y§z)
U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF INSPECTOR GENERAL
Catalyst for Improving the Environment
Evaluation Report
EPA's Voluntary Chemical
Evaluation Program Did Not
Achieve Children's Health
Protection Goals
Report No. 11-P-0379
July 21, 2011
-------
Report Contributors:
Gabby Fekete
Jeffrey Harris
Jee W. Kim
Steve Weber
Abbreviations
BPA Bisphenol A
ChemRTK Chemical Right-to-Know
EO Executive order
EPA U.S. Environmental Protection Agency
OCHP Office of Children's Health Protection
OCSPP Office of Chemical Safety and Pollution Prevention
OIG Office of Inspector General
OPPT Office of Pollution Prevention and Toxics
TERA Toxicology Excellence for Risk Assessment
TSCA Toxic Substances Control Act
VCCEP Voluntary Children's Chemical Evaluation Program
Cover photos: From left: An unborn child and two children in different stages of childhood.
(EPA's Office of Children's Health Protection)
Hotline
To report fraud, waste, or abuse, contact us through one of the following methods:
e-mail: OIG Hotline@epa.gov
phone: 1-888-546-8740
fax: 703-347-8330
online: http://www.epa.gov/oig/hotline.htm
write: EPA Inspector General Hotline
1200 Pennsylvania Avenue NW
Mailcode 8431P (Room N-4330)
Washington, DC 20460
-------
,tfED STj,
U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
11-P-0379
July 21, 2011
Why We Did This Review
We conducted this review to
determine the outcomes of the
U.S. Environmental Protection
Agency's (EPA's) Voluntary
(Children's Chemical
Evaluation Program (VCCEP)
toward meeting its original
goal and the goals outlined
under the Chemical Right-to-
Know Initiative (ChemRTK).
Background
Executive Order (EO) 13045
directed federal agencies to
place a high priority on
protecting children from
environmental and safety
risks. The goal of the 1998
ChemRTK was to give
citizens information on the
effects of chemicals to enable
them to make informed
choices in the home and
marketplace. ChemRTK
satisfied EO 13045 by
directing EPA to undertake
testing on chemicals to which
children are disproportionately
exposed. EPA accordingly
established the VCCEP pilot.
For further information,
contact our Office of
Congressional, Public Affairs
and Management at
(202)566-2391.
The full report is at:
www.epa.qov/oiq/reports/2011/
20110721-11-P-0379.pdf
Catalyst for Improving the Environment
EPA's Voluntary Chemical Evaluation Program
Did Not Achieve Children's Health Protection Goals
What We Found
The VCCEP pilot did not achieve its goals to design a process to assess and report
on the safety of chemicals to children. The pilot's design did not allow for desired
outcomes to be produced. Specifically, the pilot had a flawed chemical selection
process and lacked an effective communication strategy. Programmatic
effectiveness was hampered by industry partners who chose not to voluntarily
collect and submit information, and EPA's decision not to exercise its regulatory
authorities under the Toxic Substances Control Act to compel data collection.
EPA has not demonstrated that it can achieve children's health goals with a
voluntary program. The VCCEP is no longer operational, and the Agency has no
plans to revive, replace, or terminate the program. As a result, the Agency is not
meeting the intent of EO 13045, ChemRTK, or the VCCEP pilot, and there
remains no readily understandable source of chemical exposure information that
the general public can access to determine potential risks to children.
What We Recommend
We recommend that EPA design and implement a new process to assess the
safety of chemicals to children that (1) identifies the chemicals with highest
potential risk to children, (2) applies the Toxic Substances Control Act regulatory
authorities as appropriate for data collection, (3) interprets results and
disseminates information to the public, and (4) includes outcome measures that
assure valid and timely results.
The Agency concurred with our findings, indicating that work ongoing by the
existing chemicals program addresses many of our concerns. EPA agreed with our
recommendations related to improving its chemical selection process and
developing performance measures for children's health protection. EPA did not
explicitly agree to develop a workable data collection strategy for applying Toxic
Substances Control Act regulatory authorities or a communications strategy for
public information dissemination, but provided information on the program's
current activities. Also, no target dates were provided by which to assess the
completion of EPA's actions taken to address our recommendations.
-------
\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
S WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
July 21, 2011
MEMORANDUM
SUBJECT: EPA's Voluntary Chemical Evaluation Program Did Not Achieve
Children's Health Protection Goals
Report No. ll-P-0379
FROM: Arthur A. Elkins, Jr.
Inspector General
TO: Steve Owens
Assistant Administrator for Chemical Safety and Pollution Prevention
This is a report on the evaluation of the U.S. Environmental Protection Agency's (EPA's) Voluntary
Children's Chemical Evaluation Program, conducted by the EPA Office of Inspector General (OIG).
This report contains findings that describe the problems the OIG has identified and corrective actions
the OIG recommends. This report represents the opinion of the OIG and does not necessarily
represent the final EPA position. Final determinations on matters in this report will be made by EPA
managers in accordance with established audit resolution procedures.
The estimated direct labor and travel costs for this report are $337,310.
Action Required
In accordance with EPA Manual 2750, you are required to provide a written response to this report
within 90 calendar days. You should include a corrective actions plan for agreed-upon actions,
including milestone dates. Your response will be posted on the OIG's public website, along with
our memorandum commenting on your response. Your response should be provided as an Adobe
PDF file that complies with the accessibility requirements of Section 508 of the Rehabilitation Act
of 1973, as amended. The final response should not contain data that you do not want to be released
to the public; if your response contains such data, you should identify the data for redaction or
removal. We have no objections to the further release of this report to the public. We will post this
report to our website at http://www.epa.gov/oig.
If you or your staff have any questions, please contact Wade Najjum at (202) 566-0832 or
najjum.wade@epa.gov. Jeffrey Harris at (202) 566-0831 or harris.jeffrey@epa.gov. or Jee Kim at
(202) 566-2912 orkim.iee@epa.gov.
-------
EPA's Voluntary Chemical Evaluation Program 11-P-0379
Did Not Achieve Children's Health Protection Goals
Table of Contents
Chapters
1 Introduction 1
Purpose 1
Background 1
Noteworthy Achievements 4
Scope and Methodology 5
2 VCCEP Did Not Achieve Children's Health Protection Goals 6
VCCEP Did Not Address the Chemicals Posing the
Greatest Potential Risk to Children 6
VCCEP Missed Opportunity to Assess Chemicals of High Concern 6
EPA Failed to Adequately Explain Chemical Information
to the General Public 8
VCCEP Pilot Did Not Produce Complete or Timely Results or
Employ EPA's Regulatory Authorities 9
EPA Lacks an Effective Children-Specific
Chemicals Management Program 12
Conclusions 14
Recommendation 14
Agency Comments and OIG Evaluation 15
Status of Recommendations and Potential Monetary Benefits 16
Appendices
A Agency Response 17
B EPA's Essential Principles for Reform of
Chemicals Management Legislation 23
C Distribution 25
-------
Chapter 1
Introduction
Purpose
The objective of this evaluation was to determine the outcomes of the U.S.
Environmental Protection Agency's (EPA's) Voluntary Children's Chemical
Evaluation Program (VCCEP). We specifically sought to determine:
The results of the VCCEP pilot
Whether the program achieved its intended goals
If there are alternative mechanisms for achieving children's health
protection goals from chemical exposures
Background
Children's health and chemical legislation reform are key issues for the current
administration. EPA Administrator Lisa Jackson testified on October 26, 2010,
before the Senate Subcommittee on Superfund, Toxics and Environmental Health
that:
Ensuring that our children are protected from exposure to
environmental threats is central to EPA's work.. .both EPA and
industry must include special consideration for exposures and
effects on groups with higher vulnerabilities - particularly
children.
Children face significant and unique threats from environmental hazards and
industrial chemicals. Children encounter their environments differently than
adults. Physically, their neurological, immunological, respiratory, digestive, and
other physical systems are still developing and can be more easily harmed by
exposure to environmental factors. Children eat more, drink more, and breathe
more than adults in proportion to their body weight. Children's exposures to
environmental pollutants are often different from those of adults because they
engage in different activities, such as playing on floors and in soil and mouthing
of their hands, toys, and other objects that can bring them into greater contact with
environmental pollutants. EPA and academic research is addressing the potential
for children's susceptibility to chemicals and on children's unique behavior and
exposure patterns. EPA budget documents cite research concluding that children
are getting steady infusions of industrial chemicals before they even are given
solid food.
11-P-0379
-------
Toxic Substances Control Act Does Not Target Children's Health
Concerns
EPA regulates chemicals under the Toxic Substances Control Act (TSCA), which
was passed in 1976. TSCA's intent is to protect human health and the
environment from risks associated with toxic chemicals.1 TSCA includes no
provisions that enable EPA to act specifically on children's health concerns.2 In
addition, TSCA limits EPA's authority to require industry to conduct health and
safety studies. Unlike laws applicable to drugs and pesticides, TSCA does not
have a mandatory program where EPA must conduct a review to determine the
safely of existing chemicals. However, a variety of authorities exist under TSCA
by which EPA can request information or require testing from the chemical
industry.3 The VCCEP pilot Federal Register notice specifically cited EPA's
TSCA Section 4 authority. Under TSCA Section 4, EPA can request additional
information via a "test rule," if the following requirements are satisfied:
1. The chemical presents an unreasonable risk of injury to human health or
the environment and/or the chemical is produced in substantial quantities
that could result in substantial human exposure
2. Existing data is inadequate for risk assessment
3. Testing is needed to develop the data necessary to conduct the needed risk
assessment
According to the Agency, since TSCA was passed in 1976, EPA has restricted or
banned 5 and required testing for 200 existing chemicals. Currently there are
approximately 84,000 chemicals on the market.
Children's Health Concerns Addressed by Executive Order 13045
and the Chemical Right-to-Know Initiative
Executive Order (EO) 13045 and the Chemical Right-to-Know Initiative
(ChemRTK) were created to address concerns about children's health issues, and,
in part, to address EPA's limitations in evaluating chemical risks. EO 13045,
"Protection of Children from Environmental Health Risks and Safety Risks," was
signed by President Clinton on April 21, 1997. This Order directed federal
agencies to place a high priority on identifying and assessing environmental
1 The Act authorized EPA to collect information on, and to regulate the production and distribution of, chemicals.
TSCA required EPA to (i) create an inventory of "existing chemicals" already in commerce, (ii) regulate
unreasonable risk from "new chemicals" introduced into commerce subsequent to the Act, and (iii) make health and
safety information available for examination while protecting manufacturers' confidential business information.
2 The Food Quality Protection Act mandates that EPA apply an additional tenfold margin of safety to take into
consideration children's particular susceptibility to pesticide exposures. The EPA Administrator is responsible for
taking subgroups, including infants and children, into consideration when determining the potential effect of
drinking water contaminants on public health under the Safe Drinking Water Act.
3 EPA authorities under TSCA Sections 8(a) and 8(d) are discussed in the report section entitled: EPA Lacks an
Effective Children-Specific Chemicals Management Program.
11-P-0379
-------
health and safety risks that disproportionally affect children and ensure that their
policies, programs, activities, and standards address these risks.
The ChemRTK was launched in April 1998 directing EPA to develop new
programs to improve the public's knowledge about potentially harmful chemicals.
Programs designed under this initiative were to ensure the public's right-to-know
basic information about the hazards and risks of widely used chemicals that
people, especially children, may be exposed to at home, at work, or in the
environment. One component of the ChemRTK aimed to ensure that parents have
the information they need to protect their children from harmful chemicals in their
environment.4 The ChemRTK specifically directed EPA to undertake testing on
chemicals to which children are disproportionately exposed. The VCCEP is this
component of ChemRTK.
Voluntary Children's Chemical Evaluation Program
After consultation with stakeholders, EPA designed a voluntary pilot program to
assess the possible risks from 23 chemicals. It was EPA's goal that the VCCEP
provide the data needed to characterize health risks to children from chemical
exposure. EPA asked the manufacturers and importers of 23 chemicals to
volunteer to provide data sufficient for EPA to evaluate the risks of these
chemicals to children's health. EPA selected chemicals found in human tissue or
fluids; food and water children may eat and drink; and air children breathe.
Thirty-five companies and 10 consortia5 volunteered to sponsor 20 of the 23
chemicals by June of 2001.
Under the pilot, if deemed necessary, EPA could request and collect up to three
tiers of increasingly detailed information on a chemical from its sponsor, as
shown in Figure I.6 Each assessment within each of the three tiers includes: a
summary of the toxicology information, a summary of the exposure information,
and a risk characterization. A data needs assessment is required for tiers 1 and 2.
The data needs assessment identifies the need for additional data to adequately
characterize the risks the chemical may pose to children. The need for additional
data was independently analyzed by a Peer Consultation Panel comprised of
experts in toxicity testing and exposure evaluations. Ultimately, EPA was
required to determine if more information and a higher tier of testing were needed
to adequately characterize risks to children. Figure 1 illustrates each of the steps
of the pilot and the respective contributions of EPA, sponsors, and peer reviewers.
4 The other two components of the ChemRTK are the High Production Volume Challenge and additions to the Toxic
Releases Inventory.
5 Consortia are groups of manufacturers producing and representing the same chemical.
Information from all three tiers may not always be necessary to adequately characterize the risk to children. The
toxicology studies included in the program are a subset of the test battery developed by the EPA to assess the effects
of pesticides on children's health.
11-P-0379
-------
Figure 1: Voluntary Children's Chemical Evaluation Program Steps
EPA Selects Chemicals for VCCEP
yellow fill: optional commitment by
sponsors
Sponsors make Tier 1
commitments
Tier 1 - Sponsors submit hazard and exposure assessments and a risk
charaterization using Tier 1 data and prepare a Tier 2 data needs assessment
cyan fill: Planned End Result of
VCCEP
Peer Consultation - review of
sponsor submission
~~~~~^ EPA reviews sponsor's ^~~~_
submission, peer consultation
results and identifies Tier 2 needs-""
Sponsors make
Tier 2 commitment
Tier 2 - sponsors revise hazard/exposure
>^^ assessment using Tier 2 data and submit Tier 3
data needs assessment
Peer Consultation - review of
sponsor submission
EPA reviews sponsor's ^~~~
submission, peer consultation
--results and identifies Tier 3 needs-'
Sponsors make
Tier 3 commitment.
Tier 3 - sponsors revise hazard/exposure
assessment using Tier 3 data
Peer Consultation - review of
sponsor submission
EPA/Sponsors: risk reduction and risk
communication
Ur__- EPA reviews hazard, exposure
-__ and risk characterization
Source: EPAOIG analysis of VCCEP announcement, Federal Register, December 26, 2000.
EPA's Office of Pollution Prevention and Toxics (OPPT), within the Office of
Chemical Safety and Pollution Prevention (OCSPP), is the national program
office and manager of the VCCEP.
Noteworthy Achievements
EPA attempted to specifically characterize chemical risks to children under the
VCCEP, a novel effort by the Agency. OPPT staff considered the structure of the
VCCEP pilot to be innovative for its time. EPA cites the use of the peer
consultation panel process as one of the innovative aspects of the VCCEP pilot.
The nature of the program created opportunities to highlight the voluntary
provision of chemical data by industry. EPA and the American Chemistry Council
sponsored an exposure workshop in December 2001 to assist industry in
formulating and reporting exposure information on the VCCEP chemicals. In
November 2006, EPA went through a detailed process to request comments from
stakeholders on the VCCEP pilot to enable the Agency to evaluate how well it
11-P-0379
-------
was meeting the objectives and made modifications based on comments
received.7
Scope and Methodology
We performed our evaluation from November 2010 to May 2011 in accordance
with generally accepted government auditing standards. Those standards require
that we plan and perform the evaluation to obtain sufficient, appropriate evidence
to provide a reasonable basis for our findings and conclusions based on our
objectives. The evidence obtained provides a reasonable basis for our findings and
conclusions based upon our objectives.
We conducted our evaluation in EPA headquarters and Research Triangle Park,
North Carolina. At EPA headquarters, we interviewed program directors and staff
from OPPT and the Office of Children's Health Protection (OCHP) regarding
their roles and experiences with the VCCEP. In Research Triangle Park, we met
with an EPA research scientist from the Office of Research and Development who
participated in the review of chemical data as a core member of the peer
consultation panel. We also interviewed a former EPA Assistant Administrator of
OCSPP and representatives from the American Chemistry Council and
Environmental Defense Fund to gain their insights on the VCCEP.
We reviewed VCCEP documents from EPA's VCCEP website, documents
maintained in EPA's public VCCEP dockets, and documents prepared by various
stakeholders. In addition, we reviewed applicable congressional testimony,
proposed legislative changes, and scientific journals. We reviewed prior
evaluation reports from the U.S. Government Accountability Office and EPA OIG
on chemical management and children issues. We also reviewed international
policies and programs that regulate chemicals.
7 At this time, no chemicals have gone through the revised VCCEP process.
11-P-0379
-------
Chapter 2
VCCEPDid Not Achieve
Children's Health Protection Goals
The VCCEP pilot did not achieve its goals to design a process to assess and report
on the safety of chemicals to children. The pilot's design did not allow for desired
outcomes to be produced. Specifically, the pilot had a flawed chemical selection
process and lacked an effective communication strategy. Children's behavior,
children's tendencies, and chemicals commonly found in children's products were
not factored in the chemical selection. Also, some industry partners chose not to
voluntarily collect and submit information, and EPA's decided not to exercise its
regulatory authorities under TSCA to compel data collection. This decision, along
with a lack of timely program execution, led to only a fraction of the chemical
assessments for the pilot being completed. Finally, the Agency failed to develop a
means to promote its results and explain its findings to the general public. The
VCCEP is no longer operational, and the Agency has no plans to revive, replace,
or terminate the program. As a result, the Agency is not meeting the intent of
EO 13045, ChemRTK, or the pilot, and there remains no readily understandable
source of chemical exposure information that the general public can access to
determine potential risks to children.
VCCEP Did Not Address the Chemicals Posing the Greatest Potential
Risk to Children
One of the central issues in the development of the pilot was chemical selection.
The impetus for the program, the ChemRTK Program, called for EPA to "assure
extensive testing on chemicals to which children are disproportionately exposed."
The chemicals in the pilot were not selected based on children's behavior,
tendencies, or a focus on those chemicals commonly found in children's products.
EPA selected chemicals that were found as contaminants in human tissue or
fluids, food and water children may eat and drink, and air children breathe. The
identification of these chemicals in monitoring systems indicated the existence of
data on these chemicals. Therefore, these were all data-rich chemicals that EPA
assumed would allow for rapid movement through the tiered system without long
delays for data acquisition. Both environmental and industry advocacy
stakeholder groups questioned EPA's selection of chemicals because the 23
chemicals selected for the VCCEP pilot were not the chemicals posing the
greatest potential risks to children
VCCEP Missed Opportunity to Assess Chemicals of High Concern
An OPPT director told us that given the state of the science, it was too
challenging to develop a program with a specific children's chemical focus at the
11-P-0379
-------
pilot's inception.8 However, there were specific chemicals not included in the
pilot that were known by EPA and the children's health community to pose
greater risks to children. For example, the pilot development process gave
substantial consideration to including phthalates. Phthalates, ultimately excluded
from the pilot, are of concern to children's health and are found in a wide range of
products, including children's toys. Since 1999, six phthalates have been
restricted for use in toys in the European Union and at least 14 other countries
have banned these phthalates in children's toys. Three of the five phthalates
included in the early materials developed for the VCCEP program but excluded
from the actual pilot were identified in scientific and regulatory materials as a
reproductive or developmental toxicant or a carcinogen. EPA's reasoning for
exclusion was that other government agencies were examining phthalates at that
time. EPA planned to obtain and post publicly all information gathered for other
agencies within a year. This information was received 4 years later.
EPA, after excluding phthalates from the pilot, ultimately published an action
plan for phthalates in 2009. This Phthalates Action Plan focused on their toxicity
and the evidence of pervasive human and environmental exposure to phthalates.9
EPA noted that, given the well-characterized health effects of phthalate exposure
in animals in conjunction with the demonstrated widespread phthalate exposure in
children, it believes that the cumulative health risks of phthalates should be
assessed to determine what actions are warranted to ensure protection of
children's health from this group of chemicals. By excluding the chemical class
from the pilot program, EPA had a significant missed opportunity to make these
determinations early on and speak to public concerns regarding phthalates and
children.
Stakeholders cited that Bisphenol A (BPA) would have posed a natural fit for the
pilot but was not considered for sponsorship or included in the draft list of
chemicals for the VCCEP. EPA did not include BPA because, at the time, BPA
was not found in the biomonitoring data used to select VCCEP chemicals. BPA is
a plasticizer commonly used in baby bottles and sippy cups. Scientific research in
the late 1990s indicated concern regarding the potential toxicity of BPA.10
Scientists with the Centers for Disease Control found BPA in the urine of nearly
all of the people tested, indicating widespread exposure to BPA in the U.S.
population. In March 2010, almost 10 years after the advent of the pilot, EPA
8 According to EPA, it became apparent during the stakeholder process used to gather input for the design of
VCCEP that there were no readily available data sources at that time that could be used to identify chemicals that
were affecting children more than the general population. EPA also noted that this information, if available, was not
provided by the affected industry stakeholders.
9 In addition, The Consumer Product Safety Improvement Act of 2008 (CPSIA) banned the use of six phthalates in
toys and child care articles at concentrations greater than 0.1 percent: DEHP, DBF, BBP, DINP, DIDP, and DnOP.
Two studies in particular pointed to the reproductive effects of BPA. vom Saal FS, Timms BG, Montano MM,
Palanza P, Thayer KA, Nagel SC, Dhar MD, Ganjam VK, Parmigiani S, Welshons WV. 1997 March 4. Prostate
enlargement in mice due to fetal exposure to low doses of estradiol or diethylstilbestrol and opposite effects at high
doses. Proc Natl Acad Sci USA 94(5): 2056-2061.; Howdeshell KL, Hotchkiss AK, Thayer KA, Vandenbergh JG,
vom Saal FS. 1999. Exposure to bisphenol A advances puberty. Nature 401(6755): 763-4.
11-P-0379
-------
created an action plan for BPA. As was the case with phthalates, EPA had a
missed opportunity to communicate risk to the public and serve as an authoritative
voice on children's health and chemical risk.11
EPA Failed to Adequately Explain Chemical Information to the
General Public
One of the goals of the pilot was to evaluate methods for public dissemination of
information received from industry on the pilot chemicals. The ChemRTK, the
impetus for the VCCEP, directed the Agency to "ensure the public's right to basic
information about the hazards and risks of widely used chemicals that people,
especially children, may be exposed to at home, at work or in the environment."
EPA's intent with VCCEP was, in part, to help parents have the information
necessary to protect their children from harmful chemicals in their environment.
In implementing the VCCEP pilot, EPA did not effectively establish a
communications strategy to achieve public understanding of the information
produced from the pilot. The communication mechanism outlined in the Federal
Register notice called for EPA to post VCCEP data and peer consultation
documents on the Agency's website and for stakeholders to be involved in
contributing to followup communication of risk information developed by
VCCEP. While EPA did post data and peer consultation documents on the
VCCEP website, according to EPA, stakeholders were rarely involved in sharing
risk information. OPPT staff did not work with EPA's OCHP12 to develop a
communications strategy or outreach materials for the VCCEP pilot. No actions
were taken to interpret the data. EPA conducted no risk communication or risk
reduction activities to educate the public, consumers, or parents regarding data
from the pilot. EPA did not translate or synthesize any of the information obtained
in the pilot to make it understandable for the public, particularly parents. EPA
took no action to evaluate any methods beyond web posting for public
dissemination of information received from sponsors. Stakeholders noted that
simply posting scientific data on the internet does not achieve the goal or intent of
EPA's ChemRTK program or the pilot.
As a consequence of the lack of attention to program communication and
coordination with internal offices, EPA provided no recommendations to the
public regarding health risks from exposure to the pilot chemicals. Additionally,
the lack of an effective communications strategy also created challenges for EPA
in promoting industry's contributions to the pilot to the public. Industry
11 In the absence of EPA statements on and data collection for chemicals such as BPA, states, municipalities, and
other countries have taken the lead role in establishing protective regulation measures. For example, BPA bans are
in place in New York, Vermont, Maryland, Minnesota, Connecticut, Massachusetts, Wisconsin, Washington,
Chicago, Illinois, Canada, and Europe.
12 EPA established OCHP in May 1997 to make the protection of children's health a fundamental goal of public
health and environmental protection in the United States. OCHP supports and facilitates Agency efforts to protect
children's health from environmental threats.
11-P-0379
-------
voluntarily entered into the VCCEP pilot, working with EPA to develop the
necessary data. However, EPA did little to publicize industry's voluntary
commitment, their findings, nor the effort undertaken to participate and conduct
the pilot.
VCCEP Pilot Did Not Produce Complete or Timely Results or Employ
EPA's Regulatory Authorities
Only a fraction of the chemical assessments for the VCCEP pilot were completed
due to the lack of pre-established deadlines for actual submissions of and review
of assessments. The Federal Register notice did provide allowable timeframes for
sponsors to conduct toxicology tests and prepare final reports. However, these
allowable timeframes were merely guidelines and did not serve as actual
deadlines, which hampered the results of the VCCEP pilot. There was no
information provided as to timeframes allotted for EPA's review of VCCEP
reports in the Federal Register notice. In addition, EPA chose not to invoke its
TSCA regulatory authority under Section 4. The constraints resulted in lengthy
data collection and review processes for both sponsors and EPA. This is
evidenced by the fact that over the course of the past 10 years, only 15 of the 23
chemicals went through the peer consultation process and EPA received sufficient
data to assess chemical risk for only 6 of the 15.
The safety to children of all pilot chemicals remains in question; EPA still needs
additional data to characterize health risks to children for the 17 chemicals
indicated in the yellow rows in Table 1. In addition, EPA has not assessed the
health risks to children for the 6 chemicals that have been identified by EPA as
"no further data needs" even though they have collected sufficient data from
sponsors.
11-P-0379
-------
Table 1: VCCEP Pilot Results
# of VCCEP
Results Reason Chemicals Name of Chemicals
Safety of
chemicals
remain in
question
No further
data needs
identified by
EPA
No sponsors
Sponsors never
provided Tier 1
information
Sponsors received
data needs decision
(EPA requesting Tier 2
or 3 studies) and
declined further
sponsorship
EPA attempted to
enter into an
Enforceable Consent
Decree to require the
sponsor to provide the
requested test data
but sponsor committed
to withdraw the
chemical from
commerce before a
test rule could be
promulgated
Sponsors never
received a data needs
decision from EPA
EPA received all
necessary information
to make a
determination
regarding data needs
from the sponsor and
through the peer
consultation process.
3
5
6
1
2
6
Ethylene dibromide,
Chlorobenzene,
m-Dichlorobenzene
p-Dichlorobenzene
Ethylene Dichloride
Trichloroethylene
Tetrachloroethylene
a-Pinene
Benzene
o-Xylene
m-Xylene
Toluene
Pentabromodiphenyl ether
Octabromodiphyenyl ether
Decabromodiphenyl ether
p-Dioxane
Ethylbenzene
Acetone
Vinylidenechloride
Methyl ethyl ketone
n-Dodecane
Decane
Undecane
Source: OIG analysis of EPA materials.
From the outset of the pilot, 3 of the 23 chemicals proposed for the pilot never
received sponsors.13 The remaining 20 sponsored chemicals entered into Tier 1 of
the pilot. For the 20 sponsored chemicals, EPA received no information from
5 chemical sponsors.14 Despite going through the peer consultation process, 2 of
According to the Agency, 3 of the original 23 chemicals were not sponsored because one was a pesticide (not
subject to TSCA) and the other two were no longer produced.
14 According to the Agency, the five sponsors did not submit Tierl information because of EPA's decision to
suspend funding for peer consultations. When it became necessary for sponsors to pay for the cost of peer
consultation, they chose not to submit the remaining Tier 1 assessments.
11-P-0379
10
-------
the 20 sponsored chemicals never received a "data needs decision" from EPA.
Sponsors opted not to provide EPA with requested higher tier studies for 7 of the
20 chemicals,15 including 1 for which EPA ultimately attempted to take regulatory
action. EPA's request for higher tier studies indicates that there was a lack of data
on tests and endpoints of concern to children. The lack of commitment by
sponsors effectively ended EPA's data collection for these chemicals.
We found that the lack of timeliness and efficiency was due to the pilot's lack of
pre-established deadlines for data submissions from sponsors, or for EPA's
issuance of data needs decisions to industry. With no pre-established deadlines for
either the sponsors or the Agency, EPA could not ensure timely completion of
chemical evaluations conducted as part of the pilot. For example, sponsors of
Benzene and Toluene took over 4 years to collect and submit their Tier 1 data to
EPA, 3 years past when EPA expected to receive the data. EPA was also not
timely in its review of submitted Tier 1 data. It took EPA almost 3 years to issue a
data needs decision for Decabromodiphenyl ether, and EPA has yet to issue data
needs decisions for two chemicals that participated in the peer consultation
process.
Although some sponsors failed to volunteer data, EPA chose not to invoke its
TSCA regulatory authority under Section 4.16 EPA stated in the past that the
Section 4 'test rule' process is time-consuming and burdensome for the Agency to
administer. The test rule process was the initial construct of the pilot. This process
provides EPA with limited authority to request health and environmental effects
testing from chemical manufacturers and processors. EPA opted to use a
voluntary structure for the VCCEP based on input from stakeholder meetings to
avoid the TSCA process for data collection under a test rule. However, per the
VCCEP Federal Register Notice, EPA did retain the authority to use a test rule if
necessary for the pilot: "If some chemicals are not sponsored in the VCCEP, EPA
will consider whether a test rule under section 4 of TSCA is appropriate." EPA
never employed the test rule to require data provision.
EPA's failure to utilize available regulatory mechanisms to compel data collection
from sponsors unwilling to commit to higher tiers of the VCCEP pilot left EPA
unable to make necessary determinations regarding the safety of a majority of
VCCEP chemicals to children. EPA was therefore constrained by both the design
of the pilot, under which sponsors committed to providing data on a tier-by-tier
basis instead of to the program as a whole, and by their failure to use existing
regulatory authorities to compel data collection.
15 According to the Agency, sponsors of two of these chemicals (pentaBDE and octaBDE) declined to do further
testing because they were ceasing the manufacture and import of those chemicals.
16 According to EPA, OCSPP currently plans to issue a proposed test rule under Section 4 that will propose that the
tests requested, but not provided, under VCCEP for pentaBDE, octaBDE, and decaBDE be required if the chemicals
continue in commerce.
11-P-0379 11
-------
EPA Lacks an Effective Children-Specific Chemicals Management
Program
According to EPA Administrator Jackson, ensuring the protection of children
from exposure to environmental threats is central to the Agency's work. EPA,
however, lacks an active children-specific chemical management program or
framework. Despite the failure of the VCCEP pilot to provide the Agency with an
effective mechanism to identify and evaluate chemicals that might pose a
particular risk to children, EPA has not developed an alternative program to fill
this critical void.
An OPPT director stated that there is not currently a children-specific existing
chemical evaluation program in EPA and no such program in development.
EPA's alternative to a specific program is to assume that children are "always a
consideration" in EPA's chemical evaluation of new chemicals because of the
inclusion of children's age groups in required testing. The pilot, however,
collected data on existing chemicals which are grandfathered under TSCA and
excluded from the review required for new chemicals by the Agency. The
Director of OCHP also stated in a separate interview that the Agency's plan for
filling the void left by the pilot is to engage other EPA offices to ensure that
children's health is addressed in their decisions and programs. He was not aware
of any plans within the Agency to create a program to evaluate chemicals and
their risks to children.
EPA recently made a commitment to prioritize chemicals in the Agency's Cross-
cutting Strategy for Environmental Justice and Children's Health. This
commitment is: "Using children's health indicators and the latest children's health
research findings, EPA will identify 5 to 10 priority chemical hazards for
children's health for EPA to target through all Agency mechanisms, including
regulations, enforcement, research, and voluntary programs (by April 2011)."17
Following through on this commitment is an important first step in meeting the
intent of EO 13045, the ChemRTK, the underpinnings of the VCCEP, and
creating a child-specific focus for chemical evaluation in the Agency. However,
EPA still lacks a program or framework that provides the public with data that
assess children's health risks from exposure to potentially toxic chemicals.
EPA supports the reauthorization and modernization of TSCA. EPA's 2011-2015
Strategic Plan states the following:
As we look to the future, it is important to work together with
Congress and stakeholders to modernize and strengthen the tools
available under TSCA to prevent harmful chemicals from entering
the marketplace and to increase confidence that those chemicals
that remain are safe and do not endanger the environment or
17 This information is not in the fiscal year 2011-2015 Strategic Plan, nor is it openly available to the public on
EPA's website. In conversations with the Agency, this measure was not cited.
11-P-0379 12
-------
human health, especially for consumers, workers, and sensitive
subpopulations like children.
The Agency's principles for TSCA reform (Appendix A) include specific
provisions for the protection of children's health, and focus on EPA's ability to
collect necessary chemical data, one of the concerns predicating the VCCEP pilot.
EPA notes that a reformed TSCA should require that exposure and hazard
assessments from manufacturers include a thorough review of the chemical's risks
to sensitive subpopulations such as children.
Under the Agency's principles for TSCA reform, EPA states that it should have
clear authority to take risk management actions when chemicals do not meet
established safety standards. The principles further state that this authority should
include the flexibility to take into account a range of considerations, including
children's health. OCSPP Assistant Administrator Steve Owens testified that in
reforming TSCA both EPA and industry must include special consideration for
exposures and effects on groups with higher vulnerabilities, particularly children.
Proposed legislation in both houses of Congress have provisions to improve
EPA's authority to reduce risk from exposure to toxic chemicals, require the
chemical industry to submit to EPA the data it needs, and improve EPA's
authority to compel testing by the chemical industry. The improvement to the
Agency's ability to obtain necessary data under statutory means would afford
EPA the capacity to construct a new, effective children's chemical program.
In lieu of TSCA reform, EPA recently proposed several modifications to its
existing chemicals program. The Agency states that it is "initiating a
comprehensive approach to enhance the Agency's current chemicals management
program within the limits of existing authorities." The activities under this
approach include the Action Plans for specific chemicals of concern, the proposal
to require additional reporting on existing chemicals, and increased transparency
in EPA's chemical management actions. Of particular note to our evaluation, EPA
stated that it plans to do the following:
Require that companies submit information to fill the remaining gaps in
basic health and safety data on high production volume chemicals18
Make the reporting of chemical use information more transparent, more
current, more useful, and more useable by the public
Prioritize chemicals for future risk management
Prioritizing chemicals includes a first attempt at developing a "Chemicals of
Concern" list under TSCA Section 5, highlighting chemicals that "may present an
unreasonable risk of injury to health and the environment." EPA states that
inclusion on the list publicly signals EPA's strong concern about the risks that
those chemicals pose and the Agency's intention to manage those risks. EPA's
18
The chemicals included in the VCCEP pilot were all High Production Volume chemicals.
11-P-0379 13
-------
successful execution of the action items listed above should aid the Agency in
considering children's health in its existing chemicals program.
EPA can also utilize tools under TSCA Section 8 to strengthen its existing
chemicals program. TSCA Section 8 focuses on data gathering activities to
provide data that EPA can utilize to identify, assess, manage, and reduce actual or
potential risks posed by exposure to existing chemical substances. TSCA
Section 8(a) gives EPA the authority to require, by rulemaking, manufacturers
and processors of chemical substances to maintain records and report such data as
EPA may reasonably require to carry out the TSCA mandates.19 In addition, under
TSCA Section 8(d), EPA has the authority to promulgate rules to require
producers, importers, and processors to submit lists and/or copies of ongoing and
completed unpublished health and safety studies. In completing the VCCEP pilot,
EPA chose not to invoke either of these tools.
Conclusions
Poor program design and the Agency's failure to use its TSCA regulatory
authorities to compel data collection resulted in the failure of the VCCEP as an
effective children-specific chemical management program. EPA demonstrated
that it could not achieve children's health goals with a voluntary program. The
VCCEP is no longer operational, and the Agency has no plans to revive, replace
or terminate the program. As a result, the Agency is not meeting the intent of
EO 13045, ChemRTK, or the pilot, and there is still no readily understandable
source of chemical exposure information that the general public can access to
determine potential risks to children.
Recommendation
We recommend that the Assistant Administrator for Chemical Safety and
Pollution Prevention
1. Design and implement a process to assess the safety of chemicals to
children. Specifically, we recommend a new design that includes:
a. A chemical selection process that identifies and includes the chemicals with
the highest risk potential to children.
b. A workable data collection strategy for applying the TSCA regulatory
authorities as appropriate.
c. A communications strategy that interprets results and disseminates
information to the public.
d. Specific outcome measures that provide assurance the process will provide
valid and timely results.
19
Examples of information that can be required to be reported include: chemical or mixture identity, categories of
use, quantity manufactured or processed, by-product description, health and environmental effects information,
number of individuals exposed, and method(s) of disposal.
11-P-0379 14
-------
Agency Comments and OIG Evaluation
The Agency agreed that as a voluntary program with no strong integrated
regulatory component to ensure results, VCCEP was not a successful model. The
Agency also provided technical corrections. We made appropriate corrections
based on our analysis of the Agency's comments. The Agency agreed in part with
our recommendation, concurring with recommendation 1 parts a. and d., but neither
concurring nor disagreeing with parts b. and c. The Agency did not provide
concrete milestone dates for the planned achievement of the actions taken to
address the recommendation. Those dates are required for each part of the
recommendation.
The Agency agreed with recommendation 1 part a. EPA stated that, since 2009, it
continues to identify priority chemicals of concern for children's health for
children's health for priority action under TSCA. While the Agency did not
explicitly agree with recommendation 1 parts b. and c., we found the Agency to be
responsive. In reference to part b., EPA stated that the regulatory tools for collecting
information related to chemical hazards, exposures, and risks have long been
regarded as unwieldy, time consuming, and overly deliberative, but committed to
use the available TSCA Section 4, 5, and 8 regulatory tools as expeditiously as
possible to gather information necessary to manage potential chemical risks. The
OIG recognizes the challenges of working within the TSCA regulatory framework
in the report.
For recommendation 1 part c., EPA stated that it has taken a series of significant
actions to increase the public's access to critical information about chemicals. EPA
drafted a proposed rule, currently in interagency review, that will establish a TSCA
Section 5(b)(4) chemicals of concern list. EPA plans to publish the data resulting
from improved Inventory Update Rule reporting, which will highlight information
on chemicals used in products intended for children. The OIG agrees that the
amendments to Inventory Update Rule reporting and additional actions taken by
EPA are important steps in determining information on chemicals in children's
products. However, because the changes to Inventory Update Rule reporting are not
yet final, the effectiveness of this work remains to be determined.
The Agency agreed with recommendation 1 part d. The Agency stated that goals and
measures developed for EPA's enhanced existing chemicals program should address
this issue.
11-P-0379 15
-------
Status of Recommendations and
Potential Monetary Benefits
POTENTIAL MONETARY
RECOMMENDATIONS BENEFITS (in SOOOs)
Claimed Agreed-To
Amount Amount
Rec.
No.
Page
No.
Subject
Status1
Action Official
Planned
Completion
Date
14 Design and implement a process to assess the U Assistant Administrator for
safety of chemicals to children. Specifically, we Chemical Safety and
recommend a new design that includes: Pollution Prevention
a. A chemical selection process that
identifies and includes the chemicals
with the highest risk potential to
children.
b. A workable data collection strategy for
applying the TSCA regulatory
authorities as appropriate.
c. A communications strategy that
interprets results and disseminates
information to the public.
d. Specific outcome measures that
provide assurance the process will
provide valid and timely results.
0 = recommendation is open with agreed-to corrective actions pending
C = recommendation is closed with all agreed-to actions completed
U = recommendation is undecided with resolution efforts in progress
11-P-0379 16
-------
Appendix A
Agency Response
MEMORANDUM
SUBJECT: Draft Evaluation Report: EPA's Voluntary Chemical Evaluation
Program Failed to Achieve Children's Health Protection Goals
FROM: Stephen A. Owens
Assistant Administrator
TO: Jeffrey Harris
Director for Programs, Cross Media Issues
Office of Inspector General
Thank you for providing my Office with the opportunity to review the draft evaluation
report: EPA's Voluntary Chemical Evaluation Program Failed to Achieve Children's Health
Protection Goals. OIG's recommendations are appreciated and clearly identify some actions that
will be important to pursue as the Agency proceeds in its efforts to address the potential health
impacts of chemicals on children. This memorandum provides responses to OIG's evaluation of
the Voluntary Children's Chemical Evaluation Program (VCCEP), comments on OIG's
recommendations, and identifies the actions the Agency will be taking in response to the
recommendations.
Response to VCCEP Pilot Evaluation
The draft report states the VCCEP pilot did not achieve its goals to design a process to
assess and report on the safety of chemicals to children.
EPA concurs with this overall evaluation and is currently actively addressing this concern
in the context of enhancing the Existing Chemicals Program authorized by the Toxic Substances
Control Act (TSCA). Our responses to additional OIG evaluation comments below provide more
detail on our enhanced chemical program.
OIG Response: The OIG appreciates EPA's concurrence with the overall conclusion of this
evaluation.
The draft report states EPA lacks an effective children-specific management program.
There are many ongoing initiatives across the Agency addressing the potential health
impacts of chemicals on children, including OCSPP's comprehensive effort to enhance the
TSCA Existing Chemicals Program with a particular emphasis on taking regulatory action to
address chemicals of concern, especially to children. Our enhanced chemicals management
effort, announced in September 2009, by Administrator Lisa Jackson, has included the
11-P-0379 17
-------
development of chemical specific action plans to identify OCSPP's planned risk management
efforts on priority chemicals of concern. This comprehensive effort to enhance the Agency's
chemicals management program also includes requiring the development and reporting and of
information needed to understand chemical risks, creating a chemicals of concern list under
section 5(b)(4) of TSCA, undertaking a host of new regulatory risk management actions (several
of which focus directly on children's potential health risks), and increasing public access to
information about chemical hazards, exposures and risks. OCSPP intends to utilize the full array
of regulatory tools under TSCA to address identified risks, including the authority to label,
restrict, or ban chemicals under Section 6 of TSCA.
Addressing chemicals of concern for children's health is a priority in our enhanced
chemical management program enhancement effort. The September 2009 announcement made
clear that children's health is a key focus of this effort and, the OCSPP website listed a number
of criteria the Agency had used (and is using) to identify chemicals for action which included "
chemicals potentially of concern for children's health because of reproductive or developmental
effects." The Action Plans include chemicals in consumer products that are of concern to
children, such as benzidine dyes and pigments; bisphenol A (BPA); penta, octa, and
decabromodiphenyl ethers (PBDEs) in products; and phthalates. Children's health will continue
to be one of the important factors we consider as we identify additional high priority chemicals
for review and action under TSCA.
OCSPP will move quickly to ensure that the Agency has the hazard, use, and exposure
data critical to prioritizing chemicals for review and making risk management decisions. EPA
will soon issue a final rule that modifies the Inventory Update Rule (IUR) to ensure the reporting
of chemical use information is more transparent, more current, more useful, and more useable by
the public. IUR requires chemical manufacturers and importers to report production volume,
processing, and use information on chemicals, including chemicals included in consumer
products intended for use by children. The final rule implementing these improvements to IUR
will provide the Agency and the public a unique and essential set of data which allows for better
understanding of the chemicals that children may be disproportionately exposed to. In addition,
OCSPP intends to require that companies submit information to fill the remaining gaps in basic
health and safety data on High Production Volume (HPV) chemicals so that their hazards are
understood. OCSPP has promulgated or is in the process of promulgating three regulations that
address 93 chemicals to accomplish this.
Among the new regulatory risk management actions that the Agency is taking in its
enhanced program that deal specifically with chemicals of concern to children are rulemakings
under section 6 of TSCA to phase out or ban the use of mercury in a range of switches, relays,
measuring devices, and other products (many of which can be found in the home or in consumer
products) and to ban the use of lead in wheel weights, and a rulemaking under section 5(a)(2) of
TSCA to require prior notification to the Agency of any new consumer use of monoglyme and
diglyme because of their potential developmental health effects.
OIG Response: As our report described, EPA has recently initiated several action items in its
existing chemicals program designed to aid the consideration of children's health. However,
these actions have not yet been fully implemented or evaluated, and their effectiveness
remains to be determined.
11-P-0379 18
-------
The draft report states VCCEP did not address the chemicals posing the greatest
potential risk to children due to its flawed chemical selection process which did not
select chemicals to which children are disproportionately exposed due to the unique
behavior and tendencies of children, and did not focus on chemicals commonly found in
children's products.
It was the intention of the designers of VCCEP to select chemicals to which children
were disproportionately exposed. However, during the stakeholder process used to gather input
for the design of VCCEP, in 2000, it became apparent that there were no readily available data
sources at that time that could be used to identify chemicals that were affecting children more
than the general population. This information was also not provided by the affected industry
stakeholders.
The chemical selection process which OCSPP decided to use for VCCEP focused on
chemicals which have been found to be present in human tissues or fluids (e.g., adipose tissue,
blood, breast milk, breath), food or water children may eat or drink, and air children may breathe
at home or at school. There were biomonitoring and environmental data in nine databases that
OCSPP used to identify chemical candidates for the VCCEP program. This chemicals selection
process was presented at the public stakeholder meetings and received support from the
stakeholders.
As a result of the lack of data on use of chemicals in children's products, in 2003 EPA
amended the IUR to require submission of this information for a subset of chemicals subject to
IUR, beginning with reporting in 2006. EPA is using these data in its current program to identify
priority chemicals with concerns for children's health. As noted above, EPA also soon will issue
a final rule making additional modifications to the IUR that will increase the number of
chemicals subject to reporting requirements on use in children's products and will further
improve the Agency's ability to identify chemicals to which children may be disproportionately
exposed.
OIG Response: The amendments to the Inventory Update Rule are an important step in
determining information on chemicals in children's products. However, because the changes
to the Inventory Update Rule are not yet final, their effectiveness remains to be determined.
We concur that the intent of the designers of VCCEP was to select chemicals to which
children were disproportionately exposed and added language to the report that details the
challenge to find readily available data sources.
The draft report states the VCCEP pilot did not produce complete results.
EPA agrees. As a voluntary program with no strongly integrated regulatory component to
ensure results, VCCEP was not a successful model. For instance, EPA funded the peer
consultation process for some of the initial chemicals as part of its commitment to the pilot
program. When it became necessary for sponsors to pay for the cost of peer consultation, they
chose not to submit the remaining Tier 1 assessments.
11-P-0379 19
-------
The draft report states the VCCEP pilot did not produce timely results because it had
no established timelines.
The Federal Register notice which announced VCCEP and solicited participation (65 FR
81699, Dec 26, 2000) states (Unit lll.V., Unit IV.5.5., and Unit VII.) that the sponsor was
expected to complete its work within the time period specified. Unit lll.V., in particular, specifies
the time EPA considers to be sufficient for the completion and report preparation of each test
listed in Table 4 (65 FR 81769 at 81714). Because VCCEP was a completely voluntary
program, however, there was no way to ensure that work would be completed on the expected
timeline. In addition, the voluntary nature of VCCEP required Peer Consultations to verify that
assessments provided by manufacturers were accurate, but peer consultations were shown to be
cumbersome and not a particularly expedient aspect of the pilot process.
OIG Response: Although there were timeframes in the VCCEP Federal Register notice for
completion of particular tests, there were no deadlines for the necessary consultations and
decision milestones among the industry sponsors, EPA, and the peer consultation panel. The
lack of pre-established deadlines for these discussions and determinations hampered the
results of the VCCEP pilot. We amended the language in the report to better reflect the
existence of timeframes for test execution.
The draft report states the VCCEP pilot had no communication strategy to promote
its results and make recommendations to the public on health risks of the pilot chemicals to
children.
A communication strategy was included in the FR notice launching the program (65 FR
81699 at 81715) in Unit IUJf., but in retrospect was not sufficient. It was also anticipated that
stakeholders would be involved in follow-up communication of risk information developed by
VCCEP but this rarely occurred.
EPA is committed to transparency, to making as much information available as possible,
and to making information available in ways that are as useful as possible to the public. OCSPP
has been working to provide the public with improved information on its Existing Chemicals
program, including information on chemicals of concern for children's health. Over the past two
years, EPA has taken a range of aggressive steps to increase the public's access to critical
information on the chemicals manufactured and used in this country, including making more
health and safety data available on the Web along with an improved search tool for navigating
the data, and a program to evaluate and challenge, as appropriate, claims of confidential business
information for information submitted under TSCA. For example, on June 8, 2011, EPA
declassified and made public the identities of more than 150 chemicals contained in 104 health
and safety studies that had been claimed confidential by industry. This is just one specific
example of EPA's commitment to take significant action to provide the public with greater
access to information on the chemicals that are manufactured and used in the United States.
11-P-0379 20
-------
OIG Response: We amended the language in the report to acknowledge the planned and
anticipated communications of pilot results as detailed in the Federal Register notice.
Nevertheless, as EPA's response acknowledges, the communications outlined in the Federal
Register notice were insufficient.
The draft report states that some industry partners chose not to voluntarily collect and
submit information.
Sponsors did volunteer to complete the Tier 1 assessments which were a substantial effort
on their part. Tier 2 commitments, however, were disappointing and revealed that relying on a
voluntary process is not a viable strategy. The enhanced Existing Chemicals Program has a
greater emphasis on regulatory actions and will address OIG's VCCEP concern associated with
the inadequacy of the voluntary approach.
OIG Response: We agree that that the Tier 2 commitments were disappointing and
evidenced the lack of viability of the VCCEP strategy. However, we disagree that sponsors
provided all necessary Tier 1 assessments. Our report details the instances when Tier 1
assessments were not completed.
Response to OIG Conclusions
The draft report concludes that poor program design and the Agency's failure to use its
TSCA enforcement authorities (this should probably be described as regulatory authorities) to
compel data collection resulted in the failure of the VCCEP as an effective children-specific
chemical management program.
EPA agrees that, as a voluntary program with no strongly integrated regulatory
component to ensure results, VCCEP was not a successful model. The enhanced Existing
Chemicals Program emphasizes a more assertive application of TSCA's regulatory tools and, we
believe, addresses OIG's recommendation.
Responses to Specific OIG Recommendations
OIG Overall Response: EPA needs to provide concrete dates and plans for achieving all
recommendations outlined below.
The draft report recommends that a chemical selection process be used that identifies
and includes the chemicals with the highest risk potential to children.
EPA agrees and, beginning in 2009, has been identifying priority chemicals of concern
for children's health. We are committed to continuing our work to identify chemicals of concern
for children's health for priority action under TSCA.
OIG Response: EPA needs to provide milestone dates for the planned achievement of the
development of a list of chemicals with the highest potential risk to children, as well as each
for the successive recommendation responses below.
11-P-0379 21
-------
The draft report recommends the development of workable data collection strategy for
applying the TSCA enforcement authorities as appropriate.
The regulatory tools for collecting information related to chemical hazards, exposures
and risks have long been regarded as unwieldy, time consuming and overly deliberative. Almost
all stakeholders involved in TSCA legislative reform discussions have recognized this. Until
meaningful reform has been enacted, EPA's enhanced Existing Chemicals Program will use the
available TSCA Section 4, 5 and 8 regulatory tools as expeditiously as possible to gather
information necessary to manage potential chemical risks. Key to this effort will be to focus on
priority chemicals so that are resources are effectively deployed on the chemicals of greatest
concern.
The draft report recommends a communications strategy that interprets results and
disseminates information to the public.
OCSPP has been working to provide the public with improved information on its Existing
Chemicals program, including information on chemicals of concern for children's health. As
indicated earlier, EPA has taken a series of significant actions to increase the public's access to
critical information on chemicals manufactured and used in this country and will continue to
enhance the information disseminated through our Existing Chemicals website by making even
more health and safety studies publicly available, and by continuing to examine and challenge,
where appropriate, claims of confidential business information in those studies. In addition, EPA
has drafted a proposed rule, currently in interagency review, that will establish a TSCA section
5(b)(4) chemicals of concern list. This list will highlight chemicals that may be a concern to
children's health. EPA will also publish the data resulting from improved IUR reporting, which
will highlight information on chemicals used in products intended for children.
OIG Response: The OIG agrees that the amendments to the Inventory Update Rule are an
important step in determining information on chemicals in children's products. However,
because the changes to the Inventory Update Rule are not yet final, their effectiveness
remains to be determined.
The draft report recommends development of specific outcome measures that provide
assurance the process will provide valid and timely result.
EPA agrees with this goal. We believe that the goals and measures developed for our
enhanced Existing Chemicals program should address this need.
Again, we appreciate the opportunity to review and comment on this draft report. Some
minor comments on some factual errors included in the draft report are listed in Attachment 1.
Should you have any questions or concerns regarding this response, please contact Ward
Penberthy, Deputy Director, Chemical Control Division, at (202) 564-8171, or Janet Weiner,
Audit Follow-up Coordinator for OCSPP at (202) 564-2309.
11-P-0379 22
-------
Appendix B
EPA's Essential Principles for Reform of
Chemicals Management Legislation
Source: EPA's Existing Chemicals Webpage:
http://www.epa.gov/opptintr/existingchemicals/pubs/principles.html
The U.S. Environmental Protection Agency (EPA) is committed to working with the Congress,
members of the public, the environmental community, and the chemical industry to reauthorize
the Toxic Substances Control Act (TSCA). The Administration believes it is important to work
together to quickly modernize and strengthen the tools available in TSCA to increase confidence
that chemicals used in commerce, which are vital to our Nation's economy, are safe and do not
endanger the public health and welfare of consumers, workers, and especially sensitive sub-
populations such as children, or the environment.
The following Essential Principles for Reform of Chemicals Management Legislation
(Principles) are provided to help inform efforts underway in this Congress to reauthorize and
significantly strengthen the effectiveness of TSCA. These Principles present Administration
goals for updated legislation that will give EPA the mechanisms and authorities to expeditiously
target chemicals of concern and promptly assess and regulate new and existing chemicals.
Principle No. 1: Chemicals Should Be Reviewed Against Safety Standards That Are Based
on Sound Science and Reflect Risk-based Criteria Protective of Human Health and the
Environment.
EPA should have clear authority to establish safety standards that are based on scientific risk
assessments. Sound science should be the basis for the assessment of chemical risks, while
recognizing the need to assess and manage risk in the face of uncertainty.
Principle No. 2: Manufacturers Should Provide EPA With the Necessary Information to
Conclude That New and Existing Chemicals Are Safe and Do Not Endanger Public Health
or the Environment.
Manufacturers should be required to provide sufficient hazard, exposure, and use data for a
chemical to support a determination by the Agency that the chemical meets the safety standard.
Exposure and hazard assessments from manufacturers should be required to include a thorough
review of the chemical's risks to sensitive subpopulations
Where manufacturers do not submit sufficient information, EPA should have the necessary
authority and tools, such as data call in, to quickly and efficiently require testing or obtain other
information from manufacturers that is relevant to determining the safety of chemicals. EPA
should also be provided the necessary authority to efficiently follow up on chemicals which have
been previously assessed (e.g., requiring additional data or testing, or taking action to reduce
risk) if there is a change which may affect safety, such as increased production volume, new uses
or new information on potential hazards or exposures. EPA's authority to require submission of
use and exposure information should extend to downstream processors and users of chemicals.
11-P-0379 23
-------
Principle No. 3: Risk Management Decisions Should Take into Account Sensitive
Subpopulations, Cost, Availability of Substitutes and Other Relevant Considerations
EPA should have clear authority to take risk management actions when chemicals do not meet
the safety standard, with flexibility to take into account a range of considerations, including
children's health, economic costs, social benefits, and equity concerns.
Principle No. 4: Manufacturers and EPA Should Assess and Act on Priority Chemicals,
Both Existing and New, in a Timely Manner
EPA should have authority to set priorities for conducting safety reviews on existing chemicals
based on relevant risk and exposure considerations. Clear, enforceable and practicable deadlines
applicable to the Agency and industry should be set for completion of chemical reviews, in
particular those that might impact sensitive sub-populations
Principle No. 5: Green Chemistry Should Be Encouraged and Provisions Assuring
Transparency and Public Access to Information Should Be Strengthened
The design of safer and more sustainable chemicals, processes, and products should be
encouraged and supported through research, education, recognition, and other means. The goal
of these efforts should be to increase the design, manufacture, and use of lower risk, more energy
efficient and sustainable chemical products and processes.
TSCA reform should include stricter requirements for a manufacturer's claim of Confidential
Business Information (CBI). Manufacturers should be required to substantiate their claims of
confidentiality. Data relevant to health and safety should not be claimed or otherwise treated as
CBI. EPA should be able to negotiate with other governments (local, state, and foreign) on
appropriate sharing of CBI with the necessary protections, when necessary to protect public
health and safety.
Principle No. 6: EPA Should Be Given a Sustained Source of Funding for Implementation
Implementation of the law should be adequately and consistently funded, in order to meet the
goal of assuring the safety of chemicals, and to maintain public confidence that EPA is meeting
that goal. To that end, manufacturers of chemicals should support the costs of Agency
implementation, including the review of information provided by manufacturers.
11-P-0379 24
-------
Appendix C
Distribution
Office of the Administrator
Assistant Administrator for Chemical Safety and Pollution Prevention
Agency Followup Coordinator
Agency Followup Official (the CFO)
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for External Affairs and Environmental Education
Director, Office of Children's Health Protection
Audit Followup Coordinator, Office of Chemical Safety and Pollution Prevention
11-P-0379 25
------- |