People are exposed mainly by breathing in air containing 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. No shelter-in-place advisory was issued for Channelview residents. The attorney general's office did not respond to requests for an interview. Air toxics include benzene and other hydrocarbons such as 1,3-butadiene, formaldehyde, acetaldehyde, acrolein, and naphthalene. Benzene is less dense than water and will float on the surface of water. Ji Z, et al. Subsequently, two other petitions were filed raising concerns about the level of benzene in spray sunscreens, spray antiperspirants, and other drug and cosmetic products. 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." Therefore, no evaluation of cancer risk posed by exposure to benzene from this event was carried out.". The CDC did not recommend further health monitoring in the community. He felt helpless. The city of Deer Park didn't respond to questions about whether it has changed its policies for responding to community benzene exposure. One Harris County official estimated that all together, more than 400 personnel took air samples throughout the response. This contamination is a public health concern and has caused significant outcry among environmental and health advocates. Several school administrators who worked for the district in 2019 did not recall being informed about high levels of benzene near the elementary school on March 31, Matt Lucas, director of communications for Deer Park ISD, said in an email. 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. Benzene is a colorless, flammable and toxic liquid with carcinogenic properties that has a sweet, gasoline-like odor. 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. The wind was blowing the smoke toward his own home. The site is secure. Texas has guidelines that define what level of exposure to various chemicals could affect people's health; for benzene, it's 180 parts per billion in an hour. Kids played kickball outside on the high school football field. 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. 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. "It's horrifying, scary. The toxin has also been shown to harm the central nervous system and reproductive organs. These results support the finding of an excess risk of leukemia in humans. After two days of vomiting and "a piercing headache, behind your eyes," he said, he drove himself to a nearby hospital Tuesday morning. Benzene is a six membered aromatic compound. Provides links and references to additional resources related to exposures to benzene. "I try not to think about it, because when I do think about it, my heart feels it," Ochoa said. Product name : Benzene Product Number : 319953 Brand : SIGALD Index-No. Rates ofleukemia, particularlyacute myeloid leukemia (AML), have been found to be higher in studies of workers exposed to high levels of benzene, such as those in the chemical, shoemaking, and oil refining industries. 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)). Since at least 2002, EPA and TCEQ inspectors had reported high emissions of benzene and other chemicals from that same area. Benzene is highly volatile and exposure occurs mostly through inhalation. (More on that, below.). Scientists at the indepenent analytical lab Valisure have found benzene in numerous consumer health and beauty product samples. Benzene is an aromatic compound emitted by crude oil. 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. By Monday - eight days after the . A: Benzene is a chemical used in the production of a wide range of industrial products, including chemicals, dyes, detergents, and some plastics.Benzene is released into the . Workers may be harmed from exposure to benzene. The analysis did not take into account the fact that hundreds of people actually sought medical care during the incident. The American Cancer Society looks to these organizations to evaluate the risks based on the available evidence. In its December statement, TPC Hot Acquisition, which owns Brut and Sure, wrote: To date, no reports of adverse events related to this recall have been reported. Fire flared up again briefly in one of the tanks, which were melting from the heat. Benzene and leukemia: An epidemiological risk assessment. Overview. ANSI Z37.4, Acceptable Concentrations of Benzene. Drug manufacturers are required to ensure the safety and quality of their drugs. 95(1):8-12, January-February 2009. Benzene. That day, his managers called him and his work team of about 10 people into the lunch room. "That spike, to me, is really pretty high. 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. Although FDA testing is rigorous and standards are high, it's not a foolproof system, she adds. As the fire at ITC spread from tank to tank, an ominous black plume of smoke spiraled over the Houston skyline. Independent lab found the chemical in more than a quarter of items it tested sometimes at levels considered life threatening. Before noon Thursday - after a little under eight hours - the city of Deer Park lifted the shelter-in-place advisory. 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. Light pointed to decades of research that has found no safe levels of benzene exposure because its so toxic at very low levels. Companies claim they arent adding it to their formulas, and the FDA theorized that its probably in contaminated thickening agents, preservatives, spray propellant or ethanol. Benzene is a colorless or light-yellow liquid chemical at room temperature. Original reporting and incisive analysis, direct from the Guardian every morning, 2023 Guardian News & Media Limited or its affiliated companies. 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. Schools canceled classes again, this time for one day. The lawsuit also asks that the company pay for residents' future doctor visits and tests for cancer. The benzene drifting through Deer Park "was a health threat to the community that went basically unshared," said Elena Craft, a senior scientist at the Environmental Defense Fund. Based on animal and human evidence, several expert agencies have evaluated the cancer-causing potential of benzene. The symptoms of acute benzene toxicity will show up anywhere from a few minutes to a few hours after exposure. FDA reminds drug manufacturers they are required to establish scientifically sound and appropriate specifications and test procedures to assure drug components (active and inactive ingredients) and finished drug products conform to appropriate quality specifications (21 CFR 211.84, 21 CFR 211.160). 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. Durant, the EPA spokesperson, characterized such spikes as "instantaneous" measurements in industrial areas that would not have prompted notification to local officials. Costatini AS, et al. "It was like watching your son drown right in front of you," Ochoa said. "[He was] gasping for air in his sleep.". Either way, read through the list of sunscreens found to contain benzene and toss yours if it made the list or it is one of the recalled Neutrogena and Aveeno sunscreens. Shonkoff, the environmental health sciences researcher at UC Berkeley, called the levels of benzene recorded by the EPA's air monitoring that day "crazy" and "very high. Drug manufacturers should contact FDA using the information provided in FDAs alert if their testing reveals benzene in a product. 2003. : 71-43-2 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, Synthesis of substances 1.3 Details of the supplier of the safety data sheet Company : Sigma-Aldrich Inc. Acute (short-term) inhalation exposure of humans to benzene may cause drowsiness, dizziness, headaches, as well as eye, skin, and respiratory tract irritation, and, at high levels . She then watched as the smoke plume settled above the mourning family during the funeral service. The Mobile Source Air Toxics (MSAT) rules reduce hazardous air pollutants, also known as air toxics, emitted by cars and trucks. Robert Hemminger, Deer Park's emergency services director at the time, told the public that benzene emissions had "significantly reduced" since that morning. Long-term . Workers in industries that make or use benzene can be exposed to this chemical. This alert has resulted in, among other things, several recent recalls of drugs containing unacceptable levels of benzene. Benzene is used in the manufacture of plastics, detergents, pesticides, and other chemicals. During this time, FDA has also been working with companies on multiple recalls related to the identification of unacceptable levels of benzene in drugs. One of the readings occurred two blocks south of the elementary school, in a neighborhood near the intersection of East San Augustine Street and East Boulevard. Avoid skin contact with gasoline. Benzene is a known human carcinogen that causes leukemia and other blood disorders. (For more information on the classification systems used by these agencies, see Determining if Something Is a Carcinogen andKnown and Probable Human Carcinogens.). "To me, it's no joke," he said, adding that he worries about whether the fumes he breathed could increase his risk of cancer. 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. 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 . This is personal.". Accessed at https://wwwn.cdc.gov/TSP/ToxFAQs/ToxFAQsDetails.aspx?faqid=38&toxid=14 on January 25, 2023. Because it contains only carbon and hydrogen atoms, benzene is classed as a hydrocarbon. Its also important to follow recommended screening guidelines, which can help detect certain cancers early. Some residents still blame the incident for lingering health problems. Valisure most frequently found benzene in body sprays, which includes deodorants and anti-perspirants: nearly half of the 108 products from 30 different brands contained it. "There have been multiple reports of community members experiencing a range of symptoms from discomfort to difficulty breathing," an email message from the school district to parents said that morning. US Department of Health and Human Services. Benzene. Despite the all-clear from city officials, Deer Park School District remained closed that Monday. On May 25, the company released a report after testing 294 sunscreens and sun aftercare products and found 78 of them contained benzene, a known carcinogen that has been linked to harmful effects in humans such as cancer and other serious medical conditions. If benzene touches the skin, it can result in redness and blisters. 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. 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. The disaster also exposed confusion over who should be responsible for telling residents to shelter in place during a chemical release. Researchers try to determine if a substance causes cancer using 2 main types of studies: Often neither type of study provides conclusive evidence on its own, so researchers usually look at both human and lab-based studies when trying to figure out if something causes cancer. Athlete . CAS 71-43-2. Breathing in high doses of benzene can affect the nervous system, which can lead to drowsiness, dizziness, headaches, tremors, confusion, and/or unconsciousness. Acute (short-term) inhalation exposure of humans to benzene may cause drowsiness, dizziness, headaches, as well as eye, skin, and respiratory tract irritation, and, at high levels . Ochoa and Contreras are two of more than 300 Houston-area residents who are suing ITC, claiming they suffered severe health impacts, including headaches, coughing up blood, respiratory infections and emotional stress during the 2019 fire - which Ochoa is fighting to forget. A low white blood cell count, which can lower the bodys ability to fight infections and might even be life-threatening. A: The health consequences of benzene exposure depend on the amount, route, and length of time of exposure, as well as age and preexisting medical conditions. You can help reduce your risk of cancer by making healthy choices like eating right, staying active and not smoking. 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. Products from household names like Purell and Suave didnt contain the chemical. "There's confusion and misinformation about sunscreen that unfortunately has led to growing skepticism and a general fear factor that sunscreens are dangerous when in fact not using them is more dangerous," says dermatologist Ava Shamban, M.D. Our partners at the Texas Tribune analyzed unreported air monitoring data from the ITC chemical fire. In Deer Park, benzene concentrations usually top out around 5 parts per billion in March, according to an analysis of TCEQ data by Ebrahim Eslami, an air quality research scientist at Houston Advanced Research Center. "It just imploded on itself and went down in a matter of seconds. Some experts who study benzene said the spikes that wafted through Deer Park and the surrounding areas over that two and a half week period could increase residents' risk of cancer, but others said it was unlikely. 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. However, the evidence is not as strong for these cancers. Long-term exposure may affect bone marrow and blood production. Benzene is a hydrocarbon, which means it is an organic compound resulting solely from the elements carbon and hydrogen. These tests can only detect recent exposures to benzene. Volume 100F: Chemical Agents and Related Occupations. FDA will advise on appropriate next steps such as notifying any entity that received contaminated API. But she added that it would be difficult to determine for sure. Consumers should stop using products that have been recalled as well as those hand sanitizers FDA recommends consumers should not use, including hand sanitizers tested by FDA and found to contain unacceptable levels of benzene. 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. (You can find the full list on page 12 of the report here.) The benzene molecule is composed of six carbon atoms joined in a planar ring with one hydrogen atom attached to each. Ochoa, the single father, left home at the usual time Monday morning and worked a 12-hour shift outdoors in the Houston Ship Channel installing pipes. 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. Agency for Toxic Substances and Disease Registry. "Absolutely striking.". A: FDA is committed to ensuring drugs Americans use are safe and effective. The remaining chemicals in the collapsing tanks were venting into the open 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. The .gov means its official.Federal government websites often end in .gov or .mil. Hand sanitizers. Q: What should consumers know about drugs being recalled for benzene contamination? Instead, they spend more time indoors playing video games. 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. Almost 1,000 people swarmed to temporary mobile health clinics in Deer Park that operated for three days after the fire started, and Texas Poison Center Network records show its hotline received almost 200 calls reporting chemical exposure from the ITC fire over a more than two-week period. Benzene can cause blood cancers like leukemia. Is the FDA serving these companies or the public? Andrews asked. Garcia, the Harris County commissioner, said it felt like "pulling teeth" to get information about air quality. Harris County Pollution Control Executive Director Latrice Babin said in an interview that telling citizens to shelter in place is "a really hard call to make," noting that even when high levels of chemicals are recorded, interpreting air quality testing also depends on weather conditions and location. This can help lower your exposure to exhaust fumes, which contain benzene (as well as other potentially harmful chemicals). 1987;52:3446034578. It's notoriously challenging to determine whether cancer was caused by exposure to a specific chemical or pollutant. It's the dead of summer, so chances are you've been putting your sunscreen stash to good use. Which sunscreens were found to contain benzene? The contamination has been most frequently detected in aerosol or spray products, some at levels the Food and Drug Administration characterized as life-threatening. Some states may have lower limits. If you feel like there's been a lot of concerning sunscreen news lately, you're not imagining it. 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. Benzene is also a natural part of crude oil and gasoline (and therefore motor vehicle exhaust), as well ascigarette smoke. Q: What is the risk from using drugs contaminated with benzene? 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). Ten of the tanks - each big enough to hold more than 3 million gallons of chemicals - collapsed, sending chemicals gushing into the nearby ship channel and killing birds and fish. Soon, the smoke blanketed their home. Levels of benzene can be higher in enclosed spaces with unventilated fumes from gasoline, glues, solvents, paints, and art supplies. In urine, benzene detection involves the measurement of benzene metabolites (end products of benzene), some of which can be measured, but this is not a fully accurate test since there can be numerous other reasons for the presence of similar metabolites in urine. ", "Benzene is associated with cancer usually after long durations (decades) of exposure," DSHS spokesperson Lara Anton said in a statement. 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. Paxton's office sued the company in 2019, but the case hasn't moved forward since 2021, according to Travis County District Court records. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Frequently Asked Questions on Benzene Contamination in Drugs, FDA Recalls Recalls, Market Withdrawals, & Safety Alerts, FDA updates on hand sanitizers consumers should not use, Sunscreen: How to Help Protect Your Skin from the Sun, FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs. Because it is volatile, it can spread to a distant source of ignition. All rights reserved. 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. 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. 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. Benzene levels are regulated in drinking water nationally and internationally, and in bottled water in the United States, but only informally in soft drinks. "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. However, most studies in people have not found an increased risk of cancers other than leukemia among those with higher exposures. 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. Help us end cancer as we know it,for everyone. He was checking the windsocks mounted around the plant and jotting down the direction of the wind to help the plant workers plan the best evacuation route - just in case. 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.
benzene + ch3ch2cocl in presence of alcl3
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