South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-36 - Frozen Desserts
Section 61-36.XII - RECALLS

For MANUFACTURED GRADE DAIRY PRODUCTS MANUFACTURERS and DISTRIBUTORS that have not been granted a Qualified Facility Exemption by the FDA, the Recall Plan requirements of 21 CFR 117.139 supersede the requirements of this section.

If 21 CFR 117.139 does not apply, each MANUFACTURED GRADE DAIRY PRODUCTS MANUFACTURER and MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTOR shall develop and maintain procedures for the notification of regulatory officials, consumer notification, and product recall, and shall implement any said procedure as necessary with respect to any product for which the PERMIT HOLDER or the DEPARTMENT has reason to believe circumstances exist that may adversely affect its safety for the consumer. If the DEPARTMENT determines, based upon representative samples, RISK analysis, information provided by the MANUFACTURED GRADE DAIRY PRODUCTS MANUFACTURER and/or MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTOR, and/or other information available to the DEPARTMENT, that the circumstances present an IMMINENT HEALTH HAZARD and that a form of consumer notice or product recall can effectively avoid or significantly minimize the threat to public health, the DEPARTMENT may order the MANUFACTURED GRADE DAIRY PRODUCTS MANUFACTURER and/or MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTOR to initiate a level of product recall or, if appropriate, issue a form of notification to customers. Each MANUFACTURED GRADE DAIRY PRODUCTS MANUFACTURER and MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTOR shall be responsible for disseminating the notice in a manner designed to inform customers who may be affected by the problem.