[Federal Register: May 25, 2007 (Volume 72, Number 101)]
[Rules and Regulations]
[Page 29276-29277]
[DOCID:fr25my07-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1989-0011; FRL-8317-5]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List

AGENCY: Environmental Protection Agency.

ACTION: Notice of partial deletion of the rocky flats plant from the
national priorities list.

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SUMMARY: The United States Environmental Protection Agency (EPA) Region
8 announces the deletion of the Peripheral Operable Unit (OU) of the
Department of Energy (DOE) Rocky Flats Plant and Operable Unit 3 (OU
3), also referred to as the Offsite Areas, encompassing approximately
25,413 acres, from the National Priorities List (NPL). The NPL
constitutes Appendix B of 40 CFR part 300, which is the National Oil
and Hazardous Substances Pollution Contingency Plan (NCP), which EPA
promulgated pursuant to Section 105 of the Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA). Rocky Flats Plant
means the property owned by the United States Government, also known as
Rocky Flats, Rocky Flats Site, or Rocky Flats Environmental Technology
Site (RFETS) as shown in figure 1. The Rocky Flats Plant is divided
into the Central and Peripheral Operable Units (Figure 2) which contain
1,308 and 4,933 acres, respectively, and OU 3 (Figure 3) which contains
approximately 20,480 acres. The 3 referenced figures are available in
the http://www.regulations.gov index identified by Docket ID no. EPA-

HQ-SFUND-1989-0011.
    EPA and the State of Colorado, through the Colorado Department of
Public Health and Environment (CDPHE), have determined that the
Peripheral OU of the Rocky Flats Plant and OU 3 (Offsite Areas) poses
no significant threat to public health or the environment and,
therefore, no further remedial measures pursuant to CERCLA are
appropriate.
    This partial deletion pertains to the surface media (soil, surface
water, sediment) and subsurface media, including groundwater, within
the Peripheral OU and OU 3 of the Rocky Flats Plant. The Central OU
will remain on the NPL.

DATES: This partial deletion of the Peripheral OU and OU 3 is effective
on May 25, 2007.

FOR FURTHER INFORMATION CONTACT: Rob Henneke, Community Involvement
Coordinator (8OC), U.S. Environmental Protection Agency, Region 8, 1595
Wynkoop Street, Denver, Colorado, 80202-1129; telephone number: 1-800-
227-8917 or<PHONE_NUMBER>, fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: The Rocky Flats Plant is a DOE facility
owned by the United States. Rocky Flats is located in the Denver
metropolitan area, approximately sixteen miles northwest of Denver,
Colorado, and ten miles south of Boulder, Colorado. Nearby communities
include the Cities of Arvada, Broomfield, and Westminster, Colorado.
The majority of the Site is located in Jefferson County, with a small
portion located in Boulder County, Colorado.
    Two OUs are present within the boundaries of the Site (the
Peripheral OU and the Central OU), while OU 3 (Offsite Areas)
encompasses property north, south, and primarily east of the Peripheral
and Central OUs. This partial deletion pertains to the surface media
(soil, surface water, sediment) and subsurface media, including
groundwater, within the Peripheral OU and OU 3. The Central OU is not
included within this partial deletion action and will remain on the
NPL.
    On March 13, 2007, EPA published a Notice of Intent for Partial
Deletion in the Federal Register (72 FR 11313) and local newspapers,
announcing a thirty day public comment period, which proposed to delete
the Peripheral OU and OU 3 from the NPL. Comments were received in the
form of letters from CDPHE dated April 3, 2007 and from the City and
County of Broomfield and City of Westminster, both April 12, 2007. The
letters from the two cities were identical in terms of the comments
each made. In all instances the state and the cities support the
actions proposed in the notice of intent for partial deletion, however,
the cities have other comments in their identical letters.
    The following are comments from the City and County of Broomfield
and City of Westminster regarding the points-of-compliance as
summarized:
    Broomfield/Westminster described that ``this partial deletion
pertains to the surface media (soil, surface water, sediment) and
subsurface media, including groundwater, within the Peripheral OU and
OU 3 of the Rocky Flats Plant. The point-of-compliance for the Central
OU is located within the Peripheral OU. The partial deletion assumes
all surface water leaving the Central OU flowing through the Peripheral
OU will meet surface water quality standards at the site boundary.
There is a potential for the drainages to become contaminated by
contaminated surface water or contaminated sediment flowing through the
drainages.''
    Broomfield/Westminster also added that ``language in the Federal
Register states the Department of Energy (DOE) will be responsible for
all future remedial actions required at the area deleted if future site
conditions warrant such actions. We support the language in the Federal
Register. Our concern is the Department of Energy will only be
evaluating surface water quality for uranium, plutonium, and americium
as it flows from the Central OU. Other potential analytes that could be
considered contaminants will not be evaluated to determine potential
impacts to surface water or the drainages within the Peripheral OU.''
    In the Responsiveness Summary, EPA explained that DOE is required
to evaluate uranium, plutonium and

americium at five locations: The terminus of the A-series ponds (GS11
at the outfall of terminal pond A-4); the terminus of the B-series
ponds (GS08 at the outfall of terminal pond B-5); the outfall of
terminal pond C-2 (GS31), all of which are in the Central OU (DOE
retained land); where Woman Creek meets Indiana (GS01); and where
Walnut Creek meets Indiana (GS03). Prior to any release from the
terminal ponds DOE is required to take pre-discharge samples. These
samples include the three radionuclides mentioned above as well as
nitrates. Based on extensive sampling throughout the life of the
cleanup project these are the only constituents requiring ongoing
evaluation at these locations. We have not found other constituents in
the surface water at levels that exceed cleanup standards. Moreover,
the Comprehensive Risk Assessment for Human Health and Ecological risk
determined that the Peripheral OU is suitable for all uses. Therefore,
monitoring of additional constituents is not needed in the Peripheral
OU in order to protect human health and the environment.
    Broomfield/Westminster ``are concerned that previous closure
documents did not address how the points-of compliance would be secured
and controlled if they are not in an area located within DOE's
jurisdiction. It is very important to us, as a downstream community, to
ensure the integrity of the monitoring stations within the deleted area
are maintained and secured.''
    In the Responsiveness Summary, EPA explained that the CAD/ROD
requires that DOE retain points-of-compliance in surface water at
discharge points from the three terminal ponds (A-4, B-5 and C-2), as
well as at the points-of-compliance near Indiana Street. DOE's
operation and maintenance responsibilities require that the monitors
remain secure and in working order. A feature of the compliance
monitoring system is that automatic alerts are sent to DOE personnel
who are responsible for operation and maintenance of the monitors
anytime there is a malfunction with the equipment. Because of this
feature, problems with the monitors are immediately identified and
corrected. As a part of operation and maintenance activities, the
Parties will determine if additional security measures to protect these
monitoring locations are needed.
    Broomfield/Westminster ``believe the protection of the monitoring
stations within the proposed deleted area is a significant and valid
concern because there were no institutional controls identified to
protect the only enforceable monitoring stations at the site. EPA
should be responsive and proactive and identify how these stations will
be controlled and protected to prevent access to the general public. It
is not good management to develop a protocol to protect the monitoring
stations after their integrity has been jeopardized.''
    In the Responsiveness Summary, EPA agrees that protection of the
monitoring stations at the site is important. Security of these
monitoring stations has not been a problem in the past. The DOE, State,
and EPA agree to review any future changes to the current uses and
activities that could jeopardize the integrity of the monitors. Since
DOE personnel receive automatic alerts whenever there are performance
problems with the compliance monitors, implementation of other security
measures is not necessary. The purpose of these monitors is to take
samples during run-off events and the likelihood of tampering with the
monitors during these events is less than the chances of failure
occurring due to equipment break down. In either case, DOE personnel
will be notified immediately and steps taken to correct the problems.
Addition of security measures as suggested by Broomfield and
Westminster will not add appreciably to the reliability of the monitors
to take samples when flow events dictate.
    EPA identifies sites that appear to present a significant risk to
public health, welfare, or the environment and maintains the NPL as the
list of those sites. Any site deleted from the NPL remains eligible for
Fund-financed actions in the unlikely event that conditions at the site
warrant such action. Section 300.425(e)(3) of the NCP states that Fund-
financed actions may be taken at sites deleted from the NPL. Deletion
of a site from the NPL does not affect responsible party liability or
impede Agency efforts to recover costs associated with response
efforts.

Lists of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: May 16, 2007.
Robert E. Roberts,
Regional Administrator, Region 8.

0
For the reasons set forth in the preamble title 40 part 300 of the Code
of Federal Regulations is amended as follows.

PART 300--[AMENDED]

0
1. The authority citation for part 300 continues to read as follows:

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR 1987 Comp., p. 193.

Appendix B--[Amended]

0
2. Table 2 of appendix B to part 300 is amended by revising the entry
for ``Rocky Flats Plant (USDOE)'' by adding a note ``P'' so that it
reads as follows:

Appendix B to Part 300--National Priorities List

                                      Table 2.--Federal Facilities Section
----------------------------------------------------------------------------------------------------------------
                State                          Site name                     City/county               Notes a
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
CO..................................  Rocky Flats Plant (USDOE)..  Jefferson and Boulder Counties.            P

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\a\ * * *
* * * * * * *
P = Sites with partial deletion(s).

 [FR Doc. E7-10055 Filed 5-24-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: March 21, 2008 (Volume 73, Number 56)]
[Rules and Regulations]
[Page 15079-15080]
[DOCID:fr21mr08-12]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 3

[USCG-2008-0073]
RIN 1625-ZA15

Sector Anchorage Western Alaska Marine Inspection and Captain of
the Port Zones; Technical Amendment

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: This rule makes a technical change in the boundary description
of the Western Alaska Marine Inspection and Captain of the Port Zones,
within the Seventeenth Coast Guard District's Sector Anchorage. This
rule will have no substantive effect on the regulated public.

DATES: This final rule is effective March 21, 2008.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2008-0073 and are available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. You may also find this
docket on the Internet at www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call Commander Todd Styrwold, Coast Guard, telephone<PHONE_NUMBER>. If
you have questions on viewing the docket, call Ms. Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory History

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under both 5 U.S.C. 553(b)(A) and (b)(B), the Coast Guard
finds that this rule is exempt from notice and comment rulemaking
requirements because this change involves agency organization, and good
cause exists for not publishing an NPRM because the change made is non-
substantive. This rule only aligns regulatory language with existing
Coast Guard internal documents that establish the boundaries of the
affected zones. The change will have no substantive effect on the
public; therefore, it is unnecessary to publish an NPRM. Under 5 U.S.C.
553(d)(3), the Coast Guard finds that, for the same reasons, good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register.

Background and Purpose

    In the Federal Register of July 2, 2007 (72 FR 36318), the Coast
Guard issued a final rule to align various regulations with internal
documents establishing a new system of sector commands. The regulation
describing the boundaries of the Western Alaska Marine Inspection and
Captain of the Port Zones, within the Seventeenth Coast Guard
District's Sector Anchorage, contained an error. Due to the length of
time since the erroneous description was issued, the Coast Guard is
issuing a technical amendment, instead of a correction notice, to
correct the description. The correction is informational and will have
no substantive effect on the regulated public.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. As this rule involves internal agency
organization and non-substantive changes, it will not impose any costs
on the public.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
This rule does not require a general NPRM and, therefore, is exempt
from the requirements of the Regulatory Flexibility Act. Although this
rule is exempt, we have reviewed it for potential economic impact on
small entities.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies. This rule does not use technical standards.
Therefore, we did not consider the use of voluntary consensus
standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD,
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded that there are no factors in this case that would limit
the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(a) and (b), of the Instruction from further
environmental documentation because this rule involves editorial,
procedural, and internal agency functions. A final ``Environmental
Analysis Check List'' and a final ``Categorical Exclusion
Determination'' are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 3

    Organization and functions (Government agencies).

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 3 as follows:

PART 3--COAST GUARD AREAS, DISTRICTS, SECTORS, MARINE INSPECTION
ZONES, AND CAPTAIN OF THE PORT ZONES

0
1. The authority citation for part 3 continues to read as follows:

    Authority: 14 U.S.C. 92; Pub. L. 107-296, 116 Stat. 2135;
Department of Homeland Security Delegation No. 0170.1, para. 2(23).

0
2. Amend Sec.  3.85-15 by revising paragraph (a) to read as follows:

Sec.  3.85-15  Sector Anchorage: Western Alaska Marine Inspection Zone
and Captain of the Port Zones; Marine Safety Unit Valdez: Prince
William Sound Marine Inspection and Captain of the Port Zones.

* * * * *
    (a) Sector Anchorage's Western Alaska Marine Inspection and Captain
of the Port Zones start near the Canadian border on the EEZ at latitude
60[deg]18'24'' N, longitude 141[deg]00'00'' W, proceeding southwest to
latitude 60[deg]01'18'' N, longitude 142[deg]00'00'' W; thence south to
the outermost extent of the EEZ at latitude 56[deg]14'50'' N, longitude
142[deg]00'00'' W; thence southwest along the outermost extent of the
EEZ to latitude 51[deg]22'15'' N, longitude 167[deg]38'28'' E; thence
northeast along the outermost extent of the EEZ to latitude
65[deg]30'00'' N, longitude 168[deg]58'37'' W; thence north along the
outermost extent of the EEZ to latitude 72[deg]46'29'' N, longitude
168[deg]58'37'' W; thence northeast along the outermost extent of the
EEZ to latitude 74[deg]42'35'' N, longitude 156[deg]28'30'' W; thence
southeast along the outermost extent of the EEZ to latitude
72[deg]56'49'' N, longitude 137[deg]34'08'' W; thence south along the
outermost extent of the EEZ to the coast near the Canadian border at
latitude 69[deg]38'48.88'' N, longitude 140[deg]59'52.7'' W; thence
south along the United States-Canadian boundary to the point of origin;
and in addition, all the area described in paragraph (b) of this
section.
* * * * *

    Dated: March 18, 2008.
Steve Venckus,
Chief, Office of Regulations and Administrative Law (CG-0943).
[FR Doc. E8-5775 Filed 3-20-08; 8:45 am]

BILLING CODE 4910-15-P


Mary Dominiak 09/ 12/ 2003 12: 12 PM To: mary dominiak cc: cc: Subject: PFOA ECA Expert Subgroup Meeting Summaries, 8/ 14 15/ 03, 8/ 19 21/ 03 You are receiving this message because you have expressed an interest in receiving information concerning the Agency's enforceable consent agreement ( ECA) process on perfluorooctanoic acid ( PFOA) and the fluorinated telomers, OPPT 2003 0012. If you no longer wish to receive this information, please reply to dominiak. mary@ epa. gov requesting that you be removed from this notification list.

**************************************************************************************** TO: PFOA ECA Technical Workgroup and Plenary Meeting Attendees Attached are summaries of the PFOA ECA Technical Expert Subgroup meetings held on August 14, 15, 19, 20, and 21, 2003.

Copies of these summaries have been submitted to the docket. If you have any comments on the accuracy of the summaries, please direct them to me. If corrections to a meeting summary are necessary, we will place the comments together with a corrected version of the summary in the docket. The materials that were used and distributed at these meetings, including agendas, attendance lists, and presentation documents, appear in the docket at OPPT 2003 0012 0181.

The summary for the PFOA ECA Telomer Degradation Technical Expert Subgroup meeting notes that a clarification conference call was scheduled for September 3, 2003. This teleconference meeting was subsequently rescheduled for September 9, 2003, and notification of the call, together with meeting materials, were provided in an email transmission from me dated September 4, 2003. These materials also appear in the docket at OPPT 2003 0012 0192. Additional materials transmitted by the Telomer Research Project ( TRP) on the morning of the meeting were forwarded to members of this notification list. These materials appear in the docket at OPPT 2003 0012 0193. The agenda, attendance form, and revised presentation materials used during the meeting appear in the docket at OPPT 2003 0012 0194. A summary of the teleconference meeting will be available at the PFOA ECA Telomer Technical Workgroup meeting scheduled for September 16, 2003, and will subsequently appear in the docket.

If you have any questions or experience any difficulty in opening the attached files, please contact me.

Sincerely,

Mary F. Dominiak U. S. Environmental Protection Agency EPA East, Mail Code 7405M 1200 Pennsylvania Avenue, NW Washington, DC 20460 Phone: 202 564 8104 Fax: 202 564 4775 Courier deliveries: 1201 Constitution Ave., NW, Room 4410; 564 4760 8 21 03 Summary, Fluoropolymer Monitoring Subgr 8 14 03 Summary, Telomer Incineration Subgro 8 15 03 Summary, Telomer Monitoring Subgro 8 19 03 Summary, Fluoropolymer Incineration Subgr 8 20 03 Summary, Fluoropolymer Aged Articles Subg 8 14 03 Summary, Telomer Degradation Subgro U. S. Environmental Protection Agency Meeting Summary September 11, 2003 PFOA ECA Telomer Incineration Technical Subgroup Meeting Summary, 8/ 14/ 03 40 participants; Attendance list and presentation materials in docket at OPPT 2003 0012 0181.

The meeting included three sections: I. Telomer Research Project ( TRP) presentation of Incineration Testing Proposal II. Discussion III. Identification of subgroup next steps I. TRP presentation TRP presented a proposal to the technical subgroup on incineration test methods for telomers. The presentation included information on TRP's approach to investigate the incineration of telomer based substances to quantitatively determine emission levels of PFOA. The proposal included the identification of representative materials for testing; description of experimental apparatus; review of relevant incineration test conditions; sampling and analysis considerations; study materials characterization; and discussion of next steps. The presentation can be found in the docket at OPPT 2003 0012 0181.

TRP defined the objectives of the desk study as the understanding of U. S. waste disposal methods for waste carpet, textile and paper and applicable incineration uses; and the review of U. S. incinerator conditions to understand typical operating temperatures. The TRP group concluded that carpet is largely landfilled or recycled, and that less than 1% of total carpet waste is incinerated. Based on these conclusions, TRP considered carpet eliminated as a possible testing component. TRP proposed conducting investigations on textile products, including medical textiles, and paper.

TRP summarized the operating conditions of Municipal Waste Combustors ( MWC) secondary chambers at a temperature range of 982NC to 1093NC. TRP further stated that operation at temperatures above 982NC is to ensure complete combustion of organic compounds prior to passing through the boiler. TRP proposed conducting thermogravimetric analysis to determine the temperature required for complete gasification.

TRP identified the testing materials as paper and textile products including medical textiles. Representative samples from each of the two product types will be prepared using a composite mixture of the LOI telomer based polymeric products, in a concentrated solid form, and in equal proportions by product and class.

TRP described the laboratory apparatus to be utilized for the experiment as being similar to the equipment used by the University of Dayton in conducting the 3M studies. Proposed experimental conditions will be at temperature levels of 900NC and 1000NC with a 2 second residence time. Three replicates will be used for each testing temperature and a blank will be run under each experimental condition. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 2 TRP indicated that sampling and analysis would include monitoring exhaust gas parameters for flow rate, oxygen, carbon dioxide, and carbon monoxide. The exhaust samples will be collected on suitable sorbent cartridge( s) and/ or in aqueous solution trap( s) for off line LC/ MS/ MS analysis at a qualified commercial laboratory. TRP stated that PFOA determination will require adaptation and validation of available methods.

TRP stated that the study materials characterization was to include elemental analysis for determination of carbon, hydrogen, nitrogen, chlorine, fluorine and oxygen by difference, as well as the PFOA content.

Lastly the TRP group suggested discussion of the next steps of the process.

II. Discussion Members of the groups discussed the proposed use of composite samples for analysis. TRP stated that the use of composite " neat chemicals" is a conservative approach that would yield higher concentrations than those seen through the use of the coated products. TRP explained that compositing was the most timely, cost efficient manner to answer the question of PFOA formation. Participants also questioned what the possible next steps would be in the event that PFOA was detected in the composite samples. Concerns are that the contribution by the individual components would be unknown based on the current testing scheme. TRP suggested focusing on the proposed testing and would consider going back and looking at the individual components at a later date.

The group suggested the inclusion of a " spiked" sample with PFOA to validate the detection and analysis methods. TRP stated their intent to conduct a fluorine mass balance analysis would eliminate the need for such a spike.

The subcommittee members discussed the proposed incineration conditions for testing. Typical MWC operating temperatures were established to be between 982NC and 1093NC; however, participants cited that some incinerators that meet medical standards operate primary zones at only 650NC. Discussions involved what the appropriate temperatures for analysis should be and what merit might be found in testing at a lower temperature ( 700NC). TRP expressed the belief that the proposed 900NC and 1000NC would adequately simulate current MWC conditions of complete gasification of the sample in chamber 1 and complete transport to chamber 2. Other interested parties suggested the lower temperatures would better inform possible PFOA sources from those incinerators operating under medical standards of 650NC. Parties noted that the goal of the TRP experiments is determining 99.99% destruction, while the goal of medical incinerators is the removal of pathogens and visible wastes. The group decided to continue this discussion once EPA has time to review literature on MWCs more closely. TRP will begin development of a protocol while leaving the temperatures blank for the interim. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 3 Interested parties expressed concerns regarding the replication of combustion conditions with regards to mixing conditions in municipal incinerators. TRP stated that the issue would be directly addressed by the " worst case" scenarios, and that the mixing of trash would lead to nondetection in the off gas.

Group members discussed the ability to evaluate the results and to put them into perspective. The suggestion was made to generate an exposure assessment that would serve to quantify and put the findings into context. TRP agreed to perform an exposure assessment as part of the ECA work.

The participants agreed that the proposed work was acceptable and that, with more detailed documentation of specific testing and analytical methods, a draft proposal suitable for incorporation into an ECA would be possible. The TRP group agreed to provide a draft testing protocol for discussion at the next Telomers Technical Workgroup meeting on September 16, 2003. EPA agreed to begin parallel work on the language for an ECA proposal document that will be paired with the TRP testing proposal.

III. Identification of subcommittee next steps ° EPA concluded that the LOI chemicals are satisfactory; however, EPA may identify additional possible products or markets by the September 16, 2003 meeting. ° EPA will begin work on a draft proposal suitable for incorporation into an ECA. ° EPA will review the TRP testing proposal and bring back comments at the Telomer Technical Workgroup meeting on September 16, 2003. ° TRP will conduct a Thermogravimetric Analysis for determination of gasification temperature. ° TRP will provide a Draft Testing Protocol by Friday, September 12, 2003, for review prior to the Telomer Technical Workgroup meeting on September 16, 2003. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 PFOA ECA Telomer Degradation Technical Subgroup Meeting Summary, 8/ 14/ 03 37 participants; Attendance list and presentation materials in docket at OPPT 2003 0012 0181.

The meeting included three sections: I. Telomer Research Project ( TRP) presentation of Biodegradation Testing Proposal II. Discussion III. Identification of subgroup next steps I. TRP presentation TRP presented a proposal to the technical subgroup on degradation for telomers. The presentation included information on TRP's approach to determining whether telomer based polymeric polymers biodegrade to PFOA. The proposal included a statement of objectives and approach; technical review and discussion of environmental fate testing logic and experimental design; summary and conclusions; and discussion of next steps. The presentation can be found in the docket at OPPT 2003 0012 0181.

TRP detailed the approach to be conducting studies designed to address partitioning and biotransformation in relevant environmental compartments. The initial step is conducting laboratory studies that are simple, focus on relevant releases, and inform the question of whether telomer based polymeric products and polymers have the potential to transform to PFOA. Results of the studies will be used to determine the need for longer term studies.

TRP defined the factors for determining the relevant environmental compartments as use/ applications, physical chemical properties, and emissions/ point of entry. TRP detailed that the areas of carpet, textiles, and paper were to be considered for emissions/ point of entry into the environment through Sewage Treatment Plants ( STPs), soil ( land applied sludge and landfill), air, and water ( STP discharge and other discharges to water).

TRP utilized a decision tree approach to detail the rationale for specific environmental fate testing dependent on the point of entry and pathways of transport into the environment. The tree detailed possible pathways for environmental entry points of STPs, soil, air, and water.

TRP narrowed the analysis of environmental pathways to include STP analysis for " down the drain" disposal, sludge, and wastewater; and soil analysis to include land applied sludge from STPs and landfill disposal of treated articles. TRP stated that water would not be considered due to no direct discharge to water; incinceration would be addressed in a separate ECA workstream; and air would be addressed by the TRP mill release and pilot study work.

TRP presented their proposed study plans to include Inherent Biodegradation in Sludge ( Zahn Wellens, OECD 302B) as an amendment to the LOI commitment, Aerobic Sewage Treatment Study ( OECD 303A), and Soil Aerobic/ Anaerobic Biodegradation Study ( OECD 304 and 307) for 2 telomer based products and 2 telomer based polymers. The purpose is to U. S. Environmental Protection Agency Meeting Summary September 11, 2003 2 characterize the products and isolated polymers before conducting testing of the 10 remaining telomer based polymer products. TRP detailed the technical hurdles associated with each of the proposed testing procedures.

TRP concluded that the study approach is a step wise progression based on relevant routes into the environment and building upon knowledge gained; considers feasible and workable biotransformation and partitioning studies that address the central question posed by EPA; is based on modification of available biodegradation test methods; utilizes available analytical method; takes into consideration the ability to conduct work in a timely manner; and is consistent with and additive to the TRP Letter of Intent ( LOI).

Lastly the TRP group suggested discussion of the next steps of the process.

II. Discussion Members of the group discussed the possibility of substituting the Semi Continuous Activated Sludge test ( SCAS) for the proposed Zahn Wellens Inherent Biodegradability test. Discussions detailed the belief that the SCAS test is a much more powerful test that would better address biodegradation. It was noted that problems are often associated with the SCAS with regards to the testing method. The group suggested that TRP review the recommendation for the SCAS test and provide comments at the next meeting.

Subgroup participants raised a concern about possible human metabolism of PFOA from inhalation of particles. The question was raised regarding whether these types of exposures were significant. TRP suggested that the pharmocokinetics study of the telomer 8 2 alcohol and the articles analysis should help identify any transformations that could occur.

Members of the group asked about consideration of the Anaerobic Sludge Digestion Study. The response was that the test has been considered; however, the belief is that the Inherent Biodegradability test would serve as a worst case indicator of PFOA generation.

Participants questioned whether the telomer 8 2 alcohol and other degradation products were being considered for analysis. The group suggested inclusion of the telomer 8 2 alcohol and identification of degradation products in the studies. The group felt identification of products other than PFOA was important information to have. Suggestions were made to use traps to obtain the volatiles and use GC/ MS analysis for screening of potential degradants. The group suggested that TRP consider the suggestions and provide comments at the next meeting.

The group discussed the adequacy of the duration time for the Inherent Biodegradation test. A test duration of 28 days is the standard for this test; however, participants asked if that time could be extended to 60 days. The comment was that extension to 60 days would not be relevant to the STP setting, as a standard detention time in STPs is 6 to 10 days. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 3 The group raised the question of the determination of rate constants for these studies. The group felt that the current proposal would yield no rate constants for future use. The group suggested that TRP consider the suggestions and provide comments at the next meeting.

III. Identification of subgroup next steps ° TRP will consider EPA's request to conduct the SCAS test in place of the Zahn Wellens test, determine whether more work can be done in the areas of rate constants, consider inclusion of the Telomer 8 2 alcohol and possible identification of degradation products. ° A copy of the Clariant hydrolysis study will be made available for review by EPA. ° TRP will provide the testing information on the radiolabeled biodegradation study by the end of August. ° EPA will review the soil study and other proposals and determine if any are ready for drafting a proposal suitable for incorporation into an ECA. ° EPA will review the proposal and submit any comments to TRP within 2 weeks. A conference call is scheduled for Sept 3, 2003 for clarification of any questions based on the comments. ° The technical subgroup will try to set aside time during the Telomer Technical Workgroup meeting on September 16, 2003 for discussion of issues. ° EPA to review proposed chemicals and make a determination if chemicals other than those stated in the LOI are necessary for evaluation. EPA is still awaiting some product information in order to finish the review. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 PFOA ECA Telomer Monitoring Technical Subgroup Meeting Summary, 8/ 15/ 03 45 participants; Attendance list and presentation materials in docket at OPPT 2003 0012 0181.

The meeting included three sections: I. Telomer Research Project ( TRP) presentation of Monitoring Proposal II. Discussion III. Identification of subgroup next steps I. TRP presentation TRP presented a proposal to the technical subgroup on environmental monitoring for telomers. The presentation included information on TRP's approach to understanding and characterizing current PFOA releases from carpet, textile, and paper industrial manufacture, uniquely attributable to telomer based polymeric products, in order to provide information on potential PFOA environmental and occupational exposures. The presentation included a review of the telomer product application process, mass balance overview, mill release model information, and mill monitoring pilot study information. The presentation can be found in the docket at OPPT 2003 0012 0181.

TRP provided a brief review of the telomer product application process to demonstrate the usefulness of the proposed mass balance analysis. Product manufacture includes the wet application of telomer based polymer, the drying of the article, and trimming of wastes from the treated article. The mass balance will focus on accounting for the amount of material on the treated article, the amount left in the application bath for wastewater treatment disposal, the amount driven off during the drying process, and the amount to landfill from article trimming.

TRP detailed the use of mill release modeling to predict the total US environmental releases and concentrations. Processing variables including average daily product usage and number of total user locations, combined with the mass balance information, will serve to allow determination of PFOA releases to air, water, and solid wastes at each user site. TRP stated this information is critical to defining the fitness of purpose for PFOA sampling and analysis methods.

TRP defined the mill monitoring pilot study as a controlled, realistic study to verify the release model with measured data including a pilot production line which is free of other contaminations. The analysis would begin with a Total Organic Fluorine ( TOF) analysis to verify the overall mass balance. Chemical specific determination of PFOA and telomer 8 2 alcohol would require development and validation of sampling and analysis methods.

TRP explained that the mill monitoring pilot study represents real commercial processing by utilization of industry standard, scaled down versions of actual mill equipment that is used industry wide for research and development. Sampling would include the application bath, exhaust air, treated article and work area air. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 2 In response to issues surrounding CBI identification of telomers for testing, TRP proposed preparation of a representative acrylic polymer of known composition and residual raw material profile, to be used on treated polyester textile fabric as the beginning experiment. Analysis of TOF would be performed to see if meaningful measurements in air, water, and treated substrates could be demonstrated to achieve the mass balance. TRP would use this analysis as the basis for validation of the mill monitoring pilot work and would begin analysis of proposed articles in the areas of carpet, textiles and paper.

TRP summarized by stating that the studies would address environmental and occupational exposures to PFOA from telomer based polymeric products used in carpet, textile and paper processes including air, water, solid and land.

Lastly the TRP group suggested discussion of the next steps of the process.

II. Discussion The facilitator of the subgroup suggested that the group consider what the purpose of the subgroup is and form questions that monitoring should answer. The discussions produced questions to be considered by the Telomer Monitoring Subgroup and questions that can be taken back to the larger Monitoring Technical Workgroup for discussion.

Members of the subgroup compiled questions they determined should be addressed within the Monitoring Technical Subgroup: ° How telomers get into the environment ° Will/ do telomers break down to PFOA ( will monitoring help us?) ° Do telomers/ PFOA enter into biota? ° Precursors  difficult to monitor for. Persistent  how/ will they be transported? How do they behave? ° Release and exposure data of PFOA in air, surface water, groundwater, sediment & soil ° Look at processing sites of telomers ° Look at manufacturing sites of telomers ° Separate chemical vs engineering uses ( use analytical chemistry at sites to distinguish branch chain vs straight chains) ° Can we attribute analyte to a specific source? ° Do we need to involve other industries to identify sources of PFOA in the environment? ( e. g., carpet mills) ° Can we go through processes of products to eliminate or identify source of PFOA? ( e. g., telomer alcohol) ° Talk to other interested parties to see what their contributions are? ° What happens to product once disposed of? U. S. Environmental Protection Agency Meeting Summary September 11, 2003 3 ° Biodegradation of telomers  does it happen on site? Need to validate model ( e. g., does it change with distance from plant?) ° Sources/ Pathways  How will monitoring data be used? ( e. g., for experiment at a specific plant or use in broader range finding study?) ° Generate emission factors/ rates to get estimate of environmental loading. ° Is the focus on future sources or on past environmental exposures? How do we aggregate or disaggregate this information? ° Make sure to quantify. What exposures of PFOA are from telomers? ° Question of disposal sites, exposures from FPOA from past uses ( risk assessment issue) ° Is there a way to monitor whether PFOA is in biota other than human blood monitoring? ° Monitoring vs. Modeling. When is monitoring necessary vs. use of models?

Members compiled questions they determined should be taken back to the Monitoring Technical Workgroup for discussion: ° Is water being contaminated on site and off site? ° Does it move to the soil on site and off site? ° How much moves to air? ° How much does volume compare ( e. g., straight PFOA telomers vs other industries)

Members of the group agreed that monitoring needs to be done, but could not agree on who should be doing it. The suggestion was made to recommend to the Monitoring Workgroup that users be invited to participate in the conversations. The recommendation would then be brought to the Plenary. The group decided to continue discussions at the next scheduled subgroup meeting.

III. Identification of subgroup next steps ° Take questions to the Monitoring Technical Workgroup on September 16, 2003. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 PFOA ECA Fluoropolymer Incineration Technical Subgroup Meeting Summary, 8/ 19/ 03 30 participants; Attendance list and presentation materials in docket at OPPT 2003 0012 0181.

The meeting included three sections: I. Fluoropolymer Manufacturing Group ( FMG) presentation of Incineration Testing Proposal II. Discussion III. Identification of subgroup next steps I. FMG presentation FMG presented a proposal to the technical subgroup on incineration test methods for fluoropolymers. The presentation included information on FMG's approach to addressing the question of whether fluoropolymer incineration is a potential source of PFOA in the environment. The proposal included the identification of representative materials for testing; review of relevant incineration conditions; presentation of key elements of the proposed testing program; and discussion of next steps. The presentation can be found in the docket at OPPT 2003 0012 0181.

FMG's discussion of representative materials identified the 4 main classes of products as dry melt resins ( FEP, PFA, THV, ETFE, and HTE); dry non melt resins/ gums ( PFTE); dry nonmelt resins/ gums ( fluoroelastomers); and aqueous dispersions ( PTFE, FEP, PFA, and THV). FMG stated that the 4 classes of products covered the range of the 12 fluoropolymer families. Each class of materials would be a composite mixture as solids, in equal proportions according to the number of companies that produce the various products.

FMG provided a detailed literature review of relevant Municipal Waste Combustor ( MWC) operating conditions. The presentation summarized the standard operating conditions of MWCs as typically operating secondary chambers at greater than 1000NC with a residence time of 2 seconds. FMG stated that over 90% of municipal solid wastes are combusted at 982NC for 2 seconds. The proposed operating conditions for incineration evaluations were conservatively identified as 900NC with a 2 second residence time.

FMG detailed the key elements of the proposed testing program including the overall test program objective, phases of testing, testing materials, experimental apparatus, experimental conditions, and sampling and analysis.

Lastly the FMG group suggested discussion of the next steps of the process. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 2 II. Discussion Members of the technical subgroup discussed the proposed 4 classes of products and how they related to the end uses. The products are to be representative of the world of fluoropolymer products and are composites of the individual products streams.

The topic of a tiered or phased approach was discussed in the event that PFOA should appear in the preliminary testing results. Participants discussed the application of the proposed screening approach and questioned what the next step would be should PFOA be identified. The conclusion was that the initial screening testing would be conducted and subsequent results be presented to the group for evaluation. Results would be presented in the form of an exposure assessment. Possible next steps would be the identification of individual contributions of products in the composite and their likelihood for incineration.

Temperature of operation for the testing was another topic for discussion. FMG proposed 900NC operating temperature based on current operating conditions of MWCs. Comparisons were made to the conditions used for the 3M incineration testing protocol used for PFOS analysis. It was clarified that the conditions of the 3M study were based on thermogravimetric analysis of the PFOS material until 99.99% destruction was observed. EPA suggested that such analyses be conducted for determination of this level of destruction. FMG stated that information on required decomposition kinetics of PFOA will be reported as a DuPont document.

The issue of the use of aqueous dispersions by processing sites was discussed. There was concern that emissions from afterburners and ovens were not being addressed in the incineration testing proposal. FMG stated that their LOI commitments of a material balance around aqueous dispersion customer facilities, decomposition kinetics information, and articles of commerce testing will support the assumption of complete destruction of PFOA during drying of aqueous dispersions.

The group discussed the phases of the testing program to clarify any issues regarding the progression of work. Questions were posed regarding the development of other test methods and the format for data reporting and development. The FMG group clarified other method development as the inclusion of Total Organic Fluorine ( TOF) in their analysis. A method for verification would be necessary for this item. FMG addressed the question of data reporting by agreement to include an exposure assessment as part of the testing report. The exposure assessment would serve to quantify the presence of PFOA in the environment from incineration.

FMG stated the credentials of Dr. Phil Taylor of the University of Dayton. Dr. Taylor was the technical lead on the incineration testing conducted on behalf of 3M, which serves as the model for the FMG testing proposal. FMG will be utilizing Dr. Taylor's expertise to conduct the incineration testing proposed. Members of the group expressed concerns regarding containers for transport of samples for analysis. FMG stated that the utilization of the University of Dayton U. S. Environmental Protection Agency Meeting Summary September 11, 2003 3 personnel would provide an additional level of confidence to the experiment due to their extensive experience in sample collection and analysis.

The participants agreed that the proposed work was generally acceptable and that, with more detailed documentation of specific testing and analytical methods, a draft proposal suitable for incorporation into an ECA would be possible. The FMG group agreed to provide a draft testing protocol for discussion at the next Fluoropolymers Technical Workgroup meeting on September 17, 2003. EPA agreed to begin parallel work on the draft proposal for an ECA document that will be paired with the FMG testing proposal.

III. Identification of subgroup next steps ° EPA will begin work on a draft incineration testing proposal for incorporation into an ECA. ° FMG will provide a Draft Testing Protocol by Friday, September 12, 2003 for review prior to the Fluoropolymer Technical Workgroup meeting on September 17, 2003. ° Decomposition Kinetics of PFOA information will be forthcoming. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 PFOA ECA Fluoropolymer Aged Articles Technical Subgroup Meeting Summary, 8/ 20/ 03 38 participants; Attendance list and presentation materials in docket at OPPT 2003 0012 0181.

The meeting included three sections: I. Fluoropolymer Manufacturers Group ( FMG) presentation of Aged Articles of Commerce Test Proposal II. Discussion III. Identification of subgroup next steps I. FMG presentation FMG presented a proposal to the technical subgroup on aged articles of commerce for fluoropolymers. The presentation included information on FMG's approach to determining whether PFOA is emitted from fluoropolymer containing articles as they age during use. The proposal included statement of goals and objectives, reiteration of aged article selection criteria, identification of selected aged articles, testing methodologies to be employed, and discussion of next steps. The presentation can be found in the docket at OPPT 2003 0012 0181.

FMG reiterated their selection criteria for aged articles from the 3 main fluoropolymer classes of melt/ extrusion, polymer drying, and liquid dispersion products/ articles. Articles were considered based upon consumer and industrial applications, high and low heat processing, potential volume, and potential human exposures.

FMG provided additional selection criteria for aqueous dispersions, non melt resins/ gums, and melt/ extrusion products by considering repeated/ long term use and human exposure during use. FMG provided sample selection trees to demonstrate the rationales behind the articles selected for testing. Plenum cables, membranes for apparel, and household cookware were selected based on the additional considerations of repeated/ long term use and human exposure during use.

FMG detailed the testing methodologies to be used as FDA Simulated Aging Protocols. Extraction protocols were chosen based on life cycle analysis of articles as well as time, temperature and solvent. The proposed validation of analytical methods would be by LC/ MS/ MS using the solvents of water, ethanol, corn oil, and ethyl acetate.

FMG proposed the next steps of the process to be the verification of existing validated analytical methods; development of protocols by determining appropriate times and temperatures; completion and review of the Study Plan with EPA and Interested Parties; and beginning the Study Plan after January 1, 2004.

Lastly the FMG group suggested discussion of the next steps of the process. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 2 II. Discussion Members of the technical subgroup questioned the assumption that PFOA is destroyed or driven off during melt/ extrusion and non melt resins/ gums processing, and during aqueous dispersion drying. FMG stated that information available on PFOA demonstrated rapid degradation at temperatures above 250NC and that fluoropolymer processing takes place at temperatures exceeding 300NC. FMG noted that test data on frying pans show no PFOA detection and that thermokinetic information is forthcoming. Based on the questions raised regarding degradation of PFOA, FMG committed to assembling a summary of all degradation product data for future discussion.

Workgroup participants discussed the selection criteria for aged articles of commerce testing. Questions were raised regarding why the plenum cables, membranes for apparel, and household cookware were chosen as opposed to items such as tubing for industrial food applications, barrier creams, medical tubing, etc. The question was posed as to if any quantitative analysis was performed when selecting the articles for testing. FMG stated that samples were chosen based on the same considerations as the articles of commerce with the addition of repeated/ long term use and human exposure potential. Professional judgment, combined with considerations of production volume and application quantity, were how the products were selected. Selected products are intended to represent the families of fluoropolymers for each class. It was noted that barrier creams were no longer produced by any of the signatories of the FMG Letter of Intent ( LOI).

Discussions regarding solvent selection included suggestions of use of such solvents as saliva, acid, chloroform, etc. to accurately evaluate substances likely to come in contact with the articles. FMG stated that the fluoropolymers by design are resistant to thermal and water insult as a characteristic of their intended use, and that solvent selection is difficult. It is known that PFOA is readily soluble in water, therefore, that is one of the solvents suggested for evaluation. Subgroup members suggested saliva as a possible solvent to take into account the possibility of children chewing on apparel and possibly being exposed. Another suggestion was the use of chloroform as a solvent due to prior success with swelling and extraction of fluoropolymers. FMG agreed to take these suggestions into consideration.

The workgroup participants posed the question of having accelerated aging evaluations take into consideration possible generation of PFOA through abrasion of products. Suggestions were made to evaluate the chewing action of a child as a possible test to simulate the chewing of apparel by children. Another suggestion was subjecting the articles to high heat and solvents to test the possible release of PFOA. FMG agreed to evaluate the possible simulation of chewing as a creative use.

Several members of the workgroup suggested determination of the PFOA content in the article for comparison with the extraction techniques proposed. FMG stated that this worst case U. S. Environmental Protection Agency Meeting Summary September 11, 2003 3 estimate would be covered by the articles of commerce testing already approved as part of the LOI process. Results of these evaluations would inform the group to the possible PFOA content in the articles. The suggestion was made that samples be taken at regular intervals during the aging process and evaluated to answer the question of content throughout the experiment.

Interested parties had concerns regarding the purity of PFOA being used and the possible formation of PFOA or precursors during the aging process.

Members of the workgroup discussed the Mabury degradation study where analysis of PTFE demonstrated the formation of PFOA and other analogs. The validity of the testing was disputed due to the possible contamination of samples from the tubing used on the experimental apparatus, and the lack of validation of data quality.

The subject of a possible mass balance analysis during the experimental aging was discussed. Participants felt that periodic analysis during aging would determine the where and how of vapor and substrate. FMG proposed evaluating samples during regular intervals throughout the proposed 10 day aging studies which would definitively determine if PFOA is generated during aging.

III. Identification of subcommittee next steps ° FMG will revisit the discussions from the meeting and provide a presentation in advance of the Fluoropolymer Technical Workgroup meeting on September 17, 2003. ° FMG will assemble a summary all degradation products data for future discussion. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 PFOA ECA Fluoropolymer Monitoring Technical Subgroup Meeting Summary, 8/ 21/ 03 46 participants; Attendance list and presentation materials in docket at OPPT 2003 0012 0181.

The meeting included three sections: I. Fluoropolymer Manufacturers Group ( FMG) presentation of Monitoring Proposal II. Discussion III. Identification of subgroup next steps I. FMG presentation FMG presented a proposal to the technical subgroup on environmental monitoring for fluoropolymers. The presentation included information on FMG's approach to understanding the role of environmental sampling and monitoring in characterizing the manufacturing contributions to PFOA levels in the environment. The presentation included the statement of objective; discussion of various models for PFOA detection in air, soil, groundwater, and water; comparison of model versus field measurements; and statement of conclusions. The presentation can be found in the docket at OPPT 2003 0012 0181.

FMG stated the overall objective of the ECA process as the enhancement of understanding of sources of PFOA in the environment and the pathways by which human exposure to PFOA is occurring. Further, the FMG group detailed the goal of this meeting as the understanding the role of environmental monitoring in characterizing the manufacturing contribution to PFOA levels in the environment. This would be done primarily by using modeling with limited sampling to provide inputs and to verify model results.

FMG provided a detailed discussion of various models for PFOA detection including the ISCST3 model for ambient air and deposition modeling; PRZM model for unsaturated soil; MODFLOW model for groundwater transport; and PDM model for river evaluations. FMG detailed the appropriateness of the models; model input requirements; and model outputs.

FMG presented comparison data between selected models and actual field measurements. FMG's conclusions drawn from the soil, groundwater, and river models were that there was good correlation between the model and measurements; and that the models were useful in providing conservative estimates, predicting a general distribution, and are good for longer term averages. Conclusions drawn from the air/ water model comparison were that there is a trend in the data where higher depositions correlate with higher groundwater measurements. FMG concluded that a direct correlation is not possible, but air modeling results can define where sampling should occur and where it is not needed. FMG stated that the open issue is whether the air dispersion model provides conservative estimates of ambient air concentrations. Their plan to resolve this issue is to develop and validate sampling and analysis method, design a verification plan, and execute a plan.

FMG concluded that these environmental models are useful and effective for characterizing the contribution of manufacturing to PFOA levels in the environment, and that the role of monitoring is to provide model input data and, where appropriate, verify model outputs. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 2 FMG's recommendations included verifying modeled ambient air concentrations; and PFOA contribution determination including analysis of APFO manufacturing, fluoropolymer manufacturing, and fluoropolymer processing.

Lastly the FMG group suggested discussion of the next steps of the process.

II. Discussion Participants discussed the impact geology variation would have on sampling and modeling results. Concerns were that the type of geology sampled could have a significant impact on the results found. The PRZM model was noted to take into account differences in geologies by consideration of different soil types.

Members of the group suggested the inclusion of fugitive emissions analysis during the monitoring process. Concerns were that the rate of fugitive emissions should be verified. It was stated that stack emissions evaluations were likely to dwarf any fugitive emissions that might occur, but that they could not be discounted.

Subgroup participants discussed the proposed dispersion processors material balance to be completed as part of the FMG Letter of Intent ( LOI) commitment. The stated purpose of the material balance was to use effluent sampling combined with engineering estimates to provide an industry balance of potential releases rather than an individual facility analysis. Discussions involved the use of the material balance results as model input. FMG committed to providing a report on this material balance work by December 31, 2003.

There were concerns raised regarding the usefulness of the air model in predicting groundwater concentrations. The participants questioned whether useful groundwater information could be found from use of the proposed air model. The proposed process would use output from the air model as input for the soil model, whose results would then be input into the groundwater model to predict groundwater values. The stated purpose of the modeling was not as a predictor of groundwater levels, but rather as a pointer of where to take samples based on the highest air model concentrations.

The group discussed the possibility of including soil testing in the monitoring efforts by emphasizing the potential for human exposure to soil, and noting that air emissions would deposit PFOA onto soil. Submitted adsorption/ desorption results were referenced as justification for excluding soil evaluations. FMG indicated that the study results showed that PFOA moves directly through soil and goes straight to the groundwater and, combined with the known high water solubility of PFOA, served to favor the position of exclusion of soil monitoring. The group suggested that FMG consider inclusion of soil sampling in their monitoring commitments. U. S. Environmental Protection Agency Meeting Summary September 11, 2003 3 Subgroup participants discussed the issue of bioaccumulation impact of PFOA on biota. Discussions involved results from a 3M study indicating bioaccumulation in fish. The group suggested that 3M be invited to present their environmental biota sampling findings at the Monitoring Technical Workgroup meeting on September 18, 2003.

Another topic for discussion was the suggested consideration of disposal sites as part of the proposed monitoring. Results of previous landfill sampling as part of the Multi Media Consent Order were cited as having groundwater concentrations of concern. The group agreed to review the results of the landfill sampling and be prepared to discuss the topic at the Monitoring Technical Workgroup meeting on September 18, 2003.

Participants brought up the possibility of modeling human blood levels, indicating that a draft model available for review in the docket ( OPPT 2003 0012 0174) utilized air and water values to predict a level in human blood. The suggestion was made to review the model information and discuss its potential relevance at the Monitoring Technical Workgroup meeting on September 18, 2003.

There were questions regarding how the sampling was conducted on the data presented. Concerns were whether gradient was taken into consideration when sampling. Participants indicated that the results could be significantly influenced by the location of the sampling.

Members of the subgroup voiced concerns regarding model variations. Concerns are based on the known variability in the input being used for the model which could significantly impact the output results. Members questioned the sensitivity of the output being generated and suggested providing error bars on the output.

Members of the group discussed the data gaps that the LOI commitment did not seem to address, including volatility and PFOA density. These topics will be carried over to the Monitoring Technical Workgroup Meeting on September 18, 2003.

III. Identification of subgroup next steps ° Progress report of ongoing air modeling from Dyneon due to EPA by September 15, 2003. ° FMG report on mass balance work of aqueous dispersion processors industry by December 31, 2003. ° FMG report on air modeling in 1st quarter of 2004. ° Subcommittee members to review the Human Blood Model and landfill sampling for discussion at the Monitoring Technical Workgroup meeting on September 18, 2003. ° 3M to provide a presentation on biota at the September 18 meeting. ° Group requested FMG consider soil sampling as part of the monitoring work. ° Take questions to the Monitoring Technical Workgroup on September 18, 2003.


MEMORANDUM 	 Date:	December 11, 2013

Subject:	Amino/Phenolic Resins Production Risk Modeling File

From:	Nick Parsons, EPA/OAQPS/SPPD/RCG 		 To:	EPA Docket File (EPA-HQ-OAR-2012 - 0133)

The attached "Mact_1347.zip" file contains the emissions inventory used for the risk modeling of the Amino/Phenolic Resins Production (APR) source category.

The attached "P&RIII HEM Inputs MACT Level.zip" file contains the Human Exposure Model (HEM) inputs for emissions from APR processes at facilities in the APR source category.

The attached "P&RIII HEM Inputs Whole Facility.zip" file contains the HEM inputs for facility-wide emissions from facilities in the APR source category.


[Federal Register Volume 81, Number 215 (Monday, November 7, 2016)]
[Notices]
[Pages 78170-78172]
[FR Doc No: 2016-26792]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0868]

Agency Information Collection Activities; Proposed Collection;
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AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry: Use of Serological Tests To Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood
Components Intended for Transfusion

OMB Control Number 0910-0681--Extension

    The guidance document implements the donor screening
recommendations for the FDA-approved serological test systems for the
detection of antibodies to T. cruzi. The purpose of the donor screening
tests is to reduce the risk of transmission of T. cruzi infection by
detecting antibodies to T. cruzi in plasma and serum samples from
individual human donors, including donors of Whole Blood and blood
components intended for transfusion. The guidance recommends that
establishments that manufacture Whole Blood and blood components
intended for transfusion should notify consignees of all previously
collected in-date blood and blood components to quarantine and return
the blood components to establishments or to destroy them within 3
calendar days after a donor tests repeatedly reactive by a licensed
test for T. cruzi antibody. When establishments identify a donor who is
repeatedly reactive by a licensed test for T. cruzi and positive on a
licensed

supplemental test, we recommend that the establishment notify
consignees of all previously distributed blood and blood components
collected during the lookback period and, if blood and blood components
were transfused, encourage consignees to notify the recipient's
physician of record of a possible increased risk of T. cruzi infection.
    Respondents to this information collection are establishments that
manufacture Whole Blood and blood components intended for transfusion.
We believe that the information collection provisions in the guidance
for establishments to notify consignees and for consignees to notify
the recipient's physician of record in the guidance do not create a new
burden for respondents and are part of usual and customary business
practices. Since the end of January 2007, a number of blood centers
representing a large proportion of U.S. blood collections have been
testing donors using a licensed assay. We believe these establishments
have already developed standard operating procedures for notifying
consignees and for the consignees to notify the recipient's physician
of record.
    The guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR 601.12 have been approved under OMB control number 0910-0338;
the collections of information in 21 CFR 606.100, 606.121, 606.122,
606.160(b)(ix), 606.170(b), 610.40, and 630.6 have been approved under
OMB control number 0910-0116; the collections of information in 21 CFR
606.171 have been approved under OMB control number 0910-0458.

    Dated: November 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26792 Filed 11-4-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 1, 2010 (Volume 75, Number 104)]
[Notices]
[Page 30421]
[DOCID:fr01jn10-102]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1907-DR; Docket ID FEMA-2010-0002]

North Dakota; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Dakota (FEMA-1907-DR), dated April 30, 2010, and
related determinations.

DATES: Effective Date: May 24, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Dakota is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of April 30, 2010.

    Eddy and McIntosh Counties for Public Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-13039 Filed 5-28-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Page 56978]
[FR Doc No: 2013-22553]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

 In the Matter of Carbiz, Inc., InZon Corporation, IQ Micro,
Inc., Irwin Financial Corporation, and Princeton Media Group, Inc.;
Order of Suspension of Trading

September 12, 2013.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Carbiz, Inc. because it has not filed any periodic reports since the
period ended October 31, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
InZon Corporation because it has not filed any periodic reports since
the period ended June 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
IQ Micro, Inc. because it has not filed any periodic reports since the
period ended June 30, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Irwin Financial Corporation because it has not filed any periodic
reports since the period ended June 30, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Princeton Media Group, Inc. because it has not filed any periodic
reports since the period ended December 31, 2006.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EDT on September 12, 2013, through 11:59
p.m. EDT on September 25, 2013.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2013-22553 Filed 9-12-13; 4:15 pm]
BILLING CODE 8011-01-P