Response to Recommendations from the Children's Health Protection Advisory Committee Regarding Evaluation of Existing Environmental Standards

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.

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

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),

[[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