The manufacturer should also be prepared to share with FDA the methods used and any available information on the potential source of the benzene to assist with FDAs analysis. Manufacturers should generally not use benzene in the manufacture of drugs. Anemia (a low red blood cell count), which can cause a person to feel weak and tired. First, yes, sunscreen itself is safe and can help protect against skin cancer, the most common cancer in the United States (it also helps curb premature aging). 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." Sleepiness. 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. FDA has been in communication with USP about removing (or omitting) those carbomer monographs from their compendium since late 2020. ", Benzene pollution lingers as life returns to normal - March 25-29, 2019. If needed, you can also contact the Occupational Safety & Health Administration (OSHA), which can provide more information or assistance. In a statement, the FDA wrote it continues to monitor the issue and work with companies to recall contaminated products. These tests can only detect recent exposures to benzene. 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. Benzene is used in the manufacture of plastics, detergents, pesticides, and other chemicals. The .gov means its official.Federal government websites often end in .gov or .mil. Q: What is benzene? Volume 100F: Chemical Agents and Related Occupations. He took his son to the hospital the next morning. Contreras, now 62, said the doctor who saw her said her symptoms were caused by "high exposure to chemicals." Kids played kickball outside on the high school football field. Is the FDA serving these companies or the public? Andrews asked. More about sun protection and sunscreens can be found on the FDA website. 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. We make every effort to keep our articles updated. 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. The Mobile Source Air Toxics (MSAT) rules reduce hazardous air pollutants, also known as air toxics, emitted by cars and trucks. 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. Shell Oil Company built the first refinery in the area in 1928, and since then, generations of Deer Park residents have crossed state Highway 225 to work in the petrochemical industry. Their study, commissioned by the Houston Health Department, is awaiting peer review. 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. That's when he first saw the smoke coming from the ITC tank farm. Areas with heavy traffic, gas stations, and areas near industrial sources may also have higher air levels. Eating foods or drinking fluids contaminated with high levels of benzene can cause vomiting, stomach irritation, dizziness, sleepiness, convulsions, and rapid heart rate. We note that if decisions to not release a drug product or to initiate a recall are likely to disrupt the drug supply, manufacturers should contact CDERs Drug Shortages Staff immediately at drugshortages@fda.hhs.gov. "[He was] gasping for air in his sleep.". 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. The attorney general's office did not respond to requests for an interview. Below is a list of commonly seen benzene-derived compounds. Then, you should speak with a toxic torts lawyer. Finding benzene everywhere we look - Chemical & Engineering News We couldnt do what we do without our volunteers and donors. 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." The CDC did not recommend further health monitoring in the community. Benzene 71-43-2 Hazard Summary Benzene is found in the air from emissions from burning coal and oil, gasoline service stations, and motor vehicle exhaust. 11.6: Delocalized Electrons: Bonding in the Benzene Molecule 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. They adapted it from the federal workplace standard, which allows worker exposure up to 1,000 parts per billion over an 8-hour work day. 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. Long term exposure to benzene through inhalation, oral intake, and skin absorption may result in cancers such as leukemia and other blood disorders. Pump gas carefully and use gas stations with vapor recovery systems that capture the fumes. In fact, you can get started today with aclaim evaluation. Athlete . 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. Whether you or someone you love has cancer, knowing what to expect can help you cope. 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. The disaster also exposed confusion over who should be responsible for telling residents to shelter in place during a chemical release. Several US government agencies regulate benzene levels and exposures. When working at potentially higher exposure levels, OSHA requires employers to provide personal protective equipment such as respirators. All three tests urine, blood, and breath must be performed shortly after exposure, or else benzene levels may not be accurately indicated by the tests. But the description of the compounds in Aromatic 200 does not fit that of benzene, said Raynor, the University of Minnesota professor. "People need to be able to make their own decisions," Hopkins said. Benzene Gas Detector Market Share by 2030 - MarketWatch If you believe that you have been exposed to benzene beyond acceptable limits, please consider speaking with a qualified personal injury attorney to help determine the strength of your claim. The wind was blowing the smoke toward his own home. Which sunscreens were found to contain benzene? CDC | Facts About Benzene 2012. Among those with the highest levels were Neutrogena, CVS, Sun Bum, Raw Elements and Banana Boat. Each refinery and importer must meet specific compliance baselines for conventional and . 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 . 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. Provides references that aid in recognizing hazards and the health effects associated with benzene in the workplace. This contamination may be related to inactive ingredients such as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons. One of TCEQ's stationary air monitors near Spencerview Athletic Complex, about four miles south of San Jacinto Elementary School, was recording an average hourly concentration of about 40 parts per billion at 9 a.m. - about eight times higher than the highest concentrations usually recorded at that location. 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. Contaminated well water, as a result of benzene leaks from underground storage tanks or hazardous waste sites containing benzene. FDA alerts drug manufacturers to the risk of benzene contamination "So you can trust that if it's 1,000 parts per billion we will let you know.". "The duration of exposure related [to the ITC fire] was much shorter. Contact us. 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 then watched as the smoke plume settled above the mourning family during the funeral service. Benzene, a commonly used industrial solvent is also an air pollutant and a potent carcinogen. When he stepped out to the backyard, a sanctuary where his family usually grills and gathers around a table to gossip, he said he experienced chest pains. 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. Among the recalled hand sanitizer brands are Art Naturals, Best Brands and Natural Wunderz. The highest levels were found in Sure, Old Spice, Secret, Equate, Right Guard, Tag and Brut. He said county officials didn't feel they were being told everything they needed to know. Learn more about FindLaws newsletters, including our terms of use and privacy policy. 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. Benzene has a sweet aromatic odor. That highlights the complexities and lack of oversight in the global supply chains that produce personal care products. Product name : Benzene Product Number : 319953 Brand : SIGALD Index-No. What does it take to outsmart cancer? Or, they came too late for residents to take action. FDA is evaluating the root cause of benzene contamination and has alerted companies to the risk of benzene contamination in drug products and reminded them of their obligation to ensure their products meet appropriate quality specifications. Our team is made up of doctors andoncology certified nurses with deep knowledge of cancer care as well as journalists, editors, and translators with extensive experience in medical writing. Benzene is formed from natural processes, such as volcanoes and forest fires, but most people are exposed to benzene through human activities. 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. Certainly, over-exposure to benzene in any setting might generate a legal claim against the institution or person that caused the exposure. All rights reserved. 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. Now, Contreras is alert to strange odors in the air and watches for anything unusual at the nearby chemical plants - especially smoke. Benzene is a colorless, flammable and toxic liquid with carcinogenic properties that has a sweet, gasoline-like odor. 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. Original reporting and incisive analysis, direct from the Guardian every morning, 2023 Guardian News & Media Limited or its affiliated companies. "Daily exposure to benzene at the levels detected in these affected Coppertone aerosol sunscreen spray products would not be expected to cause adverse health consequences based on generally accepted exposure modeling by numerous regulatory agencies," said Coppertone in its news release. Accessed at https://wwwn.cdc.gov/TSP/ToxFAQs/ToxFAQsDetails.aspx?faqid=38&toxid=14 on January 25, 2023. Benzene is an organic chemical compound with the molecular formula C 6 H 6. Stay up-to-date with how the law affects your life. (For more information on the classification systems used by these agencies, see Determining if Something Is a Carcinogen andKnown and Probable Human Carcinogens.). The lawsuit also asks that the company pay for residents' future doctor visits and tests for cancer. Deer Park officials appeared to rely more on air monitoring readings from its hired contractor than the EPA's. 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. "After the fire fight was over, that's when the benzene issues began to rear their ugly head," said Royall, the former assistant chief of Harris County Fire Marshal's Office. 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. Molecular Weight 78.11. The highest levels of exposure typically have been in the workplace, although high-level exposures have decreased greatly over the last several decades due to federal and state regulations. 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 March 2021, FDA received a citizen petition raising concerns about the level of benzene in certain hand sanitizers and other products. Drug manufacturers with a risk for benzene contamination should test their drugs accordingly and should not release any drug product batch that contains benzene above 2 ppm, consistent with the recommendations described in ICH Q3C. The Occupational Safety & Health Administration (OSHA) is the federal agency responsible for health and safety regulations in most workplaces. Some women who have breathed in high levels of benzene for many months have had irregular menstrual periods and ovary shrinkage, but it is not known for sure if benzene caused these effects. Rinsky RA, Smith AB, Hornung R, et al. FDA evaluates and assesses the information provided in citizen petitions of this type and, if appropriate, initiates an independent testing and verification process. Benzene: Can it cause leukemia? - Medical News Today Cancer.org is provided courtesy of the Leo and Gloria Rosen family. In general, if you suspect that you may have been overexposed, you should act quickly to ensure an accurate reading. Although FDA testing is rigorous and standards are high, it's not a foolproof system, she adds. Meeting with a lawyer can help you understand your options and how to best protect your rights. At the ITC tank farm, the fire was out, but a new danger emerged. Hand sanitizers. They cant reliably show how much benzene youve been exposed to, nor can they predict possible health effects. Four years later, Deer Park residents who fell ill - some of them children, elderly or otherwise at higher risk - said they sensed at the time that they were more exposed to chemicals than they were told. Occupational exposure to benzene. 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. "Anytime you see any kind of black smoke out there, it's not good," he said. 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. "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. Drug manufacturers should contact FDA using the information provided in FDAs alert if their testing reveals benzene in a product. The .gov means its official.Federal government websites often end in .gov or .mil. We note that certain United States Pharmacopeia National Formulary (USP-NF) carbomer monographs allow for levels of benzene of 100 ppm or greater. Meanwhile, a portion of a dike wall surrounding the tank farm collapsed, sending petrochemicals, firefighting foam and contaminated water gushing into Tucker Bayou. 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. Certain hand sanitizers and aerosol drug products have been recalled due to benzene contamination. Advocates took aim at the Food and Drug Administration for failing to do more to protect the public. 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.