Paxton's office sued the company in 2019, but the case hasn't moved forward since 2021, according to Travis County District Court records. FDA reminds manufacturers of NDA and ANDA products of their obligation to submit a Field Alert Report (FAR) if testing reveals their drug products contain benzene above 2 ppm (21 CFR 314.81(b)(1)(ii)). 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. For additional questions, contact CDER-benzene@fda.hhs.gov. Harris County is also using a $1 million grant from the American Chemistry Council to create a new guide for emergency response to chemical disasters. New Engl J Med. Levels of benzene can be higher in enclosed spaces with unventilated fumes from gasoline, glues, solvents, paints, and art supplies. On the heels of the report, Johnson & Johnson is recalling five of its sunscreens. "My soul remembers. The USEnvironmental Protection Agency (EPA)maintains the Integrated Risk Information System (IRIS), an electronic database of human health effects from exposure to various substances in the environment. It evaporates quickly when exposed to air. Benzene, a known cancer-causing chemical, was found in over half of 108 batches of antiperspirant and deodorant body sprays from 30 different brands, according to a citizen's petition filed this . An official website of the United States government, : Below is a list of commonly seen benzene-derived compounds. A second shelter-in-place when benzene "rears its ugly head" - March 21-22, 2019. The .gov means its official.Federal government websites often end in .gov or .mil. Eddie Guevara, who's now 22, said officials should have been more honest with the public. These tests can only detect recent exposures to benzene. Long-term exposure to high levels of benzene has been tied to thedevelopment of leukemiaand other cancers, as well as various menstrual issues in women and birth defects in their children. Soon, the smoke blanketed their home. "What we're seeing is a fundamental problem in the manufacturing of a lot of consumer products." To date, Valisure has tested 662 . We couldnt do what we do without our volunteers and donors. In fact, you can get started today with aclaim evaluation. "We care a lot. But what Ochoa and other residents weren't told by federal, state and local officials at the time was that long after the fire was extinguished and life seemed to go back to normal, an invisible danger remained. ", "They are striking concentrations of benzene," Shonkoff said. Studies have typically focused on workers who are exposed to the chemical over years. Motoring down East 13th Street, the van passed brick houses, a United Methodist Church and an elementary school with a playground nestled in the shade of tall, skinny pine trees. The Texas Tribune is a nonprofit, nonpartisan media organization that informs Texans - and engages with them - about public policy, politics, government and statewide issues. 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. Long-term exposure may affect bone marrow and blood production. Which sunscreens were found to contain benzene? Residents didn't learn of the high benzene levels until a 10 a.m. press conference on Monday, when Adams, the federal on-scene coordinator for the EPA, said there was a benzene spike that weekend above the action level "in the community" - he didn't say where - and added that the agency notified local officials. Then, their city. Benzene is one of the 20 most widely used chemicals in the United States. Independent testing has found hundreds of popular personal care items in the US to be contaminated with benzene, a highly carcinogenic chemical, prompting several big brands to voluntarily recall dozens of products in recent months. ", 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. Breathing in high doses of benzene can affect the nervous system, which can lead to drowsiness, dizziness, headaches, tremors, confusion, and/or unconsciousness. Cars zoomed past her. The formation of benzene from benzoate can lead to an increase in benzene content over a drugs shelf-life and should be considered when determining the appropriate timing for benzene testing, e.g., testing at release and on stability (21 CFR 211.165, 211.166), and establishment of an appropriate expiration date (21 CFR 211.137). Benzene is a colorless, flammable and toxic liquid with carcinogenic properties that has a sweet, gasoline-like odor. 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. Some residents still blame the incident for lingering health problems. One Harris County official estimated that all together, more than 400 personnel took air samples throughout the response. Still, the state renewed the chemical permit for ITC's Deer Park facility less than a year after the fire. FDA will communicate new information as it becomes available. Benzene has a sweet aromatic odor. Ingredients that are hydrocarbons or are manufactured with benzene or other hydrocarbons may indicate a higher likelihood of benzene contamination. Twice, city officials advised residents of Deer Park, the city closest to the fire, to shelter indoors. Exposures to benzene are addressed in specific OSHA standards for general industry, maritime, and construction. By Monday - eight days after the . Extrapolated across the state as a whole, the benzene leakage from gas appliances is the equivalent of adding 60,000 passenger cars to the roadventing their exhaust directly into your kitchen. The city of Deer Park and ITC contracted with a company called CTEH to conduct hand-held air monitoring. All rights reserved. That highlights the complexities and lack of oversight in the global supply chains that produce personal care products. benzene (C6H6), simplest organic, aromatic hydrocarbon and parent compound of numerous important aromatic compounds. Ochoa said he asked whether his symptoms were related to the chemical fire. Instead, they spend more time indoors playing video games. "Anytime you see any kind of black smoke out there, it's not good," he said. No shelter-in-place advisory was issued for Channelview residents. 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. We continually gain additional knowledge about drugs which allows us to identify and quickly address previously unknown risks to consumers. Our partners at the Texas Tribune analyzed unreported air monitoring data from the ITC chemical fire. 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. 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. Name Benzene is formed from natural processes, such as volcanoes and forest fires, but most people are exposed to benzene through human activities. This alert has resulted in, among other things, several recent recalls of drugs containing unacceptable levels of benzene. 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 is released into the air in cigarette smoke, emissions from automobiles, and burning coal and oil. In late September, Coppertone also announced a recall of five of its popular sunscreens after detecting benzene. "People need to be able to make their own decisions," Hopkins said. We make every effort to keep our articles updated. These results support the finding of an excess risk of leukemia in humans. Independent lab found the chemical in more than a quarter of items it tested sometimes at levels considered life threatening. They cant reliably show how much benzene youve been exposed to, nor can they predict possible health effects. Those workplace standards, he added, were a compromise between now-outdated benzene science and the economic impact on businesses. In particular, FDA has also discussed with manufacturers the need for a special focus on ingredients that are hydrocarbons or are manufactured with benzene or other hydrocarbons. Emissions above that level don't trigger any regulatory action by the agency. Valisure is now petitioning for the Food and Drug Administration to recall the products on its list. Cancer.org is provided courtesy of the Leo and Gloria Rosen family. Browse Benzene and related products at MilliporeSigma. The NTP has classified benzene as known to be a human carcinogen.. "If we get something sustained above [1,000 parts per billion], we notify the local governments to evacuate or shelter-in-place, whichever is more appropriate for the community," Adams said. The wind was blowing the smoke toward his own home. We're improving the lives of cancer patients and their families through advocacy, research, and patient support to ensure that everyone has an opportunity to prevent, detect, treat, and survive cancer. 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. FDA will advise on appropriate next steps such as notifying any entity that received contaminated API. 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. Hand sanitizers. Benzene is not an ingredient intentionally used in sunscreens, but the products on Valisure's list were found to be contaminated with benzene. But this doesn't mean you should stop wearing sunscreen altogether. Sleepiness. 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. An analysis of air quality data from a TCEQ's stationary Deer Park monitor southwest of City Hall shows that benzene emissions had risen early that morning to 61 parts per billion in an hour. The dangers of benzene mean that you should be alert to the possibility of exposure beyond acceptable levels. By the next morning, the fire had spread to five additional tanks at the ITC facility, according to TCEQ and city of Deer Park records. Meanwhile, an untold number of people were breathing benzene fumes without protection. FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors. 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. 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. ", High levels of benzene detected for two weeks after the ITC fire. OSHA limits exposure to benzene in the air in most workplaces to 1 ppm (part per million) during an average workday and a maximum of 5 ppm over any 15-minute period. Advocates took aim at the Food and Drug Administration for failing to do more to protect the public. It's the dead of summer, so chances are you've been putting your sunscreen stash to good use. But when an incident occurs at a facility like ITC that's located in an unincorporated area of the county, deciding who has jurisdiction can be complicated. Q: Should consumers continue using sunscreen? Federal rules allow benzene to be used in the manufacture of personal care products, and that can cause it to end up in goods, even if its not listed as an ingredient. More about sun protection and sunscreens can be found on the FDA website. If any drug product batches with benzene above 2 ppm are already in distribution, the manufacturer should contact FDA to discuss the voluntary initiation of a recall by contacting the appropriate Division of Pharmaceutical Quality Operations in the Office of Regulatory Affairs. The highest benzene levels among the dry shampoos were found in a popular brand called Not Your Mother's, which touts its "clean, quality ingredients." Other brands found to have elevated . Application holders notified of benzene results from the manufacturer of an API used in their product are required to submit FARs. Now, Contreras is alert to strange odors in the air and watches for anything unusual at the nearby chemical plants - especially smoke. 2023 American Cancer Society, Inc. All rights reserved. Harris County Judge Lina Hidalgo assured the public during a press conference that afternoon that the county was using "very conservative estimates to determine the threshold of dangerous levels of air quality.". Is the FDA serving these companies or the public? Andrews asked. He said they needed the money. Agency for Toxic Substances and Disease Registry. Toxic benzene has been found in antiperspirants, shampoos, sunscreens, hand sanitizers, and other products. ANSI Z37.4, Acceptable Concentrations of Benzene. In a statement to the Tribune, the EPA said that when benzene readings topped the 1,000 parts per billion threshold in neighborhoods for at least a minute, Unified Command directed air quality inspectors to the area to take more measurements and confirm whether the concentrations were expected to linger in the area. Public Health Service, National Toxicology Program. Long term exposure to benzene through inhalation, oral intake, and skin absorption may result in cancers such as leukemia and other blood disorders. Benzene is a known human carcinogen that causes leukemia and other blood disorders. The fire prompted Deer Park officials to advise residents to shelter in place that Sunday. "I'd be out here looking at the fire and start to feel my heart going crazy," he said. Experts say more shelter-in-place advisories should have been issued. The benzene molecule is composed of six carbon atoms joined in a planar ring with one hydrogen atom attached to each. It is only slightly soluble in water but readily soluble with most organic solvents. That was below the 1,000 parts per billion threshold set by Unified Command, but it was 12 times above the highest concentration of benzene typically found in the area. Workers may be harmed from exposure to 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). 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)). Sun safety is important for everyone and all skin colors, and consumers can reduce risks from sun exposure with continued use of sun protection measures, including sunscreen. "Absolutely striking.". Occupational exposure to benzene. We note that certain United States Pharmacopeia National Formulary (USP-NF) carbomer monographs allow for levels of benzene of 100 ppm or greater. To eliminate confusion and because of the safety concerns associated with these unacceptable levels of benzene, FDA has asked USP to remove (or omit) these monographs from their compendium. The fire began after a tank's pump failed and began to leak naphtha, a highly flammable liquid. That's when he first saw the smoke coming from the ITC tank farm. She could taste the smoke; she had the distinct sense that the smell would stick to her all-black attire and linger in her firmly pressed curly hair. 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." In a written statement, Pablo Sanchez-Soria, a senior toxicologist at CTEH, said that using short time frames to measure benzene levels - in this case one minute in the community - help officials "take early action" to reduce human exposure. What benzene is. 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. So you want to check Valisure'sor Johnson & Johnson's list of impacted products rather than scanning your sunscreen's ingredient list to see whether "benzene" is listed. 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. Federal regulations limit exposure to benzene in the workplace (see below). (For more information on the classification systems used by these agencies, see Determining if Something Is a Carcinogen andKnown and Probable Human Carcinogens.). The chatty little boy - who told a doctor that his breathing problems felt like "bugs getting in my nose, like little tiny worms" clogging his nostrils and lungs - is now wary of playing outside at playgrounds, his father says. (modern). Benzene is a colorless or light-yellow liquid chemical at room temperature. At the American Cancer Society, we have a vision to end cancer as we know it, for everyone. But the description of the compounds in Aromatic 200 does not fit that of benzene, said Raynor, the University of Minnesota professor. That day - four days after the ITC fire began - the EPA finally deployed its air monitoring bus, the rolling lab that could sample the air while it drove. Benzene drifts into Deer Park, but residents aren't warned - March 31, 2019. "It was like watching your son drown right in front of you," Ochoa said. 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 high readings along the highway likely wouldn't have prompted a response, he said, because the benzene levels quickly dropped again. TheInternational Agency for Research on Cancer (IARC)is part of the World Health Organization (WHO). The public was not warned the entire day. A low blood platelet count, which can lead to excess bruising and bleeding. "I was watching him and knowing, he doesn't even realize he's suffocating," he said. The Consumer Product Safety Commission (CPSC) considers any product containing 5% or more by weight of benzene to be hazardous, requiring special labeling. Deer Park city officials lifted the shelter-in-place advisory at 5:30 a.m., stating no air quality readings had exceeded "action levels." 2018. If you are exposed to benzene at your workplace, talk to your employer about limiting your exposure through process changes (such as replacing the benzene with another solvent or enclosing the benzene source) or by using personal protective equipment. Accessed at https://publications.iarc.fr/123 on January 25, 2023. 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." By FindLaw Staff | If benzene touches the skin, it can result in redness and blisters. Anemia (a low red blood cell count), which can cause a person to feel weak and tired. 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. "ITC cares," she said, as her eyes filled with tears. This voluntary recall is being conducted out of an abundance of caution.. 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. 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. People can be exposed to benzene from gasoline fumes, automobile exhaust, emissions from some factories, and wastewater from certain industries. Benzene levels in rooms containing tobacco smoke can be many times higher than normal. At room temperature, benzene is a clear, colorless-to-light yellow liquid that is highly flammable. Benzene evaporates into the air very quickly. Robert Hemminger, Deer Park's emergency services director at the time, told the public that benzene emissions had "significantly reduced" since that morning. US Department of Health and Human Services. FDAs guidance Field Alert Report Submission: Questions and Answers Guidance for Industry addresses how to submit a FAR. Product name : Benzene Product Number : 319953 Brand : SIGALD Index-No. 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. Benzene is an organic chemical compound with the molecular formula C 6 H 6. "You want to be able to trust officials and ITC representatives telling people you will be OK," Guevara said. Castiel kept waking Ochoa up with "horrible and terrifying" snoring. A: FDA is committed to ensuring drugs Americans use are safe and effective. The capability of superhalogen induced ionization of benzene molecules has been reported based on ab initio calculations. 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. Benzene is made from coal and petroleum sources and is present in gasoline. "I'm very proud to stand here as mayor and recognize all of the officials and volunteers who waited in line to take their turn to fight for our community," Mouton said. As officials declared victory, Mario Ochoa's mother could hardly breathe. Contact a qualified product liability attorney to make sure your rights are protected. Despite the all-clear from city officials, Deer Park School District remained closed that Monday. Q: Is benzene in drugs a new problem? (. "Benzene is linked to blood cancers such as leukemia and other cancers and conditions like [acute lymphoblastic leukemia], [chronic myelogenous leukemia], Non Hodgkins lymphoma, and aplastic anemia," adds Dr. Chadha. But a draft shared with the Tribune shows that while it identifies 22 chemicals, including benzene, that could threaten residents' health, it does not set a specific threshold for issuing a shelter-in-place advisory. We are going through that process with each of these citizen petitions. Benzene (C 6 H 6) is a highly flammable, colorless liquid that evaporates quickly into the air. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. "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 aesthetic dermatology. The most frequent symptoms were headache, throat irritation, nausea, coughing, dizziness and vomiting. 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 was experimentally confirmed to be flat molecule by Dame Kathleen Londsale with X-ray crystallography. It's notoriously challenging to determine whether cancer was caused by exposure to a specific chemical or pollutant. The fire had been out for days when Ochoa, a 39-year-old pipe fitter at an industrial construction company, sat awake late into the night worrying about his son, who complained that his head hurt. 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. Certainly, over-exposure to benzene in any setting might generate a legal claim against the institution or person that caused the exposure. Other people who may be exposed to benzene at work include steel workers, printers, lab technicians, gas station employees, and firefighters. A group of massive tanks, some containing millions of gallons of highly flammable chemicals used to make plastic and gasoline, had caught fire at a chemical storage facility owned by Intercontinental Terminals Company, a Texas-based company owned by Japanese conglomerate Mitsui Group. In 2021, the market is growing at a steady rate and with the . "I don't believe that most companies are trying to deceive the public or are overstating their potency, safety, or protection intentionally; however, there are some real failures within the systems that are cause for concern.". Global price of benzene 2017-2022. 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. In May 2021, an independent laboratory called on the US Food and Drug Administration (FDA) to issue a recall after detecting benzene, a known human carcinogen, in 78 batches of sunscreen and after . Benzene emissions spiked to abnormally high and potentially dangerous levels for more than two weeks after nearby residents were told it was safe to return to school and work, according to a Texas Tribune analysis of U.S. Environmental Protection Agency air-monitoring data. ITC said in a statement to the Tribune that there were "no longer-term public health impacts to the community" from the incident, pointing to an analysis by the Texas Department of State Health Services. Deer Park said in a statement later that day that the city was obtaining "normal levels" of air pollutants. "It was a missed opportunity because [the data from the EPA's mobile lab] could've been used to inform some of the public health decisions, but it doesn't seem like it was.". Rinsky RA, Smith AB, Hornung R, et al. Ochoa said he and his fellow workers were indeed concerned. A: Yes. With exposures from less than five years to more than 30 years, individuals have developed, and died from, leukemia.