Quick answer: Yes — rice processors and exporters need standard FDA Food Facility Registration and a U.S. Agent. If you export infant rice cereal specifically, FDA has a binding action level of 100 ppb for inorganic arsenic; for other rice products there's no equivalent numeric limit yet, but arsenic remains an FDA monitoring priority. Orionex provides Food Facility Registration and U.S. Agent services for rice exporters starting at $300/year.
Why Arsenic Is Rice's Defining FDA Issue
Rice absorbs inorganic arsenic from soil and irrigation water more readily than most other grains, largely because it's grown in flooded paddies, which increases arsenic's bioavailability. This isn't a manufacturing defect — it's a characteristic of how rice grows — but it's exactly why FDA has focused specific attention on rice, above and beyond standard food safety requirements.
The Infant Rice Cereal Action Level — Scoped Correctly
In August 2020, the FDA finalized an action level of 100 parts per billion (ppb) for inorganic arsenic in infant rice cereal — and it's important to be precise about scope here: this level applies specifically to infant rice cereal (white, brown, organic, and conventional), not to rice or rice products in general. There is currently no FDA-wide binding numeric arsenic limit for rice sold for general consumption.
That said, an action level isn't just a suggestion. Under 21 CFR 109.4, FDA can use an action level as evidence that a food is adulterated under the FD&C Act if levels exceed it — meaning infant rice cereal above 100 ppb is a real enforcement exposure, not just a quality recommendation.
FDA's own testing shows the industry has been closing the gap: in 2018 testing, 76% of infant rice cereal samples met the 100 ppb level, up from 47% in 2014 and just 36% between 2011–2013 — improvement FDA attributes largely to selective sourcing of lower-arsenic rice varieties and growing regions, plus more systematic testing.
If you export infant rice cereal: arsenic testing before shipment isn't optional in practice, even though the guidance itself is technically non-binding. A single sample over 100 ppb gives FDA grounds to treat your product as adulterated.
FDA's Closer to Zero Program
The infant rice cereal action level sits inside a broader FDA initiative called Closer to Zero, which targets reducing exposure to toxic elements — arsenic, lead, cadmium, and mercury — specifically in foods commonly eaten by babies and young children. If your rice products are marketed toward infants or toddlers in any form (cereals, puffs, snacks), expect this program's priorities to shape what FDA is watching for, even in categories without a finalized numeric action level yet.
What About Rice for General Consumption?
For rice sold to the general population — not infant products — there's no equivalent binding action level today. That doesn't mean arsenic is irrelevant: FDA's general adulteration authority under the FD&C Act still applies, and consistently high arsenic levels could draw scrutiny even without a specific numeric threshold. Good manufacturing practice in this space, as FDA has described it in the infant cereal context, centers on selective sourcing — some rice varieties and growing regions naturally test lower for inorganic arsenic than others — and routine testing as part of your supplier verification process.
FSVP for Rice Importers
U.S. importers of rice must maintain a Foreign Supplier Verification Program (FSVP) for each foreign supplier, the same as most other food categories. See our FSVP service page for pricing and scope.
U.S. Agent Requirement for Rice Facilities
Every foreign rice processing facility registering with the FDA must designate a U.S. Agent physically located in the United States, serving as FDA's official point of contact for your facility.
Orionex Regulatory Solutions is a trusted FDA U.S. Agent for rice processors and exporters, physically based in Casper, Wyoming USA. Learn about our U.S. Agent services →
Rice Compliance Checklist
FDA Food Facility Registration
Register your facility and designate a U.S. Agent — the baseline requirement.
Test Against 100 ppb If Exporting Infant Cereal
Confirm inorganic arsenic levels before shipment if your product falls in this category.
Source Selectively for Other Rice Products
Lower-arsenic rice varieties and growing regions reduce risk even without a binding limit.
FSVP Program
U.S. importers need a complete FSVP program per supplier.
Renew Every Two Years
Food Facility Registration renews biennially — next window: October 1 – December 31, 2026. See our renewal guide.
What Orionex Provides for Rice Exporters
The FDA charges no government fee for Food Facility Registration. Orionex's fixed pricing:
- Food Facility Registration + U.S. Agent + Certificate: $300/year
- Additional facility (same owner): $150/year
- FSVP Program Development: $400/supplier — see FSVP details →
Note: Orionex handles your Food Facility Registration, U.S. Agent designation, and importer FSVP program. Arsenic testing itself needs an accredited food safety lab — contact us if you'd like a referral.
Why Rice Exporters Choose Orionex
FDA Registration & U.S. Agent for Rice — From $300/Year
Orionex handles FDA Food Facility Registration and U.S. Agent services for rice processors and exporters, plus FSVP program development for U.S. importers sourcing from abroad.