What Is Benzene? Carcinogen Found in Some Sunscreens, Explained Stay up-to-date with how the law affects your life. Cigarette smoke is a major source of benzene exposure. This can result in: There is also some evidence that long-term exposure to benzene might harm reproductive organs. The van captured benzene levels spiking to more than 1,000 parts per billion by volume on several days during its monitoring. He added that the city verified high benzene readings with multiple sources before deciding whether to tell residents to go inside. 95(1):8-12, January-February 2009. The Tribune's analysis shows that benzene levels continued to spike close to, but not surpassing, 1,000 parts per billion for the rest of that Sunday morning in residential areas of Deer Park. That Sunday morning, it drove through an invisible cloud of benzene - logging a reading above 1,000 parts per billion near San Jacinto Elementary School. 2023 American Cancer Society, Inc. All rights reserved. Note that 2-chlorophenol = o-chlorophenol. Concurrently, the agency will review any Field Alert Reports from drug manufacturers that identify the presence of benzene, in addition to other available information. These include the rubber industry, oil refineries, chemical plants, shoe manufacturers, and gasoline-related industries. The EPA warned in a press release that exposure could cause headaches and nausea, and then Harris County Public Health Executive Director Dr. Umair Shah encouraged residents to call the "Ask a Nurse" hotline if they experienced symptoms. Manufacturers of nonapplication products, including over-the-counter monograph drug products, should contact FDA using the information in the table below when testing reveals benzene in a product. A massive 2005 explosion at a BP refinery in Texas City, about 35 miles to the south next to Galveston Bay, killed 15 workers and injured nearly 200 others. 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. In the Wynfield Estates neighborhood, where many of the homes are two-story red brick and shaded by big oak trees, Anthony Guevara, Eddie's 14-year-old brother, didn't go to school that Monday because his eyes were burning and his throat stung. "It was like watching your son drown right in front of you," Ochoa said. Benzene is made from coal and petroleum sources and is present in gasoline. The .gov means its official.Federal government websites often end in .gov or .mil. The International Conference on Harmonization (ICH) Q3C Impurities: Residual Solvents guidance and companion document Q3C Tables and List provide guidance on limited cases where the presence of benzene may be tolerated. An air quality report provided by CTEH shows that it did not not detect any concentrations of benzene above 1,000 parts per billion in Deer Park, Pasadena, Galena Park or Channelview on March 31, however, the report does not indicate at what time the readings were taken. For example, the report said Harris County Pollution Control, which has a special team to respond to fires involving hazardous materials and other chemical incidents, had meager staffing and "antiquated" or out-of-service equipment during the 2019 fire. Report on Carcinogens, Fifteenth Edition. A: Certain hand sanitizers and aerosol (spray) drugs, including antiperspirants and sunscreens, have been recalled due to benzene contamination. Places Where Benzene May Be Found. FDA will advise on appropriate next steps such as notifying any entity that received contaminated API. It is used primarily as a solvent in the chemical and pharmaceutical industries, as a starting material and an intermediate in the synthesis of numerous chemicals, and in gasoline. They decided they would issue public warnings only when benzene levels reached 1,000 parts per billion in the air over one minute - a level that scientists who study benzene now say was too high. As the fire at ITC spread from tank to tank, an ominous black plume of smoke spiraled over the Houston skyline. When inhaled in large quantities over a short period, benzene can affect the central nervous system and cause symptoms including dizziness, a rapid heart rate and headaches. "People were telling me these horror stories from other refineries that were happening, people getting sick," Ochoa said. Here's what you need to know about this news, including how to find out if your favorite sunscreen made the list of products containing benzene. Benzene - Overview | Occupational Safety and Health Administration Deer Park said in a statement later that day that the city was obtaining "normal levels" of air pollutants. (. "So you can trust that if it's 1,000 parts per billion we will let you know.". It evaporates quickly when exposed to air. It is harmful to the eyes, skin, airway, nervous system, and lungs. Throughout the response, a plane brought in by the EPA flew above the fire and the plume, monitoring the air and providing eyes from above, while TCEQ and Harris County employees on the ground recorded benzene levels on hand-held air monitors, in addition to CTEH's monitoring efforts for the city and company. As for the Johnson & Johnson recall? Available Every Minute of Every Day. As FDA works to better understand the potential sources of benzene in drugs, FDA reminds manufacturers of drugs marketed under approved applications and manufacturers of other drugs, including over-the-counter monograph drug products, of their obligation to ensure their products conform to appropriate quality specifications. Benzene really shouldnt be there at all, he said. Benzene. A second shelter-in-place when benzene "rears its ugly head" - March 21-22, 2019. In its report, Valisure argues that sunscreen production does not require benzene and that the FDA should "better define limits for benzene contamination in drug and cosmetic products." The Mobile Source Air Toxics (MSAT) rules reduce hazardous air pollutants, also known as air toxics, emitted by cars and trucks. 15 Sunscreens Without Benzene and the Recall List - InStyle In 2020, FDA identified the potential for unacceptable levels of benzene in certain carbomers (which may be used as thickening agents in drugs) based on the allowable limits in USP monographs. Data from TCEQ's stationary and handheld monitors also indicated elevated benzene concentrations near the same times and locations as the EPA's mobile lab. We can also help you find other free or low-cost resources available. Benzene | NIOSH | CDC ", Fire rages as residents fall ill - March 17-19, 2019. But she added that it would be difficult to determine for sure. Below are some of the resources we provide. Valisures hand sanitizer analysis found the highest levels of benzene in small brands that popped up as demand for the product spiked. Q: What should manufacturers know about benzene in drugs? Areas with heavy traffic, gas stations, and areas near industrial sources may also have higher air levels. As officials declared victory, Mario Ochoa's mother could hardly breathe. ANSI Z37.4, Acceptable Concentrations of Benzene. The chemical formula of benzene is C 6 H 6 , so it consists of six carbon . Facts About Benzene. Anemia (a low red blood cell count), which can cause a person to feel weak and tired. For information regarding a specific legal issue affecting you, pleasecontact an attorney in your area. 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. Contreras, now 62, said the doctor who saw her said her symptoms were caused by "high exposure to chemicals." The findings suggest that benzene contamination is widespread and is probably in more products that have not yet been tested, said David Light, Valisures chief executive. "We didn't realize the amount of people that were going to actually show up," said Michael McClendon, the director of the Office of Public Health Preparedness and Response at Harris County Public Health. Benzene Factsheet. But Adams said the EPA concluded that the high levels did not last long enough in the area to prompt action. Eddie Guevara, who's now 22, said officials should have been more honest with the public. The Occupational Safety & Health Administration (OSHA) is the federal agency responsible for health and safety regulations in most workplaces. We note that if decisions to not release a drug product or to initiate a recall are likely to disrupt the drug supply, manufacturers should contact CDERs Drug Shortages Staff immediately at drugshortages@fda.hhs.gov. Some local officials now say more should've been done to communicate with the public when air quality worsened - and they're working on changing their protocols. Robert Hemminger, Deer Park's emergency services director at the time, told the public that benzene emissions had "significantly reduced" since that morning. 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.". Contact a qualified product liability attorney to make sure your rights are protected. The company said it has installed additional gas detectors and emergency shutdown valves in multiple areas of its facility. IARC classifies benzene as carcinogenic to humans, based on sufficient evidence that it causes acute myeloid leukemia (AML). An official website of the United States government, : Long-term . Bob Royall, then-assistant chief for the Harris County Fire Marshal's Office, said it was one of the longest fires that he had battled in his almost five-decade career. 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. "That almost killed some firefighters," Royall said. Benzene is a potentially dangerous chemical. Cancer.org is provided courtesy of the Leo and Gloria Rosen family. 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. Toxic benzene has been found in antiperspirants, shampoos, sunscreens, hand sanitizers, and other products. Despite the all-clear from city officials, Deer Park School District remained closed that Monday. Fight between neighbors leads to shooting in NE Houston, police say, New details about King Charles' coronation, 6 shot, 2 fatally, at after-prom party in Mississippi, Conroe ISD secures campuses amid manhunt for alleged mass shooter, Erin Douglas, Alejandra Martinez, and Caroline Covington, The Texas Tribune, San Jacinto Battleground State Historic Site, is known as an industry-friendly environmental consulting firm. Use common sense around any chemicals that might contain benzene. Meanwhile, a portion of a dike wall surrounding the tank farm collapsed, sending petrochemicals, firefighting foam and contaminated water gushing into Tucker Bayou. Benzene drifted for miles through the community. In late September, Coppertone also announced a recall of five of its popular sunscreens after detecting benzene. Benzene (C 6 H 6) is a highly flammable, colorless liquid that evaporates quickly into the air. FDAs guidance Field Alert Report Submission: Questions and Answers Guidance for Industry addresses how to submit a FAR. Because it is volatile, it can spread to a distant source of ignition. "We don't know the source of the benzene, but it could relate to how a particular ingredient was manufactured, where it was sourced, or how it moved through the supply chain," Tod Cooperman, M.D., wrote in a review of the Valisure report for ConsumberLab.com. Is the FDA serving these companies or the public? Andrews asked. Levels of benzene can be higher in enclosed spaces with unventilated fumes from gasoline, glues, solvents, paints, and art supplies. Benzene overexposure is linked to the development of the following symptoms: drowsiness, dizziness, rapid or irregular heartbeat, headaches, tremors, confusion, and unconsciousness. Cars zoomed past her. Manufacturers should not use benzene in the manufacture of drugs. "The duration of exposure related [to the ITC fire] was much shorter. On March 31, two weeks after the ITC fire erupted into flames, the EPA mobile lab was still driving around Deer Park, testing the air. The below chart summarizes when and how manufacturers should contact FDA if testing reveals the presence of benzene and the information FDA may request from drug manufacturers when following up: As FDA evaluates the root cause of benzene contamination in certain drugs, the agency is taking a stepwise approach to address the potential for benzene contamination in marketed drug products by first identifying products that should be immediately recalled or not released for distribution based on a benzene level in the products above 2 ppm consistent with the considerations described in ICH guidance. Benzene is one of the 20 most widely used chemicals in the United States. FDA continues to monitor the issue of benzene in drugs and is proactively working with companies, when appropriate, to recall products and encourage retailers to remove products from store shelves and online marketplaces when quality issues arise. Athlete . Benzene evaporates into the air very quickly. Harris County produced an analysis of what went wrong during the response. We are going through that process with each of these citizen petitions. However, when a class one solvent (such as benzene) is "unavoidable in order to produce a drug product," it should be limited to concentrations of 2 parts per million (ppm). CDC | Facts About Benzene The first lasted 18 hours immediately after the fire broke out, and the second came three days later when air monitoring detected extremely high levels of benzene - an invisible, sweet-smelling hydrocarbon often found in crude oil and cigarettes. benzene (C6H6), simplest organic, aromatic hydrocarbon and parent compound of numerous important aromatic compounds. We note that certain United States Pharmacopeia National Formulary (USP-NF) carbomer monographs allow for levels of benzene of 100 ppm or greater. As a result, there are strict controls on benzene emissions. A: Yes. Popular Dry Shampoos Found to Have Cancer-Causing Chemical If any readings crossed that threshold, Adams said the agencies would notify local officials and the public. Provides references that aid in recognizing hazards and the health effects associated with benzene in the workplace. Then, Unified Command notified local authorities. Benzene is a chemical that is a colorless or light yellow liquid at room temperature. At room temperature, benzene is a clear, colorless-to-light yellow liquid that is highly flammable. However, the evidence is not as strong for these cancers. Costatini AS, et al. Deer Park officials appeared to rely more on air monitoring readings from its hired contractor than the EPA's. Pharmaceutical Quality Resources, Recalls, Market Withdrawals and Safety Alerts, Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program, Current Good Manufacturing Practice (CGMP) Regulations, Questions and Answers on Quality-Related Controlled Correspondence, FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs, Q3C Impurities: Residual Solvents guidance, Division of Pharmaceutical Quality Operations in the Office of Regulatory Affairs, Field Alert Report Submission: Questions and Answers Guidance for Industry, appropriate ORA Division Recall Coordinators, Field Alert Reports are required for ANDAs and NDAs with such findings for distributed drug products (21 CFR 314.81(b)(1)). Johnson & Johnson didn't disclose exactly how much benzene was found in its sunscreens, but the company stated in its press release that "based on exposure modeling and the Environmental Protection Agency's (EPA) framework, daily exposure to benzene in these aerosol sunscreen products at the levels detected in our testing would not be expected to cause adverse health consequences." Levels of benzene can be higher in enclosed spaces with unventilated fumes from gasoline, glues, solvents, paints, and art supplies. Carcinogenic chemical benzene found in hundreds of US personal care It is only slightly soluble in water but readily soluble with most organic solvents. Ochoa said he and his fellow workers were indeed concerned. Areas with heavy traffic, gas stations, and areas near industrial sources may also have higher air levels. She drove herself to an emergency room, not knowing yet that her son had gone to the hospital a day earlier for the same symptoms. Product name : Benzene Product Number : 319953 Brand : SIGALD Index-No. Benzene is not an ingredient intentionally used in sunscreens, but the products on Valisure's list were found to be contaminated with benzene."Benzene is a chemical that, when activated with exposure to the skin, blood, or organs, can affect changes in your DNA that cause mutations for cancers," says Madhuri Chadha, M.D., founder of Dr. Madh Skin Solutions and radiologist currently working in . 2018. Its also important to avoid secondhand smoke. It wasn't the first sign of trouble: Around 11:30 p.m. the night before, a neighboring industrial facility near ITC reported "high benzene detections" and said one of its workers was vomiting and being sent to a hospital, Unified Command records show. The fire began after a tank's pump failed and began to leak naphtha, a highly flammable liquid. Benzene is a colorless or light-yellow liquid chemical at room temperature. When he stepped out to the backyard, a sanctuary where his family usually grills and gathers around a table to gossip, he said he experienced chest pains. (, "Post-market consumer testing may often be different from preliminary formula testing for any number of reasons or factors," says Dr. Shamban. When working at potentially higher exposure levels, OSHA requires employers to provide personal protective equipment such as respirators. Toxic benzene lingered after shelter-in-place warnings ended following Researchers analyzed 15 studies and said workers routinely exposed to benzene on the job had a 40 percent higher risk of developing leukemia than people who didn't work around the chemical. SAFETY DATA SHEET Revision Date 04/15/2023 Version 6 - Sigma-Aldrich Q: What is benzene? "My soul remembers. Ingredients that are hydrocarbons or are manufactured with benzene or other hydrocarbons may indicate a higher likelihood of benzene contamination. Deer Park resident Eddie Guevara, 19, was working a Sunday shift at a chemical plant in La Porte, a town just east of Deer Park, the day the ITC fire broke out. Whether you want to learn about treatment options, get advice on coping with side effects, or have questions about health insurance, were here to help. Q: What is the risk from using drugs contaminated with benzene? Several US government agencies regulate benzene levels and exposures. In order to ensure their products conform to appropriate quality specifications (21 CFR 211.84, 21 CFR 211.160), and consistent with the recommendations in the ICH Q3C guidance, applicants and manufacturers who identify risks of benzene contamination from drug components or confirm the presence of benzene in a drug product should also take steps to use ingredients without benzene, or, if justified, use suppliers that minimize risk of unacceptable benzene impurity levels. People can also be exposed to benzene in contaminated drinking water and some foods (although the levels are usually very low).

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