The Food Safety Modernization Act grants the Food and Drug Administration significant new authority and imposes significant new requirements on facilities producing animal feed, including ethanol facilities that produce animal feed coproducts. Since 2011, when FSMA was signed into law, FDA has been busy drafting various proposed rules and reviewing industry feedback. In September, FDA released supplemental proposed regulations, including key changes to the current good manufacturing practice (CGMP) and hazard analysis and risk-based preventive controls for food for animals regulation (also known as the preventive controls for animal feed rule). These proposed changes have the potential to impact all ethanol producers, and the industry should be thinking about how facility procedures should be amended to ensure future FSMA compliance.

Although several rules may impact ethanol facilities, the preventive control rule is the one likely to have the most significant impacts on day-to-day operations. Two key components of this rule form the basis for the required written food safety plan that each facility will be required to implement and maintain.

The first is the hazard analysis and preventive controls section. Very generally, this section would require that covered facilities (a) perform a hazard analysis to identify and evaluate known or reasonably foreseeable feed safety hazards; (b) establish preventive controls to prevent or significantly minimize any “significant” hazards (hazards for which a person knowledgeable in food safety would establish controls); (c) monitor the preventive controls (including written procedures); (d) verify the controls are working; (e) maintain a written food safety plan that incorporates all of the above elements; and (f) maintain records regarding the monitoring and verification steps. Ethanol facilities without existing feed safety expertise will need to engage outside technical experts, as the hazard analysis and a number of the related steps must be done by a qualified individual. All of this will need to be in writing and maintained for review by FDA upon request.

The second key aspect of this rule is the CGMP requirement, something that has been required for many years for food facilities, as well as feed facilities manufacturing medicated feeds. However, this is the first time they have been applied broadly to all animal feed facilities. The CGMPs form the basic principles upon which a facility’s food safety system is built. As revised, the CGMPs would cover areas such as plant personnel (hygienic practices), plant construction and grounds (waste disposal, ventilation, easy to clean facility), sanitation (maintaining plant in good and clean repair, effective pest control), sanitary facilities and controls (clean/adequate water supply, properly designed plumbing system, hand wash facilities), equipment and utensils (able to be cleaned and well maintained), plant operations (proper procedures to prevent contamination), and holding and distribution (proper containers to avoid contamination, inspection of incoming containers). Just one example of a rule that may significantly impact ethanol facilities is proposed 21 CFR Section 507.17, which, among other things, would require facilities to: “protect animal food stored outdoors in bulk by any effective means, including (i) Using protective coverings; (ii) Controlling areas over and around the bulk animal feed to eliminate harborages for pests; and (iii) Checking on a regular basis for pests and pest infestation.” 
At first glance, this would appear to require ethanol facilities to cover DDGSs and other coproducts stored outdoors, control the pests (birds, rodents, insects, etc.) around the bulk storage, and regularly check for pest infestation. 

Although there are a few exemptions to these requirements, they primarily apply to very small businesses, farms and certain facilities engaged solely in holding feed products. It is unlikely these exemptions will apply to many, if any, ethanol facilities.

As a result of a lawsuit by a consumer activist group against FDA, followed by a court-issued consent decree, FDA must release a final preventive controls for animal feed rule by Aug. 30, 2015. Once the final rules are released, ethanol facilities that produce animal feed coproducts will have one year to become FSMA compliant. Given the detailed and potentially onerous requirements of these rules, we highly recommend that facilities take concerted steps to engage technical experts to assist with implementing CGMPs and preventative controls well before the 2016 compliance deadline. 
 

Author: Andrew Anderson,
Partner, Faegre Baker Daniels
515-447-4703
andrew.anderson@FaegreBD.com

Contributors: Steve Toeniskoetter, Associate
Rachael Dettmann Spiegel, Associate