FSMA: Important dates and reminders
By: Phil Sneed
The Food Safety Modernization Act is just over five years old at this point, having been signed into law Jan. 4, 2011.
The FSMA has been called the most sweeping reform of the country's food safety laws in more than 70 years, according to the Federal Drug Administration. Essentially, the law aims to shift the focus of responding to contamination to outright prevention.
To do so, the law granted the FDA more authority to regulate how foods are grown, harvested and subsequently processed. This means that every aspect of the U.S. food system, from importers to manufacturers, including those transporting products from one point to another, will be affected in some way.
"Some important dates are approaching that the transportation sector has to be aware of."
Even though five years have passed, portions of the law have not been fully enacted. Authorities believed implementation of the entire 89 page FSMA law at once would result in more harm than good. And as such, it has gradually been rolled out.
Some important dates are approaching that everyone in the transportation sector has to be aware of. To ignore these regulations, however time consuming they may be, may result in hefty fines.
Various implementation dates
It must be noted, first, that various implementation dates exist. Shippers, carriers and more will want to thoroughly organize and keep track of these dates because some of them may get lost in the shuffle.
Preventive Controls for Human Food
This rule was first proposed in January 2013 and involved the outreach of numerous consumer groups, academia and federal, state and local regulatory departments. It was then finalized Sept. 17, 2015.
The rule has already gone into effect for small businesses that average less than $1 million in annual sales of human food, plus the market value it being manufactured, processed, packed or held without sale. Businesses subject to the pasteurized milk ordinance will have three years (September 2018) to comply.
Companies with 500 or fewer full-time employees have to comply by September 2019, and all other businesses must meet compliance by September 2016.
This rule is important because it mandates that preventive controls are to be in place to eliminate or minimize hazards, including throughout the supply chain. Food monitoring therefore is instrumental, and refrigerated transportation will have to be relied upon.
"Refrigerated transportation will have to be relied upon."
The third part of the rule specifically relates to the supply chain. Manufacturing and processing facilities must have a risk-based supply chain program if raw materials are involved.
Facilities must then make sure foods are received only from verified suppliers. If unverified suppliers are being utilized temporarily, then the materials must be verified before acceptance.
Under this rule, brokers and distributors are allowed to conduct these verification tests.
If companies find themselves unsure of what their next steps should be, the FDA will offer assistance with regards to hazards prevention, environmental monitoring and more.
Sanitary Transport of Human and Animal Food rule
This rule is still in the proposal stage but incorporates many aspects that pertain to transportation. According to the FDA, the Sanitary Transport of Human and Animal Food rule would establish criteria to maintain the safety of food during transport, including best practices, record keeping and training, among other areas.
As discussed by Talking Logistics, a final rule is expected by the end of March. If the final rule is published by then, then the FDA hopes to make the requirements effective 60 days later.
The proposed rule will encompass shippers, motor carriers and receivers. Shippers will be required to meet more regulations. For example, the FDA may mandate shippers specify in writing its sanitary requirements to the carrier.
Shippers will also be asked to ensure recordkeeping requirements are met and that sanitation and temperature checks on semitrailers are performed.
Carriers would subsequently have to show the shipper, and potentially the receiver, documentation that it has maintained the appropriate temperature control required during transport.
"The proposed rule will encompass shippers, motor carriers and receivers."
Motor carriers will be mandated to provide information about the last three cargoes hauled and the time that passed between cleanings.
While the FDA is hoping to put the rules into effect at the end of May, exemptions or delays may apply in certain situations. If a business is not a motor carrier, shipper or receiver, has fewer than 500 full-time employees and less than $25.5 million in receipts, then they have two years to meet compliance.
Businesses that are not small and not excluded from coverage would have one year to comply.
Total exemption includes:
- Shippers, carriers and receivers that have less than $500,000 in annual sales
- Transportation of live animals, compressed food gases and shelf food in a container
- Transportation of raw agricultural commodities
The FDA estimates that STHAF would apply to approximately 83,609 businesses, a number that takes into account the transportation sector.
Other than meeting compliance, this is an important rule to follow because it will have economic effects. Annually, businesses can expect to spend $360 to meet the compliance requirements.
In the coming months and years, shippers, receivers, carriers and motor carriers should start, if they haven't done so already, to meet compliance requirements as mandated by the FDA and FSMA.
To ensure no information or deadlines are missed, head to the FDA's official page for the law.