The short answer
Frozen fruit and vegetables are processed foods for FDA. The freezing plant must have FDA food facility registration with a U.S. Agent and follow the Current Good Manufacturing Practice and Preventive Controls rule (21 CFR part 117) — usually with a written food safety plan. Every shipment needs Prior Notice, and the U.S. importer needs an FSVP.
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The big risks FDA watches in this category are viruses in frozen berries (hepatitis A and norovirus) and Listeria monocytogenes in frozen vegetables — because many people eat frozen fruit in smoothies without cooking it.
What FDA found in frozen berries
FDA tested 1,558 samples of frozen strawberries, raspberries and blackberries between November 2018 and September 2023:
| Result | Number |
|---|---|
| Hepatitis A virus positives | 8 |
| Norovirus positives | 10 |
| Prevalence | Under 1% for each berry type |
Positive imported lots were refused entry or recalled, and in four cases FDA flagged the firm’s future shipments for 180 days or placed the firm on Import Alert 99-35. In January 2025 FDA released a prevention strategy for enteric viruses in fresh and frozen berries, noting that outbreaks have been linked to imported berries.
Key controls for exporters
- 1Farm and harvest hygieneSick-worker policies, toilets and handwashing in the field, clean harvest containers — especially for hand-picked berries that are not washed or cooked.
- 2Water qualityFor washing, blanching and cooling water.
- 3Blanching and Listeria controlValidated blanching for vegetables where used, and an environmental monitoring program for Listeria in the freezing and packing area.
- 4Food safety planA written hazard analysis and preventive controls prepared by a PCQI. See what is a PCQI.
- 5Pesticide testingAgainst U.S. tolerances, not home-country limits.
Rules that do — and don’t — apply
- FSMA 204 traceability: FDA’s FAQs say frozen produce is not on the Food Traceability List in that form, so the extra traceability records do not apply to frozen fruit and vegetables. Fresh-cut and fresh produce are a different story. See FSMA 204.
- Produce Safety Rule: applies to growing and harvesting fresh produce on farms; the freezing plant follows part 117.
- Labels: name (“frozen sliced mango”), ingredients if anything is added (sugar, syrup, ascorbic acid), Nutrition Facts, net quantity, and cooking instructions where the product is not meant to be eaten raw.
Example: frozen raspberries from Serbia and frozen okra from India
A Serbian raspberry freezer focuses on harvest hygiene and supplier controls for pickers, and its U.S. importer verifies these controls under FSVP — because the berries may go straight into smoothies. An Indian frozen okra packer focuses on validated blanching, Listeria environmental monitoring and pesticide testing, and prints “Cook before eating” instructions. Both need FDA registration, Prior Notice and an importer with an FSVP.
FDA food facility registration with U.S. Agent from $300. FSVP program for your importer from $400. Prior Notice $15 per shipment.
Frequently asked questions
Do frozen fruit and vegetables need FDA registration?
Yes. The facility that freezes or packs them for the U.S. must register with FDA and name a U.S. Agent.
Are frozen vegetables covered by the FSMA 204 traceability rule?
No. FDA’s FAQs say frozen produce is not on the Food Traceability List in that form.
Does FDA test imported frozen berries?
Yes. FDA tested 1,558 samples between 2018 and 2023 and found hepatitis A in 8 and norovirus in 10. Positive imported lots were refused or recalled.
Does freezing kill viruses?
No. Hepatitis A and norovirus survive freezing, which is why prevention at harvest and packing matters.
Sources
- FDA — Microbiological surveillance sampling FY19–23: frozen berries
- FDA — Prevention strategy for enteric viruses in berries (January 17, 2025)
- FDA — FSMA Food Traceability Rule FAQs
Figures and rules checked on November 11, 2026. This article is general information, not legal advice.