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FDA is evaluating the root cause of benzene contamination and has alerted companies to the risk of benzene contamination in drug products and reminded them of their obligation to ensure their products meet appropriate quality specifications. Benzene is highly volatile and exposure occurs mostly through inhalation. Benzene can also be absorbed through the skin during contact with a source such as gasoline, but because liquid benzene evaporates quickly, this is less common. If you feel like there's been a lot of concerning sunscreen news lately, you're not imagining it. The Consumer Product Safety Commission (CPSC) considers any product containing 5% or more by weight of benzene to be hazardous, requiring special labeling. The report found that health effects from benzene "were not expected to have occurred" due to the "short" amount of time high levels were detected. Visit our attorney directory to find a lawyer near you who can help. Use common sense around any chemicals that might contain benzene. When working at potentially higher exposure levels, OSHA requires employers to provide personal protective equipment such as respirators. (You can find the full list on page 12 of the report here.) "We care a lot. The high readings along the highway likely wouldn't have prompted a response, he said, because the benzene levels quickly dropped again. While benzene levels continued to spike near the ITC facility, neighboring chemical plants were warned to shelter in place Friday afternoon - the nearby community was not. For example, sunshine can cause chemical reactions that transform the pollution into smog, strong winds can quickly dissipate the pollutants and samples taken near highways could also detect pollution from vehicles. In many cases, Valisure found one batch of a product would contain benzene while another of the same product would not. "Sufficiently protective values must be balanced against the inherent risk associated with actions such as evacuation.". "After the fire fight was over, that's when the benzene issues began to rear their ugly head," said Royall, the former assistant chief of Harris County Fire Marshal's Office. Benzene - Benzene - Sigma-Aldrich Leaving the cemetery, Contreras said she began to get headaches and feel nauseous as she drove to visit a friend in the Heights, a quiet Houston neighborhood known for its Victorian-style homes. By Wednesday afternoon, four days after the ITC plant ignited, federal, state and local officials hosted a press conference to announce the fire was finally out. Rodney Reed, an assistant chief at the Harris County Fire Marshal's Office who worked in the county's emergency operations center at the time, said when officials spotted spikes in benzene emissions, they called Unified Command, "and they'd [say] they had a break of the foam blanket.". (A substance that causes cancer or helps cancer grow is called acarcinogen.) As one of the most commonly-made chemicals in the United States, benzene is often used to make many other chemicals. "These concentrations are higher than we would normally consider protective," Richard Nickle, an environmental health scientist at the CDC's Agency for Toxic Substances and Disease Registry, said in an April 2019 email to Harris County officials. Benzene was experimentally confirmed to be flat molecule by Dame Kathleen Londsale with X-ray crystallography. The operation turned to tamping down benzene emissions and emptying the chemicals from the ruptured tanks. FDA will advise on appropriate next steps such as notifying any entity that received contaminated API. Four years later, Deer Park residents who fell ill - some of them children, elderly or otherwise at higher risk - said they sensed at the time that they were more exposed to chemicals than they were told. "It's horrifying, scary. "I was watching him and knowing, he doesn't even realize he's suffocating," he said. People can also be exposed to benzene in contaminated drinking water and some foods (although the levels are usually very low). Benzene is a carcinogenic substance that is present in a great number of modern products and industries. Benzene really shouldnt be there at all, he said. Among those with the highest levels were Neutrogena, CVS, Sun Bum, Raw Elements and Banana Boat. Sleepiness. A: FDA has been working with companies to address benzene issues in drugs prior to March 2021, including through recalls. The most frequent symptoms were headache, throat irritation, nausea, coughing, dizziness and vomiting. Certain hand sanitizers and aerosol drug products have been recalled due to benzene contamination. But exposure to benzene at levels high enough to cause these symptoms is pretty rare. The FDAs system really lacks independent review because it relies on companies to self report, Light said. The bigger concern is the long-term effects of low-level benzene exposure. Kids played kickball outside on the high school football field. Or, they came too late for residents to take action. Hand sanitizers. Benzene and Cancer Risk | American Cancer Society It has a sweet odor and is highly flammable. Ji Z, et al. A few days into the crisis, officials from the EPA, the Texas Commission on Environmental Quality and Deer Park had to make a crucial decision: How much benzene in the air is too much for people to breathe? Meanwhile, residents, news reports and meteorologists anxiously tracked the black smoke plume that snaked over the Houston area. In a statement, EPA spokesperson Joe Robledo clarified that benzene readings below the 1,000 parts per billion action level did not prompt notifications to the public. "We were really trying to get to a place where we were being fair to the industry, but also transparent to the public about whether there was still harm.". If you have been injured, it's in your best interests to seek immediate medical treatment. American Cancer Society medical information is copyrightedmaterial. Chemical Safety and Health - WHO But Adams said the EPA concluded that the high levels did not last long enough in the area to prompt action. Likewise, the US Food and Drug Administration (FDA) sets a limit of 5 ppb in bottled water. "We didn't want to alarm the public needlessly," Hemminger said. Benzene is commonly found in air, but the levels in most places are usually very low. By clicking Accept All Cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Long-term exposure to benzene mainly harms the bone marrow, the soft, inner parts of bones where new blood cells are made. Benzene is also a natural part of crude oil and gasoline (and therefore motor vehicle exhaust), as well ascigarette smoke. Its vapor is heavier than air and may sink into low-lying areas. When more foam was applied, he added, the benzene levels would drop. Provides links and references to additional resources related to exposures to benzene. In a December statement, the agency said it was investigating the situation, doing its own testing and urged companies to recall contaminated products. In the end, officials decided that Deer Park and ITC would lead response efforts. The time lag between exposure and cancer can be a long period of time, he said. Please try again. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. But before you rub on another coat of SPF 50, you might want to do some quick research on the brand that you've been using (in addition to checking its expiration date, ofc). Manufacturers of NDA and ANDA drug products whose testing reveals their drug products contain benzene below 2 ppm should contact FDA at CDER-benzene@fda.hhs.gov. Why have there been so many recent reports of drugs containing benzene? | Last reviewed December 15, 2022. They said the fire was nothing to worry about because the wind was blowing the danger away, but employees could go home if they were personally concerned. If you've experienced these symptoms following exposure to benzene in any of the above-listed contexts, contact your doctor or go directly to a medical facility for testing. Places Where Benzene May Be Found. That Monday afternoon, the same day as the press conference, the bus recorded three benzene spikes well above 1,000 parts per billion across the street from the ITC facility between 4 and 4:30 p.m. On Tuesday, EPA and TCEQ officials held another press conference and said that they had "no notifications of air monitoring results" above 1,000 parts per billion. Still, the FDA lists benzene as a class one solvent, meaning that it should not be used in the manufacture of drug substances, excipients (substances added to drugs such as fillers or preservatives), and drug products, because "because of [it's] unacceptable toxicity" or "deleterious environmental effect." The air monitoring "seems like a waste" if the public wasn't immediately told about the danger, said Craft, one of the authors of the study that concluded that more shelter-in-place advisories and air quality warnings should have been issued during the ITC disaster. Brent Weber, who was ITC's "incident commander" during the fire and is now the company's president and CEO, said during the same press conference that the company had encountered issues pumping the chemicals out of the damaged tanks over the weekend that caused an increase in benzene emissions. The map shows benzene levels along the van's route. Pump gas carefully and use gas stations with vapor recovery systems that capture the fumes. But the risk of explosions and chemical fires always hangs over them. FDA will communicate new information as it becomes available. The wind was blowing the smoke toward his own home. But Seth Shonkoff, an associate researcher of environmental health sciences at the University of California-Berkeley, said it's "inappropriate to use occupational standards in a community setting" because they are designed for workers who are typically healthy adults trained to prevent chemical exposure with equipment such as respirators. Provides assistance and information about the management of occupational exposures to benzene. Several common household brands including Sun Bum, Neutrogena, Banana Boat, and CVS-brand sunscreen were all found to contain unsafe levels of benzene, according to Valisure's test. Stokes, the Deer Park city manager, declined to answer questions about the high levels of benzene recorded on March 31 by the EPA and TCEQ. Global price of benzene 2017-2022. Long term exposure to benzene through inhalation, oral intake, and skin absorption may result in cancers such as leukemia and other blood disorders. FDA intends to issue guidance for manufacturers on recommended test methods and appropriate steps for manufacturers needing to modify their formulation or manufacturing process for a legally marketed drug product. For additional questions, contact CDER-benzene@fda.hhs.gov.
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