Title of Regulation: 18VAC65-20. Regulations of the Board of Funeral Directors and Embalmers (amending 18VAC65-20-510; adding 18VAC65-20-581).

Statutory Authority: §§ 54.1-2400 and 54.1-2803 of the Code of Virginia.

Public Hearing Information:

January 16, 2018 - 10:05 a.m. - Department of Health Professions, Perimeter Center, 9960 Mayland Drive, 2nd Floor, Suite 201, Henrico, VA

Public Comment Deadline: February 23, 2018.

Agency Contact: Corie Tillman Wolf, Executive Director, Board of Funeral Directors and Embalmers, 9960 Mayland Drive, Suite 300, Richmond, VA 23233, telephone (804) 367-4479, FAX (804) 527-4471, or email fanbd@dhp.virginia.gov.

Basis: 18VAC65-20, Regulations of the Board of Funeral Directors and Embalmers, are promulgated under the general authority of Chapter 24 of Title 54.1 of the Code of Virginia. Subdivision 6 of § 54.1-2400 provides the board with authority to promulgate regulations to administer the regulatory system.

Authority for the board to take disciplinary action for failure to obtain permission to embalm and for refrigeration of human remains is found in § 54.1-2806 of the Code of Virginia.

Purpose: The purpose of this regulatory action is to provide clear, enforceable regulations on the meaning of the statutory requirement for "express" permission to embalm and on the requirement to maintain a body in refrigeration at no more than approximately 40 degrees. The board has received complaints and noted deficiencies on compliance with these requirements. Both the licensees and the public need clarity on these matters so public health and safety is not jeopardized.

Substance: Guidance document 65-18 specifies that subdivision 26 of § 54.1-2806 and § 54.1-2811.1 B of the Code of Virginia state that a dead human body "shall not be embalmed in the absence of express permission by a next of kin of the deceased or a court order." The board interprets "express permission by a next of kin" to mean written authorization to embalm as a specific and separate statement on a document or contract provided by the facility. Express permission may include direct, verbal authorization to embalm, provided it is followed as soon as possible by a written document signed by the next of kin confirming the verbal authorization to embalm and including the time, date, and name of the person who gave verbal authorization.

Guidance document 65-18 specifies that § 54.1-2811.1 B of the Code of Virginia states, "if a dead human body is to be stored for more than 48 hours prior to disposition, a funeral services establishment having custody of such body shall ensure that the dead human body is maintained in refrigeration at no more than approximately 40 degrees Fahrenheit or embalmed." The Board of Funeral Directors and Embalmers interprets this provision as meaning that if a body is to be in the possession of the funeral home or crematory for more than 48 hours from the time the funeral establishment or crematory takes physical possession of the body until embalming, cremation, or burial, the body is to be placed in a mechanical refrigeration unit suitable for storing human remains. The board does not interpret lowering the air conditioning in a storage room to 40 degrees or packing the body in ice or dry ice as meeting the statutory requirement.

The board would view evidence of compliance with § 54.1-2811.1 B of the Code of Virginia as a working refrigeration unit in the funeral home or crematory or a letter of agreement or contract with another funeral establishment, hospital, or morgue to allow the funeral home or crematory to refrigerate in its refrigeration unit. The board would view evidence of the body being "maintained in refrigeration" as log entries indicating times of placement and removal of a body in refrigeration.

In order to enforce its interpretative statements on permission to embalm and refrigeration of human remains, the board has incorporated the guidance into its regulations.

Issues: The primary advantage of the amendments to the public is assurance of proper care of the human remains of their loved ones, so an unembalmed body is not allowed to deteriorate with refrigeration or conversely, remains are not embalmed without express permission of the next of kin. There are no disadvantages to the public.

There are no advantages or disadvantages to the Commonwealth, except more clarity in regulation will assist the board in interpretation of the law.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Funeral Directors and Embalmers (Board) proposes to incorporate in the regulation that written permission to embalm a dead human body and mechanical equipment to refrigerate a dead human body are required.

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

Estimated Economic Impact. Virginia Code § 54.1-2806 (26)¹ and § 54.1-2811.1 (B)² state that a dead human body "shall not be embalmed in the absence of express permission by a next of kin of the deceased or a court order." In Guidance Document 65-8,³ the Board interprets "express permission" to mean verbal authorization so long as the verbal authorization is followed by a signed written document. A written authorization would help determine if in fact there was an authorization in case there is a dispute. Containing the requirement in regulation as opposed to having it in a guidance document should better inform the public and regulants concerning what is required and should bolster the Board's authority to enforce it through disciplinary action. If additional enforcement capacity brings some facilities currently out of compliance into compliance, they are unlikely to incur any significant costs since a written permission may be incorporated into forms currently maintained by a funeral establishment.

The Board also proposes to incorporate in the regulation its current interpretation expressed in the Guidance Document 65-18⁴ of the Virginia Code § 54.1-2811.1 (B) stating that "if a dead human body is to be stored for more than 48 hours prior to disposition, a funeral services establishment having custody of such body shall ensure that the dead human body is maintained in refrigeration at no more than approximately 40 degrees Fahrenheit or embalmed." The Board interprets this provision to mean that the body be either embalmed or placed in a mechanical refrigeration unit suitable for storing human remains. The Board does not interpret lowering the air conditioning in a storage room to 40 degrees or packing the body in ice or dry ice as meeting the statutory requirement. If a facility does not have a mechanical refrigeration unit, it can contract with another funeral establishment, hospital, or morgue that has such equipment to store the body. Containing the requirement in regulation as opposed to having it in a guidance document should better inform the public and regulants concerning what is required and should bolster the Board's authority to enforce it through disciplinary action. If additional enforcement capacity brings some facilities currently out of compliance into compliance, they may incur costs: of $3,000 to $5,000 to purchase a refrigeration unit⁵, to embalm the body, to contract for refrigeration, or to transfer the remains to another establishment.

Businesses and Entities Affected. There are 76 branch establishments, 113 crematories, and 430 funeral establishments licensed in Virginia. Although it is known there are facilities currently out of compliance with the proposed regulation, there is no estimate of the number of such facilities. Virginia Code § 54.1-2811.1, which has been in effect since 2010, requires a dead human body to be maintained in refrigeration at no more than approximately 40 degrees Fahrenheit or embalmed. Furthermore, the guidance documents have been in effect since January 10, 2017. Therefore, it is presumed that the majority of funeral establishments have refrigeration or have made arrangements for storage of human remains in refrigeration.

Localities Particularly Affected. The proposed changes do not disproportionally affect particular localities.

Projected Impact on Employment. No significant impact on employment is expected.

Effects on the Use and Value of Private Property. If a facility has to purchase refrigeration equipment for $3,000 to $5,000, its profit would be lowered by the purchase amount and consequently its asset price may be reduced.

Real Estate Development Costs. No impact on real estate development costs is expected.

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. There is no estimate of the number of independently owned small businesses. Many of the funeral establishments have been bought by large national chains in recent years according to the Department of Health Professions. The costs and effects on them are the same as those discussed above.

Alternative Method that Minimizes Adverse Impact

Given the language in the Virginia Code, there is no alternative method that minimizes the potential adverse impact.

Adverse Impacts:

Businesses. Some of the affected funeral establishments may be non-small businesses since many have been bought by large national chains in recent years. The adverse impacts discussed above apply to them.

Localities. The proposed amendments will not adversely affect localities.

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

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¹https://law.lis.virginia.gov/vacode/title54.1/chapter28/section54.1-2806/

²https://law.lis.virginia.gov/vacode/title54.1/chapter28/section54.1-2811.1/

³http://townhall.virginia.gov/L/GetFile.cfm?File=C:\TownHall\docroot\GuidanceDocs\223\GDoc_DHP_6169_v1.pdf

⁴http://townhall.virginia.gov/L/GetFile.cfm?File=C:\TownHall\docroot\GuidanceDocs\223\GDoc_DHP_6168_v1.pdf

⁵Source: Department of Health Professions

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

Summary:

The proposed amendments clarify requirements for the express permission needed to embalm a body and for the proper refrigeration of a human body.

Part VII
Standards for Embalming and Refrigeration

18VAC65-20-510. Embalming report.

A. In accordance with the provisions of subdivision 26 of § 54.1-2806 and subsection B of § 54.1-2811.1 of the Code of Virginia, express permission by a next of kin for embalming means written authorization to embalm as a specific and separate statement on a document or contract provided by the funeral establishment. Express permission may include direct, verbal authorization to embalm, provided it is followed as soon as possible by a written document or statement signed by the next of kin confirming the verbal authorization to embalm and including the time, date, and name of the person who gave verbal authorization.

B. Every funeral establishment shall record and maintain a separate, identifiable report for each embalming procedure conducted, which shall at a minimum include the following information:

1. The name of the deceased and the date of death;

2. The date and location of the embalming;

3. The name and signature of the embalmer and the Virginia license number of the embalmer; and

4. If the embalming was performed by a funeral service intern, the name and signature of the supervisor.

18VAC65-20-581. Refrigeration requirements.

A. If a dead human body is to be in the possession of a funeral establishment or crematory for more than 48 hours from the time the funeral establishment or crematory takes physical possession of the body until embalming, cremation, or burial, the body shall be placed and maintained in refrigeration in a mechanical refrigeration unit suitable for storing human remains in accordance with subsection B of § 54.1-2811.1 of the Code of Virginia.

B. The mechanical refrigeration unit may be located in the funeral establishment or crematory, or the funeral establishment or crematory may enter into an agreement or contract with another funeral establishment, crematory, or other licensed entity for refrigeration in a mechanical refrigeration unit.

C. Evidence of compliance with the requirement for refrigeration shall be maintained as a log entry or other documentation indicating times of placement in and removal of a body in refrigeration.