From the Farm and Ranch Freedom Alliance
by Judith McGeary, Esq.
After seven years of debates in Congress and FDA, the Food Safety Modernization Act (FSMA) regulations are final and in effect.
Flow charts to help farmers, artisan producers, and food businesses figure out whether or not they are subject to these expensive new regulations are available online at www.farmandranchfreedom.org/fsma, and we will be posting additional articles shortly.
One of the important things to realize, however, is that “exempt” doesn’t mean you can ignore the new regulations completely. There are a few basic requirements, and there are implications that go beyond the issue of what is legally required. This article will address the questions that we have been receiving on these aspects of the rules and the exemptions.
This article is not legal advice. Please consult an attorney for any questions about what you must do to comply with the regulations. The regulations are in Title 21 of the Code of Federal Regulations, Part 112.
As a reminder, FSMA does not govern meat production. Meat is regulated by the USDA, not FDA.
There are two main rules at issue. The first is the “Preventive Controls Rule,” which imposes requirements on “facilities” – business that pack, hold, store, manufacture, or process food. The second is the Produce Safety Rule, which regulates how farmers grow and harvest fruits, vegetables, mushrooms, nuts, and sprouts. Both rules include the Tester-Hagan exemption that we successfully fought for in Congress, but it takes different forms in the two rules. The FDA uses the term “qualified exemption” for the Tester-Hagan provision.
For the Preventive Controls Rule, facilities that have less than $1 million in gross sales annually (based on a 3-year rolling average, and adjusted for inflation) have a qualified exemption. For the Produce Safety Rule, the farm must meet two requirements in order to have a qualified exemption:
- Food sales averaging less than $500,000 per year during the previous three years; and
- The farm’s sales to qualified end-users must exceed sales to all others combined during the previous three years. A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away.
REQUIREMENTS FOR EXEMPT PRODUCERS
If you have a “qualified exemption,” you must still meet certain modified requirements. First, you must disclose the name and the complete business address of the farm where the produce was grown either on the label of the produce (when a food packaging label is generally required) or with a “prominent and conspicuous” display at the point of purchase. The latter requirement can be met by a statement on an invoice or other documents delivered contemporaneously with the produce in the normal course of business, including electronic notice for Internet sales. The complete business address must include the street address or a P.O. box, city, state, and zip.
In addition, facilities with a qualified exemption must register with the FDA and:
- Submit a statement to FDA that it satisfies this definition. You do not need to submit supporting documentation, but you must retain the financial records in your own files.
- Submit a statement to FDA that you have either done a simplified HARPC plan or that you are in compliance with applicable State and local food safety laws.
Unlike the rule for facilities, farms that have a qualified exemption do not need to submit anything to FDA to initially establish their exemption; but you do need to maintain “adequate records necessary to demonstrate that your farm satisfies the criteria for a qualified exemption, including a written record that you have performed an annual review and verification of your farm’s continued eligibility for the qualified exemption.”
All records under the rule must include the name and location of the farm, a description of the product, and the date and time of the activity documented. The records must be created contemporaneously (i.e., at the time the events occurred, not recreated later), be legible and indelible, and be dated. Except for sales receipts kept in the normal course of business, the records must also be signed or initialed by the person creating them.
It is important to recognize that the exemptions mean that the producer is not legally required to comply with the new requirements imposed by FDA. However, the exemptions do not limit what a private business can choose to require. If you sell to grocers, schools, or other large buyers, some of them may have concerns about buying produce that is not raised under the new standards.
In practical terms, it may be useful to take one of the workshops that will be offered around the country on the new FSMA requirements – such as the one that will be offered at the annual Farm and Food Leadership Conference in Central Texas on September 25, 2016 (go to www.FarmAndRanchFreedom.org for more information). Identify those measures that you are already doing on your farm, as well as those that you could implement without significant expense, and then be ready to explain the safety measures you are taking to potential buyers.
One type of buyer may pose a particular challenge. Food facilities that are not exempt will be required to have a “supplier verification” program. In general, the regulated facilities will have to take fairly extensive steps to address food safety by their suppliers. If they are buying ingredients from exempt farmers or exempt facilities, then the requirements are significantly less. While the requirements are on the buyer (the regulated facility), this obviously impacts the seller (the exempt farmer). The buyer will need the following written assurances from the exempt farmer of facility:
- Assurance that the seller is in fact exempt, to be submitted annually;
- Assurance that the farm “acknowledges that its food is subject to section 402 of the Federal Food, Drug, and Cosmetic Act,” which addresses the prohibition on selling adulterated food; or, if the seller is an exempt facility, assurance that the facility complies with State and local food safety laws.
If you sell to a regulated facility, they may or may not realize that they don’t have to deal with the full supplier verification requirements in order to buy from you. You may find yourself in the position of having to explain the regulations to your buyers in order to keep them as customers, so be prepared.
Deadlines: The FDA set deadlines for coming into compliance based on the size of the farm or facility. Farms that have a qualified exemption – i.e. less than $500,000 in gross sales and more than half sold direct to “qualified end users” – must begin keeping the records necessary to prove that exemption as of January 2016 (this year).
For more information, visit www.FarmAndRanchFreedom.org/FSMA.