Current through 2024-51, December 18, 2024
Section 144-235-7 - PRODUCT RECALL PROCEDUREA. GENERAL REQUIREMENTS. Each bottled water plant operator shall develop and maintain written procedures for the notification of the Department, consumer notification, and product recall, and shall implement any said procedure as necessary with respect to any product for which the operator or Department knows or has reason to believe circumstances exist that may adversely affect its safety for the consumer. In order to facilitate product identification or recall, each bottled water product shall contain a code that is designed to remain affixed to the container during use and which contains either the date of manufacture, or a lot number.B. DEPARTMENT NOTIFICATION. A bottled water supplier who knows that the standard of quality has been exceeded or has reason to believe that circumstances exist which may adversely affect the safety of bottled water, including but not limited to source contamination, spills, accidents, natural disasters, or breakdowns in treatment, shall notify the Department immediately.C. CONSUMER NOTIFICATION. If the Department determines, based upon representative samples, risk analysis, information provided by the bottled water supplier, and other information available to the Department, that the circumstances present an imminent hazard to the public health 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 water supplier to initiate a level of product recall approved by the Department or, if appropriate, issue a form of notification to customers. The bottled water supplier shall be responsible for disseminating the notice in a manner designed to inform customers who may be affected by the problem. The water bottler shall, where appropriate, provide the notice to radio and television media or to the newspaper serving the affected public, or shall in the alternative directly notify affected users where doing so in a manner approved by the Department can effectively avoid or minimize the risk to public health. Product recalls shall conform to the procedures and policies of U.S. FDA 21 CFR Section 7. 10- 144 C.M.R. ch. 235, § 7