Updated: Jul 17, 2020
By Ashley Ellixson
As promised, I will continue the series on the Food Modernization Act (FSMA) today with a closer look at whom FSMA applies to and to what extent it affects those impacted.
If you would like a quick overview or missed my first post on FSMA, you can read it here. I will be focusing on the five key areas I discussed in that blog post from here on out. Today I am going to look more closely at the Preventive Controls (aka Preventive Rule). This rule is a big player in the FSMA and whether you need to be in compliance (and by when) is imperative.
The Preventive Rule
The Food and Drug Administration (FDA) released proposed revisions to the Preventive Controls for Human Food (Preventive Rule-Section 103) of FSMA on September 19, 2014 with a comment period that ended on December 15, 2014. The overview of the Preventive Rule will reflect those proposed changes even though they are not yet final.
The Preventive Rule has two main parts: 1) requirements for hazard analysis and risk-based preventive controls (HARPC) and 2) Good Manufacturing Practice (GMP) requirements. The recently proposed rules outline new requirements and updates to existing standards for facilities which manufacture, process, pack, or hold human food. In short, this section focused on processors as opposed to producers, discussed below. The following is a list of key provisions and new requirements to the Preventive Rule.
Hazard Analysis: The hazard analysis plan required by this section must identify and evaluate hazards for each type of food manufactured, processed, packed or held at the facility. (FSMA Section 103)
Farms That Pack and Hold for Other Farms: Farms will no longer be required to register as a food facility solely because it packs or holds raw agricultural commodities grown on other farms under different ownerships. FDA is proposing to define “packing and holding” as a traditional farming activity and would be subject to the produce safety rule detailed below instead of the Preventive Rule. However, farms that further process or manufacture will be subject to the Preventive Rule. (FDA Website)
Preventive and Monitoring Controls: The plan must identify preventive controls that substantially minimize or prevent hazards. Preventive controls are defined as process controls, food allergen controls, sanitation controls, and a recall plan. The plan must document all procedures performed to ensure preventive controls are being implemented. (FSMA Section 103)
Corrective Actions: The plan must identify a procedure that would take place if preventive controls are not sufficiently executed to minimize the reoccurrence of a problem, evaluate for food safety, and stop the hazardous food from entering the stream of commerce. (FSMA Section 103)
Verification of Implementation and Effectiveness: FDA is also determining whether preventive controls should require a facility to conduct product testing to confirm implementation and effectiveness of preventive procedures. Additionally, FDA is looking into whether a facility should also conduct environmental monitoring to ensure implementation and effectiveness of procedures if contamination of a “ready-to-eat” food with an environmental pathogen is a substantial hazard. (FDA Website)
Supplier Program: Supplier controls, as opposed to the facility controls discussed above, are proposed to be required when the receiving facility’s hazard analysis identifies a significant hazard from a raw material or ingredient and that hazard is measured before the facility receives the raw ingredient from a supplier. If this provision were adopted, the facility would have the freedom to choose how to appropriately verify a hazard from a supplier that appropriately fits the entities. (FDA Website)
Current Good Manufacturing Practices (CGMPs): The proposed rule includes clarification on protections against cross-contaminated food by allergens, stylistic language changes, and removal of certain provisions containing recommendations. Facilities which are exempt or subject to modified requirements for hazard analysis and preventive controls would generally be subject to GMP requirements. (Sustainable Agriculture Website)
To Whom Does the Preventive Rule Apply?
Determining whether the Preventive Rule applies to you is based on whether you qualify as a “facility” or “farm” as its defined by FDA. If you are a “facility” you must register with the FDA and will be subject to the proposed Preventive Rule. A “facility” is defined as “any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States.”(21 CFR 1 § 227(b)(2)). If you are a “farm” or retail food establishment you generally are not subject to the Preventive Rule. For example, farmers’ markets, community supported agriculture programs (CSA), and other direct-to-consumer sale structures come under the definition of retail food establishment and are not subject to the Preventive Rule.
As noted above, the Preventive Rule is split into two main parts and because of this, coverage under these two parts must be determined separately since certain facilities may be subject to one and not the other.
1. Requirements For Hazard Analysis and Risk-Based Preventive Controls (HARPC)
2. Good Manufacturing Practice (GMP) Requirements
Certain facilities are either exempt from HARPC requirements or subject to modified requirements. Exempt facilities include those covered by pre-existing regulations such as juice, seafood, and dietary supplements and facilities solely in the business of storing agricultural commodities such as grain elevators (21 CFR 1 § 226(f) & (g)). Facilities with a modified requirement are those defined as very small business and facilities which average less than $500,000 in average annual gross sales of all food in a previous three-year period, and sell the majority of their food directly to consumers, restaurants, or retailers within the same state or within 275 miles from the facility. (Sec. 103(C)(3) of FSMA).
In reference to the GMPs, if you operate a facility you are generally subject to the requirements. The only facilities FDA has excluded from GMPs are warehouses and grain elevators that store raw agricultural commodities intended for further processing. This includes both fruits and vegetables.
Compliance dates vary depending on what type of facility definition you fall under.
Small Business: A business which employs fewer than 500 people and does not qualify for an exemption would have to comply two years after publication of the final rule.
Very Small Business: A business with less than $2.5 million in total annual sales would have three years after publication of the final rule to comply. If the facility is a “qualified facility,” it would be subject to modified requirements for preventive controls.
Other Businesses: A business which is not small or very small and does not qualify for an exemption would have to comply one year after publication of the final rule.
For further information on the Preventive Rule, visit the FDA website. Stay tuned for another FSMA post next week!