The requirements of this Consent Order apply to all commercial manufacturing
(including importing), processing, distribution in commerce, use and disposal of the chemical
substance Fluorinated propenoic poly alkyl ether ester (P-17-0175)("the PMN substance") in the
United States by Agfa Corporation ("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 Consent 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 Consent Order.
(1) Export. Until the Company begins commercial manufacture ofthe PMN substance for

Internet Address (URL) • http //www epa gov
Recycled/Recyclable • Printed with Vegetable Oil Based Inks on 100% Postconsumer. Process Chlorine Free

Paper

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use in the United States, the requirements of this Consent Order do not apply to manufacture,
processing or distribution in commerce of the PMN substance solely for export in accordance with
TSCA §§12(a) and 12(b), 40 C.F.R. § 720.3(s) and 40 C.F.R. Part 707. However, once the
Company begins to manufacture, process, or distribute in commerce 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 Consent 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 Consent Order, and
count towards any production limit test triggers in the Testing section of this Consent Order.
(2) Research & Development ("R&D"). The requirements of this Consent 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 C.F.R. § 720.3(cc), and 40 C.F.R. § 720.36. The requirements ofthis Consent 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 as
defined at 40 C.F.R. § 720.30(i).
(3) Byproducts. The requirements of this Consent Order do not apply to the PMN
substance when it is produced, without separate commercial intent, only as a "byproduct" as
defined at 40 C.F.R. § 720.3(d) and in compliance with 40 C.F.R. § 720.30(g).
(4) No Separate Commercial Pw:pose. The requirements of this Consent Order do not
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apply to the PMN substance when it is manufactured, pursuant to any of the exemptions in 40
C.F.R. § 720.30(h), with no commercial purpose separate from the substance, mixture, or article of

 - 3which it is a part.
(5) Imported Articles. The requirements of this Consent Order do not apply to the PMN
substance when it is imported as part of an "article" as defined at 40 C.F .R. § 720.3(c) and in
compliance with 40 C.F.R. § 720.22(b)(l).
(6) Completely Reacted (Cured). The requirements of this Consent Order do not apply to
quantities ofthe PMN substance after they have been completely reacted (cured).

(c) Automatic Sunset. If the Company has obtained for the PMN substance a Test Market
Exemption ("TME") under TSCA §5(h)(l) and 40 C.F.R. § 720.38 or a Low Volume Exemption
("LVE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)(4) and 40
C.F.R. § 723.50(c)(l) and (2) respectively, the Company must cease manufacture and processing
under these exemptions as of the effective date of this Consent Order.

II. TERMS OF MANUFACTURE, PROCESSING,
DISTRIBUTION IN COMMERCE. USE, AND DISPOSAL
PENDING SUBMISSION AND EVALUATION
OF INFORMATION
PROHIBITION
The Company is prohibited from manufacturing (which under TSCA includes importing),
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 PMN substance,

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and the completion of EPA's review of, and regulatory action based on, that information, except in
accordance with the conditions described in this Consent 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 § 8(e) of TSCA must reference the
appropriate PMN identification number for the PMN substance and contain a statement that the
PMN substance is subject to this Consent Order. Additional information regarding§ 8(e) reporting
requirements can be found at www.epa.gov/oppt/tsca8e.

(b) Notice of Study Scheduling. The Company must notify, in writing, the EPA Monitoring
Assistance and Media Programs Division, Office of Enforcement and Compliance Assurance
(OECA), U.S. Environmental Protection Agency, ofthe following information within 10 days of
scheduling any study required to be performed pursuant to this Consent Order, or within 15 days
after the effective date of this Consent 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 PMN substance and a statement
that the PMN substance is subject to this Consent Order.
The written notice should be submitted to EPA/OECA as follows:

 -5Postal Mail Address
U.S. Environmental Protection Agency
GLP Section Chief- Pesticides, Water and Toxics Branch
Monitoring Assistance and Media Programs Division (2227 A)
Office of Enforcement and Compliance Assurance
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460

Courier Delivery Address
U.S. Environmental Protection Agency
GLP Section Chief- Pesticides, Water and Toxics Branch
Monitoring Assistance and Media Programs Division (2227 A)
Office of Enforcement and Compliance Assurance
Room 7117B
1200 Pennsylvania Avenue, N.W.
Washington, DC 20004
A copy of the letter submitted to EPA/OECA must also be submitted concurrently as a support
document for the PMN, using the procedures set out in 40 C.F.R. § 720.40.

(c) Good Laboratory Practice Standards and Test Protocols. Each study performed to address the
risks identified in this Consent Order must be conducted according to TSCA Good Laboratory
Practice Standards at 40 C.F.R. Part 792 and using methodologies generally accepted in the
relevant scientific community at the time the study is initiated. Before starting to conduct any

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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 C.F.R. § 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.
EPA may notify the Company in writing that EPA finds that the data generated by a study
(including studies not performed or information not generated under this Consent Order) are
scientifically valid and unequivocal and indicate that, despite the terms of this Consent 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, 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, processing,
distribution, use and disposal of the PMN substance, unless either:
(1) within 2 weeks from receipt ofthe 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, process, distribute, use and dispose
of the PMN substance in accordance with the terms of this Consent Order pending EPA's response

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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 must comply with any requirements imposed by EPA's response or cease all
manufacture, processing, distribution, use and disposal of the PMN substance.

(e) Other Requirements. Regardless ofthe satisfaction of any other conditions in this Testing
section, the Company must continue to obey all the terms of this Consent Order until otherwise
notified in writing by EPA. The Company may, based upon submitted test data or other relevant
information, petition EPA to modify or revoke provisions of this Consent Order pursuant to
Section VI of this Consent Order.

RISK NOTIFICATION

(a) If as a result of the test data required under the terms of this Consent Order, 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 an SDS or MSDS, as described in 40
C.F.R. § 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 (which includes import), processed,
or used in the Company's workplace, the Company must add the new information to an SDS or
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

 - 8date the Company becomes aware of the new information described in paragraph (a) of this
section, are provided an SDS or MSDS containing the information required under paragraph (a)
within 90 days from the time the Company becomes aware of the new information.

MANUFACTURING

(a)(l) Prohibition. The Company must not cause, encourage, or suggest the manufacture (which
includes import) of the PMN substance by any other person.
(2) Sunset Following SNUR. Subparagraph (a)(l) will expire 75 days after promulgation
of a final SNUR governing the PMN substance under§ 5(a)(2) ofTSCA unless the Company is
notified on or before that day ofan action in a Federal Court seeking judicial review of the SNUR.
If the Company is so notified, subparagraph (a)(l) will not expire until EPA notifies the Company
in writing that all Federal Court actions involving the SNUR have been resolved and the validity of
the SNUR affirmed.
(3) Notice of SNUR. If and when EPA promulgates a final SNUR for the PMN substance
and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company must notify
each person whom it causes, encourages or suggests to manufacture the PMN substance of the
existence of the SNUR.

(b) The Company may not:
(1) manufacture (excluding import) the PMN substance in the United States (i.e., import
only); and
(2) manufacture the PMN substance beyond an annual manufacture (which includes
import) volume of 60 kg.

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USE
(a) The Company may not use the PMN substance other than as described in the PMN as a
leveling agent for coatings applied to aluminum printing plates.

DISTRIBUTION
(a) Export Notice Reguirement. No later than the date of distribution, the Company must notify in
writing any person to whom it distributes the PMN substance that, due to the issuance of this
Consent Order, the PMN substance is subject to the export notification requirements of TSCA §
12(b) and 40 C.F.R. Part 707, Subpart D. Such notice must 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) ifthe specific chemical identity is
confidential, the generic chemical identity.

(b) Distribution Reguirements. Except after the PMN has been applied to aluminum printing
plates, except as provided in paragraph (c), the Company is permitted to 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§ S(e) ofTSCA, the PMN substance is subject to the export
notification requirements ofTSCA § 12(b) and 40 C.F.R. Part 707, Subpart D. Such notice must

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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) ifthe
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 applied to aluminum printing plates.
(3) Not use the PMN substance other than as described in the PMN as a leveling agent for
coatings applied to aluminum printing plates.

(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 Company shall ensure that each ofthe sealed containers of the substance leaving
its workplace for distribution in commerce is labeled with the following information:
A statement ofthe health hazards(s) and precautionary measure(s), if any, identified by the
Company for the PMN substance; the identity by which the PMN substance may be commonly
recognized; a statement of the environmental hazard(s) and precautionary measure(s), if any,

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identified by the Company for the PMN substance; a statement of exposure and precautionary
measure(s), if any, identified by the Company 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 substance, the Company obtains knowledge that a recipient of the PMN substance has failed
to comply with any of the conditions specified in paragraph (b) of this Distribution section or, after
paragraph (b) expires in accordance with subparagraph (e)(1), has engaged in a significant new use
ofthe PMN substance (as defined in 40 C.F.R. Part 721, Subpart E) without submitting a
significant new use notice to EPA, the Company must cease supplying the PMN substance to that
recipient, unless the Company is able to document each of the following:
( 1) That the Company has, within 5 working days, notified the recipient 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 ofthe 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.

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(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) ofthis 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 must cease supplying the PMN substance to that recipient, must notify EPA of
the failure to comply, and is permitted to resume supplying the PMN substance to that recipient
only upon written notification from the Agency.

(e) Sunset Following SNUR and Notification ofSNUR. (1) Paragraphs (b) and (c) ofthis
Distribution section will expire 75 days after promulgation of a final SNUR for the PMN substance
under§ 5(a)(2) ofTSCA, unless the Company is notified on or before that day of an action in a
Federal Court seeking judicial review of the SNUR. If the Company is so notified, paragraphs (b)
and (c) of this Distribution section will not expire until EPA notifies the Company in writing that
all Federal Court actions involving the SNUR have been resolved and the validity of the SNUR
·affirmed.
(2) When EPA promulgates a final SNUR for the PMN substance and paragraph (b) of this
Distribution section expires in accordance with subparagraph (e )(1 ), the Company must 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 require 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.

 - 13-

III. RECORDKEEPING
(a) Records. The Company must maintain the following records until 5 years after the date they
are created and must make them available for inspection and copying by EPA in accordance with §
11 ofTSCA:
(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) ofthis Consent 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 Consent Order are
exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 5
years from the date of their creation, copies ofthe export label and export notice to EPA, required
by TSCA §§ 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) ofthis Consent
Order are exempt from all the requirements in this Recordkeeping section, if the Company
maintains, for 5 years from the date oftheir creation, the records required by 40 C.F.R. §
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 Consent Order, the Company must 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 (which includes import) volume of the PMN
substance and the corresponding dates of manufacture;

 - 14(3) Records documenting the names and addresses (including shipment destination
address, if different) of all processors outside the site of manufacture (which includes import) to
whom the Company directly sells or transfers the PMN substance, the date of each sale or transfer,
and the quantity of the PMN substance sold or transferred on such date;
(4) Records documenting the address of all sites of manufacture (which includes import),
processing, and use;
(5) Records documenting compliance with any applicable manufacturing, processing, use,
and distribution restrictions in the Manufacturing, Use, and Distribution sections of this Consent
Order, including distributees' written agreement to comply with the Distribution section of this
Consent Order;
(6) Copies of any Transfer Documents and notices required by the Successor Liability
section of this Consent Order, if applicable; and,
(7) The Company must keep a copy of this Consent Order at each of its sites where the
PMN substance is manufactured (which includes import).

(b) Applicability. The provisions ofthis Recordkeeping Section are applicable only to activities
ofthe Company and its Contract Manufacturer, if applicable, and not to activities ofthe
Company's customers.

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 C.F.R.
Part 1320, particularly 5 C.F.R. § 1320.5(b), the Company is not required to respond to this
"collection of information" unless this Consent Order displays a currently valid control number
from the Office of Management and Budget ("OMB"), and EPA so informs the Company. The

 15
"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

INFORMATION

(a) EPA's Request for Information. Pursuant to§ 11 ofTSCA and 40 C.F.R. § 720.122, EPA may
occasionally conduct

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 Consent Order; and/or,
(6) Any other information reasonably related to determining compliance with this Consent
Order or conducting an inspection for that purpose.

 - 16-

(b) Company's Response. The Company must 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 must 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 must demonstrate a good faith effort to provide reasonably accurate and detailed answers
to all ofEPA's requests.

(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the
Company submits to EPA pursuant to paragraph (b) will be protected in accordance with §14 of
TSCA and 40 C.F .R. Part 2, Subpart B. In order to make a confidentiality claim for information
submitted to EPA, an authorized official of the Company must certify that it is true and accurate
that the Company has:
(1) Taken reasonable measures to protect the confidentiality of the information;
(2) Determined that the information is not required to be disclosed or otherwise made
available to the public under any other Federal law;
(3) A reasonable basis to conclude that the disclosure of the information is likely to cause
substantial harm to the competitive position of the Company; and
(4) A reasonable basis to believe that the information is not readily discoverable through
reverse engineering.
CBI claims for chemical identity must be accompanied by a generic chemical identity, which may
be that used for the PMN. CBI claims must be accompanied by subst(llltiations in accordance with
TSCA § 14(c)(5). Guidance on substantiating CBI claims may be found at
https://www.epa.gov/tsca-cbi/substantiating-cbi-claims-under-tsca-time-i itiaJ-submission.

 - 17V. 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 Consent 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. Ifthe 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 C.F.R. § 720.102, the Successor in Interest must
submit a new PMN to EPA and comply fully with§ 5(a)(1)(B) ofTSCA and 40 C.F.R. Part 720
before commencing manufacture (which includes import) of the PMN substance.
(2) After NOC. If the transfer from the Company to the Successor in Interest is effective
after EPA receives a NOC, the Successor in Interest must comply with the terms of this Consent
Order and will not be required to submit a new PMN to EPA.

(c) Definitions. The following definitions apply to this Successor Liability section of the Consent
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

 - 18license 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 C.F.R. § 720.22(a)(3) and 40 C.F.R. § 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 ofthe transfer, the
Company must 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 Consent Order.
(2) Notice to EPA. Within 10 business days ofthe effective date of the transfer, the
Company must, by registered mail, submit the fully executed Notice of Transfer document to EPA
at:
Postal Mail Address
U.S. Environmental Protection Agency
New Chemicals Management Branch (7405M)
1200 Pennsylvania Avenue, N.W.
Washington, D.C. 20460

Alternatively. the document may be submitted by courier:
U.S. Environmental Protection Agency

 - 19-

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. Copies of the Transfer Document must also be made available for inspection
pursuant to§ 11 ofTSCA, must state the effective date of transfer, and must contain provisions
which expressly transfer liability for the PMN substance under the terms of this Consent Order
from the Company to the Successor in Interest.

(e) Liability.
(1) The Company will be liable for compliance with the requirements of this Consent
Order until the effective date of the transfer described above.
(2) The Successor in Interest will be liable for compliance with the requirements of this
Consent Order effective as of the date of transfer.
(3) Nothing in this section may 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 Consent Order may be modified only via the procedures in this Section. The Company
may request in writing at any time, based upon new information on the human health or

 -20-

environmental effects of, or human exposure to or environmental release of, the PMN substance,
that EPA agree to modify or revoke substantive provisions of this Consent Order, including, but
not limited to, testing requirements, workplace protections, disposal requirements, or discharge
limits. 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 Consent Order. However, in determining whether to amend or revoke the
substantive provisions of this Consent 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 Consent 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 described
therein are no longer necessary to protect against 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 substance.
In addition, the Company may request in writing at any time that EPA make other
modifications to the language ofthis Consent 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 Consent Order as issued.

 - 21 -

VII. EFFECT OF CONSENT ORDER
(a) Waiver. By consenting to the entry of this Consent Order, the Company waives its rights to
receive service of this Consent Order no later than 45 days before the end of the applicable review
period pursuant to§ 5(e)(l)(B) ofTSCA and to challenge the validity of this Consent Order in any
subsequent action. Consenting to the entry of this Consent 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) Effective Date. This Consent Order shall be effective upon the expiration of the PMN review
period after the EPA's receipt of a fully executed copy of the Consent Order. The EPA will notify
the Company of its receipt ofthe fully executed copy of the Consent Order.

Maria J. Doa, .D., Director
Chemical Control Division
Office of Pollution Prevention and Toxics

 ATTACHMENT A
DEFINITIONS

[Note: The attached Consent 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 Consent 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 (which includes import) the PMN substance under the conditions specified in Section
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.
"Intermediate" means any chemical substance that is consumed, in whole or in part, in
chemical reactions used for the intentional manufacture of another chemical substance( s) or
mixture(s), or that is intentionally present for the purpose of altering the rates of such chemical
reactions.
"Manufacture" means to produce or manufacture in the United States or import into the
customs territory of the United States.
"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 or processed.
••pMN substance" means the chemical substance described in the Premanufacture notice
submitted by the Company relevant to this Consent 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.

 - 3"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 C.P.R. Part 792 without prior or subsequent Agency
review 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-reviewed protocols, are
inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of
the potential risk of iJ\iury to human health or the environment of the PMN substance.
"SDS" means safety data sheet, the written listing of data for the chemical 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.
"Site-limited intermediate" means an intermediate manufactured, processed, and used only
within a site and not distributed in commerce other than as an impurity or for disposal. Imported
intermediates cannot be "site-limited."
"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 C.P.R.§ 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 S(e) CONSENT ORDER

Company (Transferor)

PMNNumber

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) ofthe 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, will
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 C.F.R. §
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 ofTSCA and 40 C.F.R. Part 2, for the PMN substance(s). Where "reasserts" or "relinquishes"
is indicated, that designation will be deemed to apply to all such claims. Where "modifies" is
indicated, such modification will 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.

 In order to make a confidentiality claim for information submitted to EPA, an authorized official
of the Successor in Interest must certify that it is true and accurate that the Successor in Interest
has:
(1) Taken reasonable measures to protect the confidentiality ofthe information;
(2) Determined that the information is not required to be disclosed or otherwise made
available to the public under any other Federal law;
(3) A reasonable basis to conclude that the disclosure of the information is likely to cause
substantial harm to the competitive position of the Successor in Interest; and
(4) A reasonable basis to believe that the information is not readily discoverable through
reverse engineering.
CBI claims for chemical identity must be accompanied by a generic chemical identity, which may
be that used for the PMN.

 - 3NOTICE OF TRANSFER OF
TOXIC SUBSTANCES CONTROL ACT
SECTION 5(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

Printed Name of Authorized Official

Title of Authorized Official

Address

City, State, Zip Code

Date