ML25267A066
| ML25267A066 | |
| Person / Time | |
|---|---|
| Issue date: | 09/22/2025 |
| From: | Dennis Galvin Plant Licensing Branch II |
| To: | Thomas S - No Known Affiliation |
| Buckberg P | |
| Shared Package | |
| ML25233A265 | List: |
| References | |
| OEDO-25-00397, EPID L-2025-CRS-0002, 2.206 | |
| Download: ML25267A066 (2) | |
Text
From:
Dennis Galvin To:
Thomas. Saporito Cc:
Petition Resource
Subject:
Screening Results - 2.206 Petition - Radioactively Contaminated Shrimp Date:
Monday, September 22, 2025 5:01:00 PM Mr. Saporito, By email dated August 20, 2025 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML25233A178), you submitted a petition to the Nuclear Regulatory Commission (NRC) for consideration under Title 10 of the Code of Federal Regulations (10 CFR) 2.206. The petition requested enforcement action against Walmart Inc. and one of its suppliers, PT. Bahari Makmur Sejati, regarding the unlicensed distribution of shrimp products. The NRC staff initiated its screening process in accordance with of NRC Management Directive (MD) 8.11, Review Process for 10 CFR 2.206 Petitions, and its associated Directive Handbook (DH) 8.11 Section II.A.2(d)
(ML18296A043). In your petition, you requested the following:
- 1. Immediately investigate Walmart and the Supplier for unlicensed activities involving byproduct material under 10 CFR Part 30.
- 2. Issue orders requiring Walmart and the Supplier to cease all distribution, sale, and possession of contaminated shrimp products containing detectable levels of Cs
[Cesium]-137.
- 3. Impose civil penalties on Walmart and the Supplier for violations of 10 CFR 30.3, which prohibits the transfer, receipt, acquisition, ownership, possession, or use of byproduct material except as authorized by a specific or general license.
- 4. Require Walmart and the Supplier to conduct comprehensive testing of all imported shrimp products for radioactive contaminants and report findings to the NRC.
- 5. Coordinate with the Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) to ensure the seizure and proper disposal of any contaminated products as radioactive waste, in accordance with NRC guidelines.
As the basis for the petition you cited the August 19, 2025, FDA advisory regarding certain imported frozen shrimp from an Indonesian firm (https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-public-not-eat-sell-or-serve-certain-imported-frozen-shrimp-indonesian-firm).
In addition to the FDA advisory you referenced in your petition, on August 21, 2025, the FDA also posted as a public service the announcement by Southwind Foods, LLC of the recall of Sand Bar/Arctic Shores/Best Yet/Great American/First Street branded frozen shrimp for possible Cs-137 contamination (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/southwind-foods-llc-recalls-frozen-shrimp-because-possible-health-risk).
The NRC staff has screened your request out of the 2.206 petition process consistent with MD 8.11, DHSection II.A.2(d)(vi), Requests to Impose a Requirement that is Outside of NRC Jurisdiction. The safety of the nations food supply (including potential radioactive contamination of food) is outside the scope of the NRCs authority under the Atomic Energy Act (AEA) of 1954, as amended, and the Energy Reorganization Act (ERA) of 1974, as
amended. The safety of the nations food supply is regulated by the FDA under the Federal Food, Drug, and Cosmetic Act of 1938, as amended. A Memorandum of Understanding between the FDA and the NRC dated December 20, 2023 (ML23262B040) affirms that the FDA, not the NRC, is responsible for the safety of the nations food supply.
In your petition, you state that Cs-137 is byproduct material as defined by 10 CFR 30.4, Definitions; that under 10 CFR 30.3, Activities requiring license, a license is required to possess and transfer Cs-137; and that no exemptions apply. Cs-137 meets item 1 of the term Byproduct material, as it is a radioactive material yielded in, or made or made radioactive by, exposure to the radiation incident to the process of producing or using special nuclear material. And while 10 CFR 30.14, Exempt concentrations, identifies concentrations of byproduct material that are exempt from the requirements for a license, 10 CFR 30.14 does not provide exempt quantities for food, as stated in 10 CFR 30.14(c):
This exemption does not apply to the transfer of byproduct material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.
However, since the safety of the nations food supply is outside the scope of the AEA and the ERA, the safety of the nations food supply is also outside the scope of the regulations in 10CFR Part 30, as reflected in 10 CFR 30.1, Scope, which states in part:
This part prescribes rules applicable to all persons in the United States governing domestic licensing of byproduct material under the Atomic Energy Act of 1954, as amended (68 Stat. 919), and under title II of the Energy Reorganization Act of 1974 (88 Stat. 1242), and exemptions from the domestic licensing requirements permitted by Section 81 of the [Atomic Energy] Act.
Therefore, the rules of 10 CFR Part 30, including 10 CFR 30.3, 10 CFR 30.4, and 10 CFR 30.14, are not applicable to the safety of the nations food supply. Accordingly, your requests for enforcement action based on potential radioactive contamination of imported food items are outside the NRCs authority.
As stated in the August 19, 2025, FDA advisory, an FDA investigation is ongoing regarding the potentially radioactively contaminated shrimp. As noted in the FDA advisory, FDA has issued guidance levels for radionuclides in domestic and imported foods (https://www.fda.gov/food/process-contaminants-food/supporting-document-guidance-levels-radionuclides-domestic-and-imported-foods).
The guidance referenced in the FDA advisory also supports FDA determined guidance levels for radionuclides in domestic and imported foods (CPG Sec. 555.880 Guidance Levels for Radionuclides in Domestic and Imported Foods)
(https://www.fda.gov/media/72014/download?attachment).
In addition, the NRC staff concluded, following review in accordance with DH Section II.B.1, that the concerns expressed in your request do not warrant immediate enforcement action by the NRC. Thank you for bringing these issues to the attention of the NRC. The 2.206 Petition Process exists to identify safety issues at NRC licensed facilities and your efforts are appreciated. For more information on the petition process please see https://www.nrc.gov/about-nrc/regulatory/enforcement/petition.html.
Respectfully,
Dennis Galvin Project Manager / Agency 2.206 Petition Coordinator U.S. Nuclear Regulatory Commission Office of Nuclear Reactor Regulation Division of Operating Reactor Licensing Plant Licensing Branch II-2 301-415-6256