WASHINGTON, Aug. 18, 2017 - Feed mills, grain processors and other facilities involved in supplying animal feed, including corn ethanol plants, face upcoming compliance dates for regulations intended to prevent spread of toxins, pathogens and other sources of contamination.
The regulations, implemented as part of the Food Safety Modernization Act, require grain and feed facilities to analyze the potential hazards in their grain supplies and processes and implement preventive controls to guard against potential contamination. Among the biggest concerns are mycotoxins, including aflatoxin, that fungus can sometimes produce in corn crops.
Larger feed facilities, those with 500 workers are more, were due to face routine government inspections as soon as next month on their preventive controls. The Food and Drug Administration has decided to give the plants another year before starting those inspections, but the agency has far taken no steps to weaken the requirements themselves, which some in the industry think are unnecessary and too burdensome.
“We still remain very concerned about the FDA’s lack of understanding on the miniscule benefit that this rule is expected to have on the feed industry,” said Richard Sellers, senior vice president of public policy and education for the American Feed Industry Association.
Industry officials say they also lack adequate guidance from FDA on how to comply with the FSMA requirements. AFIA has provided members its advice on how to comply, but that’s not enough, he said. Among the key concerns is: what steps must facilities put in place to show FDA they have an adequate pest control program.
FDA has released a draft guidance document for implementing “customary good manufacturing practices” (CGMPs) the first step in comply with the FSMA regulation, but is still developing the agency’s guidance for hazard analysis and preventive controls. Facilities with more than 500 employees were required to have proper CGMPs by last September.
CGMPs include general practices that any well-run plant does, including cleaning and proper maintenance of equipment. Preventive controls are intended to prevent specific hazards, such as mycotoxins or bacterial contamination, for which a particular plant would be at risk.
“Without official guidance, we are basically encouraging our members to move along with what we think is best when it comes to the hazard analysis and risk-based preventive controls portion of FSMA,” Sellers said.
Dave Fairfield, senior vice president of feed services for the National Grain and Feed Association, said many large companies already have safety plans and preventive controls in place, and other companies are moving forward in developing theirs, but at this point they don’t whether they will meet FDA’s expectations. “We’ve got regulatory text, but the words can mean a lot of different things,” said Fairfield.
Facilities with fewer than 500 employees but sales of more than $2.5 million a year must have CGMPs in place by next month - Sept. 18 is the official deadline - and then they have one more year to implement their preventive controls. Compliance dates for the smallest plants are in 2018 and 2019 respectively.
For ethanol plants, which are required to comply with FSMA because their main byproduct, distillers grains, is sold for livestock feed, implementing the CGMPs has been fairly straightforward. In some cases, it means doing things like hiring a pest control service or repairing a door, said Chad Poppe, director of compliance for Compli Associates, a Sioux Falls, S.D.-based consulting firm that advises about 60 ethanol plants on implementing FSMA regulations.
Ethanol plants fall into the smaller plant category, facilities with fewer than 500 employees but more than $2.5 million in annual sales, so they have until next month to have their CGMPs in place.
The FSMA safety plans for ethanol plants would include testing for mycotoxins and spelling out restrictions on where the distillers grains can be sold depending on levels of contamination that are found. The plan could dictate for example, that distillers grains with excessive levels of vomitoxin, or deoxynivalenol (DON), couldn’t be sold for swine feed, for example.
Another preventive control for an ethanol plant: Installing magnets on a conveyor belt to trap loose nuts or bolts.
A 2015 study by George Mason University’s Mercatus Center questioned whether FDA was justified in regulating livestock and poultry feed.
The agency’s preliminary regulatory impact analysis (PRIA) “appears to present evidence that the rule is not needed. It shows that costly recalls have created the right incentives in the animal feed industry to prevent further recalls,’ the study said.
The study said the feed recalls mentioned in the PRIA largely involved salmonella outbreaks linked to pet food and the intentional melamine contamination of pet food in China. “Thus, at a minimum, the only rule necessary might be one for pet foods,” which would affect only 300 to 400 processors, compared to the the 4,000 to 7,000 facilities involved in feed production, the authors wrote.
The Trump administration is so far going forward with the regulations. “We really feel that the preventive controls provisions are in the best interest of public health,” Jenny Murphy, a consumer safety officer at FDA’s Center for Veterinary Medicine, said in a Q&A posted on the agency website:
“The responsibility is on the firm to make sure it is addressing animal food safety. By keeping the compliance dates but not beginning routine regulatory inspections, we’re protecting food safety while giving facilities additional time to make sure the system is working correctly and to make adjustments if needed.”
Even though FDA won’t start its routine inspection of facility preventive controls for another year, inspectors will be checking plants’ CGMPs and will look over their preventive control plans to make sure they are adequate.
Murphy also left the door open to taking action against feed facilities, including mandating recalls, if they ship unsafe products.
Feed mills owned by vertically integrated livestock operations are exempt from the FSMA regulations because they are considered farms.