[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; 
([email protected]).

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),

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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