making a difference for dairy
Be Heard

Regulatory RoundUp

Get Involved

Advocacy: Dairy Counts

Join the Discussion

Dairy Forum

Dairy Delivers℠: The Economic Impact of Dairy Products
Advocacy: Dairy Counts
FDA Milk Safety Memoranda
Buyers' Guide
Member Hotlines
Dairy Market Prices
Quick Links

Dairy Facts 2016

FDA Releases FSMA Draft Guidance on Heat-Treating Foods

Sep 06, 2017

The Food and Drug Administration last week released draft guidance to help food manufacturers establish and implement proper heat treatment, such as baking or cooking, to prevent the presence of pathogens in food products. The document is the sixth chapter of draft guidance released by FDA to help companies comply with the Preventive Controls for Human Food rule stemming from the Food Safety Modernization Act (FSMA). The rule has been in effect for large companies since September 2016, and it will go into effect for businesses with fewer than 500 full-time employees on Sept. 18, 2017. Very small businesses, averaging less than $1 million per year in annual sales, must comply with the rule by Sept. 18, 2018.

The new chapter of FDA’s “Hazard Analysis and Risk-Based Preventive Controls for Human Food” draft guidance explains FDA’s current thinking on how food manufacturers should best design and validate heat treatments. It also includes examples that show companies how to apply heat treatments, including how to monitor the process to verify that a treatment is properly applied and how to conduct corrective actions, as needed.

The draft guidance may be applied by all dairy food companies, including those who produce products regulated under the Grade “A” Pasteurized Milk Ordinance (PMO), to the extent the PMO does not already provide prescriptive requirements for a heat treatment, such as pasteurization. The chapter does not include guidance on controlling bacterial pathogens by heat treatments such as aseptic and retort processes, which some dairy companies use to create shelf-stable products. Earlier this month, FDA released specific guidance for aseptic and retort processes that details which requirements under FSMA apply and do not apply. 

FDA said that it intends to release 14 more chapters of the guidance in the future. Since the announcement of the final rule in 2015, IDFA has hosted several webinars, courses, calls and event sessions aimed at helping members comply with the rule.

Read “Use of Heat Treatments as a Process Control” on the FDA website.

Members with questions may contact John Allan, IDFA vice president of regulatory affairs and international standards, at for more information.

Dairy Delivers