Source: Heather Overton, NCDA&CS, 2/2/15

(Joe Reardon, assistant commissioner for the N.C. Department of Agriculture and Consumer Services, answers questions about FSMA in this blog series.)

What brought about the Food Safety Modernization Act?
The Centers for Disease Control and Prevention estimates that 1 in 6 Americans, representing about 48 million people, get sick from foodborne illnesses each year. These illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths each year. Foodborne illnesses represent a significant public health issue that can be largely prevented.

Through the passage of FSMA, Congress intended to overhaul the existing food safety system to better protect the public. FSMA strengthens the existing food safety system and shifts the focus more to preventing rather than reacting to food safety problems after they occur. This shift from reaction to prevention is a cornerstone of FSMA along with provisions to strengthen inspections, expand response activities, increase the safety of imported foods and enhance partnerships with state and local regulatory partners.

How has the N.C. Department of Agriculture and Consumer Services been involved in FSMA’s rule-making process?
We are extremely fortunate here in North Carolina to have strong, forward-leaning food safety leadership to guide our implementation of FSMA. Agriculture Commissioner Steve Troxler is a tireless advocate for food safety and is deeply committed to ensuring the safety of food grown, raised, caught or made here in North Carolina. In food safety, we all have a common goal. We are dedicated to ensuring that consumers have access to the freshest, healthiest and safest food possible. We are equally committed to ensuring that our industry has the tools to be successful in meeting these new food safety requirements.

In 2013, in his role as president of the National Association of State Departments of Agriculture, Commissioner Troxler established a technical working group to review proposed FSMA rules. This group, now 23 states and 70 members strong, has dedicated hundreds of hours over the past two years to the systematic and methodical review of all seven areas of FSMA rules. This group provided more than 250 pages of comments to the U.S. Food and Drug Administration during the comment period. These comments include potential impacts on industry, unintended consequences and suggested revisions.

What is covered under FSMA?
FSMA covers every aspect of food production. More specifically, the act:
• Amends the existing Federal Food, Drug and Cosmetic Act to incorporate risk-based preventive controls into the growing, harvesting, packing and holding of fresh produce commonly served raw.
• Applies risk-based preventive controls to virtually all aspects of human- and animal-food manufacturing — from baked goods to pet treats.
• Addresses safety of imported foods, sanitary transportation of food and the intentional adulteration of food. The food safety enhancements are intended to apply equally to both domestic and foreign suppliers of food.
• Establishes and clarifies the role of industry in assuring the safe production of food.
• Establishes requirements for industry to develop and implement processes to minimize the potential for contaminated foods reaching the consuming public.

The act requires the FDA to issue regulations in seven areas: produce safety, preventive controls for human food production, preventive controls for animal food production, foreign-supplier verification, third-party accreditation for foreign auditors, intentional adulteration and sanitary transportation of food. Beginning in January 2013, FDA issued proposed rules covering all seven areas; each rule was open for public comment for a period ranging from a few months to nearly a year. Response to the proposed rules was monumental, with more than 39,000 comments posted to the official docket for produce safety regulations alone. In fact, each rule received a substantial number of comments.

What is the current status of FSMA?
The FDA is operating under a court order to complete the rules on a specified timetable; the preventive controls (human and animal food) and produce safety rules will be the first final rules issued, in August and October of this year, respectively.

As we put the rules review phase behind us, industry and regulators must shift the focus to implementation. There is no question that FSMA will have a significant impact on both industry and the regulatory community. Our department is busy preparing for the upcoming regulatory changes and is committed to ensuring that industry has the necessary tools for successful implementation. Significant outreach, education and technical assistance must take place before regulation begins. Industry and regulators will also need substantial training in order to understand the new food safety provisions found in the various FSMA rules.
In upcoming blogs we will continue to explore FSMA implementation and cover such important topics as the potential impact of FSMA on industry; how farms and businesses can determine which rules apply to their operations; and how to assess infrastructure and resource needs in preparation for FSMA implementation. The NCDA&CS, along with trusted partners in cooperative extension, local universities and associations, is dedicated to providing the assistance necessary for our local growers, packers and manufacturers to be successful in the new regulatory world.