Specialty Crops Program --- A FSMA Resource for You

Leanne Skelton, USDA/FDA Liaison

For farmers that grow, harvest, pack and ship fruits and vegetables, FSMA’s Produce Safety Rule marks the first time that you will be regulated in these activities by the FDA. We’ve heard that many farmers are uncertain of what to do to comply. In addition, manufacturers/processors, already regulated by FDA for good manufacturing practices (GMP), may also face new preventive controls-focused requirements.  Importers of produce and processed foods also have a new regulation to comply with.

USDA knows that education and training will play a vital role in how the regulations are implemented and how farmers can comply with them.  SCP continues to be a resource to help you as you work toward compliance. We are deeply entrenched in the educational components of FDA’s implementation strategy via the Produce Safety Alliance (PSA), the Food Safety Preventive Controls Alliance (FSPCA), and the Sprout Safety Alliance. All of the alliances are prominent in FDA’s overarching training strategy and SCP is committed to ensure its staff goes through the training the alliances are developing. SCP’s Specialty Crops Inspection Division (SCID) Training Branch plans to have a few staff members seek “trainer” status. 

If your facility is subject to the preventive controls for human foods rule, the FSPCA website has additional information and resources.  Finally, the Sprout Safety Alliance website offers educational materials and tools for sprout growers. Of note, sprout growers are subject to the Produce Safety Rule including additional requirements specifically for sprout growers (see Subpart M of the Produce Safety Rule).

USDA continues its commitment to help FDA understand the diversity of the farming community and help farmers and packers, processors and sprout growers of all sizes and production systems better understand how to comply with the regulations. Farms and facilities that may be exempted or excluded from the rule may want to demonstrate compliance in order to maintain or gain market access, since we anticipate that some buyers will expect their produce suppliers to meet the FDA requirements.

USDA personnel serve as technical advisors on the produce safety and preventive controls “operational teams” established by FDA to develop implementation and compliance strategies.  For farms and packinghouses that are either exempt or excluded from the rule, some buyers require or will accept a USDA Good Agricultural Practices (GAPs) audit.  Furthermore, in the preamble language of the Produce Safety Rule, FDA stated its intent to leverage existing marketplace accountability measures that are already in place, such as our USDA GAP Program services or Marketing Orders/Agreements that incorporate food safety elements from the Produce Safety Rule. 

USDA will continue to provide feedback to FDA on a variety of technical assistance approaches they are developing, including establishing the Technical Assistance Center or “TAN” to be responsive to questions from industry and regulators; establishing a Produce Safety Network across the country; and, along with USDA’s National Institute of Food and Agriculture (NIFA), establishing the National Coordination Center and four Regional Centers whose focus is on training and technical assistance.

USDA administers a number of grant and loan programs through AMS, NIFA, the National Resource Conservation Service, and other agencies.  Be sure to check the website for these opportunities and eligibility requirements.  Should you have any questions, SCP can assist in connecting you with our USDA colleagues that manage these various programs.

About the author: Understanding the uncertainty and anxiety within SCP’s customer base, coupled with the FDA’s keen interest in collaboration, Leanne has been “on loan” to FDA for most of the past seven years to provide input on the regulations, the associated research, education, outreach and training, and implementation and compliance strategies. You can contact her at (202) 720-0982 or leanne.skelton@ams.usda.gov.