New, Evolving Coproducts Require Regulatory Due Diligence

The biofuels story is not yet completely written. Many exciting developments are on the horizon and some are within our grasp. Indeed, cellulosic ethanol is here and being commercialized. Gen 1.5 processes increasingly are being implemented throughout the industry.  Existing Generation 1 dry grind plants continue to evolve. Engineers and scientists at new startups as well as long-established companies continue to find new ways to extract more uses and value upstream from kernels of corn and downstream from coproduct materials. 

We also are entering an era with an increased emphasis on human food safety, and thus on feed safety. After all, feed ultimately becomes food for people when fed to livestock and other food-producing animals. During the past two years, we have reviewed and commented on two key rulings in the Food Safety Modernization Act, including the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (FDA-2011-N-0992), and the Sanitary Transport of Human and Animal Food (FDA-2013-N-0013). FSMA is expanding the scope of the U.S. Food and Drug Administration.

We must, therefore, make sure that we do our due diligence when it comes to the products we make and the processes we use to manufacture them, being cognizant of the relevant regulations.

To be sold in the U.S. marketplace, all feed ingredients must meet specific, defined legal definitions. These definitions are published each year by the Association of American Feed Control Officials. Those relevant to the ethanol industry are shown in Table 2. Current definitions include both wet and dry products and many were developed and approved for fuel and beverage alcohol several years ago.

Most dry grind ethanol plants produce coproducts meeting these definitions, as do beverage distilleries here in the U.S. If you make traditional distillers coproducts, then more than likely your coproducts are already defined appropriately. But, are you making a new type of coproduct?  If so, does it fall in line with one or more of these definitions?  If it does not, then you need to develop a new definition. The AAFCO Official Publication is printed annually or you can subscribe to the online publication which is updated continuously.

As an example, in recent years most fuel ethanol plants have implemented oil removal technologies and many in the industry, including the Distillers Grains Technology Council, have worked to establish a legal definition for distillers oil so that it legally can be sold in the U.S. See Table 1 for the approved definition.
 
Defining New Coproducts
But, the industry isn’t standing still. Every year, much research is conducted to further fractionate compounds from either the grain or the coproduct streams. These include fiber, proteins and other nutrients. Meanwhile, research also is being conducted to produce fermentation products other than ethanol from corn, such as isobutanol.  Which of these new technologies will become commercial reality?  Or, if they are already commercialized, which will be successful in the long term?  It is difficult to predict the future. But, one thing is certain: if you are developing new coproducts, or are even thinking about it, start your journey toward compliance now.

In order to legally sell a new coproduct, the new feed ingredient must be proven safe for its intended use. There are three mechanisms to gain authorization for a new feed ingredient: the AAFCO definition process, the Food Additive Petition process or the generally regarded as safe (GRAS) determination with voluntary notification. All three of these mechanisms for approval can be very lengthy, ranging from one to three or more years, requiring extensive documentation.

Although it is dependent on the product and company preference as to which path to take, most follow the official AAFCO process to establish the legal identity and get a published definition in the AAFCO official publication.  “A Guide to Submitting New Ingredient Definitions to AAFCO” is available on the AAFCO.org website. In the process, companies work with an AAFCO investigator, who also will work with the U.S. Food and Drug Administration to develop the definition and prove the safety of the ingredient.  After the initial review, the proposed feed ingredient definition package is submitted to the FDA Center for Veterinary Medicine, where the supporting scientific information is assessed, including manufacturing information, ingredient safety and utility data. Once completed, FDA will issue its recommendation to the AAFCO Ingredient Definition Committee and, if all goes well, will result in an official AAFCO definition for your coproduct. 

If, however, the FDA determines the new ingredient may result in human safety concerns, the company must submit a food additive petition to the FDA.  After this process, if the ingredient is determined to be safe, the FDA will issue a regulation under section 21 of the Code of Federal Regulations (21 CFR). 

A third approach is to establish the ingredient is safe for the intended use via a GRAS affirmation. GRAS is for specified uses only and does not imply approval for all applications in animal feed. If general recognition standards, often defined as published information in peer reviewed journals, can be met, the GRAS determination can be submitted under the voluntary notification procedures, either through self-affirmation or the FDA's GRAS notification program.

Being proactive is important when developing and commercializing new processes and products.  If you have any questions or need any assistance with DDGS or other coproducts please contact us. We look forward to helping you as the industry continues to evolve.


Author: Kurt A. Rosentrater
Executive Director, Distillers Grains Technology Council
515-294-4019
[email protected]