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Home My WebLink AboutCOM 0771.048 2020-2022 P/GRNRMC, Doi l(1 coMM.711 In Strong Support of Bill 167, AN ORDINANCE AMENDING CHAPTER 14 OF THE HAWAII COUNTY CODE 1983 (2016 EDITION, AS AMENDED), BY ADDING A NEW ARTICLE RELATING TO PROHIBITION OF NON-MINERAL SUNSCREEAI. Joe DiNardo — Toxicologist 6. May 12, 2022 ..,`_ . Dear Chair Rebecca Villegas, Co-Chair Heather Kimball,and members of the Committee on Climate esilieii & Natural Management I would like to thank the Committee on Climate Resilience & Natural Management for the opportunity to comment on this very important environmental and human health bill relating to non-mineral sunscreens (organic sunscreen actives).The following comments are based on my experience with product development, regulatory compliance as well as pre-clinical and clinical safety testing with some environmental testing of Over- the-Counter sunscreen actives and formulations dating back to 1976. After review of hundreds of scientific papers currently in the literature as well as authoring/co-authoring 11 publications on the topic of sunscreen toxicity, the toxicological impact of organic sunscreen actives (which have been removed from the FDA's Generally Recognized As Safe& Effective or GRASE list in 2019—see below) is clear.These substances are not only reported to cause irritant/allergic contact dermatitis in humans, but have been associated with numerous types of toxicological adverse reactions including reproductive and carcinogenic effects in humans as well as in aquatic and terrestrial species. Additionally, it is important to note that the current US Food, Drug and Cosmetic Law states that it is industry's responsibility to demonstrate that these chemicals/products are "safe and effective for human use" and it is not the responsibility of citizen's or the government to demonstrate these concerns.To date it is unclear if industry has conducted or is even thinking of conducting such studies; in fact, the only thing that industry has appeared to do is disagree with the data and successfully lobby congress to fund the Environmental Protection Agency(EPA) to fund the National Academy of Sciences (NAS) to review the available data with a panel consisting of mainly industry supporters. FDA is responsible for Human Health &Safety and NOAA is responsible for U.S. National Marine Sanctuaries; the EPA and/or NAS have no jurisdiction directly related to sunscreen regulations for humans or environmental impact to protected coral reefs. FDA's Official View: As published by FDA in the February 26, 2019 Federal Register(https://www.govinfo.gov/content/pkg/FR-2019- 02-26/odf/2019-03019.pdf): Because the public record does not currently contain sufficient data to support positive GRASE determinations for cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate 0, sulisobenzone, oxybenzone, or avobenzone, we are proposing that these ingredients are Category Ill. For example, the available literature includes studies indicating that oxybenzone is absorbed through the skin to a greater extent than previously understood and can lead to significant systemic exposure, as well as data showing the presence of oxybenzone in human breast milk, amniotic fluid, urine, and blood plasma. The significant systemic availability of oxybenzone, coupled with a lack of data evaluating the full extent of its absorption potential, is a concern, among other reasons, because of questions raised in the published literature regarding the potential for endocrine activity in connection with systemic oxybenzone exposure. Nearly all of these sunscreen active ingredients also have limited or no data characterizing their absorption. Comm. No. -111.141 Ref. To: P f c1244 ono Ref. Date MAY 1 7 2022 Additionally, FDA published a "Fact Sheet" outlining the specific concerns/changes needed for industry compliance (https://www.fda.Pov/media/124655/download): On February 21, 2019, FDA issued a proposed rule describing the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective(GRASE) and not misbranded. This action is an important example of FDA's ongoing efforts to ensure that sunscreens are safe and effective for regular, life-long use. The agency anticipates these changes will improve the quality, safety, and efficacy of sunscreens Americans use every day. FDA will continue to work with industry and public health stakeholders to make sure that consumers have access to safe and effective sunscreens. 1.Proposed GRASE Status of Active Ingredients Listed in the Stayed 1999 Final Monograph FDA has proposed the following categories for the 16 sunscreen monograph ingredients. GRASE*for use in sunscreens Not GRASE**for use in sunscreens ***Insufficient data for use in sunscreens Zinc oxide and titanium dioxide Aminobenzoic acid(PABA)and Cinoxate,dioxybenzone, trolamine salicylate ensulizole,homosalate, meradimate,octinoxate, octisalate,octocrylene,padimate 0,sulisobenzone,oxybenzone, avobenzone *GRASE=Generally Recognized as Safe and Effective**These ingredients are not currently marketed. ***For those ingredients in the"insufficient data" category,FDA proposes that it needs additional data to determine that sunscreens with these ingredients would be GRASE. National Oceanic and Atmospheric Administration (NOAA)Official View - https://oceanservice.noaa.gov/news/sunscreen-corals.html: Common chemicals used in thousands of products to protect against harmful effects of ultraviolet light threaten corals and other marine life. SUNSCREEN CHEMICALS AND MARINE LIFE How sunscreen chemicals enter our environment: �I re-eI 2 CLC.. .� Z...� , lrurGln unvxc Ta�� c ea l•'4S y� How sunscreen chemicals can affect marine life: .7.4.#114 _ '' Chemlrals In some sunscreens GREEN ALGAE+`TsVs-Sg' 11 j;,- COR4I .... k `T �?nT1 jMUssELs #:�K-t that ran harm marine life: k „dp • I •3-Banryhdena camphor �t`t - eW o ren P �'� tAtiviv� � � •a-Methyltrentylldone a �.y nL 3 42 r"'A. 'ti• `' �,-T S�k`"��; 3' camphor a„":6 i{t,?'ti�� $� "1`.� '-` <.s•sr ,.Y h r3 �=Pt •Octocrylene �e(l;,'A+ a` ' _- •Benzophenone I a A o •- ¢ cf '�'�" ► .Ben[ophenone-B a •oo-paen %_ •nanortamom le.me - `" •n.nnz�ne alae Q�,1Cnndamage PED Can decrease fertility and p p g Can accumulate In tissues and •ocnno*ate Immune and reproductive reproduction,and cause female be transferred to young. o rhe^zpne systems,and deform young. characteristics in male fish. Here are a few ways to protect ourselves and marine life: Consider sunscreen withoutchemicals that can harm marine life,seek shade between 10 am&2 pm,and use Ultraviotet'Protection Factor(UPF)sunwear. 410 Seek shade Umbrella Sun'hat Sunscreen UV Sun glasses Sun shirt Leggings _• ' ISI sap.251s oceansertice.noaa.govfsunscreen Mahalo for your efforts to protect your citizens, the environment and the reefs! References:The following list of references support the toxicity of the various organic sunscreen actives currently removed from the GRASE Category I list that are currently under FDA scrutiny. 1) C.A. Downs, Elizabeth Bishop, M. Silvia Diaz Cruz, S. Abbas Haghshenas, Didier Stien,Alice M.S.Rodriguese, Cheryl M.Woodley, Adria Sunyer-Caldu, Shadan Nasseri Doust, William Espero, Gene Ward, Aref Farhangmehr, S. Maryam Tabatabaee Samimi, Michael J. Risk, Philippe Lebarone,Joseph DiNardo. Oxybenzone contamination from sunscreen pollution and its ecological threat to Hanauma Bay, Oahu, Hawaii, U.S.A. In Press Journal Pre- proof Available at https://www.sciencedirect.com/science/article/abs/pii/S004565352103352X 2) Downs CA, DiNardo JC, Stien D, Rodrigues AMS, Lebaron P. Correspondence: Response to the Letter to the Editor by Dr. Christian Surber. Chem Res Toxicol. 2021 Aug 11. doi:10.1021/acs.chemrestox.1c00217. 3) DiNardo JC, Downs CA. Failure to Protect: Do Sunscreens Prevent Skin Cancer in Humans?Toxicol: Open Access 2021, 7:3-8 Available at https://www.omicsonline.org/open-access/failure-to-protect-do-sunscreens-prevent-skin-cancer-in-humans.pdf 4) Downs CA, DiNardo JC, Stien D, Rodrigues AMS, Lebaron P. Benzophenone accumulates over time from the degradation of octocrylene in commercial sunscreen products. Chem. Res.Toxicol. 2021, 34, 4, 1046-1054. DOI: 10.1021/acs.chemrestox.0c00461 5) DiNardo JC, Downs CA. Fall from GRASE:The Sunsetting of the Sunscreen Innovation Act. American Journal of Dermatological Research and Reviews. 2021, 4:39. DOI: 10.28933/ajodrr-2020-12-2805. Available at httqs://escipub.com/Articles/AJODRIVAJODRR-2020-12-2805.pdf 6) DiNardo,J.C. Correspondence: Letter to the Editor regarding "The banned sunscreen ingredients and their impact on human health: a systematic review". Int J Dermatol. August 15, 2020,60:e19 https://doi.org/10.1111/ijd.15087 7) DiNardo,J.C. and Downs, C.A.; Should a Toxicological Risk Assessment of Ubiquitous Chemicals Be Done Using Data From Only One Source of Exposure? Open Acc J of Toxicol. 2020; 4(2):555633. 001: 10.19080/OAJT.2020.04.555633. Available at https://iuniperpublishers.com/oait/pdf/OAJT.MS.ID.555633.pdf 8) DiNardo,J.C. and Downs, C.A.; Why Evaluate the Sunscreen Active Oxybenzone (Benzophenone-3) for Carcinogenicity and Reproductive Toxicology or Consider it Unsafe for Human Use? Dermatol Res 2019; 1:1-3. Available at http://scivisionpub.com/pdfs/why-evaluate-the-sunscreen-active-oxybenzone-benzophenone3-for- carcinogenicity-and-reproductive-toxicology-or-consider-it-unsafe-f-932.pdf 9) DiNardo,J.C. and Downs, C.A.; Can Oxybenzone Cause Hirschsprung's Disease? Reprod Toxicol. 2019 Jun;86:98-100. doi: 10.1016/j.reprotox.2019.02.014. P 10) DiNardo,J.C. and Downs, C.A.; Should We Use Products Containing Chemical UV Absorbing Sunscreen Actives on Children? Clin Dermatol Res J 2019, 4:1-2. https://www.scitechnol.com/peer-review/should-we-use-products- containing-chemical-uv-absorbing-sunscreen-actives-on-children-YOcB.php?article id=9314 11) DiNardo,J.C. and Downs, C.A.; Dermatological And Environmental Toxicological Impact Of The Sunscreen Ingredient Oxybenzone (Benzophenone-3).J Cosmet Dermatol, 2018 Feb;17(1):15-19. FDA and National Toxicology Program Communications: 12) FDA-1978-N-0018-15832 Comments on Proposed 2019/2021 Sunscreen monograph (November 11, 2021) https://www.regulations.gov/comment/FDA-1978-N-0018-15832 13) FDA-2021-P-0985 (September 9, 2021) HI, CA, FL and VI Citizen Petition on 3 Toxic O's https://www.regulations.gov/search?filter=FDA-2021-P-0985 14) FDA-2021-P-0508-0001 Remove Octocrylene Products from Store Shelves Petition (August 5, 2021): https://www.requlations.gov/document/FDA-2021-P-0508-0001 15) FDA-2021-P-0680-0001 Remove Octocrylene from Category III to CategoryII Petition (June 3, 2021): https://www.regulations.gov/document/FDA-2021-P-0680-0001 16) FDA-2020-P-1297 SPF 30+ Petition (April 17, 2020): https://www.requlations.gov/search?filter=FDA-2020-P-1297 17) FDA-1978-N-0018-1508(April 5, 2019)—Toxicological Review(350—400 references noted) ... https://www.requlations.gov/search/comment?filter=FDA-1978-N-0018-1508 18) FDA-1978-N-0018-1081 (March 11, 2019)—General Sunscreen Comments(29 references noted) ... https://www.requlations.gov/search/comment?filter=FDA-1978-N-0018-1081 19) National Toxicology Program (NOVEMBER 19, 2019)—Carcinogenicity Testing on Oxybenzone httos://ntp.niehs.nih.gov/ntp/about ntp/trpanel/2019/december/publiccomm/dinardo20191119 trprp 508.pdf 20) National Toxicology Program (September 21, 2021)—Modified One-Generation Reproductive Toxicity Testing on Oxybenzone https://ntp.niehs.nih.gov/ntp/about ntp/trpanel/2021/october/publiccomm/dinardo oxvbenzone20210928 trp rp 508.pdf 21) National Toxicology Program (September 21, 2021)—Modified One-Generation Reproductive Toxicity Testing on Octinoxate https://ntp.niehs.nih.gov/ntp/about ntp/trpanel/2021/october/publiccomm/dinardo octinoxate20210928 trprp 508.pdf