One Year Later: The FSMA and the Food and Beverage Industry

CAPA Compliance Stock ImageA year has passed since the Food Safety Modernization Act (FSMA) was signed into law. Some of the changes envisioned under the FSMA are already in place, such as the FDA's new mandatory food-recall authority and the authority to detain food products that the agency has reason to believe are adulterated or misbranded. The FDA said in its one-year progress report that it has already used its "food detention" authority three times. It has also met its mandate of inspecting 600 foreign facilities in 2011.

But the FSMA is a massive undertaking, and the FDA has a long way to go in implementing it. The agency is lagging behind in the rulemaking process and in the publication of regulations and guidances. Other FSMA requirements, such as increased inspections of facilities (based on risk), depend on a significantly bigger FDA budget, which is unlikely in these tough economic times.

The FSMA means a stricter regulatory environment, but it also offers an opportunity for the food and beverage companies and related businesses to improve their own processes and operations and to implement preventive controls.

So, for the food and beverage industry, what does the FSMA mean? What now? First, industry members must remember that the FSMA is primarily meant to help protect the public from foodborne illnesses and to ensure food safety. About 48 million people—one in six Americans—get sick and 3,000 die each year from foodborne illnesses, according to the Centers for Disease Control and Prevention. The new law provides critical preventive controls and allows greater oversight.

Second, the FSMA is but a reflection of the changing food safety landscape. Even if it takes the FDA some time to fully implement the law, the fact remains that there is heightened public awareness and scrutiny about food safety. Now more than ever, food and beverage companies, food growers, processors, packaging companies, distributors, retailers, and food service companies must be proactive in ensuring the quality of their products and protecting their brands. Now is the best time to prepare for the changes under the FSMA.

Key Provisions

The U.S. Department of Agriculture remains the primary authority for regulating meat, poultry, and egg products. But the FSMA significantly expands the enforcement power of the FDA, the key entity responsible for the safety and protection of approximately 85 percent of U.S. food products. Key provisions of the law cover the following areas:

  • Records Access
  • Hazard Analysis and Risk-Based Preventive Controls
  • Performance Standards
  • Standards for Produce Safety
  • Protection Against Intentional Adulteration
  • Sanitary Transportation of Food
  • Increased Inspection Frequency
  • Enhanced Tracking, Tracing, and Recordkeeping Requirements
  • Reportable Food Registry
  • Mandatory Recall Authority
  • Accreditation of Laboratories
  • Foreign Supplier Verification
  • Voluntary Qualified Importer Program
  • Authority to Require Import Certifications for Food
  • Accreditation of Third-Party Auditors

Unique Opportunity

The FSMA means a stricter regulatory environment, but it also offers an opportunity for the food and beverage companies and related businesses to improve their own processes and operations and to implement preventive controls. It offers them the opportunity to shift the spotlight from the negative to the positive—from the bad publicity of foodborne illnesses and food recalls to the proactive efforts of the industry to ensure food safety.

So if you're asking: What now? You can start by learning more about the FSMA requirements and keeping abreast of the latest developments in its implementation. Keep an eye on industry activities and perhaps offer your input in the rulemaking process. More importantly, take a closer look at your quality and food safety processes and start improving them to ensure compliance.


-FSMA One-Year Progress Report, available at: FDA report and website viewed on March 22, 2012.

-Estimates of Foodborne Illness in the United States, CDC web site viewed on March 23, 2012.

Cindy Fazzi, a copywriter at MasterControl Inc., writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master's degree in journalism from Ohio State University.

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.