Compliance timetables arriving for federal Food Safety Act

Ray Mueller

Darboy — Federal legislation directed at creating “a food safety culture” is set to take effect at various stages over the next five years, Wisconsin Milk Marketing Board vice president for dairy company communications and technical services Matt Mathison reminded members of the Eastern Wisconsin Cheesemakers and Buttermakers Association at their 23rd annual convention.

Federal legislation directed at creating “a food safety culture” is set to take effect at various stages over the next five years.

That legislation is the Food Safety Modernization Act (FSMA), which was signed into law in early 2011 by President Barack Obama and which is to be administered by the federal Food and Drug Administration (FDA).

Development of the accompanying rules, consideration of more than 8,000 public comments to the original proposal and more than 1,300 to the supplemental proposal, and preparation of the final rule delayed the publication of those rules until September 16, 2015, Mathison observed.

What took effect even before the formal approval of the FSMA rules was the authority given to the FDA for mandatory recalls of food products, access to records covered by bio-terrorism laws, and the registration of food facilities in every even year, Mathison pointed out.

Compliance schedule

For the risk-based Preventive Controls for Human Food (PCHF) provision in FSMA, the compliance date is September 17, 2018 for businesses with less than $1 million in annual food sale. The same date applies to businesses subject to the pasteurized milk ordinance.

Food businesses with more than $1 million in annual sales but with less than the equivalent of 500 full-time employees have a compliance date of September 18, 2017 while all other businesses had a compliance date of September 19, 2016. Mathison indicated that the latter businesses most likely meet the requirements if they were already observing the good manufacturing standards and are carrying out the hazard analysis protocols.

Regarding good manufacturing practices, Mathison pointed out that one-third of food product recalls are due to cross contact with allergens. He said attention to training also needs to be emphasized in manufacturing plants.

With an exception for farms and retail food outlets, the PCHF regulation applies to all manufacturers, processors, packers, and holders of human foods from both domestic and imported sources, Mathison noted. There is also an exception for the food businesses with less than $1 million in annual sales or that have had an average less than $500,000 in sales for the previous three years.

Supply chain program

Another element of FSMA is the food supply chain program, which has compliance dates of September 19, 2018 and 2019 respectively for the non-exempt businesses with less than and more than the equivalent of 500 full-time employees. Mathison described this as “the biggest area of change” being addressed by the FSMA.

A supply chain program is “common sense” because it addresses the question of “who controls the safety of foods” but the FSMA provisions create a complexity that has so far extended the effective compliance date by two years, Mathison remarked. He explained that the supply chain program encompasses the use of approved suppliers, the determining, conducting, and documenting verification of supplier activities, and possibly having to verify the controls carried out by an entity other than the supplier.

Implementation difficulties

Development of a verification program on foreign suppliers has been delayed because the proposal for pay for it with a fee has prompted strong opposition within the industry, Mathison reported. Beyond that, he added, the FDA does not have enough inspectors to oversee that program and writing of the rules for a 3rd party accreditation program has not been completed.

An accompanying federal rule that proposed in December of 2013 and for which the final rule was published on May 27, 2016 requires food companies to have mitigation strategies to protect food against intentional adulteration. That plan, being titled “Food Defense Plan Builder,” can be submitted online, Mathison pointed out.

Compliance dates for the food defense rule are June 26, 2021 for very small food businesses, July 27, 2020 for those with less than the equivalent of 500 full-time employees, and July 26, 2019 for the larger businesses (those with the equivalent of more than 500 full-time employees).

Compliance support

For having a staff member meet the qualifications for overseeing the PCHF provisions of the FSMA, the Wisconsin Milk Marketing Board is offering 2 ½ day training sessions for developing and applying the risk-based preventive controls. Mathison said the next session is scheduled in March. Individuals can also qualify by having the appropriate job experience, he added.

In addition, the Wisconsin Cheese Makers Association has received a $152,000 federal grant from the National Institute of Food and Agriculture to help its members comply with the FSMA requirements, the association's executive director John Umhoefer told the convention attendees. He said the funding would support visits to plants by two specialists to provide consulting and training on the FSMA rules.

The project will be launched in early 2017 with a series of regional workshops for training on FSMA rules, Umhoefer reports. Those workshops will be open to all dairy manufacturers in the state.

By September of 2017, most dairy processors in Wisconsin must have food safety plans pertaining to the manufacturing practices, hazard analysis, and risk-based preventive controls for human food, Umhoefer indicates. He says the goal of the project is to help at least 50 of the affected processors in 2017 and notes that businesses with less than $1 million in food sales have until September of 2018 to comply.

Mathison can be reached by phone at (608) 203-7221 or (608) 444-1587 or by e-mail to To contact Umhoefer, call (608) 828-4550 or send an e-mail to