Toxic Substances: Status of EPA's Efforts to Develop Lead Hazard
Standards (Letter Report, 05/16/94, GAO/RCED-94-114).

Lead poisoning is the most common and devastating environmental disease
of young children, according to the Centers for Disease Control.
Millions of U.S. children from all geographic areas have harmful lead
levels in their blood. A major cause of lead poisoning is lead-based
paint. To address this problem, Congress required the Environmental
Protection Agency (EPA) to develop by April 1994 (1) standards defining
hazardous lead levels in paint, household dust, and soil; (2) standards
for inspecting and removing lead-based paint; and (3) guidelines to
avoid creating lead-based paint hazards during renovations and
remodeling. Although abatement guidelines for lead-based paint have been
developed for public housing, no standards exist for use in private
homes and municipal buildings to help identify and remove lead hazards
safely and effectively. This report reviews EPA's efforts to develop the
standards and guidelines for lead hazards. GAO discusses the status of
these efforts as of April 1994 and the additional steps EPA needs to
take to issue the standards and guidelines.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  RCED-94-114
     TITLE:  Toxic Substances: Status of EPA's Efforts to Develop Lead 
             Hazard Standards
      DATE:  05/16/94
   SUBJECT:  Toxic substances
             Hazardous substances
             Safety regulation
             Pollution control
             Housing construction
             Housing repairs
             Standards evaluation
             Environmental legislation
             Environmental monitoring
             Federal regulations
IDENTIFIER:  Baltimore (MD)
             Boston (MA)
             Cincinnati (OH)
             
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Cover
================================================================ COVER


Report to the Chairman, Subcommittee on Health and the Environment,
Committee on Energy and Commerce, House of Representatives

May 1994

TOXIC SUBSTANCES - STATUS OF EPA'S
EFFORTS TO DEVELOP LEAD HAZARD
STANDARDS

GAO/RCED-94-114

Toxic Substances


Abbreviations
=============================================================== ABBREV

  EPA - Environmental Protection Agency
  HUD - Department of Housing and Urban Development
  OMB - Office of Management and Budget

Letter
=============================================================== LETTER


B-256299

May 16, 1994

The Honorable Henry A.  Waxman
Chairman, Subcommittee on Health
 and the Environment
Committee on Energy and Commerce
House of Representatives

Dear Mr.  Chairman: 

Lead poisoning is the most common and devastating environmental
disease of young children, according to the Centers for Disease
Control.  Millions of U.S.  children from all geographic areas and
socioeconomic groups have lead in their blood at levels high enough
to cause adverse health effects.  A major cause of lead poisoning is
lead-based paint, and its presence in housing is the primary focus of
concern because of the amount of time that very young children--those
most susceptible to the disease--spend in their homes. 

To address this problem, the Congress enacted the Residential
Lead-Based Paint Hazard Reduction Act of 1992.\1 Among other things,
the act required the Environmental Protection Agency (EPA) to
develop, by April 28, 1994, (1) standards defining hazardous levels
of lead in lead-based paint, household dust, and soil; (2) standards
for performing inspection and abatement activities for lead-based
paint; and (3) guidelines to avoid creating lead-based paint hazards
in performing renovation and remodeling activities.  Although the
Department of Housing and Urban Development (HUD) has developed
abatement guidelines for lead-based paint hazards for the
Department's housing programs, no standards exist for general use in
private housing and public buildings to facilitate identifying and
removing lead hazards in a safe and effective manner. 

You requested that we review EPA's efforts to develop the standards
and guidelines for lead hazards.  Specifically, this report discusses
the status of these efforts as of April 1994 and the additional
actions that EPA must complete to issue the standards and guidelines. 


--------------------
\1 Enacted by the Congress on October 28, 1992, as title X of the
Housing and Community Development Act of 1992 (P.L.  102-550). 


   RESULTS IN BRIEF
------------------------------------------------------------ Letter :1

EPA did not issue the standards defining hazardous levels of lead in
paint, dust, and soil by the legislatively imposed April 1994
deadline, although the renovation and remodeling guidelines were
issued on time.  While EPA expects to issue the standards by late
1995, the date appears optimistic, given that the regulatory review
process alone may take 2 years or more. 

Although EPA has completed the technical work needed to develop a
standard defining hazardous levels of lead in lead-based paint, the
agency must complete a number of activities before it can develop
similar standards for lead-contaminated dust and soil and issue the
three interrelated standards at the same time.  According to EPA
officials, additional time is required to (1) complete research on
lead-contaminated dust and soil, (2) develop proposed standards, and
(3) complete the regulatory review process.  Consequently, EPA's lead
hazard standards might not be issued until September 1995--more than
a year after the April 1994 date required by the Residential
Lead-Based Paint Hazard Reduction Act.  In the interim, EPA plans to
issue, in May 1994, guidance defining hazardous levels of lead in
lead-based paint, dust, and soil. 

EPA's efforts to develop lead inspection and abatement standards have
also been delayed, primarily because of the agency's extensive
efforts to consult with state and local governments and other
interested parties to ensure that the standards will meet their
needs.  EPA officials expect to issue these standards by November
1995, rather than by April 1994 as the act required. 

The delays that EPA has experienced in issuing the lead hazard
standards may have serious environmental and health consequences
because lead-based paint abatement activities continue to be
performed without adequate standards to protect the public.  To
address this problem in the interim, we believe that EPA should
promote the general public use of existing guidelines established by
HUD for abating lead-based paint in housing under its programs. 


   BACKGROUND
------------------------------------------------------------ Letter :2

Lead is a dangerous and pervasive poison that adversely affects
virtually every system in the body.  Lead poisoning occurs through
exposure to lead in air, dust, soil, water, food, and products such
as paint.  Because young children frequently place their fingers and
objects in their mouth, they can ingest lead by swallowing paint
chips and lead-contaminated dust or soil.  Paint, dust, soil, and
drinking water are the primary media through which children are
poisoned by lead.  According to EPA, lead-based paint is the
principal cause of the most severe cases of lead poisoning among
children and is thought to be the primary source contributing to lead
contamination in household dust and soil.  Although EPA has
established recommended exposure limits for lead in drinking water,
standards that define specific conditions under which lead-based
paint and lead-contaminated dust and soil pose health hazards have
not yet been established. 

The Residential Lead-Based Paint Hazard Reduction Act of 1992
required EPA to develop standards for identifying and removing lead
hazards.  Among its provisions, the act directed EPA to promulgate
regulations by April 1994 that identify hazards associated with (1)
lead-based paint, (2) lead-contaminated dust, and (3)
lead-contaminated soil.  These regulations are to provide
health-based standards for identifying the conditions under which
lead-based paint poses a health hazard.  Because lead in household
dust and soil comes primarily from deteriorating paint, hazards
associated with lead-contaminated dust and soil are included under
the act's definition of lead-based paint hazards.  The standards are
intended to identify dangerous levels of lead in these media and will
be used by contractors and others in conducting inspection and
abatement activities. 

The act also directed EPA to promulgate, by April 28, 1994,
regulations that provide standards for performing lead-based paint
activities, taking into account reliability, effectiveness, and
safety.  Lead-based paint activities governed by these regulations
include (1) conducting risk assessments and inspecting for and
abating lead hazards in and around most housing constructed before
1978 (when the sale of lead-based paint to consumers was banned) and
(2) identifying and removing lead-based paint and associated
materials and conducting demolition activities involving public
buildings built before 1978, commercial buildings, bridges, and other
similar structures.  These standards, in conjunction with the lead
hazard standards, are intended for inspectors and abatement
contractors to use in ensuring that lead hazards are identified and
eliminated in the safest and most effective manner. 

The lead hazard and abatement standards proposed by EPA must undergo
the federal regulatory review process which, in the past, has taken
up to 2 years or more to complete.  Under this process, the proposed
regulation is reviewed consecutively by EPA senior management, the
Office of Management and Budget (OMB), and the public.  Once EPA
staff make modifications to the proposed rule in response to the
review comments, the proposed regulation is again reviewed within EPA
and by OMB.  The Administrator, EPA, then signs the regulation, which
is then published in the Federal Register as a final rule. 

In addition, the act required EPA to develop, by April 28, 1994,
guidelines for renovation and remodeling activities that may create a
risk of exposure to dangerous levels of lead.  These guidelines
describe measures to be taken by contractors to avoid creating
lead-based paint hazards in renovating and remodeling homes. 


   ADDITIONAL NEEDED EFFORTS WILL
   DELAY ISSUANCE OF STANDARDS
   DEFINING LEAD HAZARDS
------------------------------------------------------------ Letter :3

Although EPA has nearly completed its work to develop a standard
defining lead-based paint hazards, much additional work is needed
before EPA can complete similar standards for lead-contaminated dust
and soil.  Additional efforts required to complete these standards
include (1) evaluating and modifying an analytical model that EPA is
considering for developing both a dust and soil standard, (2)
completing further research on and analysis of a number of issues
concerning lead-contaminated dust and soil, and (3) completing the
review process for issuing the standards as a federal regulation. 

In August 1993, EPA developed a strategy and schedule for completing
the standards by April 1994.  Although EPA has experienced numerous
delays in developing the standards since the strategy was issued, the
agency has not analyzed the remaining tasks and formally revised its
milestones for issuing the standards.  Nevertheless, EPA officials
told us that these efforts are extensive and complex and could not be
completed by the April 1994 date specified in the Residential
Lead-Based Paint Hazard Reduction Act.  Instead, although EPA has not
revised its schedule, agency officials estimated that EPA may issue
all three lead hazard standards by September 1995.  In the interim,
EPA plans to issue guidance defining hazardous lead levels in paint,
dust, and soil on the basis of the scientific analysis that EPA has
completed to date. 


      TECHNICAL WORK ON LEAD-BASED
      PAINT STANDARD IS
      ESSENTIALLY COMPLETE
---------------------------------------------------------- Letter :3.1

In developing its lead-based paint standard, EPA relied heavily on
guidelines that HUD had previously developed to address lead-based
paint hazards in public housing.\2 HUD's guidelines provide
information on the need for and the appropriate methods of
identifying and abating lead-based paint.  They are a compilation of
technical protocols, practices, and procedures for (1) the testing,
abatement, cleanup, and disposal of lead-based paint in residential
structures and (2) the protection of workers from the hazards of
lead-based paint.  HUD's guidelines (1) include provisions to control
the generation of lead-contaminated dust during lead paint abatement
activities and (2) specify maximum levels of lead-contaminated dust
permissible after paint abatement.  Unlike HUD's guidelines, EPA's
lead paint standard will not address the permissible level of dust or
soil contamination after abatement activities; such levels will be
defined in the separate dust and soil hazard standards that EPA is
developing. 

Although EPA's paint standard is essentially completed, the agency
does not plan to issue this standard until its dust and soil
standards are also completed.  Because of the interrelationship
between hazards that arise from lead-based paint and
lead-contaminated dust and soil, EPA officials believe that the
hazards should be addressed in a simultaneous, coordinated manner and
plan to issue the standards in a single regulation.  However,
delaying the issuance of a paint standard while completing the dust
and soil standards may have serious environmental and health
consequences because paint abatement activities performed in the
interim must proceed without adequate standards to protect the
public. 


--------------------
\2 HUD's activities and programs relating to lead-based paint hazards
in housing are discussed in a number of our reports, including
Lead-Based Paint Poisoning:  Children Not Fully Protected When
Federal Agencies Sell Homes to the Public (GAO/RCED-93-38, Apr.  5,
1993) and Toxic Substances:  Federal Programs Do Not Fully Address
Some Lead Exposure Issues (GAO/RCED-92-186, May 12, 1992). 


      EPA IS DEVELOPING DATA
      NEEDED FOR LEAD-CONTAMINATED
      DUST AND SOIL STANDARDS
---------------------------------------------------------- Letter :3.2

To develop a standard for lead-contaminated dust, EPA is evaluating a
model for assessing the biologic response to and potential health
risks from exposure to such dust in a specified area.  By evaluating
lead exposure from dust and considering human lead intake and body
absorption, the model predicts a distribution of children's
blood-lead levels that can be related to health risks. 

A number of critics have questioned the reliability of the risk
predictions that would be derived from EPA's model.  During a June
1993 public meeting at which EPA presented its proposed technical
approaches to developing the lead hazard standards, numerous
participants expressed concerns that (1) the model's results had not
been validated and (2) the model was not designed to use key data
needed to determine lead contamination hazards. 

EPA has undertaken a number of activities to address the concerns
about the model.  To validate the model's results, EPA compared the
dust hazard levels derived from the model with levels derived
independently by analyzing epidemiological studies on the correlation
between lead-contaminated dust and levels of lead in blood.  EPA has
not completed research efforts that address the concern that the
model was not designed to use key dust measurement data.  The model
currently considers only "dust concentration"--the amount of lead per
unit weight of dust--rather than "dust loading"--the amount of dust
per household area.  However, according to EPA officials, the
dust-loading measurement may be the appropriate measurement to use
with the model in establishing the dust standard.  Therefore, EPA is
determining the correlation between the dust concentration and
dust-loading measurements so that necessary modifications can be made
to utilize the model. 

In addition, EPA officials told us that the agency did not have
sufficient research data on the correlation between household dust
and levels of lead in blood to use with the model.  They said that
such data available from previous studies are of limited use with the
model because the studies did not control for the extent to which
exposure to sources of lead other than dust, such as paint and soil,
may have affected the levels of lead in blood.  EPA is currently
evaluating the results of research completed in December 1993 to
determine how to utilize the information in setting the standard. 

According to EPA officials, an internal EPA committee established by
the Assistant Administrator for Prevention, Pesticides, and Toxic
Substances found in April 1994 that additional work is needed to (1)
validate the model for use in developing the standards and (2)
analyze epidemiological studies relating lead-contaminated dust to
blood-lead levels.  This work may require an additional 6 months or
more to complete. 

EPA officials told us that the model being evaluated for developing
the lead-contaminated dust standard may also be used for the
lead-contaminated soil standard.  In addition, EPA is analyzing
studies to determine the effectiveness of removing lead-contaminated
soil to reduce the level of lead in children's blood.  The studies
were performed under cooperative agreements between EPA and the
cities of Baltimore, Maryland; Boston, Massachusetts; and Cincinnati,
Ohio.  They showed little or no reduction in the level of lead in the
children's blood after lead-contaminated soil was removed from around
their house. 

EPA must determine how the studies should be used, given their
limitations.  For example, the three studies analyzed only the effect
that removing soil with relatively low lead content may have on
children with low levels of lead in their blood.  The studies did not
consider children who live in areas with high levels of lead in the
soil nor the potential effects that removing lead-contaminated soil
would have on children with higher blood-lead levels.  Furthermore,
EPA officials believe that the studies might have shown a greater
benefit associated with the removal of lead-contaminated soil if the
children in the studies had been monitored after abatement for more
than the 11-month period covered by the studies.  Finally, the
studies measured the effects of changes in the levels of lead in the
soil but did not provide data on the effects of stable soil-lead
levels. 

Once the dust and soil standards are developed, they and the
lead-based paint standard will become a proposed regulation. 
According to EPA officials, because of the time required to complete
research, develop proposed standards, and complete the regulatory
review process, the lead hazard standards might not be issued until
September 1995.  Although EPA has not revised this estimate in light
of the EPA committee's recent finding that additional technical work
is needed on the model and epidemiological studies, EPA officials
said that they plan to develop a revised schedule for completing the
standards. 


      EPA WILL ISSUE INTERIM LEAD
      HAZARD GUIDANCE
---------------------------------------------------------- Letter :3.3

Because of delays in completing the lead hazard standards, EPA plans
to issue, in May 1994, technical guidance defining the levels of lead
in paint, dust, and soil that are hazardous.  The guidance does not
have to undergo the regulatory review process and, therefore, can be
issued well before the standards are issued.  The defined levels of
lead hazards will be based on the scientific analysis that EPA has
completed on the standards to date.  EPA officials believe that the
guidance will provide the public and workers with some measure of
protection from lead hazards until the standards can be completed. 


   LEAD ABATEMENT STANDARDS WILL
   BE DELAYED
------------------------------------------------------------ Letter :4

Although EPA has made progress in developing the lead abatement
standards required by the Residential Lead-Based Paint Hazard
Reduction Act, they were not completed by the April 28, 1994,
deadline specified in the act.  EPA officials expect to issue the
standards by November 1995.  According to EPA officials, the
standards will contain required basic work practices for abatement
contractors and will refer contractors to the lead inspection and
abatement guidelines developed by HUD to address lead-based paint
hazards in its housing programs. 

EPA is developing a consolidated rule that will include its abatement
standards as well as contractor training, accreditation, and
certification requirements.  According to EPA officials, the agency
has experienced delays primarily because of efforts to provide
interested parties opportunities for early involvement in the
standards' development process in order to tailor the various
components of the regulation to the parties' needs.  EPA has held
public meetings and consulted with representatives from labor unions,
national organizations representing abatement and building
contractors, training organizations, public interest groups, state
and local governments, and other involved federal agencies (such as
HUD and the Occupational Safety and Health Administration).  In
addition, the development of the lead abatement standards was delayed
by the need to resolve within EPA a number of issues concerning
interpretations of the act and to perform a cost-benefit analysis
relating to the rule, which is required by Executive Order 12866. 

EPA officials submitted a draft proposed rule to OMB in early April
1994.  Because the abatement standards are part of a proposed
regulation, they will be published in the Federal Register for public
review and comment after OMB's review and must undergo all of the
subsequent steps of the regulatory review process. 


   RENOVATION AND REMODELING
   GUIDELINES WERE ISSUED ON
   SCHEDULE
------------------------------------------------------------ Letter :5

EPA officials issued guidelines for renovation and remodeling
activities by the April 28, 1994, deadline specified in the act.  As
required under the act, EPA is distributing the renovation and
remodeling guidelines to persons involved in home renovation and
remodeling activities.  The guidelines are included in a publication
entitled Reducing Lead Hazards When Remodeling Your Home.  The
guidelines do not include procedures for conducting lead abatement
activities but recommend that those conducting lead abatements
consult HUD's abatement guidelines.  EPA's renovation and remodeling
guidelines are being sent to hardware and paint stores, employee
organizations, trade organizations, and state and local agencies. 


   HUD'S GUIDELINES COULD PROVIDE
   PROTECTION UNTIL EPA'S
   STANDARDS ARE DEVELOPED
------------------------------------------------------------ Letter :6

Given that delays in the development of EPA's lead inspection and
abatement standards could result in continued exposure to lead
hazards, we raised with EPA officials the option of promoting wider
use of HUD's guidelines, which were established for HUD's housing
programs and which could also be applied to other residences and
buildings.  EPA officials told us that adopting HUD's guidelines as
EPA's standards on an interim basis would require nearly as much time
as issuing EPA's final regulations.  However, these officials said
that interim use of HUD's inspection and abatement guidelines could
be promoted through the National Lead Information Center
clearinghouse, which was established to disseminate information
relating to lead hazards, and/or by referring to HUD's guidelines in
EPA's home renovation and remodeling guidelines issued in April 1994. 
As noted earlier, EPA refers to HUD's lead abatement guidelines in
the renovation and remodeling guidelines; however, EPA has not taken
action to promote the use of HUD's guidelines in the clearinghouse. 


   CONCLUSIONS
------------------------------------------------------------ Letter :7

Despite a conscientious effort, EPA did not meet its legislatively
imposed April 1994 deadline for issuing the lead hazard and lead
abatement standards, although the renovation and remodeling
guidelines were issued on time.  Delays have resulted from the need
to (1) complete a number of complex research and analysis activities
to obtain the information necessary for developing the hazard
standards for lead-contaminated dust and soil and (2) build consensus
on the lead abatement standards by involving key interested parties
in the development process. 

EPA has not yet analyzed the remaining tasks, resources, and time
required to complete the standards and revised its milestones. 
Agency officials stated that they see value in revising their
schedule for issuing the standards and providing this information to
the Congress.  In the interim, these officials tentatively estimate
that the lead hazard standards could be issued by September 1995 and
the abatement standards by November 1995.  In our opinion, both dates
may be optimistic, given that the regulatory review process alone may
take 2 years or more. 

Although EPA's lead-based paint standard is nearly developed and
could be issued in advance of the dust and soil standards, the
standard does not address the permissible level of dust or soil
contamination that remains after--and may even be increased
by--lead-based paint abatement activities.  Consequently, although
lead-based paint is considered to be the principal cause of the most
severe cases of lead poisoning among children, EPA believes that the
three standards should be issued together because of the
interrelationship between paint, dust, and soil in creating lead
hazards.  In the interim, EPA plans to release in May 1994 guidance
defining hazardous levels of lead in paint, dust, and soil. 

We believe that EPA's decision to issue guidance defining lead
hazards is reasonable.  However, EPA should also promote the use of
lead-based paint inspection and abatement guidelines that HUD has
developed for its housing programs.  While the reference to HUD's
guidelines in EPA's home renovation and remodeling guidelines is an
appropriate step, we believe that EPA should take measures to
encourage more widespread use of HUD's guidelines during abatement
activities in public and commercial buildings, schools, and other
nonresidential facilities.  Vehicles for promoting the use of these
guidelines include the National Lead Information Center clearinghouse
and EPA's guidance defining hazardous levels of lead, which is to be
issued in May 1994. 


   RECOMMENDATIONS
------------------------------------------------------------ Letter :8

To guide EPA's efforts in developing the lead standards, we recommend
that the Administrator, EPA, assess the additional steps, resources,
and time required to complete the lead hazard and abatement
standards.  EPA should then revise its schedule for issuing the lead
standards and identify the major tasks required and related
milestones.  Once completed, EPA should provide this information to
the appropriate congressional committees to assist them in their
oversight activities. 

To ensure that the public is protected from lead-based paint hazards
before the standards are issued, we recommend that the Administrator,
EPA, promote the use of HUD's lead inspection and abatement
guidelines among abatement contractors, state and local government
agencies, and the public. 


   AGENCY COMMENTS
------------------------------------------------------------ Letter :9

We discussed the information in this report with the Deputy Director
of EPA's Office of Pollution Prevention and Toxics and the Acting
Director of the Office's Program Development Branch.  These officials
generally agreed with the facts presented, and their views have been
incorporated in the report where appropriate.  As requested, we did
not obtain written comments on a draft of this report. 


   SCOPE AND METHODOLOGY
----------------------------------------------------------- Letter :10

To identify EPA's efforts to develop the standards and guidance, we
interviewed the Deputy Director of EPA's Office of Pollution
Prevention and Toxics, the Acting Director of the Office's Program
Development Branch, and other EPA officials.  We also obtained
numerous internal EPA documents relating to the development of the
standards and guidance and HUD's guidelines for lead-based paint
abatement.  In addition, we discussed technical activities undertaken
to develop EPA's standards and guidance with technical experts within
EPA's Office of Research.  Our work was conducted between February
1993 and April 1994 in accordance with generally accepted government
auditing standards. 


--------------------------------------------------------- Letter :10.1

As arranged with your office, unless you publicly announce its
contents earlier, we plan no further distribution of this report
until 30 days after the date of this letter.  At that time, we will
send copies to the Administrator, EPA, and the Director, OMB.  We
will make copies available to others on request. 

This work was performed under the direction of Peter F.  Guerrero,
Director, Environmental Protection Issues, who can be reached at
(202) 512-6111 if you or your staff have any questions.  Major
contributors to this report are listed in appendix I. 

Sincerely yours,

Keith O.  Fultz
Assistant Comptroller General


MAJOR CONTRIBUTORS TO THIS REPORT
=========================================================== Appendix I


   RESOURCES, COMMUNITY, AND
   ECONOMIC DEVELOPMENT DIVISION,
   WASHINGTON, D.C. 
--------------------------------------------------------- Appendix I:1

Bernice Steinhardt, Associate Director
Edward A.  Kratzer, Assistant Director
Vincent P.  Price, Evaluator-in-Charge


   PHILADELPHIA REGIONAL OFFICE
--------------------------------------------------------- Appendix I:2

Richard E.  Schultz (retired)
John L.  Hoelzel (retired)

