[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Rules and Regulations]
[Pages 30027-30034]
[FR Doc No: 2011-12763]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1983-0002; FRL-9310-8]

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

AGENCY: Environmental Protection Agency.

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) Region 8 is
publishing a direct final Notice of Partial Deletion of the remaining
portions of Operable Unit 9 (OU9), the Residential Populated Areas, of
the California Gulch Superfund Site (Site), located in Lake County,
Colorado, from the National Priorities List (NPL). The NPL, promulgated
pursuant to section 105 of the Comprehensive Environmental Response,
Compensation, and Liability

Act (CERCLA) of 1980, as amended, is an appendix of the National Oil
and Hazardous Substances Pollution Contingency Plan (NCP). This direct
final partial deletion is being published by EPA with the concurrence
of the State of Colorado, through the Colorado Department of Public
Health and Environment (CDPHE) because EPA has determined that all
appropriate response actions at these identified parcels under CERCLA,
other than operation, maintenance, and five-year reviews, have been
completed. However, this partial deletion does not preclude future
actions under Superfund.
    This partial deletion pertains to the remaining portions of OU9,
the Residential Populated Areas. Subunits A and B, residential waste
rock piles, and the parks and playgrounds within Operable Unit 9 were
partially deleted from the NPL on January 30, 2002. In addition, OU2,
OU8, and OU10 have been partially deleted from the NPL. The Yak Tunnel
(OU1), D&RGW Slag Piles and Easement (OU3), Upper California Gulch
(OU4), ASARCO Smelter/Colorado Zinc-Lead Mill Site (OU5), Stray Horse
Gulch (OU6), Apache Tailing (OU7), Arkansas River Floodplain (OU11),
and Site-wide Surface and Groundwater Quality (OU12) will remain on the
NPL and are not being considered for deletion as part of this action.

DATES: This direct final partial deletion is effective July 25, 2011
unless EPA receives adverse comments by June 23, 2011. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final partial deletion in the Federal Register informing the
public that the partial deletion will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1983-0002, by one of the following methods:
     http://www.regulations.gov. Follow on-line instructions
for submitting comments.
     E-mail: Linda Kiefer<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Linda Kiefer, Remedial Project Manager,
Environmental Protection Agency, Region 8, Mail Code 8EPR-SR, 1595
Wynkoop Street, Denver, CO 80202-1129.
     Hand delivery: Environmental Protection Agency, Region 8,
Mail Code 8EPR-SR, 1595 Wynkoop Street, Denver, CO 80202-1129. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID no. EPA-HQ-SFUND-
1983-0002. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.

Docket

    All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at:

U.S. EPA Region 8, Superfund Records Center, 1595 Wynkoop Street,
Denver, CO 80202.<PHONE_NUMBER> or toll free<PHONE_NUMBER>; Viewing
hours: 8 a.m. to 4:30 p.m., Monday through Friday, excluding holidays.

 and

Lake County Public Library, 1115 Harrison Avenue, Leadville, CO 80461,
(719) 486-0569

FOR FURTHER INFORMATION CONTACT: Linda Kiefer, Remedial Project
Manager, U.S. Environmental Protection Agency, Region 8, Mailcode EPR-
SR, 1595 Wynkoop Street, Denver, CO 80202-1129,<PHONE_NUMBER> e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Partial Deletion Procedures
IV. Basis for Site Partial Deletion
V. Partial Deletion Action

I. Introduction

    EPA Region 8 is publishing this direct final Notice of Partial
Deletion for the remaining portions of Operable Unit 9 (OU9),
Residential Populated Areas, of the California Gulch Superfund Site
(Site), from the National Priorities List (NPL). The NPL constitutes
Appendix B of 40 CFR part 300, of 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) of 1980, as amended. EPA
maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment. Sites
on the NPL may be the subject of remedial actions financed by the
Hazardous Substance Superfund (Fund). This partial deletion of the Site
is proposed in accordance with 40 CFR 300.425(e) and is consistent with
the Notice of Policy Change: Partial Deletion of Sites Listed on the
National Priorities List. 60 FR 55466 (Nov. 1, 1995). As described in
300.425(e)(3) of the NCP, a portion of a site deleted from the NPL
remains eligible for Fund-financed remedial action if future conditions
warrant such actions.
    Because EPA considers this action to be noncontroversial and
routine, this action will be effective July 25, 2011 unless EPA
receives adverse comments by June 23, 2011. Along with this direct
final Notice of Partial Deletion, EPA is co-publishing a Notice of
Intent for Partial Deletion in the ``Proposed Rules'' section of the
Federal Register. If adverse comments are received within the 30-day
public comment period on this partial deletion action, EPA will publish
a timely withdrawal of this direct final Notice of Partial Deletion
before the effective date of the partial deletion and the partial
deletion will not take effect. EPA will, as appropriate, prepare a
response to comments and continue with the deletion process on the
basis of the Notice of Intent for Partial Deletion and the comments

already received. There will be no additional opportunity to comment.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III discusses procedures that EPA is using
for this action. Section IV discusses the remaining portion of OU9,
Residential Populated Areas, of the California Gulch Superfund Site and
demonstrates how it meets the deletion criteria. Section V discusses
EPA's action to partially delete the Site parcels from the NPL unless
adverse comments are received during the public comment period.

II. NPL Deletion Criteria

    The NCP establishes the criteria that EPA uses to delete sites from
the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted
from the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), EPA will consider, in
consultation with the State, whether any of the following criteria have
been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. All appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible parties is
appropriate; or
    iii. The remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-
year reviews to ensure the continued protectiveness of remedial actions
where hazardous substances, pollutants, or contaminants remain at a
site above levels that allow for unlimited use and unrestricted
exposure. EPA conducts such five-year reviews even if a site is deleted
from the NPL. EPA may initiate further action to ensure continued
protectiveness at a deleted site if new information becomes available
that indicates it is appropriate. Whenever there is a significant
release from a site deleted from the NPL, the deleted site may be
restored to the NPL without application of the hazard ranking system.

III. Partial Deletion Procedures

    The following procedures apply to the deletion of the remaining
portions of OU9 of the Site:
    (1) EPA has consulted with the State of Colorado prior to
developing this direct final Notice of Partial Deletion and the Notice
of Intent for Partial Deletion co-published in the ``Proposed Rules''
section of the Federal Register.
    (2) EPA has provided the state 30 working days for review of this
notice and the parallel Notice of Intent for Partial Deletion prior to
their publication today, and the State, through the Colorado Department
of Public Health and Environment, has concurred on the partial deletion
of the Site from the NPL.
    (3) Concurrently with the publication of this direct final Notice
of Partial Deletion, a notice of the availability of the parallel
Notice of Intent for Partial Deletion is being published in a major
local newspaper, the Leadville Herald Democrat. The newspaper notice
announces the 30-day public comment period concerning the Notice of
Intent for Partial Deletion of the Site from the NPL.
    (4) The EPA placed copies of documents supporting the partial
deletion in the deletion docket and made these items available for
public inspection and copying at the Site information repositories
identified above.
    (5) If adverse comments are received within the 30-day public
comment period on this partial deletion action, EPA will publish a
timely notice of withdrawal of this direct final Notice of Partial
Deletion before its effective date and will prepare a response to
comments and continue with the deletion process on the basis of the
Notice of Intent for Partial Deletion and the comments already
received.
    Deletion of a portion of a site from the NPL does not itself
create, alter, or revoke any individual's rights or obligations.
Deletion of a portion of a site from the NPL does not in any way alter
EPA's right to take enforcement actions, as appropriate. The NPL is
designed primarily for informational purposes and to assist EPA
management. Section 300.425(e)(3) of the NCP states that the deletion
of a site from the NPL does not preclude eligibility for further
response actions, should future conditions warrant such actions.

IV. Basis for Partial Site Deletion

    The following information provides EPA's rationale for deleting the
remaining portion of OU9, Residential Populated Areas of the California
Gulch Superfund Site from the NPL.

Site Background and History

    The California Gulch Superfund Site (Site), EPA ID No.
COD980717938, is located in Lake County, Colorado approximately 100
miles southwest of Denver. The Site was proposed for inclusion on the
National Priorities List, December 30, 1982, 47 FR 58476, and listed on
September 8, 1983, 48 FR 40,658. The Site is in a highly mineralized
area of the Colorado Rocky Mountains covering approximately 18 square
miles of a watershed that drains along California Gulch to the Arkansas
River. The Site includes the City of Leadville, various parts of the
Leadville Historic Mining District, Stringtown, and a section of the
Arkansas River from the confluence of California Gulch to the
confluence of Two-Bit Gulch. Being a Rocky Mountain community, the City
of Leadville (population 2,801) has a high percentage of second homes.
Commercial, residential, and industrial properties and vacant lots are
mixed in together. Mining, mineral processing, and smelting activities
have occurred at the Site for more than 130 years. Mining in the
district began in 1860, when placer gold was discovered in California
Gulch. As the placer deposits were exhausted, underground workings
became the principal method for removing gold, silver, lead and zinc
ore. As these mines were developed, waste rock was excavated along with
the ore and placed near the mine entrances. Ore was crushed and
separated into metallic concentrates at mills, with mill tailing
generally slurried into tailing impoundments. The Leadville area was
the site of extensive gold, silver, lead and zinc mining, milling and
smelting operations. Most of the facilities ceased operations around
1900, although several facilities continued operations into the 1920s
(Western Zinc) and the 1960s (AV Smelter).
    All of the mines within the Site boundaries are presently inactive,
and all of the mills and smelters have been demolished. As a result of
these operations, the Site contains mill tailing (the fine-grained
residue remaining after milling and separation has removed the metal
concentrates form the ore) impoundments, fluvial deposits, slag piles,
mine waste rock piles (mine development rock and low grade ore removed
to gain access to an ore body, and often deposited near adits and shaft
openings), and mine water drainage tunnel which have further
distributed heavy metals throughout the area. In addition, smelters,
which previously operated at the Site, have historically been a source
of heavy metals from dust and stack emissions.
    The Site was placed on the NPL due to concerns regarding the impact
of acidic and metals laden mine drainage on surface waters leading to
California Gulch and the impact of heavy metals loading into the
Arkansas River. A Site-wide Phase I Remedial Investigation

(Phase I RI), which primarily addressed surface and groundwater
contamination, was issued in January 1987. As a result of the Phase I
RI, EPA identified the first operable unit, the Yak Tunnel, to address
the largest single source of metallic loading. A number of additional
Site-wide studies followed the Phase I RI.
    EPA agreed, pursuant to a May 2, 1994 Consent Decree (1994 CD), to
divide the Site into 12 operable units (OUs). With the exception of
OU12, the operable units pertain to distinct geographical areas
corresponding to areas of responsibility for the identified responsible
parties and/or to distinct sources of contamination. The OUs are as
follows:

1. Yak Tunnel/Water Treatment Plant
2. Malta Gulch Tailing Impoundments and Lower Malta Gulch Fluvial
Tailing
3. D&RGW Slag Piles and Easement
4. Upper California Gulch
5. ASARCO Smelter Sites/Slag/Mill Sites
6. Starr Ditch/Stray Horse Gulch/Lower Evans Gulch/Penrose Mine Waste
Pile
7. Apache Tailing Impoundments
8. Lower California Gulch
9. Residential Populated Areas
10. Oregon Gulch
11. Arkansas River Valley Floodplain
12. Site-wide Surface and Groundwater

    To date, OU2; OU8; OU10; and parts of OU9--Subunits A and B,
residential mine waste rock piles, and the parks and playgrounds--have
been partially deleted from the NPL.

OU9 Background and History

    The soils in OU9 have been highly disturbed by human activities.
The yards of most residences have grass cover over either native soil
or imported fill. The sources of fill materials have included areas
outside the Site and waste rock and tailing from California and Stray
Horse Gulch. Even though mining operations are no longer active at the
Site, waste products and other residues from past mining and smelting
activities are present in OU9--some as visible features. Additionally,
smelter emissions and slag may have contaminated some residential
soils.
    OU9 includes residential area soils in those portions of the Site
where the land use is residential or that were zoned as residential/
populated areas and as low-density residential areas on or before
September 2, 1999. A map of OU9, named OU9 Partial Deletion--
Residential Areas, can be found in the docket at http://www.regulations.gov under California Gulch. Residential area soils are
defined as soils in the residential area of the Site (see Attachment A
of the 1994 CD) which may have been impacted by past smelting and
mining activities. This encompasses the City of Leadville, Stringtown,
and outlying areas zoned for residential use. Included are residential
properties, yards, parks, vacant lots, schools yards, playgrounds, and
community use areas, including unpaved streets and alleys. Additionally
OU9 includes 38 mine waste piles located within the populated areas of
eastern Leadville. For ease in determining compliance with blood
monitoring performance standards, OU9 was geographically divided into
statistical subunits A through G.
    Subunits A and B (the shaded area of OU9 on the map in the docket),
38 residential waste rock piles, and the parks and playgrounds within
OU 9 were partially deleted from the NPL on January 30, 2002.
    The remaining portion of OU9 (shown in yellow on the map in the
docket) are the subject of this deletion. EPA is the lead agency for
OU9; Colorado Department of Public Health and Environment (CDPHE) is
the support agency. Under the 1994 CD, ASARCO assumed responsibility
for OU9.

Remedial Investigations and Feasibility Study (RI/FS)

Remedial Investigations
    The State of Colorado, EPA and certain Potentially Responsible
Parties have conducted various studies and investigations to evaluate
the nature and extent of contamination within the Site. In 1991,
Remedial Investigations (RIs) began for several areas within the Site,
including mine waste rock piles, tailing disposal areas, surface water
and aquatics, groundwater, smelter sites, residential/populated area
soils, slag piles, and terrestrial studies. These studies have
determined lead in soils to be the primary contaminant of concern in
OU9.
Interim Response--The Kids First Program
    ASARCO and many community members argued that there are numerous
environmental sources of lead in the residential areas of Leadville.
One primary source was mining-related primary sources such tailing and
mine waste piles. Other primary sources include lead-containing paint
on interior and exterior surfaces of homes and lead found in food,
water, and residential soils. As recommended by ASARCO and the
community, the interim response was designed to reduce overall lead-
related risk to children in Leadville, including responses that address
sources that would not normally be remediated under CERCLA authorities.
As part of the 1994 CD with EPA and the State, ASARCO agreed to
undertake actions to address all sources of lead in lieu of soil
removal only at each residence. To determine the effectiveness of the
actions, the level of lead in children's blood was voluntarily
monitored and performance standards in relation to concentrations of
lead in the blood of children were established.
    In 1995, ASARCO began implementing the Lead Risk Reduction Program
(LRRP), more commonly known as the Kids First Program (KF). ASARCO
agreed to operate KF as an interim response action until EPA selected a
remedy for OU9.
    The purpose of KF, a risk reduction response program based on
voluntary participation, was to: (1) Provide information to the
community, and (2) reduce children's exposure to secondary sources of
lead. KF consisted of a variety of services and remedial response
activities designed to: (1) Gather information from the community, (2)
identify residences for which response actions are needed, (3) plan and
prioritize the risk reduction responses for these residences, (4)
perform the risk reduction responses, and (5) provide additional
information and services to the community.
    Initially KF targeted residences where sample soil lead levels were
found above 3,500 mg/kg because EPA established an interim response
level of 3,500 mg/kg lead for Leadville residential soils. The basis
for this value is presented in the 1994 CD, along with a discussion of
trigger criteria for other significant environmental media (dust, paint
and water). These trigger criteria were used by the KF work group to
identify and prioritize locations for response actions.
    Residences with children that had blood-lead levels greater than 10
[mu]g/dl, measured during the 1991 Blood-Lead Study or any subsequent
blood-lead monitoring, were targeted for priority response in the
program.
    Information used in the evaluation of residences and the selection
of appropriate response actions (if needed) came from a variety of
sources. Response programs included within KF were:
     The blood-lead monitoring program by Lake County Health
Department;
     A lead information hotline and a door-to-door survey
within priority exposure areas; and

     Additional environmental sampling and property assessment.
    The Lake County Health Department managed the voluntary blood-lead
monitoring program, which was funded by ASARCO. The blood-lead
monitoring program was a key component of the interim response program.
Ongoing blood-lead monitoring was provided upon request for children
below the age of 72 months (6 years) and for pregnant/nursing women.
The data were used as one means of identifying individuals who had
blood-lead levels greater than 10 [mu]g/dl. The data were also used in
the finalization of the Baseline Risk Assessment.
    All homeowners or residents who responded via the hotline/office or
door-to-door surveys received information about the program. The
Information Hotline and the door-to-door surveys resulted in the need
for additional environmental sampling of soils, paint, dust, water, and
blood-lead levels. Environmental sampling was conducted if the
residence: (1) Was located in the 3,500 mg/kg lead soils priority area,
(2) had a child with a blood-lead level greater than 10 [mu]g/dl, (3)
had a pregnant or nursing woman in the home, (4) was known to have
paint in poor condition or known to have another possible lead source
(lead pipes, certain hobbies, etc.), or (5) was requested by a resident
who is not within the designated priority risk area.
    The first year remediations were performed at 37 properties in
accordance with Action Memoranda prepared for each property. The KF
work group developed and approved all action and no-action
determinations. The property owners consented on all investigations and
remediations.
    KF integrated a variety of lead toxicity intervention and abatement
methods. Additionally, KF addressed reducing children's exposure to
lead in soils, dust-containing lead in residences, and additional lead
sources such as paint and tap water. For these reasons, KF was
presented as an alternative in the feasibility study when it was
revised and renamed the Lake County Community Health Program (LCCHP).
Risk Assessments
    Concurrent with the interim response, numerous risk assessments
were conducted as part of the investigation. They included Baseline
Human Health Risk Assessments (BRAs): Part A (Weston 1996), Part B
(Weston 1996), and Part C (Weston 1995); Ecological Risk Assessment for
Terrestrial Ecosystems (Weston 1997); Surface Water Human Health Risk
Assessment (Golder 1996); Groundwater Baseline Human Health Rick
Assessment (Golder, June 1996) and Baseline Aquatic Ecological Risk
Assessment (Weston 1995).
    The Baseline Human Health Risk Assessments (BRAs) concluded that
lead was the only contaminant of concern (COC) for OU9. There are no
locations on-Site where antimony, barium, cadmium, beryllium, chromium,
copper, mercury, nickel, silver, thallium, or zinc are of significant
concern in residential soil. The risk assessment also concluded that
non-lead metals (including arsenic and manganese) in residential soils
do not pose a significant health risk to residents.
    The risk assessment for lead was supported by a large body of Site-
specific data. Included were: (1) Extensive measurements of lead in
soil and dust in residential locations, (2) an extensive demographics
survey, data on lead levels in water and paint (both interior and
exterior), (3) data on the physical and chemical forms of lead at
various locations around the community, and (4) an informative
community-wide blood-lead study involving 314 children (about 65% of
the total population of children at the Site). This data was used to
support two parallel lines of investigation and assessment. The first
of these employed EPA's Integrated Exposure Uptake and Biokinetic
(IEUBK) model to calculate the expected impact of lead levels in soil
and dust on blood-lead levels in area children. The second approach
compared the measured blood-lead values in area children with relevant
national blood-lead statistics in order to help evaluate the current
effects of actual Site exposure to lead.
    Several ecological risk assessments were performed on a site-wide
basis for the California Gulch Site. These are available in the docket
or on the EPA Web site, http://www.epa.gov/region8/superfund/co/calgulch/. These assessments showed a potential unacceptable risk to
small mammals and breeding birds. However, given the data available,
there was little evidence of population-level effects on small mammals
or breeding birds. In addition, calculated ecological risk due to
potential exposure to tailing or waste rock media found in other
operable units was higher than risks resulting from potential exposure
to surrounding soils found in OU9.
Feasibility Study (FS)
    The Final Residential Soil Feasibility Study, completed by Golder
Associates in November of 1998, evaluated seven remedial alternatives
to address the residential soils of properties, yards and open space
areas within OU9 where lead levels exceeded the trigger level of 3,500
mg/kg.
    One alternative in the FS was the LCCHP, a revised version of the
KF used during the interim response. The LCCHP combined blood-lead
monitoring, education, community awareness, and residence specific
response actions reduced the potential for children to be exposed to
lead in Leadville and surrounding areas. This program addressed lead in
soil and dust, interior and exterior paint, plumbing fixtures, and
dietary and household sources. It also included institutional controls
to ensure effectiveness of the LCCHP. Operation and maintenance
activities included LCCHP administration and the blood-lead monitoring
program.

Selected Remedy

    Signed on September 2, 1999, the OU9 Record of Decision (1999 ROD)
selected a remedy for addressing lead in soils in residential
population areas. The selected remedy was the LCCHP with institutional
controls (ICs) to ensure the effectiveness of the LCCHP. In September
2009, an Explanation of Significant Differences required ICs for the 17
mine waste piles remaining in OU9.
    The Remedial Action Objectives (RAO) from the 1999 ROD are:
     RAO-1: No more than 5% of children age 0-72 months
residing within OU9, either now or in the future, should have blood-
lead values exceeding 10 [mu]g/dl.
     RAO-2: No more than 1% of children age 0-72 months
residing within OU9, either now or in the future, should have blood-
lead values exceeding 15 [mu]g/dl.
     RAO-3: Reduce direct exposure of lead incurred by children
which result in optimal risk reduction through effective use of
resources.
LCCHP
    The LCCHP combined (1) Community awareness and education, (2)
residence-specific response actions to reduce the risk of lead exposure
to children in Leadville and (3) blood-lead monitoring. Funding for the
LCCHP was from a trust fund established by ASARCO under the 1994 CD.
LCCHP Community Awareness and Education
    The LCCHP involved an extensive education and intervention program
to manage lead exposure at the Site. The educational program focused on
raising public awareness about risks from lead

and encouraged participation in the LCCHP. Outreach included the
hotline, door-to-door contacts, public notices, mailings, publications,
meetings and incentives. Education included individual face-to-face
consultations with residents and customized recommendations for
specific actions that reduced the residents' risk to lead exposure. The
recommendations made to each resident were based on the results of
environmental lead sampling at their homes and specific information
collected by the program about their daily habits and activities.
Follow-up education, consultation, and intervention continued with
families that had young children by the Lake County Health Department
through their blood-lead monitoring program; Women, Infants, and
Children (WIC); and Head Start.
LCCHP Residence-Specific Actions
    Through this program, Leadville residents were able to request an
investigation of lead levels in soil, dust, paint, and water on their
property. Properties owners could also request a re-investigation if
conditions changed. The LCCHP investigated and remediated lead
concentrations in soil, paint, dust, and water on a property-by-
property basis. Sampling plans were designed for each individual
investigated property. Action was taken when trigger levels were
exceeded. All investigations and remediations were performed with the
consent of the property owners. Owner contact and consent, sampling
plans, analytical data, remediation activities and final closeout
procedures were extensively documented. Property Documentation Reports
(completion reports) were sent to property owners and are kept on file
at EPA.
LCCHP Blood-Lead Monitoring
    The LCCHP also included voluntary blood-lead monitoring (with
financial incentives, as appropriate) for all children six years old
and under, and pregnant or nursing women. As part of the program,
appropriate actions were taken when the concentration of lead in blood
of a child or a pregnant or nursing woman exceeded the blood-lead
criterion, or when the concentration of lead exceeded a specified set
of trigger criteria for one or more of the environmental media at a
residence.
LCCHP Trigger Levels
    These trigger criteria are summarized below:

 Blood-lead greater than or equal to 10 [mu]g/dL;
 Soil with lead concentrations greater than or equal to 3,500
mg/Kg;
 Dust in houses with lead concentrations greater than or equal
to 2,000 ppm;
 Tap water with lead concentrations greater than or equal to 15
[mu]g/l; and
 Interior or exterior paint, in poor condition, with the
following lead levels:
     Greater than or equal to 1 mg/cm\2\ triggers educational
action, and
     Greater than or equal to 6 mg/cm\2\ triggers active
remediation

    When one or more of the trigger criteria were exceeded, a work
group evaluated a range of different response actions. The most
appropriate response action was determined by evaluating the nature and
extent of the exceedance, overall protectiveness of the action,
compliance with applicable or relevant and appropriate requirements,
long-term effectiveness and permanence, short-term effectiveness,
implementability, cost effectiveness, and community impacts. The work
group also considered the views of the property owner, and only
implemented response actions when property owners provided permission.
Extensive education and intervention programs to manage lead exposure
at the Site were an integral component of each action considered.
Scientific Review of LCCHP
    Since the LCCHP was considered a ``pilot project'' that involved a
number of innovative approaches, the program was (1) evaluated by a
group of outside scientists and (2) included ongoing review to ensure
that the program was operating as intended and that human health was
being adequately protected. The ongoing review included the
establishment of performance standards which when met would indicate
the successful completion of the LCCHP and the beginning of operation
and maintenance.
Performance Standards
    The 1999 ROD provided that performance standards would be
established during the remedial design phase. These performance
standards were necessary to determine if the blood-lead monitoring
program met the RAOs. The performance standards were set out in a July
2002 addendum to the OU9 remedial design and are summarized in the
Final Methods and Standards for Evaluating the Performance of the
LCCHP.
    As documented in annual reports beginning in 2002, the data
collected was analyzed, and the results were compared to the
performance standards, expressed as goals for blood-lead levels in
children, to determine the effectiveness of the program.
    During the calendar year 2005, the performance standards
established by EPA for the selected remedy were met. This conclusion is
supported and documented in the 2005 LCCHP annual report.
    The LCCHP was implemented as required by the ROD and under the
Methods and Standards for Evaluating the Performance of the Program.
ASARCO continued to execute the LCCHP until July 2005 when ASARCO
declared bankruptcy, after which EPA managed the LCCHP soil
investigations and cleanups. The work group continued the blood-lead
monitoring and education/outreach programs.

Response Actions

    KF conducted several time critical removal actions from October
1995 to April 2000. Under the LCCHP from April 2000 to the summer of
2009, time critical removal actions were completed on multiple
residences, commercial properties and vacant lots.
    From October 1995 to the summer of 2009, 1040 properties were
investigated. 270 of those properties required a soil removal action.
Forty properties, which may or may not have had soil removals, have had
dust removed or paint repaired/replaced. The EPA conducted the last
property assessment and response actions in the summer of 2009.
``Last Call''
    In an effort to include any property that had not participated in
the LCCHP, a ``last call'' for property owners to have their property
investigated was given in 2006 by the EPA and ASARCO. EPA sent a letter
notifying property owners of the ``last call'' and published several
notices in the Leadville Herald Democrat. EPA completed investigations
and remediation of ``last call'' properties in the summer of 2009.
    Due to ASARCO's bankruptcy in 2005, EPA proceeded to finish the
assessment and cleanup of properties that were already scheduled for
work. Additionally, EPA also investigated and cleaned up properties
from the ``last call.'' Due to the short construction season in Lake
County, the last Site assessment and on the ground construction work
was not completed until the summer of 2009.
Institutional Controls (ICs)
    On March 15, 2010, Lake County passed a resolution approving the
LCCHP Phase 2 Work Plan and adopting the LCCHP Phase 2 as an IC for
OU9. With the County's passing of the resolution to adopt the LCCHP
Phase 2 Work Plan as an IC for OU9, remedial action was completed.

    Moreover on December 23, 2009, the County also passed a resolution,
which serves as an IC. The resolution amends the Lake County Land
Development Code Chapter 3.2. The Lake County Building and Land Use
Department (LCBLUD) is required to provide building permit applicants
within the boundaries of the remaining 38 mine waste piles in OU9 with
a handout regarding Best Management Practices for managing potentially
contaminated soils in Lake County. Each applicant is obligated to sign
a document attesting to the fact that he/she received, read and
understood the Lake County Best Management handout. No building permit
will be issued without the applicant's written acknowledgement provided
to the LCBLUD. Additionally, written proof of approval from the CDPHE
is a condition precedent to issuance of a building permit by the
LCBLUD.

Operation and Maintenance

    The LCCHP Phase 2 Work Plan also serves as the operations and
maintenance (O & M) plan for OU9. The goal of the LCCHP Phase 2 is to
maintain the progress made in reducing overall lead-related risk to
children and pregnant and nursing women who live in Leadville through
education, blood-lead monitoring of children, investigation when
elevated blood lead is detected, and a cleanup response, if
appropriate.
    In addition to blood-lead monitoring, the LCCHP Phase 2 includes
community education and outreach. Under the modified program, Lake
County provides information to residents and families with children to
promote ongoing community awareness of health risks from lead
exposures. The Lake County Public Health Agency provides this
information several ways, including periodic public notices in the
newspaper, brochures in physicians' offices, and handouts during
immunization visits. Additionally, Lake County provides counseling,
education and small incentives to families who participate in the
modified program's blood-lead monitoring program.
    The most significant change from the LCCHP (remedial action) is
that residential environmental sampling and cleanup for soil, dust and
paint are only offered:
    (1) When children or pregnant/nursing mothers living at a property
have blood-lead levels at or above the Center for Disease Control's
level of concern, currently 10 [mu]g/dl; or
    (2) At the specific recommendation of either the work group or the
Lake County Public Health Agency.
    The original program allowed residents to request environmental
sampling with no preconditions. This service is no longer available. In
addition, the work group may not offer environmental sampling if
preliminary investigation indicates the source of lead exposure is
solely from household items such as consumer goods, toys, candy, etc.
Environmental sampling and cleanup will occur as directed by the work
group and only with the consent of the resident and/or property owner.
    The County and State administer the LCCHP Phase 2 with EPA
oversight. The Lake County Public Health Agency monitors blood-lead
concentrations in individual children who live within the County, and
provides workshops and educational material to families about
preventing exposure to lead. CDPHE performs data management,
environmental sampling and cleanup upon recommendation of the work
group.

Five-Year Review

    The remedies at the entire Site, including OU9, require ongoing
five-year reviews in accordance with CERCLA Section 121(c) and Section
300.430(f)(4)(ii) of the NCP. The next five-year review for the
California Gulch Site is scheduled for 2012.
    In the 2007 five-year review for the Site, the OU9 remedy that was
determined was protective of human health and the environment. However,
concerns were noted about continued protectiveness because ICs were not
in place and an O & M Plan did not exist. Those concerns were resolved
when the work group approved the LCCHP Phase 2 as an IC and O & M Plan
for properties in OU9, and Lake County adopted ICs by resolution.

Community Involvement

    Public participation activities have been satisfied as required in
CERCLA Section 113(k), 42 U. S. C. 9613(k) and CERCLA Section 117, 42
U. S. C. 9617. Documents in the partial deletion docket which the EPA
relied on for recommendation for the partial deletion from the NPL are
available to the public in the information repositories and a notice of
availability of the Notice of Intent for Partial Deletion has been
published in the Leadville Herald Democrat to satisfy public
participation procedures required by 40 CFR 300.425(e)(4).
    A fact sheet outlining the new LCCHP Phase 2 was presented to the
public in June 2009. The public commented and EPA responded. The State,
the Lake County Commissioners and the Mayor of Leadville are supportive
of the deletion of OU9.

Determination That the Criteria for Deletion Have Been Met

    More specifically for OU9, EPA and the State have determined that
the responsible parties completed all appropriate response actions. EPA
has consulted with the State, Lake County Commissioners, and the City
of Leadville, Colorado, on the proposed partial deletion of OU9 from
the NPL prior to developing this Notice of Partial Deletion. Through
the five-year reviews, EPA has also determined that the response
actions taken are protective of public health or the environment and,
therefore, taking of additional remedial measures is not appropriate.
    Pursuant to CERCLA section 121(c) and the NCP, EPA will finalize
the next five-year review in 2012 to ensure the continued
protectiveness of remedial actions where hazardous substances,
pollutants, or contaminants remain at the Site above levels that allow
for unlimited use and unrestricted exposure.

V. Deletion Action

    The EPA, with concurrence of the State of Colorado through the
Colorado Department of Public Health and Environment on February 16,
2011, has determined that all appropriate response actions under
CERCLA, other than operation, maintenance, monitoring and five-year
reviews, have been completed. Therefore, EPA is deleting the remaining
portions of OU9, the Residential Populated Areas, from the NPL.
    Because EPA considers this action to be noncontroversial and
routine, EPA is taking it without prior publication. This action will
be effective July 25, 2011 unless EPA receives adverse comments by June
23, 2011. If adverse comments are received within the 30-day public
comment period, EPA will publish a timely withdrawal of this direct
final notice of partial deletion before the effective date of the
partial deletion and it will not take effect. EPA will prepare a
response to comments and continue with the deletion process on the
basis of the notice of intent to partially delete and the comments
already received. There will be no additional opportunity to comment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping

requirements, Superfund, Water pollution control, Water supply.

    Dated: May 10, 2011.
James Martin,
Regional Administrator, Region 8.

    For the reasons set out in this document, 40 CFR part 300 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 1 of Appendix B to part 300 is amended by revising the entry
under ``California Gulch'', Colorado to read as follows:

Appendix B to Part 300--National Priorities List

                                       Table 1--General Superfund Section
----------------------------------------------------------------------------------------------------------------
                State                          Site name                City/county             Notes \(a)\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
CO...................................  California Gulch........  Leadville...............  P

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

[FR Doc. 2011-12763 Filed 5-23-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 80 (Wednesday, April 28, 2021)]
[Notices]
[Pages 22414-22419]
[FR Doc No: 2021-08839]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2020-0473; FRL-10020-39]

Seventy-Fourth Report of the TSCA Interagency Testing Committee
to the Administrator of the Environmental Protection Agency; Receipt of
Report and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing
Committee (ITC) transmitted its Seventy-Fourth Report of the ITC to the
Administrator of the Environmental Protection Agency (EPA) on April 13,
2020. In the Seventy-Fourth Report of the ITC, which is included with
this notice, the ITC is revising the Priority Testing List by adding 15
of the 20 High-Priority Substances, designated as such under TSCA, and
24 organohalogen flame retardants. EPA is hereby announcing the receipt
of and invites public comment on the ITC Report reproduced at the end
of this notice.

DATES: Comments must be received on or before May 28, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0473, by using the Federal eRulemaking
Portal at http://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Diana Fahning, Data Gathering and Dissemination Division (7410M),
Office of Pollution Prevention and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This notice is directed to the public in general. It may, however,
be of particular interest to you if you manufacture (defined by statute
to include import) and/or process chemical substances described in this
notice that are subject to the Toxic Substances Control Act (TSCA), 15
U.S.C. 2601, et seq. and you may be identified by the North American
Industrial Classification System (NAICS) codes 325 and 32411. Because
this notice is directed to the general public and other entities may
also be interested, the Agency has not attempted to describe all the
specific entities that may be interested in this action.

B. What is the Agency's authority?

    TSCA section 4(e) created the TSCA ITC as an independent advisory
committee to the Administrator of the U.S. EPA. The ITC was created to
make recommendations to the EPA Administrator on prioritizing and
selecting chemicals for testing or information reporting to meet the
coordinated data needs of its member U.S. Government organizations.
Such recommendations are presented to the EPA Administrator in the form
of additions to the TSCA section 4(e) Priority Testing List. The ITC
transmits revisions to the Priority Testing List to the EPA
Administrator in ITC reports that EPA publishes in the Federal Register
for public comment as directed by TSCA.

C. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information submitted in
an electronic storage device such as a flash drive, disk or CD-ROM that
you mail to EPA, mark the outside of the device as CBI and then
identify electronically within the device the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

    EPA is publishing the following ITC report and is soliciting
comment on the revisions to the Priority Testing List and any
information relevant to this listing.

A. Seventy-Fourth Report of the ITC

    In the 74th ITC Report, the ITC is revising the TSCA section 4(e)
Priority Testing List by adding 15 High-Priority Substances designated
pursuant to TSCA section 6(b) and 24 organohalogen flame retardants to
the Priority Testing List. The ITC requests that EPA add these chemical
substances and the other five High-Priority Substances and six
organohalogen flame retardants currently on the Priority Testing List
to 40 CFR 716.120(a), which is the list of substances subject to 40 CFR
part 716, under the procedures in Sec.  716.105.

B. Status of the TSCA Section 4(e) Priority Testing List

    The chemical substances being added to the TSCA section 4(e)
Priority Testing List can be found below in Table 1 of the 74th ITC
Report and the remainder of the chemicals and chemical categories can
be found in Table 2 of the report. In addition to the chemical
substances being added to the Priority Testing List in the 74th ITC
Report, the Priority Testing List includes 2 alkylphenols, 45 HPV
Challenge

Program orphan chemicals, cadmium, a category of cadmium compounds, 6
non-phthalate plasticizers, 25 phosphate ester flame retardants, 2
other flame retardants, 9 chemicals to which children living near
hazardous waste sites may be exposed, and 19 diisocyanates and related
compounds.

    Authority: 15 U.S.C. 2601 et seq.

Michael S. Regan,
Administrator.

Seventy-Fourth Report of the TSCA Interagency Testing Committee to the
Administrator of the Environmental Protection Agency (EPA)

Table of Contents

Summary
I. Background
II. TSCA Section 8(d) Health and Safety Data Reporting Rule
III. Activities During the May 2020 ITC Meeting and Revisions to the
TSCA Section 4(e) Priority Testing List: Addition of 15 High-Priority
Substances and 24 Organohalogen Flame Retardants
IV. References
V. The TSCA Interagency Testing Committee

Summary

    In this 74th ITC Report, the ITC is revising the Toxic Substances
Control Act (TSCA) section 4(e) Priority Testing List by adding 15
High-Priority Substances and 24 organohalogen flame retardants and
requesting that EPA add these chemicals to the TSCA section 8(d) Health
and Safety Data Reporting rule. The ITC is also requesting that EPA add
the other five High-Priority Substances and six organohalogen flame
retardants specified in Unit III. of this report, and currently on the
Priority Testing List, to the Health and Safety Data Reporting rule.

I. Background

    The ITC was established under section 4(e) of TSCA and recommends
to EPA chemical substances and mixtures to be given priority
consideration for the development of information under TSCA section
4(a). These recommendations are made in the form of a list known as the
Priority Testing List. The ITC revises the Priority Testing List as it
determines necessary and transmits such revisions to the EPA
Administrator with the ITC's rationales for the revisions. ITC Reports
are available from regulations.gov http://www.regulations.gov after
publication in the Federal Register and on EPA's website https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/interagency-testing-committee-itc-reports. The ITC produces its revisions to the
Priority Testing List with administrative and technical support from
EPA staff, ITC Members, and their U.S. Government organizations. ITC
members and staff are listed at the end of this report.

II. TSCA Section 8(d) Health and Safety Data Reporting Rule

    Following receipt of the ITC's report (and the revised Priority
Testing List) by the EPA Administrator, and following the public
comment period on this report and consideration of any such comments
received, EPA's Office of Pollution Prevention and Toxics (OPPT) may
add the chemicals from the revised Priority Testing List to the TSCA
section 8(d) Health and Safety Data Reporting rule (40 CFR part 716)
(Ref. 1). The Health and Safety Data Reporting rule requires
manufacturers (including importers) of chemical substances and mixtures
added to the Health and Safety Data Reporting rule to submit lists and
copies of unpublished health and safety studies to EPA.

III. Activities During the May 2020 ITC Meeting and Revisions to the
TSCA Section 4(e) Priority Testing List: Addition of 15 High-Priority
Substances and 24 Organohalogen Flame Retardants

    During the May 2020 ITC meeting, the ITC discussed the 20 High-
Priority Substances designated by EPA under TSCA section 6(b) and
information-gathering options for these substances. Five of these High-
Priority Substances were already on the Priority Testing List, added
previously by the 69th ITC Report (Ref. 2). The ITC discussed adding
the remaining 15 High-Priority Substances to the Priority Testing List
and also requesting the addition of those chemical substances to the
TSCA section 8(d) Health and Safety Data Reporting rule (40 CFR part
716) so that EPA may obtain unpublished health and safety studies on
all 20 High-Priority Substances.
    During the May 2020 ITC meeting, the ITC also discussed adding a
group of organohalogen flame retardants to the Priority Testing List to
obtain unpublished health and safety studies on 30 organohalogen flame
retardants, six of which were previously added to the Priority Testing
List by the 69th ITC Report.
    The 15 High-Priority Substances and 24 organohalogen flame
retardants being added to the Priority Testing List are listed in Table
1 of this unit. The remainder of the chemical substances and mixtures
on the Priority Testing List is provided in Table 2 of this unit.
    The five High-Priority Substances that were already listed on the
Priority Testing List are 1,1-dichloroethane (CAS No. 75-34-3), 1,2-
dichloroethane (CAS No. 107-06-2), ethylene dibromide (CAS No. 106-93-
4), tris(2-chloroethyl) phosphate (TCEP) (CAS No. 115-96-8), and
phosphoric acid, triphenyl ester (TPP) (CAS No. 115-86-6). The ITC is
also requesting the addition of these chemical substances to the TSCA
section 8(d) Health and Safety Data Reporting rule so that EPA can
obtain unpublished health and safety studies on these substances.
    The six organohalogen flame retardants that were already listed on
the Priority Testing List are bis(2-ethylhexyl) tetrabromophthalate
(CAS No. 26040-51-7), 2-ethylhexyl 2,3,4,5-tetrabromobenzoate (CAS No.
183658-27-7), phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl
tetrakis(2-chloroethyl) ester (CAS No. 38051-10-4), tris(2-
chloroisopropyl)phosphate (CAS No. 13674-84-5), tris(2-chloropropyl)
phosphate (CAS No. 6145-73-9), and tris(1,3-dichloro-2-propyl)
phosphate (CAS No. 13674-87-8). The ITC is also requesting the addition
of these chemical substances to the TSCA section 8(d) Health and Safety
Data Reporting rule so that EPA can obtain unpublished health and
safety studies on these substances.

Chemical Substances Added to the Priority Testing List

1. High-Priority Substances
    i. Recommendation. The ITC is adding the 15 High-Priority
Substances listed in Table 1 of this report to the Priority Testing
List. The ITC is also requesting the addition of these chemical
substances to the TSCA section 8(d) Health and Safety Data Reporting
rule so that EPA can obtain to obtain unpublished health and safety
studies on health effects, physical/chemical properties, environmental
fate, environmental effects, and exposure.
    ii. Rationale for recommendation. The 20 High-Priority Substances
identified in this report have been designated High-Priority under TSCA
section 6(b) because EPA has found that each of these chemical
substances may present an unreasonable risk of injury to health or the
environment under the conditions of use for that chemical substance
(Ref. 4). The development of information on these chemical substances
under TSCA section 4(a) will enable EPA to inform its risk evaluation
findings of whether any of these High-Priority Substances present an
unreasonable risk of injury to health or

the environment under the conditions of use for each of these chemical
substances.
    iii. Supporting information. TSCA section 6 requires EPA to address
existing chemical substances with a three-stage process. The three
stages of EPA's process for ensuring there are no unreasonable risks
associated with the conditions of use of existing chemical substances
are (1) prioritization, (2) risk evaluation, and (3) risk management.
Prioritization and risk evaluation are carried out in accordance with
procedural regulations at 40 CFR part 702, subparts A and B,
respectively.
    During prioritization EPA designates a chemical substance as either
High-Priority for risk evaluation, or Low-Priority for which risk
evaluation is not warranted at the time. A High-Priority Substance is
defined under TSCA section 6(b)(1)(B)(i) as ``a chemical substance that
the Administrator concludes, without consideration of costs or other
nonrisk factors, may present an unreasonable risk of injury to health
or the environment because of a potential hazard and a potential route
of exposure under the conditions of use, including an unreasonable risk
to potentially exposed or susceptible subpopulations identified as
relevant by the Administrator.''
    During the prioritization process, EPA identifies chemical
substances that are candidates for prioritization and then uses
reasonably available information to screen each candidate chemical
substance against certain criteria and considerations specified in TSCA
section 6(b)(1)(A):
     The hazard and exposure potential of the chemical
substance;
     Persistence and bioaccumulation of the chemical substance;
     Potentially exposed or susceptible subpopulations;
     Storage near significant sources of drinking water;
     The conditions of use or significant changes in the
conditions of use of the chemical substance;
     The volume or significant changes in the volume of the
chemical substance manufactured or processed; and
     Other risk-based criteria that EPA determines to be
relevant to the designation of the chemical substance's priority.
    Conditions of use is defined under TSCA section 3(4) to mean ``the
circumstances, as determined by the Administrator, under which a
chemical substance is intended, known, or reasonably foreseen to be
manufactured, processed, distributed in commerce, used or disposed
of.''
    Under this process, EPA issues a proposal to designate each
chemical substance as either a High-Priority Substance or Low-Priority
Substance based on the results of the screening review and other
relevant information. Following additional public comment opportunity,
EPA finalizes the designation for each chemical substance. Final
designation of a chemical substance as a High-Priority Substance
initiates the risk evaluation process for that chemical substance. The
risk evaluation process has begun for each of these 20 High-Priority
Substances. Under TSCA section 4(a)(2), EPA may by rule, order, or
consent agreement ``require the development of new information relating
to a chemical substance or mixture if the Administrator determines that
the information is necessary. . .to perform a risk evaluation under
section [6(b)] . . .''
    iv. Information needs. Under TSCA section 4(a)(2), EPA can by Test
Order require testing when there is a need for information and all
reasonably available information has been assessed. Order authority can
be used to efficiently obtain information to inform the TSCA section 6
prioritization and risk evaluation processes. Information needs
specific to each of the 20 High-Priority Substances have been
identified and would be informed under this authority. Additionally,
collection of health and safety data on health effects, toxicokinetics,
environmental effects, environmental fate, physical chemical
properties, and exposure would inform EPA activities involving these
chemicals.
2. Organohalogen Flame Retardants
    i. Recommendation. The ITC is adding a group of 24 ``organohalogen
flame retardants'' (OFRs) to the Priority Testing List. In addition to
adding these chemicals substances to the Priority Testing List, the ITC
is also requesting their addition to the TSCA section 8(d) Health and
Safety Data Reporting rule so that EPA can obtain unpublished health
and safety studies on these chemical substances.
    ii. Rationale for recommendation. CPSC requested that additive,
nonpolymeric OFRs be added to the Priority Testing List because CPSC
voted to grant a petition to begin rulemaking for this class of
chemicals under the Federal Hazardous Substances Act and needs
information on these OFRs for such purposes. OFRs may be added to
consumer products to prevent or slow combustion, but are additive,
i.e., not covalently bound to the substrate, which can be textiles,
polymers, or foam. Most OFRs are semi-volatile compounds (SVOCs), that
can migrate into air, where they bind to airborne particles and
surfaces in the home. In addition to direct contact with OFR-containing
products, a substantial portion of exposure is believed to occur from
exposure to household dust, especially in children. Biomonitoring
studies and measurements of household dust and indoor air demonstrate
that exposure to OFRs is nearly ubiquitous.
    Many OFRs have been shown to cause health effects. Health effects
associated with OFRs include carcinogenicity (e.g., halogenated alkyl
phosphates), developmental effects (polybrominated diphenyl ethers,
PBDEs), and developmental neurotoxicity (i.e., Decabromodiphenyl ether
(decaBDE)). However, most OFRs have little or no published human health
and safety data.
    At the meeting to discuss the 74th report of the ITC, ITC members
supported CPSC's request to add these OFR's to the Priority Testing
List and had no comment as to their inclusion on the draft Priority
Testing List.
    iii. Supporting information. In 2015, CPSC was petitioned by a
number of organizations and individuals, such as consumer groups,
medical associations, workers, and firefighter organizations, to ban
the use of all additive, non-polymeric OFRs under the authority of the
Federal Hazardous Substances Act in the following consumer products:
(1) Durable infant or toddler products, children's toys, child care
articles, or other children's products (other than car seats, which are
under Department of Transportation's jurisdiction); (2) residential
upholstered furniture; (3) mattresses and mattress pads; and (4) the
plastic casings of electronic devices (Ref. 5).
    CPSC granted the petition in 2017 and directed staff to complete a
scoping and feasibility study in cooperation with the National Academy
of Sciences, Engineering, and Medicine (NASEM). The task for this
project was to develop a scientifically based scoping plan to identify
the potential health hazards associated with additive, nonpolymeric
OFRs as a class. The NASEM Committee published the report, ``A Class
Approach to Hazard Assessment of Organohalogen Flame Retardants'' in
May 2019 (Ref. 6). A key conclusion of the NASEM Committee is that OFRs
cannot be treated as a single class. Rather, the NASEM Committee
identified 14 subclasses of OFRs, based on chemical structure,
physicochemical properties of the chemicals, and predicted biologic
activity. The NASEM Committee identified 161 OFRs and

more than 1,000 analog chemicals. CPSC staff is undertaking the risk
assessment of 14 classes of OFRs following the recommendations of the
NASEM Committee.
    iv. Information needs. Preliminary searches show that little or no
health and safety data are available for many of the 161 OFRs,
including the OFRs being added to the Priority Testing List in this
report and the six OFRs already on the Priority Testing List. CPSC
needs health and safety data for the OFRs; all studies with relevant
information will help fill existing data gaps. Of special interest are
studies to help assess risks to consumers.

  Table 1--High-Priority Substances and Organohalogen Flame Retardants
                Being Added to the Priority Testing List
------------------------------------------------------------------------
                   Chemical substance                          CASRN
------------------------------------------------------------------------
Organohalogen Flame Retardants:
    Bis(hexachlorocyclopentadieno)cyclooctane...........      13560-89-9
    1,2-Bis(2,4,6-tribromophenoxy)ethane................      37853-59-1
    1,1'-Ethane-1,2-diylbis(pentabromobenzene)..........      84852-53-9
    2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-         20566-35-2
     tetrabromophthalate................................
    2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-            3072-84-2
     phenylene)oxymethylene]]bis[oxirane]...............
    Mixture of chlorinated linear alkanes C14-17 with 45-     85535-85-9
     52% chlorine.......................................
    N,N-Ethylene-bis(tetrabromophthalimide).............      32588-76-4
    Pentabromochlorocyclohexane.........................         87-84-3
    (Pentabromophenyl)methyl acrylate...................      59447-55-1
    Pentabromotoluene...................................         87-83-2
    Perbromo-1,4-diphenoxybenzene.......................      58965-66-5
    Phosphonic acid, (2-chloroethyl)-, bis(2-                  6294-34-4
     chloroethyl) ester.................................
    Propanoic acid, 2-bromo-, methyl ester..............       5445-17-0
    Tetrabromobisphenol A-bis(2,3-dibromopropyl ether)..      21850-44-2
    Tetrabromobisphenol A bis(2-hydroxyethyl) ether.....       4162-45-2
    Tetrabromobisphenol A diallyl ether.................      25327-89-3
    Tetrabromobisphenol A dimethyl ether................      37853-61-5
    2,4,6-Tribromoaniline...............................        147-82-0
    1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene.........       3278-89-5
    Tris(2-chloroethyl) phosphite.......................        140-08-9
    Tris(2,3-dibromopropyl) phosphate...................        126-72-7
    1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-             52434-90-9
     2,4,6(1H,3H,5H)-trione.............................
    Tris(tribromoneopentyl)phosphate....................      19186-97-1
    2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine...      25713-60-4
High-Priority Substances:
    1,3-Butadiene.......................................        106-99-0
    Butyl benzyl phthalate (BBP)--1,2-Benzene-                   85-68-7
     dicarboxylic acid, 1-butyl 2(phenylmethyl) ester...
    Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic            84-74-2
     acid, 1,2-dibutyl ester)...........................
    o-Dichlorobenzene...................................         95-50-1
    p-Dichlorobenzene...................................        106-46-7
    trans-1,2-Dichloroethylene..........................        156-60-5
    1,2-Dichloropropane.................................         78-87-5
    Dicyclohexyl phthalate..............................         84-61-7
    Di-ethylhexyl phthalate (DEHP)--(1,2-Benzene-               117-81-7
     dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester)....
    Di-isobutyl phthalate (DIBP)--(1,2-Benzene-                  84-69-5
     dicarboxylic acid, 1,2-bis-(2methylpropyl) ester)..
    Formaldehyde........................................         50-00-0
    1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-                         1222-05-5
     hexamethylcyclopenta [g]-2-benzopyran (HHCB).......
    Phthalic anhydride..................................         85-44-9
    4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol]             79-94-7
     (TBBPA)............................................
    1,1,2-Trichloroethane...............................         79-00-5
------------------------------------------------------------------------

                          Table 2--Remainder of TSCA Section 4(e) Priority Testing List
----------------------------------------------------------------------------------------------------------------
             Chemical substance                                     CASRN                         ITC report No.
----------------------------------------------------------------------------------------------------------------
1,1-Dichloroethane.........................  75-34-3............................................              69
1,2,3-Propanetricarboxylic acid, 2-          77-90-7............................................              69
 (acetyloxy)-, tributyl ester; Acetyl tri-n
 -butyl citrate.
Phosphoric acid, triethyl ester; Triethyl    78-40-0............................................              69
 phosphate.
Ethanol, (2-butoxy-), 1,1'',1''-phosphate;   78-51-3............................................              69
 Tri(2-butoxyethyl) phosphate.
Ethane, 1,1,2,2-tetrachloro-; 1,1,2,2-       79-34-5............................................              69
 Tetrachloroethane.
Benzene, 1,3-diisocyanato-2-methyl.........  91-08-7............................................              69
1,1'-Biphenyl, 4,4'-diisocyanato-3,3'-       91-97-4............................................              69
 dimethyl-.
[1,1'-Biphenyl]-4,4'diamine; Benzidine.....  92-87-5............................................              69
Benzene, 1,1'-methylenebis[4-isocyanato-...  101-68-8...........................................              69
Hexanedioic acid, 1,6-bis(2-ethylhexyl)      103-23-1...........................................              69
 ester; Di(2-ethylhexyl) adipate.
Benzene, 1,1'-[1,2-ethanediylbis(oxy)]bis-.  104-65-5...........................................              55
Ethane, 1,2-dibromo-; 1,2-Dibromoethane....  106-93-4...........................................              69
2-Propenal; Acrolein.......................  107-02-8...........................................              69
Ethane, 1,2-dichloro-; 1,2-Dichloroethane..  107-06-2...........................................              69
1-Pentene, 2,4,4-trimethyl.................  107-39-1...........................................              55
2-Pentene, 2,4,4-trimethyl-................  107-40-4...........................................              55

Phenol, 2-(1,1-dimethylethyl)-4-methyl-....  108-95-2...........................................              69
Phosphoric acid, triphenyl ester; Triphenyl  115-86-6...........................................              69
 phosphate.
Ethanol, 2-chloro-, phosphate (3:1); Tris-   115-96-8...........................................              69
 (2-chloroethyl) phosphate.
1,3,5-Triazine, hexahydro-1,3,5-trinitro-    121-82-4...........................................              55
 (RDX).
Phosphoric acid, tris(2-methylpropyl)ester;  126-71-6...........................................              69
 Triisobutyl phosphate.
Phosphoric acid tributyl ester; Tributyl     126-73-8...........................................              69
 phosphate.
Ethanesulfonic acid, 2-[methyl[(9Z)-1-oxo-9- 137-20-2...........................................              55
 octadecen-1-yl]amino]-, sodium salt (1:1).
4-(1,1,3,3-tetramethylbutyl) phenol........  140-66-9...........................................              41
1(2H)-Naphthalenone, 3,4-dihydro-..........  529-34-0...........................................              55
Benzene, 2,4-diisocyanato-1-methyl-........  584-84-9...........................................              69
1,2-Butadiene..............................  590-19-2...........................................              55
Propanoic acid, 2-bromo-...................  598-72-1...........................................              55
Hexane, 1,6-diisocyanato-..................  822-06-0...........................................              69
Phosphoric acid, 2-ethylhexyl diphenyl       1241-94-7..........................................              69
 ester; 2-Ethylhexyl diphenyl phosphate.
Phenol, methyl-; Cresol....................  1319-77-3..........................................              69
Phosphoric acid, tris(methylphenyl) ester;   1330-78-5..........................................              69
 Tricresyl phosphate, mixed isomers.
Tannins....................................  1401-55-4..........................................              55
Propanenitrile, 3-(dimethylamino)-.........  1738-25-6..........................................              55
Oxirane, 2-[(2-methylphenoxy)methyl]-......  2210-79-9..........................................              55
1-Butanol, sodium salt (1:1)...............  2372-45-4..........................................              55
Phenol, 2-(1,1-dimethylethyl)-4-methyl-....  2409-55-4..........................................              55
Tetradecane, 1-chloro-.....................  2425-54-9..........................................              55
1,3,5,7-Tetrazocine, octahydro-1,3,5,7-      2691-41-0..........................................              55
 tetranitro- (HMX.
Benzene, 1,3-bis(1-isocyanato-1-             2778-42-9..........................................              69
 methylethyl)-.
Ethenesulfonic acid, sodium salt (1:1).....  3039-83-6..........................................              55
1,3,5-Triazine-2,4,6(1H,3H,5H)-trione,       3779-63-3..........................................              69
 1,3,5-tris(6-isocyanatohexyl)-.
Naphthalene, 1,5-diisocyanato-.............  3173-72-6..........................................              69
Cyclohexane, 5-isocyanato-1-                 4098-71-9..........................................              69
 (isocyanatomethyl)-1,3,3-trimethyl-.
2-Butenal..................................  4170-30-3..........................................              55
Hexadecane, 1-chloro-......................  4860-03-1..........................................              55
Cyclohexane, 1,1'-methylenebis[4-isocyanato- 5124-30-1..........................................              69
 .
Benzene, 1-isocyanato-2-[(4-                 5873-54-1..........................................              69
 isocyanatophenyl)methyl]-.
Phosphoric acid, P,P' -[(1-                  5945-33-5..........................................              69
 methylethylidene)di-4, 1-phenylene]
 P,P,P',P' -tetraphenyl ester; Tetraphenyl
 Bisphenol A diphosphate.
1-Propanol, 2-chloro-, 1,1'',1''-phosphate;  6145-73-9..........................................              69
 Tris(2-chloro-1-propyl) phosphate.
Tris(chloropropyl) phosphate (mixture of     6145-73-9; 13674-44-5; 76025-08-6; 76649-15-5......              69
 isomers).
1,4-Benzenedicarboxylic acid, 1,4-bis(2-     6422-86-2..........................................              69
 ethylhexyl) ester; Di(2-ethylhexyl)
 terephthalate.
Propanoic acid, 2-methyl-, 1,1'-[2,2-        6846-50-0..........................................              69
 dimethyl-1-(1-methylethyl)-1,3-
 propanediyl] ester; 2,2,4-Trimethyl-1,3-
 pentanediol diisobutyrate.
Aluminum...................................  7429-90-5..........................................              69
Cadmium....................................  7440-43-9..........................................              68
Cadmium compounds category.................  No CAS No..........................................              68
Creosote...................................  8001-58-9..........................................              55
Isocyanic acid, polymethylenepolyphenylene   9016-87-9..........................................              69
 ester.
2-Propanol, 1-chloro-, 2,2',2''-phosphate;   13674-84-5.........................................              69
 Tris(1-chloro-2-propyl) phosphate.
2-Propanol, 1,3-dichloro-, phosphate (3:1);  13674-87-8.........................................              69
 Tris(1,3-dichloro-2-propyl) phosphate.
Hexane, 1,6-diisocyanato-2,4,4-trimethyl-..  15646-96-5.........................................              69
Hexane, 1,6-diisocyanato-2,2,4-trimethyl-..  16938-22-0.........................................              69
Urea, sulfate (2:1)........................  17103-31-0.........................................              55
Urea, sulfate (1:1)........................  17976-43-1.........................................              55
2,4,6,8,3,5,7-                               21351-39-3.........................................              55
 Benzotetraoxatriplumbacycloundecin-3,5,7-
 triylidene, 1,9-dihydro-1,9-dioxo.
Formic acid, compd. With 2,2',2'-            24794-58-9.........................................              55
 nitrilotris[ethanol] (1:1).
Phenol, dimethyl-, 1,1',1'-phosphate;        25155-23-1.........................................              69
 Trixylyl phosphate.
1,2-Benzenedicarboxylic acid, 3,4,5,6-       26040-51-7.........................................              69
 tetrbromo-, 1,2-bis(2-ethylhexyl) ester;
 Bis(2-ethyl-1-hexyl) tetrabromophthalate.
Phosphoric acid, methylphenyl diphenyl       26444-49-5.........................................              69
 ester; Cresyl diphenyl phosphate.
Benzene, 1,1'-methylenebis[isocyanato-.....  26447-40-5.........................................              69
Benzene, 1,3-diisocyanatomethyl-...........  26471-62-5.........................................              69
2,5-Furandione, dihydro-3-(octen-1-yl)-....  26680-54-6.........................................              55
1,3-Diazetidine-2,4-dione, 1,3-bis(3-        26747-90-0.........................................              69
 isocyanatomethylphenyl)-.
Hexane, 1,6-diisocyanato-,homopolymer;       28182-81-2.........................................              69
 hexamethylene diisocyanate (HDI)
 homopolymer.
Benzothiazole, 2-[(chloromethyl)thio]-.....  28908-00-1.........................................              55
Ethanol, 2-(2-butoxyethoxy)-, sodium salt    29761-21-5.........................................              69
 (1:1).
Phosphoric acid, P,P' -[2,2-                 38051-10-4.........................................              69
 bis(chloromethyl)-1,3-propanediyl]
 P,P,P',P' -tetrakis(2-chloroethyl) ester;
 2,2-Bis(chloromethyl)-1,3-propanediyl
 tetrakis(2-chloroethyl) phosphate.
Phosphoric acid, isodecyl diphenyl ester;    38321-18-5.........................................              55
 Isodecyl diphenyl phosphate.
Phosphoric acid, (1,1-dimethylethyl)phenyl   56803-37-3.........................................              55
 diphenyl ester.
Phosphoric acid, bis[(1,1-                   65652-41-7.........................................              69
 dimethylethyl)phenyl] phenyl ester; Bis
 (tert-butylphenyl) phenyl phosphate.
Phosphorodithioic acid, O,O-di-C1-14-alkyl   68187-41-7.........................................              55
 esters.
Coal, anthracite, calcined.................  68187-59-7.........................................              55

Cyclohexane, 2-heptyl-3,4-bis(9-             68239-06-5.........................................              69
 isocyanatononyl)-1-pentyl-.
Amides, tall-oil fatty, N,N-di-Me..........  68308-74-7.........................................              55
Fatty acids, tall-oil, sulfonated, sodium    68309-27-3.........................................              55
 salts.
Decanoic acid, mixed esters with             68441-66-7.........................................              55
 dipentaerythritol, octanoic acid and
 valeric acid.
Naphtha (petroleum), clay-treated light      68527-22-0.........................................              56
 straight-run.
Benzenesulfonic acid, C10-16-alkyl derivs.,  68584-25-8.........................................              55
 compds. with triethanolamine.
Distillates, hydrocarbon resin prodn.        68602-81-3.........................................              55
 higher boiling.
Phosphorodithioic acid, O,O-di-C1-14-alkyl   68649-42-3.........................................              55
 esters, zinc salts.
Aromatic hydrocarbons, C8, o-xylene-lean...  68650-36-2.........................................              55
Distillates (petroleum), hydrofined          68782-97-8.........................................              55
 lubricating-oil.
Hydrocarbons, C12-20, catalytic alkylation   68919-17-5.........................................              55
 by-products.
Phenol, isobutylenated, phosphate (3:1);     68937-40-6.........................................              69
 Isobutylated phenol phosphate.
Phenol, isopropylated, phosphate (3:1);      68937-41-7.........................................              69
 Isopropylated triphenyl phosphate.
Benzene, mixed with toluene, dealkylation    68953-80-0.........................................              55
 product.
Aromatic hydrocarbons, C9-16, biphenyl       68955-76-0.........................................              55
 deriv.-rich.
Tar, coal, high-temp., high-solids.........  68990-61-4.........................................              55
Terpenes and Terpenoids, C10-30, distn.      70084-98-9.........................................              55
 residues.
Ethanol, 2,2'-oxybis-, rxn products with     71077-05-9.........................................              55
 ammonia, morpholine product tower residues.
Phosphoric acid, bis(2-chloro-1-             76025-08-6.........................................              69
 methylethyl) 2-chloropropyl ester; Bis(1-
 chloro-2-isoprpyl) (2-chloropropyl)
 phosphate.
Phosphoric acid, 2-chloro-1-methylethyl      76649-15-5.........................................              69
 bis(2-chloropropyl) ester; Bis(2-
 chloropropyl) (I-chloro-2-isopropyl)
 phosphate.
Branched 4-nonylphenol (mixed isomers).....  84852-15-3.........................................              37
Benzene, 1,1'-oxybis-,tetrapropylene derivs  119345-02-7........................................              55
1,2-Cyclohexanedicarboxylic acid, 1,2-       166412-78-8........................................              69
 diisononyl ester.
Phosphoric trichloride, reaction products    181028-79-5........................................              69
 with bisphenol A and phenol; Bisphenol A
 diphosphate.
Benzoic acid, 2,3,4,5-tetrabromo-, 2-        183658-27-7........................................              69
 ethylhexyl ester; 2-Ethylhexyl-2,3,4,5-.
tetrabromobenzoate.........................
Phenol, tert-Bu derivs., phosphates (3:1);   220352-35-2........................................              69
 Butylated triphenyl phosphate.
1,2-Cyclohexanedicarboxylic acid, 1,2-       474919-59-0........................................              69
 dinonyl ester, branched and linear.
----------------------------------------------------------------------------------------------------------------

IV. References

1. EPA. 40 CFR part 716. Health and Safety Data Reporting. Available
online at: https://www.ecfr.gov/cgibin/textidx?SID=94b50835053a07b80c3517fff641aeba&mc=true&node=pt40.33.716&rgn=div5.
2. ITC. Sixty-Ninth Report of the TSCA Interagency Testing Committee
to the Administrator of the Environmental Protection Agency; Receipt
of Report and Request for Comments; Notice. Federal Register (77 FR
30856, May 23, 2012) (FRL-9346-3). Available online at: http://www.gpo.gov/fdsys/pkg/FR-2012-05-23/pdf/2012-12493.pdf.
3. EPA. 40 CFR 716.120. Substances and listed mixtures to which this
subpart applies. Available online at: https://www.ecfr.gov/cgibin/textidx?SID=94b50835053a07b80c3517fff641aeba&mc=true&node=pt40.33.716&rgn=div5#se40.33.716_1120.
4. EPA. High-Priority Substance Designations Under the Toxic
Substances Control Act (TSCA) and Initiation of Risk Evaluation on
High-Priority Substances; Notice of Availability. Federal Register
(84 FR 71924, December 30, 2019) (FRL-10003-15). Available online
at: https://www.govinfo.gov/content/pkg/FR-2019-12-30/pdf/2019-28225.pdf.
5. CPSC. U.S. Consumer Product Safety Commission Petition: Products
Containing Organohalogen Flame Retardants. Docket ID number: CPSC-
2015-0022. Available online at: https://www.regulations.gov/docket?D=CPSC-2015-0022.
6. CPSC. National Academies of Sciences, Engineering, and Medicine
2019. A Class Approach to Hazard Assessment of Organohalogen Flame
Retardants. Washington, DC: The National Academies Press. https://doi.org/10.17226/25412. Available online at: http://nap.edu/25412.

V. The TSCA Interagency Testing Committee

    The following is a list of the statutory organizations with
representatives on the ITC.

Council on Environmental Quality (vacant)
National Institute of Standards and Technology (vacant)
Environmental Protection Agency, Tala Henry, Member
National Institute of Environmental Health Sciences, Chad Blystone,
Member
National Institute for Occupational Safety and Health, Evan Frank,
Member
National Science Foundation (vacant)
Occupational Safety and Health Administration, Jonathan Bearr, Member
National Cancer Institute, Mark Miller, Member
Food and Drug Administration, Suzanne Fitzpatrick, Member
Consumer Product Safety Commission, Joel Recht, Member

    Liaison Organizations with Representatives:

Agency for Toxic Substances and Disease Registry, Custodio V. Muianga,
Member
Department of the Interior, Barnett A. Rattner, Member
U.S. Department of Agriculture, Cathleen Hapeman, Member, and Clifford
Rice, Alternate

[FR Doc. 2021-08839 Filed 4-27-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 4, 2010 (Volume 75, Number 42)]
[Notices]
[Page 9917]
[DOCID:fr04mr10-94]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2009-0001]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request, OMB No. 1660-0105; Household Preparedness
Telephone Survey

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 30-day notice and request for comments; revision of a
currently approved information collection; OMB No. 1660-0105; FEMA Form
088-0-2, Household Preparedness Telephone Survey.

-----------------------------------------------------------------------

SUMMARY: The Federal Emergency Management Agency (FEMA) has submitted
the information collection abstracted below to the Office of Management
and Budget for review and clearance in accordance with the requirements
of the Paperwork Reduction Act of 1995. The submission describes the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before April 5, 2010.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director, Office
of Records Management, 1800 South Bell Street, Arlington, VA 20598-
3005, facsimile number<PHONE_NUMBER>, or e-mail address FEMA-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Collection of Information

    Title: Community Preparedness and Participation Survey.
    Type of information collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0105.
    Form Titles and Numbers: FEMA Form 088-0-2, Household Preparedness
Telephone Survey.
    Abstract: FEMA's Community Preparedness Division would like to
renew a currently approved collection to evaluate the state of
preparedness nationally. The Community Preparedness Division analyzes
the data collected through this telephone survey of the public to
identify progress and gaps in citizen and community preparedness and
participation. This information is used by the Community Preparedness
Division, and Citizen Corps Councils to tailor awareness and
recruitment campaigns, messaging and public information efforts, and
strategic planning initiatives to more effectively improve the state of
citizen preparedness and participation across the country.
    Affected Public: Individuals or households.
    Estimated Number of Respondents: 9,750.
    Frequency of Response: Once.
    Estimated Average Hour Burden per Respondent: .33 burden hours.
    Estimated Total Annual Burden Hours: 3,247 hours.
    Estimated Cost: $70,784.60.

    Dated: February 19, 2010.
Larry Gray,
Director, Office of Records Management, Office of Management, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2010-4446 Filed 3-3-10; 8:45 am]
BILLING CODE 9111-05-P


[Federal Register Volume 88, Number 139 (Friday, July 21, 2023)]
[Notices]
[Page 47151]
[FR Doc No: 2023-15456]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-D-4417, FDA-2013-N-1619, FDA-2018-D-2613, FDA-
2021-N-0341, FDA-2016-N-2066, FDA-2022-N-0862, and FDA-2022-N-1874]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Current Good Manufacturing Practice            0910-0139       6/30/2026
 (CGMP): Manufacturing, Processing,
 Packing, and Holding of Drugs; GMP for
 Finished Pharmaceuticals (Including
 Medical Gases and Active Pharmaceutical
 Ingredients)...........................
Current Good Manufacturing Practice in         0910-0606       6/30/2026
 Manufacturing, Packaging, Labeling, or
 Holding Operations for Dietary
 Supplements............................
Prescription Drug Advertisements........       0910-0686       6/30/2026
Federal-State Food Regulatory Program          0910-0760       6/30/2026
 Standards..............................
Certification of Identity for Freedom of       0910-0832       6/30/2026
 Information and Privacy Act Requests...
The Real Cost Campaign Outcomes                0910-0915       6/30/2026
 Evaluation Study: Cohort 3 (Outcomes
 Study).................................
Perceptions of Prescription Drug               0910-0916       6/30/2026
 Products with Medication Tracking
 Capabilities...........................
------------------------------------------------------------------------

    Dated: July 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-15456 Filed 7-20-23; 8:45 am]
BILLING CODE 4164-01-P