PREPROPOSAL STATEMENT OF INQUIRY
STATE BOARD OF HEALTH
[Filed May 6, 2020, 11:03 a.m.]
Subject of Possible Rule Making: WAC 246-80-021 Prohibition vitamin E acetate, the state board of health (board) is considering permanently adopting existing emergency rules to 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.
Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 43.20.050
Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: 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 multi-state 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 US 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 considering adopting a permanent ban of vitamin E acetate in vapor products.
Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: Department of health and the liquor and cannabis board will be invited to participate in rule making to assure coordination across agencies.
Process for Developing New Rule: The board will use a collaborative rule-making approach. The board will work with partner health and regulatory agencies in drafting the rule and will reach out to stakeholders for additional input. The board will keep stakeholders and interested parties informed of the rule making through email, the board's listserv and rule-making website, and notices in the Washington State Register. Stakeholders and interested parties will have opportunity to provide comments throughout the rule-making process, including informal review of the draft rule, formal review and comment on the proposed rule, and at the board's public hearing.
Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Samantha Pskowski, P.O. Box 47990, Olympia, WA 98504-7990, phone 306-789-2358, TTY 711, email email@example.com, website sboh.wa.gov.
Additional comments: To be added to the listserv for this rule making email Samantha.Pskowski@sboh.wa.gov with the subject line "Vitamin E Acetate - Subscribe." For more information please view the website at https://sboh.wa.gov/Rulemaking/CurrentRulesandActivity/VaporProductsandFlavors.
May 6, 2020
Michelle A. Davis