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In regard to the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) is expected to publish four proposed rules on Jan. 4, 2012, the first anniversary of its enactment. The FDA has set a self-imposed 60-day comment period for each. The four rules expected to be unveiled are:
To address concerns on these new rules, the FDA is expected to hold public meetings in Maryland, California and Illinois approximately one month after publishing them to allow for public comment. The hope is to create and continue a dialogue with industry, to discuss the positive and negative aspects of the rules during the pre-meeting that will lead up to the public meetings.
Public meetings are expected to take place as follows:
More information, as well as a list of frequently asked questions, is available here from the FDA.