Tag Archives: produce safety rule

Jennifer Allen
Food Safety Attorney

Staying a Step Ahead on Produce Safety

By Jennifer Allen
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Jennifer Allen

The FDA continues to make revisions and improvements to its Produce Safety Rule, with input from various stakeholders. One thing that is a constant drumbeat is that food growers and manufacturers need to do a better job of keeping consumers safe from foodborne illness arising from produce that was traditionally thought of by consumers as safe to eat (think spinach, romaine lettuce and red onions). Through the produce regulations (21 CFR 112.1-112.213), the FDA is attempting to come to grips with the seemingly endless parade of produce-based outbreaks, arming the food industry with an additional weapon for use in the constant battle with foodborne illness.

The regulations, broadly speaking, require farms of a certain size to develop processes relating to employee hygiene and training, agricultural water, biological soil amendments (compost, manure and the like), and buildings and equipment to decrease the risk of contamination of produce during growing, harvesting, packing and holding. But what does that mean for food manufacturers?

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One way to understand the regulations is to consider them in the context of a dish that seems to be increasingly popular in restaurants: the beet salad. Starting with the beets, the regulations do not apply to them. Why? Because the regulations don’t apply to produce that is rarely consumed raw. The FDA has provided an exhaustive list of this kind of produce and beets are, not surprisingly, on that list.

But what about the rest of the salad. Typical beet salads often contain leafy greens like spinach and arugula, and other produce such as carrots and avocado. With the produce regulations in place, food manufacturers should expect, and even demand, a greater level of safety and accountability from their suppliers with respect to these kinds of produce. All of these salad ingredients are considered covered produce under the act. But even though the regulations cover these ingredients, whether they provide food manufacturers with greater guarantees of safety and accountability really depends on who is growing, harvesting, packing and holding the produce before it reaches the manufacturing facility.

Broadly speaking, the regulations only apply to farms, which are generally defined as those establishments that grow and harvest the produce. Facilities that pack and hold produce must also follow the new regulations if they are majority owned by a farm that grows and harvests the produce. Non-farm packing and holding facilities can choose between following the new regulations or following current good manufacturing practices generally applicable to all foods (you can find these practices at 21 CFR 117). Establishments that only hold or transport produce are not required to follow either regulation.

What’s more, not all farms are covered under the new regulations. Farms that on average sell less than $25,000 per year of produce, adjusted for inflation with 2011 as the baseline year, are not covered by the regulations at all. And farms that sell an average of less than $500,000 of food each year, adjusted for inflation, may seek an exemption from the regulations if the amount of food they sell each year direct to consumers—or to restaurants and retail establishments within the same state or less than 275 miles away—exceeds the amount of all other food sales. That means the smaller and more local the farms a manufacturer sources from, the less likely it is that the manufacturer must follow the new regulations. It also means that if produce is packaged and held by a middleman, that middleman may not have to follow the new regulations either.

How To Mitigate Risk When Sourcing Produce

How does a food manufacturer then develop the knowledge necessary to have some power over what enters its facility and what risks to accept in sourcing produce? Well, if produce comes directly from a farm covered under the new regulations, the manufacturer should make sure that its supply contract requires the farm to provide regular certification that its produce has been grown, harvested, packed and held in compliance with the regulations. The same goes for produce coming from a packing and holding facility that is majority farm-owned. But even if the produce comes from a non-farm packing and holding facility, manufacturers can seek reassurance of safety in several ways.

If a produce supplier is not covered under the FDA Produce Safety regulations, manufacturers can still require certification that their suppliers comply either with the produce safety regulations or with existing current good manufacturing practices. If manufacturers have strong bargaining power over non-farm suppliers, they might even consider requiring that the supplier voluntarily comply with all or some of the produce safety regulations. Or manufacturers could require that the supplier obtain certification from the grower that the produce was grown and harvested in compliance with the produce regulations or (for non-covered or exempt farms) that the grower otherwise complied with current good manufacturing practices.

Even if produce comes from non-covered or exempt farms, manufacturers may still consider asking the farm to follow basic practices that mitigate the risk of contamination. Although the produce regulations include certain larger-scale, and costly, measures, they also include some simple requirements that even small farms can implement cost-effectively.

Question manufacturers should consider include: Has a company representative visited the farm that grows its produce? If it has, did workers have access to bathrooms or handwashing facilities? How clean was the area where the workers sort and pack the produce?

Depending on the amount of bargaining power a manufacturer has, it might be able to convince the grower to install portable toilets or handwashing stations, or to clean up its sorting area. Even installing signs that instruct workers to wash their hands or report to a supervisor if they are sick, can go a long way toward mitigating the risk of contamination.

At minimum, manufacturers should keep good records showing who grew, harvested, packed and held their produce, so that in the event of an outbreak of a foodborne illness, they can provide FDA with essential information to help determine the source. Manufacturers should also ensure that their supply contracts contain provisions requiring suppliers to notify them promptly whenever the suppliers have reason to suspect that produce may have become contaminated.


FDA Wants to Change Agricultural Water Requirements in Produce Safety Rule

By Food Safety Tech Staff
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After years of foodborne illness outbreaks that have been suspected to originate in pre-harvest agricultural water, FDA is proposing changes to the FSMA Produce Safety Rule. The proposed rule would revise subpart E, changing certain pre-harvest agricultural water requirements for covered produce other than sprouts.

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms. As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response in an agency update. “The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

Under the proposed rule, farms would be required to conduct yearly systems-based agricultural water assessments to assess and guide measures that would reduce risks related to pre-harvest agricultural water. According to the FDA, the assessment would consist of evaluating the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land.

With the current agricultural water compliance dates for covered produce other than sprouts set to begin in January 2022, the FDA plans to exercise enforcement discretion for those requirements while also proposing another rule that extends the compliance dates for all agricultural water requirements under the Produce Safety Rule.

The full details of the FSMA Proposed Rule on Agricultural Water are available on FDA’s website.


FDA Announces Enforcement Discretion Related to Produce Safety Rule

By Food Safety Tech Staff
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FDA has announced it will exercise enforcement discretion for Produce Safety Rule requirements that apply to entities that grow, harvest, pack and hold wine grapes, hops, pulse crops and almonds. The agency added that it will “consider pursuing rulemaking to address the unique circumstances” that the above-mentioned products present. It also issued the guidance document, “Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds”.

Scott Gottlieb, M.D., FDA

FDA Commissioner Announces Steps To Support Produce Safety Rule

By Food Safety Tech Staff
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Scott Gottlieb, M.D., FDA

FDA Commissioner Scott Gottlieb, M.D., announced the next steps in their approach to implement the Produce Safety Rule that was established by FSMA. During the September 12th speech at the National Association of State Departments of Agriculture, Dr. Gottlieb outlined new measures the FDA will be taking, including compliance dates for agricultural water standards, recognized water-testing methods, and inspections related to non-water requirements of the produce rule.

According to the press release, Dr. Gottlieb also announced steps the FDA will take to “address concerns related to the complexity and feasibility of implementing standards for agricultural water.” One proposed rule concerning agricultural water compliance dates, if finalized, would extend compliance dates by up to four years for produce other than sprouts.

The press release states the reasoning behind this change is allowing the FDA to revisit those standards, ensuring they are implementable for farmers across the country. Sprouts are an exception here because of their high risk for contamination and will remain subject to original compliance dates.

The announcement also covered key changes to produce farm inspections, water testing methods and training opportunities for producers and regulators. For more information, see the press release here and the full text of Dr. Gottlieb’s speech here.

Compliance, food safety

FDA Releases Small Entity Compliance Guide for Produce Safety Rule

By Food Safety Tech Staff
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Compliance, food safety

Learn more about FSMA implementation strategy at the 2017 Food Safety Consortium | November 28–December 1FDA has released a Small Entity Compliance Guide (SECG) to help small and very small businesses comply with the Produce Safety Rule. The SECG provides assistance for farmers in determining whether they are eligible for a qualified exemption and can help them understand the modified requirements as a result.

The compliance dates under the Produce Safety rule are as follows:

  • Small businesses: January 28, 2019
  • Very small businesses: January 27, 2020
  • Sprout operations: January 26, 2018 (small businesses) and January 28, 2019 (very small businesses)
  • There are also extended compliance dates for certain agricultural water requirements

FSMA Brief: Industry Challenged by Training and Produce Safety Rule

By Maria Fontanazza
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With several FSMA compliance dates now in effect, much of the focus is on where companies need help. According to Kathy Gombas, former deputy director at CFSAN, the industry is struggling with FSMA training. Many companies don’t understand the FSMA rule exemptions and supply chain requirements, and they just don’t know where to start. “Industry needs affordable and timely resources,” said Gombas during a panel discussion at the Food Safety Summit earlier this month. “There are a lot of tools out there, but they’re costly.”

Efforts are underway to address these challenges. FDA has issued more than a dozen guidance documents pertaining to the rule. In addition, tools such as model plans and templates can help companies with their food safety plans, and the agency is almost ready to publish a web-based food safety plan builder that will be freely accessible on FDA’s website, according to Gombas. Several sources of technical assistance are available, including state and trade associations, academia, and the technical assistance network (TAN). However, when companies have inquiries, the key is to provide them with a response in a timely manner, said Gombas.

The Produce Safety rule is another hot spot for hurdles. Although 90% of it aligns with Good Agricultural Practices that have been in place for more than a decade, industry’s response to the rule remains one of fear and confusion, said David Gombas, former vice president of technical services for the United Fresh Produce Association. “Water testing is probably the most complicated aspect of the regulation,” he said. The rule calls for testing procedures that many produce companies never had to conduct before. Some testing must be done within a certain period of time, and the lower number of testing labs in rural areas of the United States will pose a problem for some producers, warned David Gombas.

There is also confusion among producers regarding whether they should follow the Produce Safety Rule or the Preventive Controls rule, which could significantly impact the steps they must take to be in compliance of either rule. To further complicate matters, Gombas pointed out that many foreign suppliers aren’t even aware that they have to be in compliance with the rule. Finally, the Produce Rule does provide a lot of room for flexibility, so Gombas predicts much of the responsibility will fall on the agency inspectors and how they expect rule to be met.



FDA Awards Nearly $22 Million to States for Produce Safety Rule

By Food Safety Tech Staff
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FDA has awarded $21.8 million to 42 states to support the implementation of the FSMA Produce Safety rule. The State Produce Implementation Cooperative Agreement Program (CAP) provides states with the resources to enable the following:

  • Form a multi-year plan to implement a produce safety system
  • Education, outreach and technical assistance
  • Prioritize farming operations covered by the rule
  • Develop programs to address the needs of farming communities

According to FDA, “the intended outcomes of this cooperative agreement program are to:

Advance efforts for a nationally integrated food safety system (IFSS)
Plan, establish, and/or enhance state and territorial produce safety programs.
Encourage the safe production of fresh fruits and vegetables.
Promote understanding and compliance with the requirements of the Produce Safety Rule.”

Applicants were classified into five tiers of funding eligibility based on the number of farms growing covered produce within the jurisdiction. The agency has also provided a list of funding award amounts by state.

Learn more about FSMA at the 2016 Food Safety Consortium | December 7–8, 2016 | Schaumburg, IL | VIEW AGENDA