The Food and Drug Administration is launching a process to prepare an environmental impact statement (EIS) regarding the use oxybenzone and octinoxate in over-the-counter sunscreen products.
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According to the “Intent to Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-The-Counter Use,” which was published in the Federal Register on May 13, 2021, the FDA will prepare an EIS “when data or information in an environmental assessment or otherwise available to the Agency leads to a finding that the proposed agency action may significantly affect the quality of the human environment.” The first step in this effort involves a “public scoping process” to evaluate any potential environmental impacts associated with the use of oxybenzone and octinoxate in sunscreens so that an EIS, if required, “can be completed prior to issuance of a final sunscreen order addressing sunscreens containing these ingredients.”
The American Academy of Dermatology Association weighed in on the FDA’s announcement, noting that it “appreciates the efforts of the agency to thoroughly examine all relevant science before issuing a final sunscreen order on these ingredients,” according to a statement released by the AADA on May 13, 2021.
The statement added: “Skin cancer is the most common cancer in the U.S., and unprotected exposure to the sun’s harmful ultraviolet rays is a major risk factor. The AADA continues to focus on encouraging members of the public to protect themselves by seeking shade, wearing protective clothing – including a lightweight and long-sleeved shirt, pants, a wide-brimmed hat and sunglasses – and applying a broad-spectrum sunscreen with an SPF of 30 or higher to all exposed skin.”
According to the FDA document, a series of developments regarding oxybenzone and octinoxate prompted the agency to take this step, including comments the agency received in response to the 2019 proposed rule titled “Sunscreen Drug Products for Over-The-Counter Human Use,” which raised concern about the potential effects of the two ingredients on coral and/or coral reefs, as well as research efforts by the National Oceanic and Atmospheric Administration Coral Reef Conservation Programs on the potential impacts of sunscreen products that include oxybenzone and octinoxate on coral reefs and other aquatic systems. Hawaii’s 2018 state law prohibiting the sale, offer of sale, and distribution of sunscreens that contain oxybenzone and/or octinoxate also influenced the agency’s decision to further evaluate the topic.
“The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including potential alternatives and the extent to which those issues and impacts will be analyzed,” the FDA document states. “At this initial stage of the scoping process, we have identified the following four alternatives: FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA [new drug application] is impermissible; FDA will conclude that the inclusion of oxybenzone and octinoxate in sunscreens marketed without an NDA is permissible; FDA will conclude that inclusion of oxybenzone in sunscreens marketed without an NDA is permissible but that the inclusion of octinoxate in sunscreens marketed without an NDA is impermissible; or FDA will conclude that inclusion of octinoxate in sunscreens marketed without an NDA is permissible but that the inclusion of oxybenzone in sunscreens marketed without an NDA is impermissible.”
Until June 14, the FDA is accepting comments from the public electronically via the Federal eRulemaking Portal at www.regulations.gov (search for Docket No. FDA-2021-N-0352) or by mail to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Md., 20852. Refer to Docket No. FDA-2021-N-0352.