“I think there’s a fair amount of confusion industry-wide about the Produce Safety Rule, because it’s constantly changing.”
That was the opening line from Maile Gradison Hermida, an attorney with Hogan Lovells US LLP who provides advice to the Almond Board, who provided a briefing to almond growers in Sacramento on recent changes to FDA regulations under the FDA Food Safety Modernization Act (FSMA).
Instead of dwelling on the unknown, Hermida told growers about what is most likely to be the new law of the land, and guided them through what their obligations are likely to be.
What products does the Produce Safety Rule cover? It covers domestic produce, imported produce, and produce for export.
While the rule explicitly covers farms, it can also apply to “secondary activities farms” that are downstream beyond growers in the almond supply chain.
“Hullers and shellers are farms if they grow almonds in the same physical location as the hulling and shelling operation… or if they are majority owned by growers that supply the majority of almonds hulled and shelled,” Hermida said.
So what does the rule mean for farms?
“Essentially what the FDA has done is perform a hazard analysis for you,” Hermida said, telling growers that many of the rules’ requirements are essentially best practices.
Produce Safety Rule Requirements
Requirements include training for workers, and reporting on practices related to:
- health and hygiene
- agricultural water
- soil amendments with animal-related organic matter
- growing, harvesting, packing, and holding activities
- equipment, tools, buildings, and sanitation
The training requirement mandates at least one supervisor or responsible party per farm to complete a Produce Safety Alliance training. Available trainings can be found at the group’s website.
“This isn’t a way for a consultant to make money,” Hermida said, “It’s a way for people to understand the fundamentals of food safety.”
Hermida recommended farms comply with the easily-met training guidelines without delay. She said that the date for growers with more than $500,000 in annual sales to start complying with the Produce Safety Rule is January 2018, but the FDA won’t begin inspections until Spring 2019.
Agricultural water requirements concern sanitary quality control of water, inspecting the farm’s water system, water testing, and more. This rule may be extended to 2022, so revisions are likely, Hermida said.
The best practices for biological soil amendments of animal origin include some practices Hermida said most growers already adhere to:
- Growers can’t apply human waste
- General requirements for handling, storing, and conveying
- Some restrictions on application method to avoid contact with produce at harvest
Commercial Processing Exemption
There are two paths to complying with the Produce Safety Rule, Hermida said: meet the standards above head-on, or use the commercial processing exemption, which will be relatively simple to do until 2020, and could be much harder after.
The exemption means disclosing to the buyer that your almonds aren’t adequately processed to control microbial hazards in documents accompanying a shipment, like a label or bill of lading, or any other document or paper associated with the shipment that a food safety manager for the customer is likely to read.
The label or similar paperwork needs to disclose that it’s “not processed to adequately reduce the presence of microorganisms of public health significance.”
Beyond that, to get the commercial exemption, “there are two pieces that have to marry up. You have your disclosure, and your assurance,” Hermida said.
That means getting a written assurance from the buyer that they will take steps to reduce the presence of microorganisms that are significant for public health. The details of what assurances are need are still being worked out, so growers going this route won’t need to worry about this until a final rule goes into effect on January 27, 2020.
Until then, the disclosure is enough.
One catch to the exemption: You can’t claim the exemption on some shipments of almonds and not others, practically speaking. All almond output, practically speaking, needs to comply with the rule or claim the exemption.
Key Takeaways
Hermida’s advice for growers was twofold: don’t panic over the Produce Safety Rule, but don’t ignore it either.
Preparation is a key to not having problems with the FDA, she said by phone after the conference.
“You need to decide ahead of time which way you’re going to go--are we going to comply with the produce rule, or do a disclosure, and have grower tags on all of our bins and document for the FDA that we’re making this disclosure?” Hermida said. “You have to make a deliberate decision about what path you’re going to follow. Taking a little time to memorialize your thoughts serves you quite well.”
For those claiming an exemption, documentation is needed to show compliance to inspectors, and talking points for that conversation help.
“You should have an inspection manual, if you don’t have one, just to tell personnel what to expect when FDA comes—do they need to have a badge, will you need a conference room, should you let them take photos?” she said. “Accompany the inspectors, never leave them alone. Take immediate corrective action whenever possible, take detailed notes.”
Above all, Hermida said, growers should take advantage of the resources and advice the Almond Board can offer. The starting point for those resources is the Almond Board website.
