HACCP and The Bottled Water Industry Taking the Final

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                  HACCP and
           The Bottled Water Industry:
             Taking the Final Steps
                                                       By Mike Miller

        ince 1984, the International            An operational step with a modest     cesses so that technical, administra-
        Bottled Water Association          effect on this quality is assigned three   tive and human factors affecting the
        (IBWA) has required its mem-       possible deficiency points; an item with   safety and quality of food are effec-
bers to satisfactorily pass a produc-      a more moderate impact, four points;       tively managed and controlled. It’s a
tion facilities audit. NSF International   and of significant impact, five points.    cradle-to-grave (or, in the case of bottled
prepared this audit for IBWA in 1984.      Processing steps crucial to protecting     water, a source-to-store) approach for
The audit’s procedure is based on U.S.     the quality of the product are only        controlling the chemical, biological
Food and Drug Administration regu-         assessed as “pass” or “fail.” These are    and physical hazards associated with
lations for bottled water and generally    known as critical control points (CCPs).   the production of a particular food.
consists of good manufacturing pro-        A bottler cited for a CCP deficiency             There are seven key steps in estab-
cesses, accepted industry quality as-      would not receive a score for its audit    lishing an HACCP system:
surance procedures and established         and would have to immediately re-             1. Conduct a hazard analysis of the
product quality standards.                 spond to IBWA with a written correc-             production process, identifying on
     The audit takes into account cer-     tive action plan for the deficiency.             a flow diagram where significant
tain standards of Codex Alimentarius—           So, for many years, IBWA and its            hazards may occur.
the World Health Organization’s food       members have what in effect has be-           2. Identify the CCPs in the produc-
manufacturing quality code—and             come the acknowledged direction food             tion process.
identifies 60 items requiring inspec-      safety and protection programs are            3. Establish critical limits for the pre-
tion during the audit. A dual weighted     taking in the United States and around           ventative measures set up to con-
rating system was used, whereby four       the world—a Hazard Analysis Criti-               trol the hazards associated with
possible levels of deficiency severity     cal Control Point (HACCP) system.                each CCP identified.
were assigned to the 60 items, specific                                                  4. Establish CCP monitoring require-
areas of the bottling operation that       HACCP defined                                    ments, verifying the effectiveness
have a potential impact on product            An HACCP system provides a stan-              of the preventative measures.
quality.                                   dard to organize food production pro-         5. Establish pre-planned corrective

O CTOBER 1999                                                                         Water Conditioning & Purification          1
     actions to take when monitoring            1. Source water collection,               water characterization is outlined in
     results show a critical limit for a        2. Transport and storage,                 Figure 1.
     preventative measure has been              3. Treatment,
     exceeded.                                  4. Bottle washing/processing, and         Transport and storage
  6. Establish an effective record-keep-        5. Filling and capping.                        Hazards that might be identified
     ing system documenting all as-                                                       during transportation and storage
     pects of the HACCP system and its        Source water collection                     could include chemical contaminants
     operation.                                    The HACCP implementation team          leaching into the water from the mate-
  7. Establish a program to verify the        would evaluate potential hazards as-        rials it contacts, dust and other air-
     HACCP system is functioning              sociated with the type of source being      borne contaminants, bacteria or mold
     properly.                                used. If it’s a municipal system using      growth in the stored water, and con-
     Naturally, there are many more           surface water, then the bottler may be      tamination from backflow or cross-
details associated with each task. In         faced with chemical contamination           connections. Again, if routine indus-
fact, entire one- and two-day seminars        from spills, runoff or airborne deposi-     try practices are put into HACCP ter-
are available exclusively covering the        tion. Contamination by bacteria and         minology, water transport and storage
proper evaluation of these steps and          protozoan cysts could be of concern, as     can be characterized as shown in Fig-
how to apply them appropriately to an         well as other physical contaminants. If     ure 2.
individual operation.                         the bottler is using such ground water
     Just to prepare to take the first step   sources as a spring or artesian well,       Treatment
in establishing a HACCP system, com-          potential hazards may be limited to              The bottler’s HACCP team evalu-
panies are advised to establish the           chemical contamination from spills or       ates perhaps the most crucial aspect of
following:                                    agricultural operations. And, if the        the bottled water production process—
  • Assemble a cross-functional team          source is under the direct influence of     water treatment—and identifies chemi-
     representing all areas involved in       surface waters, bacteria and protozoan      cals leaching from contact materials
     the product’s production.                cysts should be considered as well          and process failure as two potential
  • Describe the product and its in-          (e.g., Giardia and Cryptosporidium).        hazards. Consequently, the team may
     tended end use.                               Once the hazards for particular        implement the following HACCP pro-
  • Have the team construct a detailed        source water are identified, a decision     cess listed in Figure 3.
     flow diagram of the process the          is made as to whether the source water           Bottle washing and processing is
     food follows.                            is a CCP. A decision tree is a series of    evaluated in the same fashion by the
  • Verify the flow diagram’s accu-           questions helping the HACCP team            HACCP team and the following haz-
     racy through on-site inspection          make this determination, and includes       ards may be identified: particles/mi-
     and documentation.                       such questions as—Are there treat-          crobes from blow molding; contami-
                                              ment processes the source water un-         nant leaching from the bottle material;
The bottling process                          dergoes that eliminates or reduces its      physical damage to reusables; chemi-
     When evaluating how an                   hazards to acceptable levels? If the        cal/microbiological contamination of
HACCP system can be assessed and              answer is yes for all hazards, then the     returned reusables, and airborne con-
implemented for a bottled water pro-          source water is not a CCP. If the answer    tamination after washing. As with the
cess, there are five major steps form-        is no for a particular hazard, then it is   previous steps in the production pro-
ing the starting basis for an imple-          a CCP, and the team must proceed            cess, routine existing control measures,
mentation team. It’s important to             through the process of developing ef-       limits and monitoring requirements
emphasize this is only a starting             fective control measures by establish-      are documented and implemented. The
point; it includes only the process-          ing critical limits (quantitative and/or    filling and capping process can then
ing and not the post-production               qualitative), monitoring requirements       be addressed using the same steps.
steps that must also be evaluated             and pre-planned corrective actions if
and documented as part of the over-           limits are exceeded.                        Final steps—filling gaps
all process.                                       Even though most bottlers would             In each of the areas discussed, the
     If bottled water production is bro-      arrive at the conclusion their source is    bottled water industry has for many
ken down into its most basic elements,        not a CCP, the industry has treated it as   years had control limits and monitor-
or modules, the steps could be catego-        though it were. Putting routine indus-      ing requirements in place that are well
rized as follows:                             try practice into HACCP terms, source       documented and operating effectively.

2      Water Conditioning & Purification                                                                          OC T O B E R 1 9 9 9
                                                                                                              Because of the ease with which current
 Figure 1. Characterization of source water hazards for bottlers
                                                                                                              industry practices fit into HACCP
 Hazard                      Control Measure(s)                   Control Limit        Monitoring             framework, it’s an appropriate time for
                                                                                                              the bottled water industry to take the
 Bacteria                    Proper construction:                 Total coliform       Weekly
                             grouting, concrete pads,                                                         lead and require its bottler members to
                             enclosures, runoff                                                               have a formalized HACCP system as a
                             diverted, pest control                                                           prerequisite for association member-
 Chemical                    Acceptable materials:                Varies: VOCs,        Weekly, monthly        ship.
                             stainless steel, PVS, FDS            nitrate, etc.        quarterly, annually,       The primary gaps needing affir-
                             food grade; controlled                                    depending on the       mation involve:
                             access, wellhead                                          particular hazard        • Establishing a HACCP team,
                                                                                                                • Documenting the CCP analysis,
 Source: NSF International                                                                                      • Ensuring current controls, limits
                                                                                                                  and monitoring are appropriate,
                                                                                                                • Developing documented pre-
 Figure 2. Transportation and storage hazards                                                                     planned corrective actions for each
                                                                                                                  control/limit, and
 Hazard                      Control Measure(s)                   Control Limits       Monitoring               • Implementing an ongoing means
 Particulates                Closed construction:                 Turbidity            Daily, weekly              to verify the HACCP system is func-
                             tight fitting lids, filtered vents                                                   tioning properly.
 Chemical                    Acceptable materials                 Purchasing           Standard
                                                                  specifications       operating              Conclusion
                                                                                                                   NSF and IBWA will be working
 Bacteria                    Ozone                                Residual             Hourly, daily          together over the next several years to
                             UV                                   Dose (intensity)     Same                   help bottlers accomplish the work nec-
                             Cleaning/sanitizing                  HPC                  Daily, weekly          essary to implement HACCP systems
                                                                                                              on an industry-wide basis. In doing so,
 Source: NSF International
                                                                                                              the bottled water industry will remain
                                                                                                              at the forefront as leaders in food in-
                                                                                                              dustry self-regulation, demonstrating
 Figure 3. HACCP process for water treatment                                                                  its commitment to public health pro-
                                                                                                              tection and quality production.
 Hazard                      Control Measure(s)                   Control Limits       Monitoring
 Chemical                    Acceptable materials                 Purchasing           Standard operating     About the author
                                                                  specifications       procedures               Mike Miller is a 23-year NSF International
                                                                                                              veteran and is general manager of its Bottled
 Process failure/            Activated carbon                     Chlorine, VOCs       Daily, quarterly
                                                                                                              Water Program. His bachelor’s degree in mi-
                                                                                                              crobiology is from the University of Michigan
                             Reverse osmosis,                     Conductivity, TDS,   Hourly, daily,
                                                                                                              and he can be reached at (800) 673-6275, (734)
                             etc.                                 etc.                 etc.
                                                                                                              769-0109 (fax) or email: miller@nsf.org . More
 Source: NSF International
                                                                                                              information on NSF’s Bottled Water Program
                                                                                                              is available at www.nsf.org

O CTOBER 1999                                                                                                 Water Conditioning & Purification            3
                Future Trends
           in Bottled Water Needs
                                                  By Kelly Reynolds, Ph.D.

        ottled water sales have contin-    heterotrophic plate count (HPC) bacte-      mised people wishing to take extra
        ued to show a marked increase,     ria .3The debate continues as to whether    precautions for reducing their risk of
        with approximately 3,605 mil-      HPC bacteria are harmful, particularly      Cryptosporidium and other types of in-
lion gallons sold in 1998 vs. 416 mil-     (see “Point” and “Counterpoint,” by         fections transmitted through drinking
lion gallons in 1978, an increase of       Don Reasoner and Joe Harrison, re-          water. Individuals wanting extra pro-
more than 800 percent in two decades.1     spectively, on pages 94 and 95 in this      tection are advised to boil their water
Even though the U.S. Environmental         issue) for immunocompromised indi-          for one minute as the best method for
Protection Agency (USEPA) maintains        viduals .                                   eliminating Cryptosporidium. As an
that public water utilities provide a            While there’s no enforceable U.S.     alternative to boiling water for in-
safe drinking water product, consum-       Food and Drug Administration (FDA)          creased safety, the CDC recommends
ers continue to pay an average of 1,000    or USEPA standard established for           use of point-of-use (POU) water treat-
times more for bottled water—largely       HPC bacteria, we use 500 colony form-       ment devices either with reverse osmo-
for two reasons. Consumer group sur-       ing units per milliliter (cfu/ml) as an     sis, an absolute one-micron rated filter
veys reveal bottled water drinkers pre-    informal guideline. HPC bacteria            or certification by NSF International un-
fer the taste relative to tap water and    aren’t necessarily harmful themselves       der Standard 53 for cyst removal. Be-
they presume the bottled product is        but are often used as an indicator of       cause bottled water treatment varies
safer.2 Consumers also like the port-      overall sanitation during bottling. The     widely, these individuals must be cer-
ability of bottled water and the fact      European Union (EU) has adopted an          tain the bottled water treatment fol-
they may purchase a consistent prod-       enforceable bottled water standard of       lows the same criteria set for POU de-
uct while traveling to different regions   100 cfu per 100 ml (at 22oC) at bottling.   vices for Cryptosporidium removal un-
with varying water quality.                The USEPA’s tap water rules provide         der Standard 53. This doesn’t guaran-
                                           that water containing over 500 cfu/ml       tee bottled water is free of other poten-
Impressive record                          is treated as a coliform-positive sample,   tial health hazards but does offer added
     These perceptions may be right on     absent proof of adequate disinfectant       assurance that it meets today’s stan-
target. There has never been a docu-       residual. The International Bottled         dards.
mented outbreak of disease associated      Water Association (IBWA) recom-
with bottled water in the continental      mends bottling plants meet a level of       Specifically for drinking
United States. Although not all bottled    <30 cfu/ml at the time of bottling, and         Consumer confidence in public
water supplies are alike, many begin       <200 cfu/ml in 90 percent of samples        water supplies continues to decrease.
with tap water and subject it to further   tested five days after bottling. Massa-     According to a survey by the Water
treatment steps to remove chlorine,        chusetts and New York have an infor-        Quality Association (WQA), more than
other chemicals, metals and minerals       mal, unenforceable bottled water guide-     50 percent of U.S. respondents worry
(and sometimes to add back minerals),      line of 500 cfu/ml; other states such as    about impurities in their tap water.
resulting in a better tasting product.     Rhode Island also have similar infor-       Recognizing the difficulty of ensuring
Having a pleasing taste and odor, how-     mal guidelines.                             a safe water supply to all consumers
ever, doesn’t necessarily mean the               Irrespective of the HPC issue, the    from the treatment plant to the tap,
water is free of microorganisms. In        Centers for Disease Control and Pre-        public water utilities are faced with a
fact, some bottled water supplies have     vention (CDC) and USEPA have is-            variety of concerns. Can utilities guar-
been shown to contain high levels of       sued a guidance for immunocompro-           antee that water be maintained from
4      Water Conditioning & Purification                                                                        OC T O B E R 1 9 9 9
                                                                                                             toring for contaminants in their raw
 Why use bottled water?                                                                                      and finished water, making the re-
 With an estimated five percent of treated water delivered to the home actually used for drinking,
 utilities are questioning whether or not to promote advance treatment, bottling and home delivery of a
                                                                                                             sults readily available to consum-
 portion of their product specifically for drinking use. Although regulations on public water supplies are   ers.
 becoming more stringent, consider the following water related facts:                                              The Natural Resources Defense
 • The CDC estimates that a million people in the United States become sick each year from
                                                                                                             Council (NRDC) recently conducted a
 consuming contaminated water.                                                                               survey of 103 bottled water manufac-
                                                                                                             turers. Most brands of bottled water
 • According to the NRDC, 40 percent of municipal water suppliers have violated federal standards in         tested were—according to the “snap-
 the recent past, and nearly 50 million Americans are currently using improperly treated or contami-         shot” analyses of a subset of regulated
 nated water.
                                                                                                             contaminants—of relatively good qual-
 • Many of the nation’s 55,000-plus community water systems are in need of significant investments to        ity (i.e., comparable to good tap water
 improve infrastructure in order to deliver safe water to their 243 million customers.4                      or meeting enforceable standards).
                                                                                                             Most waters contained no detectable
 • There continues to be an increase in pathogens identified in water, affecting immunocompromised           bacteria, and the levels of synthetic
 populations, who are also 10-to-1,000 times more likely to die from certain enteric pathogen infections.    organic chemicals and inorganic
 • An estimated 240 million of toxic agents will be released into the environment in 2000, a reduction
                                                                                                             chemicals were either below detection
 from 350 million pounds in 1988.5                                                                           limits or well below applicable stan-
                                                                                                             dards. However, the survey recom-
 • One in four Americans lives within four miles of a Superfund cleanup site.5                               mended that the origin and treatment
                                                                                                             level of bottled water should be care-
 • In 1996, there were 141,617 drinking water standard violations reported by 47,918 of the 170,942
                                                                                                             fully evaluated, as not all products are
 public water systems in the nation.6
                                                                                                             the same.
 • Ten new microbes and 50 new chemicals have been listed as candidate drinking water contaminants                 The IBWA points out that “bottled
 (those requiring research on health effects or in need of regulation) by the USEPA.7 Rules are              water is one of the most highly regu-
 currently being developed for arsenic, sulfates, radon and radionuclides, total trihalomethanes             lated products under FDA regulatory
 (TTHMs), bromates, and chlorates in water.                                                                  authority.” IBWA’s member compa-
                                                                                                             nies produce and distribute 85 percent
                                                                                                             of all bottled water sold in the United
source to tap under increased regula-                    small systems where compliance                      States. This industry is regulated on
tory pressure? In addition, what cost                    with new rules and regulations may                  three levels: federal, state and trade
would this present to the consumer?                      be cost prohibitive. To implement this              association (for those that are mem-
Given that less than five percent of                     option, POU/POE units must be                       bers).
treated water delivered to the home is                   owned, controlled and maintained                          IBWA members are required to
actually used for drinking, it’s esti-                   by the public water system or a per-                follow a production process that en-
mated, some utility administrators                       son under contract with the water                   sures safety and quality by:
question whether they should promote                     system. There have also been inci-                    • Collecting source water from pro-
advance treatment, bottling and home                     dences where bottled water supplies                       tected underground springs, wells
delivery of a portion of their product                   were given to households when the                         or municipal supplies,
specifically for drinking (see Why use                   public water quality did not meet                     • Practicing a multi-barrier ap-
bottled water?)                                          government standards.                                     proach including source pro-
                                                              The FDA published a final rule                       tections and monitoring, and
Standards and regulations                                amending the quality standard for                         with such treatment as reverse
     Under the 1996 amendments of                        bottled water by establishing or re-                      osmosis, ultraviolet light, mi-
the Safe Drinking Water Act (SDWA),                      vising allowable levels for five inor-                    cron filtration, distillation and
Congress required the USEPA to start                     ganic chemicals, 17 synthetic vola-                       ozonation,
a number of new initiatives. A variety                   tile organic chemicals (VOCs), nine                   • Observing federal regulations of
of new treatment rules are on the hori-                  pesticide chemicals and five non-                         good manufacturing practices
zon focusing on contaminant occur-                       pesticide chemicals.8 Additionally,                       (GMPs), quality standards and
rence studies, consumer confidence                       the amendments require the FDA                            labeling standards, as well as ob-
reports, compliance of POU devices                       conduct feasibility studies on how                        serving state regulations includ-
and bottled water, and groundwater                       bottlers might supply the same in-                        ing source and facility inspec-
treatment.                                               formation as required by utilities’                       tions.
     The SDWA states that POU and                        Consumer Confidence Reports                           • Following industry regulations
point-of-entry (POE) devices can be                      (CCRs). Bottled water manufactur-                         including annual, unannounced
used as compliance technologies for                      ers would be expected to begin moni-                      plant inspections by a nationally
O CTOBER 1999                                                                                                Water Conditioning & Purification      5
    recognized third party organiza-             As utilities continue their im-              6. U.S. Environmental Protection Agency,
                                                                                              “USEPA Annual National Summary Re-
    tion enforcing an IBWA set of stan-     provements in water quality dis-                  ports,” Washington, D.C., (also available at
    dards, many stricter than the           closure, so too should the bottled                www.epa.gov/safewater/safe).
                                                                                              7. Federal Register, Vol. 63, No. 40, p.10274,
    FDA’s.                                  water industry promise to continue                W-97-11, FRL-5972-5, March 1998.
                                            its intra-industry quality control,               8. Federal Register , 61 FP 13258, March 16,
Conclusion                                  up to and including regulated con-
     Federal CCRs require utilities to      sumer protection. Bottled water
                                                                                              About the author
mail each of their customers an an-         stands to thrive well into the new                  Dr. Kelly A. Reynolds is a research scientist
nual report telling where they get their    millenium as consumer informa-                    at the University of Arizona with a focus on
water, how it’s treated and what’s          tion about the quality and limita-                the development of rapid methods for detect-
detected so consumers can better judge      tions of public tap water supplies                ing human pathogenic viruses in drinking
their potential risks related to particu-   grows in complexity.                              water. She is also a member of the WC&P
                                                                                              Technical Review Committee.
lar water supplies. Information is now
available for all detected impurities,      References
                                            1. “Bottled Water Sales Bubbling Up,” U.S.         If you have questions concerning this
not just those levels with established      Water News, March 1998.
                                            2. AWWA Research Foundation, “Consumer             column, or if there’s a topic you would
standards. In addition, the USEPA’s
                                            Attitude Survey on Water Quality Issues,”          like addressed, please let us know.
Office of Groundwater and Drinking          1993, p. 19.                                       Contact “On Tap,” at: WC&P Maga-
Water now has an Internet site allow-       3. Olson, Erik D., Bottled Water: Pure Drink or
                                            Pure Hype? , Report for the National Re-           zine, 2800 E. Fort Lowell Rd., Tuc-
ing individuals to “surf their water-       sources Defense Council, February 1999.            son, AZ 85716 USA; (520) 323-6144,
shed” (www.epa.gov/surf/). The site         Also available online at: www.nrdc.org/
                                            nrdcpro/inx/publ.html                              (520) 323-7412 (fax); email:
supplies information regarding spe-         4. U.S. Environmental Protection Agency,           publicom@azstarnet.com
cific utilities and any violations to       “Drinking Water Infrastructure Needs Sur-
established rules and regulations, in-      vey: First Report to Congress,” USEPA Re-
                                            port #812-R-97-001, January 1997.
cluding a U.S. map allowing consum-         5. U.S. Environmental Protection Agency,
ers easy access by clicking a state and     “Environmental Goals for America: With
                                            Milestones for 2005,” USEPA, Government
choosing the appropriate county and/        Review Draft, Policy, Planning and Evalua-
or public water supplier.                   tion 2162, Dec. 20, 1996.

           • Circle 75 on Reader Service Card •                                    • Circle 78 on Reader Service Card •

6      Water Conditioning & Purification                                                                                   OC T O B E R 1 9 9 9