On Monday, the U.S. Food and Drug Administration released its draft Environmental Impact Statement (EIS) for the proposed produce safety rule under the Food Safety Modernization Act. The statement considers the four areas in the proposed rule that could significantly affect the environment: the definition of covered farms, water quality standards, the use of raw manure and compost, and provisions affecting domesticated and wild animals. The water standards were found to potentially have a significant adverse environmental impact, but FDA noted that most farms would not need to switch from surface water to groundwater or chemically treat their water because of a provision in the rule’s supplemental changes which would allow time for potentially dangerous microbes in agricultural water to die off. “There are critical groundwater shortages in certain parts of the country that would exist even if this proposed rule were not enacted,” the agency said in a Constituent Update. “Actions that may lead to increases in groundwater drawdown in parts of the country experiencing severe shortages would be considered a significant environmental impact.” A comment period of 60 days has opened for the draft EIS. Comments will be accepted until Friday, March 13, and the agency said it does not plan to extend the comment period. FDA will also hold a public meeting on the EIS on Tuesday, Feb. 10, in College Park, MD. The agency will consider public comments while drafting the final EIS and evaluate the potential alternatives it presents before finalizing the produce safety rule.
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The
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As part of modernization plans,
The FDA has issued final guidance for manufacturers of infant formula and laboratories conducting testing on infant formula.
The guidance was developed to help manufacturers and laboratories in the design,
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or
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