This voluntary recall is being conducted out of an abundance of caution.. Long-term exposure may affect bone marrow and blood production. Benzene is a colorless, flammable liquid with a sweet odor. 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 International Conference on Harmonization (ICH) Q3C Impurities: Residual Solvents guidance describes limited cases where the presence of benzene may be tolerated. 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. You can help reduce your risk of cancer by making healthy choices like eating right, staying active and not smoking. Procter & Gamble, Bayer, CVS and Johnson & Johnson have issued voluntary recalls for widely distributed brands including Brut, Sure, Pantene, Herbal Essences, Old Spice, Secret, Tinactin, Lotrimin, Coppertone, Neutrogena and Aveeno. (For more information on the classification systems used by these agencies, see Determining if Something Is a Carcinogen andKnown and Probable Human Carcinogens.). 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. Cigarette smoke (either from smoking yourself or fromsecondhand smoke) accounts for about half of the exposure to benzene in the United States. The EPA limits concentrations of benzene in drinking water to 5 ppb (parts per billion). It has a sweet odor and is highly flammable. 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 site is secure. The .gov means its official.Federal government websites often end in .gov or .mil. In 2021, the market is growing at a steady rate and with the . Guevara worries that his family won't know the full impact of their benzene exposure for years. But Seth Shonkoff, an associate researcher of environmental health sciences at the University of California-Berkeley, said it's "inappropriate to use occupational standards in a community setting" because they are designed for workers who are typically healthy adults trained to prevent chemical exposure with equipment such as respirators. A: FDA has alerted drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors. Whether you or someone you love has cancer, knowing what to expect can help you cope. "We didn't want to alarm the public needlessly," Hemminger said. The below chart summarizes when and how manufacturers should contact FDA if testing reveals the presence of benzene and the information FDA may request from drug manufacturers when following up: As FDA evaluates the root cause of benzene contamination in certain drugs, the agency is taking a stepwise approach to address the potential for benzene contamination in marketed drug products by first identifying products that should be immediately recalled or not released for distribution based on a benzene level in the products above 2 ppm consistent with the considerations described in ICH guidance. Together, were making a difference and you can, too. This contamination is a public health concern and has caused significant outcry among environmental and health advocates. Here's what you need to know about this news, including how to find out if your favorite sunscreen made the list of products containing benzene. This range is typically called the aromatic region of an 1 H NMR spectrum. 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. Though spray-on sunscreen was found to be contaminated most frequently, the chemical was also detected in lotions and gels. The TCEQ referred the ITC case to Attorney General Ken Paxton, whose office typically handles major industrial accidents. 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. Ochoa said he and his fellow workers were indeed concerned. There is much less evidence linking benzene to any other type of cancer. Fire flared up again briefly in one of the tanks, which were melting from the heat. undefined. 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. Such changes are commonly found in human leukemia cells. Ochoa grabbed a few pillows and tucked himself in a corner, hugging his son tight. FDA is also aware of ingredients, such as the antifungal preservative sodium benzoate, that in combination with chemicals, such as antioxidants in a drug formulation, may yield benzene under certain conditions. 2021. The American Cancer Society looks to these organizations to evaluate the risks based on the available evidence. With exposures from less than five years to more than 30 years, individuals have developed, and died from, leukemia. Areas with heavy traffic, gas stations, and areas near industrial sources may also have higher air levels. 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. 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. The city of Deer Park and ITC contracted with a company called CTEH to conduct hand-held air monitoring. Mouton thanked first responders for their service. Eddie Guevara, who's now 22, said officials should have been more honest with the public. Agency for Toxic Substances and Disease Registry. Then, Unified Command notified local authorities. 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. Their study, commissioned by the Houston Health Department, is awaiting peer review. 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. When inhaled in large quantities over a short period, benzene can affect the central nervous system and cause symptoms including dizziness, a rapid heart rate and headaches. But exposure to benzene at levels high enough to cause these symptoms is pretty rare. 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. This process includes securing product samples and performing independent evaluation of collected samples to assess the data presented in the citizen petition. County health providers screened more than 900 people and referred the worst cases to local hospitals. 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 . Exposure to benzene liquid or vapor can irritate the skin, eyes, and throat. Castiel kept waking Ochoa up with "horrible and terrifying" snoring. 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. Cars zoomed past her. The American Cancer Society offers programs and services to help you during and after cancer treatment. He said they needed the money. The emissions prompted the city of Deer Park to issue a second shelter-in-place advisory. If you feel like there's been a lot of concerning sunscreen news lately, you're not imagining it. "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.". Ten of the tanks - each big enough to hold more than 3 million gallons of chemicals - collapsed, sending chemicals gushing into the nearby ship channel and killing birds and fish. 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 The high readings along the highway likely wouldn't have prompted a response, he said, because the benzene levels quickly dropped again. Benzene is a colorless or light-yellow liquid chemical at room temperature. 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. The symptoms of acute benzene toxicity will show up anywhere from a few minutes to a few hours after exposure. New Engl J Med. (You can find the full list on page 12 of the report here.) When possible, limit the time you spend near idling car engines. Q: What should consumers know about drugs being recalled for benzene contamination? : 601-020-00-8 CAS-No. Now, Contreras is alert to strange odors in the air and watches for anything unusual at the nearby chemical plants - especially smoke. 2012. 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. Before sharing sensitive information, make sure you're on a federal government site. Robert Hemminger, Deer Park's emergency services director at the time, told the public that benzene emissions had "significantly reduced" since that morning. "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. (, 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. 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. The dangers of benzene mean that you should be alert to the possibility of exposure beyond acceptable levels. 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. A: Certain hand sanitizers and aerosol (spray) drugs, including antiperspirants and sunscreens, have been recalled due to benzene contamination. Places Where Benzene May Be Found. Benzene levels in rooms containing tobacco smoke can be many times higher than normal. Benzene can cause blood cancers like leukemia. "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. Benzene, a commonly used industrial solvent is also an air pollutant and a potent carcinogen. 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. Benzene is a six membered aromatic compound. This article has been written and reviewed for legal accuracy, clarity, and style byFindLaws team of legal writers and attorneysand in accordance withour editorial standards. It is absolutely critical that you do not delay. Therefore, no evaluation of cancer risk posed by exposure to benzene from this event was carried out.". 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." The last updated date refers to the last time this article was reviewed by FindLaw or one of ourcontributing authors. 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 pollution lingers as life returns to normal - March 25-29, 2019. All rights reserved. Benzene, a known cancer-causing chemical, was found in over half of 108 batches of antiperspirant and deodorant body sprays from 30 different brands, according to a citizen's petition filed this . In its report, Valisure argues that sunscreen production does not require benzene and that the FDA should "better define limits for benzene contamination in drug and cosmetic products." 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. ", "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.
Benzene - Cancer-Causing Substances - NCI 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. Rodney Reed, an assistant chief at Harris County Fire Marshal's Office, said that each city, as well as multiple county agencies, have the authority to issue shelter-in-place advisories. The toxin has also been shown to harm the central nervous system and reproductive organs. If you are person who smokes,try to quit. Harris County Judge Lina Hidalgo assured the public during a press conference that afternoon that the county was using "very conservative estimates to determine the threshold of dangerous levels of air quality.". That day, his managers called him and his work team of about 10 people into the lunch room. Products from household names like Purell and Suave didnt contain the chemical. She stopped along a highway median, opened her car door and threw up. Some devices, including the EPA's air monitoring bus, were not deployed until days after the fire broke out. Subsequently, two other petitions were filed raising concerns about the level of benzene in spray sunscreens, spray antiperspirants, and other drug and cosmetic products. Deer Park officials appeared to rely more on air monitoring readings from its hired contractor than the EPA's. The attorney general's office did not respond to requests for an interview. The wind was blowing the smoke toward his own home. A: Benzene is a chemical used in the production of a wide range of industrial products, including chemicals, dyes, detergents, and some plastics.
Benzene Factsheet. Product name : Benzene Product Number : 319953 Brand : SIGALD Index-No. "It was scary.". "With possible catastrophic consequences if we failed.". Paxton's office sued the company in 2019, but the case hasn't moved forward since 2021, according to Travis County District Court records. Medical authorities such as the Center for Disease Control and Prevention, the American Academy of Dermatology, and major physicians associations endorse similar recommendations. Benzene is made from coal and petroleum sources and is present in gasoline. The Mobile Source Air Toxics (MSAT) rules reduce hazardous air pollutants, also known as air toxics, emitted by cars and trucks. These tests can only detect recent exposures to benzene. While scientists have found that years of repeated exposure to benzene causes cancer, the long-term impact of being exposed to brief but high levels of benzene is less certain. Experts say more shelter-in-place advisories should have been issued.
Benzene and Cancer Risk | American Cancer Society FDA will advise on appropriate next steps such as notifying any entity that received contaminated API. 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. Some residents still blame the incident for lingering health problems. 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. Workers in industries that make or use benzene can be exposed to this chemical. A final report is expected this year. Whether you want to learn about treatment options, get advice on coping with side effects, or have questions about health insurance, were here to help. | Last reviewed December 15, 2022. However, most studies in people have not found an increased risk of cancers other than leukemia among those with higher exposures. At room temperature, benzene is a clear, colorless-to-light yellow liquid that is highly flammable.
Benzene | Definition, Discovery, Structure, Properties, & Uses The disaster also exposed confusion over who should be responsible for telling residents to shelter in place during a chemical release. Firms, FindLaws team of legal writers and attorneys, Complaint For Loss Due To Product Defect and For Discovery, Industrial cleaning and degreasing formulations, Gasoline storage, shipment, and retail operations, The air around waste sites and gas service stations, Contaminated well water, as a result of benzene leaks from underground storage tanks or hazardous waste sites containing benzene.
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