How Is Produce Regulated?

Who regulates your produce? Is it the FDA? The USDA? Or someone else? And, how often is it regulated? Do you know the answer to any of these questions? It is important that your produce has and meets food safety requirements, right?

Who Regulates Fresh Produce?

Technically, your produce is regulated by the FDA, and as a result of a law that was signed in 2011 by President Obama, the Food Safety Modernization Act (FSMA), the FDA will start to play a larger role by requiring more from growers, packers and processors. However, the current answer to the question of who regulates your produce is the buyers. Think in terms of grocery stores: Costco, Safeway, Walmart, etc., restaurant chains: McDonald’s, Taco Bell, Panda Express, etc., and food service: Sysco, US Foods, etc. The buyers are the companies from which you purchase your produce. They are the ones deciding which growers they buy from, and therefore, they implement food safety requirements for their suppliers.

What do Produce Buyers Require?

Buyers provide a list of customer specifications that are product specific. That refers to their requirements for the product size, percentage of defects, color, how the produce is packed into cartons/boxes/clamshells and at which weight, etc. The customers (buyers) also have food safety requirements that they implement for their suppliers. If the suppliers do not meet their requirements, they will not buy from them. A common requirement is that the supplier receives a third-party audit, based on the buyer’s list of allowable audit types.

Third-Party Audits

There are multiple third-party audits to choose from. Typically, the buyer determines which audits are acceptable and the supplier chooses from their list of approved audits. The current global industry standard is that buyers require GFSI (Global Food Safety Initiative) benchmarked audits, which are all required to include the same audit criteria in order to receive the benchmark. The GFSI audits are commonly required when exporting product to Europe, while there is still a bit more flexibility on the audit type for produce that is distributed within the United States (depending on the buyer).

When these audits are performed, depending on the audit scheme, there is an audit one day per year, or there are other schemes that only require audits once every three years, with a surveillance audit in the meantime where the auditor checks for continuing compliance. With this one day a year review and no continuous review throughout the year, there is no guarantee that the supplier is following the food safety requirements at all times. Another issue with receiving an audit from a third-party food safety auditing company is that money is changing hands. So, even though it is supposed to be a non-biased audit, there is still a money game at play.

There are also other audits required by buyers that are performed on a routine basis by a government inspector. For example, the CDFA (California Department of Food and Agriculture) performs annual audits for each LGMA grower, which includes growers in California and Arizona that are members of the Leafy Green Marketing Association.

Why Should You Care About Food Safety?

Just as you want the person preparing your food in a restaurant to wash their hands after using the restroom and before touching your food, this is the same idea with the workers who are harvesting your food. Not only do we worry about suffering from a foodborne illness, but we should also care about what happens to our produce before it makes it to our kitchen, regardless of whether or not it makes us sick.

Some examples of other factors that are reviewed during field audits, besides hygiene, include:

Fertilizer and pesticide applications
Water source
What is taking place in the adjacent land
Previous land use

What Food Safety Requirements does the FDA Regulate?

Currently, the FDA focuses on produce facilities (e.g., packinghouses, processing plants) when they perform inspections. However, due to the limited workforce of specialized workers focused on produce, the visits are not frequent. They average around once every three years, except for when there is an outbreak or recall investigation. There is no requirement for visits to produce growing operations.

As FSMA is phased into practice within the next couple of years (the larger operations have a quicker compliance date), produce operations will be responsible for meeting the new food safety requirements set forth by the FDA and will also require additional reporting to the FDA when issues are found (e.g., by a third-party auditor). The idea is for the FDA to become more involved with produce operations to help prevent outbreaks from occurring. However, larger produce operations that already deal with larger buyers are already in compliance with most of the new FDA requirements. So, at this point, FSMA will be more of a way to bring the smaller operations up to speed.

Food Safety Modernization Act (FSMA)

FSMA was originally signed into law by President Obama in 2011, with the goal of increasing prevention efforts in order to decrease the need to react to food safety issues after the fact. FSMA consists of seven different rules that will require all food producers, shippers and importers to follow, and which will be regulated by the FDA.

Who Has to Follow FSMA?

All companies that grow, ship, pack, process or import produce will be required to follow these rules. This means that all food that is produced in the U.S. and all food that is imported into the U.S. will be required to follow the same rules. In a typical supply chain, there are a lot of companies that just do one thing (e.g., grow) and then pass the product on to the next step. This same thing applies to growers in other countries that sell and ship their product to another company in the U.S. In these cases, the companies will need to require more from the suppliers in order to verify that they are following all of the rules and regulations set forth by FSMA.

Although these rules apply to all food suppliers in the U.S., there are some exceptions.

Smaller growers will have a longer time-frame to comply with the rules. However, those that have an annual income of $25,000 or less as an average for the previous three years will not be required to participate.
Certain products are exempt from the growing portion of the rule for crops that the FDA has deemed “rarely consumed raw,” including items such as figs, asparagus, sweet corn, peanuts, etc. (You can see more of which crops are on the exemption list here.)

Who Does FSMA Affect?

As mentioned previously, FSMA affects everyone associated in the production of fruits and vegetables. However, larger produce companies have already been implementing a majority of these food safety practices for years. This is due to the large buyers that require certain criteria from their suppliers. As a result, there might be a few things that the larger companies have to alter, but for the rest, they already have these rules in place.

The smaller producers are the ones who are going to have a lot of changes to make, which does make sense as to why they are given a longer time-frame to comply with the new food safety regulations. A lot of the smaller growers and packers do not have a food safety program in place, which not only includes practicing food safety, but having records to verify that they are practicing food safety. As a result, it appears that food safety audits will play an even bigger role with the smaller producers in order to help them comply with FSMA.

Food Safety Audits

Although the FDA has begun to implement FSMA and require new standards by food producers, the FDA has also publicly stated that they do not have the resources to properly verify that all food producers are following the FSMA requirements. For this reason, food safety audits will begin to play an even bigger role. The FDA is allowing audit schemes to benchmark themselves against the FSMA requirements, meaning that if they can show that they cover all of the FSMA requirements, then that will suffice.

When auditors arrive to conduct food safety audits, they are only there for 1-2 days to observe the implemented food safety practices, as well as to review the records and documentation to verify what is actually being performed. The only follow-up after the audit is if the producer submits corrective actions (within the time-frame allotted by the audit scheme), and the auditor can either accept or reject them. In most cases, there is no follow up site visit or any documentation review throughout the year.

Food Safety Regulations: Areas for Improvement

As with anything, there are always areas for improvement. Based on my experience working with food safety, here are a few of the main issues that I recognize:

More work and follow up is needed by the FDA. Click here to see a great report detailing issues found with FDA follow up, and the response from FDA.
Food safety audits are just a snapshot in time. They take place 1-2 days per year (if that) and the auditor reviews what they see that day, a random sampling of records from the previous 12 months and that is it. Unless the buyers continue to oversee the suppliers throughout the year, there is no guarantee that the suppliers are maintaining the practices that they were able to demonstrate on the day of the audit.
Although food safety is highly regulated from field to grocery store, there is no sort of oversight at the grocery store level. This is one of my biggest pet peeves because I know how hard all of the food producers work to get their food safely to the grocery store, but once the food is at the actual grocery store, there is not as much oversight. One example is the storage temperature of the produce on display. Another example is that multiple people touch each individual piece of produce, and who knows where their hands have been. However, my biggest concern at the grocery store level is the cleanliness of the shelves used to display the produce, and the misters used on the produce. I normally encounter the worst scenarios where the heads of lettuce are being displayed.

I would be interested to hear about your experiences with food safety, and what you think could be improved with the current status of food safety regulations in the food industry. Please leave your comments below!

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