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

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 18, 2013.

Effective Date: January 3, 2014.

Agency Contact: Stephanie Merritt, Department Counsel, Department of Forensic Science, 700 North Fifth Street, Richmond, VA 23219, telephone (804) 786-2281, or email stephanie.merritt@dfs.virginia.gov.

Basis: Section 19.2-188.1 of the Code of Virginia requires the department to evaluate and, where applicable, approve field tests for the detection of drugs, pursuant to regulations adopted in accordance with the Administrative Process Act, for use by law-enforcement officials. Law-enforcement officers may then testify to the results of department-approved field tests at certain preliminary hearings. The amendments to the Regulations for the Approval of Field Tests for Detection of Drugs (6VAC40-30) were adopted by the Forensic Science Board pursuant to §§ 9.1-1101 and 9.1-1110 A 1 of the Code of Virginia.

Purpose: The Regulations for the Approval of Field Tests for Detection of Drugs assist law enforcement and the criminal justice system by providing information critical to the probable cause determination necessary at the time of the arrest and subsequent preliminary hearing. This process positively impacts judicial economy and constitutional due process. Ultimately, therefore, the ability of law enforcement and the courts to rely on the results of drug field tests protects the health, safety, and welfare of the citizens of the Commonwealth.

The amendments change verbiage relating to the department's assessment of field test kits pursuant to § 19.2-188.1 of the Code of Virginia from an "approval" process to an "evaluation" process. Because approval is not automatic, but rather depends on the kit's performance during the evaluation process, these amendments achieve the goal of more accurately expressing the neutrality of the evaluation process.

The amendments also clarify the procedure for resubmitting requests for evaluation after disapproval. If a field test kit is disapproved, there is typically an exchange of information between the department and the manufacturer regarding why the kit was disapproved and any changes made to the kit upon resubmission. The amendments formalize this process by requiring the kit manufacturer to explain changes or corrections made between evaluations by the department.

Finally, the amendments require manufacturers submitting field test kits for evaluation to pay the actual costs of the "street drug preparations" used in the evaluation process. The existing $50 fee was originally intended to cover the manpower costs associated with this testing and has not changed since the regulation's 2006 effective date. This fee does not address the cost of the street drug preparations used in the evaluation process. The street drug preparations, or the known substances needed to actually test the efficacy of a particular field test, are also called "standards" in the scientific community. The standards for controlled drugs, particularly standards for newly emerging drugs such as research chemicals (e.g., bath salts) are difficult to obtain and more expensive than other scheduled substances such as heroin or cocaine. For example, the 10 mg sample necessary for a single evaluation of a 25C-NBOMe field test costs the department $448. In a recent request for evaluation, the fees to be paid by the kit manufacturer totaled $1,000, but the actual cost to department for materials alone would be $1,700. The department's budget does not address these costs, nor does the department have a control over the number and frequency of costly field tests submitted for evaluation. Currently, these rising costs are supported by Virginia tax dollars.

Rationale for Using Fast-Track Process: The amendments to 6VAC40-30, involving the change of "approval" language to more neutral "evaluation" terminology as well as a clarification regarding the resubmission process, are minor and do not change existing, substantive procedures. Additionally, the amendment to 6VAC40-30-80 requires drug field test kit manufacturers to pay the actual cost of the street drug preparations. Based on the current information regarding requests for evaluation, this cost would affect only eight out-of-state kit manufacturers. In September 2012, the department conducted a periodic review of this regulation and received no public comment. Likewise, the Forensic Science Board discussed and voted to adopt these amendments at its January and May 2013 public meetings, and no member of the public offered a comment. Given these facts, as well as the clear cost savings to the Commonwealth, the department does not expect these amendments to be controversial.

Substance: In addition to nonsubstantive verbiage changes regarding the "evaluation" process, the amendments clarify the resubmission process by noting that resubmitted requests for approval "shall be accompanied by a detailed explanation of all modifications or changes to the test, the test instructions or the manufacturer's claims since the. . . most recent evaluation." This procedure merely formalizes the current practice in which the department and field test manufacturer discuss issues surrounding the resubmission of a previously disapproved field test. The amendments to 6VAC40-30-80 require the field test manufacturers to pay the actual cost of the street drug preparations.

Issues: The proposed clarification of the existing language and resubmission procedure will inform and benefit the public, stakeholders, and kit manufacturers. The public generally benefits from the efficient and neutral field test evaluation process to the extent the proper use of department-approved drug field tests assists law-enforcement officials with probable cause determinations and facilitates the judicial process. The transfer of the actual cost of the street drug preparations used during the kit evaluation process from the Commonwealth to the manufacturers is a benefit to Virginians, but arguably a disadvantage to the eight out-of-state kit manufacturers, particularly any manufacturer seeking to transfer its kit quality control responsibilities to the department because it will be required to pay the actual cost of repeated evaluations.

The department currently bears the cost of the street drug preparations used in the field test kit evaluation process. By transferring this cost to the manufacturers, the Commonwealth will be relieved of a financial burden that is increasingly costly.

The department believes the proposed changes benefit the Commonwealth and its citizens.

Small Business Impact Report of Findings: This regulatory action serves as the report of findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Forensic Science Board (board) proposes to: 1) require manufacturers submitting field test kits for evaluation to pay the actual costs of the street drug preparations used in the evaluation process, and 2) add clarifying language.

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

Estimated Economic Impact. The Regulations for the Approval of Field Tests for Detection of Drugs assist law enforcement and the criminal justice system by providing information critical to the probable cause determination necessary at the time of the arrest and subsequent preliminary hearing. This process positively impacts judicial economy and Constitutional due process. Ultimately, therefore, the ability of law enforcement and the courts to rely on the results of drug field tests protects the health, safety and welfare of the citizens of the Commonwealth.

Under the current regulations, manufacturers submitting field test kits for evaluation/approval are charged $50 for each drug for which individual evaluation/approval is requested. The existing $50 fee was originally intended to cover the manpower costs associated with this testing and has not changed since the regulation's 2006 effective date. This fee does not address the cost of the street drug preparations used in the evaluation process. The street drug preparations, or the known substances needed to actually test the efficacy of a particular field test, are also called standards in the scientific community. The standards for controlled drugs, particularly standards for newly emerging drugs such as research chemicals (e.g., bath salts), are difficult to obtain and more expensive than other scheduled substances such as heroin or cocaine. For example, the 10mg sample necessary for a single evaluation of a 25C-NBOMe field test cost the Department of Forensic Science (Department) $448.¹ In a recent request for evaluation, the fees to be paid by the kit manufacturer totaled $1000, but the actual cost to the Department for materials alone would be $1700.² Effectively, the costs of the street drug preparations are paid for by Virginia taxpayers.

The Department is aware of eight field test kit manufacturers likely to be affected by the proposal to charge the actual costs of the street drug preparations used in the evaluation process. All eight are located outside of Virginia. The firm that has most frequently submitted field test kits for evaluation is located in Europe. So under the status quo, Virginia taxpayers are subsidizing services for firms that are located out of state, and in particular a firm located out of country.

There is no compelling reason to provide this subsidy. There is no current concern that there would be a lack of reliable field tests for the detection drugs without it. The tax dollars currently being used for this subsidy would likely provide greater benefit for the Commonwealth by either being used for a more productive purpose or by not being collected from the public. Thus, the proposal to charge the actual costs of the street drug preparations used in the evaluation process will most likely produce a net benefit for the Commonwealth.

Businesses and Entities Affected. The proposed amendments affect the eight manufacturers of field test kits for drug detection who have or have indicated an interest in submitting field test kits for evaluation/approval. All eight firms are located outside of the Commonwealth.

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

Projected Impact on Employment. The proposal amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property within the Commonwealth.

Small Businesses: Costs and Other Effects. The proposed amendments are unlikely to significantly affect small businesses within the Commonwealth.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments are unlikely to significantly affect small businesses in the Commonwealth.

Real Estate Development Costs. The proposed amendments are unlikely to significantly affect real estate development costs.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, a determination of the public benefit, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

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¹ Source: Department of Forensic Science

² Ibid

Agency's Response to Economic Impact Analysis: The Department of Forensic Science concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The amendments (i) change verbiage relating to the Department of Forensic Science's assessment of field test kits from an "approval" process to an "evaluation" process in an effort to more accurately express the neutrality of the evaluation process, (ii) clarify the procedure for resubmitting requests for evaluation after disapproval, and (iii) require manufacturers submitting field test kits for evaluation to pay the actual costs of the "street drug preparations" used in the evaluation process.

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 used outside of a chemical 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 A of the Code of Virginia.

"Manufacturer" means any entity which that makes or assembles field test units or field test kits 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 which 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 which that has been encountered or is likely to be encountered by a law-enforcement officer as a purported drug in the Commonwealth.

Part II
Process for Approval of Field Tests

6VAC40-30-20. Authority for approval.

Section 19.2-188.1 A 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 identify 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.

6VAC40-30-30. Request for approval evaluation.

A. Any manufacturer who that wishes to have submit field tests or field test kits approved for evaluation shall submit a written request for approval evaluation to the department director at the following address:

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

B. Materials sufficient for at least 10 field tests shall be supplied for each drug for which the manufacturer requests approval 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 tests.

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.

D. This approval 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 approval evaluation. In order to be approved, the field test must correctly react in a clearly observable fashion to the naked eye, and perform in accordance with manufacturers' instructions and claims.

6VAC40-30-40. Notice of approval decision.

The department will notify each manufacturer in writing of the approval or disapproval of each test for which approval evaluation was requested. Should any test not be approved, the manufacturer may resubmit their request for approval evaluation of that field test according to the previously outlined procedures at any time. Resubmitted requests for approval shall be accompanied by a detailed explanation of all modifications or changes to the test, the test instructions, or the manufacturer's claims since the department's most recent evaluation of the test.

6VAC40-30-50. Maintenance of approved status.

The department may require that this approval evaluation be done as often as annually for routine purposes. If any modifications are made to an approved field test by the manufacturer, the department shall be notified in writing of the changes. If unreported modifications are discovered by the department, the department may require that all testing and approval evaluations be repeated for the particular manufacturers' manufacturer's approved field tests 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 A 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.

6VAC40-30-60. Publication.

Upon completion of such testing evaluations and in concurrence with the approval authority, the department will periodically publish a list of approved field tests in the General Notices section of the Virginia Register of Regulations. The department will also periodically publish the list on its website. The department may, in addition, provide copies of its approval list to any agency subject to this chapter. The department may share any information or data developed from this testing with these agencies.

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 inherently tentative presumptive chemical tests.

Part III
Fees

6VAC40-30-80. Fees.

Manufacturers shall pay the actual cost of the street drug preparation and will be charged a fee of $50 for each drug or type of drug for which individual approval evaluation is requested. The department will evaluate review the manufacturers' manufacturer's request and notify them the manufacturer in writing of the amount due before testing the evaluation begins. Manufacturers who wish to withdraw a request for approval evaluation shall immediately notify the department in writing. The department's assessment of the amount of payment required will be based upon a detailed evaluation review of the manufacturer's request and that amount will be final. Approval will not be granted The evaluation process will not be initiated before full payment is made to the Treasurer of Virginia.