Title of Regulation: 6VAC40-30. Regulations for the Approval of Field Tests for Detection of Drugs (amending 6VAC40-30-10, 6VAC40-30-30, 6VAC40-30-40, 6VAC40-30-50, 6VAC40-30-70, 6VAC40-30-80).

Statutory Authority: § 9.1-1110 of the Code of Virginia.

Public Hearing Information:

January 6, 2020 - 9:30 a.m. - Department of Forensic Science, Central Laboratory, 700 North 5th Street, Richmond, VA 23219

Public Comment Deadline: January 8, 2020.

Agency Contact: Amy M. Curtis, Department Counsel, Department of Forensic Science, 700 North 5th Street, Richmond, VA 23219, telephone (804) 786-6848, FAX (804) 786-6857, or email amy.curtis@dfs.virginia.gov.

Basis: Section 19.2-188.1 of the Code of Virginia provides that the Department of Forensic Science shall approve field tests for use by law-enforcement officers to enable them to testify to the results obtained in any preliminary hearing regarding whether any substance, the identity of which is at issue in such hearing, is a controlled substance, imitation controlled substance, or marijuana, as defined in § 18.2-247 of the Code of Virginia. The Forensic Science Board is granted the power to adopt regulations, pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), for the administration of Chapter 11 (§ 9.1-1100 et seq.) of Title 9.1 of the Code of Virginia; §§ 18.2-268.6, 18.2-268.9, 19.2-188.1, and 19.2-310.5 of the Code of Virginia; and any provisions of the Code of Virginia as they relate to the responsibilities of the department.

Purpose: The Forensic Science Board is aware of the significant concerns for the safety of law-enforcement officers as they handle unknown substances that may contain extremely lethal synthetic opioids. As the Drug Enforcement Administration advised, the use of presumptive chemical tests on suspected controlled substances creates a risk of potential lethal exposure to law enforcement. This risk has become so significant that most law-enforcement agencies have decided to forgo the use of the presumptive chemical tests by their officers.

Presumptive mobile instruments are an alternative to presumptive chemical tests. Some presumptive mobile instruments can test through clear plastic and glass packaging, which greatly reduces the risk of exposure to law enforcement. As with chemical field tests, these presumptive mobile instruments could produce false positives and false negatives and should only be utilized by law-enforcement officers for the limited purpose outlined in § 19.2-188.1 of the Code of Virginia. Law-enforcement agencies would not be required to purchase these instruments, but once approved by the department, these instruments would be an additional option available for law enforcement.

Substance: The proposed amendments expand the definition of "field test" to include presumptive mobile instruments, in addition to presumptive chemical tests. In response to the expanded definition, the regulations will be amended to set forth a process for the evaluation, approval, reevaluation, and fee schedule for presumptive mobile instruments. The proposed changes include amendments in (i) 6VAC40-30-10 to include presumptive mobile instruments in the definition of "field test" and eliminate the term "field test kit"; (ii) 6VAC40-30-30 to establish two different procedures for evaluations and requirements for approval of presumptive chemical tests and presumptive mobile instruments; (iii) 6VAC40-30-40 to insert the term "field" before "test" as it occurs; (iv) 6VAC40-30-50 to establish a separate set of requirements for maintenance of approved status for presumptive mobile instruments; (v) 6VAC40-30-70 to amend the term "presumptive chemical tests" to the broader term "field tests"; and (vi) 6VAC40-30-80 to establish a separate fee schedule for approval of presumptive mobile instruments.

Issues: The advantage to the public of this proposed regulatory change is that law enforcement has an increased ability to test suspected controlled substances in the field with a greatly reduced risk of exposure as compared to the currently approved presumptive chemical tests. This supports the goal of public safety. There are no disadvantages for the public.

There are no advantages or disadvantages to the Department of Forensic Science. As with the currently approved presumptive chemical tests, law-enforcement officers would still be required to submit the suspected controlled substances to the Department of Forensic Science for laboratory analysis so that those confirmed results may be utilized at trial.

As for the Commonwealth, in addition to reducing the risk of exposure for law-enforcement officers, the results obtained can be utilized by law-enforcement officers for the purpose of obtaining criminal charges, and § 19.2-188.1 of the Code of Virginia permits law-enforcement officers to testify to those results at the preliminary hearing stage. With the confirmation of the presumptive results by the department through laboratory analysis, there are no disadvantages to the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Forensic Science Board (Board) proposes to expand the definition of "field test" to include presumptive mobile instruments, in addition to presumptive chemical tests.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Virginia Code § 19.2-188.1(A) permits any law enforcement officer to testify in any preliminary hearing as to the results of any field tests that have been approved by the Department of Forensic Science (DFS) pursuant to the Regulations for the Approval of Field Tests for Detection of Drugs. "Field test" is not defined in the statute. The regulation currently defines "field test" to include "any presumptive chemical test unit used outside of a chemical laboratory environment to detect the presence of a drug."

As law enforcement began to encounter increasingly lethal opioids, the Drug Enforcement Administration advised law-enforcement agencies of the dangers associated with presumptive chemical testing of suspected controlled substances. Consequently, according to the Department of Forensic Science (DFS), most law-enforcement agencies no longer use the presumptive chemical field tests currently authorized in the regulation. Specifically, in October 2017, a local Virginia law-enforcement agency advised DFS that it had ceased to use the presumptive chemical field tests due to safety concerns for their officers. A representative of that agency requested that DFS consider approving a presumptive mobile instrument that the agency had obtained for use. Since the current language of the regulation is limited to presumptive chemical tests, DFS was unable to consider the approval of that presumptive mobile instrument.

Accordingly, the Board now proposes to expand the definition of "field test" to include presumptive mobile instruments, in addition to presumptive chemical tests. Manufacturers of presumptive mobile instruments would be able to submit their products to DFS for evaluation. 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 agency. The proposed amendments would be beneficial in that it would allow law enforcement to perform field tests at reduced risk to their health and safety. The proposal does not produce cost.

Businesses and Entities Affected. The proposed amendments potentially affect the Virginia State Police, other state law-enforcement agencies, the Virginia Indigent Defense Commission, local law-enforcement agencies, local Commonwealth's Attorneys' offices, and the Criminal Defense Bar.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments may increase demand for presumptive mobile instrument. This may lead to increased employment at their manufacturers.

Effects on the Use and Value of Private Property. The proposed amendments may increase the use of presumptive mobile instruments, and the value of their manufacturers.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendments are unlikely to significantly affect costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendments do not adversely affect businesses.

Localities. The proposed amendments do not adversely affect localities.

Other Entities. The proposed amendments do not adversely affect other entities.

Agency's Response to Economic Impact Analysis: The agency concurs with the analysis of the Department of Planning and Budget.

Summary:

The proposed amendments (i) modify the definitions of "field test" and "field test kit" to include presumptive mobile instruments; (ii) provide a process by which the department evaluates presumptive mobile instruments; (iii) establish a separate set of requirements for maintenance of approved status for presumptive mobile instruments; and (iv) provide the fee schedule for approval of presumptive mobile instruments.

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 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 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 Department of Forensic Science 700 North Fifth Street Richmond, VA 23219

B. 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.

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 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 resubmit 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 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 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.

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 Virginia.