Subscribe to our monthly Newsletter

You will promptly receive all the news about the traceability world. Software, training, bibliography or opinion articles.


Are you ready for FSMA?

April 17, 2016 7:38 am1 commentViews: 16

ROCHESTER, Minn. — Changes to regulations surrounding grain storage and processing are ahead via the Food Safety Modernization Act, which gave the Food and Drug Administration new authority over human and animal food.

Luckily, many operations already have practices in place fitting the rules FDA has released guiding its new oversight, though some additional documentation might be necessary.

Industry experts have organized education sessions to help those involved in handling grain get a handle on FSMA and what it means for their operations. In Minnesota, the state Department of Agriculture, the Minnesota Grain and Feed Association, the National Grain and Feed Association and the Governor’s Food Safety and Defense Task Force of Minnesota partnered to offer three informational meetings to help parse out the rules.

Though the law was passed in 2011, portions of it have rollout dates into 2018. FSMA includes the Veterinary Feed Directive, which affects feeds containing antibiotics and goes into effect Jan. 1, 2017. That’s not all that applies to grain elevators and mills, it’s just the regulation that’s going into effect first, said Doug Lueders, commercial feed program manager with the Minnesota Department of Agriculture.

“You’re going to have to work at this,” said David Fairfield, feed services senior vice president for the National Grain and Feed Association.

Prevention is the focus

The FDA’s expanded authority focuses on prevention, particularly through the use of best management practices. Details vary depending on the size and type of grain-handling business. The basics:

• Several new authorities were granted to the FDA. Facilities that handle human or animal food will have to register online with the FDA every two years. The agency may issue mandatory recalls on products if the situation warrants. It also has broader authority to access food- and feed-related records if a food safety incident occurs. Further, FDA now will be inspecting all food and feed facilities. Inspections will focus on having processes in place, and inspectors will need to readily observe that those processes are being followed. If facilities need to be reinspected or in the course of a mandatory recall, FDA may impose fees to the tune of $217 per hour.

• The new rules apply to any facility that must register as a “food facility,” including animal feed, with FDA according to the Bioterrorism Act, Fairfield said. Farms generally are exempted, regardless of size. A notable exception to the farm exemption rule includes contract livestock growers who are feeding feed brought in from a farm that isn’t their own (farms not under the same management).

• Within FSMA, the subsection regarding human and animal food current good management practices and preventive controls doesn’t apply to businesses, particularly grain elevators or warehouses, that solely store grain and oilseeds and don’t process them in any way beyond hulling, shelling, drying, packing and/or holding. Fairfield posited that operations handling dried distillers grains need clarification under the new rules. Grain millers and processors, however, likely will have to comply, and feed and pet food manufacturers will, too.

• CGMPs involve demonstrating good practices at the facility. These are generally things that inspectors should be able to observe, such as having a hand-washing facility or a logical place to put clothing, such as the office rather than the receiving area. All efforts are fairly common sense to avoid potential contamination. CGMPs don’t require documentation or recordkeeping other than records showing training has occurred that are retained for two years.

• Operations that process human and animal food will have to conduct a hazard analysis and implement preventive controls for identified hazards, all of which needs to be documented in a written food safety plan. Hazards include anything “known and reasonably foreseeable” that has the potential to cause illness or injury in humans or animals, according to the rule. Preventive controls are risk-based practices used to prevent feed from becoming adulterated. A qualified individual, whether via experience, training or both, must put together or oversee the compilation of the written plan. Matt Frederking, vice president of regulatory affairs and quality with Ralco Nutrition, dove deep into details regarding CGMPs, preventive controls and other details surrounding FSMA implementation during the Minnesota informational meetings.

Because Canada is so close and feedstuffs occasionally cross international lines, Fairfield noted, entities that import grain, oilseeds and feed ingredients from elsewhere will need to go through a foreign supplier verification program. This applies to the importer only, not necessarily the warehouser of the imported product, Fairfield said. In certain situations, importers will have to go through accreditation via a third-party auditor.

More details coming

FDA hasn’t released details regarding its Sanitary Transportation of Food and Food Defense and Intentional Adulteration rules within FSMA. Those are expected later this spring. While the Sanitary Transportation of Food rule will apply to all non-farm feed handlers, the Food Defense and Intentional Adulteration rule is likely to have a narrower, more human food focus, Fairfield said.

“First, you need management commitment,” Frederking said. “I hope there’s a team behind you at home that’s going to help you implement this. Figure out how to apply this knowledge to your facility.”

These details just scratch the surface of FSMA. When it was first published in the Federal Registrar, it ran for more than 600 pages. Fairfield and Frederking encourage those in the human and animal food industries to read the full act and start parsing out what it means for their operation now rather than waiting until the appropriate implementation date is right around the corner.

Leave a Reply