&EPA
 www.epa.gov
                       TECH
                         invirohn
BRIEF
                                             iTechnol'
                                                  Qualitative Spot Test Kits for Lead in Paint
 The U.S. EPA Environmental Technology Verification (ETV)
 Program1 in collaboration with the U.S. EPA Office of
 Pollution Prevention and Toxics (OPPT), evaluated the
 performance of four lead spot test kits (Table 1). The goal of
 the evaluation was to determine whether or not each test kit
 could achieve both the false negative and false positive
 performance criteria of 40 CFR 745.88(c) as published in
 the final Lead; Renovation, Repair and Painting (RRP) Rule
 (see box). ETV used an EPA-approved test/quality
 assurance plan (T/QAP) which was based 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.). Cost of kit, quickness of results,
 and ease of use were also evaluated for these kits.

 Technology Description and Verification Testing

 A primary objective of ETV testing was to provide data for
 the second phase of EPA's lead paint test recognition
 program. Results from the verification test for each
 participating kit were submitted by the ETV Program to
 OPPT for consideration of recognition.

 The tested technologies were portable and designed to be
 used by renovation contractors to test lead in paints in pre-
 1978 homes. Testing was conducted by using performance
 evaluation materials (PEMs) developed  by EPA for the ETV
 project. The PEMs were painted panels with various known
 amounts of lead concentrations and made from different
 substrates (wood, metal, drywall and plaster). Kits were
 tested under controlled laboratory conditions and were not
 field tested.  PEM samples were analyzed in duplicates  by the test kits and also analyzed by the reference method
 (ICP-AES). The test kits were evaluated based on qualitative results, indicating only the presence or absence of lead
 in the paint at specified  concentrations. Performance results were provided on sensitivity, precision, false positive/
 negative rates, matrix effects, and operational factors. The analyses were performed according to the vendor's
 recommended procedures in  the user instructions or manual. No direct comparisons were made between
 technologies.

                                   •
                                       Table 2 summarizes some of the performance data for the tested
                                       technologies.  Additional information is available in the full verification
                                       reports and verification summary statements which can be found at http://
                                       www.epa.gov/etv/este.htmltfpcgstklp.

                                       Based on the  results of the ETV study of vendor-submitted lead test kits,
                                       EPA recognized a test kit that when used by a certified renovator can
                                       reliably determine that regulated lead-based paint is not present on wood,
                                       ferrous metal  (alloys that contain iron), drywall and plaster surfaces. See
                                       http://www.epa.gov/lead/pubs/testkit.htm.

'The ETV Program operates largely as a public-private partnership through competitive cooperative agreements with non-profit research institutes. The
program provides objective quality-assured data on the performance of commercial-ready technologies. Agency priorities such as the project in this report,
which require the use of contracts rather than cooperative agreements, are verified under Environmental and Sustainable Technology Evaluations (ESTE)
projects. Verification does not imply product approval or effectiveness. ETV does not endorse the purchase or sale of any products and services mentioned in
this document.
                                                                  Environmental, Health, and Regulatory
                                                                     Background of Lead at a Glance

                                                             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 fostered the development of improved
                                                             test kits for lead-based paint surfaces to meet the
                                                             following response criteria: (1) A demonstrated
                                                             probability (with 95% confidence) of a negative
                                                             response less than or equal to 5% of the time for
                                                             paint containing lead at or above the regulated
                                                             level of 1.0 mg/cm2 or 0.5% by weight (2) A
                                                             demonstrated probability (with 95% confidence) of
                                                             a positive response  less than or equal to 10% of
                                                             the time for  paint containing lead below the
                                                             regulated level, 1.0 mg/cm  or 0.5% by weight.

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Table 1. Verified Qualitative Spot Test Kits for Paint in Lead
Test Kit
ANDalyze, Inc., Lead-in-
Paint Test Kit
ESCATech, Inc., D-Lead"
Paint Test Kit
Industrial Test Systems,
Inc., LeadPaintCheck
Silver Lake Research,
LeadAVERT™ Test Kit
Technology Description as Provided by the Vendor
Utilizes a sensor/fluorimeter platform to quantitatively detect lead in paint. The test is based on a
sensing technology which utilizes DNA to identify lead.
Chemical spot test kit that detects the presence or absence of lead in surface coatings. This test se-
lectively dissolves the lead from the paint sample with a proprietary solvent followed by a color
change reaction with sulfide ion. A visual comparison to a color standard is then used to determine
the presence of lead and a concentration range.
A semi-quantitative test kit that detects, using a photometer, the presence or absence of lead in
paint. Samples are prepared by homogenizing the paint chip samples in the acid solution.
Antibody-based test for the detection of lead in paint samples. The test uses specific monoclonal
antibodies that recognize and bind to lead atoms extracted from paint with a weakly acidic, low-
toxicity extraction solution. Results are read visually.
                                   Table 2. Selected Performance of Qualitative Lead Test Kits
          Vendor
   Observed
 Overall False
Positive Rates1
   Observed
 Overall False
Negative Rates2
  False Positive
Rate Based on the
  Modeled Prob-
 ability of Test Kit
  Response3(%)
  False Negative
Rate Based on the
Modeled Probabil-
 ity of Test Kit Re-
   sponse 4(%)
Overall Cost ($) /
 number of Test,
    Based on
  Consumables
       ANDalyze, Inc
     4-5
     9-12
    19.6-45.2
      45-75
     300/50
      ESCATech, Inc.,
    16-29
                        65.6-97.2
                          0.4-5.4
                          84.50/24
Industrial Test Systems, Inc.,
    14-16
      1-2
    53.3-80.9
     6.9-18.2
    99.99/50
    Silver Lake Research
    12-22
     37-56
     1.7-82.4
    23.7-99.1
    39.95/20
 1.  Rates for both technical and nontechnical operators are based on a cut-off concentration of 0.8 mg/cm , as well as all levels evaluated below this concentra-
    tion.  Results are presented as overall false positive rates across all applicable PEMs combined and also based on lead paint type (i.e., white or yellow lead),
    substrate (i.e., drywall, metal, plaster, or wood), and topcoat paint color (i.e., grey, red or white). Note that the observed false positive rates presented pro-
    vide a general representation of the ability of the test kit to correctly identify regulated lead paint when it is absent at the cut-off concentration of 0.8 mg/
    cm2 and all levels evaluated below this concentration.

 2.  Rates for both technical and nontechnical operators are based on a cut-off concentration of 1.2 mg/cm , as well as all levels evaluated above this concentra-
    tion. Results are presented as overall false negative rates across all applicable PEMs combined and also based on lead paint type (i.e., white or yellow lead),
    substrate (i.e., drywall, metal, plaster, or wood), and topcoat paint color (i.e., grey, red or white). Note that the observed false negative rates presented pro-
    vide a general representation of the ability of the test kit to correctly identify regulated lead paint when it is present at the cut-off concentration of 1.2 mg/
    cm2 and all levels evaluated above this concentration.

 3.  The false positive rate (at the upper bound of a 95%prediction interval) is evaluated only at 0.8 mg/cm2. Evaluating at only this level ensures that a test kit
    can adequately perform at concentrations of lead paint closest to the current regulatory level.  Under the RRP rule, a test kit must yield a demonstrated
    probability (with 95% confidence) of no more than 10% false positives at lead concentrations below 0.8 mg/cm2.

 4.  The false negative rate (at the lower bound of a 95% prediction interval) is evaluated only at 1.2 mg/cm2. Evaluating at this  level ensures that a test kit can
    adequately perform at concentrations of lead paint closest to the current regulatory level. Under the RRP rule, a test kit must yield a demonstrated prob-
    ability (with 95% confidence) of no more than 5% false negatives at concentrations above 1.2 mg/cm2.
 Contact Information

 ETV ESTE Project

 Julius M. Enriquez
 U. S. Environmental Protection Agency
 Office of Research and Development
 Phone: (513)569-7285, enriquez.iulius@epa.gov

 OPPT Recognition of Lead Test Kits

 Samuel Brown
 U. S. Environmental Protection Agency
 Office of Pollution Prevention and Toxics
 Phone: (202)566-0490, brown.sam@epa.gov
                                 References:

                                 U.S. EPA, ETV. http://www.epa.gov/etv.

                                 U.S. EPA, Lead in Paint, Dust, and Soil. 01 Dec. 2010. http://
                                 www.epa.gov/lead/index.html.

                                 Performance Characteristics of Qualitative Spot Test Kits for Lead
                                 in Paint, http://www.epa.gov/nrmrl/std/etv/este.htmltfpcqstklp
                                                                                    EPA/600/S-11/006
                                                                                            July 2011

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