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Preventive Controls Rules Published Yesterday in Federal Register

Sep 18, 2015

The Food and Drug Administration (FDA) last week released pre-publication versions of its final Food Safety Modernization Act (FSMA) rules on “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” and “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.” These rules, known as the Preventive Control Rules, appeared yesterday in the Federal Register.  

“We are happy to see that many of the positive changes in the supplemental proposed rule will remain in the final version. Overall, the final rules seem to reflect many of the changes that industry had requested over the past few years,” said John Allan, IDFA vice president of regulatory affairs and international standards.

IDFA is still in the process of carefully reviewing the nearly 450 pages of final rules and will hold a webinar on September 24 to help members prepare for compliance. Register for IDFA’s Preventive Control Webinar here.

FDA will hold a public meeting about the final rules in Chicago on October 20. More information about the public meeting is available here.

Human Food Preventive Control Rule Highlights

  • All facilities regulated by the Pasteurized Milk Ordinance (PMO) will have their compliance deadline extended to September 17, 2018, to allow the National Conference of Interstate Milk Shipments to further align the PMO with the this rule during its 2017 meeting.
  • Environmental monitoring for pathogens in production facilities is not required, except when necessary to verify the effectiveness of sanitation controls for ready-to-eat food that is exposed to the environment prior to packaging and does not receive treatment or include a control measure that would significantly minimize the pathogen.
  • Finished-product testing is not required, but FDA expects facilities that produce food that has been associated with outbreaks of foodborne illnesses would establish product testing programs more often than those that do not produce such foods.
  • Facilities are allowed to manage a recall plan at the facility or corporate level, and it must be managed as a preventive control measure, not as a Current Good Manufacturing Practice (cGMP). 
  • Large and medium-sized facilities must comply with these rules next September. Small businesses (fewer than 500 full-time equivalent employees) must comply with the rules starting September 2017. Very small businesses (averaging less than $1 million per year in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale) have until September 2018 to comply.

Animal Food Preventive Control Rule Highlights

  • The definition of “further processing” excludes activities that are incidental to holding and distributing human food by-products, like passive dewatering or holding a food at a temperature to facilitate easier transportation, when the food is being diverted to animal feed.
  • FDA is considering updating the compliance policy guides that address the diversion of adulterated or contaminated human food to animal food.  The agency is developing several guidance documents, including one on Human Food By-Products for Use as Animal Food that will likely cover dairy by-products. 
  • Businesses have a staggered number of years after publication of the final animal rule to comply, based on business size.

IDFA Webinar to Include FDA Officials and FSMA Experts

With a year until these rules begin to be enforced for large and mid-sized companies, IDFA has developed a webinar to help members ensure that facilities and suppliers will be prepared. The webinar, “FDA Preventive Controls Final Rules: Learn what’s new and how they will impact your business,” will feature presenters from FDA and Hogan Lovells, IDFA’s outside legal counsel. The webinar will be held September 24, 2:00 - 4:00 p.m. Eastern.

The FDA officials will discuss the rules and what is generally required for compliance. The speakers from Hogan Lovells, who are renowned experts on the Food Safety Modernization Act, will cover what the rules will mean to the dairy industry. They are:

  • Jenny Scott, Senior Scientific Advisor, FDA Center for Food Safety and Applied Nutrition
  • Jenny Murphy, Consumer Safety Officer, FDA Center for Veterinary Medicine
  • Joseph Levitt, Partner, Hogan Lovells US, LLP
  • Elizabeth Fawell, Counsel, Hogan Lovells US, LLP   

Register for IDFA’s Preventive Control Webinar here.

Member with questions may contact Allan at

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