The U.S. Food and Drug Administration (FDA) publishes the federal rule on keeping human and animal food safe while it moves by truck or rail. It also publishes food-storage guidance with target refrigerator and freezer temperatures. For food importers and brands that need refrigerated or frozen storage in Miami, these two FDA sources show where temperature control is expected and which agreements and records matter. This guide explains both in plain words and ends with a list of what to prepare.
Key Takeaways
- According to the FDA, the Sanitary Transportation rule covers shippers, loaders, carriers by motor or rail vehicle, and receivers of human and animal food.
- The FDA lists failure to properly refrigerate food as one of the risky practices the rule aims to prevent.
- The FDA exempts food that is completely enclosed by a container, but that exemption does not cover food that requires temperature control for safety.
- FDA storage guidance says to keep the refrigerator at or below 40° F (4° C) and the freezer at 0° F (-18° C).
- Miami Alliance 3PL offers cold storage, refrigerated and frozen, in Miami as one of its specialty storage services.
In This Article
Two FDA Sources Behind Cold Storage Decisions
Federal food rules can look like one big block to a food importer or brand that needs refrigerated or frozen space. Two FDA publications speak most directly to temperature. The first is the FDA Food Safety Modernization Act (FSMA) final rule on Sanitary Transportation of Human and Animal Food. It covers food moving by motor or rail vehicle. The second is an FDA consumer update, Are You Storing Food Safely?, which gives target temperatures for refrigerators and freezers.
The two documents carry different weight. According to the FDA, the transportation rule is one of seven foundational rules proposed since January 2013 to create a modern, risk-based framework for food safety. The storage page is written for consumers at home. Treat it as a public reference point, not a commercial standard. Its numbers are still easy to put into written handling instructions. This guide covers both documents and ends with a checklist for companies comparing 3PL services in Miami for refrigerated and frozen food.
Who the Sanitary Transportation Rule Covers
The FDA says the rule sets requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food. Each of them must use sanitary practices to keep that food safe. According to the agency, the goal is to prevent practices that create food safety risks. Its examples are "failure to properly refrigerate food", inadequate cleaning of vehicles between loads, and failure to properly protect food.
Two points matter for Miami importers:
- The FDA states that the requirements do not apply to transportation by ship or air because of limitations in the law.
- The rule still reaches shippers in other countries who send food to the United States by ship or air and arrange for the intact container to be transferred onto a motor or rail vehicle for transportation within the U.S. This applies if the food will be consumed or distributed in the United States.
Taken together, these two points mean a refrigerated container that arrives at PortMiami by sea and then moves inland by truck can bring the rule into play for the truck move, when the conditions the FDA describes are met.
The FDA also notes two points about exports. Companies transporting food intended for export are covered until the shipment reaches a port or U.S. border. The rule does not apply to exporters who ship food through the United States by motor or rail vehicle if the food does not enter U.S. distribution.
What the Rule Says About Temperature Control
According to the FDA, the rule sets requirements in four areas: vehicles and transportation equipment, transportation operations, training, and records. Temperature appears in more than one of them.
- Vehicles and equipment. The FDA says vehicles and transportation equipment must be suitable and adequately cleanable for their intended use. They must also be "capable of maintaining temperatures necessary for the safe transport of food".
- Transportation operations. The agency lists adequate temperature controls among the required measures. The others are keeping ready-to-eat food from touching raw food, protecting food from contamination by non-food items in the same load or a previous load, and protecting food from cross-contact. The FDA describes cross-contact as the unintentional incorporation of a food allergen.
- Training. According to the FDA, covered carriers must give food safety training to transportation operations personnel when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport. That training must be documented.
- Records. Carriers must keep records of written procedures, agreements and training. The FDA says the retention time depends on the type of record and when the activity occurred, but does not exceed 12 months.
The common thread is written agreements. It is easier to show who sets the temperature, who checks it and who trains the driver when the shipper and carrier settle those points in writing before a load moves.
Exemptions, Waivers and Small Businesses
The FDA lists several exemptions. They include:
- shippers, receivers or carriers with less than $500,000 in average annual revenue;
- food transshipped through the United States to another country;
- food imported for future export that is neither consumed nor distributed in the United States.
One exemption deserves a close read from cold-chain sellers. The FDA exempts transportation of food that is completely enclosed by a container. That exemption does not cover food that requires temperature control for safety. Packaging alone does not take temperature-sensitive food out of the rule.
The FDA has also published three waivers for businesses whose transportation operations are subject to Federal-State or local controls. They cover:
- certain Grade A milk operations;
- certain permitted food establishments that provide food directly to consumers, such as restaurants and retail food establishments;
- certain molluscan shellfish operations under the National Shellfish Sanitation Program.
For compliance timing, the FDA defined small businesses in two ways. The first is businesses other than motor carriers that are not also shippers or receivers, employing fewer than 500 persons. The second is motor carriers with less than $27.5 million in annual receipts.
FDA Storage Guidance: The 40° F and 0° F Benchmarks
In its consumer update on food storage, the FDA says to keep the refrigerator at or below 40° F (4° C) and the freezer at 0° F (-18° C). It also says to check temperatures periodically with appliance thermometers. The agency explains that keeping foods chilled at proper temperatures is one of the best ways to prevent or slow the growth of bacteria such as Salmonella, E. coli O157:H7 and C. botulinum.
Several points in that guidance are easy to turn into written handling instructions:
- Do not crowd a refrigerator or freezer so tightly that air can't circulate.
- Do not leave food that needs refrigeration at room temperature for more than two hours, or one hour if the air temperature is above 90° F.
- Food handled and stored properly in the freezer at 0° F stays safe, because freezing stops bacteria from growing. Quality still declines over time, according to the FDA, and freezer burn is a quality issue, not a safety issue.
- Use refrigerated ready-to-eat foods as soon as possible, because Listeria can grow, especially above 40° F (4° C).
- Keep food away from cleaning products and chemicals.
The FDA also gives guidance for power outages. A full freezer keeps an adequate temperature for about 48 hours if the door stays closed. Refrigerated perishable food held above 40° F for four hours or more should be discarded. Those benchmarks are a useful starting point for any outage plan.
What to Prepare Before Booking Cold Storage
- A temperature spec for each SKU. State whether each item is refrigerated or frozen, based on the label or the manufacturer's directions. The FDA advises checking storage directions on labels.
- Written shipper and carrier agreements. Decide in writing who is responsible for sanitary conditions and temperature during each truck or rail move. The FDA ties carrier training duties to that agreement.
- Equipment confirmation. Ask carriers to confirm their trailers can maintain the temperatures your food needs.
- Organized records. Keep written procedures, agreements and training records in one place.
- Separation notes. Flag raw items, ready-to-eat items and allergens that must not share space or touch.
- An exception plan. Define what happens to product when a reading is out of range. Use the FDA's 40° F and four-hour benchmarks as reference points.
- Customs coordination. For imports, line up your licensed customs broker early so receiving can be scheduled after clearance. The inbound receiving checklist covers the dock side.
- A line to the FDA. The FDA FSMA Food Safety Technical Assistance Network answers questions submitted online or by mail. The FDA's Small Entity Compliance Guide explains the rule for smaller firms.
What This Means for Businesses Using 3PL Services in Miami
For food importers and brands, the FDA material leads to two practical questions when comparing 3PL services in Miami. Can the provider store refrigerated and frozen product? And can responsibility for each truck move be clearly assigned in writing? Miami Alliance 3PL offers cold storage, refrigerated and frozen, in Miami. It also offers dry and ambient storage, customs-bonded storage, and FDA-regulated storage for food, dietary supplements and cosmetics, alongside general and climate-controlled warehousing.
The company's Medley facility is a 20,000+ sq ft climate-controlled warehouse. It is 8 miles from Miami International Airport and minutes from PortMiami, with access to Port Everglades. For imports, the company coordinates receiving after customs clearance with the client's licensed customs broker. The team works in English and Spanish, which helps when Latin American suppliers are part of the chain. Minimum spend is $1,000/month, there is no minimum order count, and there are no long-term contracts.
To discuss refrigerated or frozen storage, request a quote or contact the team at (786) 873-8819 or contact@miamialliance3pl.com. Hours are Monday-Friday 8AM-6PM EST and Saturday 9AM-2PM EST. For more background, see the cold storage 3PL warehouse guide and the full list of Miami 3PL services.
Talk to a Miami 3PL Team
Miami Alliance 3PL runs warehousing, ecommerce fulfillment, Amazon FBA prep and wholesale distribution from 8780 NW 100th ST in Medley, Florida. Call (786) 873-8819 or email contact@miamialliance3pl.com.
Get an Instant QuoteFrequently Asked Questions
Does the FDA Sanitary Transportation rule apply to food that arrives by ship?
According to the FDA, the requirements do not apply to transportation by ship or air because of limitations in the law. The rule does apply to shippers in other countries who send food by ship or air and arrange for the intact container to be moved onto a motor or rail vehicle for transportation within the U.S. This applies if the food will be consumed or distributed in the United States.
What refrigerator and freezer temperatures does the FDA recommend?
In its consumer food-storage guidance, the FDA says to keep the refrigerator at or below 40° F (4° C) and the freezer at 0° F (-18° C). It recommends checking refrigerator and freezer thermometers at least once a week. That page is written for households, so businesses should also follow product labels and their own written procedures.
Is packaged refrigerated or frozen food exempt from the rule?
The FDA exempts transportation of food that is completely enclosed by a container. That exemption does not cover food that requires temperature control for safety, so packaging alone does not remove temperature-sensitive food from the rule. Sellers should review the FDA's full exemption list and its Small Entity Compliance Guide.
Does Miami Alliance 3PL offer cold storage among its 3PL services in Miami?
Yes. Miami Alliance 3PL offers cold storage, refrigerated and frozen, in Miami as part of its specialty storage, alongside general and climate-controlled warehousing. Minimum spend is $1,000/month, and there are no long-term contracts.
What records does the Sanitary Transportation rule require?
According to the FDA, carriers must keep records of written procedures, agreements and training. The retention time depends on the type of record and when the covered activity occurred, but does not exceed 12 months.
Sources
This guide is based on these official sources. Facts about the rules come from those pages; facts about Miami Alliance 3PL come from the company.
- U.S. Food and Drug Administration: FSMA Final Rule on Sanitary Transportation of Human and Animal Food | FDA
- U.S. Food and Drug Administration: Are You Storing Food Safely? | FDA