CAS 71-43-2. Benzene is used in the manufacture of plastics, detergents, pesticides, and other chemicals. Toxic burn pits put the health of US veterans at risk. A: FDA has alerted drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors. For two months after the 2019 fire, an Environmental Protection Agency van traveled around a region east of Houston capturing thousands of measurements of benzene - a known human carcinogen that can cause headaches, nausea and other symptoms. 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. Chemical Safety and Health - WHO "Benzene is a chemical that, when activated with exposure to the skin, blood, or organs, can affect changes in your DNA that cause mutations for cancers," says Madhuri Chadha, M.D., founder of Dr. Madh Skin Solutions and radiologist currently working in aesthetic dermatology. Benzene is a component of products derived from coal and petroleum and is found in gasoline and other fuels. 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%). Its also important to follow recommended screening guidelines, which can help detect certain cancers early. Why have there been so many recent reports of drugs containing benzene? A: While benzene is not usually used in the manufacture of drugs, the contamination may be related to inactive ingredients in drugs such as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons (chemicals made of hydrogen and carbon). 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. On six of those days, the spikes occurred in industrial areas near the ITC facility, but on March 31 - a full two weeks after the fire began - benzene spikes above 1,000 parts per billion were recorded in a residential area of Deer Park. Legally reviewed by Garrett Monteagudo, Esq. As he installed pipes, he said his lungs ached when he took deep breaths. Meanwhile, a portion of a dike wall surrounding the tank farm collapsed, sending petrochemicals, firefighting foam and contaminated water gushing into Tucker Bayou. Areas with heavy traffic, gas stations, and areas near industrial sources may also have higher air levels. Fewer than 10 miles from where Guevara stood, firefighters rushed to the ITC facility and put their lives on the line in a war against the fire - fueled by 12.3 million gallons of highly flammable chemicals - that would burn for 64 hours straight. Benzene is a hydrocarbon, which means it is an organic compound resulting solely from the elements carbon and hydrogen. 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. Eddie Guevara, who's now 22, said officials should have been more honest with the public. Areas with heavy traffic, gas stations, and areas near industrial sources may also have higher air levels. "I'm a single father, I had to work," Ochoa said. FDAs guidance Field Alert Report Submission: Questions and Answers Guidance for Industry addresses how to submit a FAR. (For more information on the classification systems used by these agencies, see Determining if Something Is a Carcinogen andKnown and Probable Human Carcinogens.). TheInternational Agency for Research on Cancer (IARC)is part of the World Health Organization (WHO). Benzene is made from coal and petroleum sources and is present in gasoline. Manufacturers should not use benzene in the manufacture of drugs. What is benzene, exactly? 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)). It may appear colorless . 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. The TCEQ, meanwhile, advised "sensitive populations" - including elderly residents, pregnant people and children - to limit outdoor physical activity and told everyone to avoid any black smoke still drifting through the area. 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. Other people who may be exposed to benzene at work include steel workers, printers, lab technicians, gas station employees, and firefighters. 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. "Benzene really shouldn't be there at all," he said. Benzene is a potentially dangerous chemical. The city also released a statement that day to its residents: "We did not receive any readings above actionable levels over the weekend," it said, citing data from CTEH, the company the city and ITC had contracted to conduct air monitoring. Report on Carcinogens, Fifteenth Edition. Places Where Benzene May Be Found. Benzene - Benzene - Sigma-Aldrich 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. What Is Benzene? Carcinogen Found in Some Sunscreens, Explained 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 After reaching a low of 498 U.S. dollars per metric ton, the global price of benzene has increased . How benzene is landing in products remains a bit of a mystery in some instances. 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. It's the dead of summer, so chances are you've been putting your sunscreen stash to good use. Although FDA testing is rigorous and standards are high, it's not a foolproof system, she adds. 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. 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. Benzene | Dangers of Exposure, Cancer Risks and Treatment 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 . The bigger concern is the long-term effects of low-level benzene exposure. It is formed through both natural processes and human activities, but importantly, a high level of exposure to benzene can be quite dangerous. 2018. Seven were now burning; the tanks contained naphtha, xylene, gas blendstock and pygas, a blend of chemicals that's rich in benzene. Benzene in soft drinks - Wikipedia "That kind of turmoil is haunting," said Ochoa, who is now 43. Though spray-on sunscreen was found to be contaminated most frequently, the chemical was also detected in lotions and gels. And now, Johnson & Johnson is voluntarily recalling five of its Neutrogena and Aveeno sunscreens some of which were mentioned in Valisure's report after their own internal testing found low levels of benzene in some samples of the products, according to a company press release. 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.. But exposure to benzene at levels high enough to cause these symptoms is pretty rare. 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). Contact a qualified product liability attorney to make sure your rights are protected. Pregnant women and persons concerned about using sunscreens on infants or children are encouraged to consult their health care professional. IARC classifies benzene as carcinogenic to humans, based on sufficient evidence that it causes acute myeloid leukemia (AML). "If we get something sustained above [1,000 parts per billion], we notify the local governments to evacuate or shelter-in-place, whichever is more appropriate for the community," Adams said. The most frequent symptoms were headache, throat irritation, nausea, coughing, dizziness and vomiting. This process includes securing product samples and performing independent evaluation of collected samples to assess the data presented in the citizen petition. This information will help inform further updates to FDAs approach to limiting benzene levels in drug products, as appropriate. Air toxics include benzene and other hydrocarbons such as 1,3-butadiene, formaldehyde, acetaldehyde, acrolein, and naphthalene. 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. Benzene is a colorless or light-yellow liquid chemical at room temperature. The email address cannot be subscribed. 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. Such changes are commonly found in human leukemia cells. Accessed at https://publications.iarc.fr/123 on January 25, 2023. When possible, limit the time you spend near idling car engines. The Occupational Safety & Health Administration (OSHA) is the federal agency responsible for health and safety regulations in most workplaces. Benzene is commonly found in air, but the levels in most places are usually very low. They cant reliably show how much benzene youve been exposed to, nor can they predict possible health effects. 2012. For reprint requests, please see our Content Usage Policy. Its vapor is heavier than air and may sink into low-lying areas. The remaining chemicals in the collapsing tanks were venting into the open air. 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. Benzene in soft drinks is of potential concern due to the carcinogenic nature of the molecule. 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. benzene (C6H6), simplest organic, aromatic hydrocarbon and parent compound of numerous important aromatic compounds. Emissions above that level don't trigger any regulatory action by the agency. Below is a list of commonly seen benzene-derived compounds. Accessed at https://ntp.niehs.nih.gov/ntp/roc/content/profiles/benzene.pdf on January 25, 2023. The fire began after a tank's pump failed and began to leak naphtha, a highly flammable liquid. Browse Benzene and related products at MilliporeSigma. It is used mainly to make other chemicals, including plastics, resins, lubricants, rubbers, dyes, detergents, drugs, and pesticides. But the description of the compounds in Aromatic 200 does not fit that of benzene, said Raynor, the University of Minnesota professor. The high readings along the highway likely wouldn't have prompted a response, he said, because the benzene levels quickly dropped again. Exposure to benzene and risk of breast cancer among shoe factory workers in Italy. 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. But Deer Park City Manager James Stokes said air monitoring readings looked "favorable" as the fire burned off the dangerous chemicals. This contamination may be related to inactive ingredients such as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons. 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 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. A low blood platelet count, which can lead to excess bruising and bleeding. TCEQ inspectors recorded three benzene spikes on handheld air monitoring devices above 1,000 parts per billion on East Boulevard the morning of March 31. Those who have purchased the products can request a refund by filling out a form online. ITC spokesperson Alice Richardson choked up during a press conference after the second shelter-in-place advisory, outlining how the company and first responders were attempting to reduce the emissions. (You can find the full list on page 12 of the report here.) Benzene is not an ingredient intentionally used in sunscreens, but the products on Valisure's list were found to be contaminated with benzene."Benzene is a chemical that, when activated with exposure to the skin, blood, or organs, can affect changes in your DNA that cause mutations for cancers," says Madhuri Chadha, M.D., founder of Dr. Madh Skin Solutions and radiologist currently working in . ", "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. Volume 100F: Chemical Agents and Related Occupations. 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. 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. Benzene overexposure is linked to the development of the following symptoms: drowsiness, dizziness, rapid or irregular heartbeat, headaches, tremors, confusion, and unconsciousness. 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 bus recorded several spikes of benzene above 1,000 parts per billion on Friday afternoon outside of the San Jacinto Battleground State Historic Site, a popular tourist destination just down the road from ITC (it was closed to the public during the fire). 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. 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. Benzene | Medical Management Guidelines | Toxic Substance Portal | ATSDR "It was a missed opportunity because [the data from the EPA's mobile lab] could've been used to inform some of the public health decisions, but it doesn't seem like it was.". Facts About Benzene. The Global Benzene Gas Detector market is anticipated to rise at a considerable rate during the forecast period, between 2022 and 2030. "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. 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. "What we're seeing is a fundamental problem in the manufacturing of a lot of consumer products." To date, Valisure has tested 662 . Benzene - Cancer-Causing Substances - NCI Concurrently, the agency will review any Field Alert Reports from drug manufacturers that identify the presence of benzene, in addition to other available information. We can also help you find other free or low-cost resources available. Accessed at https://emergency.cdc.gov/agent/benzene/basics/facts.asp on January 25, 2023. International Agency for Research on Cancer. 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. 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. 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.