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Overview of EPA's Lead Paint Test Kit Recognition Program

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Prospective Vendors Information Call

April 16, 2009 - The ETV Program, through its contractor Battelle, will host a vendor meeting via teleconference to discuss the upcoming ETV verification of qualitative spot test kits for lead in paint. The meeting will be held from 1:00 to 3:00 p.m. EST. The teleconference will focus on the test/quality assurance plan being developed for this verification test, including test parameters and overall test design. Time will be allowed for answering questions. Any vendor interested in having their test kits verified under ETV is encouraged to participate in this meeting. For more information or to obtain the call-in number for the teleconference, contact Stephanie Buehler, at (614) 424-3972 or buehlers@battelle.org.

Phase 1

In the April 22, 2008, Federal Register Notice, EPA indicated that three test kits that previously met the false-negative criteria, as verified through the National Institute of Standards and Technology (NIST) evaluation, would be recognized provided that the kits still used the same formulation that was evaluated by NIST. After further investigation of these three kits, it was determined that two of the three still used the same formulations and therefore were recognized in a January 2009 website announcement on EPA's lead Web site. Recognition of these kits will last until EPA publicizes its recognition of the first improved test kit developed under Phase 2.

In addition, manufacturers with test kits that were not recognized under the NIST evaluation were eligible to apply in September 2008 to have their kits tested. These kits were tested to determine if they could also be recognized as meeting the requirement of having a false negative response rate of less than or equal to 5 percent of the time (with 95 percent confidence). Only test kits that were commercially available at that time were eligible to go through this evaluation process. These test kits were evaluated by EPA using the same NIST-developed protocol referenced in Phase 1 and provided in the NIST report entitled, "Spot Test Kits for Detecting Lead in Household Paint, a Laboratory Evaluation" (NISTIR 6398, May 2000). EPA is currently evaluating the results of this testing and anticipates making and posting recognition determinations to the EPA lead Webpage in early summer 2009.

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Phase 2

During the second phase of the recognition process, EPA will evaluate and recognize improved test kits that meet the performance criteria set for Phase 1 (a false negative rate of less than or equal to 5 percent with 95 percent confidence) and a demonstrated probability of a false positive response of no more than 10 percent (with 95 percent confidence) at levels below the regulated level. EPA will evaluate test kit performance using data obtained through EPA's Environmental Technology Verification (ETV) Program. The goal of ETV is to provide credible performance data for commercially-ready environmental technologies. The ETV program will begin accepting applications for testing the newly developed test kits in May 2009. Vendors will be given a chance to review the Test Quality Assurance Protocol (T/QAP) from May 1 – June 15, 2009. Then the T/QAP will be finalized and will be used in the subsequent testing. ETV will perform over 1,700 tests on each lead detection technology. Each vendor should plan accordingly to ensure that they have a sufficient number of test kits and supplies manufactured and available for ETV testing by the test initiation date (see schedule below). For a description of the ETV application process and a list of contacts see www.epa.gov/nrmrl/std/etv/howtoapply.html.

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Requirements for submitting a kit for ETV testing under Phase 2

Each test kit should contain everything that is necessary to perform ETV testing based on the manufacturer's instructions, such as:

  1. Paint extraction mechanism
  2. Kit's chemical reagent solution
  3. Manufacturer's instructions
  4. Date of expiration or shelf life for kit along with kit's reproduction date.
  5. Enough test kits and supplies to perform 1,760 tests (the final number of necessary tests will be discussed with the vendor after signing the ETV agreement)
  6. Material Safety Data Sheets

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Additional goals

The following are additional goals for the improved test kits under Phase 2:

  1. Easy to use - test kits can be reliably used by a person with minimum training by just following manufacturer's instructions
  2. Rapid results - test kits should give results within one hour
  3. Inexpensive

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Schedule:

Phase 1
Begin testing of commercially available kits December 2008
EPA recognition of NIST-reviewed kits January 2009
Recognition of commercially available kits June/July 2009
 
Phase 2 (see Note1)
ETV application period begins for kits May 1, 2009
Vendors review Test Quality Assurance Protocol(T/QAP)* May 1 – June 15, 2009
ETV application period ends for kits September 30, 2009
Manufacturer/Vendor signs agreement and submits kits for ETV testing September/October 2009
ETV Testing of kits begins November 2009
ETV Testing of kits ends February/March 2010
Recognitions of new kits announced (see Note1) September 1, 2010
1 Note: If four or more vendors/manufacturers apply and are ready for ETV testing prior to September 30, 2009, EPA may initiate ETV testing early (July-August time frame) for those vendors, and then will conduct an additional round of ETV testing in November for vendors that apply later in the year but by the September 30 deadline. For vendors that initiate and successfully perform under the early ETV testing, EPA will recognize their kits prior to September 1, 2010.

* This refers to all prospective vendors, whether they have a ready test kit or not, who may be interested in having their kits recognized under Phase 2. T/QAP will be finalized after June 15 and will be used in the subsequent verification testing of the lead test kits.

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