Update to ATSDR Policy Guideline for Dioxins and Dioxin-Like Compounds in Residential Soil, 78441-78442 [E6-22388]
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Federal Register / Vol. 71, No. 250 / Friday, December 29, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[ATSDR–228]
Update to ATSDR Policy Guideline for
Dioxins and Dioxin-Like Compounds in
Residential Soil
Agency for Toxic Substances
and Disease Registry (ATSDR), U.S.
Department of Health and Human
Services (HHS).
ACTION: Request for public comments on
the revised Policy Guideline document
used by health assessors to evaluate
health hazards associated with exposure
to dioxins and dioxin-like compounds
in residential soil.
pwalker on PROD1PC69 with NOTICES
AGENCY:
SUMMARY: ATSDR is seeking public
comment on the draft revision of its
1998 Policy Guideline for Dioxins and
Dioxin-Like Compounds in Residential
Soil. The policy is intended to assist
health assessors who must evaluate the
public health implications of dioxin and
dioxin-like compounds (e.g., 2,3,7,8tetrachlorodibenzo-p-dioxin [TCDD],
chlorinated dibenzodioxins [CDDs],
chlorinated dibenzofurans [CDFs], and
other structurally related groups of
chemicals from the family of
halogenated aromatic hydrocarbons) in
residential soils near or on hazardous
waste sites. The 1998 policy established
a screening level of 0.05 ppb TEQ (50
ppt), an evaluation level (>0.05 ppb
TEQ, <1 ppb), and an action level of 1
ppb TEQ (1,000 ppt) for dioxins in
residential soil.
ATSDR revised the 1998 policy
because it has been used inconsistently
over the past eight years. The ATSDR
‘‘action’’ level has been misinterpreted
by health assessors and others as ... (1)
A soil concentration that defines a
public health hazard, (2) an ATSDR
clean-up level which implies the need
for site remediation, and (3) an initial
screening level that defines a safe level
of exposure, below which there is no
public health concern. In addition, the
‘‘action’’ level triggered a set of
‘‘potential public health actions’’,
including surveillance, research, health
studies, community education, and
exposure investigations. However,
ATSDR believes that these actions could
be considered in some circumstances
when the 1 ppb level in soil is not
exceeded. In response to these concerns
ATSDR has updated its Policy
Guideline for Dioxins and Dioxin-Like
Compounds in Residential Soil. The key
elements in the updated ATSDR Policy
Guideline for Dioxins and Dioxin-Like
VerDate Aug<31>2005
18:15 Dec 28, 2006
Jkt 211001
Compounds in Residential Soil are as
follows:
• Deletion of the 1 ppb action level as
the criteria for taking specific public
health actions.
The 1-ppb dioxin soil concentration
should not be used as a comparison
value for defining public health hazards
in public health assessments and
consultations. The 1-ppb action level
can be cited by health assessors as the
Superfund Dioxin Cleanup policy
criteria (EPA 1989, 1998).
Retention of the 0.05 ppb Screening
Level
The minimal risk level (MRL)-based
environmental media evaluation guide
(EMEG) of 0.05 ppb for dioxin TEQ in
soil is retained as the basis for screening
soil concentrations. Levels exceeding
this screening level should be evaluated
as described in the ATSDR Public
Health Assessment Guidance Manual
(PHAGM) (ATSDR 2005). This
clarification will ensure that evaluation
of dioxins and dioxin-like compounds
in soil will be done in the same manner
as all other soil contaminants.
Recommendation To Conduct Exposure
Pathways Analyses for Dioxins and
Dioxin-Like Compounds
The focus of the guideline is the
assessment of direct exposure to soil
contamination, particularly soil
ingestion. However, health assessors
should be aware of the potential impact
of indirect exposure pathways on
exposed populations in site-specific
health assessments. This document does
not provide specific guidance on how
these indirect pathways should be
assessed. However, the PHAGM
document does provide assistance in
evaluating indirect exposure pathways
such as food chain contamination
(ATSDR 2005).
Updated TEFs
The 2006 World Health Organization
Toxicity Equivalency Factors (TEFs) for
dioxins and dioxin-like compounds
have been included in the updated
document.
Background Information
In 1998, the Agency for Toxic
Substances and Disease Registry
(ATSDR) adopted a Final Policy
Guideline for Dioxin and Dioxin-Like
Compounds (De Rosa et al. 1999a). The
1998 policy guideline was accompanied
by a Technical Support Document for
ATSDR Policy Guideline (De Rosa et al.
1999b). The initiative to develop this
policy guideline was based on a request
from the U.S. Environmental Protection
Agency (EPA) to evaluate the
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
78441
protectiveness of the EPA Superfund
Policy for Dioxins in Residential Soils,
which established 1 part per billion
(ppb) (1,000 parts per trillion [ppt]) total
dioxin toxicity equivalents (TEQ) as the
starting point for making clean-up
decisions. In addition, the 1998 policy
guideline was to provide guidance to
health assessors in evaluating the public
health implications of dioxin and
dioxin-like compounds (e.g., 2,3,7,8tetrachlorodibenzo-p-dioxin [TCDD],
chlorinated dibenzodioxins [CDDs],
chlorinated dibenzofurans [CDFs], and
other structurally related groups of
chemicals from the family of
halogenated aromatic hydrocarbons) in
residential soils near or on hazardous
waste sites. As stated in the 1998
document, ‘‘these guidelines and
procedures apply to human exposure for
direct ingestion of soils contaminated
with dioxin and dioxin-like compounds
in residential areas and may not be
appropriate for other exposure
scenarios.’’ The 1998 Policy Guideline
established a screening level of 0.05 ppb
TEQ (50 ppt), an evaluation level (>0.05
ppb TEQ, <1 ppb), and an action level
of 1 ppb TEQ (1,000 ppt) for dioxins in
residential soil and made
recommendations for specific
considerations or public health actions.
ATSDR has established
environmental screening values for
chemicals to be used by health assessors
to assess exposures. No other chemical
has an action level as was established
for dioxins in soil in the 1998 policy
guideline. This inconsistency alone has
led to confusion regarding the
appropriate screening value for soil
dioxin levels.
The primary objectives of the updated
Policy Guidelines are to provide greater
consistency in ATSDR Health
Assessments and to bring dioxin
assessments in line with how all other
chemicals are evaluated by the agency.
Summary of Peer Review for Document
The public comment draft of the
revised policy has undergone internal
review and clearance within ATSDR. In
addition, the revised draft was reviewed
by the National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry (NCEH/
ATSDR) Board of Scientific Counselors
(BSC). Public testimony was received
during the meeting of the NCEH/ATSDR
BSC. ATSDR also received peer review
comments from health assessors in
several state health departments.
Information about the ‘‘Update to
ATSDR Policy Guideline for Dioxins
and Dioxin-Like Compounds in
Residential Soil’’, including the draft
document, fact sheet, peer review
E:\FR\FM\29DEN1.SGM
29DEN1
78442
Federal Register / Vol. 71, No. 250 / Friday, December 29, 2006 / Notices
comments and ATSDR responses, is
available on the ATSDR Web site at:
https://www.atsdr.cdc.gov/substances/
dioxin/policy/.
DATES: Comments concerning this
document must be received by February
27, 2007.
ADDRESSES: Public comments should be
forwarded to Ms. Athena Gemella,
ATSDR, Office of Science, 1600 Clifton
Road, N.E., Mail stop E–28. Atlanta, GA.
30333, or e-mail at AGemella@cdc.gov.
FOR FURTHER INFORMATION CONTACT: Ms.
Athena Gemella, Office of Science,
telephone (404) 498–0621.
Dated: December 22, 2006.
Kenneth Rose,
Acting Director, Office of Policy, Planning
and Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. E6–22388 Filed 12–28–06; 8:45 am]
outcome even though it accounts for
nearly one half of all perinatal mortality.
There is currently no nationally
accepted definition of what constitutes
a stillbirth, and there are no universally
recommended, standardized stillbirth
evaluation protocols in use for the
evaluation of fetal deaths. The proposed
survey has been designed to evaluate
and assess the knowledge, attitudes and
practice management patterns of
obstetricians in the metropolitan Atlanta
area regarding stillbirths in general, as
well as in their medical practice. This
information will be used to identify
prevailing deficiencies leading to
incomplete and inaccurate reporting of
data relative to stillbirths, and to
develop targeted awareness and
educational strategies for participating
MACDP facilities. Ongoing, accurate
and reliable population-based registries
of stillbirths are essential for conducting
epidemiologic studies on the causes of
and risk factors for this pregnancy
outcome. This survey will be mailed to
randomly selected obstetricians whose
practices serve residents of the 5
counties comprising metropolitan
Atlanta. This survey will be conducted
once and will take approximately 2–3
months to collect the data. NCBDDD is
requesting OMB clearance for 1 (one)
year. There is no cost to the survey
respondents except for the time
necessary to complete the survey. The
total annual burden hours are 122
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Metropolitan Atlanta Stillbirth
Management Survey: Knowledge,
Attitudes and Practice Patterns from
Obstetricians,—New—National Center
on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
BILLING CODE 4163–70–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day-07–06AI]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
The U.S. Congress House Report 108–
792 (joint conference report for the
Fiscal Year 2005 omnibus
appropriations bill) provides specific
funding to devise a comprehensive
strategy for expanding existing birth
defects surveillance systems to
incorporate surveillance data on all
intrauterine fetal deaths of 20 or more
week’s gestation into the Metropolitan
Atlanta Congenital Defects Program
(MACDP). Stillbirth is largely an
understudied adverse pregnancy
ESTIMATE OF ANNUALIZED BURDEN HOURS
Respondents
Participant
status
Number of
respondents
Obstetricians ...................................................
Non-Participant ...............................................
Participant ......................................................
Dated: December 22, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–22381 Filed 12–28–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
[Document Identifier: CMS–R–284]
Centers for Medicare & Medicaid
Services
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
pwalker on PROD1PC69 with NOTICES
AGENCY:
VerDate Aug<31>2005
18:15 Dec 28, 2006
Jkt 211001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
120
480
Number of
reponses per
respondent
1
1
Average
burden per
response
(in hours)
1/60
15/60
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection;.
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[Federal Register Volume 71, Number 250 (Friday, December 29, 2006)]
[Notices]
[Pages 78441-78442]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22388]
[[Page 78441]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[ATSDR-228]
Update to ATSDR Policy Guideline for Dioxins and Dioxin-Like
Compounds in Residential Soil
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), U.S.
Department of Health and Human Services (HHS).
ACTION: Request for public comments on the revised Policy Guideline
document used by health assessors to evaluate health hazards associated
with exposure to dioxins and dioxin-like compounds in residential soil.
-----------------------------------------------------------------------
SUMMARY: ATSDR is seeking public comment on the draft revision of its
1998 Policy Guideline for Dioxins and Dioxin-Like Compounds in
Residential Soil. The policy is intended to assist health assessors who
must evaluate the public health implications of dioxin and dioxin-like
compounds (e.g., 2,3,7,8-tetrachlorodibenzo-p-dioxin [TCDD],
chlorinated dibenzodioxins [CDDs], chlorinated dibenzofurans [CDFs],
and other structurally related groups of chemicals from the family of
halogenated aromatic hydrocarbons) in residential soils near or on
hazardous waste sites. The 1998 policy established a screening level of
0.05 ppb TEQ (50 ppt), an evaluation level (>0.05 ppb TEQ, <1 ppb), and
an action level of 1 ppb TEQ (1,000 ppt) for dioxins in residential
soil.
ATSDR revised the 1998 policy because it has been used
inconsistently over the past eight years. The ATSDR ``action'' level
has been misinterpreted by health assessors and others as ... (1) A
soil concentration that defines a public health hazard, (2) an ATSDR
clean-up level which implies the need for site remediation, and (3) an
initial screening level that defines a safe level of exposure, below
which there is no public health concern. In addition, the ``action''
level triggered a set of ``potential public health actions'', including
surveillance, research, health studies, community education, and
exposure investigations. However, ATSDR believes that these actions
could be considered in some circumstances when the 1 ppb level in soil
is not exceeded. In response to these concerns ATSDR has updated its
Policy Guideline for Dioxins and Dioxin-Like Compounds in Residential
Soil. The key elements in the updated ATSDR Policy Guideline for
Dioxins and Dioxin-Like Compounds in Residential Soil are as follows:
Deletion of the 1 ppb action level as the criteria for
taking specific public health actions.
The 1-ppb dioxin soil concentration should not be used as a
comparison value for defining public health hazards in public health
assessments and consultations. The 1-ppb action level can be cited by
health assessors as the Superfund Dioxin Cleanup policy criteria (EPA
1989, 1998).
Retention of the 0.05 ppb Screening Level
The minimal risk level (MRL)-based environmental media evaluation
guide (EMEG) of 0.05 ppb for dioxin TEQ in soil is retained as the
basis for screening soil concentrations. Levels exceeding this
screening level should be evaluated as described in the ATSDR Public
Health Assessment Guidance Manual (PHAGM) (ATSDR 2005). This
clarification will ensure that evaluation of dioxins and dioxin-like
compounds in soil will be done in the same manner as all other soil
contaminants.
Recommendation To Conduct Exposure Pathways Analyses for Dioxins and
Dioxin-Like Compounds
The focus of the guideline is the assessment of direct exposure to
soil contamination, particularly soil ingestion. However, health
assessors should be aware of the potential impact of indirect exposure
pathways on exposed populations in site-specific health assessments.
This document does not provide specific guidance on how these indirect
pathways should be assessed. However, the PHAGM document does provide
assistance in evaluating indirect exposure pathways such as food chain
contamination (ATSDR 2005).
Updated TEFs
The 2006 World Health Organization Toxicity Equivalency Factors
(TEFs) for dioxins and dioxin-like compounds have been included in the
updated document.
Background Information
In 1998, the Agency for Toxic Substances and Disease Registry
(ATSDR) adopted a Final Policy Guideline for Dioxin and Dioxin-Like
Compounds (De Rosa et al. 1999a). The 1998 policy guideline was
accompanied by a Technical Support Document for ATSDR Policy Guideline
(De Rosa et al. 1999b). The initiative to develop this policy guideline
was based on a request from the U.S. Environmental Protection Agency
(EPA) to evaluate the protectiveness of the EPA Superfund Policy for
Dioxins in Residential Soils, which established 1 part per billion
(ppb) (1,000 parts per trillion [ppt]) total dioxin toxicity
equivalents (TEQ) as the starting point for making clean-up decisions.
In addition, the 1998 policy guideline was to provide guidance to
health assessors in evaluating the public health implications of dioxin
and dioxin-like compounds (e.g., 2,3,7,8-tetrachlorodibenzo-p-dioxin
[TCDD], chlorinated dibenzodioxins [CDDs], chlorinated dibenzofurans
[CDFs], and other structurally related groups of chemicals from the
family of halogenated aromatic hydrocarbons) in residential soils near
or on hazardous waste sites. As stated in the 1998 document, ``these
guidelines and procedures apply to human exposure for direct ingestion
of soils contaminated with dioxin and dioxin-like compounds in
residential areas and may not be appropriate for other exposure
scenarios.'' The 1998 Policy Guideline established a screening level of
0.05 ppb TEQ (50 ppt), an evaluation level (>0.05 ppb TEQ, <1 ppb), and
an action level of 1 ppb TEQ (1,000 ppt) for dioxins in residential
soil and made recommendations for specific considerations or public
health actions.
ATSDR has established environmental screening values for chemicals
to be used by health assessors to assess exposures. No other chemical
has an action level as was established for dioxins in soil in the 1998
policy guideline. This inconsistency alone has led to confusion
regarding the appropriate screening value for soil dioxin levels.
The primary objectives of the updated Policy Guidelines are to
provide greater consistency in ATSDR Health Assessments and to bring
dioxin assessments in line with how all other chemicals are evaluated
by the agency.
Summary of Peer Review for Document
The public comment draft of the revised policy has undergone
internal review and clearance within ATSDR. In addition, the revised
draft was reviewed by the National Center for Environmental Health/
Agency for Toxic Substances and Disease Registry (NCEH/ATSDR) Board of
Scientific Counselors (BSC). Public testimony was received during the
meeting of the NCEH/ATSDR BSC. ATSDR also received peer review comments
from health assessors in several state health departments.
Information about the ``Update to ATSDR Policy Guideline for
Dioxins and Dioxin-Like Compounds in Residential Soil'', including the
draft document, fact sheet, peer review
[[Page 78442]]
comments and ATSDR responses, is available on the ATSDR Web site at:
https://www.atsdr.cdc.gov/substances/dioxin/policy/.
DATES: Comments concerning this document must be received by February
27, 2007.
ADDRESSES: Public comments should be forwarded to Ms. Athena Gemella,
ATSDR, Office of Science, 1600 Clifton Road, N.E., Mail stop E-28.
Atlanta, GA. 30333, or e-mail at AGemella@cdc.gov.
FOR FURTHER INFORMATION CONTACT: Ms. Athena Gemella, Office of Science,
telephone (404) 498-0621.
Dated: December 22, 2006.
Kenneth Rose,
Acting Director, Office of Policy, Planning and Evaluation, National
Center for Environmental Health/Agency for Toxic Substances and Disease
Registry.
[FR Doc. E6-22388 Filed 12-28-06; 8:45 am]
BILLING CODE 4163-70-P
