United States
             Environmental Protection
             Agency
             Atmospheric Research and Exposure
             Assessment Laboratory
             Research Triangle Park, NC 27711
Office of Pollution Preven&on    Final Draft
and Toxics            June 1993
Washington, DC 20460
             Research and Development
&EPA
Outreach to
Manufacturers of
Lead Test Kits

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       OUTREACH TO MANUFACTURERS OF
                 LEAD TEST KITS
                        by
                     K. K. Luk
                    L. L, Hodson
                  W. F. Gutknecht

                    Prepared for

                    R.  J. Cramer
        Office of Pollution Prevention and Toxics
         U.S. Environmental Protection Agency
                  Washington, DC
                EPA Project Officers

                    S. L. Harper
                    M. E. Beard
Atmospheric Research and Exposure Assessment Laboratory
         U.S. Environmental Protection Agency
          Research Triangle Park, NC 27709

             EPA Contract No. 68-02-4550
            RTI Project No. 91U-5960-040

                     June 1993

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                                   DISCLAIMER

      The information  in  this document  has been funded  wholly  by the United States
Environmental Protection Agency under EPA Contract 68-02-4550 to the Research Triangle
Institute.  It has been subjected to the Agency's peer and administrative review, and it has  been
approved for publication as an EPA document.  Mention of trade names or commercial products
does not constitute endorsement or recommendation for use.

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                             ACKNOWLEDGEMENTS

      This document was prepared under the direction of Ms. Sharon L. Harper and Mr.
Michael E. Beard, Atmospheric Research and Exposure Assessment Laboratory (AREAL), U.S.
Environmental Protection Agency, Research Triangle Park, NC.
      Special acknowledgement is given to Dr.  R. J. Gamer, formerly with the Office of
Pollution Prevention and Toxics, U.S. Environmental Protection Agency, Washington, DC, for
his careful review.

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                          TABLE OF CONTENTS

Section                                                        Page No.

1.1 INTRODUCTION	  1
2.0 OUTREACH TO MANUFACTURERS	2
2.1 APPROACH	2
2.2 INTERVIEW QUESTIONS  	2
2.3 RESPONSES TO QUESTIONS 	 3
3.0 RESULTS, DISCUSSION AND RECOMMENDATIONS	8
4.0 REFERENCES	 11

Appendix A.  Letter Submitted to Test Kit Manufacturers Requesting
           Review of Report and Responses to Questions

Appendix B.  Additional Comments from HybriVet Systems

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                                   SECTION 1
                                INTRODUCTION

   An initial exploration of the general behavior and responsiveness of five lead test kits
commercially available as of the fall of 1990 was performed. The intent was simply to
obtain an initial overview of the responses of all the kits to the same limited number of
test parameters and materials.
   Copies of a draft report of this investigation entitled "Evaluation of Lead Test Kits
for Analysis of Paint, Soil and Dust" were submitted to each test kit manufacturer in
October, 1991, both for their review and also to provide information which might be
valuable to the  manufacturers for the purpose  of improving  their kits.    The
manufacturers' identities were coded in this draft report. The manufacturers were then
contacted and sent a questionnaire  regarding their product and plans for the future.
After the outreach was completed (spring 1992), the draft evaluation report was revised,
the manufacturers' names included, and the report published as "Investigation of Test
Kits for Detection of Lead in Paint, Soil and Dust," EPA 600/R-93/085.
   The objective of this report is to present a discussion of the results of this outreach
to the test kit manufacturers.

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                                 SECTION 2
                      OUTREACH TO MANUFACTURERS

2.1    APPROACH

   Each manufacturer was asked to review a draft of the report, "Evaluation of Lead
Test Kits for Analysis of Paint, Soil and Dust,"1 and two RTT/EPA documents, "Options
for  a Lead Analysis Laboratory Accreditation Program"2 and "Options for a Test Kit
Certification Program"3 and to provide comments on the test kit evaluation report. (See
Appendix A)  A list of interview questions approved by the EPA Project Officer (See
Section 2.2) was included with these reports. The manufacturers were asked to prepare
responses to  these questions that then would be discussed in either a  telephone
conference call or in a face-to-face meeting.  The manufacturers were contacted a month
after their receipt of the reports to schedule a conference.  Telephone conferences were
chosen by the manufacturers for their convenience and cost saving.
   Only three companies out of the five successfully completed the outreach process.
Verify, Inc. apparently is no longer in business and the Innovative Synthesis Corp. could
never be reached.

2.2    INTERVIEW QUESTIONS

   The following questions were addressed to the five different manufacturers:

1.  Would you like your company's name to appear in the final report?
2.  Will your  company provide a toll-free 800 number to respond to  questions from
   consumers?
3.  Is your company planning to clarify the instructions for the kit based on the findings
   of this study?
4.  Is your company planning to provide instructions for disposal of the reagents and
   used materials from the  test  kits, as well as instructions for cleanup of  tested
   surfaces?

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5.  Will your company consider providing gloves with the test kit (at least one pair)?

6.  What is your current production capacity?

7.  For what market was your kit designed?

8.  What percentage of your kits have been sold to homeowners?

9.  Does your company plan to improve your present test kit or to develop a more
   quantitative kit?

10.    What type(s) of research would be helpful to further develop a more quantitative
      kit?

11.    Do you think reference materials will be helpful to  you in developing a more
      effective test kit? What materials would be needed?

12.    Do  you feel that independent verification of the performance of test  kits  is
      needed?  What agency or organization should be responsible?  Would your
      company support this effort?

2.3    RESPONSES TO QUESTIONS


   Telephone conference calls were held with the three manufacturers that responded

to the request for additional information.  The responses to each question are listed

below for Frandon Lead Alert (F), HybriVet LeadCheck (LC) and Merck EM Quant (M).


1.  Would you like your company's name to appear in the final report?

   F:     No problem with name on the report.

   LC:   Yes, provided that our concerns and reservations on how the tests were
         carried out are included in the report.

   M:    Yes, we would like our name  to appear in the final report.

2.  Will your company provide a toll-free 800 number to respond to questions from
   consumers?

   F:     Company will provide toll-free 800 number.

   LC:   HybriVet Systems already provides an 800 number (1-800-262-LEAD) for our
         consumers to use to order product  (LeadCheck Swabs), or to ask questions
         about the product. The 800 number has been in operation  since spring, 1990.

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   M:    We already have a toll-free number.

3.  Is your company planning to clarify the  instructions for the kit based on the
   findings of this study?

   F:    Yes, the company will try its best to clarify the instructions.

   LC:   HybriVet Systems had already planned to rewrite the Instruction Manual
         before the results of this study were released.  Most of the clarifications were
         written in response to our customers' experiences over the past two years.
         This study verified the need for many of title changes we made.  A working
         copy of the new instructions has been included for your review and comment.

   M:    Instructions can always be altered, if necessary.

4.  Is your company planning to provide instructions for disposal of the reagents and
   used materials from the test kits,  as well as for cleanup of tested surfaces?

   F:    Already had instruction for disposal  of reagents (flush down the drain with
         water).

   LC:   LeadCheck Swabs do not contain any toxic or hazardous  materials.  Conse-
         quently, the consumer  is instructed  to dispose of the used Swabs in their
         normal trash receptacles. Our consumers are instructed to dean the test area
         to remove dust and  dirt prior to testing the surface with the Swab and
         following the test, to clean-up any residual reagents and/or pink color with
         their normal household cleaner.

   M:    Really does not apply to our kit.

5.  Will your company consider providing gloves with the kit (at least one pair)?

   F:    Yes, will consider providing one pair of gloves.

   LC:   Since LeadCheck Swabs contain no hazardous or toxic substances, gloves are
         not necessary to handle the Swabs. As a normal safety precaution, however,
         we  do encourage  our customers to use common sense safety practices.  For
         example, they are instructed not to use the Swabs near food or while eating
         or smoking, and to store the Swabs and confirmation card away from children.

   M:    Gloves aren't really needed.

6.  What is your current production capacity?

   F:    Product capacity depends on demands, can be 100,000 or 20,000.

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   LC:   Current capacity allows for production of 30/000 kits per week.  However,
         production can be increased substantially if demand requires it.

   M:    Hard to answer.  With an accurate forecast almost any demand can be met

7.  For what market was your kit designed?

   F:    Kits designed for home use.

   LC:   LeadCheck Swabs were designed to serve both the consumer and industrial
         markets as a screening tool to detect the presence of hazardous levels of lead
         on any solid surface, including painted surfaces.  Since LeadCheck Swabs are
         a presumptive test for lead and not a quantitative test, they cannot take the
         place of a professional inspection for lead.  The product is used by some
         inspectors, however, as an adjunct screening tool to the XRF.  Since the Swabs
         are sensitive to lead in dust, many lead abatement professionals in Massachu-
         setts are using the Swabs to monitor their clean-up procedures.  For this
         purpose HybriVet Systems has worked out a special protocol for wiping a
         square foot area, which detects amounts  of lead in excess of 200 ug/sq. ft.
         (amount of lead allowed/sq. ft. following  abatement procedures). According
         to Dave Renner (Middlesex Deleading, Marlboro, MA), following abatement
         of lead paint, surfaces and  floors are repeatedly washed with TSP until a
         negative reading is obtained with the Swabs using our dust protocol. When
         this procedure is followed, the area has passed inspection for clearance. Such
         a practice avoids repeated clean-ups and reinspections for clearance purposes.
         I have  included the dust protocol designed for this purpose.

   M:    The market for which the kit was designed is  a little difficult to define. The
         kit is made in Germany by our parent company, Merck, and we aren't sure
         what their original plans  were.  Our kits are marketed through laboratory
         supply distribution and a host of regional dealers.

8.  What percentage of your kits have been sold to homeowners? to professionals?

   F:    98%  were for home use.

   LC:   Our records  indicate that 75% of our kits have been sold to homeowners and
         25%  have been sold to professionals.

   M:    Since our national distributors deal in laboratory supply, the  vast majority
         probably are professionals. Niche accounts may include some homeowners,
         but very few.

9.  Does your  company plan to improve your present  test kit or to develop a more
   quantitative kit?

   F:    Yes,  company is planning to develop a more quantitative test kit.

                                      5

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   LC:   HybriVet Systems is always open to suggestions tor improvement of the
         LeadCheck Swab product.  The original LeadCheck Swab product, which
         appeared on the market in February 1988, was redesigned and improved in
         its present monoswab form and was first marketed in September 1990. The
         patent for LeadCheck Swabs was issued on August 13, 1991.  HybriVet
         Systems does plan to further improve LeadCheck, primarily in  the area of
         more  efficient procedures for the extraction of lead from surfaces prior to
         reaction with the swabs.   To assist in the accomplishment of these  goals,
         HybriVet Systems has submitted an SBER grant proposal to the EPA, entitled,
         "Detection and Measurement of Lead in Lead-Based Paints: Development of
         Field Test Kits."  This Phase I SBIR grant proposes:

      1.  To develop a series of lead paint standards as tools for this study. A wide
         variety of paints which use different binders, lead pigments, and lead dryers
         will be made following old lead-based paint formulations.

      2.  To explore an exhaustive list of possible extraction solvents used in the paint
         industry  and in paint removal as possible solvent(s) to use directly in the
         Swab  configuration or as a pretreatment prior to the use of the Swab.
         Recommendations for both the consumer and the professional user will be
         made.

      3.  To examine other lead reactive reagents  for improved sensitivity to lead
         and/or stability for a quantitative test to be developed in a Phase IL applica-
         tion.

   M:    Yes. There will probably be a whole product line of similar products, which
         will include the use of a portable, hand-held instrument.

10.    What type(s) of research would be helpful to further develop a more quantita-
      tive kit?

   F:    Research material.  No straight answer to what type of research.

   LC:   It would be extremely helpful to have a set of reference standards for lead-
         based paint, soil and dust to use as tools and checks as we attempt to improve
         on the performance of the Swabs. Although we propose to establish our own
         lead-based paint standards in the Phase I SBIR grant to EPA, we would be
         delighted to include any reference standards developed by either EPA or NIST
         in our study as  they became available.

   M:    Same answer as question 9.

11.    Do you think reference materials will be helpful to you in developing a more
      effective  test kit? What materials would be needed?

   F:    Reference materials will be very helpful.

                                      6

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LC:   As indicated in #10, reference standards are indeed needed to develop more
      effective test kits. Lead-based reference standards should include samples that
      contain a variety of lead-pigments, lead driers and paint binders (linseed oil,
      alkyds, epoxies, etc. that were commonly used in lead pigments prior to 1978).
      Reference standards for dust and soil should also be prepared.

M:    Reference materials may be more useful in helping the end user ascertain how
      the kit is performing, or recognize what a positive reading would look like.

   Do you feel that independent verification of the performance of a test kit is
   needed?  What agency or organization should be responsible? Would your
   company support this effort?

F:    Verification of the performance of test kits is good only if it will not delay the
      progress of the  development of the product.  Probably EPA  or RTI are
      appropriate organizations for this.

LC:   Yes,  independent verification of the performance of the test kit is needed.
      Such an independent verification of LeadCheck Swabs would assure  our
      customers that the kit does what we claim it can do.  The EPA Center for
      Environmental Measurements for Quality Assurance seems to be an appropri-
      ate agency to review test kits. HybriVet Systems would both welcome  and
      support this effort.

M:    We have already addressed our concerns regarding verification.  The agency
      who is enforcing the law is the one who should be responsible, i.e., the EPA.
      There should be a separate classification for field test or pre-screening type
      kits and once again this should not be compared to the quantisation achievable
      with conventional analytical instrumentation.

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                                  SECTION 3
              RESULTS, DISCUSSION AND RECOMMENDATIONS

3.1    Summary of Results

   Each of the three kit manufacturers that responded to the outreach effort indicated
that they considered the test kit evaluation report to be fair to their particular product.
Several suggestions were made for changes in the report. These have been considered
and changes made where appropriate.  One change made was to note that anionic and
cationic interferences cannot be differentiated and that one can only speak of a "salt"
interference. Another was to note that the number of real-world samples available for
evaluation was small,  which often resulted in large differences between the  lead
concentration in one sample and  the next lower and/or higher one.  Additional
comments from HybriVet are presented in Appendix B.
   The three companies all indicated a  serious interest in being of  service  to  their
customers  through availability  of  a toll-free 800 number.  This interest was also
demonstrated through  their current plans or willingness to clarify  the instructions
included with each kit. None of the manufacturers considered the reagents in their kits
to be hazardous. None thought laboratory gloves were needed, Frandon, HybriVet and
Merck all  stated that they  have the capability to manufacture as many kits as can be
sold.
   The Frandon test kit is designed for home use while the HybriVet and Merck kits are
designed for both home and professional use. HybriVet is promoting their kit as an
adjunct screening tool to the XRF with their  protocol  for detection of more than 200
ug/sq. ft. of lead on surfaces.
   All three manufacturers plan to develop and market quantitative kits. HybriVet is
seeking an EPA grant to perform needed research while Merck is turning to the parent
company in Germany for this development
   All three manufacturers also stated that the availability of reference materials would
be extremely useful, both for development of new, quantitative kits and also as quality
                                      8

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assurance materials for both qualitative and quantitative kits.
   Finally,  all three manufacturers agree that verification of test kit performance is
desirable.  However,  there were reservations about a verification process  slowing
development and marketing of new products.

3.2    Discussion

      As noted, outreach to  the kit manufacturers has been beneficial to both the
manufacturers and the EPA. The manufacturers have been presented with data showing
the responses of their kits to a  variety of laboratory-prepared and real-world lead-
containing  materials.   Both strengths and  limitations have been  identified.  The
manufacturers have also been made aware of the needs of both the homeowner and the
professional tester  as determined by EPA. The manufacturers are responding to these
needs both by improvement of their current kits and development of new, quantitative
kits. The EPA has also benefited as it now better understands the direction being taken
by  manufacturers, and also their current needs.  Among these needs are method
evaluation  materials.  Manufacturers have expressed a need for  paint,  soil and dust
materials which would be used  both as quality  control check samples for currently
available kits and as research materials to be used to assist in the development of new
kits. Paint, soil and dust materials representing the variety of samples and varying lead
concentrations expected in the field are seen as necessary.  Another need recognized is
independent verification of the performance of modified and/or new test kits  as they
become available in the market.

3.3    Recommendations

      As a result of this outreach effort, several recommendations have been developed.
These are as follows:

(1)    Maintain continous communications between EPA and test kit manufacturers.
      Regular communication will allow EPA to alert the manufacturers to  changes in

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      policy, new regulations, and/or new findings about the health effects of lead that
      might result in the manufacturers modifying or developing new products.  Also,
      as a result of this communication, EPA should be able to determine the needs for
      research and development that would be most expediently performed by the
      government.

(2)    Develop a repository of paint, soil and dust method evaluation materials.
      Outreach has shown a need for materials for both kit testing and kit development.
      Paint, soil and dust materials  are needed.  The concentrations of lead in  these
      should  reflect the levels  of concern described in a report entitled "Proposed
      Performance Criteria for Lead Test Kits and Other Methods"4 that are based on
      regulations and health effects. Further more, the  outreach has indicated that a
      range of lead levels are needed with each material, with no large gaps between
      the individual concentrations. Finally it was generally agreed through discussion
      with the manufacturers that  the materials should be  real-world.  This would
      include paint chips on select substrates as well as powdered paint, and also dust
      on wipes and filters as well as bulk  dust.

(3)    Establish a set of test kit  performance specifications  for both qualitative and
      quantitative test kits.
      Test kit manufacturers have indicated  an interest  in  test kit performance
      specifications for use in evaluating current kits and for development of new kits.
      EPA has developed performance criteria, which are presented in Reference 1 of
      this report and which may serve as the basis for specifications in the future. The
      publication of specifications should assure that kits are  available that do provide
      measurements at levels of concern and that the results obtained can  be used to
      make decisions about risk, the need  for abatement and others.
                                       10

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                                 SECTION 5
                                REFERENCES

1.  Luk, K. K., L.  L. Hodson, D. S.  Smith,  J. A. CKRourke  and W.  F.  Gutknecht,
   "Investigation of Test Kits for Detection of  Lead in Paint, Soil and Dust," EPA
   600/R-93/085, May 1993.

2.  Estes,, E. D., E.  E. Williams and W, F. Gutknecht, "Options for a Lead Analysis
   Laboratory Accreditation Program," EPA Contract No. 68-02-4550, January 1991.

3.  Estes, E. D., E. E. Williams and W. F. Gutknecht, "Options for a Test Kit Certification
   Program," EPA Contract No. 68-02-4550, February 1991.

4.  Williams, E. E., E. D. Estes and W. F. Gutknecht, "Analytical Performance Criteria for
   Lead  Test  Kits and  Other Analytical Methods," EPA  Contract No.  68-02-4550,
   February 1991.
                                      11

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           Appendix A

    Letter Submitted to Test Kit
Manufacturers Requesting Review of
 Report and Response to Questions

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RESEARCH  TRIANGLE  INSTITUTE
Center for Environmental Measurements and Quality Assurance
                                                        October  15,  1991
       Dr. Donald M. Wallace
       Frandon Enterprises, Inc.
       "Frandon Lead Alert Kit"
       S11 North 48th Street
       Seattle, Washington  98103

       Dear Dr. Wai lace:

            Thank you for your  Interest and willingness to review our study  of  five
       lead test Kits on the market, Including your brand.  Three reports  prepared at
       RTI are enclosed for your review and/or use.  These are:

            "Evaluation of Lead Test Kits for Analysis of Paint, Soil and  Dust"

            "Options for a Test Kit Certification Program"

            "Analytical  Performance Criteria for Lead Test Kits and Other  Analytical
            Methods"

            Please review the  test kit evaluation report and call us when  you are
       ready to discuss  It. Hopefully your review will take no longer than  three
       weeks.   We will then plan either a teleconference or meeting to review the
       results.   Also enclosed Is a set of questions which we would also like to
       discuss during the teleconference or face-to-face meeting.
            As we have told you on the phone,  the goal  of this work Is to  help the
       general public and also professionals In the lead field be aware of the
       capabilities of available test kits and also to help test kit manufacturers to
Post Office Box 12194     Research Triangle Park, North Carolina 27709-2194
Telephone 919541-6914    Fax:919541-5929
                                           A-l

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further  Improve their Iclts and/or to develop new kits.  Again, thank you, and
we  look  forward to your reply.

                                                 Sincerely,
                                                 Kate K. Luk
                                                 Research Chemist
                                                 WlI I lam F. Gutknecht
                                                 Department Manager
KKL:WFG:aca
CC:  Dr. CJapp, PACE Environs
                                    A-2

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       Interview Questions With Lead Test Kit Manufacturers
1.  Would you like your company's name to appear in the final
    report ?

2.  Will your company provide a toll-free 800 number to respond
    to questions from consumers ?

3.  Is your company planning to clarify the instructions for the
    kit based on the findings of this study ?

4.  Is your company planning to provide instructions for disposal
    of the reagents and used materials from the test kits as well
    as instructions for cleanup of tested surfaces ?

5.  Will your company consider providing gloves with the kit (at
    least one pair) ?

6.  What is your current production capacity ?

7.  For what market was your kit designed ?

8.  What percentage of your kits have been sold to homeowners ?
    to professionals ?

9.  Does your company plan to improve your present test kit or to
    develop a more quantitative kit ?

10. What type(s) of research would be helpful to further develop
    a more quantitative kit ?

11. Do you think reference materials will be helpful to you in
    developing a more effective test kit ?  What materials would
    be needed ?

12. Do you feel that independent verification of the performance
    of test kits is needed ?  What agency or organization should
    be responsible ?  Would your company support this effort ?
                               A-3

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RESEARCH  TRIANGLE   INSTITUTE
Center for Environmental Measurements and Quality Assurance
                                                         October 15, 1991
        Dr.  Meredith Hunter/Mr.  Brad Evans
        Hybrlvet  Systems LeadCheck Swabs
        4  Mechanic Street
        Natlck, MA  01760

        Dear  Dr.  Hunter  and Mr.  Evans:

             Thank you for  your  Interest and willingness to review our study of five
        lead  test  kits on the market,  Including your brand.  Three reports prepared at
        RTI  are enclosed for your  review and/or use.  These are:

             "Evaluation of Lead Test  Kits for Analysis of Paint,  Soil and Dust"

             "Options for a Test Kit Certification Program"

             "Analytical  Performance Criteria for  Lead Test Kits and Other Analytical
             Methods"

             Please  review  the test  kit  evaluation report  and call  us when you are
        ready to discuss  It.   Hopefully  your review will  take no longer  than three
       weeks.  We will  then plan  either a teleconference  or meeting to  review the
       results.   Also enclosed  Is a set of questions which we would also like to
       discuss during the  teleconference or face-to-face  meeting.
             As we have  told you on  the  phone, the goal  of this work Is  to help the
       general public and  also  professionals In the lead  field be aware of the
       capabilities  of  available  test kits and also to help test  kit manufacturers to
Post Office Box 12194    Research Triangle Park, North Carolina 27709-2194
Telephone 919 541-6914     Fax: 919 541-5929
                                            A-4

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further  Improve  their kits and/or  to  develop new kits.   Again,  thank  you,  and
we  look  forward  to your reply.

                                                  Sincerely,
KKL:WFG:aca
                                                  Kate  K.  Luk
                                                  Research Chemist
                                                  Wl 11 lam  F. Gutknecht
                                                  Department Manager
                                    A-5

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RESEARCH  TRIANGLE   INSTITUTE

Center for Environmental Measurements and Quality Assurance
                                                         October  15,  1991
       Mr. Al Souther I and
       E.M. Science
       480 Democrat Rd.
       Glbbstown, NJ  08027

       Dear Mr. Souther I and:

            Thank you for your  Interest and willingness  to  review our  study  of  five
       lead test kits on the market,  Including your brand.  Three reports  prepared at
       RTI are enclosed for your review and/or use.  These  are:

            "Evaluation of Lead Test Kits for Analysis of Paint, Soil  and  Dust"

            "Options for a Test Kit Certification Program"

            "Analytical Performance Criteria for Lead Test  Kits and Other  Analytical
            Methods-

            Please review the test kit evaluation report and call us when  you are
       ready to discuss It.  Hopefully your review will  take no longer than  three
       weeks.  We will then plan either a teleconference or meeting to review the
       results.  Also enclosed  Is a set of questions which  we would also like to
       discuss during the teleconference or face-to-face meeting.
            As we have told you on the phone, the goal of this work is to  help the
       general public and also professionals In the lead field be aware of the
       capabilities of available test kits and also to help test kit manufacturers to
Post Office Box 12194     Research Triangle Park, North Carolina  27709-2194
Telephone 919 541-6914    Fax: 919 541-5929
                                              A-6

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further  Improve  their kits and/or  to develop new kits.  Again, thank you, and
we  look  forward  to your reply.

                                                 Sincerely,
                                                 Kate K. Luk
                                                 Research Chemist
                                                 Wl11 lam F.  Gutknecht
                                                 Department  Manager
KKL:WFG:aca
                                  A-7

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RESEARCH  TRIANGLE  INSTITUTE

Center for Environmental Measurements and Quality Assurance
                                                         October 15,  1991
       Mr.  Barry Soslnsky
        Innovative Synthesis Corporation
        "The Lead Detective"
        1425 Beacon Street
       Newton,  MA  02168

       Dear Mr. Soslnsky:

             Thank you for  your  Interest and willingness  to  review our  study of five
        lead test kits on the market,  Including your  brand.   Three reports prepared at
       RTl  are  enclosed for your  review and/or use.   These  are:

             "Evaluation of Lead Test  Kits  for  Analysis of Paint,  Soil  and Dust"

             "Options  for a Test Kit Certification  Program"

             "Analytical  Performance Criteria for Lead Test  Kits and  Other Analytical
             Methods"

             Please review  the test kit  evaluation  report and call  us when you are
       ready to discuss It.  Hopefully  your review will  take no  longer than three
       weeks.   We will  then plan  either a  teleconference or  meeting  to review the
       results.  Also enclosed  Is a set of questions which  we would  also like to
       discuss  during the  teleconference or face-to-face meeting.
             As  we have  told you on the  phone,  the  goal of this work  Is to help the
       general  public and  also professionals In the  lead field be  aware of  the
       capabilities of  available  test kits and also  to help test  kit manufacturers to
Post Office Box 12194     Research Triangle Park, North Carolina 27709-2194
Teleohone 919541-6914    Fax:919541-5929
                                         A-8

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further  Improve their tclts and/or to develop new kits.  Again,  thank you, and
we  look  forward to your reply.

                                                 Sincerely,
                                                 Kate K. Lufc
                                                 Research Chemist
                                                 Wi I Mam F. Gutknecht
                                                 Department Manager
KKL:WFG:aca
                                      A-9

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      Appendix B

Additional Comments from
    HybriVet Systems

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                         ADDITIONAL COMMENTS


1.  The instructions listed in Table 1 for Test Kit A (LeadCheck) under Soil and Dust
   are incorrect. The instructions we provide our customers tell them to first activate
   the Swab and them rub it into a small sample of dust that has been collected onto
   a piece of waxed paper. Under these conditions the Swab is very sensitive to small
   amounts of lead-paint dust.  Our protocol for extracting lead from soil involves an
   overnight soak in concentrated lemon juice (citric acid), followed by an analysis of
   a small drop of the  lemon juice supernatant with an activated LeadCheck Swab.
   We wondered if it would be possible to reevaluate dust and soil samples using the
   protocols designed  by Hybrivet Systems, Inc.  for these matrices. We feel that the
   results would indicate that LeadCheck Swabs are more sensitive for lead in dust
   and soil than reported.

2.  In the section entitled, 2.3 Metal Interference Studies, it is possible that the
   reduced sensitivity found for lead acetate solutions may not be due to the presence
   of the acetate ion.  Under basic conditions, lead forms insoluble Pb(OH)2 and
   precipitates out of solution.  It is thus possible that the observed reduction in
   sensitivity is  NOT due to interference oy acetate ion. but simply the result of the
   removal of available Pb+2 ion from solution in the form of insoluble Pb(OH)2. If
   this interpretation is correct, then the amount of free Pb+2 in a solution of lead
   acetate would decrease over time as the lead precipitates from solution as
   Pb(OH)2.

3.  In Table 4, we disagree with the interpretation of the reaction of "A original Kit"
   (LeadCheck Swabs) with barium to be positive. Rhodizonate reacts with  barium
   to form an orange color quite distinct from the pink color observed for lead.  Since
   orange can be distinguished from pink, we hesitate to call this reaction positive.

4.  In the absence of lead paint standards, we spiked paints with lead nitrate. With
   these standards, LeadCheck Swabs were as sensitive to lead as was the S9dium
   sulfide test (see enclosed Performance Characteristics Sheet).  Tests designed to
   indicate performance characteristics showed that the Swabs gave a clear positive
   result at t).4% lead  and a plus/minus result at 0.3% lead.  These values are
   conservative estimates.  Consequently, we were surprized at RTI's findings that the
   Swab did not activate 100% of the time until  1.9 mg/sq.in.  It is possible that the
   paint film used as a standard in the RTT study contained lead pigments such as
   lead chromates that are less soluble or extractable than the usual lead  carbonates
   or lead oxides found in household lead-based paints. Also, it is possible that
   certain paint binders form a "film" on the surface that is less penetrable by the acid
   buffer supplied by the Swab. The instructions supplied with the LeadCheck kit
   instruct me user to  cut down through all layers of paint to the substrate, and to rub
   the Swab into the cut out notch. Ifany one of the layers of paint contains lead, the
   Swab will turn pink. It is possible that a fresh cut through the layer of paint
   exposes a matrix that is more easily penetrated by the acid extraction supplied by
   the Swabs. Retesting the paint film standard used  by RTI after a fresh cut is made
   may give the requisite sensitivities for lead.
                                       B-l

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