WSR 20-19-144

PROPOSED RULES

STATE BOARD OF HEALTH

[Filed September 23, 2020, 10:51 a.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 20-07-055.

Title of Rule and Other Identifying Information: Chapter 246-500 WAC, Handling of human remains, the state board of health (board) is considering rules regarding final disposition of human remains through alkaline hydrolysis and natural organic reduction. The board may also consider other updates as needed.

Hearing Location(s): On November 9, 2020, at 10:45 a.m. In response to the coronavirus disease 2019 (COVID-19) public health emergency, the state board of health (SBOH) will not provide a physical location for this hearing to promote social distancing and the safety of the citizens of Washington state. A virtual public hearing, without a physical space, will be held instead. Board members, presenters, and staff will all participate remotely. The public may login using a computer or device, or call-in using a phone to listen to the meeting through the GoToWebinar application. The public may submit verbal comments during the specified rules hearing segment. Link: https://attendee.gotowebinar.com/register/5079916753476116752. You can also dial-in and listen/observe only using your phone: Dial-in: +1 (415) 665-0052, Access Code: 369-072-375.

Date of Intended Adoption: November 9, 2020.

Submit Written Comments to: Samantha Pskowski, P.O. Box 47990, Olympia, WA 98504-7990, email https://fortress.wa.gov/doh/policyreview, by October 28, 2020.

Assistance for Persons with Disabilities: Contact Samantha Pskowski, phone 360-789-2358, TTY 711, email samantha.pskowski@sboh.wa.gov, by November 5, 2020.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of this proposal is to incorporate new methods for the final disposition of human remains into existing rules around the handling of human remains. The legislature authorized ESSB 5001 (chapter 432, Laws of 2019) which allows for alkaline hydrolysis and natural organic reduction as allowable methods of final disposition. The proposed rule incorporates these new methods into existing requirements for the handling of human remains and new requirements specific to these methods of disposition to prevent and control health hazards.

Reasons Supporting Proposal: On May 1, 2020, ESSB 5001 went into effect which legalizes two new disposition methods for human remains; alkaline hydrolysis and natural organic reduction. Alkaline hydrolysis is a chemical process which breaks down human remains to bone and liquid components, similar to traditional cremation. The resultant remains are similar to that of traditional cremation. Natural organic reduction is the process of naturally reducing the human body in a contained, accelerated process. Washington, upon enactment of this law, became the first state in the country and first place in the world to authorize this disposition for human remains.

The board's current rules identify requirements for the handling of human remains, requirements for refrigeration and other allowable activities, and specific requirements related to remains following cremation. The current rules do not include alkaline hydrolysis or natural organic reduction as allowable activities. In addition, due to the uniqueness of natural organic reduction and alkaline hydrolysis, the proposed rule incorporates requirements specific to each disposition method.

Based on these reasons, the board is proposing to adopt rules that incorporate alkaline hydrolysis and natural organic reduction into existing rules regarding the handling of human remains.

Statutory Authority for Adoption: RCW 43.20.050 (2)(f).

Statute Being Implemented: RCW 43.20.050 (2)(f); chapter 68.05 RCW.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: SBOH, governmental.

Name of Agency Personnel Responsible for Drafting and Implementation: Samantha Pskowski, 101 Israel Road S.E., Tumwater, WA 98504-7990, 360-789-2358; Enforcement: Funeral and Cemetery Board, 405 Black Lake Boulevard S.W., Olympia, WA 98502, 360-664-1555.

A school district fiscal impact statement is not required under RCW 28A.305.135.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Samantha Pskowski, P.O. Box 47990, Olympia, WA 98504-7990, phone 360-789-2358, TTY 711, email samantha.pskowski@sboh.wa.gov.

The proposed rule does impose more-than-minor costs on businesses.

Small Business Economic Impact Statement

1. Description of the proposed rule, including: A brief history of the issue; an explanation of why the proposed rule is needed; and a brief description of the probable compliance requirements and the kinds of professional services that a small business is likely to need in order to comply with the proposed rule.

The proposed rule incorporates two new methods of disposition for human remains into the board's existing rules for the handling of human remains. Natural organic reduction and alkaline hydrolysis were approved by the legislature during the 2019 regular session in ESSB 5001 as authorized methods for the disposition of human remains. The board's current rule requires updating to include these new methods and address specific health and safety concerns related to each.

The proposed rule updates definitions by including new definitions for alkaline hydrolysis, natural organic reduction, effluent reduction, and reduction facility operator, as well as amending the definition of human remains to incorporate remains after new processes.

The proposed rule seeks to expand the instances when barrier precautions are required by expanding to include when there is potential contact with hazardous chemicals, dust, or other potentially hazardous materials. Currently, these are only required when contact with blood, body fluids, or internal tissue of the deceased is likely. In addition, the proposed rule would require precautions to prevent injuries by chemicals and allow a sewage system approved by the local health officer or department to be used for the disposal of effluent, a byproduct of alkaline hydrolysis.

The proposed rule seeks to make changes to the activities for which an embalmer may delay refrigeration of human remains. This includes adding hydrolyzing and reduction by natural organic reduction as allowable activities. Additionally, the proposed rule removes an allowable activity, viewing for up to one hour for identification, which has caused confusion among the industry and contradicts with another allowable activity (i.e., viewing for a period of time not to exceed twenty-four hours). The proposed rule also prohibits certain activities when the remains are confirmed or suspected to suffer from defined contagious diseases, including those identified by the local health officer or medical examiner, or have been treated with certain medication within a defined period of time.

The proposed rule incorporates alkaline hydrolysis by creating a new section that outlines requirements for the vessel used in the process. Alkaline hydrolysis can be completed using a vessel with high temperatures and pressure or low temperatures and atmospheric pressure; the proposed rule requires a high temperature vessel to reach a minimum temperature of 250 degrees Fahrenheit for a minimum of thirty minutes. Operators who choose to use low temperature vessels must have documentation that a third-party has conducted a validation study and results prove that the process destroys pathogens, including prions, in both the airspace and water.

In addition to incorporating specific alkaline hydrolysis requirements, the proposed rule also outlines specific requirements for natural organic reduction. Natural organic reduction facilities would be required under the proposed rule to sample the final product of the reduction process according to test methods developed by the United States Composting Council and conduct testing according to a prescribed schedule for fecal coliform or Salmonella, arsenic, cadmium, copper, lead, mercury, molybdenum, nickel, selenium, and zinc. Facilities would also be required to test for physical contaminants in all instances of natural organic reduction. Facilities would be required under the proposed rule to maintain an annual report of all testing and provide it upon request. Testing would require businesses to obtain third-party testing of reduced human remains or to obtain the equipment and licensure for in-house laboratory services.

The proposed rule also incorporates into requirements for both human remains following alkaline hydrolysis and natural organic reduction, authority for the local registrar to issue a burial-transit permit in addition to issuance of the permit for remains that have been unclaimed for ninety or more days. This change maintains consistency with existing language regulating cremated human remains.

2. Businesses required to comply with the proposed rule using the North American Industry Classification System (NAICS) codes and what the minor cost thresholds [are].

NAICS Code: 812220

NAICS Business Description: Cemeteries and crematories

# of businesses in WA: 72

Minor Cost Threshold = 1% of Average Annual Payroll: $2,088.31

Minor Cost Threshold = .3% of Average Annual Receipts: $2,442.02

NAICS Code: 81221

NAICS Business Description: Funeral homes and funeral services

# of businesses in WA: 113

Minor Cost Threshold = 1% of Average Annual Payroll: $3,532.16

Minor Cost Threshold = .3% of Average Annual Receipts: $3,366.12

3. Analysis of the probable cost of compliance, identifying the probable costs to comply with the proposed rule, including: Cost of equipment, supplies, labor, professional services and increased administrative costs; and whether compliance with the proposed rule will cause businesses to lose sales or revenue.

Alkaline Hydrolysis: The required test under this proposed rule is estimated to cost between $16,000 and $20,000. This requirement has the potential to be an additional cost to either a manufacturer who wants to sell equipment in Washington State or an operator who wants to use a model that has not previously been validated. Under the proposed rule, once validated, the documentation can be used by any other operators using the same low-temperature alkaline hydrolysis vessel model without additional testing requirements. This proposal would require third-party validation and therefore, an operator or manufacturer would not be required to purchase any additional equipment. The cost cited above would cover a third-party validation of the equipment, including equipment, supplies, labor, and professional services. It is not anticipated that this requirement would increase administrative costs, cause businesses to lose sales or revenue.

Natural Organic Reduction: Required testing in the proposed rule includes physical contaminant testing which can be done in conjunction with existing rule through the department of licensing to sift final reduced remains. Therefore, the required test under this proposed rule does not add any additional cost as the cost has been assumed elsewhere. The proposed rule also requires testing of a total of eighty instances of natural organic reduction, including the first twenty followed by twenty-five percent of the monthly instances until the total has been reached for the following metals and other testing parameters: Fecal coliform or Salmonella, arsenic, cadmium, lead, mercury, selenium.

The estimated cost for these tests is $60 for the fecal coliform, $175 for the Salmonella test, and $126 for a combined metals test. Testing requirements would phase out, for purposes of this analysis it is assumed that due to this, facilities would not operate their own testing labs.

The cost of the proposed testing is estimated to be approximately $186 per sample and therefore, testing on the required schedule is estimated to cost $12,276.

4. Analysis of whether the proposed rule may impose more than minor costs on businesses in the industry. Currently, there are no alkaline hydrolysis or natural organic reduction facilities in Washington state, however, based on outreach to prospective businesses, at the time of this writing there are anticipated to be one alkaline hydrolysis facility and three natural organic reduction facilities. The prospective alkaline hydrolysis facility has not indicated if the intention is to utilize a high- or low-temperature system. Therefore, for purposes of this analysis we assume they will choose a low-temperature system and be subjected to the costs associated with this rule making.

As calculated above, the cost of complying with the rule making for an alkaline hydrolysis facility who wishes to use a low-temperature system would be between $16,000 and $20,000. This cost would be a one-time cost that could be paid by the system's manufacturer or the facility operator. In addition, this cost would be required for each system once. For example, if Manufacturer A develops and tests System A, then Operator A may use System A and Operator B may utilize System A in Washington state without these costs.

For natural organic reduction facilities, the cost of compliance with rule making is estimated to be $12,276 for each entity. Facilities would be required to complete testing for eighty instances of natural organic reduction at an estimated cost $186 per sample.

The potential total cost for an alkaline hydrolysis facility, dependent on their desired equipment is more than 1% of average annual payroll or 0.3% of average annual gross business income for the cemeteries and crematories industry and funeral homes and funeral services industry which have a minor cost estimate of $2,442.02 and $3,532.16 respectively.

5. Determination of whether the proposed rule may have a disproportionate impact on small businesses as compared to the ten percent of businesses that are the largest businesses required to comply with the proposed rule. For alkaline hydrolysis, at the time of this analysis there is only one facility anticipated to open, therefore this assessment cannot be completed.

For natural organic reduction, there is an anticipated three entities that will provide this service, none of which at this time are anticipated to meet the definition of small business (employing fewer than fifty employees). It is not expected that this rule would have a disproportionate impact on small businesses, as each business is expected to complete an identical number of tests for a prescribed list of parameters. Each natural organic reduction facility, regardless of size, is expected to have costs related to this rule making of $12,276. For lower volume facilities, this cost would be spread out over a longer period of time and higher volume facilities having a greater upfront cost. Based on survey of prospective facility operators, it is estimated that the lowest volume facility would see these costs span over approximately eight years with the highest volume facility having costs spread over approximately three years.

6. If the proposed rule has a disproportionate impact on small businesses, identify the steps taken to reduce the costs of the rule on small businesses. If the costs can not be reduced, provide a clear explanation of why. The proposed rule does not have a disproportionate impact on small businesses.

7. Description of how small businesses were involved in the development of the proposed rule. At this time, each entity that has been identified as a prospective operator of an alkaline hydrolysis or natural organic reduction facility is categorized as a small business. The board filed the CR-101 in March of 2020, announcing the exploration of rule making related to incorporating alkaline hydrolysis and natural organic reduction into existing rules on the handling of human remains. Since that time, board staff have engaged prospective business owners in Washington state as well as equipment manufacturers out-of-state to understand these new disposition methods and develop rules for the safe handling of remains. The board released for informal comment a draft in August 2020 and received written feedback from a business that has been incorporated into the proposed rule.

8. Identify the estimated number of jobs that will be created or lost as the result of compliance with the proposed rule. As a result of compliance with the proposed rule, there is no estimated job creation or loss.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Samantha Pskowski, P.O. Box 47990, Olympia, WA 98504-7990, phone 360-789-2358, TTY 711, email samantha.pskowski@sboh.wa.gov.

September 23, 2020

Michelle A. Davis

Executive Director