Proposed Text
Part I
Definitions
6VAC40-30-10. Definitions.
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 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 unit
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
tests 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
assembles field 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 or
field test kits for evaluation shall submit a written request for
evaluation to the department director at the following address:
Director |
B. For presumptive chemical tests, Materials 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 are
provided with the field test or field test kit and which describe
the use and interpretation of the teststest. The manufacturer
shall also include exact specifications as to the chemical composition of all
chemical or reagents used in the presumptive chemical tests. These 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.
C. 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 non-sequentially 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 resubmit their 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 test.
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, but are not limited to,
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.
6VAC40-30-70. Liability.
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 presumptive
chemical field tests.
Part III
Fees
6VAC40-30-80. Fees.
For presumptive chemical tests, manufacturers 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 $2500 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 Virginia.