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HomeMy WebLinkAboutCOM 0771.051 2020-2022 p/c,RNRMG Pill ( ,7 044.11( From: Denis Dudley Sent: Sunday, May 15, 2022 6:41 AM To: Council Testimony Subject: Soluble Organic UV Filters (SOUVF) are neither safe nor effective —® Attachments: SUBMISSION in Support of BILL 167 MAY 2022.docx; °` �' Pp �- Towards_a_paradigm_shift_in_environmental_health_d.pdfr r-- Attention:Chairperson Rebecca Villegas and Committee Members. v Please consider our submission with respect to BILL 167 now before your Committee. We are far from your shores in Ontario, Canada. Yet,we consider it our duty as physicians and grand parents to advise you of the current and accurate science regarding SOUVF sunscreens. It should resonate with the public at large and your Members on the Committee on Climate Resilience& Natural Management that after 50 years the FDA cannot declare these petrochemical benzene compounds,with known pesticidal effects to be safe or effective. Permeation and bioavailability is now an established fact in humans and wildlife.Just the fact of their bioavailability to the humans, particularly the fetus and young children,should disqualify them for use. There appears to be a common pathway for toxicity to humans and the marine eco-system. First PERMEATION then HORMONE DISRUPTION, DNA mutation and genotoxicity. Coral has an epidermis similar to human skin but less complex.An unintended consequence of human use of SOUVF sunscreens is the degradation of the coral and the entire marine habitat. Your Members are busy people but I would encourage them to read the second attachment on the bioethics and principles necessary to safeguard environmental health.This landmark paper uses oxybenzone as a Case Study but the issues are true for most of the SOUVF Group, based on the endocrine principle of isoform function. Hawaiians and their Regulators should focus mainly on the public interest. "Environmental health ethics(not to be confused with environmental ethics,which does not focus principally on the health of people) represents an approach where human health stands paramount in the context of and connection with the environment, non-human species, and possibly,future human generations". (Matouskova and Vandenberg 2021). In 1991, I found oxybenzone and avobenzone in fetal blood. I have dedicated my professional life since to unmasking the facts about these pernicious chemicals, which have no demonstrable benefit after 50 years of use. Thirty years of science including the FDA studies from 2019 confirm this alarming fact. Until the FDA develops a new Sunscreen Monograph that declares 12 SOUVF to be GRASE and not " Marketed Unapproved Drugs", based on the tests that prove safety and efficacy beyond a reasonable doubt,a good place to start would be prohibition or at least a WARNING Label and a CAUTION to pregnant or nursing mothers and others who may be more at risk—young or adolescent children, and couples trying to conceive. This occurs for almost everything that is bioavailable to vulnerable groups, even low dose aspirin, many OTC agents and vitamins, and many prescription drugs. In the meantime, it falls to your Committee to protect the Keiki of Hawaii and your fragile coral reefs and pristine waters. Respectfully submitted for your consideration. Yours truly, Dr. Denis K. L. Dudley MD, FRCS(C). Mobile:613-292-8457. Comm. No. 11 t•✓I Ref. To: PIMAR-MG Ref. Date MAY 1 7 2022 To: Chairperson Rebecca Villegas,Co-Chairperson Heather Kimbal,and Committee Members, The Committee on Climate Resilience& Natural Management. IN SUPPORT of BILL 167. From: > Denis K. Dudley MD, FRCS(C), Board Certified in OB-GYN, USA, Canada, Great Britain. Sub-Specialist in Maternal Fetal Medicine and Reproductive Endocrinology. DKLD@rogers.com > Sharyn A. Laughlin MD, FRCP(C), Board Certified Dermatologist, USA & Canada. Sub-Specialist Practice in Photobiology& Laser Dermatology,slaughlin@rogers.com. Introduction:SOLUBLE Organic UV Filters(SOUVF)are a hazard to humans,wildlife,and the environment. Hawaii leads the world in confronting this pervasive hazard that is not being properly addressed by regulators and health care professionals. SOUVF are petrochemicals or linked benzene rings with side chain substitutions. Benzene is a known carcinogen and toxin to mammals. "Ethical and practical considerations should be included in decisions about the commercial, pervasive application of synthetic compounds and that the current flawed practice of cost-benefit analysis be recognized for what it is: a technocratic approach to support corporate interests" (Matouskova & Vandenberg Environmental Health 2022). Persuasive science now proves that SOUVF sunscreens DO NOT prevent cancer in the general population. The simple explanation is that even containing avobenzone,the only UVA filter in the group,they lack sufficient UVA1 protection to prevent skin cancer.Zinc oxide at 25% is an INSOLUBLE filter with the UVA protection required to prevent skin cancer(Dudley et al,Current Problems in Dermatology 2021). Most importantly, it is one of the INSOLUBLE filters that never permeate intact skin, becoming bioavailable to every cell in the human body like every SOUVF petrochemical. Without bioavailability—there is zero risk of Endocrine Nervous Disruption (END) or DNA mutations leading to a host of serious,often irreversible effects in humans and wildlife.Adverse effects of several SOUVF are well documented in the scientific literature. Despite the FDA position confirming 50 years of science that 12 SOUVF cannot be designated as Generally Regarded As Safe and Effective(GRASE), industry and their consultants still claim that there is no evidence of toxicity. One scientometric review lists 453 papers describing the reported toxicity of SOUVF (Carve et al, Science of the Total Environment 2021). No Benefit: Fifteen papers in the literature prove sunscreens have not prevented skin cancer over the past 50 years in a general population. Melanoma has tripled and keratinocyte cancers have doubled in the USA since 1970. The 5 most recent papers underscore that this "assumption" repeated daily by industry and dermatologists is without scientific merit. Even dermatologists have seen the obvious, posing the question in the Journal of the American Academy of Dermatology or JAAD 2019: "Could it be that the nearly universal recommendation of dermatologists and professional societies(e.g.,American Academy of Dermatology,World Health Organization)to use sunscreen to prevent skin cancer is unfounded?" No benefit from soluble organic UV filters after 60 years of use is demonstrable at this time. SOUVF should be prohibited for human use based on the principle of "first do no harm" due to their maleficence.There is substantial evidence of highly probable(proven beyond a reasonable doubt)or potential toxicity and adverse effects of SOUVF on humans and wildlife.Since there is NO BENEFIT, no level of risk is acceptable. Human Toxicity:Hundreds of papers in peer-reviewed literature show adverse effects from exposure to SOUVF sunscreens, including but not limited to: Perinatal complications—Miscarriages, abnormal fetal growth, preeclampsia (high BP), and the birth defects of spina bifida, and Hirschsprung's Disease. Adolescent or early adult diseases — abnormal puberty, obesity, metabolic syndrome, polycystic ovarian syndrome,thyroid disorders.Adult to older ages— obesity, diabetes,endometriosis and fibroids in women, infertility in both genders, and thyroid and prostate cancers. Environmental Toxicity: SOUVF have polluted every global water reservoir—tap water,streams, lakes, rivers, reefs, and oceans —even the Arctic. The toxicity to land and marine animals, and many organisms in our linked eco- systems is well established by hundreds of scientific publications,too numerous to be listed here. Pollution with SOUVF includes effluents and freshwaters,swimming pools and seawater,and even the open waters of the Pacific Ocean.They persist and contaminate the marine environment,including sediments, beach sand,soils and sludge that pose a risk for benthic organisms. • SOUVF are found in the tissues of natural populations of aquatic organisms : mussels, crustacean, eels, fishes, marine mammals, aquatic birds, and Franciscana dolphins from Brazil.SOUVFbioaccumulation in the food webs pose a secondary threat to humans. Even lettuce is now contaminated (Diaz-Cruz 2021) and the same group just reported the contamination of sea grass in the Mediterranean. • Many ecotoxicological studies show the widespread toxicity to numerous aquatic species. Hormonal and epigenetic effects of SOUVF have been demonstrated from in-vitro tests on human cells, numerous species of fish e.g. zebra fish, daphnia magna + many others, frogs, plankton, algae, and sea anemones. Many other toxic effects are described in wildlife and marine species, (too numerous to list here), which impact the stress level and species succession in marine phyto- and zooplankton, and endangered coastal marine species (e.g. seagrasses, bivalves, fishes, crustaceans and microorganisms) that make up the eco-system where the coral is the sentinel organism. The damage is well established to the entire marine eco-system, including pelagic and benthic fauna. It requires decisive and urgent action for environmental justice. Comments: No other industrial or medical chemical, drug or therapeutic agent, pesticide or germicide has polluted the bodies of 96.8%of Americans tested (Calafat-CDC 2004), a majority of Europeans (Schlumpf 2010), and is found in every global water source. No prudent parent would ever knowingly apply a petrochemical similar to engine oil or gas, similar to DDT and other pesticides that is an estrogen mimic, which pollutes the human body and every brain cell, saturating tissues from the frequent and often daily application of a SOUVF sunscreen, for absolutely NO BENEFIT. • Cancer statistics support the studies that show NO BENEFIT. Mortality from skin cancer in the USA rose by 54% between 1975 and 2017.The Global Burden of Disease Study(2015) reported that from 2005 to 2015,there was a 27.2%and 42.9%increase in the global death rate from melanoma and NMSC,respectively.There is a steady annual rise in global keratinocyte (SCC, BCC) cancer rates at 3-8% The National Cancer Institute reports that melanoma rates in the United States tripled between 1975 and 2014. The incidence of BCC (Basal Cell Carcinoma) and SCC (Squamous cell carcinoma) increased by 145%and 263% respectively from 1976-1984 and 2000-2010. Melanoma is a leading cause of cancer death in women ages 15-35,and the incidence of melanoma increased by 8X in young women and 4X among young men. No other human cancer has ever risen in this exponential fashion—more proof that SOUVF that make up 90%of global sunscreens are an obvious failure in the prevention of skin cancer. • The 5 most recent reviews show that SOUVF DO NOT prevent skin cancer confirming eleven other studies between 1973-2015. They are available from the published literature —Silva et al (2018), Waldman,& Grant-Kels (2019), Rueegg et al (2019), DiNardo and Downs(2021), and Dudley et al (2021). • Six ethical principles MUST guide environmental health decision-making: sustainability, beneficence, non- maleficence,justice,community,and precautionary substitution (Matouskova and Vandenberg(2021).The ethical and moral framework in medicine codifies 4 guiding principles: non-maleficence or the first rule (often translated as "do no harm"), beneficence, justice, and respect for autonomy, all in step with the environmental health paradigm. The application of lust two of these principles: non-maleficence and beneficence calls for an absolute ban on all 12 SOUVF petrochemicals being used as sunscreens. The risk to the unborn for whom there is clearly no benefit can never be quantified. It is malfeasance just to expose a fetus to these petrochemical ENDs, made more egregious with the congenital defects already reported. We have stated for over a decade, that the failure of obstetric caregivers to counsel expectant mothers about bioavailability to mother and fetus, established by 25 years of literature and the FDA, is arguably medical malpractice with serious ethical and legal implications. • Even dermatologists now acknowledge this issue. "Dermatologists should specifically endorse physical sunscreen in patients of child-bearing age, particularly as zinc oxide and titanium dioxide are designated as GRASE, until the safety and sequelae of sunscreens containing oxybenzone use during pregnancy is fully understood."(Viola and Grant Kels,JAAD 2021).This"understanding"will never emerge.Simply stated-SOUVF are not safe for humans or wildlife. Unavailable after 70 years, it is improbable that safety data will ever be provided, especially for the fetus. Proper studies addressing fetal risks are neither ethical nor feasible, nor relevant, as there is no benefit to the fetus or mother. Regulators and Legislators should apply the Precautionary Principle and protect both environmental and human health. Polluting our newborn descendants raises the question of environmental and intergenerational justice(Matouskova and Vandenberg-2021). • Benefit Risk Assessment (BRA) is the cornerstone of clinical medicine, epidemiology, and public health. It is a sound precept or common sense approach for parents and life in general. It has never been formally applied to the use of SOUVF sunscreens. It is now up to scientists, physicians, legislators, and regulators armed with accurate and current information,to do so on behalf our progeny and our planet.