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Report and notification of a dose to an embryo/fetus or a nursing child.

CFR · 2024-01-01 · US · Title 10

(a) A licensee shall report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of byproduct material or radiation from byproduct material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user. (b) A licensee shall report any dose to a nursing child that is a result of an administration of byproduct material to a breast-feeding individual that— (1) Is greater than 50 mSv (5 rem) total effective dose equivalent; or (2) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician. (c) The licensee shall notify by telephone the NRC Operations Center no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraphs (a) or (b) in this section. (d) By an appropriate method listed in § 30.6(a) of this chapter, the licensee shall submit a written report to the appropriate NRC Regional Office listed in § 30.6 of this chapter within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in paragraphs (a) or (b) in this section. (1) The written report must include— (i) The licensee's name; (ii) The name of the prescribing physician; (iii) A brief description of the event; (iv) Why the event occurred; (v) The effect, if any, on the embryo/fetus or the nursing child; (vi) Wha

official document · source cfr-2024 · id 10:§ 35.3047