[Federal Register Volume 64, Number 22 (Wednesday, February 3, 1999)]
[Notices]
[Pages 5277-5284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2447]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-6228-7]
Response to Recommendations from the Children's Health Protection
Advisory Committee Regarding Evaluation of Existing Environmental
Standards
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA asked the federal Children's Health Protection Advisory
Committee (CHPAC) to recommend five existing standards that may merit
reevaluation in order to further protect children's environmental
health. This document includes EPA's response to the CHPAC
recommendations. EPA will reevaluate the chloralkali National Emission
Standard for Hazardous Air Pollutants (mercury); the implementation and
enforcement of the (Farm) Worker Protection Standards; pesticide
tolerances for organophosphates (chlorpyrifos, dimethoate, methyl
parathion); atrazine pesticide tolerances and Maximum Contaminant Level
in drinking water; and will review indoor and ambient air quality as
they relate to asthma. EPA's decision to reevaluate is based in large
part on recommendations from the Children's Health Protection Advisory
Committee and public comments in response to a Federal Register
document of October 3, 1997.
In September 1996, EPA issued a report on Environmental Health
Threats to Children (EPA 175-F-96-001) that described how and why
children are affected by an array of complex environmental threats to
their health. The report included a National Agenda to Protect
Children's Health from Environmental Threats in which EPA called for a
national commitment to ensure a healthy future for our children. We
called on national, state and local policy makers--as well as each
community and family--to learn about the environmental threats our
children face; to participate in an informed national policy debate on
how together we can best reduce health risks for children; and to take
action to protect our Nations's future by protecting our children.
The first element of the National Agenda committed the
Administration to ``. . . ensure, as a matter of national policy, that
all standards EPA sets are protective enough to address the potentially
heightened risks faced by children--so as to prevent environmental
health threats wherever possible--and that the most significant current
standards be reevaluated as we learn more.'' We further state that `` .
. . EPA will select--with public input and scientific peer review--five
of its most significant public health and environmental standards to
reissue on an expedited basis under this new policy.''
Background
In order to meet our commitment to public input, EPA sought advice
through two channels: formal notice and comment, and the formation of a
Federal Advisory Committee composed of individuals representing diverse
viewpoints. On October 3, 1997, EPA issued a document and request for
comments from the public as to existing EPA standards that, if revised
as a result of review and evaluation, would strengthen and increase
children's environmental health protection. EPA received comments from
18 individuals and organizations. (Attachment A to this document
includes the list of submitters, a summary of the comments, and EPA's
response to the public comments.) Further, on September 9, 1997, EPA
issued a document in the Federal Register that it had established a
Children's Health Protection Advisory Committee (CHPAC) under the
Federal Advisory Committee Act, Public Law 92-463, to advise the
Administrator on various issues of children's environmental health
protection.
One of the first actions undertaken by the CHPAC, at the request of
EPA, was to develop a set of recommendations to the Administrator
concerning which existing rules EPA should reevaluate. They started by
reviewing the public comments that were submitted in response to the
October 3, 1997, Federal Register document. Based on extensive
deliberations the CHPAC submitted their recommendations in a consensus
report dated May 28, 1998. (See Attachment B for the selection criteria
used by the CHPAC in their deliberations.) The following section lists
the CHPAC recommendations, excerpts the discussion that accompanied the
recommendations in the report (in italics), and outlines EPA's
response.
We congratulate the Children's Health Protection Advisory Committee
for their success in deliberating and recommending actions to improve
EPA's regulations. We believe that EPA's response to these
recommendations advances our goal to better protect our Nation's
children.
FOR FURTHER INFORMATION CONTACT: If you have a need for further
information you may write to Meg Kelly, Office of Children's Health
Protection, USEPA (MS1107), 401 M Street, SW, Washington, D.C. 20460;
(kelly.margaret@epa.gov).
SUPPLEMENTARY INFORMATION:
CHPAC Recommendation: Reevaluate the National Emission Standard for
Hazardous Air Pollutants (NESHAP) for Chloralkali Plants
CHPAC Report Discussion: ``The CHPAC recommends that EPA take a
holistic approach to evaluate all sources of mercury emissions. Mercury
is a relevant issue to more than one media (air, water), which
contributes to its entry into the environment, for example, by
electricity (coal-burning) generation, incineration and discharge into
water sources. Human exposure occurs primarily through fish
consumption. Mercury exposure is associated with adverse health effects
in humans. Depending on dose, the effects can range from severe to less
severe, most notably, neurological, developmental, and reproductive
effects.
By the end of 1998, EPA is scheduled to complete a multimedia
strategy addressing mercury. We support EPA's multimedia approach and
schedule for the issuance of this strategy.
We encourage EPA to proceed diligently with implementation to
protect children from mercury emissions, including those from
municipal, medical, and hazardous waste combustion.
Although the CHPAC selected the National Emission Standard for
[[Page 5278]]
Hazardous Air Pollutants (NESHAP) for chloralkali plants for
reevaluation, EPA resources should not be diverted from the evaluation
of other larger sources of mercury emission. Important criteria for its
selection are that the standard has not been re-evaluated or revised
since its promulgation in 1973, children's health was not considered in
the original development of the standard, and new information and data
based on peer reviewed science suggest that risks to children and the
persistent and bioaccumulative nature of mercury were not considered
during the setting of the standard.
The CHPAC recognizes the Water Quality Criteria Standard as one
means by which the EPA can regulate the prevention of contaminated fish
by mercury and ensure children's protection from hazardous levels of
mercury. The CHPAC recommends that EPA address the largest sources of
mercury emissions expeditiously and prevent further contamination of
fish by revising the Water Quality Criteria Standard. Studies have
shown that once mercury enters water, either directly or through air
deposition, it can bioaccumulate in fish and animal tissue at the top
of the food chain in concentrations much greater than those found in
water.
Another specific concern is the emission of mercury from electric
(coal-burning) utility boilers (regulatory determination by the EPA is
due in November 1998). Important criteria for its selection are that
there is currently no regulation of hazardous air pollutant emissions,
such as mercury, from electric utility boilers, and electric utility
boilers are the largest contributor of overall anthropogenic sources of
mercury emissions in the United States (EPA Mercury Report to Congress
1997).''
EPA's Response: EPA agrees with the CHPAC recommendation that the
NESHAP for chloralkali plants be revisited and has begun a process to
revise this standard. A proposed rule will include emissions limits
based on control technology and on management practices. EPA projects a
proposal date of November 1999, and expects to issue a final standard
in November 2000. In order to ensure protection of children, the Office
of Air and Radiation (OAR) will analyze the risk from chloralkali
plants to support the rule making--an unusual step for a technology-
based standard. However, OAR believes the risk assessment will provide
us with information on potential children's risks that is important to
determining the appropriate level of the standard. Results of the risk
analysis may be used to justify setting a standard more stringent than
the maximum achievable control technology (MACT) floor, but any
standard set will be no less stringent than the floor.
Discussion: On November 16, 1998, EPA issued a draft Multimedia
Strategy for Priority Persistent, Bioaccumulative, and Toxic Pollutants
(http://www.EPA.gov/pbt/strategy.htm). This strategy includes a
multifaceted draft Action Plan for Mercury. EPA believes that this
action plan addresses the concerns expressed by the CHPAC in their
report. It recognizes the multimedia threat posed by methyl mercury--
the compound to which mercury is transformed through natural
environmental processes--and the need to control human exposure to
methyl mercury, through multiple concerted approaches targeted at air,
water, sediment and land. Further, EPA is proposing additional
reporting of mercury releases under the Toxic Release Inventory to
improve citizens' right to know about releases in their environment.
EPA has taken several important steps to reduce the levels of
mercury, including reducing emissions from municipal waste combustors
and medical waste incinerators. These combined actions, once fully
implemented (December 2000 for municipal waste combustors; September
2002 for medical waste incinerators) will reduce mercury emissions
caused by human activities by 50% from 1990 levels. EPA also entered
into a partnership with the American Hospital Association whose goal is
to virtually eliminate hospital mercury waste by the year 2005.
Further, final regulations for hazardous waste combustion
facilities (incinerators, cement kilns, lightweight aggregate kilns)
are expected to be promulgated in February 1999. The EPA is responding
to extensive public comment including new emissions data and comments
on the methodology used to estimate mercury emissions from these
facilities. The final rule is expected to achieve a substantial overall
reduction in mercury emissions from these hazardous waste combustion
facilities.
The CHPAC highlighted their concern that EPA resources not be
diverted from the evaluation of other larger sources of mercury
emission. EPA assures the CHPAC that the Mercury Action Plan addresses
all known important sources of mercury. For example, EPA is also
developing regulations to limit emissions of hazardous air pollutants,
including mercury, from five additional source categories--industrial,
commercial, other nonhazardous solid waste combustors, gas turbines,
and stationary internal combustion engines. Proposed regulations are
due by the end of the year 2000. In addition, EPA will consider the
impacts to children's health along with many other factors (e.g.,
controllability and costs) as part of the regulatory determination for
coal-fired electric utility power plants.
EPA agrees with the CHPAC that we should revise water quality
criteria that are used by states and tribes to establish enforceable
water quality standards. EPA's Office of Water (OW) is accelerating
development of a revised water quality human health criterion for
mercury which will reflect two major departures from past approaches:
A revised human health methodology will provide for use of
bioaccumulation factors to estimate the build up of mercury in fish-
tissue rather than using bioconcentration factors. This means that
water quality criteria will now be based on biomagnification in the
food chain. An improved means to estimate fish consumption is also
included. A draft revised Water Quality Criteria Methodology for Human
Health was published in August 1998. Although not regulations, these
criteria do propose fish intake and body weights that more accurately
reflect actual characteristics of women of childbearing age and
children. OW is taking public comment on the proposal. A final human
health criteria methodology is projected to be available by the end of
1999.
An updated human health risk assessment will result from
an interagency review of recent human data on methyl mercury. This
review will concentrate on levels of exposure to mercury associated
with subtle neurological endpoints and is aimed at achieving consensus
among Federal agencies on estimates of human risk. A workshop was
conducted in November 1998. In addition, Congress required, in the
report that accompanied EPA's 1999 appropriation, a 18-month National
Academy of Sciences study and recommendation on the reference dose for
methyl mercury. This study will begin in January 1999. A peer review of
application of the new methodology to methyl mercury is projected for
completion by mid 2000.
Finally, the CHPAC report indicated concerns about emissions of
mercury from electric (coal-burning) utility boilers. In order to
support a regulatory determination (now required by December 15, 2000)
and potential future regulatory action, EPA will gather high quality
emissions data about coal-fired electric generating plants to address
[[Page 5279]]
current uncertainties about mercury emissions. To accomplish this, we
are requiring all coal-fired power plants above 25 megawatts (MW) to
provide the results of analysis to determine the mercury content of the
coal they are burning. In addition, a sample of plants will be required
to perform stack testing for quantity and species of mercury emissions.
The information obtained from this effort will allow EPA to calculate
the amount and species of mercury emitted by each coal-fired plant
above 25 MW. This information will be available to the public.
CHPAC Recommendation: Reevaluate the (Farm) Worker Protection
Standards
CHPAC Report Discussion: ``Children may be exposed to pesticides
through employment in farm work, by eating fruits and vegetables
directly from the fields while at work, or by drift from field
applications to neighboring residential areas and schools. Pregnant and
lactating women who work in farm fields or reside in neighboring areas
can also expose fetuses and neonates to pesticides. The current (farm)
worker protection standard has not considered these pesticide exposures
to children. Under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), EPA has the authority to regulate these childhood and
prenatal exposures to pesticides through the worker protection standard
including labeling, reentry intervals, personal protective equipment,
worker education and training, and posting and signs.
The CHPAC recommends that EPA expeditiously re-evaluate the worker
protection standard in order to determine whether it adequately
protects children's health. In its reevaluation, EPA should, for
example, consider using standardized data on size and age-specific
weight and height for modeling children's exposure when more specific
data on children's exposure to individual pesticides may be lacking.''
EPA's Response: EPA agrees with CHPAC that improvements are needed
in its regulatory efforts to protect the health of children in
agricultural areas. Because the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) gives EPA broader authority than identified by
CHPAC, however, EPA intends to carry out a more comprehensive set of
initiatives than recommended by CHPAC. Specifically, EPA is working, or
planning work, in the following areas: consistency and effectiveness in
state implementation and enforcement of the Worker Protection Standards
(WPS); application of available regulatory tools; verification of
national compliance; determination whether the regulation is meeting
its goal; education of farmers, workers, and state regulators;
reassessment of the scope, quality, and medium of safety training; and
educating the medical community. In particular, we agree that we need
to better address the safety needs of women and children as
agricultural workers. The following discussion outlines steps that EPA
is prepared to take to improve the health of farm worker children in
response to the specific CHPAC recommendations.
EPA is committed to conduct an internal review of the process used
to establish entry intervals for pesticides in order to affirm that the
process adequately factors in the special needs of children and women
employed as farm workers. The review will be conducted in 1999.
However, it is not EPA's plan to repropose the Worker Protection
Standard (WPS) because we believe implementation and enforcement of the
standard can be improved to protect the health of children who work in
agriculture without a regulatory change.
EPA's Office of Pesticide Programs is in the process of revising
its exposure assessment Standard Operating Procedures. We anticipate
the result will be to account for and better characterize pesticide
exposure scenarios involving spray drift and other residential
exposures that may occur from pesticide use in nearby agricultural
areas or from agricultural workers who may carry pesticide residues
into the home.
On a broader level, EPA is proposing a national assessment of
implementation and enforcement of the WPS. The assessment will include
the establishment of a worker protection assessment group composed of
EPA, the U.S. Department of Agriculture (USDA), the Department of Labor
(DOL), the Department of Health and Human Services (DHHS), state
regulators, state extension service safety educators, farm worker
advocacy groups, farm worker service/training associations,
agricultural employer associations, farm worker clinicians' networks,
and others to provide national direction to state programs. The goals
of the group will be to:
Assess the current program status;
Generate a consortium of interests that can effect change
in the programs;
Provide a means to foster the partnerships essential to
make the program work;
And most important, to provide a continuing forum to focus
and resolve worker protection issues.
The worker protection assessment group will be established and
begin work in 1999. It will develop a strategic plan for the national
worker protection program and issue annual reports detailing
accomplishments and progress toward achieving its goals.
Discussion: EPA will also collect actual data on pesticide
exposures by co-funding and providing consultation to the National
Institute for Occupational Safety and Health (NIOSH) for pesticide case
reporting projects (surveillance systems) in five states: California,
New York, Texas, Oregon and Florida. The surveillance systems, located
in the state health department, include the collection of reports on
human incidents of pesticide intoxication, review of trends in disease
over time and the response to outbreaks of disease. There is emphasis
placed on outreach and training to involved groups within the community
(industry/farmers, workers, community residents, health care providers
and local government). Whenever possible, information is obtained on
take-home exposures to children as well as evaluation of child or
adolescent farm work. It is anticipated that preliminary data on the
first year of pesticide case reports for these five states will be
available in late 1999.
In April 1998, EPA held a workshop to initiate a multi agency
effort to create a national plan for increasing training and awareness
among health care providers of pesticide-related health conditions
(``Pesticides and National Strategies for Health Care Providers'').
This initiative is led by EPA in partnership with the DOL, HHS and
USDA. Workshop proceedings have been distributed and working groups are
developing implementation strategies. A national meeting is anticipated
in late 1999 to provide a forum for public discussion of the final
recommendations.
EPA will also continue its role in providing coordination and
expertise to the following important activities targeted at children
who work in agriculture:
EPA initiated a study of pesticide exposure among children
living along the US-Mexico border as part of the Border XXI
environmental health project. Currently, the study design is being
developed. EPA staff will provide medical consultation to the research
team.
In 1998, the first federally-funded research centers
dedicated solely to studying children's environmental health hazards
were selected. The joint EPA/HHS funding created eight ``Centers of
Excellence in Children's
[[Page 5280]]
Environmental Health Research.'' Two of these centers involve farm
worker children: The University of California at Berkeley will evaluate
pesticide exposures and related growth / developmental status in the
Salinas area, and the University of Washington will study the health of
children living in the farm worker community in Yakima Valley.
EPA contributed funds and had representation on the
planning committee for the Pediatric Environmental Health Conference to
be held in San Francisco in September 1999. The conference will focus
on pediatric environmental health and will target health care providers
as well as the trainers/professors of health care providers. Sections
of the conference will deal with pesticides and children's health.
CHPAC Recommendation: Reevaluate the Atrazine Drinking Water
Maximum Contaminant Level (MCL) and the Atrazine Pesticide
Tolerance
Contaminant Level (MCL) and the Atrazine Pesticide Tolerance
CHPAC Report Discussion: ``Atrazine is a herbicide that belongs to
the triazine class. Atrazine has been linked to adverse health effects
including cancer and birth defects. Atrazine has been detected in
drinking water throughout the Midwest and other parts of the nation.
When EPA established the tolerance and 1991 drinking water standards
for atrazine, children's differential exposure was not considered and
children's differential susceptibility was not fully evaluated. New
information has since become available to the EPA concerning the
mechanism of action underlying its carcinogenic effect. Hormonal
effects were further investigated and triggered the need for the
reevaluation of both the carcinogenic effects of this compound as well
as the developmental and reproduction studies. Reviewing the tolerances
and the established drinking water standard in concert will provide EPA
with an opportunity to evaluate a chemical's impact on children's
health via aggregate routes of exposure. Reconsideration of the
tolerances and drinking water standard for atrazine should be given top
priority in EPA's implementation of the Safe Drinking Water Act and the
Food Quality Protection Act.''
EPA's Response: The preliminary risk assessment for atrazine will
be prepared by December 1999 and published as part of a Reregistration
Eligibility Document by June 2000. The public will have 60 days to
comment on the Atrazine findings following publication of this
document.
The drinking water standard will be based on the new risk
assessment conducted by the pesticide office. Reevaluation of the
atrazine Maximum Contaminant Level (MCL) should be complete
approximately 18 months after the risk assessment is completed.
Discussion: The triazine pesticides are in the first tier of
pesticides that EPA is re-evaluating in order to comply with the
requirements of the Food Quality Protection Act. Scientific questions
regarding the health effects of the triazine pesticides should be
resolved by September 2000. EPA's Science Advisory Board (SAB) and
Science Advisory Panel (SAP) will be examining key issues related to
the risk assessment, including cancer mechanism, in the fall of 1999.
Once EPA receives comment from the SAB/SAP, the Agency will complete a
comprehensive review of the risks and benefits of the use of atrazine,
including the following assessments:
Evaluate the concentrations of the pesticide in water and
assess risk in drinking water for infants, children, and adults;
Assess dietary risk from ingestion in adult and children's
diet;
Determine requirements for use of personal protective
equipment, re-entry time, and application method, including an
evaluation of children workers and re-entry intervals;
Assess ecological risk; and
Consider economic factors and alternative pesticides
during the analysis of benefits.
CHPAC Recommendation: Reevaluate Pesticide Tolerances for Methyl
Parathion, Dimethoate, and Chlorpyrifos
CHPAC Report Discussion: ``EPA scientific panels have found that
organophosphate and carbamate insecticides disrupt the central nervous
system via a cholinesterase inhibition mechanism of toxicity. Because
children's central nervous systems continue to develop until puberty,
they are particularly vulnerable to the effects of some neurotoxins.
Children can be exposed to these insecticides through food, homes,
schools, employment, and other sources.
Data indicate that children's patterns of dietary intake are
distinct from adults' patterns. When EPA established the tolerances for
these insecticides, children's differential exposure was not considered
and children's differential susceptibility was not fully evaluated. Of
the 39 pesticides registered for use on food, thirteen are detected in
food according to FDA and USDA pesticide residue data. Five of these
account for 90 percent of the dietary risk of neurotoxicity and three
(methyl parathion, dimethoate, and chlorpyrifos) represent the bulk of
that risk. Reconsideration of the tolerances for these three pesticides
should be given top priority in terms of data collection and other
necessary steps in EPA's implementation of the Food Quality Protection
Act.''
EPA's Response: The preliminary risk assessment for dimethoate was
released for a 60-day public comment period on September 9, 1998. The
next steps in the process for this pesticide include analyzing the
comments received; deciding whether to revise the risk assessment based
on the comments; and proposing risk mitigation measures to address any
concerns, including dietary, worker, and ecological, identified in the
risk assessment. By the end of January 1999, EPA will issue a revised
risk assessment and any proposed risk mitigation measures for 60 days
of public comment.
The preliminary risk assessment for methyl parathion has been
completed, reviewed by the registrant for errors, and is now available
for public comment. The public will have 60 days to comment on the risk
assessment. Following public review, the assessment for methyl
parathion will follow the same process as dimethoate.
The preliminary draft risk assessment for chlorpyrifos is being
worked on and is expected to be completed in Spring 1999. Following
completion, it will proceed in the same way as dimethoate and methyl
parathion.
Discussion: Organophosphates are in the first tier of pesticides
that EPA is re-evaluating in order to comply with the requirements of
the Food Quality Protection Act. EPA is presently working on a
methodology to assess cumulative risks posed by the organophosphate
pesticides as a group, and will explicitly include data on children's
risk in the risk assessments. We expect to propose such a methodology
in the summer of 1999 for a 60-day public comment period. Moreover, EPA
is following a process recommended by the federal Tolerance
Reassessment Advisory Committee to increase the transparency of EPA's
risk assessments and decisions, and allow the public to participate in
the process.
CHPAC Recommendation: Review the following areas as they relate to
Asthma:
Indoor Air Quality
Ambient Air Quality Standards (Particulate Matter, Sulfur
Dioxide)
[[Page 5281]]
CHPAC Report Discussion: ``The CHPAC recognizes the high priority
in addressing childhood asthma and the need to better understand and
respond to the relationship of asthma prevalence and exacerbation to
indoor and ambient air quality. It also recognizes that indoor air
quality, which can significantly aggravate and may contribute to the
development of childhood asthma, demands timely scientific study and
action. Definitive progress in these areas using a sound scientific
approach will result in a significantly improved health outcome for all
children. EPA's Science Advisory Board and the Presidential/
Congressional Commission on Risk Assessment and Risk Management have
also identified indoor air pollution as a high human health risk
warranting additional attention.
Selecting a broad area rather than a single standard was a
purposeful decision by the CHPAC designed to encourage a comprehensive
examination of all aspects of air quality. The CHPAC strongly desired
to address asthma. The CHPAC encourages a holistic review of outdoor
and indoor air quality and strongly feels that this is a more useful
recommendation than the identification of a specific standard. Examples
include evaluating the effectiveness of existing EPA guidance on indoor
air quality relating to asthma and additional emphasis on protecting
the health of children with asthma in development of PM monitoring and
research programs.
By including this broad category, the CHPAC is hopeful that EPA
will take a leadership role by providing impetus for action with regard
to indoor air (including environmental tobacco smoke (ETS), pesticides,
biological contaminants, and volatile organic chemicals) through a
coordinated strategy with other federal agencies. The CHPAC recommends
that EPA continue to support sound research programs on concentrations
and exposure assessments of ambient air pollutants on asthma, such as
PM, and to obtain timely exposure data for risk assessments in areas
such as the short-term SO2 standard.
The CHPAC recognizes that much of the value of the regulatory re-
evaluation effort is identification of process improvements that can be
applied to future risk assessment and rulemaking efforts. The CHPAC
further recognizes that a disciplined approach in the area of air
quality can have high learning value, given the breadth and diversity
of the issues and the potential to promote multi-agency coordination
and cooperation.''
EPA's Response: EPA strongly agrees with the CHPAC's recommendation
that EPA undertake a fully integrated effort to address both indoor and
outdoor pollution factors that contribute to childhood asthma. As CHPAC
is aware, asthma rates in the U.S. have been increasing at an alarming
rate and particularly troubling is the fact that asthma has increased
160% in children less than five years of age since 1980. Approximately
5.5 million children now suffer from asthma; 150,000 are hospitalized
each year; and asthma is the leading cause of school absenteeism due to
chronic illness.
Efforts to integrate and expand the Agency's commitment to
addressing the multifaceted asthma issue are being addressed under the
President's Task Force on Children's Environmental Health Risks and
Safety Risks. The Task Force has identified asthma as one of four
Priority Areas to receive special emphasis. EPA, along with the
Department of Health and Human Services and other Federal Agencies, is
developing a comprehensive cross-government action plan to address
asthma. The action plan will identify the research and surveillance
activities needed to understand the causes of childhood asthma and the
scope of the problem as well as identify the public health practice and
outreach needs and opportunities to begin to turn the tide on childhood
asthma rates. Experts on asthma-related and environmental issues from
EPA, the Department of Health and Human Services, and the Department of
Housing and Urban Development are collaborating in this effort.
The action plan calls for substantially increased emphasis on
asthma research, asthma surveillance activities, and increased
implementation of public health programs to reduce childhood asthma by
reducing environmental asthma triggers. The action plan places
significant emphasis on reducing the disproportionate burden of asthma
on minorities and children living in poverty, on community-based
programs, effective partnerships, and evaluation of programs. The
action plan will contain specific recommendations and key actions to be
taken in the following areas:
Strengthening and accelerating research on environmental
factors that cause or worsen asthma;
Expanding implementation of public health programs that
use the best available scientific knowledge to reduce environmental
exposures to asthma triggers, including indoor and ambient air
pollution;
Establishing a nationwide surveillance system for
collecting and analyzing asthma data; and,
Identifying and eliminating inequalities in the health
burden of asthma with respect to poor and minority children.
In FY99, EPA is substantially expanding its programs to address the
environmental factors that affect asthma in children:
EPA has funded eight Centers for Children's Environmental
Health and Prevention Research, five of which are specifically focused
on asthma.
EPA is also developing an integrated research strategy to
address ambient air pollution sources such as ozone and particulate
matter that may exacerbate asthma, as well as to better understand the
relationship between asthma and indoor pollutants such as dust mite and
cockroach allergen, molds, and other indoor contaminants such as
pesticides and VOC's.
We are also funding a comprehensive assessment of the role
of indoor allergens in the induction and exacerbation of asthma through
the National Academy of Sciences Institute of Medicine.
EPA is expanding education of physicians and other health
care providers, teachers, school administrators, children and parents
about those factors that are known to contribute to childhood asthma
triggers such as tobacco smoke and allergens in homes, schools and day
care facilities. We will place significant emphasis on evaluating
existing and developing programs for effectiveness.
Attachment A--Public Comments Responding to Federal Register
Document Dated October 3, 1997 (62 FR 51854-51855), ``Review and
Evaluation of EPA Standards Regarding Children's Health Protection
From Environmental Risks''
In the October 3, 1997, Federal Register document EPA asked the
public to submit comments to help the Agency determine which five
existing standards merited reevaluation for the following reasons:
New scientific information or data are available
indicating adverse effects on children;
There is a new understanding of routes of exposure to
children;
The regulated substance is persistent and bioaccumulative;
New methodologies to evaluate human health risks are
available;
New epidemiology studies exist;
New toxicity studies exist;
New environmental monitoring studies exist.
[[Page 5282]]
Following is a list of the 18 organizations or individuals who
commented on the document:
American Lung Association
American Water Works Association (AWWA) Government Affairs Office
California Communities Against Toxics
Chemical Manufacturers Association (CMA)
Chemical Specialties Manufacturers Association
Children's Environmental Health Network
Citizen-at-Large
City of Milwaukee Health Department
The Connecticut Agricultural Experiment Station
ESC Consulting
Florida International University
Missouri Department of Health
National Association of County and City Health Officials (NACCHO)
The National Center for Lead-Safe Housing (The Center)
Natural Resources Defense Council
Rhone-Poulenc
Seeger, Potter, Richardson, Luxton, Joselow & Brooks, L.L.P for the
Lead Industries Association, Inc. (LIA)
State of Wisconsin
Following is a summary of comments submitted by the 18
organizations or individuals in response to the Federal Register
document:
1. EPA should also include recently promulgated standards as part
of the standard review.
2. EPA should select for review the national air quality standards
for particulate matter, nitrogen dioxide and sulfur dioxide
3. The American Lung Association (ALA) filed a legal challenge to
EPA's decision not to revise the national air quality standard for
sulfur dioxide. Regardless of the court decision, ALA recommends that
EPA include the sulfur dioxide standard for review and evaluation.
4. AWWA does not believe that at this time there is sufficient data
to warrant a change in existing drinking water regulations.
5. The Safe Drinking Water Act (SDWA) typically considers children
separately in risk assessment process.
6. The Safe Drinking Water Act (SDWA) requires EPA to review
existing drinking water standards every six years which will ensure new
data and information will be considered.
7. Concerned about the impact to children's health from persistent,
bioaccumulative toxins (PBTs)--dioxins, PCBs and mercury.
8. PCBs are toxic to children during brain development.
9. Millions of lbs. of PCBs remain in use and dispersed into the
environment through mismanagement and accidents.
10. The latest mercury study and ATSDR Toxicological Report on
mercury cannot correctly quantify or locate mercury emissions due to
inadequate monitoring and reporting.
11. EPA reports that 1.6 million women/children are at risk from
mercury poisoning.
12. Perchlorate is an endocrine disrupting chemical that affects
children's brain development; action level should be set to protect
children not adults.
13. Despite the FQPA, we remain concerned about the exposure of
children to pesticides through food and non-food exposures. There is
evidence of increased rates of leukemia in homes with pesticide
application.
14. A programmatic review of PBTs and their impact on children is
absolutely necessary.
15. Many of the hazardous air pollutants, for which no emission
limits are being set, are reproductive and developmental toxicants.
16. Standard as defined in the Federal Register document is too
narrow.
17. EPA should:
(a) more closely coordinate efforts to protect children's health
with other federal agencies to ensure that limited federal resources
are focused on the biggest health risks to children;
(b) consider for review certain regulatory standards that due to
their imposition, inadvertently increase risk to children; and
(c) clarify criteria for evaluating proposed changes to existing
regulations.
18. EPA should work with the Chemical Specialties Manufacturers
Association to reform/streamline registration of antimicrobial and
pesticide products to assure these products are available to protect
children and others from exposure to microorganisms and insect borne
diseases.
19. EPA should review standards and compliance programs related to
drinking water to assure drinking water is free from microorganisms
caused by inadequate disinfection.
20. EPA should promote effective cleaning products as part of its
indoor air quality program and its child health initiative.
21. We recommend that EPA review and discourage publications that
recommend that consumers formulate their own household cleaning
products, which could increase environmental risks to children and
others.
22. The Network strongly urges the Agency to take a broader view of
what is considered a ``standard'' for the purposes of this review.
23. The Agency needs to review how its risk assessments are
conducted, the default assumptions used, and change them to
appropriately reflect pediatric issues.
24. The Agency should evaluate the standards it is considering for
review in large part based on assumptions inherent in the risk
assessments (e.g., did the exposure estimates account for children's
behavior; did toxicology studies include fetal and neonatal exposure;
did the standard consider appropriate toxicological endpoints?)
25. The Agency needs to look at chemicals by class or by mechanism
of action as ``one standard'' rather than a chemical-by-chemical
approach.
26. The Agency should use this exercise as an Agency-wide education
opportunity to further the goals of the child health protection
initiative and to expedite the universal adoption of similar practices
throughout the Agency.
27. The five standards selected should be from a variety of
different program offices or across program offices.
28. The Agency should move expeditiously, set aggressive deadlines
and follow them.
29. The Agency must review all standards and should publicly
announce the process and schedule by which it will conduct the review.
30. Persistent toxic substances are too dangerous to the biosphere
and environment, deleterious to the human condition and should not be
released in the environment in any quantity.
31. Risk assessment and chemical-by-chemical regulation undermine
pollution prevention efforts--elimination of persistent toxic
substances should not be subject to a risk benefit calculation.
32. Although fluoride is often not considered a toxic substance, it
is suspected to impact the mental development of children.
33. We propose addressing the cumulative effects of various
pathways of exposure.
34. The specific recommendations are based on problems evident in
our urban environments--children of these families may be especially
vulnerable because of conditions associated with poverty:
(a) Persistent toxins in the drinking water supply (cadmium and
compounds, chlordane, DDT/DDE, Dieldrin, Hexachlorobenzene, a-HCH, lead
and compounds, Lindane, Mercury and compounds, PCBs, Polycyclic organic
matter (POM), TCDD (dioxins),
[[Page 5283]]
TCDF (furans), Toxaphene, Nitrogen compounds);
(b) Volatile organics found in ambient air in urban areas;
(c) Lead in soil--there appear to be conflicting standards among
the EPA, HUD, and U.S. Public Health Service regarding lead in soils. A
universal standard would be helpful in the battle against child lead
poisoning. The standards for lead do not address multiple source
exposure;
(d) Aeroallergens in the household--currently no standard--EPA may
want to be more proactive with the increase in childhood asthma;
(e) Fish consumption advisories--relative to mercury and PCBs
current standards do not address bioaccumulation effects in children;
and
(f) Common pesticides and herbicides frequently used in lawn care.
35. EPA should consider the risk of arsenic exposure to children
through arsenic treated wood.
36. Children may be exposed to arsenic from treated wood products
by direct hand to mouth contact with the wood or from arsenic
contaminated soil under wooden decks. Soil may become contaminated by
leaching, deterioration of the wood, or sawdust generated during
construction.
37. Arsenic is linked to skin and bladder cancer.
38. Research links arsenic to lower IQ's.
39. 50,000,000 pounds of arsenic are imported into the U.S. every
year for treating lumber.
40. Millions of treated decks and playscapes leach arsenic into the
soil and children are exposed via direct contact with the wood and the
soil.
41. EPA is inconsistent in the application of its policies and
regulations (i.e., safety factors to protect children's health.)
42. If arsenic were evaluated today it would not stand up to the
risk calculations under FQPA.
43. The arsenic MCL is 17-fold greater than the triazine MCL even
though arsenic has an estimated 100-fold greater NOAEL than triazine
and is a class ``A'' human carcinogen.
44. There is no explanation for a decade-old delay in acting to
lower the arsenic MCL which may have caused harm to an entire
generation of children exposed to imported arsenic in a variety of ways
that are unique to children's active daily lives.
45. We propose that EPA review the standards for lead poisoning in
the following areas: paint, soil, dust, and drinking water.
46. All public water systems shall be fluoridated to improve the
dental health of children.
47. All public and private water system/supplies shall be safe for
children to drink.
48. Children shall reside in adequate housing that is not
dangerous, crowded or cost more than 30% of family income.
49. Children shall not be exposed to high concentrations of lead in
their environment.
50. Recommends systematically reevaluating all standards.
51. Hope that standards are selected, reviewed, and adopted with
respect to their impact at the local level.
52. Suggest that EPA consider standards for asthma hazards such as
mites, mold, and cockroaches.
53. The National Center for Lead-Safe Housing (the Center) has
worked with EPA in the development of standards for lead. The person
submitting the comment also indicated that the Center is broadening its
mission to include environmental hazards and hopes to work with EPA if
the agency decided to work on standards related to children's
respiratory diseases.
54. ``Standard'' as described in the FRN is too restrictive--all
EPA standards (including existing and technology based), guidelines
(risk assessment and toxicological), and unregulated threats should
also be considered.
55. The following five proposals address the solicitation of the
FRN but should not be seen as an endorsement of the EPA strategy, but
rather an illustration of the types of threats from which children are
not well protected:
(a) Review of tolerances for all pesticides which act via
inhibition of acetyl cholinesterase;
(b) Review of tolerance for all triazine herbicides found in
drinking water in the U.S.;
(c) Review of drinking water standards for microorganisms and
disinfection byproducts;
(d) Review of all standards designed to protect children from
environmental lead exposure, and issuance of the Title X lead hazard
disclosure rules; and
(e) Review of the SO2 air quality standard to protect
children with asthma, issuance of standards for acid aerosols and
diesel exhaust, and vigorous implementation of the new standard for
ozone and fine particulates to protect the asthmatic children.
56. A variety of environmental influences are risks to children's
health including intake by pregnant mothers of alcohol, cigarettes, and
controlled substances. Other factors that affect children's health
include diet and access to adequate medical care.
57. We encourage EPA to examine those standards which give exposure
to lead, radon, and asbestos.
58. The Lead Industries Association is concerned that the mention
of lead exposure in the FRN as a children's health problem gives the
impression that one or more lead regulations should be tightened to
adequately protect children's health. From the outset lead regulations
have been developed to protect children's health.
59. Existing lead regulations are protective of children's health
and should not be included in the Committee's list of regulatory
standards needing reconsideration and downward revision. Children's
blood lead levels are declining under the existing lead regulatory
regime and there is no need or justification for costly, more stringent
regulation.
60. Many serious health problems afflict our nation's children--
including the need for universal immunization and prenatal care,
reduction of infant mortality rates, and threats from the rising risk
of HIV infection, abuse, neglect, drug use, and violence.
61. The use of water containing the action level for copper would
more than double the amount of copper in an infant's diet. Infants less
than two years of age have a limited ability to excrete copper.
62. Children who consume more than two servings of fish per week
can develop elevated blood mercury levels.
63. Instead of a drinking water standard, EPA has a lifetime health
advisory for ammonia-nitrate based on the taste/odor threshold instead
of a health-based effect. Studies associate ammonia ingestion with
alteration in the gastric mucosa and risk of gastric cancer
neurotoxicity.
EPA Response to Federal Register Document Comments
EPA believes all the comments had merit, however, not all of them
were directed at the question we asked, i.e., to identify existing
standards that were worthy of reevaluation to better protect children's
environmental health. Nor did they all address issues within the
purview of EPA. Some of those who commented asked us to reevaluate
recently promulgated standards, which we had specifically excluded from
coverage in the document. In addition, standards currently in
litigation were determined by EPA to be inappropriate for reevaluation
at this time. However, EPA did consider all comments that recommended
existing standards for reevaluation. Further, all the comments were
referred to the CHPAC work group charged with submitting
[[Page 5284]]
recommendations to the Agency for re-evaluating existing standards.
In many instances, EPA found that there was no new information
sufficient to support a decision to revise an existing standard. For
example, in the case of dioxin, the Agency is revising its risk
assessment, but that information is not yet available. When it is
available, the Agency may re-evaluate existing standards if that is
indicated by new data. Similarly, EPA is engaged in a large, multi year
research and data collection effort to better define health risks,
occurrence and exposure, and treatment effectiveness for microbial
contaminants and disinfection byproducts in drinking water. Research
areas include reproductive and developmental effects, and sensitive sub
population exposures. The final Stage I Rule for Disinfectants and
Disinfectant By Products was issued on December 16, 1998. A health
assessment for fetuses, infants and children was conducted to support
the rule.
In some cases, EPA is already engaged in re-evaluating standards
identified in the public comments. Examples include the reevaluation of
the organophosphate and triazine pesticides. The Agency is required by
the Food Quality Protection Act (FQPA) to re-evaluate all pesticide
tolerances, basing new decisions on aggregate exposures and common
mechanisms of action. The FQPA requires use of an additional
uncertainty factor to protect children unless reliable data demonstrate
the additional factor is unnecessary. Further, the Agency issued on
November 16, 1998, a Draft Multimedia Strategy for Priority Persistent,
Bioaccumulative, and Toxic (PBT) Pollutants which includes an Action
Plan for Mercury. The goal of the strategy is to further reduce risks
to human health and the environment from existing and future exposure
to priority PBTs such as mercury, dioxins, furans, chlordane, DDT,
dieldrin, toxaphene, hexachlorobenzene, alkyl-lead and PCBs. Further a
draft rule for identifying lead hazards in dust, soil and paint was
issued on June 3, 1998.
In summary, EPA's decisions to reevaluate the Chloralkali NESHAP
(mercury); the implementation and enforcement of the (Farm) Worker
Protection Standards; pesticide tolerances for the organophosphates
(chlorpyrifos, dimethoate, methyl parathion); atrazine (pesticide
tolerance and MCL); and to review indoor and ambient air quality as
they relate to asthma are based in part and are supported by
recommendations received through the Federal Register document and from
the Children's Health Protection Advisory Committee.
Attachment B--CHPAC Screening Criteria to Select Rules for Re-
Evaluation (2/24/98)
Children's health protection would be strengthened if these
regulation-based standards, policies or rules were re-evaluated and
subsequently changed because:
A. Children's health was not considered in the original development
of the standard, such as:
Exposure estimates did not adequately account for
children's behavior;
Toxicology studies did not include fetal, neonatal, and
early childhood exposure; or
The standard did not consider the full range of
appropriate toxicological endpoints for fetal, neonatal, and early
childhood exposure.
B. Children's health was considered but new information or data
suggest the standard does not adequately protect children. The new
information or data, based on peer-reviewed science, may include
considerations such as:
Descriptions of adverse health effects in children;
Increased susceptibility for children to specific
substances because of their unique physiology;
New understanding of routes of exposure to children;
Mechanisms of exposure that better reflect children's
activities;
Whether, and the extent to which the regulated substance
is persistent and bioaccumulative;
Improved methodologies for evaluating human health risks;
Epidemiology studies; consideration of disproportionate
exposures to sub-populations (e.g., geographic, racial);
Toxicity studies;
Environmental monitoring studies; or
Cumulative, aggregate risks.
C. Major threats to children's health will be addressed such that a
change in the regulation will result in a significant improved health
outcome for children:
Severity of health outcome of concern;
Number of children adversely affected;
Substances to which children are highly exposed; or
Substances to which children are highly susceptible.
D. Revisions will have broad precedent setting impacts in terms of
changing the procedures, guidelines, and overall culture of the Agency
to include children's environmental health issues in all aspects of its
work.
E. Children's health issues could be assigned higher priority for
rules selected (e.g., how revisions to the rules fit Agency existing
plans/schedules).
F. Rules will span a diverse list of hazards (e.g., variety of
substances and/or media programs) and a variety of health endpoints
(e.g., cancer, non-cancer).
G. Rules whose effectiveness in protecting children's health would
be greatly enhanced by revisions that facilitate its implementation or
improve its enforceability.
Dated: January 26, 1999.
E. Ramona Trovato,
Director, Office of Children's Health Protection.
[FR Doc. 99-2447 Filed 2-2-99; 8:45 am]
BILLING CODE 6560-50-U
