[Federal Register Volume 70, Number 130 (Friday, July 8, 2005)]
[Rules and Regulations]
[Pages 39630-39637]
From the Federal Register Online via the Government Publishing 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 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 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: [email protected].
    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: [email protected].
    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: [email protected].
    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: 
[email protected] or Laura L. Bunte, Chemical Control Division 
(7405M); telephone number: (202) 564-8087; fax number: (202) 564-4765; 
e-mail address: [email protected].
    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 (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 799 
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
Information on TSCA 12(b) export notification (40 CFR part 707) is 
available at http://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 http://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, http://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), 
http://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