Getting Ready for FSMA Compliance

Whether producers must comply in September or next year or even 2018, they need to become FSMA-aware now and especially aware of their customers' needs.
By Chris Bliley | July 21, 2016

While our major regulatory focus within the industry has been the renewable fuel standard and the U.S. EPA’s latest proposal for 2017, it is essential that plants keep an eye on another major federal regulation that will have a significant impact on our industry—the Food Safety Modernization Act. FSMA, enacted in 2011 as a response to a number of high-profile cases of foodborne illness, is the first major update to our nation’s food regulation since the inception of the Federal Food, Drug and Cosmetic act in 1938.

FSMA has four major components: risk-based preventive controls, inspection and compliance, imported food safety and recall authority. Since enactment, the Food and Drug Administration has been busy writing specific regulations for both human and animal food facilities. While Growth Energy made a valiant attempt to keep coproducts from further regulation, similar to the exemption that brewers received for spent grains, the FDA did not agree and has included ethanol production facilities and coproducts in its comprehensive regulations for animal food in the final rule released last year.

Under the FSMA regulation, larger facilities have to meet the first compliance date Sept. 19 with current good manufacturing practices (cGMPs) in place. The deadline for preventive controls comes one year later. For smaller facilities with fewer than 500 employees the deadlines are extended for another year (cGMP by September 2017 and preventive controls by 2018). There are even longer deadlines for very small facilities with average sales of $2.5 million or less in the three preceding years. 

Although the near-term compliance deadline only impacts larger producers, everyone in the industry needs to think about how the marketplace will react. In fact, many are already seeing notices from customers about having to be in compliance with FSMA.

To that end, plants need a compliance plan that includes a hazard analysis, preventive controls, supplier verification, monitoring procedures, recall policy, corrective action and record keeping. A compliance plan requires standard operating procedures that address such things as personnel, pest control, water supply and plumbing, equipment and utensils and plant operations, among others. 

Growth Energy, working with a producer member advisory board and program registrar Compli Associates, has developed the Animal Food Quality Assurance program. The AFQA is designed to be a comprehensive and practical quality assurance program that is available at cost to lead any biofuel production facility on the path to FSMA compliance. The AFQA is a complete quality assurance package. It includes an annual on-site audit to verify compliance and a summary report of the audit findings and related corrective actions. There will be public documentation of AFQA compliance upon meeting the requirements, along with free program updates as the program continues to develop in response to the changing regulatory landscape and customer needs. We have met with the FDA and presented the AFQA program to them, and have incorporated key feedback into the AFQA development and will continue to do so. For more information on the AFQA program or to get specific pricing for your plant, visit www.afqaprogram.com.

Whether you have to meet compliance in September or next year or even 2018, you need to make yourself FSMA-aware now. Equally important, you need to make yourself aware of what your customers may soon demand from the marketplace. Don’t wait until the last minute. The FDA has provided a great deal of material on the new regulation and you can subscribe for email updates at www.fda.gov/Food/GuidanceRegulation/FSMA. 

While we have provided a comprehensive program with the AFQA that we think will best help you achieve compliance, no matter which plan or vendor you choose, the most important thing for any facility and for our industry is to ensure that your plant is compliant with the new food safety law.


Author: Chris Bliley
Director of Regulatory Affairs, Growth Energy
cbliley@growthenergy.org
202-545-4000