If benzene touches the skin, it can result in redness and blisters. "You don't know what you are inhaling or putting in your body," Anthony Guevara said. At room temperature, benzene is a clear, colorless-to-light yellow liquid that is highly flammable. During this time, FDA has also been working with companies on multiple recalls related to the identification of unacceptable levels of benzene in drugs. 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. 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. Q: What is 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. In 2021, the market is growing at a steady rate and with the . Contacting the Drug Shortages Staff in writing allows manufacturers of certain covered drug products to meet applicable obligations to report discontinuances or interruptions in drug manufacture under 21 U.S.C. Emissions above that level don't trigger any regulatory action by the agency. 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. DEER PARK, Texas -- A week after the massive chemical fire that spewed toxic smoke over this Houston suburb had been extinguished in March 2019, Mario Ochoa cradled his 4-year-old son and prayed the child's cough would ease so they could both sleep. The NTP has classified benzene as known to be a human carcinogen.. Limit or avoid exposure to fumes from solvents, paints, and art supplies, especially in unventilated spaces. "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. Benzene is a component of products derived from coal and petroleum and is found in gasoline and other fuels. She has a grandson with respiratory issues and feels like it's her duty. Learn more about FindLaws newsletters, including our terms of use and privacy policy. People are exposed mainly by breathing in air containing benzene. 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. The symptoms of acute benzene toxicity will show up anywhere from a few minutes to a few hours after exposure. Places Where Benzene May Be Found. But Deer Park City Manager James Stokes said air monitoring readings looked "favorable" as the fire burned off the dangerous chemicals. Benzene levels are regulated in drinking water nationally and internationally, and in bottled water in the United States, but only informally in soft drinks. 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. In order to ensure their products conform to appropriate quality specifications (21 CFR 211.84, 21 CFR 211.160), and consistent with the recommendations in the ICH Q3C guidance, applicants and manufacturers who identify risks of benzene contamination from drug components or confirm the presence of benzene in a drug product should also take steps to use ingredients without benzene, or, if justified, use suppliers that minimize risk of unacceptable benzene impurity levels. ", 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. Meanwhile, a portion of a dike wall surrounding the tank farm collapsed, sending petrochemicals, firefighting foam and contaminated water gushing into Tucker Bayou. "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. 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. Because it is volatile, it can spread to a distant source of ignition. It is not known if benzene exposure affects fertility in men. 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. But this doesn't mean you should stop wearing sunscreen altogether. 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. The analysis did not take into account the fact that hundreds of people actually sought medical care during the incident.
Deodorant and antiperspirant recall: What the finding of the - CNN Legally reviewed by Garrett Monteagudo, Esq. People can be exposed to benzene from gasoline fumes, automobile exhaust, emissions from some factories, and wastewater from certain industries. TheInternational Agency for Research on Cancer (IARC)is part of the World Health Organization (WHO). 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. The products include the five-ounce cans o Copperton Pure & Simple SPF 50, Coppertone Pure & Simple Kids SPF 50, Coppertone Pure & Simple Baby SPF 50, Coppertone Sport Mineral SPF 50, according to the Today Show, in addition to the 1.6-ounce can of Coppertone Sport Spray SPF 50. The emissions prompted the city of Deer Park to issue a second shelter-in-place advisory. But they kept working. If FDAs testing raises any safety concerns, then FDA will work with manufacturers to address those concerns. 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 . ToxFAQs for Benzene. 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. 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. 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.
Johnson & Johnson, which recalled sunscreens in July, said 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.. Benzene is a component of products derived from coal and petroleum and is found in gasoline and other fuels. Guevara worries that his family won't know the full impact of their benzene exposure for years. If needed, you can also contact the Occupational Safety & Health Administration (OSHA), which can provide more information or assistance. It is harmful to the eyes, skin, airway, nervous system, and lungs. Tax ID Number: 13-1788491. FDA recommends consumers do not use products that are being recalled or those hand sanitizers FDA recommends consumers should not use. Benzene in soft drinks is of potential concern due to the carcinogenic nature of the molecule.
11.6: Delocalized Electrons: Bonding in the Benzene Molecule Provides links and references to additional resources related to exposures to benzene. Since at least 2002, EPA and TCEQ inspectors had reported high emissions of benzene and other chemicals from that same area. "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.
BENZENE | Occupational Safety and Health Administration FDA recommends consumers use broad spectrum sunscreens with SPF values of at least 15, which have been shown to reduce the risk of skin cancer and early skin aging when used with other sun protection measures. 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. "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.". "Do you have anything that you can cover up with?" At the ITC tank farm, the fire was out, but a new danger emerged. Protons on carbons directly bonded to an aromatic ring, called benzylic protons, show up about 2.0-3.0 PPM. 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. The TCEQ, for its part, has beefed up its ability to test for airborne chemicals, adding new air monitors in the ship channel area since 2019 and purchasing three new air monitoring vehicles. The state health agency used that number when it analyzed the potential for health problems from the ITC fire, but TCEQ spokesperson Victoria Cann said the number "does not constitute a bright line" for health impacts and is "precautionary in nature." ITC said in a statement that morning that air monitoring readings were "well below hazardous levels." "Benzene really shouldn't be there at all," he said. undefined. What does it take to outsmart cancer? We continually gain additional knowledge about drugs which allows us to identify and quickly address previously unknown risks to consumers. Benzene is a chemical found in nature and manufactured products. 2023 American Cancer Society, Inc. All rights reserved. For additional questions, contact CDER-benzene@fda.hhs.gov. Its vapor is heavier than air and may sink into low-lying areas. Tumori. Texas' health agency similarly concluded that although benzene is a carcinogen, exposure during the incident "is not expected to increase people's risk of cancer. 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). 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. At room temperature, benzene is a colorless, or pale yellow, liquid with a . . Benzene is a carcinogenic substance that is present in a great number of modern products and industries.
Benzene | Medical Management Guidelines | Toxic Substance Portal | ATSDR Q: Is benzene in drugs a new problem? 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. To be clear, benzene isn't an ingredient intentionally included in any of the Johnson & Johnson products or the ones on Valisure's list; the products were found to be contaminated with benzene. People can also be exposed to benzene in contaminated drinking water and some foods (although the levels are usually very low). ", 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].". FDA and USP are working on the official removal of those carbomers and are planning to provide manufacturers with a period of time to reformulate products using safer drug components to avoid causing supply disruptions from the immediate removal of the carbomer monographs. Brent Weber, who was ITC's "incident commander" during the fire and is now the company's president and CEO, said during the same press conference that the company had encountered issues pumping the chemicals out of the damaged tanks over the weekend that caused an increase in benzene emissions.
"We are monitoring the air continuously, and there's nothing that's even come close to registering any kind of action item.". 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. 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. With exposures from less than five years to more than 30 years, individuals have developed, and died from, leukemia. Then another tank collapsed. Its also important to follow recommended screening guidelines, which can help detect certain cancers early. The Texas Tribune is a nonprofit, nonpartisan media organization that informs Texans - and engages with them - about public policy, politics, government and statewide issues. 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. Research. Benzene. It is highly toxic and is a known carcinogen; exposure to it may cause leukemia. 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. They could smell the chemicals in the air. On the heels of the report, Johnson & Johnson is recalling five of its sunscreens. 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. Benzene is released into the air in cigarette smoke, emissions from automobiles, and burning coal and oil. 95(1):8-12, January-February 2009. 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. Benzene can cause blood cancers like leukemia. On July 15, Johnson & Johnson voluntarily recalled and is advising consumers to stop using five of its Neutrogena and Aveeno aerosol spray sunscreens after benzene was detected in samples. "People were telling me these horror stories from other refineries that were happening, people getting sick," Ochoa said. Benzene evaporates into the air very quickly. As fire crews fought the last remnants of the fire, life in Deer Park returned to normal. 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. (More on that, below.). 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. This is personal.".
Benzene and Cancer Risk | American Cancer Society 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 colourless liquid with a characteristic odour and is primarily used in the production of polystyrene. 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 . Exposure to benzene has been linked with a higher risk of cancer, particularlyleukemiaand other cancers of blood cells. A: FDA is committed to ensuring drugs Americans use are safe and effective. Accessed at https://iris.epa.gov/ChemicalLanding/&substance_nmbr=276 on January 25, 2023. Still, the state renewed the chemical permit for ITC's Deer Park facility less than a year after the fire. Levels of benzene can be higher in enclosed spaces with unventilated fumes from gasoline, glues, solvents, paints, and art supplies. She stopped along a highway median, opened her car door and threw up. The level of exposure depends upon the dose, duration, and work being done. The county has created a community air response monitoring program, expanded staffing and purchased more disaster response equipment, said Dimetra Hamilton, a Harris County Pollution Control spokesperson. The first lasted 18 hours immediately after the fire broke out, and the second came three days later when air monitoring detected extremely high levels of benzene - an invisible, sweet-smelling hydrocarbon often found in crude oil and cigarettes. 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. 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. Why have there been so many recent reports of drugs containing benzene? Those who have purchased the products can request a refund by filling out a form online. ", "Benzene is associated with cancer usually after long durations (decades) of exposure," DSHS spokesperson Lara Anton said in a statement. Specifically, the ICH Q3C guidance explains that Class 1 solvents such as benzene should not be employed in the manufacture of drug substances, excipients, or drug products because of their unacceptable toxicity. Benzene was experimentally confirmed to be flat molecule by Dame Kathleen Londsale with X-ray crystallography. Certainly, over-exposure to benzene in any setting might generate a legal claim against the institution or person that caused the exposure. ", "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. TCEQ's stationary air monitor indicates that benzene concentrations in Deer Park had reduced to more typical levels by the late afternoon. 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 . 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. 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. Making Strides Against Breast Cancer Walks, ACS Center for Diversity in Research Training, Perfluorooctanoic Acid (PFOA), Perfluorooctane Sulfonate (PFOS), and Related Chemicals. 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. "It was scary.". The FDAs system really lacks independent review because it relies on companies to self report, Light said. Benzene is a six membered aromatic compound. The American Cancer Society looks to these organizations to evaluate the risks based on the available evidence. Mouton thanked first responders for their service. Despite the all-clear from city officials, Deer Park School District remained closed that Monday. There's been a growing concern among consumers that you can never be too sure what's in the sunscreen you're using or if its claims are valid. The last updated date refers to the last time this article was reviewed by FindLaw or one of ourcontributing authors. A 2010 analysis in the journal Environmental Health concluded that "exposure to benzene at work increases the risk of leukemia.". "People need to be able to make their own decisions," Hopkins said. Each refinery and importer must meet specific compliance baselines for conventional and . Which sunscreens were found to contain benzene? Hand sanitizers. Benzene is less dense than water and will float on the surface of water. But if you are concerned about benzene, you can limit your exposure in several ways . The most frequent symptoms were headache, throat irritation, nausea, coughing, dizziness and vomiting. A propellant like butane thats refined very early in the manufacturing process touches dozens of different hands in its journey from raw material to sunscreen on a shelf, yet nobody detected benzene, Light said. Pregnant women and persons concerned about using sunscreens on infants or children are encouraged to consult their health care professional. 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. "I'm a single father, I had to work," Ochoa said. Benzene can also be added in emergency situations, like the pandemic, or if it provides significant therapeutic advantages. 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. At the American Cancer Society, we have a vision to end cancer as we know it, for everyone. Some residents still blame the incident for lingering health problems. "My soul remembers. All rights reserved. An official website of the United States government, : Long term exposure to benzene through inhalation, oral intake, and skin absorption may result in cancers such as leukemia and other blood disorders. Stephen Rappaport, a leading environmental health sciences researcher who studies chemical exposures and professor emeritus at UC Berkeley's School of Public Health, said there is "no safe level for a carcinogen," but added, "the evidence shows it tends to be people who have a fairly high exposure for fairly long periods of time [who develop cancer]." Cars zoomed past her. Because of the dangerousness of the substance, various state departments, including the EPA, DHHS, and OSHA,regulate the presence of benzenein a variety of contexts. If you think you may have been exposed to benzene over a long period of time, talk to a doctor.
Your Gas Stove May Be Leaking Benzene Into Your Kitchen 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. Because it contains only carbon and hydrogen atoms, benzene is classed as a hydrocarbon. FDA has ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure the availability of safe and effective drugs for the American public. Scientists at the indepenent analytical lab Valisure have found benzene in numerous consumer health and beauty product samples. They cant reliably show how much benzene youve been exposed to, nor can they predict possible health effects. Then, their city. 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. There is much less evidence linking benzene to any other type of cancer. It is absolutely critical that you do not delay. Benzene is not an ingredient intentionally used in sunscreens, but the products on Valisure's list were found to be contaminated with benzene. "I thought to myself, 'This is not a migraine - this is totally different,' " she said.
Below is a list of commonly seen benzene-derived compounds. 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. 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. Before sharing sensitive information, make sure you're on a federal government site. "It's horrifying, scary. Benzene is one of the 20 most widely used chemicals in the United States. The American Cancer Society medical and editorial content team. 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. The Mobile Source Air Toxics (MSAT) rules reduce hazardous air pollutants, also known as air toxics, emitted by cars and trucks. Harris County produced an analysis of what went wrong during the response. We make every effort to keep our articles updated. 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. Now, Contreras is alert to strange odors in the air and watches for anything unusual at the nearby chemical plants - especially smoke. 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. 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. Federal Register. Whether you or someone you love has cancer, knowing what to expect can help you cope. Benzene overexposure is linked to the development of the following symptoms: drowsiness, dizziness, rapid or irregular heartbeat, headaches, tremors, confusion, and unconsciousness. (, It's also important to know that everyone is exposed to benzene frequently because it's found in the air from gas stations, vehicle exhaust, tobacco smoking, and certain manufacturing plants. Drug manufacturers should contact FDA using the information provided in FDAs alert if their testing reveals benzene in a product. 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).
Finding benzene everywhere we look - Chemical & Engineering News 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. "I can stand here today and tell you with assurance, that safety to the public is priority No.
Popular Dry Shampoos Found to Have Cancer-Causing Chemical 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)). Published by Statista Research Department , Mar 24, 2023. "That almost killed some firefighters," Royall said.
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