|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
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Petitions Control Branch
Food and Drug Administration
Department of Health and Human Services
Washington, DC 20204
The Food Safety and Inspection Service (FSIS) is claiming a categorical exclusion from requirements that it conduct an environmental assessment for the action proposed in the petition entitled "Ionizing Radiation as an Additive in Unrefrigerated, Refrigerated, and Frozen Poultry Products," submitted to the Food and Drug Administration (FDA) on August 19, 1999. In the petition, FSIS requested FDA to amend its regulations governing the irradiation of poultry (21 CFR 179.26(6)) by raising the maximum dose allowed for poultry products to 4.5 kGy (450 krad) for refrigerated or unrefrigerated product and 7.0 kGy (700 krad) for frozen product. FSIS also requested that FDA amend ' 179.26(6) of its regulations to remove the requirement that any packaging of irradiated poultry not exclude oxygen, i.e., that it be air permeable.
FSIS claims the exclusion under 21 CFR 25.32(j), which states that neither environmental assessments nor environmental impact assessments need to be prepared for the following type of action:
(j) Approval of a food additive petition, GRAS affirmation petition, or the granting of a request for exemption from regulation as a food additive under Sec. 170.39 of this chapter, when the substance is to be used as a component of a food-contact surface of permanent or semipermanent equipment or of another food-contact article intended for repeated use.
Although the additive in question (sources of ionizing radiation) would never actually be in contact with the poultry products to be treated, the ionizing radiation emitted from the source would repeatedly contact the product, so as to bring about the desired antimicrobial effects.
Finally, FSIS knows of no extraordinary circumstances indicating that the action proposed by the petition would significantly affect the quality of the human environment. Available data indicates that the irradiation of poultry at the requested dosages and under the requested conditions would neither threaten serious harm to the environment (21 CFR 25.21(a)) nor violate Federal, State, or local laws or requirements imposed for the protection of the environment (40 CFR 1508.27 (b)(10)).
Daniel L. Engeljohn, PhD
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