Application holders notified of benzene results from the manufacturer of an API used in their product are required to submit FARs. 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. FDA reminds manufacturers that changes in raw materials throughout the lifecycle of the drug, including changes in raw material suppliers, warrant additional scrutiny for the potential risk of benzene contamination. (A substance that causes cancer or helps cancer grow is called acarcinogen.) He felt helpless. Stay away from cigarette smoke. 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). Below is a list of commonly seen benzene-derived compounds. Benzene pollution lingers as life returns to normal - March 25-29, 2019. Several national and international agencies study substances in the environment to determine if they can cause cancer. Note that 2-chlorophenol = o-chlorophenol. 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). Accessed at https://emergency.cdc.gov/agent/benzene/basics/facts.asp on January 25, 2023. International Agency for Research on Cancer. But, "of course they are going to downplay it.". Q: What is the risk from using drugs contaminated with benzene? Final Rule. By clicking Accept All Cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. 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." Limit or avoid exposure to fumes from solvents, paints, and art supplies, especially in unventilated spaces. 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. A: Yes. Benzene is highly volatile and exposure occurs mostly through inhalation. In the Wynfield Estates neighborhood, where many of the homes are two-story red brick and shaded by big oak trees, Anthony Guevara, Eddie's 14-year-old brother, didn't go to school that Monday because his eyes were burning and his throat stung. "I thought to myself, 'This is not a migraine - this is totally different,' " she said. They could smell the chemicals in the air. The report found that health effects from benzene "were not expected to have occurred" due to the "short" amount of time high levels were detected. The fire began after a tank's pump failed and began to leak naphtha, a highly flammable liquid. It may appear colorless . Because it contains only carbon and hydrogen atoms, benzene is classed as a hydrocarbon. The wind was blowing the smoke toward his own home. Ochoa quit his job as a pipe-fitter and found a job that doesn't expose him to chemicals. Ji Z, et al. "We are monitoring the air continuously, and there's nothing that's even come close to registering any kind of action item.". How benzene is landing in products remains a bit of a mystery in some instances. Benzene has been shown to cause chromosome changes in bone marrow cells in the lab. Light pointed to decades of research that has found no safe levels of benzene exposure because its so toxic at very low levels. This can help lower your exposure to exhaust fumes, which contain benzene (as well as other potentially harmful chemicals). 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. Q: Should consumers continue using sunscreen? Though the agency lacks the authority to order recalls and may be limited in its pre-market authority to require testing, advocates are calling on the FDA to clarify an existing benzene limit, set new exposure limits, and conduct more testing of products on store shelves to ensure they are safe, instead of leaving that up to independent labs. In general, if you suspect that you may have been overexposed, you should act quickly to ensure an accurate reading. Benzene. Benzene can also be absorbed through the skin during contact with a source such as gasoline, but because liquid benzene evaporates quickly, this is less common. By Wednesday afternoon, four days after the ITC plant ignited, federal, state and local officials hosted a press conference to announce the fire was finally out. Contact us. Those workplace standards, he added, were a compromise between now-outdated benzene science and the economic impact on businesses. (, "Post-market consumer testing may often be different from preliminary formula testing for any number of reasons or factors," says Dr. Shamban. A: FDA has alerted drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors. Q: What should consumers know about drugs being recalled for benzene contamination? "I don't think anyone really understood the magnitude," Craft said. Available Every Minute of Every Day. "I'd be out here looking at the fire and start to feel my heart going crazy," he said. Accessed at https://ntp.niehs.nih.gov/ntp/roc/content/profiles/benzene.pdf on January 25, 2023. 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. Ochoa said he and his fellow workers were indeed concerned. Benzene evaporates into the air very quickly. Manufacturers of nonapplication products, including over-the-counter monograph drug products, should contact FDA using the information in the table below when testing reveals benzene in a product. Benzene levels in rooms containing tobacco smoke can be many times higher than normal. 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 staff checked him out and took his temperature, then told him to take ibuprofen or Tylenol for the headaches and over-the-counter nausea medication. But she added that it would be difficult to determine for sure. "I try not to think about it, because when I do think about it, my heart feels it," Ochoa said. Which sunscreens were found to contain benzene? 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. Toxic benzene has been found in antiperspirants, shampoos, sunscreens, hand sanitizers, and other products. 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. 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 can also be added in emergency situations, like the pandemic, or if it provides significant therapeutic advantages. The email address cannot be subscribed. 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). (modern). Likewise, the US Food and Drug Administration (FDA) sets a limit of 5 ppb in bottled water. People can be exposed to benzene from gasoline fumes, automobile exhaust, emissions from some factories, and wastewater from certain industries. New Engl J Med. This is personal.". What benzene is. 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. The Centers for Disease Control and Prevention reviewed air monitoring data from the incident and found that the concentrations of benzene exceeded what the agency considers safe - but did not believe they were high enough to cause widespread cases of cancer. Cancer Information, Answers, and Hope. However, most studies in people have not found an increased risk of cancers other than leukemia among those with higher exposures. Products from household names like Purell and Suave didnt contain the chemical. Here you'll find in-depth information on specific cancer types including risk factors, early detection, diagnosis, and treatment options. He took his son to the hospital the next morning. Benzene, a commonly used industrial solvent is also an air pollutant and a potent carcinogen. (, 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. 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. American Cancer Society medical information is copyrightedmaterial. Cars zoomed past her. Its also important to follow recommended screening guidelines, which can help detect certain cancers early. Still, the company decided to recall those five varieties of aerosol sunscreens "out of an abundance of caution," according to the press release. 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. Certain hand sanitizers and aerosol drug products have been recalled due to benzene contamination. Q: What should manufacturers know about benzene in drugs? Use common sense around any chemicals that might contain benzene. Benzene is a six membered aromatic compound. The NIOSH sets benzene's recommended occupational exposure limit at .1 parts per million (ppm), which makes Valisure's findings of 2 ppm or higher in some sunscreens, from Neutrogena, Sun Bum, and . 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. On March 31, two weeks after the ITC fire erupted into flames, the EPA mobile lab was still driving around Deer Park, testing the air. Legally reviewed by Garrett Monteagudo, Esq. Agency for Toxic Substances and Disease Registry. She then watched as the smoke plume settled above the mourning family during the funeral service. Spray sunblock and sun aftercare lotions. 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. Benzene and leukemia: An epidemiological risk assessment. ANSI Z37.4, Acceptable Concentrations of Benzene. 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. FDAs guidance Field Alert Report Submission: Questions and Answers Guidance for Industry addresses how to submit a FAR. "It's horrifying, scary. 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. Instead, they spend more time indoors playing video games. Eating foods or drinking fluids contaminated with high levels of benzene can cause vomiting, stomach irritation, dizziness, sleepiness, convulsions, and rapid heart rate. It's highly toxic to humans, which means it can harm you if you swallow it, touch it, or breathe it in. 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)). 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. Independent lab found the chemical in more than a quarter of items it tested sometimes at levels considered life threatening. The disaster also exposed confusion over who should be responsible for telling residents to shelter in place during a chemical release.
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