The NTP has classified benzene as known to be a human carcinogen.. Benzene pollution lingers as life returns to normal - March 25-29, 2019. In such scenarios, the FDAs limit is two parts per million, but some products that provided no therapeutic advantage were found with levels as high as 21 ppm. Or, they came too late for residents to take action. The Occupational Safety & Health Administration (OSHA) is the federal agency responsible for health and safety regulations in most workplaces. TCEQ inspectors recorded three benzene spikes on handheld air monitoring devices above 1,000 parts per billion on East Boulevard the morning of March 31. Here you'll find in-depth information on specific cancer types including risk factors, early detection, diagnosis, and treatment options. All rights reserved. Benzene is made from coal and petroleum sources and is present in gasoline. But Valisure, an online pharmacy that conducts routine batch tests of common consumer health products, recently shared some not-so-amazing findings about some sunscreens that may already be on your shelf. 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. Benzene dissolves only slightly in water and will float on top of water. We can also help you find other free or low-cost resources available. The contamination has been most frequently detected in aerosol or spray products, some at levels the Food and Drug Administration characterized as life-threatening. Among the recalled hand sanitizer brands are Art Naturals, Best Brands and Natural Wunderz. ", Benzene pollution lingers as life returns to normal - March 25-29, 2019. Benzene - Cancer-Causing Substances - NCI When more foam was applied, he added, the benzene levels would drop. Meeting with a lawyer can help you understand your options and how to best protect your rights. "Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies," said Coppertone in its news release. 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. She has a grandson with respiratory issues and feels like it's her duty. Then another tank collapsed. Public Health Service, National Toxicology Program. The Centers for Disease Control and Prevention reviewed air monitoring data from the incident and found that the concentrations of benzene exceeded what the agency considers safe - but did not believe they were high enough to cause widespread cases of cancer. For reprint requests, please see our Content Usage Policy. And because I'm a single dad with a kid, I gotta find a different way.". Benzene is one of the 20 most widely used chemicals in the United States. There are short-term and long-term exposure limits for benzene in the workplace, maximum acceptable benzene concentrations in drinking water, and exposure limits for benzene that include recommendations for specialized breathing equipment around higher levels of the compound. For additional questions, contact CDER-benzene@fda.hhs.gov. Benzene (C 6 H 6) is a highly flammable, colorless liquid that evaporates quickly into the air. C6-Zero says it did not use benzene before Marengo explosion Benzene has a sweet aromatic odor. The benzene molecule is composed of six carbon atoms joined in a planar ring with one hydrogen atom attached to each. Emissions above that level don't trigger any regulatory action by the agency. Benzene is an aromatic compound emitted by crude oil. He took his son to the hospital the next morning. 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. The company said it has installed additional gas detectors and emergency shutdown valves in multiple areas of its facility. Medical professionals useseveral teststo determine whether you've been overexposed to benzene, each of which measures benzene levels in your blood, breath, or urine. Stay away from cigarette smoke. undefined. Q: What is the risk from using drugs contaminated with benzene? Still, the state renewed the chemical permit for ITC's Deer Park facility less than a year after the fire. Deer Park city officials lifted the shelter-in-place advisory at 5:30 a.m., stating no air quality readings had exceeded "action levels." Benzene is a hydrocarbon, which means it is an organic compound resulting solely from the elements carbon and hydrogen. The symptoms of acute benzene toxicity will show up anywhere from a few minutes to a few hours after exposure. It is highly toxic and is a known carcinogen; exposure to it may cause leukemia. Q: Should consumers continue using sunscreen? Workers may be harmed from exposure to benzene. IARC classifies benzene as carcinogenic to humans, based on sufficient evidence that it causes acute myeloid leukemia (AML). If any readings crossed that threshold, Adams said the agencies would notify local officials and the public. Dr. Shamban and Dr. Chadha both agree that mineral sunscreens (which will include titanium dioxide or zinc oxide in the ingredient list) are great options if you feel iffy about using chemical formulas. "Based on our experience, the [1,000 parts per billion] action level for 1 minute for benzene across community areas was highly conservative," Sanchez-Soria said. Report on Carcinogens, Fifteenth Edition. Deer Park said in a statement later that day that the city was obtaining "normal levels" of air pollutants. Overview. Products from household names like Purell and Suave didnt contain the chemical. "One of the things that I think the government tries hard to do is to be fair to everyone without being too quick to overly react," Garcia said. Adrian Garcia, a Harris County commissioner who represents Deer Park, said the county was "scrambling" to get current air quality data from the company or from federal and state agencies to inform their decisions. ", At a March 26 press conference - nine days after the fire started - an EPA official said the agency would "get it out to the community to take action" if it detected benzene levels above that level. Contact us. Global benzene prices 2022 | Statista A: FDA has been working with companies to address benzene issues in drugs prior to March 2021, including through recalls. A: FDA is committed to ensuring drugs Americans use are safe and effective. Fire flared up again briefly in one of the tanks, which were melting from the heat. "That kind of turmoil is haunting," said Ochoa, who is now 43. ", When a reporter asked Deer Park Mayor Jerry Mouton about the strong smells that continued to waft through the city almost a week after the fire was extinguished, the mayor said those smells were "normal. ", "It's concerning that would be the case for an emergency situation," she said, adding that "you will see people hurt and harmed if it's your only number for taking action. Accessed at https://wwwn.cdc.gov/TSP/ToxFAQs/ToxFAQsDetails.aspx?faqid=38&toxid=14 on January 25, 2023. There are still moments - often late into the night, when he remembers that week of the fire - when those same feelings of panic come flooding back through his mind. New Engl J Med. Valisures hand sanitizer analysis found the highest levels of benzene in small brands that popped up as demand for the product spiked. Provides assistance and information about the management of occupational exposures to benzene. At FindLaw.com, we pride ourselves on being the number one source of free legal information and resources on the web. "It was like watching your son drown right in front of you," Ochoa said. Yet throughout the area that day, residents from Deer Park and surrounding cities swarmed the pop-up county health clinics complaining of eye, ear, nose and throat irritation, severe headaches and trouble breathing. Benzene has been shown to cause chromosome changes in bone marrow cells in the lab. 1987;316:10441050. What Is Benzene? Carcinogen Found in Some Sunscreens, Explained 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). The affected sunscreens: Neutrogena Beach Defense aerosol sunscreen, Neutrogena Cool Dry Sport aerosol sunscreen, Neutrogena Invisible Daily defense aerosol sunscreen, Neutrogena Ultra Sheer aerosol sunscreen, and Aveeno Protect + Refresh aerosol sunscreen. Q: What should manufacturers know about benzene in drugs? Out of 260 samples from 168 brands sold on Amazon, at pharmacies and at box stores such as Target, 44, or about 17%, had detectable levels of benzene. An official website of the United States government, : The US banned benzenes use as an ingredient nearly 45 years ago, and it is somewhat unique in that its pretty well established to be incredibly toxic thats been known for decades to over a century, said David Andrews, senior scientist at the public health advocate Environmental Working Group. If you think you may have been exposed to benzene over a long period of time, talk to a doctor. A final report is expected this year. Long-term . Carcinogenic chemical benzene found in hundreds of US personal care At the ITC tank farm, the fire was out, but a new danger emerged. A lot of people have become wary of chemical sunscreens (formulas that incorporate chemicals rather than minerals to block UV rays) following reports that the FDA is evaluating their safety and that they may harm coral reefs. Before sharing sensitive information, make sure you're on a federal government site. Benzene is a chemical that is a colorless or light yellow liquid at room temperature. Cars zoomed past her. Climbing benzene concentrations near the facility led the EPA and TCEQ to send inspectors into Deer Park, where they found benzene was drifting through neighborhoods near where Eddie Guevara and his family of five live. Drug manufacturers with a risk for benzene contamination should test their drugs accordingly and should not release any drug product batch that contains benzene above 2 ppm, consistent with the recommendations described in ICH Q3C. We continually gain additional knowledge about drugs which allows us to identify and quickly address previously unknown risks to consumers. The site is secure. "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.". When possible, limit the time you spend near idling car engines. In many cases, Valisure found one batch of a product would contain benzene while another of the same product would not. Benzene in soft drinks - Wikipedia Eddie Guevara, who's now 22, said officials should have been more honest with the public. Despite the all-clear from city officials, Deer Park School District remained closed that Monday. As a result, there are strict controls on benzene emissions. "To me, it's no joke," he said, adding that he worries about whether the fumes he breathed could increase his risk of cancer. 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." Cigarette smoke is a major source of benzene exposure. "Anytime you see any kind of black smoke out there, it's not good," he said. 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. Please try again. It is only slightly soluble in water but readily soluble with most organic solvents. After reaching a low of 498 U.S. dollars per metric ton, the global price of benzene has increased . "You don't know what you are inhaling or putting in your body," Anthony Guevara said. As shown in Figure \(\PageIndex{5}\), the cyclic array of six \2P_z\)-orbitals (one on each carbon) overlap to generate six molecular orbitals, three bonding and three antibonding. 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. 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. Our team is made up of doctors andoncology certified nurses with deep knowledge of cancer care as well as journalists, editors, and translators with extensive experience in medical writing. A few hours later, around 1:30 a.m. Sunday, two people working on cleanup operations at the ITC plant became ill and went home. Your Gas Stove May Be Leaking Benzene Into Your Kitchen Volume 100F: Chemical Agents and Related Occupations. People are exposed mainly by breathing in air containing benzene. TheUS National Toxicology Program (NTP)is an interagency program that includes the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). Benzene is a carcinogenic substance that is present in a great number of modern products and industries. Protons on carbons directly bonded to an aromatic ring, called benzylic protons, show up about 2.0-3.0 PPM. 15 Sunscreens Without Benzene and the Recall List - InStyle FDA continues to monitor the quality of drugs and, when appropriate, encourages retailers to remove products from store shelves and online marketplaces when issues arise. The staff checked him out and took his temperature, then told him to take ibuprofen or Tylenol for the headaches and over-the-counter nausea medication. "Do you have anything that you can cover up with?" Molecular Weight 78.11. Manufacturers should also be prepared to provide FDA with test results and any information available on the potential source of the benzene to assist in FDAs analysis. 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. 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. Anita Desikan, one of the authors of a December 2022 study of the ITC fire and a senior analyst for the Center for Science and Democracy at the Union of Concerned Scientists, said the action level used during the ITC incident was "out of line with basically every other measure I've seen [for] benzene. Benzene | Medical Management Guidelines | Toxic Substance Portal | ATSDR "Out of an abundance of caution, we are recalling certain lots of these specific aerosol sunscreen spray products.". Benzene Factsheet. Occupational Safety & Health Administration, Occupational Safety and Health Administration, Outreach Training Program (10- and 30-hour Cards), OSHA Training Institute Education Centers, Severe Storm and Flood Recovery Assistance. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. This includes testing of raw materials and finished product batches (21 CFR 211.165) prior to release to ensure they meet appropriate specifications for identity, strength, quality, and purity. The .gov means its official.Federal government websites often end in .gov or .mil. 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. But, "of course they are going to downplay it.". These kinds of sunscreens are only one element of a skin-cancer prevention strategy that should also include other sun protective behaviors such as wearing protective clothing that adequately covers the arms, torso, and legs; wearing sunglasses and a hat that provides adequate shade to the whole head; and seeking shade whenever possible during periods of peak sunlight. But the EPA's air monitoring bus continued detecting elevated levels of benzene as it drove through the industrial areas lining the Houston Ship Channel early that week, the Tribune's analysis shows. Experts say more shelter-in-place advisories should have been issued. 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. The fire began after a tank's pump failed and began to leak naphtha, a highly flammable liquid. This information will help inform further updates to FDAs approach to limiting benzene levels in drug products, as appropriate. Original reporting and incisive analysis, direct from the Guardian every morning, 2023 Guardian News & Media Limited or its affiliated companies. In Deer Park, the sirens that warn the public of industrial accidents are tested every week, and schoolchildren are drilled on how to shelter in place twice a year, with the assistance of "Wally Wise Guy," a cartoon turtle who "knows it's wise to go inside his shell" when there's danger. However, the evidence is not as strong for these cancers. Some studies have also suggested links tochildhood leukemia(particularly AML) as well asacute lymphocytic leukemia (ALL),chronic lymphocytic leukemia (CLL), and other blood-related cancers (such asmultiple myelomaandnon-Hodgkin lymphoma) in adults. Locals say they love their community - where block after block of single-family homes are surrounded by lush yards - because it's quiet, safe and has great schools. Harris County commissioners invested more than $11 million to implement the report's recommendations. But Deer Park City Manager James Stokes said air monitoring readings looked "favorable" as the fire burned off the dangerous chemicals. After two days of vomiting and "a piercing headache, behind your eyes," he said, he drove himself to a nearby hospital Tuesday morning. Workers in industries that make or use benzene can be exposed to this chemical. At room temperature, benzene is a colorless, or pale yellow, liquid with a . As Martyn Smith, a professor of toxicology and the Kenneth Howard and Marjorie Witherspoon Kaiser Endowed Chair in Cancer Epidemiology at University of California at Berkeley, explained to the Washington Post, "It's the building block for many chemicals in our world, including many drugs like aspirin and other things. (You can find the full list on page 12 of the report here.) Anemia (a low red blood cell count), which can cause a person to feel weak and tired. For short-term exposure to high levels of benzene, the Centers for Disease Control and Prevention (CDC) recommends getting away from the source of benzene, removing any clothing that may have benzene on it, washing exposed areas with soap and water, and getting medical care as soon as possible. Weve invested more than $5 billion in cancer research since 1946, all to find more and better treatments, uncover factors that may cause cancer, and improve cancer patients quality of life. Though the agency doesnt have exposure limits, it informs companies that solvents such as benzene should not be employed in the manufacture of drug substances, excipients, or drug products because of their unacceptable toxicity., Some companies have capitalized on the confusing regulations and gaps to downplay the problem. Finding benzene everywhere we look - Chemical & Engineering News 15.4: Spectral Characteristics of the Benzene Ring "I can stand here today and tell you with assurance, that safety to the public is priority No. The disaster also exposed confusion over who should be responsible for telling residents to shelter in place during a chemical release. Benzene is commonly found in air, but the levels in most places are usually very low. 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. In the past it was also commonly used as an industrial solvent (a substance that can dissolve or extract other substances) and as a gasoline additive, but these uses have been greatly reduced in recent decades. The toxin has also been shown to harm the central nervous system and reproductive organs. Shell Oil Company built the first refinery in the area in 1928, and since then, generations of Deer Park residents have crossed state Highway 225 to work in the petrochemical industry. Benzene levels are regulated in drinking water nationally and internationally, and in bottled water in the United States, but only informally in soft drinks. In a December statement, the agency said it was investigating the situation, doing its own testing and urged companies to recall contaminated products. The dangers of benzene mean that you should be alert to the possibility of exposure beyond acceptable levels. The public was not warned the entire day. You can help reduce your risk of cancer by making healthy choices like eating right, staying active and not smoking. Cancer.org is provided courtesy of the Leo and Gloria Rosen family. Toxic benzene lingered after shelter-in-place warnings ended following 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)). Fewer than 10 miles from where Guevara stood, firefighters rushed to the ITC facility and put their lives on the line in a war against the fire - fueled by 12.3 million gallons of highly flammable chemicals - that would burn for 64 hours straight. Rapid or irregular heartbeat. But the risk of explosions and chemical fires always hangs over them. What were seeing is a fundamental problem in the manufacturing of a lot of consumer products. To date, Valisure has tested 662 items and found the chemical in 180, or about 27%, of products. Then, Unified Command notified local authorities. "I thought to myself, 'This is not a migraine - this is totally different,' " she said. With exposures from less than five years to more than 30 years, individuals have developed, and died from, leukemia. These include the rubber industry, oil refineries, chemical plants, shoe manufacturers, and gasoline-related industries. Some devices, including the EPA's air monitoring bus, were not deployed until days after the fire broke out. ", In the same press conference, Adam Adams, the federal on-scene commander for the EPA, said that air monitoring results, "have been consistent - no detections [of benzene].".
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