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More about sun protection and sunscreens can be found on the FDA website. (, 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. For additional questions, contact CDER-benzene@fda.hhs.gov. Short-term exposure to high levels of benzene can cause drowsiness, dizziness, unconsciousness, and death. The map shows benzene levels along the van's route. 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. 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. That day - four days after the ITC fire began - the EPA finally deployed its air monitoring bus, the rolling lab that could sample the air while it drove. (More on that, below.). 1987;52:3446034578. Q: What should manufacturers know about benzene in drugs? 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 . 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. A: Yes. In the end, officials decided that Deer Park and ITC would lead response efforts. "[He was] gasping for air in his sleep.". That day, his managers called him and his work team of about 10 people into the lunch room. 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. Though spray-on sunscreen was found to be contaminated most frequently, the chemical was also detected in lotions and gels. No shelter-in-place advisory was issued for Channelview residents. Manufacturers should not use benzene in the manufacture of drugs. 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. In many cases, Valisure found one batch of a product would contain benzene while another of the same product would not. 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. By FindLaw Staff | Costatini AS, et al. Molecular Weight 78.11. undefined. 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. (. An analysis of air quality data from a TCEQ's stationary Deer Park monitor southwest of City Hall shows that benzene emissions had risen early that morning to 61 parts per billion in an hour. New Engl J Med. 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. SAFETY DATA SHEET Revision Date 04/15/2023 Version 6 - Sigma-Aldrich