DDG manufacturers seek better understanding of FSMA compliance

By Katie Fletcher | August 07, 2014

A popular breakout session at the 2014 American Coalition for Ethanol conference discussed the potential impacts the Food and Drug Administration’s Food Safety Modernization Act may have on plant operations. Paula Emberland of Christian and Associates PLLP, Randy Ives of Gavilon and Charles Hurburgh of Iowa State University explained the proposed legislation, inspection and compliance, as well as the preventive controls and standards required that will have implications associated with dried distillers grains (DDGs) and other coproducts at ethanol plant operations.

President Obama signed FSMA into law Jan. 4, 2011. The act includes three additional rules: preventative controls for human food and animals, standards for produce safety and foraging supplier verification program for importers.

It wasn’t long before this that in 2010 Congress passed food safety legislation, determining science based standards for fruits and vegetables and now they have the new ability to hold food companies accountable for preventing contamination, with new inspection resources.

FSMA makes FDA’s inspection rights of concern to facilities that manufacture, process, pack or hold ingredients and finished products that are intended to be fed to animals, including livestock, pets and others. The FDA required registration of such facilities by Jan. 31, 2013. The panel at the ACE conference reminded producers to reregister their plant, with the next registration period being Oct. 1 through Dec. 31.

The proposed rule for animal feed is broke down into two areas. One area is current good manufacturing practices (cGMPs), involved with hygienic personnel practices and training, facility operations, maintenance, sanitation, equipment, processes, control, etc. The other is hazard analysis and risk-based preventative controls. In this area each facility would be required to prepare and implement a written food safety plan, which includes hazard analysis and recall plan monitoring among other requirements.

A written food safety plan would be required to detail the facility’s hazard analysis and risk-based preventative controls, as well as the facility’s monitoring, corrective actions, verification activities and recordkeeping requirements.  

The proposed rule was announced in October 2013 with a 120 day comment period, however, on June 17the FDA reopened the comment period due to the number of comments received, for an additional 60 days. The final rule is to be issued by Aug. 30, 2015, effective 60 days after the final rule is published. The sliding scale of compliance dates range based on size of facility. Large and other facilities must comply 12 months post publication of final rule, small or less than 500 employees 2 years and very small facilities 3 years.

The tone of the panel was to inform producers, so they are complying correctly with FSMA and can properly manage FDA inspections, and to discuss whether it should be viewed as an opportunity or a problem.

“Change is coming, distillers are a food, feed is food to the FDA,” Ives said. “One third of the corn used to make ethanol becomes distillers grains, most of which is fed to animals used to provide food.”

Adulteration was discussed on the panel, referring to substances that render the product harmful to human health. DDG producers become concerned with this because some don’t have covered or separate facilities for storage, and from time to time there is the capacity for contamination. “You can’t have rodents, birds, chemicals other things that can contaminate,” Ives said. “Restrict access, you can pick and choose what you want to do.”

Overall, Ives said that you have to keep the animal happy and healthy, and FSMA is ensuring this happens. Sanitary transportation is also encompassed in the rule. “Know what the trucker had in the truck the previous three loads,” Hurburgh said.

Supplier verification was another topic brought up in the panelist’s presentation. “Supplier verification means proof of analysis,” Hurburgh said. “The concept means the buyer has a more accurate statement of the, particularly food safety issues, in whatever it is they are buying, which includes DDGs and mycotoxin levels, also may include such things as amino acids because there is a passage in FSMA that refers to nutrient imbalance as a source of food safety.”

Hurburgh stressed the importance of documenting every step of the handling process, referring to FSMA as an IT guru’s hey day.

FDA is also going to designate high-risk foods (HRFs) for additional recordkeeping requirements. Designation of HRFs must be based on historical public health significance and outbreaks, feed included. “We don’t think too many ag products are going to fall into that category, except—the gorilla in the room for ag products is mycotoxins,” Hurburgh said. “It creates large issues for certain animal feed uses and pet food.”

Hurburgh said that it is not clear how intensely the FDA is going to look at mycotoxins, but “if it is intensive then bulk handling and bulk receiving of products will be pretty important.”

Rules on the horizon include FDA mandatory recall authority for DDGs and improving reportable food registry comments open until August 18. By 2015-‘16 full compliance of FSMA regulations is required.

“They are going to keep looking to try to ensure food safety,” Ives said. He ended his presentation by telling the audience that FSMA is coming soon to a production facility near you.

The general advice for producers was to make sure to keep accurate records, clean facilities and updated on the rules, because the FDA’s presence will continue to grow. “The new reality in the feed and biofuels world is that FDA is here to stay,” Ives said. “Ethanol companies need to get ahead of the curve by understanding FDA’s involvement in the industry.”