§ 40:734 — Good manufacturing practices and operational requirements

A. All bottled water, including mineral water, shall be filtered and processed and packaged in accordance with the FDA Good Manufacturing Practice Regulations (GMPs) 21 CFR Parts 110 and 129, and any rules adopted by the department.
B. Bottled water production, including transporting, processing, packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for microbiological contamination of the finished product. These conditions and controls shall include the following:
(1) Bottled water shall be subject to effective germicidal treatment by ozonation or carbonation at a minimum of three volumes of carbon dioxide or other equivalent disinfection approved by the department, except that the requirement for filtration and germicidal treatment shall not apply to a bottled water product for which an exemption has been granted by the department pursuant to the criteria as contained in R.S. 40:739.
(2) Bottled water shall not be transported or stored in bulk tanks or processed or bottled through equipment or lines used for any nonfood product.
(3) Bottled water which originates from a surface water source which is not protected from surface contamination shall be subjected to ozonation, filtration, or another effective process which removes or destroys the cysts of the parasite giardia lamblia.
C. Each bottled water plant operator shall develop and maintain written procedures for 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 attached to the container during use and which contains either the date of manufacture or a lot or batch number.
D. A bottled water supplier who knows that a primary maximum contaminant level 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 promptly.
E. 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 health. Product recalls shall conform to the procedures and policies of 21 CFR Part 7.
F. Where a maximum contaminant level has been violated but circumstances, including risk analysis and representative samples, indicate that the violation of the maximum contaminant level has been promptly corrected and that already-distributed product will not cause illness and presents no significant health risk, a recall and media notification of consumers is unnecessary. In such circumstances where a recall or media notification is unnecessary, but where there may be significant consumer complaints of product taste or odor, the department may order the bottler to communicate the exceedance of the maximum contaminant level and the implementation of corrective measures by direct mailings to affected customers or by newspaper publication.
G. Artesian water may be collected with the assistance of external force to enhance the natural underground pressure so long as such measures do not alter the physical properties, composition, and quality of the water.
H. Natural water shall not be modified by blending with water of another type or by deletion or addition of dissolved solids, except as related to disinfection or other treatment to reduce the concentration of any naturally present constituent which exceeds government sanctioned or approved safety standards or guidelines. It may be collected and transported by pumps, pipes, tunnels, trucks, or similar devices.
I. Spring water shall be collected only at the spring or through a bore hole that is adjacent to the point of emergence. Spring water collected with the assistance of external force to protect the water shall retain all the physical properties of and be of the same composition and quality as the water that flows naturally to the surface of the earth.
J. No person shall operate a bottled water plant or bottle water for the purpose of sale or distribution in this state without first obtaining a permit required by the state sanitary code demonstrating that the source, bottling facility treatment and bottling practices, and product water meet the requirements of this Part and regulations adopted hereunder. The department by regulation may establish a reasonable fee for a permit application, which fee shall be based on the cost of processing application and shall be the same for in-state and out-of-state bottlers. An annual renewal fee shall be established. The application fee and the annual renewal fee shall not exceed two hundred dollars.
K. For bottled water imported from outside the United States the required showing shall include a certification signed by the department or agency with jurisdiction over bottled water in the country of origin that describes the requirements of said country for the source, bottling facility, treatment, bottling practices, and product water; states the date of the last officially authorized inspection by the department or agency or acceptable third party inspection organization and review of said source, facility, treatment, bottling practices, and product water in light of such requirements; and certifies that said source, facility, treatment, bottling practices, and product water meet all of the requirements of the country of origin except those that are in conflict with U.S. state and federal laws and regulations.
L. As a condition of receiving a permit and annually thereafter, the bottler shall receive a plant inspection demonstrating compliance with the good manufacturing practices and operational requirements of this Part. Said inspection shall be conducted by the state in which the bottling facility is located, by the federal FDA, or by a third party inspection organization acceptable to the department.
M. A bottled water plant shall not be operated except under the supervision of a competent person qualified by experience, education, and training to operate and maintain the plant's facilities. Said person must hold a certificate demonstrating that he has successfully completed a technical training course, developed and administered by the department or by a third party organization that is acceptable to the department, that covers periodic instruction and testing in plant, source, and product sanitation; operation and maintenance of water treatment technology; and the maintenance and monitoring of source and product water quality in accordance with these bottled water standards.

Legislative History

Acts 1991, No. 623, §1.