Food Safety Modernization Act

Earlier this week, the FDA published three anticipated waivers to the Food Safety Modernization Act’s Sanitary Transportation of Human and Animal Food Rule. The waivers may be of interest to certain shippers, carriers, and receivers of Grade “A” milk and milk products, food establishments that transport food, and businesses that transport molluscan shellfish.

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The final Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Rule (“Produce Safety Rule”) has proven to be one of the more confusing foundational rules issued by the U.S. Food and Drug Administration (“FDA”) under the Food Safety Modernization Act (“FSMA”). In particular, farmers have struggled to understand and come

On November 13, 2015, the U.S. Food and Drug Administration (FDA) finalized and released several new rules related to food safety. The new rules primarily deal with produce farm safety standards and with imported foods. They account for three of the FDA’s seven rules implementing the Food Safety Modernization Act. Previously, the FDA released rules on preventive controls both for human food and animal food. Still to be released are rules on sanitary food transportation and on protecting food against intentional adulteration. Below is a summary of the three newly released rules.

Produce safety. For the first time, produce growth, harvesting, packing, and holding will be subject to minimum federal safety standards. This rule refines the FDA’s 2013 proposed rule on produce safety and takes into account comments from businesses concerned about the financial burden of new regulations. The grace period for compliance varies depending on the size of the produce farm, with larger farms having less time to get in compliance. Several items addressed by the rule include:

  • Water quality and testing – The FDA has created criteria for water quality and is mandating testing of water for E. coli at frequency levels based on the water’s source.
  • Raw manure and compost – The rule sets limits on detectable amounts of certain bacteria in compost. It also establishes that raw manure on organic fields may continue to be used up to 90 days before harvest.
  • Sprouts – The FDA includes specific requirements for sprouts as they have recently been the subject of illness outbreaks and are considered especially susceptible to dangerous bacteria.
  • Animals – Farms are not required to exclude animals from growing areas, but standards are now in place for grazing animals, working animals, and intrusion by wild animals.
  • Cleanliness – The rule puts requirements on produce worker hygiene and also requires training for the same. In addition, the rule sets standards on equipment, tools, and buildings to prevent produce contamination.


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As part of the Food Safety Modernization Act (FSMA) passed in March of 2011, the FDA was given a mandate to update its regulations to create a new set of regulations/rules that enables it to prevent the introduction of adulterated food into the human and animal food supply in the U.S., as opposed to relying on the reactive approach it has utilized to date. The FDA is nearing the end of its rulemaking procedures to create Current Good Manufacturing Practices (or “cGMPs”) for animal foods. The comment period ended in March, 2014 and a final rule is expected shortly.

With the drafting of this new rule, the FDA has created similar cGMP requirements for manufacturers of animal food products. The rule would establish regulations controlling nearly every aspect of animal food production, from sourcing raw ingredients and on site storage and processing to the packaging, labelling and shipping of final products and waste and even to such seemingly minute details as the landscaping surrounding manufacturing facilities. These cGMPs would require animal food manufacturers to:
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