WSR 20-18-012

PROPOSED RULES

STATE BOARD OF HEALTH

[Filed August 21, 2020, 1:25 p.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 20-10-113.

Title of Rule and Other Identifying Information: WAC 246-80-021 Prohibition—Vitamin E acetate, the state board of health is proposing rules to permanently adopt existing emergency rules which ban the sale of vapor products containing vitamin E acetate. This applies to the sale, offer for sale, or possession with intent to sell or offer for sale vapor products containing vitamin E acetate at any location or by means including by telephone or other method of voice transmission, the mail or any other delivery service or the internet or other online service.

Hearing Location(s): On October 13, 2020, at 2:30 p.m.

In response to the coronavirus disease 2019 (COVID-19) public health emergency, the state board of health 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 meeting 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 public comment and rules hearing segments.

1. To access the meeting online and register https://attendee.gotowebinar.com/register/4735583794817723406.

2. You can also dial-in and listen/observe only using your phone: Call in: +1 (562) 247-8422; Access Code: 521-354-641.

Date of Intended Adoption: October 13, 2020.

Submit Written Comments to: Samantha Pskowski, P.O. Box 47990, Olympia, WA 98504-7990, email https://fortress.wa.gov/doh/policyreview, by October 1, 2020.

Assistance for Persons with Disabilities: Contact Samantha Pskowski, phone 360-789-2358, TTY 711, email samantha.pskowski@sboh.wa.gov, by October 6, 2020.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of this proposal is to create a new section of rule to prohibit the inclusion of vitamin E acetate in vapor products. This proposal would make permanent an existing emergency rule that prohibits the sale of vapor products containing vitamin E actetate [acetate]. This includes the sale, offer for sale, or possession with intent to sell or offer for sale vapor products containing vitamin E acetate at any location or by means including telephone or other method of voice transmission, the mail or other delivery service, or the internet or other online service.

Reasons Supporting Proposal: In July 2019, the United States Centers for Disease Control and Prevention (CDC), United States Food and Drug Administration (FDA), state and local health departments, and other clinical and public health partners began investigating outbreaks of e-cigarette or vaping associated lung injury (EVALI). In September 2019, the CDC activated its Emergency Operations Center to aid in the investigation of the multistate outbreak. As of its final update on February 18, 2020, the CDC has identified two thousand eight hundred seven confirmed cases reported across fifty states, the District of Columbia, Puerto Rico and the United States Virgin Islands, including sixty-eight deaths confirmed in twenty-nine states and the District of Columbia. Twenty-seven cases of EVALI, including two deaths, have been reported in Washington state.

As part of the investigation into the multistate outbreak of EVALI, the CDC conducted laboratory tests of forty-eight samples of fluid collected from the lungs of patients with vaping-associated lung disease from ten states. An article released on November 8, 2019, showed that all of the samples contained vitamin E acetate, providing direct evidence of vitamin E acetate at the primary site of injury in the lungs. Vitamin E acetate is a chemical that is used as an additive or thickening ingredient in vapor products. The CDC has not determined that vitamin E acetate is present in only THC vapor products or only non-THC vapor products. THC was identified in eighty-two percent of the samples, and nicotine was identified in sixty-two percent of the samples. A further study found ninety-four percent of EVALI patients tested had vitamin E acetate in the bronchoalveloar lavage but no samples from a health comparison group indicated evidence of vitamin E. Two samples showed presence of other toxicants (one each) in the EVALI group but did not provide sufficient evidence to identify another toxicant as the source of disease. The CDC has identified vitamin E acetate as a chemical strongly linked to EVALI and recommends that vitamin E acetate not be added to vapor products.

Based on these findings, the board is proposing to adopt rules that institute a permanent ban of vitamin E acetate in vapor products.

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

Statute Being Implemented: RCW 43.20.050 (2)(f).

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

Name of Proponent: Washington state board of health, governmental.

Name of Agency Personnel Responsible for Drafting: Samantha Pskowski, 101 Israel Road S.E., Tumwater, WA 98504-7990, 360-789-2358; Implementation and Enforcement: Justin Nordhorn, 1025 Union Avenue S.E., Olympia, WA 98504, 360-664-1726.

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 not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. The cost threshold for the industry of beverage and tobacco product manufacturing and miscellaneous store retailers is $5,641.52 and $2,503.84 respectively.

The cost of removing vitamin E acetate from vapor products has been determined to be $0.27 per 5mL of product. The thickening agent is used in some vapor products and is not considered to be an essential product.

Cost of thickening agent per product = Total cost of total thickening agent.

Total thickening agent/(Total volume of product * amount of thickening agent per product).

To estimate the total cost to industry, an estimate of the total product sold is needed. Given the lack of publicly available information on the vapor product industry, an estimate was calculated using other available information. The Washington state department of revenue estimated revenue of $19 million from the state's vapor product tax. The tax is structured as a $0.27/mL for pod devices under 5 mL and $0.09 for products over 5 mL. Assuming fifty percent of revenue comes from pod devices and fifty percent from products of 5 mL, it can be estimated that there will be 28,148,148 products of 5 mL sold annually. Therefore, the total cost of the rule would be $7,599,999. We do not have a way of knowing the distribution of this cost across individual retailers, so therefore the cost of the rule spread evenly among all licensed vapor product retailers would be an estimated $1,900 per establishment.

Therefore, the average cost of the rule per establishment does not exceed the average cost threshold for the industry and does not require a small business economic impact statement.

August 21, 2020

Michelle A. Davis

Executive Director