Beyond Feed

Proposed FDA regulations raise compliance questions among ethanol producers.
By Susanne Retka Schill | June 10, 2014

Under the Food Safety Modernization Act, the ethanol industry is facing another set of recordkeeping requirements, new good manufacturing practices (GMP) and a new agency looking over its shoulder, the Food and Drug Administration. Exactly what those FSMA rules will require isn’t known yet—the deadline for the final rule to be published isn’t until next summer, and it appears most in the industry will have a couple of years to comply once they are promulgated.

Though compliance with FSMA is not imminent, many are wondering just how much change lies ahead for distillers grains producers. The ethanol industry will get a second look at the proposed rules later this summer, when revisions to several sections are reopened for comment.  The two of most interest to the ethanol industry include GMPs for the production of animal food and preventive controls. Long in place for human food manufacturing, GMPs will be a new requirement for the animal feed industry. Hazard analysis and preventive controls will be new to both human and animal food manufacturers.
The first reworking of food safety rules in many years, FSMA reflects the growing need to move away from reaction to prevention, says Daniel McChesney, director of the office of surveillance and compliance at the FDA Center for Veterinary Medicine. The change in focus found in the FSMA legislation was supported by consumers, Congress, industry and the agency, he says. “It was driven by a lot of things, one, the globalization of the food and feed supply.”

McChesney says a 2007 incident played a big role in the adoption of FSMA. “There was concern over food safety and people were talking about moving towards prevention,” McChesney recalls. “Then we ended up with melamine in pet food and FDA got 18,000 consumer calls about sick and dying pets.”  It was the most calls the agency had gotten ever, or since. “Pet food was the snowball that started rolling down the mountainside. Things really picked up quickly after that and moved toward prevention.” FDA’s role in ensuring food safety has been expanded and within FDA, the Center for Veterinary Medicine is expanding its role, from overseeing the manufacturing of medicated feeds, to ensuring GMPs and preventive controls are in place among feed manufacturers and suppliers of feed ingredients.

The timeline between the act becoming law in 2011 and the deadline for publication of proposed rules was tight. “On the animal feed GMP side,” McChesney says, “we looked at the time frame, we looked at writing GMPs and we said we’re going to take the human GMPs, modify them slightly, put that out as our proposal and ask industry, are these practical?” 

Industry Reaction
The feed industry found multiple problems. “From an animal feed standpoint, we do not think that good manufacturing requirements need to be as stringent for animal feed as they need to for human food,” says David Fairfield, vice president, feed services for the National Grain and Feed Association. There are obvious reasons, he points out, when, where and how animals are raised is compared to how humans live. “The idea that animal feed needs to be produced under the same hygienic standards and conditions as human food is not realistic,” he says. “We commented extensively to FDA.” Indeed, NGFA submitted more than 100 pages of comments. “Our view is that the preventive control requirements are way too onerous as well,” he adds. While he expects modifications to the language, he does not expect the recent calls for an exemption or special treatment of spent brewers grains in the regulation to be extended to the fuel ethanol industry’s coproduct.

McChesney confirms that, explaining that the issue is broader than just spent brewers grains. “When we put out new language, it will be addressing all the human food manufacturing coproducts going to animal feed, and not just the spent grains, though admittedly, the spent grains brewers were the most vocal.” Though the end product, distillers grains, is the same, the two industries are in very different categories, he says. “The real difference is that the brewers and human distillers are working under the human food GMPs, starting with food grade material, using food grade vessels.” The fuel ethanol process, on the other hand, is industrial, without similar requirements in place.

He adds that in reviewing the 2,000-some comments made on the rule, there was a common theme. “Basically, all said the GMPs were too prescriptive as written and they needed to be modified or changed to be more appropriate for animal feed. We’ve taken that to heart and we’re doing that.” The revisions should be reopened for comment later this summer, he adds.

Ethanol Impact
Although the ethanol industry isn’t relishing the thought of a new set of regulatory requirements, many are thinking that it’s too far off to worry about now. However, industry veterans encourage the industry to start planning early.

“The guiding principle of providing a safe product is good,” says Harold Tilstra, manager of tech support for ingredients merchandising business at Purina Animal Nutrition. “And, the public deserves to know there are processes in place that help with that.” While he is sympathetic with the reluctance to embrace more regulation, he says the ethanol industry needs to avoid creating a perception with the public that it doesn’t care about its product being safe. “The track record on distillers grains safety is very good,” he adds. “I’m hard pressed to think of any situation related to food safety attributable to the use of ethanol coproducts.”

Randy Ives, director of ethanol services at Gavilon Group LLC, suggests the first challenge for the ethanol industry will be a change in attitude. Working in the ethanol industry since 1994, he remembers when distillers grains was considered a low-value byproduct that got little attention. That has evolved, he says, “to where we recognize consistent quality in the coproducts means better returns to investors, less issues with customers. It flows better, the product’s not burnt and we have less rejected loads. We started paying attention to all the details.” The change in attitude coming with FSMA is highlighted in the use of the word “food” instead of “feed,” Ives points out. “That’s the difference from 20 years ago. Everything was feed then, but we’re producing a food ingredient. We are part of the food chain.” FSMA will be new for everybody in the feed industry, not just ethanol producers, he continues.

Some ethanol producers are getting a head start as they prepare for another set of export requirements. About 75 ethanol plants have indicated they will comply with the Chinese Decree 118, Ives reports, which is almost identical to FSMA (but different from the registration issue discussed in the page 56 contribution from U.S. Grains Council in this issue).

Change Ahead
Helping ethanol producers meet the China export requirements, Iowa-based Rick Brehm draws upon a couple of decades of experience in the feed industry as well as time managing an ethanol plant. He suggests the biggest changes coming to meet both the China requirements and FSMA will be in wet and dry distillers storage. “I think we will find we’re going to have to either not allow the large overhead doors to be open all the time or we’re going to have to find a way to prevent the birds and insects from getting in.” Hanging strips of plastic or sliding screen doors with sensors that automatically open and close them, much like doors on a grocery store, are possible solutions. The handling of wet cake may be the most challenging, he adds. “A lot of the wet feed pads are more open than what dried distillers grains storage buildings are,” he says, adding that he suspects there will be requirements to rotate inventory and clean the pad. Avoiding possible contamination from birds and other wild animal droppings—a potential source of salmonella or other contaminants—is the goal.
Another situation he’s seen that will need to be evaluated is the use of the grains building for other storage. “I think people will have the ability to store metal or machine parts, but I don’t think they’ll be able to store any liquid in containers that could potentially leak or be torn and potentially contaminate distillers grain.”

Bob Miller, another consultant with many years in the beverage alcohol industry and four years as an ethanol plant manager, has also visited with ethanol producers about FSMA compliance. “What is clear is that much remains to be done and waiting for absolute clarity is not an option,” he says. One of his concerns is the handling of antibiotics to treat infections in the fermenters.  “If the ethanol plant is going to continue to use antibiotics, the plan must address the possibility of drug residues occurring in distillers grains or any other coproduct, such as corn oil, that is sold or could be sold as an animal feed,” he says.

While many plants are moving away from routine use of antibiotics, “I don’t foresee that in the near term antibiotics are going away,” Brehm concurs. “But compared to the feed industry, there is very little recordkeeping of antibiotics, and that may change.” He describes the inventory controls in place in medicated feed manufacturing, where at the end of a shift the medications are weighed and the inventory balanced within a tenth or quarter pound. “You didn’t want to find that somebody accidently poured a whole bag of something in when they saw a one on the recipe and it meant one pound,” Brehm explains. “Taking inventory at the end of the day, you could stop shipment on a product until you figured out exactly what had happened.”

Best management practices and hazard analysis are not new to the ethanol industry. These tools have long been used in safety programs, along with employee training and recordkeeping requirements to demonstrate compliance. Standard operating procedures are commonly used as part of process management, and many BMPs regarding distillers grains are already widely used. Sulfur related problems in cattle, for example, were traced back to sulfur from process additives getting concentrated in the distillers grains. The industry quickly learned what needed to be done to prevent reoccurrences. Aflatoxins are another known hazard and the industry has figured out how to put preventive controls in place to avoid concentrated levels in the coproduct.

As distillers grains is more widely used at higher inclusion rates, new issues may emerge, suggests the FDA’s McChesney. Something that wasn’t an issue at a 10 percent inclusion rate may present problems when fed at 50 or 60 percent rates, he says. “It’s that sort of problem the rule is trying to prevent. You want to be preventive, you don’t want to find out after you’ve had a bunch of sick animals.”    

Author: Susanne Retka Schill
Senior Editor, Ethanol Producer Magazine
[email protected]