&EPA
www.epa.gov
.ology Verification Program
E
Environmental and Sustainable Technology Evaluations (ESTE):
Verification of Qualitative Spot Test Kits for Lead in Paint
Impact Statement
The ingestion of household dust containing lead from
deteriorating or abraded lead paints is a common cause of
lead poisoning in children. Although the use of lead-based
paint has been banned by the U.S. Consumer Product Safety
Commission since 1978, EPA estimates that 37.8 million
pre-1978 housing units and child-occupied facilities are still
in use. Since many of these housing units and facilities may
have interior or exterior paint containing lead, quick,
simple, and reliable test kits are needed to test or screen for
the presence or absence of lead-based paint.
On April 22, 2008, EPA issued the final Lead; Renovation.
Repair, and Painting (RRP) Program Rule. The rule
addresses lead-based paint hazards created by renovation,
repair, and painting activities that disturb lead-based paint
in target housing and child-occupied facilities. Under this
rule, EPA must foster the development of improved test kits
for lead-based paint surfaces that have false negative rates
of no more than 5% and false positive rates of no more than
10%, as measured against the federal standards for lead-
based paint. The rule also establishes a two phase process
for evaluating and recognizing test kits that can be used to
determine the presence or absence of regulated levels of
lead in lead-based paint surfaces. For Phase 1, existing
commercially available test kits will be evaluated by EPA
Office of Pollution Prevention and Toxics (OPPT) via an
equivalent process as described below.
ETV Program
The ETV Program is operated out of EPA's
Office of Research and Development. ETV
verifies the performance of innovative
technologies using credible, quality-assured
protocols developed using a stakeholder
process. The goal of ETV is to provide
credible performance data for commercial
ready environmental technologies. Market
input is conveyed by the active involvement
of stakeholder groups consisting of
technology buyers, sellers, permitters,
consultants, financiers, exporters and others
within each sector. ETV operates as a
public-private partnership through
cooperative agreements between EPA and
private nonprofit testing and evaluation
organizations. Agency priorities, which
require the use of contracts rather than
cooperative agreements, are verified under
Environmental and Sustainable Technology
Evaluations (ESTE) projects. See
http://www.epa.gov/etv/este.html for more
information.
Under this rule, EPA also determined that the Environmental Technology Verification Program (ETV) is
a suitable vehicle for obtaining independent laboratory validation of test kit performance needed for this
program. For Phase 2, EPA OPPT has arranged for ETV to verify the test kits and will provide data for
the second phase of EPA's recognition program.
EPA OPPT Test Kit Evaluation and Recognition Program
Under the first phase of this program, EPA OPPT will evaluate and recognize existing commercially-
available test kits that have a demonstrated probability (with 95% confidence) of a negative response less
than or equal to 5% of the time at or above the lead regulated level of 1.0 mg/cm or 0.5% by weight.
OPPT will base their evaluation on data collected using the National Institute of Standards and
Technology (NIST) protocol found in the NIST report entitled "Spot Test Kits for Detecting Lead in
Household Paint: A Laboratory Evaluation." EPA OPPT has also arranged to test commercially available
kits that were not tested under this study using the NIST protocol. EPA OPPT will start accepting
applications for the first phase of the evaluation process on September 1, 2008. OPPT will also, on a first-
come first-served basis, provide performance evaluation materials (PEMs) to vendors who have lead test
kits that are commercial ready. Developers that are interested in obtaining PEM samples or in being
evaluated for recognition by EPA OPPT should visit www.epa.gov/lead for more information.
During the second phase of this program, EPA OPPT will evaluate and recognize improved test kits that
meet the criteria set for the first phase and a demonstrated probability (with 95% confidence) of a false
positive response of no more than 10% of lead in paint at levels below the regulated level. EPA OPPT
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will evaluate kit performance using data obtained by the ETV Program. ETV will start accepting
applications for testing test kits in March 2009. After September 1, 2010 test kits must meet the above
requirements to be recognized by EPA OPPT. Developers of commercially available kits that are
interested in using verification results for the purpose of being recognized by EPA OPPT should visit
www.epa.gov/lead for more information.
ESTE Spot Test Kits for Lead in Paint Project
ETV will verify the performance of the improved test kits for Phase 2 using an EPA-approved test/quality
assurance plan (T/QAP) that is capable of demonstrating whether or not each test kit can achieve both the
false negative and false positive criteria of 40 CFR 745.88(c) as published in the final lead RRP rule. ETV
will base this T/QAP on ASTM International's E1828, Standard Practice for Evaluating the Performance
Characteristics of Qualitative Chemical Spot Test Kits for Lead in Paint, as well as input provided by
stakeholders (buyers, sellers, permitters, consultants, financiers,
exporters, etc.), OPPT, and others. Cost, speed, and ease of use
will also be considered.
The test kits will be tested using PEMs developed for the ETV
project. PEMs are painted panels with known lead
concentrations and made from different substrates. They will be
similar in design to the PEMs developed by OPPT, but with
different lead concentrations. The actual number and types of
painted test surfaces shall be determined based on stakeholder
and EPA input and shall be documented in the final T/QAP
which will be posted on the ETV web site. Both synthetic
painted film strips and real-world painted house components
(containing lead-based paint) may be used. ETV will publish
results in a verification report and statement, which will be
posted on the ETV Web Site.
References
U.S. EPA, Lead: Renovation, Repair, and Painting Program: Lead Hazard Information Pamphlet:
Notice of Availability: Final Rule. Federal Register. 40 CFR Part 745, April 22, 2008
.
U.S. EPA, ETV Case Studies: Demonstrating Program Outcomes. EPA/600/R-06/001. January 2006
.
U.S. EPA, Lead in Paint, Dust, and Soil Web Site. Accessed August 2008, .
Time Line for Phase 2
Verification
September 2008 - ETV posted the
vendor application process
March 2009 - T/QAP approved
May 2009 - Verification testing of
test kits
September 1, 2010 - After this date
test kits must meet both of the
required probability criteria to be
recognized by EPA
For further information contact:
ETV ESTE Project
Julius M. Enriquez
U. S. Environmental Protection Agency
Office of Research and Development
National Risk Management Research Laboratory
26 W. Martin Luther King Dr.
Cincinnati, OH 45268
Phone:513-569-7285 Fax: 513-569-7158
email: enriquez.julius@epa.gov
OPPT Evaluation and Recognition Program
Samuel Brown
U. S. Environmental Protection Agency
Office of Pollution Prevention and Toxics
USEPA Headquarters, Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Mail Code: 7404T, Washington, DC 20460
Phone: 202-566-0490 Fax: 202-566-0469
email: brown.sam@epa.gov
www.epa.gov/etv
December 2008
EPA/600/S-08/025
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