Title of Regulation: 18VAC65-20. Regulations of the Board of Funeral Directors and Embalmers (amending 18VAC65-20-170, 18VAC65-20-171, 18VAC65-20-400, 18VAC65-20-435, 18VAC65-20-436, 18VAC65-20-580).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: September 11, 2013.

Effective Date: September 26, 2013.

Agency Contact: Lisa Russell Hahn, Executive Director, Board of Funeral Directors and Embalmers, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4424, FAX (804) 527-4637, or email lisa.hahn@dhp.virginia.gov.

Basis: 18VAC65-20, Regulations of the Board of Funeral Directors and Embalmers, are promulgated by the Board of Funeral Directors and Embalmers under the general authority of § 54.1-2400 of the Code of Virginia, which establishes the general powers and duties of health regulatory boards, including the responsibility to promulgate regulations in accordance with the Administrative Process Act that are reasonable and necessary for the administration of a regulatory program. Sections 54.1-2803 and 54.1-2804 of the Code of Virginia authorize the board to establish standards of service and practice and to determine the qualifications to enable any person to engage in the practice of funeral service, preneed funeral planning, funeral directing, embalming, and the operation of a funeral service establishment.

Purpose: This action is in response to a periodic review of regulations. The overall purpose of the amended regulation is clarification and ease of compliance with requirements for funeral establishments. Less restrictive regulations for establishment applicants, managers of record, and embalming equipment will result in a modest decrease in the regulatory burden without any associated risk of harm to the public. The board will continue to have the ability to monitor compliance and enforce regulations that protect the public health and safety in the handling and disposition of human remains.

Rationale for Using Fast-Track Process: The fast-track process is being used because the changes are mostly less restrictive and clarifying. There should be no controversy from these periodic review recommendations.

Substance: Amendments will (i) require less time for submission of an application for a new establishment prior to the establishment opening for business; (ii) eliminate the specific 40-hour a week requirement for a manager of record to be employed by an establishment; (iii) clarify a requirement for compliance with OSHA standards; and (iv) allow a first aid kit to be kept either in a preparation room or immediately accessible to the room.

Issues: There are no real advantages or disadvantages to the public. Clarification of rules or a modest reduction in regulatory requirements will benefit licensees, but there is not likely to be a perceptible advantage to the consumer. There are no advantages or disadvantages to the Commonwealth.

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 proposed changes will 1) eliminate the specific 40-hour a week requirement for a manager of record to be employed by a funeral establishment, 2) reduce the required advance notification time for submission of an application for a new establishment prior to opening, 3) allow a first-aid kit to be kept in a preparation room, and 4) clarify the requirements for compliance with certain federal health and safety standards.

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

Estimated Economic Impact. One of the proposed changes will eliminate the specific 40-hour a week requirement for a manager of record to be employed by a funeral establishment. According to the Department of Health Professions (DHP) the intent of the requirement for a full-time manager of record is to ensure that there is a person responsible to the Board of Funeral Directors and Embalmers (Board) for operation of the establishment at all times. Currently, regulations specify that full-time must be 40 hours per week. The proposed regulation would require that the manager must be employed full-time without specifying a number of hours. If a manager can be fully in charge and employed full time for a fewer number of hours per week, that would satisfy the proposed regulations. This change will allow more flexibility to the funeral establishments and their employees serving as the manager of record in determining the terms of their labor contract.

Another proposed change will reduce the required advance notification time for submission of an application for a new establishment prior to opening. Currently, a completed application must be on file at least 45 days prior to opening an establishment to allow for scheduling and completing an inspection of the location by DHP. The proposed change will reduce the required advance notification from 45 days to 30 days. With this change, an applicant will have 15 additional days to have all of the required elements in place prior to an opening inspection. DHP does not anticipate any significant administrative difficulties due to shorter notifications.

The proposed changes will also allow a first-aid kit to be kept in a preparation room. Currently, a first-aid kit must be immediately accessible to the preparation room. According to DHP, the kit may be more useful if maintained in the preparation room. Thus, the proposed change will give an establishment an additional option to place a first aid kit. While this change provides additional flexibility to the establishments in conducting their operations, no significant economic impact is expected.

Finally, the proposed changes will clarify the requirements for compliance with federal Occupational Safety and Health Administration standards. No significant effect, other than improving the clarity of these regulations, is expected from this change.

Businesses and Entities Affected. These regulations apply to 1,439 funeral service providers, 426 funeral service establishments, 62 branch funeral establishments, 43 surface transportation and removal service providers, and 97 crematories.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. The proposed changes are not expected to have a significant direct impact on employment.

Effects on the Use and Value of Private Property. No significant effect on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. According to DHP, while many of the affected establishments are small businesses, some are owned by large, national corporations. The economic effects discussed above apply to small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed changes do not impose any adverse impact on small businesses.

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

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.

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 for amendments to 18VAC65-20, Regulations of the Board of Funeral Directors and Embalmers.

Summary:

The amendments are a result of a periodic review of 18VAC65-20, Regulations of the Board of Funeral Directors and Embalmers, and are clarifying in nature or intended to make the requirements somewhat less restrictive. Amendments (i) require less time for submission of an application for a new establishment prior to opening for business; (ii) eliminate the specific 40-hour per week requirement for a manager of record to be employed by an establishment; (iii) clarify the requirement for compliance with federal Occupational Safety and Health Administration standards; and (iv) allow a first aid kit to be kept either in a preparation room or immediately accessible to the room.

Part III
Requirements for Licensure

18VAC65-20-170. Requirements for an establishment license.

A. No person shall maintain, manage, or operate a funeral service establishment in the Commonwealth, unless such establishment holds a license issued by the board. The name of the funeral service licensee or licensed funeral director designated by the ownership to be manager of the establishment shall be included on the license.

B. Except as provided in § 54.1-2810 of the Code of Virginia, every funeral service establishment and every branch or chapel of such establishment, regardless of how owned, shall have a separate manager of record who has responsibility for the establishment as prescribed in 18VAC65-20-171. The owner of the establishment shall not abridge the authority of the manager of record relating to compliance with the laws governing the practice of funeral services and regulations of the board.

C. At least 45 30 days prior to opening an establishment, an owner or licensed manager seeking an establishment license shall submit simultaneously a completed application, any additional documentation as may be required by the board to determine eligibility, and the applicable fee. An incomplete package will be returned to the licensee. A license shall not be issued until an inspection of the establishment has been completed and approved.

D. Within 30 days following a change of ownership, the owner or licensed manager shall request a reinspection of the establishment, submit an application for a new establishment license with documentation that identifies the new owner, and pay the licensure and reinspection fees as required by 18VAC65-20-70. Reinspection of the establishment may occur on a schedule determined by the board, but shall occur no later than one year from the date of the change.

E. The application for licensure of a branch or chapel shall specify the name of the main establishment.

18VAC65-20-171. Responsibilities of the manager of record.

A. The Every funeral establishment shall have a manager of record shall be who is employed full time by and in charge of the establishment for at least 40 hours a week.

B. The manager shall be fully accountable for the operation of the establishment as it pertains to the laws and regulations governing the practice of funeral services, to include but not be limited to:

1. Maintenance of the facility within standards established in this chapter;

2. Retention of reports and documents as prescribed by the board in 18VAC65-20-700 during the period in which he serves as manager of record; and

3. Reporting to the board of any changes in information as required by 18VAC65-20-60.

Part IV
Registration

18VAC65-20-400. Registration of surface transportation and removal services.

All persons applying to own or operate a surface transportation and removal service, according to requirements of § 54.1-2819 of the Code of Virginia, shall submit an application package for registration which shall include:

1. A completed and signed application;

2. The fee prescribed in 18VAC65-20-70 A 3; and

3. Additional documentation as may be required by the board to determine eligibility of the applicant, including, but not limited to, evidence of training in the requirements compliance with standards of the Occupational Safety and Health Administration (OSHA) for universal precautions and blood-borne pathogens.

18VAC65-20-435. Registration of crematories.

A. At least 30 days prior to opening a crematory, any person intending to own or operate a crematory shall apply for registration with the board by submitting a completed application and fee as prescribed in 18VAC65-20-70. The name of the individual designated by the ownership to be the crematory manager shall be included on the application. The owner of the crematory shall not abridge the authority of the crematory manager relating to compliance with the laws governing the practice of funeral services and regulations of the board.

B. Every crematory, regardless of how owned, shall have a manager who has (i) achieved certification by the Cremation Association of North America (CANA); the International Cemetery, Cremation and Funeral Association (ICCFA); or other certification recognized by the board and (ii) received training in compliance with requirements standards of the Occupational Health and Safety Administration (OSHA) for universal precautions and blood-borne pathogens. Every crematory manager registered by the board prior to July 8, 2009, shall have one year from that date to obtain such certification.

C. The manager shall be fully accountable for the operation of the crematory as it pertains to the laws and regulations governing the practice of funeral services, to include but not be limited to:

1. Maintenance of the facility within standards established in this chapter;

2. Retention of reports and documents as prescribed by the board in 18VAC65-20-436 during the period in which he serves as crematory manager; and

3. Reporting to the board of any changes in information as required by 18VAC65-20-60.

D. All persons who operate the retort in a crematory shall have certification by the Cremation Association of North America (CANA); the International Cemetery, Cremation and Funeral Association (ICCFA); or other certification recognized by the board. Every operator in a crematory registered by the board prior to July 8, 2009, shall have one year from that date to obtain such certification. Persons receiving training toward certification to operate a retort shall be allowed to work under the supervision of an operator who holds certification for a period not to exceed six months.

E. A crematory providing cremation services directly to the public shall also be licensed as a funeral service establishment or shall be a branch of a licensed establishment.

F. The board may take disciplinary action against a crematory registration for a violation of § 54.1-2818.1 of the Code of Virginia or for the inappropriate handling of dead human bodies or cremains.

18VAC65-20-436. Standards for registered crematories or funeral establishments that operate a crematory relating to cremation.

A. Authorization to cremate.

1. In accordance with § 54.1-2818.1 of the Code of Virginia, a crematory shall require a cremation authorization form executed in person or electronically in a manner that provides a copy of an original signature of the next-of-kin or his representative, who may be any person designated to make arrangements for the decedent's burial or the disposition of his remains pursuant to § 54.1-2825 of the Code of Virginia; an agent named in an advance directive pursuant to § 54.1-2984; or a sheriff, upon court order, if no next-of-kin, designated person, or agent is available.

2. The cremation authorization form shall include an attestation of visual identification of the deceased from a viewing of the remains or a photograph signed by the person making the identification. The identification attestation shall either be given on the cremation authorization form or on an identification form attached to the cremation authorization form.

3. In the event visual identification is not feasible, a crematory may use other positive identification of the deceased as a prerequisite for cremation pursuant to § 54.1-2818.1 of the Code of Virginia.

B. Standards for cremation. The following standards shall be required for every crematory:

1. Every crematory shall provide evidence at the time of an inspection of a permit to operate issued by the Department of Environmental Quality (DEQ).

2. A crematory shall not knowingly cremate a body with a pacemaker, defibrillator or other potentially hazardous implant in place.

3. A crematory shall not cremate the human remains of more than one person simultaneously in the same retort, unless the crematory has received specific written authorization to do so from the person signing the cremation authorization form.

4. A crematory shall not cremate nonhuman remains in a retort permitted by DEQ for cremation of human remains.

5. Whenever a crematory is unable to cremate the remains within 24 hours upon taking custody thereof, the crematory shall maintain the remains in refrigeration at approximately 40° Fahrenheit or less, unless the remains have been embalmed.

C. Handling of human remains.

1. Human remains shall be transported to a crematory in a cremation container and shall not be removed from the container unless the crematory has been provided with written instructions to the contrary by the person who signed the authorization form. A cremation container shall substantially meet all the following standards:

a. Be composed of readily combustible materials suitable for cremation;

b. Be able to be closed in order to provide complete covering for the human remains;

c. Be resistant to leakage or spillage; and

d. Be rigid enough for handling with ease.

2. No crematory shall require that human remains be placed in a casket before cremation nor shall it require that the cremains be placed in a cremation urn, cremation vault or receptacle designed to permanently encase the cremains after cremation. Cremated remains shall be placed in a plastic bag inside a rigid container provided by the crematory or by the next-of-kin for return to the funeral establishment or to the next-of-kin. If cremated remains are placed in a biodegradable container, a biodegradable bag shall be used. If placed in a container designed for scattering, the cremated remains may be placed directly into the container if the next-of-kin so authorized in writing.

3. The identification of the decedent shall be physically attached to the remains and appropriate identification placed on the exterior of the cremation container. The crematory operator shall verify the identification on the remains with the identification attached to the cremation container and with the identification attached to the cremation authorization. The crematory operator shall also verify the identification of the cremains and place evidence of such verification in the cremation record.

D. Recordkeeping. A crematory shall maintain the records of cremation for a period of three years from the date of the cremation that indicate the name of the decedent, the date and time of the receipt of the body, and the date and time of the cremation and shall include:

1. The cremation authorization form signed by the person authorized by law to dispose of the remains and the form on which the next-of-kin or the person authorized by § 54.1-2818.1 of the Code of Virginia to make the identification has made a visual identification of the deceased or evidence of positive identification if visual identification is not feasible;

2. The permission form from the medical examiner;

3. The DEQ permit number of the retort used for the cremation and the name of the retort operator; and

4. The form verifying the release of the cremains, including date and time of release, the name of the person and the entity to whom the cremains were released and the name of the decedent.

18VAC65-20-580. Preparation room equipment.

The preparation room or rooms shall be equipped with:

1. A ventilation system which operates and is appropriate to the size and function of the room;

2. Running hot and cold water;

3. Flush or slop sink connected with public sewer or with septic tank where no public sewer is available;

4. Metal, fiberglass or porcelain morgue table;

5. Covered waste container;

6. Instruments and apparatus for the embalming process;

7. A means or method for the sterilization of reusable instruments by chemical bath or soak; autoclave (steam); or ultraviolet light;

8. Disinfectants and antiseptic solutions;

9. Clean gowns or aprons, preferably impervious to water;

10. Rubber gloves for each embalmer or intern using the room;

11. An electric aspirator or hydroaspirator equipped with a vacuum breaker;

12. An eye wash station that is readily accessible; and

13. A standard first aid kit, which is immediately accessible, either in the preparation room or outside the door to the preparation room.