The U.S. Food and Drug Administration (FDA) has issued a finalized rule under the Food Safety Modernization Act (FSMA) that is intended to help prevent the contamination of human and animal food during transportation. Among other things, the sanitary transportation rule requires those transporting food by motor or rail vehicle to follow recognized best practices for hygiene, including the provision of appropriate temperature control, cleaning between loads and security measures. The rule was initially proposed in February 2014 and its final iteration took into consideration the comments of some 200 stakeholders. See Federal Register, April 6, 2016. Issue 599
Category Archives Issue 599
The U.S. Food and Drug Administration (FDA) has issued draft guidance proposing an action level of 100 µg/kg for inorganic arsenic in rice cereals for infants. The agency has also released supporting documentation for its proposal as well as a risk assessment that includes (i) “a quantitative estimate of lung and bladder cancer risk from long-term exposure to these products and the predicted impact of various scenarios to reduce the risk,” and (ii) “a qualitative assessment of certain potential non-cancer risks, in certain susceptible life stages.” “We conclude that the 100 µg/kg action level will help protect the public health and is achievable with the use of current good manufacturing practice, but we especially welcome comments and information bearing on the achievability and public health benefits and risks of 100 µg/kg, as compared with other potential action levels (including no action level),” states FDA, which will consider comments submitted by…
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