"Even if I didn't want to, I had to.". 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. Benzene can also be added in emergency situations, like the pandemic, or if it provides significant therapeutic advantages. However, most studies in people have not found an increased risk of cancers other than leukemia among those with higher exposures. Public Health Service, National Toxicology Program. All rights reserved. "So you can trust that if it's 1,000 parts per billion we will let you know.". A: Benzene is a chemical used in the production of a wide range of industrial products, including chemicals, dyes, detergents, and some plastics. 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. Federal regulations limit exposure to benzene in the workplace (see below). 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 . Firms, FindLaws team of legal writers and attorneys, Complaint For Loss Due To Product Defect and For Discovery, Industrial cleaning and degreasing formulations, Gasoline storage, shipment, and retail operations, The air around waste sites and gas service stations, Contaminated well water, as a result of benzene leaks from underground storage tanks or hazardous waste sites containing benzene. 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. 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. At room temperature, benzene is a colorless, or pale yellow, liquid with a . 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. She stopped along a highway median, opened her car door and threw up. Is the FDA serving these companies or the public? Andrews asked. Making Strides Against Breast Cancer Walks, ACS Center for Diversity in Research Training, Perfluorooctanoic Acid (PFOA), Perfluorooctane Sulfonate (PFOS), and Related Chemicals. "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. Independent lab found the chemical in more than a quarter of items it tested sometimes at levels considered life threatening. Benzene is commonly found in air, but the levels in most places are usually very low. 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. Rinsky RA, Smith AB, Hornung R, et al. 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. PDF Benzene - US EPA Manufacturers should not use benzene in the manufacture of drugs. "I was gasping for air.". 15 Sunscreens Without Benzene and the Recall List - InStyle ", 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. Can a new law help? One way manufacturers can meet the requirements of 211.84, 211.160 and 211.165 is by using tools such as risk assessments to determine they have the appropriate specifications, test methods, and controls to ensure drugs are free from contamination. What all this means to you as a sunscreen user: If the sunscreen you have is on this list or was one of the recalled Johnson & Johnson products, Dr. Chadha recommends that you throw it out immediately and switch to a sunscreen that's not on the list to get your UVA and UVB protection. Loren Hopkins, Chief Environmental Science Officer of Houston's health department, said she realized that when officials issue shelter-in-place advisories and nothing else, the message to the public is confusing: "It's all fine, up until all of the sudden it's terrible," she said. 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. Ji Z, et al. Q: What should manufacturers know about benzene in drugs? Provides references that aid in recognizing hazards and the health effects associated with benzene in the workplace. 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. 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. Four years after Ochoa, his 62-year-old mother, his son and countless others were sickened by the ITC fire, federal regulators are still investigating. This contamination may be related to inactive ingredients such as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons. 2015. Ochoa said he asked whether his symptoms were related to the chemical 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. 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. The lab, Valisure, last year detected benzene in hand sanitizers, sunscreens, deodorant, dry shampoos, conditioners, antiperspirants, deodorants, body sprays and anti-fungal treatments. In 2021, TCEQ approved a rule that allows the agency to consider major explosions or fires when it decides whether to issue permits to a company - a change that agency staff pushed because of the ITC fire. She has a grandson with respiratory issues and feels like it's her duty. When inhaled or swallowed, benzene has been found to cause different types of tumors in lab animals such as rats and mice. FDA has recommended the United States Pharmacopeia (USP) remove (or omit) certain carbomer monographs from their compendium that allow for unacceptable levels of benzene (a USP monograph is a written document that provides the quality expectations for a medicine or ingredient). 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. 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. 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). Cancer.org is provided courtesy of the Leo and Gloria Rosen family. In addition, FDA recommends consumers do not use recalled sunscreen products. The American Cancer Society looks to these organizations to evaluate the risks based on the available evidence. 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. 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 has discussed with manufacturers conducting risk assessments to evaluate the possible presence of benzene in their drug products and components, including active ingredients and inactive ingredients. 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. If you are person who smokes,try to quit. Characteristic 1 H NMR Absorptions of Aromatic Compounds. Benzene - Benzene - Sigma-Aldrich A final report is expected this year. He said county officials didn't feel they were being told everything they needed to know. The city of Deer Park and ITC contracted with a company called CTEH to conduct hand-held air monitoring. 356C(b) and FDAs associated regulations. Molecular Weight 78.11. "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.". Together, were making a difference and you can, too. Tumori. "You want to be able to trust officials and ITC representatives telling people you will be OK," Guevara said. At room temperature, benzene is a clear, colorless-to-light yellow liquid that is highly flammable. Some of these mono-substituted compounds (labeled in red and green), such as phenol or toluene, can be used in place of benzene for the chemical's base name. As fire crews fought the last remnants of the fire, life in Deer Park returned to normal. These tests can only detect recent exposures to benzene. Provides links and references to additional resources related to exposures to benzene. The site is secure. She then watched as the smoke plume settled above the mourning family during the funeral service. The International Conference on Harmonization (ICH) Q3C Impurities: Residual Solvents guidance describes limited cases where the presence of benzene may be tolerated. Here you'll find in-depth information on specific cancer types including risk factors, early detection, diagnosis, and treatment options. People are exposed mainly by breathing in air containing benzene. It may appear colorless . The site is secure. Its also important to follow recommended screening guidelines, which can help detect certain cancers early. ", "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. 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. 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. 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. 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. The Occupational Safety & Health Administration (OSHA) is the federal agency responsible for health and safety regulations in most workplaces. Application holders notified of benzene results from the manufacturer of an API used in their product are required to submit FARs. 2023 American Cancer Society, Inc. All rights reserved. "These concentrations are higher than we would normally consider protective," Richard Nickle, an environmental health scientist at the CDC's Agency for Toxic Substances and Disease Registry, said in an April 2019 email to Harris County officials. Protons directly attached to an aromatic ring, commonly called aryl protons, show up about 6.5-8.0 PPM. "Absolutely striking.". 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. Protons on carbons directly bonded to an aromatic ring, called benzylic protons, show up about 2.0-3.0 PPM. 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. In general, if you suspect that you may have been overexposed, you should act quickly to ensure an accurate reading. Overview. What Is Benzene and How Toxic Is It? - Jill Carnahan, MD At the American Cancer Society, we have a vision to end cancer as we know it, for everyone. Long-term . Benzene pollution lingers as life returns to normal - March 25-29, 2019. 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. 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. (For more information on the classification systems used by these agencies, see Determining if Something Is a Carcinogen andKnown and Probable Human Carcinogens.). Facts About Benzene. The companys statement was posted by the FDA on its website even though agency scientists found in a July analysis obtained by Consumer Reports that benzene-contaminated sunscreen did pose a life-threatening risk. Benzene has been shown to cause chromosome changes in bone marrow cells in the lab. Deer Park said in a statement later that day that the city was obtaining "normal levels" of air pollutants. 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. Limit or avoid exposure to fumes from solvents, paints, and art supplies, especially in unventilated spaces. TheEPA classifies benzene as a known human carcinogen. ToxFAQs for Benzene. The American Cancer Society offers programs and services to help you during and after cancer treatment. More about sun protection and sunscreens can be found on the FDA website. 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. Levels of benzene can be higher in enclosed spaces with unventilated fumes from gasoline, glues, solvents, paints, and art supplies. He said they needed the money. With exposures from less than five years to more than 30 years, individuals have developed, and died from, leukemia. 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. 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. The formation of benzene from benzoate can lead to an increase in benzene content over a drug's shelf-life' and should be considered when determining the appropriate timing for benzene testing . 2003. The analysis did not take into account the fact that hundreds of people actually sought medical care during the incident. 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. They reopened state Highway 225, which borders the cluster of petrochemical plants and is residents' main route to drive into Houston for work. FDA alerts drug manufacturers to the risk of benzene contamination The symptoms of acute benzene toxicity will show up anywhere from a few minutes to a few hours after exposure. First responders transitioned from firefighting to frantically spraying the ruptured tanks with enormous amounts of industrial firefighting foam, hoping to create a blanket to tamp down emissions. Long-term exposure may affect bone marrow and blood production. 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. As the fire at ITC spread from tank to tank, an ominous black plume of smoke spiraled over the Houston skyline. Drug manufacturers should contact FDA using the information provided in FDAs alert if their testing reveals benzene in a product. Benzene | Medical Management Guidelines | Toxic Substance Portal | ATSDR 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. 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. Benzene is used in the manufacture of plastics, detergents, pesticides, and other chemicals. 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. Stay up-to-date with how the law affects your life. "Anytime you see any kind of black smoke out there, it's not good," he said. 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. A 2010 analysis in the journal Environmental Health concluded that "exposure to benzene at work increases the risk of leukemia.". Name A low blood platelet count, which can lead to excess bruising and bleeding. 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. Accessed at https://wwwn.cdc.gov/TSP/ToxFAQs/ToxFAQsDetails.aspx?faqid=38&toxid=14 on January 25, 2023. Consistent with the recommendations of the ICH Q3 guidance, manufacturers should not use benzene in the manufacture of drugs. The level of exposure depends upon the dose, duration, and work being done. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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