US FDA ikupereka kuyesa kovomerezeka kwa asibesitosi pazodzikongoletsera zomwe zili ndi ufa wa talc

Pa Disembala 26, 2024, bungwe la US Food and Drug Administration (FDA) lidapereka lingaliro lofunikira loti opanga zodzoladzola aziyesa mayeso a asbestosi pazogulitsa zomwe zili ndi talc molingana ndi zomwe 2022 Cosmetic Regulatory Modernization Act (MoCRA). Lingaliroli likhudza kwambiri makampani opanga zodzoladzola, makamaka pamsika wa ufa wa talcum.

Njira zodziwira zomwe a FDA akuganiza zimaphatikizanso mitundu iwiri: polarized light microscopy (PLM): njira iyi imatha kusanthula zitsanzo zambiri ndikuzindikira asibesitosi powona mawonekedwe a crystallographic (monga mtundu, mitundu yambiri, refractive index, birefringence, ndi zina zambiri. ) ndi particle morphology. Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selective Electron Diffraction (TEM/EDS/SAED): Njirayi imatha kuzindikira tinthu tating'onoting'ono ndikuzindikira asibesitosi posanthula kapangidwe kazinthu, mawonekedwe a kristalo, ndi mawonekedwe a tinthu.

A FDA adanena kuti kuphatikiza njira ziwirizi zitha kukulitsa kuzindikira kwa asibesitosi. Ngakhale PLM ili ndi kukula kochepa, imatha kusanthula zitsanzo zambiri; Ndipo TEM/EDS/SAED imatha kuzindikira ulusi wocheperako. Njira ziwirizi zimathandizirana, kuwongolera kulondola komanso kumveka bwino kwa kuzindikira.

Lingaliro la International Standard Consistency limagwirizana ndi miyezo yapadziko lonse lapansi. European Union, Canada, ndi Japan akhazikitsa malamulo okhwima ofanana kuti awonetsetse kuti zinthu za talc sizikhala ndi kuipitsidwa kwa asibesitosi. Njira zazing'ono zazing'ono monga PLM ndi TEM zimagwiritsidwa ntchito kwambiri padziko lonse lapansi kuti zizindikire molondola asibesitosi. Mulingo wogwirizanawu sikuti umangoteteza thanzi la ogula, komanso umalimbikitsa malonda apadziko lonse lapansi ndikuwonjezera chidaliro cha ogula pachitetezo cha zinthu za talc padziko lonse lapansi.

Lingaliro la FDA likunena momveka bwino kuti ngati asibesito apezeka mu zodzoladzola kapena talc yogwiritsidwa ntchito mu zodzoladzola, mankhwalawo amatengedwa kuti aipitsidwa ndikuphwanya lamulo la Federal Food, Drug, and Cosmetic Act. Lamuloli limapereka maziko omveka bwino azamalamulo.

Cholinga chachikulu cha lingaliroli ndikuchepetsa chiopsezo cha ogula ku asibesitosi ndikupewa matenda okhudzana nawo. Nthawi yomweyo, zithandizanso opanga kuchepetsa kuchuluka kwa kukumbukira kwazinthu ndikuchepetsa kuopsa kwa magwiridwe antchito.

Kuphatikiza apo, lingaliro ili likudzaza mipata ina mu malangizo a MoCRA, makamaka ponena za kusamvetsetsa bwino kwa miyezo yoyesera chitetezo cha zodzikongoletsera ndi mabizinesi ang'onoang'ono ndi apakatikati. A FDA tsopano afotokoza momveka bwino njira zoyesera za asibesitosi mu talc, ndikupereka malangizo omveka bwino pamakampani.

A FDA atsegula nthawi yowunikira anthu kuti athe kutenga nawo mbali pagulu ndi masitepe otsatirawa, ndi tsiku lomaliza la March 27, 2025. Izi zimapereka mwayi kwa makampani ndi anthu kuti atenge nawo mbali pa kayendetsedwe ka kayendetsedwe ka kayendetsedwe kake. Ngati pamapeto pake, lamulo latsopanoli lidzasintha kwambiri chitetezo cha talc chomwe chili ndi zodzoladzola komanso kupereka chitetezo champhamvu pa thanzi la ogula.

Lingaliro la FDA likuwonetsa kutsindika kwa akuluakulu oyang'anira pachitetezo cha zodzoladzola, makamaka pozindikira asbestos, carcinogen yodziwika bwino. Potengera lingaliro latsopano la FDA, Bureau Veritas ikulimbikitsa kuti opanga zodzoladzola ayambe kuwunika ndikusintha njira zawo zowongolera bwino msanga, makamaka pazogulitsa zomwe zili ndi talc. Mabizinesi oyenerera ayenera kufunafuna thandizo lanthawi yake kuchokera ku mabungwe oyesa a gulu lachitatu, kuphunzitsa ogwira ntchito oyenera, ndikukhazikitsa njira yabwino yoyendetsera zinthu kuti awonetsetse kuti akutsatira malamulo atsopano, kukhala ndi mbiri yabwino, komanso kudalirika kwa ogula.

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