Comments on Texas Bottled Water Regulations
Comments on Texas Bottled Water Regulations
April 17, 2002
Ms. Julie W. Loera
Chief, Training and Evaluations
Manufactured Foods Division
Texas Department of Health
1100 West 49th St.
Austin, Texas 78756
Subject: Comments on Current Rules Governing Bottled and Vended Water, Title 25, Texas Administrative Code 229.81-91
Dear Ms. Loera:
The International Bottled Water Association (IBWA) appreciates the opportunity to participate in the Department of Health’s review process for the Rules Governing Bottled and Vended Water (25 TAC 229.81-91).
IBWA is the trade association representing the bottled water industry. Founded in 1958, IBWA member companies account for more than 80 percent of all bottled water sales in the U.S. The association’s membership includes domestic and international bottlers, distributors, and suppliers.
IBWA’s comments will address the bottled water provisions of the regulations. Following are IBWA’s comments, organized by section within §229.
Rule §229.83 Water Hauling
Sections 229.83(3)(B), (C), and (D) and 229.83(4) of the current bottled water rule require a minimum chlorine residual of 0.5 mg/l in water being hauled. The Texas Department of Health (Department) adopted these requirements from provisions in regulations governing public drinking water (§290.40(K)) in the Texas Administrative Code, administered by the Texas Natural Resources Conservation Commission (TNRCC).
IBWA believes the current requirement for a minimum chlorine residual of 0.5 mg/l needs to be reviewed to eliminate direct conflict with federal rules governing disinfectants and disinfection byproducts (D/DBPs) in bottled water so that bottlers may comply with the U.S. Food and Drug Administration’s (FDA) new D/DBP standards of quality (SOQs), which were effective January 1, 2002. In this new rule, FDA amended the bottled water standard of quality in 21 CFR §165.110(b) by adopting allowable levels for three residual disinfectants [chloramines (4.0 mg/l), chlorine (0.5 mg/l), and chlorine dioxide (0.8 mg/l)] and three types of disinfection byproducts (DBP’s) [bromate (0.010 mg/l), chlorite (1.0 mg/l), and haloacetic acids (0.060 mg/l)]. The FDA ruling also permits bottled water manufacturers whose natural source water has not been treated with chlorine to forego testing their source for disinfectants or disinfectant byproducts.
Bottled water manufacturers and IBWA have invested substantial time and resources to comply with the new D/DBP SOQ’s, including researching alternative treatment methods to eliminate or reduce DBPs.
IBWA suggests that the Department expand its scope of responsibility for bottled water to encompass the entire process pathway from natural water source (wellhead or spring) to finished, packaged food product. From a regulatory standpoint, transported bulk water intended for use in bottled water should not be considered for human consumption until it has completed a bottling process that includes a multi-barrier approach to ensure the quality of the bottled water. Such a distinction is the regulatory difference between bottled water as a food product and public drinking water.
Such a change in scope will provide a clear line of regulatory jurisdiction that clearly delineates bottled water as a food product. It will also need to be coordinated with the TNRCC, which currently regulates the permitting of water sources and establishes public drinking water rules. We strongly urge the Department to begin such discussions with TNRCC as soon as possible so that regulatory changes to address this issue can be incorporated in the Department’s regulatory review of the bottled and vended water regulations.
IBWA respectfully requests that the Department repeal the requirement for residual chlorine in transported bulk water, and submits the following language from the IBWA Model Code for consideration in modifying the §229.83(3):
Tankers, hoses, pumps, and other appurtenances shall be solely dedicated to the hauling of potable bulk water. Tankers shall be cleaned, sanitized and inspected internally for tank integrity on a routine basis. Water intended for bottling shall not be stored, transported, processed, or bottled through equipment or lines used for milk, other dairy products, and non-beverage foods. Non-dedicated beverage equipment and lines used for other beverages shall be sanitized using a hot clean-in-place (CIP) process, or equivalent. The process must be addressed in the plant’s sanitization standard operating procedure (SSOP) manual and HACCP plan, and shall include provisions for monitoring, critical limits, appropriate corrective action, and records.
Rule §229.84 Microbiological Control Standards
Section 229.84(1) permits transported bulk water to be treated by alternative means to control microbiological contamination, such as “ozonation, chlorination, exposure to ultraviolet light, or other qualified disinfection approved by the Department.” This appears to conflict with the §229.83(3)(D) as discussed above.
Rule §229.84(B) and (C) Microbiological Control Standards
IBWA recently amended its Model Code with new requirements for multi-food equipment. This new standard seeks to further ensure the quality and safety of bottled water packaged in multi-food lines and fillers. IBWA has incorporated safeguards to ensure sanitary equipment conditions. The potential for cross contamination is minimized, if not eliminated.
We submit the following language for consideration by the Department in §229.84(2) & (3) regarding use of multi-food equipment in the bottling of water.
Water intended for bottling shall not be stored, transported, processed, or bottled through equipment or lines used for milk, other dairy products, and non-beverage foods. Non-dedicated beverage equipment and lines used for other beverages shall be sanitized using a hot clean-in-place (CIP) process, or equivalent. The process must be addressed in the plant’s sanitization standard operating procedure (SSOP) manual and HACCP plan, and shall include provisions for monitoring, critical limits, appropriate corrective action, and records.
Rule 229.85 Labeling and Advertising
IBWA supports uniformity of labeling requirements for bottled water. Currently, under Rule §299.85(b), bottled water labels must include the location of the source of the bottled water.
When FDA established bottled water regulations, it reviewed the issue of bottled water labeling. It concluded that the name of a specific source was not a material fact for determining if the label was misleading. In the preamble of the of the final rule (60 FR No 218, pages 57104-5), FDA concluded that “the brand name and the name of the manufacturer distinguish bottled water as much as the specific source.” Coupled with the necessary contact information for consumers to inquire about a product, FDA concluded that there was no basis for requiring sources on bottled water labels.
In addition, the requirement for a source on bottled water labels appears to run counter to the heightened awareness and need for security in the production of food products and protection of our water infrastructure. Substantial resources are being expended to protect water supply sources and increase security for those sources.
The elimination of this requirement would also eliminate the obstacles to interstate commerce of bottled water and reduce the need to maintain varying label inventories.
IBWA suggests that the Department repeal the requirement to include the location of the source on bottled water labels as contained in Rule §229.85 (b).
Rule §229.88 Certificates of Competency
IBWA agrees with the Department’s requirement that a bottled water plant be under the supervision of an individual who has demonstrated competency in such areas as GMPs, HACCP, treatment technologies, quality assurance/quality control, and regulatory requirements. To that end, IBWA established its certified plant operator (CPO) program in the mid 1980s. Over the years, the program has been improved and expanded. It is currently the most comprehensive training and testing program for bottled water plant operators. The existing program is based upon material published in IBWA’s Plant Technical Reference Manual, published in 2001, and the IBWA Model Code.
IBWA promotes and supports a strong curriculum of training and certification of bottled water plant operators. We believe that there are significant differences between processing of bottled water and public drinking water, and such differences warrant more specific training and testing of competent plant operators. IBWA recommends that the Department revise the existing language in §229.88 to in an effort to permit reciprocity and standardize the certification process between the Department and IBWA:
A bottled water plant shall be operated 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 from IBWA or an applicable regulatory agency demonstrating that he or she has successfully passed the IBWA certified plant operator examination or an equivalent examination developed and administered by the applicable regulatory agency or by a third party organization that is acceptable to the applicable regulatory agency and IBWA, 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 applicable bottled water standards.
Rule §229.89 Examination
IBWA has administered its CPO examination for approximately ten years. IBWA permits employees of bottler, candidate bottler, distributor, and supplier members to become CPOs. When a CPO candidate achieves a score of 75% or higher, such certification is valid for a period of three The current series of exams, developed in 2001, consists of 150 multiple choice questions covering topics such as GMPs, the HACCP system of managing food safety, water treatment technologies, product quality, and recordkeeping.
The exam is proctored by IBWA staff, or by an alternate proctor approved by IBWA’s Director of Technical Affairs and primary trainer, Robert Hirst. CPO candidates register for the exam directly with IBWA and pay the appropriate fee. Candidates who do not achieve a passing score are encouraged to register for a future exam.
Certification is maintained in either of two ways:
1. Each CPO must earn 18 IBWA CEUs, equivalent to 18 contact hours of training, during each three year certification period.
2. If the CPO does not earn a minimum of 18 IBWA CEUs, he/she must once again register for and pass the IBWA CPO exam.
IBWA is keenly interested in sharing information about the IBWA CPO program, and in working with the Department to develop a coordinated program for bottled water certified plant operators that is representative of industry technologies and practices. We are very interested in meeting with you and others from the Department in Austin to further discuss this objective and how it may be implemented in a manner beneficial to the Department, to the Texas CPO candidates, and to IBWA. We will contact you to discuss such a meeting.
IBWA offers the above recommendations to strengthen and update the state’s bottled and vended bottled water rules. We are willing to meet with you as appropriate to discuss these suggestions further and look forward to continued participation with the Department in improving the safety and quality of bottled water in Texas.
If you have any questions, or need more information, please do not hesitate to contact either one of us: Bob Hirst, Director of Technical Affairs, at firstname.lastname@example.org, or Patrick Donoho, Vice President of Government Relations, at email@example.com. We may also be reached by telephone at (703) 683-5213, or by fax at (703) 683-4074.
INTERNATIONAL BOTTLED WATER ASSOCIATION
Robert R. Hirst
Director, Technical Affairs
Vice President, Government Relations