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. 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." Valisures hand sanitizer analysis found the highest levels of benzene in small brands that popped up as demand for the product spiked. Since at least 2002, EPA and TCEQ inspectors had reported high emissions of benzene and other chemicals from that same area. ", Fire rages as residents fall ill - March 17-19, 2019. Final Rule. Which sunscreens were found to contain benzene? Guevara worries that his family won't know the full impact of their benzene exposure for years. We can also help you find other free or low-cost resources available. 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.. 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. The Occupational Safety & Health Administration (OSHA) is the federal agency responsible for health and safety regulations in most workplaces. How benzene is landing in products remains a bit of a mystery in some instances. The symptoms of acute benzene toxicity will show up anywhere from a few minutes to a few hours after exposure. FDA evaluates and assesses the information provided in citizen petitions of this type and, if appropriate, initiates an independent testing and verification process. 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. An official website of the United States government, : The toxin has also been shown to harm the central nervous system and reproductive organs. The International Conference on Harmonization (ICH) Q3C Impurities: Residual Solvents guidance describes limited cases where the presence of benzene may be tolerated. But before you rub on another coat of SPF 50, you might want to do some quick research on the brand that you've been using (in addition to checking its expiration date, ofc). ", High levels of benzene detected for two weeks after the ITC fire. Air toxics include benzene and other hydrocarbons such as 1,3-butadiene, formaldehyde, acetaldehyde, acrolein, and naphthalene. Climbing benzene concentrations near the facility led the EPA and TCEQ to send inspectors into Deer Park, where they found benzene was drifting through neighborhoods near where Eddie Guevara and his family of five live. Benzene is released into the air in cigarette smoke, emissions from automobiles, and burning coal and oil. That's when he first saw the smoke coming from the ITC tank farm. 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. The federal, state and local officials who formed a "Unified Command" near the ITC facility after the fire erupted had to choose a threshold on the spot because there's no accepted national standard for how much benzene in the air should be considered dangerous. 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. Despite the large monitoring effort primarily led by the feds and the state, the results were "limited," often delayed, and not always immediately provided to local officials, according to a Harris County report. "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. Benzene pollution lingers as life returns to normal - March 25-29, 2019. Instead, they spend more time indoors playing video games. Protons on carbons directly bonded to an aromatic ring, called benzylic protons, show up about 2.0-3.0 PPM. If you feel like there's been a lot of concerning sunscreen news lately, you're not imagining it. Benzene can cause blood cancers like leukemia. ITC's operational permit is up for renewal this year and some residents have raised safety concerns about the facility ahead of the permit renewal; a public hearing will be held in May. 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. 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This can help lower your exposure to exhaust fumes, which contain benzene (as well as other potentially harmful chemicals). If benzene touches the skin, it can result in redness and blisters. They said the fire was nothing to worry about because the wind was blowing the danger away, but employees could go home if they were personally concerned. 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. Agency for Toxic Substances and Disease Registry. The level of exposure depends upon the dose, duration, and work being done. According to a preliminary report from the U.S. Chemical Safety and Hazard Investigation Board, the fire began in tank 80-8 and then spread to other nearby tanks. The American Cancer Society medical and editorial content team. 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. In 2020, the city created its own benzene guidelines that are far lower than what was used during the ITC incident: The guidelines say officials should consider a shelter-in-place advisory if benzene levels exceed 72 parts per billion over one hour and evacuations if the level hits 200 parts per billion for an hour. Their study, commissioned by the Houston Health Department, is awaiting peer review. Deer Park is one of a string of suburbs hugging the Houston Ship Channel, which is lined by chemical plants, refineries, smokestacks and flare towers that burn like enormous candles over a massive industrial skyline. "I try not to think about it, because when I do think about it, my heart feels it," Ochoa said. 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 highest levels were found in Sure, Old Spice, Secret, Equate, Right Guard, Tag and Brut. Breathing in high doses of benzene can affect the nervous system, which can lead to drowsiness, dizziness, headaches, tremors, confusion, and/or unconsciousness. Several common household brands including Sun Bum, Neutrogena, Banana Boat, and CVS-brand sunscreen were all found to contain unsafe levels of benzene, according to Valisure's test. 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. It's the dead of summer, so chances are you've been putting your sunscreen stash to good use. ", "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. She then watched as the smoke plume settled above the mourning family during the funeral service. "It's horrifying, scary. Areas with heavy traffic, gas stations, and areas near industrial sources may also have higher air levels. Experts say more shelter-in-place advisories should have been issued. 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. Firefighters and other first responders were ordered to wear respirators if the benzene level hit 500 parts per billion over 5 minutes, according to records obtained by the Tribune. Benzene has a sweet aromatic odor. The EPA bus typically only took measurements from 9 a.m. to 5 p.m. "Oh my God," Zhang said after seeing the benzene readings the EPA gathered near Channelview on March 29. Out of 260 samples from 168 brands sold on Amazon, at pharmacies and at box stores such as Target, 44, or about 17%, had detectable levels of benzene. Benzene - Cancer-Causing Substances - NCI 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. Paxton's office sued the company in 2019, but the case hasn't moved forward since 2021, according to Travis County District Court records. In a December statement, the agency said it was investigating the situation, doing its own testing and urged companies to recall contaminated products. 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. The data was collected by a mobile laboratory that roamed the area for two months after the fire erupted - one of many air quality devices deployed to monitor pollution at the time. He said they needed the money. The fire prompted Deer Park officials to advise residents to shelter in place that Sunday. Its also important to avoid secondhand smoke. 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. Making Strides Against Breast Cancer Walks, ACS Center for Diversity in Research Training, Perfluorooctanoic Acid (PFOA), Perfluorooctane Sulfonate (PFOS), and Related Chemicals. Ochoa quit his job as a pipe-fitter and found a job that doesn't expose him to chemicals. The map shows benzene levels along the van's route. 2023 American Cancer Society, Inc. All rights reserved. "Sufficiently protective values must be balanced against the inherent risk associated with actions such as evacuation.". New Engl J Med. 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. Still, the state renewed the chemical permit for ITC's Deer Park facility less than a year after the fire. Benzene is commonly found in air, but the levels in most places are usually very low. Benzene is not an ingredient intentionally used in sunscreens, but the products on Valisure's list were found to be contaminated with benzene. Use common sense around any chemicals that might contain benzene. Several US government agencies regulate benzene levels and exposures. ", 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. The emissions prompted the city of Deer Park to issue a second shelter-in-place advisory. 11.6: Delocalized Electrons: Bonding in the Benzene Molecule 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 lawsuit also asks that the company pay for residents' future doctor visits and tests for cancer. ", "Benzene is associated with cancer usually after long durations (decades) of exposure," DSHS spokesperson Lara Anton said in a statement. Yet throughout the area that day, residents from Deer Park and surrounding cities swarmed the pop-up county health clinics complaining of eye, ear, nose and throat irritation, severe headaches and trouble breathing. Consistent with the recommendations of the ICH Q3 guidance, manufacturers should not use benzene in the manufacture of drugs. The high readings along the highway likely wouldn't have prompted a response, he said, because the benzene levels quickly dropped again. For additional questions, contact CDER-benzene@fda.hhs.gov. Robert Hemminger, Deer Park's emergency services director at the time, told the public that benzene emissions had "significantly reduced" since that morning. 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. But Valisure, an online pharmacy that conducts routine batch tests of common consumer health products, recently shared some not-so-amazing findings about some sunscreens that may already be on your shelf. 2012. "That almost killed some firefighters," Royall said. 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 less dense than water and will float on the surface of water. But when an incident occurs at a facility like ITC that's located in an unincorporated area of the county, deciding who has jurisdiction can be complicated. 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. But Deer Park City Manager James Stokes said air monitoring readings looked "favorable" as the fire burned off the dangerous chemicals. Hemminger, the former Deer Park official, said in an interview that the city only warned residents if emissions exceeded the "action level" within the city's boundaries and were expected to linger, based on weather forecasts and subsequent readings. (You can find the full list on page 12 of the report here.) Meanwhile, an untold number of people were breathing benzene fumes without protection. Toxic burn pits put the health of US veterans at risk. Benzene is produced by both natural and man-made processes. Benzene, a Carcinogen Led to Sunscreen Recalls - Health IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. 15.3: Nomenclature of Benzene Derivatives - Chemistry LibreTexts By FindLaw Staff | But the description of the compounds in Aromatic 200 does not fit that of benzene, said Raynor, the University of Minnesota professor. But exposure to benzene at levels high enough to cause these symptoms is pretty rare. 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 . The TCEQ referred the ITC case to Attorney General Ken Paxton, whose office typically handles major industrial accidents. CTEH is known as an industry-friendly environmental consulting firm and is frequently hired by companies during chemical emergencies. 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." But the foam ripped apart with each big gust of wind and quickly dissolved on the hot chemicals like whipped cream melting on hot coffee. 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. Gasoline Mobile Source Air Toxics | US EPA Q: What should consumers know about drugs being recalled for benzene contamination? Emissions above that level don't trigger any regulatory action by the agency. The NTP has classified benzene as known to be a human carcinogen.. 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. Its also important to follow recommended screening guidelines, which can help detect certain cancers early. Some devices, including the EPA's air monitoring bus, were not deployed until days after the fire broke out. Note that 2-chlorophenol = o-chlorophenol. Ochoa said he asked whether his symptoms were related to the chemical fire. 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." In a press release that day, the city assured the public that the air quality in Deer Park was not a concern. "We feel safe at this time. IARC classifies benzene as carcinogenic to humans, based on sufficient evidence that it causes acute myeloid leukemia (AML). Centers for Disease Control and Prevention. They cant reliably show how much benzene youve been exposed to, nor can they predict possible health effects. Interventions to reduce both work and general population exposure include promoting the use of alternative solvents in industrial processes, developing and implementing policies and legislation to remove benzene from consumer products, discouraging domestic use of benzene . Q: What should manufacturers know about benzene in drugs? An official website of the United States government, : The American Cancer Society looks to these organizations to evaluate the risks based on the available evidence. It is harmful to the eyes, skin, airway, nervous system, and lungs. 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. Soon, the smoke blanketed their home. Short-term exposure to high levels of benzene can cause drowsiness, dizziness, unconsciousness, and death. Ash rained down on nearby neighborhoods. The site is secure. TermsPrivacyDisclaimerCookiesDo Not Sell My Information, Begin typing to search, use arrow keys to navigate, use enter to select, Please enter a legal issue and/or a location, Begin typing to search, use arrow As one of the most commonly-made chemicals in the United States, benzene is often used to make many other chemicals. 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. Available Every Minute of Every Day. In December 2020, the brand Purito came under fire for labeling its sunscreen as SPF 50 while independent lab results suggested it only provided SPF 19 protection. The contamination has been most frequently detected in aerosol or spray products, some at levels the Food and Drug Administration characterized as life-threatening. The EPA limits the percentage of benzene allowed in gasoline to a yearly average of 0.62% by volume (with a maximum of 1.3%). In Deer Park, Guevara said his eyes burned and his heart fluttered that first evening after he went home - he said he wasn't aware of the shelter-in-place advisory.