A regulatory impact analysis (RIA) must be prepared for rules with significant regulatory action/s and/or with significant effects as per section 3(f)(1)) greater than $100 million or more in any one year
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Excessive ROS triggers oxidative stress Although ROS production in mitochondria is in balance with an intracellular antioxidant system under physiological conditions, the balance is easy to be disrupted under pathological conditions, such as radiation, hypoxia, cytokines, hyperlipidemia, and hyperglycemia, which results in the accumulation of ROS, facilitating oxidative stress, cell damage, and diseases, such as cancer, cardiovascular disease, neurological disease, respiratory disease, and so on
Nobody can give you an honest probability of harm because the studies that would generate one have not been done