FSMA Files: Focus on the Produce Safety Rule

by | Aug 5, 2015


The federal Food Safety Modernization Act was signed into law in January 2011. This act represents significant and historic change in food regulation and addresses every aspect of food production from farm to fork. Assistant Commissioner Joe Reardon will address FSMA and its impact to agriculture in this blog series.

North Carolina consumers enjoy a rich bounty of locally grown fresh fruits and vegetables nearly year round. Our farms produce some of the finest fresh fruits and vegetables that can be enjoyed right off the farm. The following focuses on the Produce Safety Rule, one of the seven rules mandated by FSMA.

Joe Reardon

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

What is the Produce Safety Rule?

The Produce Safety Rule establishes standards for the safe growing, harvesting, packing and holding of produce on domestic and foreign farms. The rule establishes standards in five areas:

• Agricultural water;
• Biological soil amendments of animal origin;
• Domesticated and wild animals;
• Equipment, tools and building sanitation;
• Worker health and hygiene; and
• Growing, harvesting, packing and holding activities.

Exemptions and special provisions, including specific requirements for the production of sprouts, are also covered in the rule.

Why was the Produce Safety Rule necessary?

According to data from the Centers for Disease Control and Prevention, 131 produce-related reported outbreaks occurred between 1996 and 2010. These outbreaks resulted in 14,350 illnesses, 1,382 hospitalizations and 34 deaths. About 20 different produce commodities were identified as the source of the outbreaks. The Food and Drug Administration recognizes that this is a significant public health burden that is largely preventable.

What impact will the Produce Safety Rule have on our fresh produce industry?

The fresh-produce industry, in general, has not been routinely inspected by a regulatory program (state or federal) prior to the passage of FSMA. This rule will bring routine food safety inspections to the farm for the first time. While many North Carolina fresh produce farmers participate in voluntary good agricultural practices audit programs, which include food safety attributes, there is a significant difference in participating in voluntary audit programs and demonstrating compliance to regulatory requirements.

We will continue to closely monitor the issuance of the final rule and assess the impact on the fresh-produce industry. Certain provisions of the rule may prove to be more impactful than others, such as the requirements for agricultural water quality, agricultural water testing frequencies and the requirements surrounding the use of biological soil amendments of animal origin.

What is NCDA&CS doing to prepare farmers for the Produce Safety Rule?

NCDA&CS is collaborating with N.C. State University and the N.C. Fresh Produce Safety Task Force to develop and deliver fresh-produce safety training and guidance for our farmers. The goal of this collaboration is a stronger food safety system that provides our farmers with the tools to be successful and consumers with continued access to the best fresh produce available.

Commissioner Troxler strongly supports measures that increase the safety of our food supply. He is also committed to providing farmers with knowledge and tools to make them successful in their efforts to comply with these new food safety requirements. The term “education before regulation” was born here in North Carolina, and we remain committed to educating our farmers before and while we regulate.

NCDA&CS is actively involved with the National Association of State Departments of Agriculture in developing an operational plan for state regulatory agencies to use as they establish produce safety inspection programs. This operational plan includes a strong educational component that includes outreach, education, training and on-farm readiness reviews to assist farmers in complying with the new rule. NASDA is actively engaged with FDA to finalize this operational plan.

What is the current status of the Produce Safety Rule and when will it come into effect?

FDA is scheduled to issue the final Produce Safety Rule by Oct. 31, 2015. Compliance with the rule begins after the final rule is issued, per the following schedule:

* Small business: No more than $500,000 average annual value of produce sold during three previous years. **Very small business: No more than $250,000 average annual value of produce sold during three previous years.

What type of produce is covered under the Produce Safety Rule?

The rule will cover most fruits and vegetables in their raw, natural and unprocessed state. It does not apply to produce that is rarely consumed raw; those produced for personal or on-farm consumption; and those destined for commercial processing such as canning. While the rule does not identify fresh fruits and vegetables covered under the standards, it does includes an exhaustive list of produce not covered.

Which farms are covered under the Produce Safety Rule?

FDA has put together a flow chart to help farmers determine if their farm is covered under the Produce Safety Rule.  Exemptions include farms with average produce sales (previous three years) under $25,000 and farms with less than $500,000 in produce sales who sell their produce to consumers (not businesses), restaurants or retail food establishments located in the state or not more than 275 miles from the farm.

Those farms that meet the eligibility requirements for a qualified exemption are subject to modified requirements such as labeling produce at the point of purchase.

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 industry associations, is dedicated to providing the assistance necessary for our local growers, packers and manufacturers to be successful in the new regulatory world.