The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:
"Agency" means any federal, state, or local government law-enforcement organization in the Commonwealth.
"Approval authority" means the Director of the Department of Forensic Science or the director's designee.
"Department" means the Department of Forensic Science.
"Drug" means any controlled substance, imitation controlled substance, or marijuana, as defined in § 18.2-247 of the Code of Virginia.
"Field test" means any presumptive chemical test
or any presumptive mobile instrument used outside of a chemical forensic
laboratory environment to detect the presence of a drug. "Field test kit" means a combination of
individual field tests units.
"List of approved field tests" means a list of field
or field test kits approved by the department for use by
law-enforcement agencies in the Commonwealth and periodically published by the
department in the Virginia Register of Regulations in accordance with §
19.2-188.1 of the Code of Virginia.
"Manufacturer" means any entity that makes or
test units or field test kits tests to be
used by any law-enforcement officer or agency in the Commonwealth for the
purpose of detecting a drug.
"Manufacturers' instructions and claims" means those
testing procedures, requirements, instructions, precautions, and
proposed conclusions that are published by the manufacturer and supplied with
the field tests
or field test kits.
"Street drug preparations" means any drug or combination of drugs and any other substance that has been encountered or is likely to be encountered by a law-enforcement officer as a purported drug in the Commonwealth.
6VAC40-30-30. Request for evaluation.
A. Any manufacturer that wishes to submit field tests
field test kits for evaluation shall submit a written request for
evaluation to the department director at the following address:
Materials For presumptive chemical tests,
materials sufficient for at least 10 field tests shall be supplied
for each drug for which the manufacturer requests evaluation. The materials
shall include all instructions, precautions, color charts, flow charts,
and the like which other accompanying informational materials that
are provided with the field test or field test kit and which
that describe the use and interpretation of the tests test.
The manufacturer shall also include exact specifications as to the chemical
composition of all chemical or reagents used in the presumptive chemical tests.
These specifications shall include the volume or weight of the chemicals and
the nature of their packaging. Safety Data Sheets for each chemical or reagent
shall be sufficient for this purpose.
The manufacturer shall also include exact specifications
as to the chemical composition of all chemicals or reagents used in the field
tests. These shall include the volume or weight of the chemicals and the nature
of their packaging. Material Safety Data Sheets for each chemical or reagent
shall be sufficient for this purpose For presumptive mobile instruments,
two nonsequentially manufactured instruments and supporting materials shall be
supplied for each model for which the manufacturer requests evaluation. These
materials shall include all instructions, all training materials regarding the
use of the instrument by law enforcement, the instrument specifications, a list
of compounds in the instrument's library, and any foundational validation
studies. If the manufacturer provides training for users of the instruments
beyond the written instructional materials, such training shall be made
available for the evaluation. The instruments shall be returned to the
manufacturer upon completion of the evaluation.
D. The department's evaluation process will require at least 120 days from the receipt of the written request and all needed materials from the manufacturer.
E. The department will use commonly encountered street drug
preparations to examine those field tests submitted for evaluation. In order to
be approved, the
field presumptive chemical test must correctly
react in a clearly observable fashion to the naked eye , and perform in
accordance with manufacturers' instructions and claims. In order to be
approved, the presumptive mobile instrument must perform in accordance with the
manufacturer's instructions and advertised claims and offer convenience and
efficiency in operation as determined by the department.
6VAC40-30-40. Notice of decision.
The department will notify each manufacturer in writing of the
approval or disapproval of each field test for which evaluation was
requested. Should any field test not be approved, the manufacturer may
their its request for evaluation of that field test
according to the previously outlined procedures. Resubmitted requests for
approval shall be accompanied by a detailed explanation of all modifications or
changes to the field test, the field test instructions, or the
manufacturer's claims since the department's most recent evaluation of the field
6VAC40-30-50. Maintenance of approved status.
The department may require that
this evaluation a
reevaluation be done as often as annually for routine purposes. If any
modifications are made to an any approved field test by the
manufacturer, other than additions to the compounds in a presumptive mobile
instrument's library, the department shall be notified in writing of the
changes. These modifications shall include any chemical, procedural,
instructional, or firmware or software modifications made to the field test.
The department may require reevaluation of any approved field test upon
receiving notification of any such modifications.
If unreported modifications are discovered by the department,
the department may require
that all evaluations be repeated for the
particular manufacturer's a reevaluation of the approved field tests
test at any time. The department shall notify the manufacturer in
writing of this requirement. Any modified field test must be approved before
it can be used in accordance with § 19.2-188.1 of the Code of Virginia.
These changes shall include, but are not limited to any chemical, procedural or
instructional modifications made to the field test.
A. The department assumes no liability as to the safety of
these field tests
or field test kits, any chemicals contained therein,
or the procedures and instructions by which they are used.
B. The department further assumes no responsibility for any
incorrect results or interpretations obtained from these
chemical field tests.
Manufacturers For presumptive chemical tests,
manufacturers shall pay the actual cost of the each street
drug preparation and will be charged a fee of $50 for each drug for which
individual evaluation is requested. For presumptive mobile instruments,
manufacturers shall pay the actual cost of each street drug preparation and a
fee of $2,500 for each model of the presumptive mobile instrument for which
evaluation is requested. The department will review the manufacturer's
request and notify the manufacturer in writing of the amount due before the
evaluation begins. Manufacturers who wish to withdraw a request for evaluation
shall immediately notify the department in writing. The department's assessment
of the amount of payment required will be based upon a detailed review of the
manufacturer's request, and that amount will be final. The evaluation
process will not be initiated before full payment is made to the Treasurer of