Final Enforceable Consent Agreement and Testing Consent Order for Four Formulated Composites of Fluoropolymer Chemicals; Export Notification, 39630-39637 [05-13493]
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39630
Federal Register / Vol. 70, No. 130 / Friday, July 8, 2005 / Rules and Regulations
Mixture/substance
Required test
(iii) Perfluoroalkyl methacrylate polymer, EPA document control number (DCN)
63040000037A
(iv) Substituted methacrylate, propenoic acid, perfluoroalkyl esters, DCN
63040000033B
(v) Perfluoroalkyl acrylic polymer, DCN 63040000037C
(vi) Poly-.beta.-fluoroalkylethyl acrylate and alkyl acrylate, ACC 174993
(vii) Poly(.beta.-fluoroalkylethyl acrylate and alkyl acrylate), ACC 70430
(viii) Polysubstituted acrylic copolymer, ACC 157381
(ix) Perfluoroalkyl acrylate copolymer latex, ACC No. 70907
(2) For Textile containing six of the following chemical substances as specified in the
ECA:
(i) Perfluoroalkylethyl acrylate copolymer, EPA-designated accession number
(ACC) 171790
(ii) Perfluoroalkyl acrylate copolymer, ACC 158022
(iii) Perfluoroalkyl methacrylate polymer, EPA document control number (DCN)
63040000037A
(iv) Substituted methacrylate, propenoic acid, perfluoroalkyl esters, DCN
63040000033B
(v) Perfluoroalkyl acrylic polymer, DCN 63040000037C
(vi) Poly-.beta.-fluoroalkylethyl acrylate and alkyl acrylate, ACC 174993
(vii) Poly(.beta.-fluoroalkylethyl acrylate and alkyl acrylate), ACC 70430
(viii) Polysubstituted acrylic copolymer, ACC 157381
(ix) Perfluoroalkyl acrylate copolymer latex, ACC 70907
[FR Doc. 05–13492 Filed 7–7–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 799
[OPPT–2003–0071; FRL–7710–5]
Final Enforceable Consent Agreement
and Testing Consent Order for Four
Formulated Composites of
Fluoropolymer Chemicals; Export
Notification
Environmental Protection
Agency (EPA).
ACTION: Notice of final consent
agreement and order.
AGENCY:
SUMMARY: Under section 4 of the Toxic
Substances Control Act (TSCA), EPA
has issued a testing consent order
(Order) that incorporates an enforceable
consent agreement (ECA) with AGC
Chemicals Americas, Inc.; Daikin
America, Inc.; Dyneon, LLC; and E.I. du
Pont de Nemours and Company (the
Companies). The Companies have
agreed to perform incineration testing of
four formulated composites of
fluoropolymer (FP) chemicals
representative of products currently
available in the marketplace. This
document announces the ECA and the
Order that incorporates the ECA for this
testing, and summarizes the terms of the
ECA. As a result of the ECA and Order
that incorporates the ECA, exporters of
any of the formulated composites
containing FP chemicals, including
persons who do not sign the ECA, are
subject to export notification
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requirements under section 12(b) of
TSCA. This document adds the four
formulated composites of FP chemicals
to the table of testing consent orders for
substances and mixtures without
Chemical Abstract Service (CAS)
Registry Numbers. Data developed from
the ECA testing will contribute to the
Agency’s efforts to determine whether
municipal and/or medical waste
incineration of FPs is a potential source
and/or pathway of environmental and
human exposure to perfluorooctanoic
acid (PFOA). The data will also
contribute to the Agency’s continuing
efforts to achieve healthy communities
and ecosystems.
DATES: The effective date of the ECA,
the Order that incorporates the ECA,
and this action is July 8, 2005.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number OPPT–2003–
0071. All documents in the docket are
listed in the EDOCKET index at http:/
/www.epa.gov/edocket/. Although listed
in the index, some information is not
publicly available, i.e., Confidential
Business Information (CBI) or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will not be placed on the Internet and
will be publicly available only in hard
copy form. Publicly available docket
materials are available either
electronically in EDOCKET or in hard
copy at the OPPT Docket, EPA Docket
Center, EPA West, Room B102, 1301
Constitution Ave., NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
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holidays. The EPA Docket Center
Reading Room telephone number is
(202) 566–1744 and the telephone
number for the OPPT Docket, which is
located in EPA Docket Center, is (202)
566–0280.
FOR FURTHER INFORMATION CONTACT: For
general information contact: Colby
Lintner, Regulatory Coordinator,
Environmental Assistance Division
(7408M); telephone number: (202) 554–
1404; e-mail address: TSCAHotline@epa.gov.
For information on the ECA, contact:
Richard W. Leukroth, Jr., Chemical
Control Division (7405M); telephone
number: (202) 564–8167; fax number:
(202) 564–4765; e-mail address:
leukroth.rich@epa.gov.
For technical information on testing
and availability of ECA test data,
contact: John Blouin, Economics,
Exposure and Technology Division
(7406M); telephone number: (202) 564–
8519; fax number: (202) 564–8528; email address: blouin.john@epa.gov.
For technical information on export
notification, contact: Richard W.
Leukroth, Jr., Chemical Control Division
(7405M); telephone number: (202) 564–
8167; fax number: (202) 564–4765; email address: leukroth.rich@epa.gov or
Laura L. Bunte, Chemical Control
Division (7405M); telephone number:
(202) 564–8087; fax number: (202) 564–
4765; e-mail address:
bunte.laura@epa.gov.
To contact any of these individuals by
mail, identify the individual by name
and Division indicated for that person,
and use this address: Office of Pollution
Prevention and Toxics (OPPT),
Environmental Protection Agency, 1200
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Pennsylvania Ave., NW., Washington,
DC 20460–0001.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general. The requirements in the ECA
and the Order that incorporates the ECA
only apply to those companies that are
specifically named in the ECA. As of
July 8, 2005, any person who exports or
intends to export any of the four
formulated composites of FP chemicals
that are the subject of the ECA and the
Order that incorporates the ECA are
subject to the export notification
requirements of TSCA section 12(b) (see
40 CFR part 707, subpart D, and Unit
IV.B.). Although other types of entities
could also be affected, most chemical
manufacturers are usually identified
under North American Industrial
Classification System (NAICS) code 325.
If you have any questions regarding the
applicability of this action to a
particular entity, contact persons listed
under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies
of this Document and Other Related
Information?
In addition to using EDOCKET (http:/
/www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 799 is available on E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. Information
on TSCA 12(b) export notification (40
CFR part 707) is available at https://
www.epa.gov/oppt/chemtest/
sect12b.htm.
II. Background
A. What are FP Chemicals?
FP chemicals are polymers mainly
consisting of carbon and fluorine atoms,
such as polytetrafluoroethylene (PTFE).
Many, but not all, commercial
fluoropolymers are chemicals made
using ammonium perfluorooctanoate
(APFO). The fluoropolymer structure is
predominantly -(CF2)x- which is a
potential source of PFOA. For all
fluoropolymer products used in
commerce, the -(CF2)- moiety is
common to all polymers. The four
formulated FP composites that are
subject to testing under the ECA are
representative of all known commercial
FP chemicals and the basic chemistries
are represented by the four composite
test substances that are subject to testing
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under this ECA (i.e., dry melt
fluoropolymer resin, dry nonmelt PTFE
homopolymer resin/gum, dry non-melt
fluoroelastomer resin/gum, aqueous
fluoropolymer dispersions).
FPs possess a set of special properties
that make them highly useful in the
products in which they are applied.
They are highly resistant to extreme
temperatures, chemicals, and weather.
FPs have a low friction coefficient, and
the lowest dielectric constant of all
plastics. They are also flame retardant,
and are highly non-stick. FPs are used
in a wide variety of industries, and their
applications encompass a wide variety
of industrial and consumer products.
Among the major industrial sectors that
use FPs are the automotive, chemical
processing, electronics/ semiconductor,
aerospace/military, medical/
pharmaceutical, building/construction,
and commercial food preparation
sectors. Some of the specific
applications of FPs in those sectors
include wire and cable insulation, Orings and shaft seals, hoses and tubing,
heat resistant/low friction metal
coatings, non-stick cookware, thread
sealant tape, breathable membranes for
apparel, weather-resistant architectural
fabric coatings, and personal care
products.
B. Why Does EPA Need Environmental
Effects Data on FP Chemicals?
EPA has identified potential human
health concerns from exposure to PFOA
and its salts. The Agency is concerned
that residual APFO used to manufacture
FPs is a source and/or pathway to
environmental and human exposure to
PFOA. In addition, there is insufficient
data to determine whether FPs could
degrade to PFOA by mechanisms that
are not fully understood at this time.
The high temperatures and retention
times used during incineration
processes, while destroying most of the
polymer molecule, may not completely
degrade these polymers. Since the
strong C-F bonds are common to all FPs,
EPA believes that the 17 individual FPs
(see Unit III.B.) with their associated
chemistries are representative of the
manner in which FPs could degrade,
potentially forming PFOA when
incinerated under the conditions
simulating current municipal and
medical waste incinerators as specified
by this ECA testing program.
In September 2002, EPA’s OPPT
initiated a priority review of PFOA
because developmental toxicity,
carcinogenicity, and blood-monitoring
data presented in an interim revised
hazard assessment raised the possibility
that PFOA might present a significant
risk to human health (Ref. 1). On
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January 4, 2005, OPPT’s Risk
Assessment Division submitted a draft
risk assessment of the potential human
health effects associated with exposure
to PFOA and its salts to EPA’s Science
Advisory Board’s (SAB)
Perfluorooctanoic Acid Risk Assessment
Review Panel for peer review (Refs. 2
and 3). These assessments revealed
uncertainties associated with the
sources and pathways of human
exposure. EPA believes that the
information to be developed under the
ECA testing will better inform the
Agency regarding the potential source(s)
and/or pathway(s) of environmental and
human exposure to PFOA.
III. ECA Development and Conclusion
A. How is EPA Going to Obtain
Environmental Testing on FP
Chemicals?
In the Federal Register of April 16,
2003 (68 FR 18626) (FRL–7303–8), EPA
initiated a public process to negotiate
ECAs concerning PFOA and
fluorpolymers. The two goals of the
ECAs resulting from these public
discussions are to develop
environmental fate and transport data,
as well as other data relevant to
identifying the pathway(s) that result in
human exposure to PFOA by air, water,
or soil; and, to characterize how PFOA
gets into those pathways, including the
products or processes that are
responsible for the presence of PFOA in
the environment. EPA anticipates that
the data to be developed under such
ECAs will be supplemental to data being
generated by ongoing testing efforts
described under industry letters of
intent (LOIs) (Refs. 4–7).
In preparation for the initial public
meeting on June 6, 2003, EPA developed
a preliminary framework document
(Ref. 8) outlining Agency data needs
that address the outstanding PFOA
source and exposure pathway questions
identified in the Federal Register notice
of April 16, 2003. EPA’s preliminary
framework document was intended to
serve as a discussion guide for the June
6, 2003, public meeting and to aid in
distinguishing between outstanding
EPA data needs and industry LOI
commitments. The preliminary
framework document was not a
predetermined list of information needs
defining the outcome of the ECA
process.
The ECA described in this document
provides for a laboratory-scale
incineration testing program for four
formulated composites of FP chemicals.
Incineration testing of FPs is one of the
data needs identified in EPA’s
preliminary framework document for
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PFOA. On June 6, 2003, the PFOA
Plenary Group (consisting of EPA and
all parties who had identified
themselves as being interested in the
ECA development proceedings after
publication of the April 16, 2003
Federal Register notice) acknowledged
that such a testing program was an
opportunity for ECA development. The
PFOA Plenary Group tasked the
Fluoropolymer Technical Workgroup (a
subgroup of the PFOA Plenary Group)
with working out the details that could
be incorporated into an ECA between
the Companies and EPA.
On July 8, 2003, the Fluoropolymer
Technical Workgroup received
proposals from the Companies and EPA
(Refs. 9 and 10) for incineration testing
of FPs. Details of the testing program
were then developed by members of the
Fluoropolymer Incineration Subgroup (a
subgroup of the Fluoropolymer
Technical Workgroup) and the subgroup
and workgroup reached consensus on
the testing to be required under the
ECA. On March 31, 2004, the
Fluoropolymer Technical Workgroup
acknowledged that this testing program
had sufficient merit for consideration by
the PFOA Plenary Group (Ref. 11). On
April 1, 2004, the PFOA Plenary Group
discussed the merit of this testing
program and recommended that EPA
consider entering into an ECA with the
Companies (Ref. 12). EPA agreed and
initiated steps to enter into this ECA
with the Companies. On January 25,
2005, EPA received the ECA signed by
the Companies, and on June 28, 2005,
EPA signed the ECA and the Order that
incorporates the ECA. The effective date
of the ECA and the Order that
incorporates the ECA is July 8, 2005.
EPA uses ECAs to accomplish testing
of chemicals for health and
environmental effects where a
consensus exists concerning the need
for and scope of testing (40 CFR
790.1(c)). The procedures for ECA
negotiations and the factors for
determining whether a consensus exists
are described at 40 CFR 790.22 and
790.24, respectively.
B. What is the Subject of the ECA and
Order Incorporating the ECA?
As specified under the ECA, four
formulated composites of FP chemicals
are the subject of and will be tested
under the ECA and the Order that
incorporates the ECA. Appendix A and
Part XXIV. of the ECA (individual
company signature pages) of the ECA
provide details on: The rationale for
formulating four composites that
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represent FP chemical products
currently available in the marketplace,
the identity of the FP chemicals used to
formulate each composite, the
procedures for formulating each
composite, and the procedures by which
each company will contribute the FP
chemical(s) for which it is obligated
under the terms of the ECA. The four
formulated composites are identified as:
Dry Non-Melt Resin (containing: Ethene,
tetrafluoro-, homopolymer, CAS No.
9002–84–0, Polytetrafluoroethylene,
Document Control Number (DCN)
63040000018A, and Propane,
1,1,1,2,2,3,3-heptafluoro-3[(trifluoroethenyl)oxy]-, polymer with
tetrafluoroethene, CAS No. 26655–00–
5); Dry Melt Fluoropolymer Resin
(containing: 1-Propene, 1,1,2,3,3,3hexafluoro-, polymer with
tetrafluoroethene, CAS No. 25067–11–2;
Propane, 1,1,1,2,2,3,3-heptafluoro-3[(trifluoroethenyl)oxy]-, polymer with
tetrafluoroethene, CAS No. 26655–00–5;
Ethene, tetrafluoro-, polymer with
trifluoro(pentafluoroethoxy)ethene, CAS
No. 31784–04–0; 1-Propene, 1,1,2,3,3,3hexafluoro-, polymer with 1,1difluoroethene and tetrafluoroethene,
CAS No. 25190–89–0; ETFE, DCN
63040000026; and, 1-Propene,
1,1,2,3,3,3-hexafluoro-, polymer with
ethene and tetrafluoroethene, CAS No.
35560–16–8); Dry Non-Melt
Fluoroelastomer Resin/Gum
(containing: 1-Propene, 1,1,2,3,3,3hexafluoro-, polymer with 1,1difluoroethene, CAS No. 9011–17–0; 1Propene, 1,1,2,3,3,3-hexafluoro-,
polymer with 1,1- difluoroethene and
tetrafluoroethene, CAS No. 25190–89–0;
1-Propene, polymer with 1,1difluoroethene and tetrafluoroethene,
CAS No. 54675–89–7; 1-Propene,
polymer with tetrafluoroethene, CAS
No. 27029–05–6; Ethene, tetrafluoro-,
polymer with
trifluoro(trifluoromethoxy) ethene, CAS
No. 26425–79–6; Ethene,
chlorotrifluoro-, polymer with 1,1difluoroethene, CAS No. 9010–75–7;
fluoroelastomer, DCN 63040000018C;
fluoroelastomer DCN 63040000018D;
and a low temperature fluoroelastomer,
ACC 137678; and, Aqueous
Fluoropolymer Dispersions (containing:
Ethene, tetrafluoro-, homopolymer, CAS
No. 9002–84–0; 1-Propene, 1,1,2,3,3,3hexafluoro-, polymer with
tetrafluoroethene), CAS No. 25067–11–
2; Propane, 1,1,1,2,2,3,3-heptafluoro-3[(trifluoroethenyl)oxy]-, polymer with
tetrafluoroethene, CAS No. 26655–00–5;
1-Propene, 1,1,2,3,3,3- hexafluoro-,
polymer with 1,1-difluoroethene and
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tetrafluoroethene, CAS No. 25190–89–0;
and polytetrafluoroethylene, DCN
63040000018B).
EPA uses a variety of numerical
identification systems for tracking
chemicals. These include CAS numbers
assigned to non-confidential chemicals,
premanufacture notice (PMN) numbers
assigned by EPA when chemicals enter
EPA’s new chemical review process,
document control numbers (DCN)
assigned by the EPA OPPT’s
Confidential Business Information
Center for EPA tracking, and Accession
(ACC) numbers provided by EPA when
a chemical identity listed on the TSCA
Inventory has been claimed as TSCA
CBI. In addition, chemicals that qualify
for a reporting exemption under the
Polymer Exemption Rule (40 CFR
723.250) may have a commercial trade
identity or an IES Method I (CAS
Inventory Expert Service) name
assigned.
C. What Testing Does the ECA for FP
Chemicals Require?
The ECA for laboratory-scale
incineration testing of four composites
of FP chemicals requires environmental
testing, as described in Table 1 of this
unit, which sets forth the required
testing, test standards, and reporting
requirements for testing to be conducted
under the ECA.
The testing included in the ECA will
be conducted in two segments, as
follows: Phase I—PFOA Transport
Testing (Phase I) and Phase II—
Fluorotelomer Incineration Testing
(Phase II). Phase I will consist of
quantitative transport efficiency testing
for PFOA. At the conclusion of Phase I,
the Companies will provide EPA with a
letter report summarizing the results. In
the event that the transport efficiency of
PFOA or total fluorine is equal to or
greater than 70%, testing will proceed to
Phase II. In the event that the transport
efficiency of PFOA and total fluorine are
both individually less than 70%, the
Companies will initiate a technical
consultation with EPA to reach
agreement on how to proceed. The
various outcomes of such a technical
consultation are laid out in Part VIII. of
the ECA.
Under Phase II, elemental analysis,
combustion stoichiometry,
thermogravimetric analysis, laboratoryscale combustion testing, and, if
required under the ECA (see Table 1,
footnote 9 of this unit), release
assessment reporting will be performed
for the four composites of FP chemicals
that are the subject of the ECA.
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TABLE 1.—REQUIRED TESTING, TEST STANDARDS, REPORTINGREQUIREMENTS: PHASES OF THE TESTING PROGRAM FOR
THE INCINERATION OF FP COMPOSITES
Phase I
PFOA Transport Testing
Test standard/Reporting requirements
Deadline
Phase I Study Plan(s)
40 CFR 790.62 (b) as annotated by Part X. of the ECA
60
EPA Requirements for Quality Assurance Project Plans
(QA/R5) 10
90
240
1
(Days)
3
Appendix C.1. of the ECA
(Days)
3
Phase I Quality Assurance Project Plan(s)
1
Quantitative PFOA transport testing
2
4,5
Phase II
Fluoropolomer Incineration Testing
Test standard/Reporting requirements
Deadline
Phase II Study Plan(s)
40 CFR 790.62 (b) as annotated by Part X. of the ECA
180
3
Phase II Quality Assurance Project Plan(s)
EPA Requirements for Quality Assurance Project Plans
(QA/R5) 10
360
3
Receipt of composite components by designated facility(ies)
Part XXIV. and Appendix A.3. of the ECA
180
7
Appendix C.2.1. of the ECA
450
8
Appendix C.2.2. of the ECA
450
8
ASTM E1868-02, as modified in Appendix B.1. of the ECA
450
8
Appendices C.2.4. and C.2.5., as annotated/supplemented
by Appendices D.1., D.2., D.3., and D.4. of the ECA
450
8
Appendix E.2. of the ECA
450
9
Elemental Analysis
6
Combustion Stoichiometry
6
Thermogravimetric Analysis
6
Laboratory-scale Combustion Testing
6
Release Assessment Report
1 Number of days, starting with the day following the event starting the time period in question. Interim progress reports must be submitted by
the Companies to EPA every 180 days beginning 180 days from July 8, 2005, until the end of the ECA testing program (see Part XIV. and Appendix E.1. of the ECA).
2 At the conclusion of Phase I, and prior to initiation of Phase II, the Companies will provide a letter report to EPA summarizing the results of
Phase I testing (see Part VII.A. of the ECA). In the event that the transport efficiency of PFOA or of total fluorine (as determined by the formulas
in Appendix C.1. of the ECA) is greater than or equal to 70%, then the Companies will proceed to Phase II. In the event that the transport efficiency of PFOA and of total fluorine (as determined by the formulas in Appendix C.1. of the ECA) are both individually less than 70% then the
Companies will initiate a Technical Consultation with EPA. The outcomes of the Technical Consultation are described in Part VIII. of the ECA.
3
Number of days after July 8, 2005, when submission is due.
of days after EPA approval of the Study Plan(s) and QAPP(s) for Phase I testing when a letter report describing transport efficiency
test result(s) and any contingency testing performed is due to EPA (see Part VII.A. and Appendix C.1.3. of the ECA). If the Study Plan(s) and
QAPP(s) are not approved by EPA within 60 days of submission of the Phase I QAPP(s), then this deadline is extended by 180 days to accommodate re-scheduling with the thermal reactor system laboratory.
5 The final report for Phase I will be submitted to EPA within 60 days of the completion of the Technical Consultation if the consultation does
not result in an agreement to conduct further testing. If the Technical Consultation results in an agreement to conduct further testing, the final report for Phase I will be included in the final report for such further testing, unless agreed otherwise in the Technical Consultation (see Part VIII. of
the ECA).
6 The results of this testing will be provided in the final report for Phase II (see Appendix C.2.5. and Appendix E.3. of the ECA).
7 Number of days from the submission of the Phase I letter report signifying that Phase II can proceed and the approval by EPA of the Phase
II QAPP(s) that the Companies must meet their individual obligations to provide the designated facility(ies) with the components for each composite to be tested under the ECA (see Part III.B. of the ECA). If Phase II is required by Technical Consultation agreement (see footnote 2 of this
table ), the deadline shall be as agreed in the Technical Consultation.
8 Number of days from the date of the final report from the ECA for the Laboratory-Scale Incineration Testing of Fluorotelomer-Based Polymers
(published elsewhere in this FEDERAL REGISTER (EPA Docket ID number OPPT–2004–0001)) and the approval of study plan(s) and QAPP(s) for
Phase II testing when this report is due, if all components of each composite are received, or EPA determines that testing shall proceed with a
partial composite(s) (see Part III.B. of the ECA). An extension of the deadline for submitting the final report from the ECA for the LaboratoryScale Incineration Tesing of Fluorotelomer-Based Polymers does not extend this deadline, unless expressly so provided.
9 In the event that Phase II laboratory-scale incineration testing identifies measurable levels of PFOA resulting from the incineration testing for
any or all of the fluoropolymer composites tested under the ECA, as defined in Appendix C.2.5.5. of the ECA, the Companies will prepare a Release Assessment Report to place in perspective the relevance of such measurable levels in the laboratory-scale incineration testing results with
respect to full-scale municipal and/or medical waste incinerator operations in the United States. If required, the Release Assessment Report will
be submitted in conjunction with the Final Report for Phase II testing (see footnotes 6 and 8 of this table ).
10 Guidance for developing Quality Assurance Project Plans can be found in the EPA document EPA QA/R-5: EPA Requirements for Quality
Assurance Project Plans, prepared by: Office of Environmental Information, EPA, March 2001. This is also available from the EPA website at
https://epa.gov/quality/qs-docs.
4 Number
D. What are the Uses for the Test Data
to be Developed Under the ECA?
EPA will use the data obtained from
the testing to be conducted under the
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ECA to assess the potential for waste
incineration of FPs to emit PFOA. This
analysis will be based on quantitative
determination of potential exhaust-gas
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levels of PFOA that may emanate from
laboratory-scale combustion testing
under conditions representative of
typical municipal and/or medical waste
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combustor operations in the United
States. The data could provide EPA with
an understanding of whether the
incineration of FPs is a source and/or
pathway for environmental and human
exposure to PFOA.
These data could also be used to
inform screening level human and
environmental exposure assessments. In
addition, the data could be used by
other Federal Agencies (e.g., the Agency
for Toxic Substances and Disease
Registry (ATSDR), the National Institute
for Occupational Safety and Health
(NIOSH), the Occupational Safety and
Health Administration (OSHA), the
Consumer Product Safety Commission
(CPSC), and the Food and Drug
Administration (FDA)) in assessing
chemical risks and in taking appropriate
actions within their programs.
IV. Other Impacts of the ECA
A. What if EPA Should Require
Additional Environmental Testing on FP
Chemicals?
If EPA decides in the future that it
requires additional data on FPs, the
Agency would initiate a separate action.
B. How Does the Order Affect TSCA
Export Notification?
As of the effective date of the ECA
and the Order that incorporates the ECA
under TSCA section 4 (i.e., the date of
publication of this document in the
Federal Register) any of the Companies,
as well as any other person, who exports
or intends to export any of the four
formulated composites of FP chemicals
that are the subject of this ECA and
Order that incorporates the ECA, in any
form, are subject to the export
notification requirements of TSCA
section 12(b). Procedures related to
export notification are described in 40
CFR part 707, subpart D. EPA maintains
lists of all chemical substances and
mixtures with CAS numbers (40 CFR
799.5000) and without CAS numbers
(40 CFR 799.5025) that are subject to
testing consent orders. This document
will add the four formulated composites
of FP chemicals that are the subject of
this ECA and Order that incorporates
the ECA to the list at 40 CFR 799.5025.
Notice and comment rulemaking is
not needed to add these chemical
substances to the list at 40 CFR
799.5025 because the export notification
requirements are imposed by statute.
Section 12(b) of TSCA requires any
person who exports or intends to export
to a foreign country a chemical
substance or mixture for which the
submission of data is required under
TSCA section 4 to submit a notification
of the export or intended export to EPA.
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An ECA is an action under TSCA
section 4 requiring the submission of
data. 40 CFR 790.1. Accordingly, EPA’s
ECA regulations require that each ECA
contain a statement that manufacturers
or processors signing the ECA, as well
as any other person, shall comply with
export notification requirements in
TSCA section 12(b). 40 CFR
790.60(a)(11). The four formulated
composites of FP chemicals identified
in this document are subject to an Order
incorporating an ECA. EPA finds that
notice and an opportunity for comment
is unnecessary to implement the export
notification requirements in TSCA
section 12(b) for the reasons stated in
this unit.
For chemical substances and mixtures
subject to other Orders incorporating
ECAs that were issued in the past, EPA
initiated separate rulemakings to amend
the lists at 40 CFR 799.5000 and 40 CFR
799.5025, thereby affording the public a
comment opportunity as well as
notifying the public of the existence of
an ECA. EPA took this step to ensure
that those companies not a party to the
ECA or Order noticed their need to
comply with TSCA section 12(b).
However, EPA now believes that a
separate rulemaking or an opportunity
to comment on the implementation of
the statutory mandate is not necessary.
C. What are the Economic Impacts of
the ECA?
Based on the economic analysis
conducted for the ECA, the Agency
expects the cost of the testing to be
performed under this ECA to range from
$100,000 to $150,000. This estimate is
based on a contact report of an inquiry
directed to a university laboratory
conducting thermal ‘‘burn’’ test
research. The estimated total cost for
industry to conduct the required testing
under the ECA is $150,000, which is the
upper end of the estimated cost range.
EPA anticipates that the costs for testing
under this ECA will have a low
potential for adverse economic impact
on the regulated community because the
costs for testing will be shared across
four companies who are signatories to
the ECA and the Order that incorporates
the ECA.
Export regulations promulgated
pursuant to section 12(b) of TSCA—40
CFR part 707, subpart D—require only
a one-time notification to each foreign
country of export for each chemical for
which data are required under section 4
of TSCA. In an analysis of the economic
impacts of the July 27, 1993,
amendment to the rules implementing
section 12(b) of TSCA (58 FR 40238),
EPA estimated that the one-time cost of
preparing and submitting the TSCA
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section 12(b) notification for a first- time
submitter of any TSCA section12(b)
notification was $62.60 (Ref. 13). When
inflated from 1992 to 2004 dollars
(4thQ) by a factor of 1.538 using the
Employment Cost Index for White
Collar Occupations (Ref. 14), the current
cost is estimated to be $96.12, or a
burden of 1.5 hours, for a first-time
submitter. An exporter who had
previously submitted a 12(b)
notification for any chemical/country
combination would incur an estimated
cost of $31.72 for preparing and
submitting a TSCA section 12(b)
notification, based on the burden
estimate of .5 hours.
V. References
1. U.S. Environmental Protection
Agency (EPA). Charles M. Auer.
Memorandum to Oscar Hernandez,
Mary Ellen Weber, and Ward Penberthy
regarding revision of PFOA Hazard
Assessment and Next Steps. September
27, 2002. Available from the EPA
Administrative Record as AR 226–1127.
2. EPA. Draft Risk Assessment of the
Potential Human Health Effects
Associated with the Exposure to
Perfluorooctanoic Acid and its Salts.
January 4, 2005. p. 117. Available from
EPA website, https://www.epa.gov/oppt/
pfoa/.
3. EPA. Science Advisory Board
(SAB) Staff Office; Notification of
Upcoming Meetings of the Science
Advisory Board Perfluorooctanoic Acid
Risk Assessment (PFOA) Review Panel.
Federal Register (70 FR 2157–2158,
January 12, 2005) (FRL–7860–5).
4. 3M Company, Dr. Larry Wending.
Letter of Intent to Stephen L. Johnson,
USEPA, to continue ongoing
environmental, health and safety
measures by Company relating to
Perfluorooctanoic Acid and its Salts
(PFOA). March 13, 2003. Available from
EPA EDOCKET as OPPT–2003–0012–
0007.
5. The Society of the Plastics Industry,
Inc., Donald K. Duncan. The
Ammonium Perfluorooctanoate (APFO)
Users. Letters of Intent to Stephen L.
Johnson, EPA, regarding responsive
Voluntary Actions by parties to evaluate
and control emissions of Ammonium
Perfluorooctanoate (APFO). March 14,
2003. Available from EPA EDOCKET as
OPPT–2003–0012–0012.
6. Telomer Research Program (TRP)
Member Companies. Letter of Intent to
Stephen L. Johnson, EPA, regarding
addressing concerns raised by EPA
about the possible association of
Perfluoroctanoic Acid (PFOA) with
telomer-based products. March 14,
2003. Available from EPA EDOCKET as
OPPT–2003–0012–0013.
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7. APFO Users, Telomer Companies,
and The 3M Company. Letter of Intent
to Stephen L. Johnson, USEPA,
regarding commitment by Companies to
assist the Environmental Protection
Agency (EPA) in its investigation of
Perfluorooctanoic Acid (PFOA) and
Ammonium Perfluorooctanoate (APFO).
March 31, 2003. Available from EPA
EDOCKET as OPPT–2003–0012–0016.
8. EPA. Preliminary Framework for
Enforceable Consent Agreement (ECA)
Data Development for PFOA and
Telomers. May 20, 2003. Available from
EPA EDOCKET as OPPT–2003–0012–
0056.
9. Fluoropolymer Manufacturer’s
Group. Incineration Research Approach.
Presentation to the Fluoropolymer
Technical Workgroup. July 8, 2003. p. 3.
Available from EPA EDOCKET as
OPPT–2003–0071–0009.
10. EPA. EPA ECA Proposal for
Fluoropolymer Incineration Testing.
Presentation to the Fluoropolymer
Technical Workgroup. July 8, 2003. p. 2.
Available from EPA EDOCKET as
OPPT–2003–0071–0009.
11. EPA. PFOA ECA Fluoropolymer
Technical Workgroup Meeting
Summary. March 31, 2004. p. 11.
Available from EPA EDOCKET as
OPPT–2003–0071–0103.
12. EPA. Enforceable Consent
Agreement Development for
Perfluorooctanoic Acid (PFOA) and
Fluorinated Telomers. Public Meeting
Summary. April 1, 2004. p. 6. Available
from EPA EDOCKET as OPPT–2003–
0071–0106.
13. EPA. Economic Analysis in
Support of the Final Rule Promulgated
under TSCA Section 12(b). William
Silagi. EPA/OPPT/RIB. Washington, DC.
June 1992.
14. Bureau of Labor Statistics (BLS).
2003. Employment Cost Index, Total
Compensation: White-Collar
Occupations (Series ID: ECS11102I),
https://data.bls.gov/cgi-bin/srgate,
extracted February 9, 2005.
15. EPA. Wendy Hoffman.
Memorandum to Richard Leukroth
regarding calculation of Paperwork
Reduction Act burden estimate for the
incineration ECAs. October 20, 2004.
Available from EPA EDOCKET as
OPPT–2003–0071–0007.
16. EPA. Lynne Blake-Hedges.
Memorandum to EPAB Staff on Unit
Burden Estimates for 12(b) Export
Notification for Section 4 Test Rules and
Enforceable Consent Agreements
(ECAs). July 20, 1999.
17. ASTM. Standard Test Method for
Loss-On Drying by Thermogravimetry.
2002 Annual Book of ASTM Standards.
Volume 14.02, Designated E 1868–02.
pp. 635–638. August 10, 2002.
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VI. Statutory and Executive Order
Reviews
39635
C. Regulatory Flexibility Act
This action announces an Order that
incorporates an ECA between EPA and
the Companies. Under Executive Order
12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993),
this action is not a ‘‘regulatory action’’
subject to review by the Office of
Management and Budget (OMB).
Since the issuance of the ECA and the
Order that incorporates the ECA, as well
as the applicability of the export
notification requirements of TSCA
section 12(b) to chemicals addressed in
the ECA and the Order that incorporates
the ECA, do not require the issuance of
a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
B. Paperwork Reduction Act
D. Unfunded Mandates Reform Act
According to the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an agency may not conduct or
sponsor, and a person is not required to
respond to, an information collection
request unless it displays a currently
valid control number assigned by OMB.
The OMB control numbers for the EPA’s
regulations in title 40 of the CFR are
listed in 40 CFR part 9.
The information collection
requirements related to the Order that
incorporates the ECA have already been
approved by OMB pursuant to the PRA
under OMB control number 2070–0033
(EPA ICR No. 1139). The one-time
public burden for this collection of
information is estimated to be
approximately 433 hours per response
(i.e., per company), or 1,732 hours total
burden for the four companies (Ref. 15).
Under the PRA, ‘‘burden’’ means the
total time, effort, or financial resources
expended by persons to generate,
maintain, retain, or disclose or provide
information to or for a Federal Agency.
For this collection, it includes the time
needed to review instructions; complete
and review the collection of
information; and transmit or otherwise
disclose the information.
The information collection
requirements related to export
notification requirements under section
12(b) of TSCA, including those related
to the ECA and the Order that
incorporates the ECA, have already been
approved by OMB pursuant to PRA
under OMB control number 2070–0030
(EPA ICR No. 0795). The public
reporting burden for this information
collection is estimated to be between .5
hours to 1.5 hours per response. The
lower estimate applies to companies
that have previously submitted a TSCA
section 12(b) notification for any
chemical or mixture, and therefore need
only update an existing form letter
assumed to have been generated
electronically. The higher estimate
applies to companies that are first-time
submitters of a TSCA section 12(b)
notification (Ref. 16), and therefore need
to write an initial letter.
This action does not impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public
Law 104–4. Therefore, this action is not
subject to the requirements of UMRA.
A. Executive Order 12866
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E. Executive Order 13132 and 13175
This action is not expected to impact
State or Tribal governments because
these governments are not expected to
export the chemicals covered by the
ECA or the Order that incorporates the
ECA. As such, the Agency has
determined that this Action will not
have a substantial direct effect on States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Nor will this action have Tribal
implications because it does not
significantly or uniquely affect the
communities of Indian Tribal
governments, or involve or impose any
requirements that affect Indian Tribes.
Accordingly, the requirements of
Executive Order 13175, entitled
Consultation and Coordination with
Indian Tribal Governments (65 FR
67249, November 6, 2000), do not apply.
F. Executive Order 13045
Executive Order 13045, entitled
Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 1985, April 23, 1997), does
not apply to this action because this
action is not designated as an
‘‘economically significant’’ regulatory
action as defined by Executive Order
12866 (see Unit VI.A.), nor does this
action establish an environmental
standard that is intended to have a
disproportionate effect on children. To
the contrary, this action will provide
data and information that EPA and
others can use to assess the risks of
these chemicals, including potential
risks to sensitive subpopulations.
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G. Executive Order 13211
This action is not subject to Executive
Order 13211, entitledActions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use.
H. National Technology Transfer
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104–
113 section 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standards
bodies. The NTTAA directs EPA to
provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards.
Guideline No. (Year)
Guideline name
ASTM E 1868-02 (August 10, 2002)
The testing conducted under the ECA
involves technical standards. The
Agency conducted a search to identify
potentially applicable voluntary
consensus standards. No such standard
was identified for incineration testing of
FP chemicals that are the subject of the
ECA. However, EPA identified a
voluntary consensus standard for
thermogravimetric analysis (Ref. 17),
which is a required element of the Phase
II ECA testing. Appendix B.1. of the
ECA describes specific modifications to
this voluntary consensus standard that
are needed to take into consideration
the unique properties of FP chemicals.
TSCA Guideline No.
Standard Test Method for Loss-OnDrying by Thermo-gravimetry
OECD Guideline No.
None
None
I. Executive Order 12898
List of Subjects in Part 799
PART 799—[AMENDED]
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
Environmental protection, Chemicals,
Exports, Hazardous substances, Health,
Laboratories, Reporting and
recordkeeping requirements.
I
Dated: June 28, 2005.
Margaret Schneider,
Acting Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances.
Therefore, 40 CFR Chapter I is
amended as follows:
I
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2. Section 799.5025 is amended by
adding the following entry to the table in
alphabetical order, to read as follows:
I
§ 799.5025 Testing consent orders for
mixtures without Chemical Abstracts
Service Registry Numbers.
*
*
*
Required test
*
*
*
*
*
Fluoropolymer composite substance:
(1) For Dry Non-Melt Resin containing the following chemical substances as specified
in the ECA:
(i) Ethene, tetrafluoro-, homopolymer, CAS No. 9002–84–0
(ii) Polytetrafluoroethylene, Document Control Number (DCN) 63040000018A
(iii) Propane, 1,1,1,2,2,3,3-heptafluoro-3-[(trifluoroethenyl)oxy]-, polymer with
tetrafluoroethene, CAS No. 26655–00–5
(2) For Dry Melt Fluoropolymer Resin containing the following chemical substances
as specified in the ECA:
(i) 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with tetrafluoroethene, CAS No.
25067–11–2
(ii) Propane, 1,1,1,2,2,3,3-heptafluoro-3-[(trifluoroethenyl)oxy]-, polymer with
tetrafluoroethene, CAS No. 26655–00–5
(iii) Ethene, tetrafluoro-, polymer with trifluoro(pentafluoroethoxy)ethene, CAS No.
31784–04–0
(iv) 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene and
tetrafluoroethene, CAS No. 25190–89–0
(v) ETFE, DCN 63040000026
(vi) 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with ethene and tetrafluoroethene,
CAS No. 35560–16–8
(3) For Dry Non-Melt Fluoroelastomer Resin/Gum containing the following chemical
substances as specified in the ECA:
(i) 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1- difluoroethene, CAS No.
9011–17–0
(ii) 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1- difluoroethene and
tetrafluoroethene, CAS No. 25190–89–0
(iii) 1-Propene, polymer with 1,1- difluoroethene and tetrafluoroethene, CAS No.
54675–89–7
(iv) 1-Propene, polymer with tetrafluoroethene, CAS No. 27029–05–6
(v) Ethene, tetrafluoro-, polymer with trifluoro(trifluoromethoxy) ethene, CAS No.
26425–79–6
17:58 Jul 07, 2005
Authority: 15 U.S.C. 2603, 2611, 2625.
*
Mixture/substance
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1. The authority citation for part 799
continues to read as follows:
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*
*
FR citation
*
Environmental effects.
......do ...............................
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July 8, 2005.
Do.
Do.
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Do.
......do ...............................
Do.
......do ...............................
Do.
......do ...............................
Do.
......do ...............................
......do ...............................
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Do.
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Mixture/substance
Required test
(vi) Ethene, chlorotrifluoro-, polymer with 1,1-difluoroethene, CAS No. 9010–75–7
(vii) Fluoroelastomer, DCN No. 63040000018C
(viii) Fluoroelastomer DCN 63040000018D
(ix) A low temperature fluoroelastomer, ACC No. 137678
(4) For Aqueous Fluoropolymer Dispersions containing the following chemical substances as specified in the ECA:
(i) Ethene, tetrafluoro-, homopolymer, CAS No. 9002–84–0
(ii) 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with tetrafluoroethene, CAS No.
25067–11–2
(iii) Propane, 1,1,1,2,2,3,3-heptafluoro-3- [(trifluoroethenyl)oxy]-, polymer with
tetrafluoroethene, CAS No. 26655–00–5
(iv) 1-Propene, 1,1,2,3,3,3- hexafluoro-, polymer with 1,1-difluoroethene and
tetrafluoroethene, CAS No. 25190–89–0
(v) Polytetrafluoroethylene, DCN No. 63040000018B
*
*
*
*
*
......do
......do
......do
......do
Do.
Do.
Do.
Do.
......do ...............................
......do ...............................
Do.
Do.
......do ...............................
Do.
......do ...............................
Do.
......do ...............................
*
*
Do.
BILLING CODE 6560–50–S
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[FR Doc. 05–13493 Filed 7–7–05; 8:45 am]
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]]>Agencies
[Federal Register Volume 70, Number 130 (Friday, July 8, 2005)]
[Rules and Regulations]
[Pages 39630-39637]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13493]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPT-2003-0071; FRL-7710-5]
Final Enforceable Consent Agreement and Testing Consent Order for
Four Formulated Composites of Fluoropolymer Chemicals; Export
Notification
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of final consent agreement and order.
-----------------------------------------------------------------------
SUMMARY: Under section 4 of the Toxic Substances Control Act (TSCA),
EPA has issued a testing consent order (Order) that incorporates an
enforceable consent agreement (ECA) with AGC Chemicals Americas, Inc.;
Daikin America, Inc.; Dyneon, LLC; and E.I. du Pont de Nemours and
Company (the Companies). The Companies have agreed to perform
incineration testing of four formulated composites of fluoropolymer
(FP) chemicals representative of products currently available in the
marketplace. This document announces the ECA and the Order that
incorporates the ECA for this testing, and summarizes the terms of the
ECA. As a result of the ECA and Order that incorporates the ECA,
exporters of any of the formulated composites containing FP chemicals,
including persons who do not sign the ECA, are subject to export
notification requirements under section 12(b) of TSCA. This document
adds the four formulated composites of FP chemicals to the table of
testing consent orders for substances and mixtures without Chemical
Abstract Service (CAS) Registry Numbers. Data developed from the ECA
testing will contribute to the Agency's efforts to determine whether
municipal and/or medical waste incineration of FPs is a potential
source and/or pathway of environmental and human exposure to
perfluorooctanoic acid (PFOA). The data will also contribute to the
Agency's continuing efforts to achieve healthy communities and
ecosystems.
DATES: The effective date of the ECA, the Order that incorporates the
ECA, and this action is July 8, 2005.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number OPPT-2003-0071. All documents in the docket
are listed in the EDOCKET index at https://www.epa.gov/edocket/.
Although listed in the index, some information is not publicly
available, i.e., Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will not be placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the OPPT Docket, EPA Docket Center, EPA
West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The EPA Docket Center Reading Room
telephone number is (202) 566-1744 and the telephone number for the
OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M); telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
For information on the ECA, contact: Richard W. Leukroth, Jr.,
Chemical Control Division (7405M); telephone number: (202) 564-8167;
fax number: (202) 564-4765; e-mail address: leukroth.rich@epa.gov.
For technical information on testing and availability of ECA test
data, contact: John Blouin, Economics, Exposure and Technology Division
(7406M); telephone number: (202) 564-8519; fax number: (202) 564-8528;
e-mail address: blouin.john@epa.gov.
For technical information on export notification, contact: Richard
W. Leukroth, Jr., Chemical Control Division (7405M); telephone number:
(202) 564-8167; fax number: (202) 564-4765; e-mail address:
leukroth.rich@epa.gov or Laura L. Bunte, Chemical Control Division
(7405M); telephone number: (202) 564-8087; fax number: (202) 564-4765;
e-mail address: bunte.laura@epa.gov.
To contact any of these individuals by mail, identify the
individual by name and Division indicated for that person, and use this
address: Office of Pollution Prevention and Toxics (OPPT),
Environmental Protection Agency, 1200
[[Page 39631]]
Pennsylvania Ave., NW., Washington, DC 20460-0001.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. The requirements
in the ECA and the Order that incorporates the ECA only apply to those
companies that are specifically named in the ECA. As of July 8, 2005,
any person who exports or intends to export any of the four formulated
composites of FP chemicals that are the subject of the ECA and the
Order that incorporates the ECA are subject to the export notification
requirements of TSCA section 12(b) (see 40 CFR part 707, subpart D, and
Unit IV.B.). Although other types of entities could also be affected,
most chemical manufacturers are usually identified under North American
Industrial Classification System (NAICS) code 325. If you have any
questions regarding the applicability of this action to a particular
entity, contact persons listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (https://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 799
is available on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
Information on TSCA 12(b) export notification (40 CFR part 707) is
available at https://www.epa.gov/oppt/chemtest/sect12b.htm.
II. Background
A. What are FP Chemicals?
FP chemicals are polymers mainly consisting of carbon and fluorine
atoms, such as polytetrafluoroethylene (PTFE). Many, but not all,
commercial fluoropolymers are chemicals made using ammonium
perfluorooctanoate (APFO). The fluoropolymer structure is predominantly
-(CF2)x- which is a potential source of PFOA. For all fluoropolymer
products used in commerce, the -(CF2)- moiety is common to all
polymers. The four formulated FP composites that are subject to testing
under the ECA are representative of all known commercial FP chemicals
and the basic chemistries are represented by the four composite test
substances that are subject to testing under this ECA (i.e., dry melt
fluoropolymer resin, dry nonmelt PTFE homopolymer resin/gum, dry non-
melt fluoroelastomer resin/gum, aqueous fluoropolymer dispersions).
FPs possess a set of special properties that make them highly
useful in the products in which they are applied. They are highly
resistant to extreme temperatures, chemicals, and weather. FPs have a
low friction coefficient, and the lowest dielectric constant of all
plastics. They are also flame retardant, and are highly non-stick. FPs
are used in a wide variety of industries, and their applications
encompass a wide variety of industrial and consumer products. Among the
major industrial sectors that use FPs are the automotive, chemical
processing, electronics/ semiconductor, aerospace/military, medical/
pharmaceutical, building/construction, and commercial food preparation
sectors. Some of the specific applications of FPs in those sectors
include wire and cable insulation, O-rings and shaft seals, hoses and
tubing, heat resistant/low friction metal coatings, non-stick cookware,
thread sealant tape, breathable membranes for apparel, weather-
resistant architectural fabric coatings, and personal care products.
B. Why Does EPA Need Environmental Effects Data on FP Chemicals?
EPA has identified potential human health concerns from exposure to
PFOA and its salts. The Agency is concerned that residual APFO used to
manufacture FPs is a source and/or pathway to environmental and human
exposure to PFOA. In addition, there is insufficient data to determine
whether FPs could degrade to PFOA by mechanisms that are not fully
understood at this time. The high temperatures and retention times used
during incineration processes, while destroying most of the polymer
molecule, may not completely degrade these polymers. Since the strong
C-F bonds are common to all FPs, EPA believes that the 17 individual
FPs (see Unit III.B.) with their associated chemistries are
representative of the manner in which FPs could degrade, potentially
forming PFOA when incinerated under the conditions simulating current
municipal and medical waste incinerators as specified by this ECA
testing program.
In September 2002, EPA's OPPT initiated a priority review of PFOA
because developmental toxicity, carcinogenicity, and blood-monitoring
data presented in an interim revised hazard assessment raised the
possibility that PFOA might present a significant risk to human health
(Ref. 1). On January 4, 2005, OPPT's Risk Assessment Division submitted
a draft risk assessment of the potential human health effects
associated with exposure to PFOA and its salts to EPA's Science
Advisory Board's (SAB) Perfluorooctanoic Acid Risk Assessment Review
Panel for peer review (Refs. 2 and 3). These assessments revealed
uncertainties associated with the sources and pathways of human
exposure. EPA believes that the information to be developed under the
ECA testing will better inform the Agency regarding the potential
source(s) and/or pathway(s) of environmental and human exposure to
PFOA.
III. ECA Development and Conclusion
A. How is EPA Going to Obtain Environmental Testing on FP Chemicals?
In the Federal Register of April 16, 2003 (68 FR 18626) (FRL-7303-
8), EPA initiated a public process to negotiate ECAs concerning PFOA
and fluorpolymers. The two goals of the ECAs resulting from these
public discussions are to develop environmental fate and transport
data, as well as other data relevant to identifying the pathway(s) that
result in human exposure to PFOA by air, water, or soil; and, to
characterize how PFOA gets into those pathways, including the products
or processes that are responsible for the presence of PFOA in the
environment. EPA anticipates that the data to be developed under such
ECAs will be supplemental to data being generated by ongoing testing
efforts described under industry letters of intent (LOIs) (Refs. 4-7).
In preparation for the initial public meeting on June 6, 2003, EPA
developed a preliminary framework document (Ref. 8) outlining Agency
data needs that address the outstanding PFOA source and exposure
pathway questions identified in the Federal Register notice of April
16, 2003. EPA's preliminary framework document was intended to serve as
a discussion guide for the June 6, 2003, public meeting and to aid in
distinguishing between outstanding EPA data needs and industry LOI
commitments. The preliminary framework document was not a predetermined
list of information needs defining the outcome of the ECA process.
The ECA described in this document provides for a laboratory-scale
incineration testing program for four formulated composites of FP
chemicals. Incineration testing of FPs is one of the data needs
identified in EPA's preliminary framework document for
[[Page 39632]]
PFOA. On June 6, 2003, the PFOA Plenary Group (consisting of EPA and
all parties who had identified themselves as being interested in the
ECA development proceedings after publication of the April 16, 2003
Federal Register notice) acknowledged that such a testing program was
an opportunity for ECA development. The PFOA Plenary Group tasked the
Fluoropolymer Technical Workgroup (a subgroup of the PFOA Plenary
Group) with working out the details that could be incorporated into an
ECA between the Companies and EPA.
On July 8, 2003, the Fluoropolymer Technical Workgroup received
proposals from the Companies and EPA (Refs. 9 and 10) for incineration
testing of FPs. Details of the testing program were then developed by
members of the Fluoropolymer Incineration Subgroup (a subgroup of the
Fluoropolymer Technical Workgroup) and the subgroup and workgroup
reached consensus on the testing to be required under the ECA. On March
31, 2004, the Fluoropolymer Technical Workgroup acknowledged that this
testing program had sufficient merit for consideration by the PFOA
Plenary Group (Ref. 11). On April 1, 2004, the PFOA Plenary Group
discussed the merit of this testing program and recommended that EPA
consider entering into an ECA with the Companies (Ref. 12). EPA agreed
and initiated steps to enter into this ECA with the Companies. On
January 25, 2005, EPA received the ECA signed by the Companies, and on
June 28, 2005, EPA signed the ECA and the Order that incorporates the
ECA. The effective date of the ECA and the Order that incorporates the
ECA is July 8, 2005.
EPA uses ECAs to accomplish testing of chemicals for health and
environmental effects where a consensus exists concerning the need for
and scope of testing (40 CFR 790.1(c)). The procedures for ECA
negotiations and the factors for determining whether a consensus exists
are described at 40 CFR 790.22 and 790.24, respectively.
B. What is the Subject of the ECA and Order Incorporating the ECA?
As specified under the ECA, four formulated composites of FP
chemicals are the subject of and will be tested under the ECA and the
Order that incorporates the ECA. Appendix A and Part XXIV. of the ECA
(individual company signature pages) of the ECA provide details on: The
rationale for formulating four composites that represent FP chemical
products currently available in the marketplace, the identity of the FP
chemicals used to formulate each composite, the procedures for
formulating each composite, and the procedures by which each company
will contribute the FP chemical(s) for which it is obligated under the
terms of the ECA. The four formulated composites are identified as: Dry
Non-Melt Resin (containing: Ethene, tetrafluoro-, homopolymer, CAS No.
9002-84-0, Polytetrafluoroethylene, Document Control Number (DCN)
63040000018A, and Propane, 1,1,1,2,2,3,3-heptafluoro-3-
[(trifluoroethenyl)oxy]-, polymer with tetrafluoroethene, CAS No.
26655-00-5); Dry Melt Fluoropolymer Resin (containing: 1-Propene,
1,1,2,3,3,3-hexafluoro-, polymer with tetrafluoroethene, CAS No. 25067-
11-2; Propane, 1,1,1,2,2,3,3-heptafluoro-3-[(trifluoroethenyl)oxy]-,
polymer with tetrafluoroethene, CAS No. 26655-00-5; Ethene,
tetrafluoro-, polymer with trifluoro(pentafluoroethoxy)ethene, CAS No.
31784-04-0; 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1-
difluoroethene and tetrafluoroethene, CAS No. 25190-89-0; ETFE, DCN
63040000026; and, 1-Propene, 1,1,2,3,3,3-hexafluoro-, polymer with
ethene and tetrafluoroethene, CAS No. 35560-16-8); Dry Non-Melt
Fluoroelastomer Resin/Gum (containing: 1-Propene, 1,1,2,3,3,3-
hexafluoro-, polymer with 1,1- difluoroethene, CAS No. 9011-17-0; 1-
Propene, 1,1,2,3,3,3-hexafluoro-, polymer with 1,1- difluoroethene and
tetrafluoroethene, CAS No. 25190-89-0; 1-Propene, polymer with 1,1-
difluoroethene and tetrafluoroethene, CAS No. 54675-89-7; 1-Propene,
polymer with tetrafluoroethene, CAS No. 27029-05-6; Ethene,
tetrafluoro-, polymer with trifluoro(trifluoromethoxy) ethene, CAS No.
26425-79-6; Ethene, chlorotrifluoro-, polymer with 1,1-difluoroethene,
CAS No. 9010-75-7; fluoroelastomer, DCN 63040000018C; fluoroelastomer
DCN 63040000018D; and a low temperature fluoroelastomer, ACC 137678;
and, Aqueous Fluoropolymer Dispersions (containing: Ethene,
tetrafluoro-, homopolymer, CAS No. 9002-84-0; 1-Propene, 1,1,2,3,3,3-
hexafluoro-, polymer with tetrafluoroethene), CAS No. 25067-11-2;
Propane, 1,1,1,2,2,3,3-heptafluoro-3- [(trifluoroethenyl)oxy]-, polymer
with tetrafluoroethene, CAS No. 26655-00-5; 1-Propene, 1,1,2,3,3,3-
hexafluoro-, polymer with 1,1-difluoroethene and tetrafluoroethene, CAS
No. 25190-89-0; and polytetrafluoroethylene, DCN 63040000018B).
EPA uses a variety of numerical identification systems for tracking
chemicals. These include CAS numbers assigned to non-confidential
chemicals, premanufacture notice (PMN) numbers assigned by EPA when
chemicals enter EPA's new chemical review process, document control
numbers (DCN) assigned by the EPA OPPT's Confidential Business
Information Center for EPA tracking, and Accession (ACC) numbers
provided by EPA when a chemical identity listed on the TSCA Inventory
has been claimed as TSCA CBI. In addition, chemicals that qualify for a
reporting exemption under the Polymer Exemption Rule (40 CFR 723.250)
may have a commercial trade identity or an IES Method I (CAS Inventory
Expert Service) name assigned.
C. What Testing Does the ECA for FP Chemicals Require?
The ECA for laboratory-scale incineration testing of four
composites of FP chemicals requires environmental testing, as described
in Table 1 of this unit, which sets forth the required testing, test
standards, and reporting requirements for testing to be conducted under
the ECA.
The testing included in the ECA will be conducted in two segments,
as follows: Phase I--PFOA Transport Testing (Phase I) and Phase II--
Fluorotelomer Incineration Testing (Phase II). Phase I will consist of
quantitative transport efficiency testing for PFOA. At the conclusion
of Phase I, the Companies will provide EPA with a letter report
summarizing the results. In the event that the transport efficiency of
PFOA or total fluorine is equal to or greater than 70%, testing will
proceed to Phase II. In the event that the transport efficiency of PFOA
and total fluorine are both individually less than 70%, the Companies
will initiate a technical consultation with EPA to reach agreement on
how to proceed. The various outcomes of such a technical consultation
are laid out in Part VIII. of the ECA.
Under Phase II, elemental analysis, combustion stoichiometry,
thermogravimetric analysis, laboratory-scale combustion testing, and,
if required under the ECA (see Table 1, footnote 9 of this unit),
release assessment reporting will be performed for the four composites
of FP chemicals that are the subject of the ECA.
[[Page 39633]]
Table 1.--Required Testing, Test Standards, Reporting Requirements:
Phases of the Testing Program for the Incineration of FP Composites
------------------------------------------------------------------------
------------------------------------------------------------------------
Phase I
------------------------------------------------------------------------
PFOA Transport Testing Test standard/ Deadline \1\
Reporting (Days)
requirements
--------------------------------
Phase I Study Plan(s) 40 CFR 790.62 (b) 60 \3\
as annotated by
Part X. of the ECA
--------------------------------
Phase I Quality Assurance EPA Requirements 90 \3\
Project Plan(s) for Quality
Assurance Project
Plans (QA/R5) \10\
--------------------------------
Quantitative PFOA transport Appendix C.1. of 240 \4,5\
testing \2\ the ECA
--------------------------------
Phase II
------------------------------------------------------------------------
Fluoropolomer Incineration Test standard/ Deadline \1\
Testing Reporting (Days)
requirements
--------------------------------
Phase II Study Plan(s) 40 CFR 790.62 (b) 180 \3\
as annotated by
Part X. of the ECA
--------------------------------
Phase II Quality Assurance EPA Requirements 360 \3\
Project Plan(s) for Quality
Assurance Project
Plans (QA/R5) \10\
--------------------------------
Receipt of composite components Part XXIV. and 180 \7\
by designated facility(ies) Appendix A.3. of
the ECA
--------------------------------
Elemental Analysis \6\ Appendix C.2.1. of 450 \8\
the ECA
--------------------------------
Combustion Stoichiometry \6\ Appendix C.2.2. of 450 \8\
the ECA
--------------------------------
Thermogravimetric Analysis \6\ ASTM E1868-02, as 450 \8\
modified in
Appendix B.1. of
the ECA
--------------------------------
Laboratory-scale Combustion Appendices C.2.4. 450 \8\
Testing \6\ and C.2.5., as
annotated/
supplemented by
Appendices D.1.,
D.2., D.3., and
D.4. of the ECA
--------------------------------
Release Assessment Report Appendix E.2. of 450 \9\
the ECA
------------------------------------------------------------------------
\1\ Number of days, starting with the day following the event starting
the time period in question. Interim progress reports must be
submitted by the Companies to EPA every 180 days beginning 180 days
from July 8, 2005, until the end of the ECA testing program (see Part
XIV. and Appendix E.1. of the ECA).
\2\ At the conclusion of Phase I, and prior to initiation of Phase II,
the Companies will provide a letter report to EPA summarizing the
results of Phase I testing (see Part VII.A. of the ECA). In the event
that the transport efficiency of PFOA or of total fluorine (as
determined by the formulas in Appendix C.1. of the ECA) is greater
than or equal to 70%, then the Companies will proceed to Phase II. In
the event that the transport efficiency of PFOA and of total fluorine
(as determined by the formulas in Appendix C.1. of the ECA) are both
individually less than 70% then the Companies will initiate a
Technical Consultation with EPA. The outcomes of the Technical
Consultation are described in Part VIII. of the ECA.
\3\ Number of days after July 8, 2005, when submission is due.
\4\ Number of days after EPA approval of the Study Plan(s) and QAPP(s)
for Phase I testing when a letter report describing transport
efficiency test result(s) and any contingency testing performed is due
to EPA (see Part VII.A. and Appendix C.1.3. of the ECA). If the Study
Plan(s) and QAPP(s) are not approved by EPA within 60 days of
submission of the Phase I QAPP(s), then this deadline is extended by
180 days to accommodate re-scheduling with the thermal reactor system
laboratory.
\5\ The final report for Phase I will be submitted to EPA within 60 days
of the completion of the Technical Consultation if the consultation
does not result in an agreement to conduct further testing. If the
Technical Consultation results in an agreement to conduct further
testing, the final report for Phase I will be included in the final
report for such further testing, unless agreed otherwise in the
Technical Consultation (see Part VIII. of the ECA).
\6\ The results of this testing will be provided in the final report for
Phase II (see Appendix C.2.5. and Appendix E.3. of the ECA).
\7\ Number of days from the submission of the Phase I letter report
signifying that Phase II can proceed and the approval by EPA of the
Phase II QAPP(s) that the Companies must meet their individual
obligations to provide the designated facility(ies) with the
components for each composite to be tested under the ECA (see Part
III.B. of the ECA). If Phase II is required by Technical Consultation
agreement (see footnote 2 of this table ), the deadline shall be as
agreed in the Technical Consultation.
\8\ Number of days from the date of the final report from the ECA for
the Laboratory-Scale Incineration Testing of Fluorotelomer-Based
Polymers (published elsewhere in this Federal Register (EPA Docket ID
number OPPT-2004-0001)) and the approval of study plan(s) and QAPP(s)
for Phase II testing when this report is due, if all components of
each composite are received, or EPA determines that testing shall
proceed with a partial composite(s) (see Part III.B. of the ECA). An
extension of the deadline for submitting the final report from the ECA
for the Laboratory-Scale Incineration Tesing of Fluorotelomer-Based
Polymers does not extend this deadline, unless expressly so provided.
\9\ In the event that Phase II laboratory-scale incineration testing
identifies measurable levels of PFOA resulting from the incineration
testing for any or all of the fluoropolymer composites tested under
the ECA, as defined in Appendix C.2.5.5. of the ECA, the Companies
will prepare a Release Assessment Report to place in perspective the
relevance of such measurable levels in the laboratory-scale
incineration testing results with respect to full-scale municipal and/
or medical waste incinerator operations in the United States. If
required, the Release Assessment Report will be submitted in
conjunction with the Final Report for Phase II testing (see footnotes
6 and 8 of this table ).
\10\ Guidance for developing Quality Assurance Project Plans can be
found in the EPA document EPA QA/R-5: EPA Requirements for Quality
Assurance Project Plans, prepared by: Office of Environmental
Information, EPA, March 2001. This is also available from the EPA
website at https://epa.gov/quality/qs-docs.
D. What are the Uses for the Test Data to be Developed Under the ECA?
EPA will use the data obtained from the testing to be conducted
under the ECA to assess the potential for waste incineration of FPs to
emit PFOA. This analysis will be based on quantitative determination of
potential exhaust-gas levels of PFOA that may emanate from laboratory-
scale combustion testing under conditions representative of typical
municipal and/or medical waste
[[Page 39634]]
combustor operations in the United States. The data could provide EPA
with an understanding of whether the incineration of FPs is a source
and/or pathway for environmental and human exposure to PFOA.
These data could also be used to inform screening level human and
environmental exposure assessments. In addition, the data could be used
by other Federal Agencies (e.g., the Agency for Toxic Substances and
Disease Registry (ATSDR), the National Institute for Occupational
Safety and Health (NIOSH), the Occupational Safety and Health
Administration (OSHA), the Consumer Product Safety Commission (CPSC),
and the Food and Drug Administration (FDA)) in assessing chemical risks
and in taking appropriate actions within their programs.
IV. Other Impacts of the ECA
A. What if EPA Should Require Additional Environmental Testing on FP
Chemicals?
If EPA decides in the future that it requires additional data on
FPs, the Agency would initiate a separate action.
B. How Does the Order Affect TSCA Export Notification?
As of the effective date of the ECA and the Order that incorporates
the ECA under TSCA section 4 (i.e., the date of publication of this
document in the Federal Register) any of the Companies, as well as any
other person, who exports or intends to export any of the four
formulated composites of FP chemicals that are the subject of this ECA
and Order that incorporates the ECA, in any form, are subject to the
export notification requirements of TSCA section 12(b). Procedures
related to export notification are described in 40 CFR part 707,
subpart D. EPA maintains lists of all chemical substances and mixtures
with CAS numbers (40 CFR 799.5000) and without CAS numbers (40 CFR
799.5025) that are subject to testing consent orders. This document
will add the four formulated composites of FP chemicals that are the
subject of this ECA and Order that incorporates the ECA to the list at
40 CFR 799.5025.
Notice and comment rulemaking is not needed to add these chemical
substances to the list at 40 CFR 799.5025 because the export
notification requirements are imposed by statute. Section 12(b) of TSCA
requires any person who exports or intends to export to a foreign
country a chemical substance or mixture for which the submission of
data is required under TSCA section 4 to submit a notification of the
export or intended export to EPA. An ECA is an action under TSCA
section 4 requiring the submission of data. 40 CFR 790.1. Accordingly,
EPA's ECA regulations require that each ECA contain a statement that
manufacturers or processors signing the ECA, as well as any other
person, shall comply with export notification requirements in TSCA
section 12(b). 40 CFR 790.60(a)(11). The four formulated composites of
FP chemicals identified in this document are subject to an Order
incorporating an ECA. EPA finds that notice and an opportunity for
comment is unnecessary to implement the export notification
requirements in TSCA section 12(b) for the reasons stated in this unit.
For chemical substances and mixtures subject to other Orders
incorporating ECAs that were issued in the past, EPA initiated separate
rulemakings to amend the lists at 40 CFR 799.5000 and 40 CFR 799.5025,
thereby affording the public a comment opportunity as well as notifying
the public of the existence of an ECA. EPA took this step to ensure
that those companies not a party to the ECA or Order noticed their need
to comply with TSCA section 12(b). However, EPA now believes that a
separate rulemaking or an opportunity to comment on the implementation
of the statutory mandate is not necessary.
C. What are the Economic Impacts of the ECA?
Based on the economic analysis conducted for the ECA, the Agency
expects the cost of the testing to be performed under this ECA to range
from $100,000 to $150,000. This estimate is based on a contact report
of an inquiry directed to a university laboratory conducting thermal
``burn'' test research. The estimated total cost for industry to
conduct the required testing under the ECA is $150,000, which is the
upper end of the estimated cost range. EPA anticipates that the costs
for testing under this ECA will have a low potential for adverse
economic impact on the regulated community because the costs for
testing will be shared across four companies who are signatories to the
ECA and the Order that incorporates the ECA.
Export regulations promulgated pursuant to section 12(b) of TSCA--
40 CFR part 707, subpart D--require only a one-time notification to
each foreign country of export for each chemical for which data are
required under section 4 of TSCA. In an analysis of the economic
impacts of the July 27, 1993, amendment to the rules implementing
section 12(b) of TSCA (58 FR 40238), EPA estimated that the one-time
cost of preparing and submitting the TSCA section 12(b) notification
for a first- time submitter of any TSCA section12(b) notification was
$62.60 (Ref. 13). When inflated from 1992 to 2004 dollars (4thQ) by a
factor of 1.538 using the Employment Cost Index for White Collar
Occupations (Ref. 14), the current cost is estimated to be $96.12, or a
burden of 1.5 hours, for a first-time submitter. An exporter who had
previously submitted a 12(b) notification for any chemical/country
combination would incur an estimated cost of $31.72 for preparing and
submitting a TSCA section 12(b) notification, based on the burden
estimate of .5 hours.
V. References
1. U.S. Environmental Protection Agency (EPA). Charles M. Auer.
Memorandum to Oscar Hernandez, Mary Ellen Weber, and Ward Penberthy
regarding revision of PFOA Hazard Assessment and Next Steps. September
27, 2002. Available from the EPA Administrative Record as AR 226-1127.
2. EPA. Draft Risk Assessment of the Potential Human Health Effects
Associated with the Exposure to Perfluorooctanoic Acid and its Salts.
January 4, 2005. p. 117. Available from EPA website, https://
www.epa.gov/oppt/pfoa/.
3. EPA. Science Advisory Board (SAB) Staff Office; Notification of
Upcoming Meetings of the Science Advisory Board Perfluorooctanoic Acid
Risk Assessment (PFOA) Review Panel. Federal Register (70 FR 2157-2158,
January 12, 2005) (FRL-7860-5).
4. 3M Company, Dr. Larry Wending. Letter of Intent to Stephen L.
Johnson, USEPA, to continue ongoing environmental, health and safety
measures by Company relating to Perfluorooctanoic Acid and its Salts
(PFOA). March 13, 2003. Available from EPA EDOCKET as OPPT-2003-0012-
0007.
5. The Society of the Plastics Industry, Inc., Donald K. Duncan.
The Ammonium Perfluorooctanoate (APFO) Users. Letters of Intent to
Stephen L. Johnson, EPA, regarding responsive Voluntary Actions by
parties to evaluate and control emissions of Ammonium
Perfluorooctanoate (APFO). March 14, 2003. Available from EPA EDOCKET
as OPPT-2003-0012-0012.
6. Telomer Research Program (TRP) Member Companies. Letter of
Intent to Stephen L. Johnson, EPA, regarding addressing concerns raised
by EPA about the possible association of Perfluoroctanoic Acid (PFOA)
with telomer-based products. March 14, 2003. Available from EPA EDOCKET
as OPPT-2003-0012-0013.
[[Page 39635]]
7. APFO Users, Telomer Companies, and The 3M Company. Letter of
Intent to Stephen L. Johnson, USEPA, regarding commitment by Companies
to assist the Environmental Protection Agency (EPA) in its
investigation of Perfluorooctanoic Acid (PFOA) and Ammonium
Perfluorooctanoate (APFO). March 31, 2003. Available from EPA EDOCKET
as OPPT-2003-0012-0016.
8. EPA. Preliminary Framework for Enforceable Consent Agreement
(ECA) Data Development for PFOA and Telomers. May 20, 2003. Available
from EPA EDOCKET as OPPT-2003-0012-0056.
9. Fluoropolymer Manufacturer's Group. Incineration Research
Approach. Presentation to the Fluoropolymer Technical Workgroup. July
8, 2003. p. 3. Available from EPA EDOCKET as OPPT-2003-0071-0009.
10. EPA. EPA ECA Proposal for Fluoropolymer Incineration Testing.
Presentation to the Fluoropolymer Technical Workgroup. July 8, 2003. p.
2. Available from EPA EDOCKET as OPPT-2003-0071-0009.
11. EPA. PFOA ECA Fluoropolymer Technical Workgroup Meeting
Summary. March 31, 2004. p. 11. Available from EPA EDOCKET as OPPT-
2003-0071-0103.
12. EPA. Enforceable Consent Agreement Development for
Perfluorooctanoic Acid (PFOA) and Fluorinated Telomers. Public Meeting
Summary. April 1, 2004. p. 6. Available from EPA EDOCKET as OPPT-2003-
0071-0106.
13. EPA. Economic Analysis in Support of the Final Rule Promulgated
under TSCA Section 12(b). William Silagi. EPA/OPPT/RIB. Washington, DC.
June 1992.
14. Bureau of Labor Statistics (BLS). 2003. Employment Cost Index,
Total Compensation: White-Collar Occupations (Series ID: ECS11102I),
https://data.bls.gov/cgi-bin/srgate, extracted February 9, 2005.
15. EPA. Wendy Hoffman. Memorandum to Richard Leukroth regarding
calculation of Paperwork Reduction Act burden estimate for the
incineration ECAs. October 20, 2004. Available from EPA EDOCKET as
OPPT-2003-0071-0007.
16. EPA. Lynne Blake-Hedges. Memorandum to EPAB Staff on Unit
Burden Estimates for 12(b) Export Notification for Section 4 Test Rules
and Enforceable Consent Agreements (ECAs). July 20, 1999.
17. ASTM. Standard Test Method for Loss-On Drying by
Thermogravimetry. 2002 Annual Book of ASTM Standards. Volume 14.02,
Designated E 1868-02. pp. 635-638. August 10, 2002.
VI. Statutory and Executive Order Reviews
A. Executive Order 12866
This action announces an Order that incorporates an ECA between EPA
and the Companies. Under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993), this action is not
a ``regulatory action'' subject to review by the Office of Management
and Budget (OMB).
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an agency may not conduct or sponsor, and a person is not
required to respond to, an information collection request unless it
displays a currently valid control number assigned by OMB. The OMB
control numbers for the EPA's regulations in title 40 of the CFR are
listed in 40 CFR part 9.
The information collection requirements related to the Order that
incorporates the ECA have already been approved by OMB pursuant to the
PRA under OMB control number 2070-0033 (EPA ICR No. 1139). The one-time
public burden for this collection of information is estimated to be
approximately 433 hours per response (i.e., per company), or 1,732
hours total burden for the four companies (Ref. 15). Under the PRA,
``burden'' means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal Agency. For this collection, it
includes the time needed to review instructions; complete and review
the collection of information; and transmit or otherwise disclose the
information.
The information collection requirements related to export
notification requirements under section 12(b) of TSCA, including those
related to the ECA and the Order that incorporates the ECA, have
already been approved by OMB pursuant to PRA under OMB control number
2070-0030 (EPA ICR No. 0795). The public reporting burden for this
information collection is estimated to be between .5 hours to 1.5 hours
per response. The lower estimate applies to companies that have
previously submitted a TSCA section 12(b) notification for any chemical
or mixture, and therefore need only update an existing form letter
assumed to have been generated electronically. The higher estimate
applies to companies that are first-time submitters of a TSCA section
12(b) notification (Ref. 16), and therefore need to write an initial
letter.
C. Regulatory Flexibility Act
Since the issuance of the ECA and the Order that incorporates the
ECA, as well as the applicability of the export notification
requirements of TSCA section 12(b) to chemicals addressed in the ECA
and the Order that incorporates the ECA, do not require the issuance of
a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.) do not apply.
D. Unfunded Mandates Reform Act
This action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public Law 104-4. Therefore, this action is
not subject to the requirements of UMRA.
E. Executive Order 13132 and 13175
This action is not expected to impact State or Tribal governments
because these governments are not expected to export the chemicals
covered by the ECA or the Order that incorporates the ECA. As such, the
Agency has determined that this Action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Nor will this action have Tribal implications because it does
not significantly or uniquely affect the communities of Indian Tribal
governments, or involve or impose any requirements that affect Indian
Tribes. Accordingly, the requirements of Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000), do not apply.
F. Executive Order 13045
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 1985, April 23,
1997), does not apply to this action because this action is not
designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866 (see Unit VI.A.), nor does this action
establish an environmental standard that is intended to have a
disproportionate effect on children. To the contrary, this action will
provide data and information that EPA and others can use to assess the
risks of these chemicals, including potential risks to sensitive
subpopulations.
[[Page 39636]]
G. Executive Order 13211
This action is not subject to Executive Order 13211,
entitledActions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this
action is not expected to affect energy supply, distribution, or use.
H. National Technology Transfer Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113 section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
The testing conducted under the ECA involves technical standards.
The Agency conducted a search to identify potentially applicable
voluntary consensus standards. No such standard was identified for
incineration testing of FP chemicals that are the subject of the ECA.
However, EPA identified a voluntary consensus standard for
thermogravimetric analysis (Ref. 17), which is a required element of
the Phase II ECA testing. Appendix B.1. of the ECA describes specific
modifications to this voluntary consensus standard that are needed to
take into consideration the unique properties of FP chemicals.
----------------------------------------------------------------------------------------------------------------
Guideline No. (Year) Guideline name TSCA Guideline No. OECD Guideline No.
----------------------------------------------------------------------------------------------------------------
ASTM E 1868-02 (August 10, 2002) Standard Test Method None None
for Loss-On-Drying by
Thermo-gravimetry
----------------------------------------------------------------------------------------------------------------
I. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
List of Subjects in Part 799
Environmental protection, Chemicals, Exports, Hazardous substances,
Health, Laboratories, Reporting and recordkeeping requirements.
Dated: June 28, 2005.
Margaret Schneider,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
0
Therefore, 40 CFR Chapter I is amended as follows:
PART 799--[AMENDED]
0
1. The authority citation for part 799 continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
0
2. Section 799.5025 is amended by adding the following entry to the
table in alphabetical order, to read as follows:
Sec. 799.5025 Testing consent orders for mixtures without Chemical
Abstracts Service Registry Numbers.
* * * * *
------------------------------------------------------------------------
Mixture/substance Required test FR citation
------------------------------------------------------------------------
* * * * * * *
Fluoropolymer composite ..................
substance:
(1) For Dry Non-Melt Resin ..................
containing the following
chemical substances as
specified in the ECA:
(i) Ethene, tetrafluoro-, Environmental July 8, 2005.
homopolymer, CAS No. 9002- effects.
84-0
(ii) ......do.......... Do.
Polytetrafluoroethylene,
Document Control Number
(DCN) 63040000018A
(iii) Propane, 1,1,1,2,2,3,3- ......do.......... Do.
heptafluoro-3-
[(trifluoroethenyl)oxy]-,
polymer with
tetrafluoroethene, CAS No.
26655-00-5
(2) For Dry Melt Fluoropolymer ..................
Resin containing the
following chemical substances
as specified in the ECA:
(i) 1-Propene, 1,1,2,3,3,3- ......do.......... Do.
hexafluoro-, polymer with
tetrafluoroethene, CAS No.
25067-11-2
(ii) Propane, 1,1,1,2,2,3,3- ......do.......... Do.
heptafluoro-3-
[(trifluoroethenyl)oxy]-,
polymer with
tetrafluoroethene, CAS No.
26655-00-5
(iii) Ethene, tetrafluoro-, ......do.......... Do.
polymer with
trifluoro(pentafluoroethoxy
)ethene, CAS No. 31784-04-0
(iv) 1-Propene, 1,1,2,3,3,3- ......do.......... Do.
hexafluoro-, polymer with
1,1-difluoroethene and
tetrafluoroethene, CAS No.
25190-89-0
(v) ETFE, DCN 63040000026 ......do.......... Do.
(vi) 1-Propene, 1,1,2,3,3,3- ......do.......... Do.
hexafluoro-, polymer with
ethene and
tetrafluoroethene, CAS No.
35560-16-8
(3) For Dry Non-Melt ..................
Fluoroelastomer Resin/Gum
containing the following
chemical substances as
specified in the ECA:
(i) 1-Propene, 1,1,2,3,3,3- ......do.......... Do.
hexafluoro-, polymer with
1,1- difluoroethene, CAS
No. 9011-17-0
(ii) 1-Propene, 1,1,2,3,3,3- ......do.......... Do.
hexafluoro-, polymer with
1,1- difluoroethene and
tetrafluoroethene, CAS No.
25190-89-0
(iii) 1-Propene, polymer ......do.......... Do.
with 1,1- difluoroethene
and tetrafluoroethene, CAS
No. 54675-89-7
(iv) 1-Propene, polymer with ......do.......... Do.
tetrafluoroethene, CAS No.
27029-05-6
(v) Ethene, tetrafluoro-, ......do.......... Do.
polymer with
trifluoro(trifluoromethoxy)
ethene, CAS No. 26425-79-6
[[Page 39637]]
(vi) Ethene, chlorotrifluoro- ......do.......... Do.
, polymer with 1,1-
difluoroethene, CAS No.
9010-75-7
(vii) Fluoroelastomer, DCN ......do.......... Do.
No. 63040000018C
(viii) Fluoroelastomer DCN ......do.......... Do.
63040000018D
(ix) A low temperature ......do.......... Do.
fluoroelastomer, ACC No.
137678
(4) For Aqueous Fluoropolymer ..................
Dispersions containing the
following chemical substances
as specified in the ECA:
(i) Ethene, tetrafluoro-, ......do.......... Do.
homopolymer, CAS No. 9002-
84-0
(ii) 1-Propene, 1,1,2,3,3,3- ......do.......... Do.
hexafluoro-, polymer with
tetrafluoroethene, CAS No.
25067-11-2
(iii) Propane, 1,1,1,2,2,3,3- ......do.......... Do.
heptafluoro-3-
[(trifluoroethenyl)oxy]-,
polymer with
tetrafluoroethene, CAS No.
26655-00-5
(iv) 1-Propene, 1,1,2,3,3,3- ......do.......... Do.
hexafluoro-, polymer with
1,1-difluoroethene and
tetrafluoroethene, CAS No.
25190-89-0
(v) Polytetrafluoroethylene, ......do.......... Do.
DCN No. 63040000018B
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 05-13493 Filed 7-7-05; 8:45 am]
BILLING CODE 6560-50-S
