[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
REGULATION OF BOTTLED WATER
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON COMMERCE, TRADE,
AND CONSUMER PROTECTION
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
JULY 8, 2009
__________
Serial No. 111-56
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
_____
U.S. GOVERNMENT PRINTING OFFICE
74-089 WASHINGTON : 2012
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC
area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, Washington, DC
20402-0001
COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont
(ii)
Subcommittee on Commerce, Trade, and Consumer Protection
BOBBY L. RUSH, Illinois
Chairman
JAN SCHAKOWSKY, Illinois CLIFF STEARNS, Florida
Vice Chair Ranking Member
JOHN SARBANES, Maryland RALPH M. HALL, Texas
BETTY SUTTON, Ohio ED WHITFIELD, Kentucky
FRANK PALLONE, New Jersey GEORGE RADANOVICH, California
BART GORDON, Tennessee JOSEPH R. PITTS, Pennsylvania
BART STUPAK, Michigan MARY BONO MACK, California
GENE GREEN, Texas LEE TERRY, Nebraska
CHARLES A. GONZALEZ, Texas MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah MICHAEL C. BURGESS, Texas
G.K. BUTTERFIELD, North Carolina
JOHN BARROW, Georgia
DORIS O. MATSUI, California
KATHY CASTOR, Florida
ZACHARY T. SPACE, Ohio
BRUCE BRALEY, Iowa
DIANA DeGETTE, Colorado
JOHN D. DINGELL, Michigan (ex
officio)
C O N T E N T S
----------
Page
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 3
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 5
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 6
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 7
Hon. Donna M. Christensen, a Representative in Congress from the
Virgin Islands, prepared statement............................. 138
Witnesses
John Stephenson, Director, Natural Resources and the Environment,
Government Accountability Office............................... 10
Prepared statement........................................... 12
Answers to submitted questions............................... 141
Joshua M. Sharfstein, Deputy Commissioner, U.S. Food and Drug
Administration................................................. 20
Prepared statement........................................... 23
Jane Houlihan, Senior Vice President for Research, Environmental
Working Group.................................................. 39
Prepared statement........................................... 41
Answers to submitted questions............................... 144
Joseph K. Doss, President, International Bottled Water
Association.................................................... 84
Prepared statement........................................... 86
REGULATION OF BOTTLED WATER
----------
WEDNESDAY, JULY 8, 2009
House of Representatives,
Subcommittee on Commerce, Trade,
and Consumer Protection,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:04 a.m., in
Room 2123 of the Rayburn House Office Building, Hon. Bart
Stupak [Chairman of the Subcommittee] presiding.
Members present: Representatives Stupak, Christensen,
Walden, Burgess, Blackburn and Barton (ex officio).
Staff present: David Rapallo, General Counsel; Theodore
Chuang, Chief Oversight Counsel; Stacia Cardille, Counsel; Anne
Tindall, Counsel; Scott Schloegel, Investigator; Jennifer
Owens, Special Assistant; Ken Marty, HHS-OIG Detailee; Lindsay
Vidal, Special Assistant; and Jen Berenholz, Deputy Clerk.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. This meeting will come to order.
Today we have a hearing titled ``Regulation of Bottled
Water.'' The chairman, the ranking member and the chairman
emeritus will be recognized for 5-minute opening statements.
Other members of the subcommittee will be recognized for 3-
minute opening statements. I will begin.
Food safety is an extremely important issue that this
committee has held nearly a dozen hearings on over the past 2
years. Time and again we hear from individuals who want more
information so they can make wise decisions about what they eat
and drink. My constituents are no exception. Today's hearing on
bottled water hits close to home. My vastly rural district in
northern Michigan contains more shoreline than any other
Congressional district except Alaska but we have a keen
awareness of water quality issues. Michigan is also home to a
large bottled water facility in Mecosta County that has not
been without controversy over the years.
In 2008, Americans consumed 8.6 billion gallons of bottled
water. Bottled water is a billion-dollar-a-year industry with
sales up more than 83 percent this decade. Many Americans
believe that the water they drink from a bottle is healthier
than the water that comes from their faucets. The Water
Research Foundation found that nearly 56 percent of bottled
water drinkers cite health and safety as the primary reason
they choose bottled water over tap water. As a result,
Americans are willing to pay top dollar for bottled water,
which costs up to 1,900 times more than tap water and uses up
to 2,000 times more energy to produce and deliver.
Over the past several years, however, bottled water has
been recalled due to contamination by arsenic, bromate,
cleaning compounds, mold and bacteria. In April, a dozen
students at a California junior high school reportedly were
sickened after drinking bottled water from a vending machine.
Consumers may not realize but many of the regulations that
apply to municipalities responsible for tap water do not apply
to companies that produce bottled water. I would like to put up
a chart that outlines some of these differences.
[Chart.]
For example, municipal tap water suppliers are required to
tell their consumers within 24 hours if they find dangerous
contaminants that exceed federal levels but this requirement
does not apply to bottled water companies. Certified
laboratories must be used to test tap water but bottled water
has no similar requirement. Tap water suppliers provide their
customers with annual consumer confidence reports that detail
the sources of their water, any contamination found, the likely
cause of contamination and any potential health effects.
Bottled water distributors are not required to provide this
report to consumers. Instead, bottled water consumers rely on
limited information found on labels and in some cases on
company Web sites.
Some companies exacerbate this problem by exaggerating
claims about the health benefits of their products. For
example, Poland Springs explains the history of its water by
saying, ``When Joseph Ricker was revived from his deathbed,
reputedly by drinking the spring's water and lived another 52
years, the water's health benefits became legendary.'' Mountain
Valley Water Company provides similar accounts of its water,
stating ``Clinical tests at hospitals in New York, St. Louis
and Philadelphia demonstrated improvements in the health of
patients suffering from kidney and liver disorders and
rheumatism as a result of drinking Mountain Valley Water.''
Aquamantra spring water explains that the words written on its
labels, mantras such as ``I am healthy'' and ``I am loved''
permeate the liquid, influencing the taste and beneficial
properties of water. The company also claims that Aquamantra
uses the design of its label to affect the molecular structure
of the water.
Today the subcommittee will receive two new reports that
raise questions about why the regulations governing bottled
water are weaker than those governing tap water, as well as
widespread public perception that bottled water is healthier
than water from the tap. The first is a report by the
Government Accountability Office that was originally requested
by our former colleagues, Hilda Solis and Al Wynn. In this
report, GAO examines whether federal and State authorities are
adequately ensuring the safety of bottled water and the
accuracy of claims regarding its purity and health benefits.
The second report is by the Environmental Working Group, which
conducted an 18-month survey of bottled water labels and Web
sites and concluded that just two of the 188 bottled water
companies surveyed provided consumers with information on the
source of their water, the manner in which it is treated and
any contaminants present. Given these findings by GAO and
Environmental Working Group, the subcommittee is sending today
to a dozen bottled water companies letters requesting
information on the source of their water, their treatment
methods and results of their contaminant testing for the past 2
years.
Even when water is treated at municipal facilities and then
bottled, there still may be questions about contaminants such
as pharmaceuticals that may be present in the treated water.
Environmental Working Group reports an estimated 25 percent of
bottled water brands that rely on tap water are drawing from
supplies that collectively contain 260 pollutants. According to
Associated Press, drugs have been found in municipal water
samples across the country. Officials in Philadelphia
discovered 56 pharmaceuticals or byproducts in treated drinking
water. Anti-epileptic and anti-anxiety medications were
detected in the treated drinking water for 18.5 million people
in southern California. And drinking water here in Washington,
D.C., and surrounding areas testified positive for six
pharmaceuticals. For these reasons, I have introduced H.R.
1359, the Secure and Responsible Drug Disposal Act of 2009,
which will provide for proper disposal through drug take-back
programs so individuals are not simply flushing their
medications down the toilet into our water systems. I am also
proud to be the original cosponsor of the Food Safety
Enhancement Act of 2009, which passed out of this committee
last month and which is again ready for Floor action, and which
provides FDA with much-needed authority to assessing testing
records of food and water supplies.
I look forward to today's hearing, and I ask for unanimous
consent that reports issued today and the other documents in
the binder prepared by staff be entered into the official
record. Without objection, they will be entered in the record
and will be used throughout the hearing.
Mr. Stupak. I next would like to turn to my friend, Mr.
Walden from Oregon, for his opening statement, please.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Thank you, Mr. Stupak.
My home State of Oregon and the 2nd Congressional district
which I represent is home to a number of water bottlers
including those located in the small central Oregon community
of Culver, EARTH20, and the eastern Oregon town of Cove with
Artesian Blue, and in the northern portion of my district in
The Dalles, H2 Oregon. These successful businesses are in many
cases providing much-needed job opportunities in areas of
Oregon that have been hard hit by today's weak economy. In
fact, Mr. Chairman, our unemployment rate is second only to
yours in Michigan.
Today's hearing raises some valid questions regarding the
differences in regulation between the Food and Drug
Administration and the EPA regarding bottled water. However, I
should note, concern that with all of the life-threatening
health priorities facing the FDA including numerous foodborne
illness outbreaks, complications with acetaminophen and swine
flu pandemic, this issue does to me seem a little secondary in
terms of the FDA's overwhelming workload on other issues.
We should also put this hearing in context. The two reports
that are the focus of today's hearing point out a few
noteworthy findings but do not assess the safety of the bottled
water itself. Neither the Government Accountability Office,
GAO, nor the Environmental Working Group, EWG, conducted any
testing of the bottled water or the bottles themselves while
completing their reports. The regulations for bottled water do
differ from those promulgated for tap water, mostly because
bottled water is considered a food product and is therefore
regulated by the Food and Drug Administration, whereas tap
water is regulated by the Environmental Protection Agency.
However, FDA does require that the standards of quality for
bottled water must be no less protective of public health than
the EPA standard. Under the FDA regulations, bottlers must
follow current Good Manufacturing Practices, also known as
GMPs.
FDA actually requires more safeguards from water bottlers
than other food processors. The GMPs for bottled water are
commodity specific. Under these GMPs, bottlers must, among
other things, test their source of water once a week for
microbiological contaminants and test finished bottled water
weekly for microbiological contaminants. Now, some of the water
bottlers in my district follow a practice of testing their
water every hour in order to meet the requirements of
purchasers of their products, so they are doing hourly water
testing.
I do have a few questions for FDA. One discrepancy between
EPA and FDA is in the case of a chemical substance called DEHP.
This is a phthalate, a substance added to plastics to change
their physical characteristics, and I am sure you are familiar
with it. FDA has yet to establish a standard for this
contaminant in bottled water, even though the EPA did over a
decade ago. An FDA taskforce is supposedly examining the
information surrounding DEHP and I want to ask the deputy
commissioner when we can expect a ruling from your agency. And
the question that I will speak to in a minute is about recycled
bottles themselves. I have some tell me that the use of
recycled bottles perhaps produces more leaching or whatever it
is that comes out of the plastic than first-time use, and I
would be curious to know if that is the case.
Conducting inspections is one way the FDA ensures the
bottlers are following GMPs. Concerns have been raised on how
frequently the plans are inspected and what access FDA
inspectors have to plant records regarding testing and other
important information during the inspection, and I would be
curious to know the legislation passed unanimously out of the
full committee that expands FDA's inspection process, if that
would apply in these cases and therefore you will get new
authority if the House and the Senate Act. I would like to hear
from the deputy commissioner as well on how the agency can
improve the inspection process and if you do need any
additional authorities. Congress needs to act. We need to know
exactly what the agency needs and why. Currently, bottlers are
not required to disclose the source of their water, the
treatment process used or the detection of any contaminants.
The question is, should they, and I look forward to your
response on that.
Mr. Chairman, I would conclude by thanking you for this
hearing but I would also like to raise the issue that July 8th
has come and gone. A number of us on this side of the aisle
have raised questions of the Environmental Protection Agency
regarding bottled-up science, and we expect the EPA to respond
to our inquiries regarding Dr. Allen Garland and his report
that is not allowed to be considered in the endangerment
finding process, and if the EPA is unwilling to respond in a
timely manner, which may well be the case, I do hope that our
request of this subcommittee to have an oversight hearing on
what appears to be the bottling up of science and debate on the
whole carbon issue will be granted an opportunity for a hearing
and a full investigation. So we will be coming back to you on
that issue, and I thank you for your time.
Mr. Stupak. Thank you, Mr. Walden.
Ms. Blackburn, opening statement, please.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman, and I do want to
welcome our witnesses and thank them for being with us today.
As you have heard, we all are concerned about bottled
water, the product that is there. We are also concerned about
tap water and the work the EPA does there. And I will submit a
written statement. Mr. Chairman, I want to take my time to just
say I would prefer that we be spending this time to look at
other issues that are important to our constituents that the
FDA and EPA deal with. There are other committee issues that we
could be looking at such as the options for reducing health
care costs for our constituents and looking at how you do that
through patient-driven, consumer-driven, patient-centered
health care. We should be looking at the Medicare trust fund
and the pressures that are on that trust fund, the ballooning
costs of Medicaid if we move to a public option as we move into
health care reform or even from my State, the lessons that
should have been learned from TennCare, which was the test case
for Hillary Clinton health care back in 1994. My State still
has this. It is the greatest public health care in the country.
That would be a great opportunity for us to look at what is
affecting us with health care. Certainly there are more
pressing issues. We are appreciative of your time to be before
us today, and while we all are concerned with leaching
chemicals that come from plastics into bottled water, we are
indeed very concerned with what we see as sequestering evidence
from EPA employees. We are concerned with what we see, health
care issues that are affecting all of our constituents and a
lack of willingness to address those in a patient-centered,
consumer-driven manner, and I yield back my time.
Mr. Stupak. Thank you. Let me just respond that, you know,
we had a hearing just before we broke here not even 2 weeks ago
on health insurance on rescissions where companies rescind
health care to people who have it, and next week is scheduled
all week in committee for the health care markup bill, so I am
sure we will have plenty of opportunities to speak of health
care.
Mr. Burgess for opening statement, please.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Mr. Chairman, and maybe I should
take a second to respond to your response, and isn't it a shame
that we have a Subcommittee on Health within the Committee on
Energy and Commerce and we are to have no markup on what is
going to be the greatest change in the delivery of health care
in America since the institution of Medicare in 1965. Certainly
the people who were in Congress in 1965 likely could have never
foreseen what Medicare would become, at least as far as the
price of that federal program, and wouldn't we all be in better
shape today if perhaps a little more care was taken back in
1965 and the object lesson for us today is, we need to take
good care and exercise due caution as we structure this major
fundamental change to American health care.
We also could have had a hearing on medical devices in this
subcommittee, which I have asked for for some and has yet been
forthcoming, so there are ways we could have made use of this
time today, Mr. Chairman, but here we are and we are going to
talk about bottled water this morning, and that is important.
Normally I have a bottle of water here so that if I get parched
in the hour that I have to address the committee, but now we
are stuck with D.C. water which there used to be a little sign
in my office in the Longworth Building that said do not drink
the tap water. I don't know if that has changed but I am a
little reluctant to drink what is before us today.
A pretty broad definition of food would be one that
included bottled water, and the tremendous breadth and depth of
the responsibility entrusted to our good friends at the Food
and Drug Administration is this $11 billion industry known as
bottled water. The average American consumer is unlikely to
think that the FDA would be the primary regulator of bottled
water but it is. The regulatory responsibility of bottled water
is split between the Environmental Protection Agency and the
federal Food, Drug and Cosmetic Act with the Food and Drug
Administration overseeing the process of taking public water in
its natural form in the environment into a convenient plastic
container for sale to the American consumer.
Now, as much I appreciate the collegiality, the
intelligence and the willingness of Dr. Sharfstein to appear
here today as a representative of the Food and Drug
Administration, it does seem odd to only have the Food and Drug
Administration here to answer tough questions and to not have
the Environmental Protection Agency to answer questions that
would fall into their jurisdiction about the standards for
municipal water versus bottled water. Currently, bottled water
requires a higher threshold of testing than municipal water.
Municipal water is required to be tested every 4 years, bottled
water every year. In fact, bottled water is currently one of
the few stand-alone industries with its own Code of Federal
Regulations regarding Good Manufacturing Processes. From the
definition of water to the testing and sampling of products,
from the length of time the records must be kept, currently 2
years, and how they should be available to the Food and Drug
Administration as well as the role of the Environmental
Protection Agency, the State and local government agencies in
helping to ensure the safety and sanitation and quality of
water, this burgeoning industry has seemingly existed in a
compliance-oriented manufacturing system rarely, if ever,
producing bad actors. It would seem that this industry is an
example of the ingenuity and innovation of the marketplace to
create a product which had, if you will pardon the pun, an
unquenchable need for a convenient, transportable water and
this good idea has been met with significant market success.
We must ensure that the trust and faith of consumers and
that the government places in the bottled water industry are
not misguided. More Americans drink bottled water than milk or
beer combined, so if there is any step in this multilayer
process to deliver this food product where the trust and faith
is misallocated, then certainly I look forward to having the
science point to a solution. Furthermore, any deficiencies in
the regulation of bottled water, any potential fraud in the
process of producing bottled water and any alleged
environmental issues of draining of our natural resources and
the burdensome transportation costs of moving the end product,
we will certainly look forward to seeing what is sure to be
voluminous evidentiary proof.
Thank you, Mr. Chairman, for your indulgence. I will yield
back the balance of my time.
Mr. Stupak. No problem. I didn't want you to get parched.
As you know, in the Health Subcommittee, you guys did hold a
hearing on medical devices last month and the 510K approval
process, so those hearings are being taken. This hearing----
Mr. Burgess. But I would submit the investigatory part of
that has not been completed, as least to my satisfaction, and I
think this subcommittee would be the appropriate place to have
that. In addition, we have got the whole question of
biosimilars out there that would probably just roll into this
health care bill and we have not had the FDA in to talk to us
about the science of biosimilars. So there is stuff we could be
doing, is the point I am trying to make.
Mr. Stupak. Absolutely, and this committee has been very
active, as you know, for the last 2 years and we hold many,
many hearings, and this one with the two reports being released
today, it really dovetails into everything we have been doing
for the last couple of years in food safety, and whether it is
BPA or the PET that we talked about here, or as Mr. Walden
brought up, the DEHP, why has it taken 15 years to put out
regulations for that, certify labs' test results, all that is
contained in this hearing so it is not just strictly bottled
water, false advertising. That is what this whole thing is
about, sort of wraps up everything we have been doing for the
last few years, and we do have these two reports coming out
today so we thought it was appropriate to have the hearing
today. Very good.
Mr. Barton, opening statement, please.
OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Barton. Thank you, Mr. Chairman. Let me say before I
give my prepared statement how much I personally appreciate
you, so don't take some of what I am about to say too
personally.
But I think it does say something, given the serious issues
which you have traditionally tackled as your subcommittee
chairmanship along with Ranking Member Walden that today's
hearing does not rank at the top of that list, and it shows
when you look on your side how much support there is. They may
all be here but they are disguised as empty chairs, if they
are.
Mr. Stupak. Well, you know, most of the committee is down
in the Consumer Protection because we are putting a new
administrator in there and that is where most of them are. In
fact, that is why we started a little late because I am also on
that subcommittee and I had to stop by there.
Mr. Barton. Well, Greg and I will take over if you want to
go down there.
Mr. Walden. Could we have a vote on that right now?
Mr. Barton. Anyway, Mr. Chairman, today's hearing does
examine several interesting questions surrounding the
differences between bottled water and tap water. These
differences arise in regulatory approaches as well as in
processing, treatment and public perception. Several of the
witnesses today including the Government Accountability Office
and the Food and Drug Administration will discuss and possibly
debate ways in which bottled water regulations should be
changed and possibly improved. Other witnesses including the
Environmental Working Group and the International Bottled Water
Association will discuss ways industry can be more transparent
and responsive to consumer inquiries. I don't have a problem
with transparency, in fact, I am pushing transparency in the
upcoming health care debate, and as you well know, I am
certainly pushing transparency at the Environmental Protection
Agency where Mr. Walden and I have asked the EPA to release
their documents concerning their suppression of the EPA report
within its own agency debating whether there really is an
endangerment finding with regard to CO2.
So those of us on the minority are concerned whether this
particular hearing is the best use of our limited oversight
hearing times. We have confronted the issue of swine flu
pandemic. We have confronted safety of products like Tylenol.
As I said a minute ago, Mr. Chairman, this one just doesn't
seem to be up to that standard of excellence which you have
established for your oversight. I hope that after this hearing
you will consider supporting Mr. Walden and myself on getting
information about the EPA's suppression of the document which
we call Carbon Gate regarding the CO2 and the
endangerment finding. We also hope that you will work with us,
as I talked with you yesterday informally about doing more
hearings and doing some action times on the automobile dealer
closure issue. I know that is something that is very important
to you personally. We await your response and Mr. Waxman's
response.
So Mr. Chairman, we always appreciate when you hold a
hearing. We always participate and we are looking forward to
going on to a little bit more intense issues in the future.
Again, thank you for holding this hearing.
Mr. Stupak. Well, thanks, Mr. Barton. And, you know, one of
the reasons why we are having this hearing because I think as
we have seen on your side a little bit, maybe we assume because
it is in a bottle like this it is healthy, it is clean, it is
pure, and that is an assumption I think we erroneously are
making, so we are doing a hearing to try to get to the issues
here because I don't think we have to wait for a deadly
outbreak of disease in bottled water like we have seen in
salmonella in peanut butter last year, and we can't say there
is zero risk here. Between 2002 and 2008, there were 23 recalls
of bottled water. Now, that is about one every quarter. Most of
them stemmed from an elevated level of contaminants such as
arsenic and bromate, both of which cause cancer. Over the past
6 years the FDA has issued three warning letters to bottled
water companies for violating safety regulations, and that is
in addition to dozens of other problems found in the EPA
inspections at water bottling facilities.
In 2007, the FDA issued a press release against drinking
mineral water imported from Armenia because the arsenic level
was 50 times greater than the federal standard. And then, like
I said, last month in southern California, we have girls sick
at a high school who were buying bottled water out of a vending
machine. So these are problems the FDA has uncovered and they
only have about two or three employees devoted to it, and like
I said earlier, I think just because it comes in a bottle, we
assume it is healthier for us. That is what most Americans
assume. We find that is not the case and that is the reason for
the hearing, and all the other things we have done this year on
salmonella, institutional review boards, dual use, so we have
got a lot going on here.
Mr. Walden, go ahead.
Mr. Walden. Well, Mr. Chairman, just two points, one I
didn't mention in my testimony but I know that water is also an
ingredient in many other drinks, and I guess the question I
would have for our panel is, well, just because it is clear and
in those bottles, how is that treated or monitored versus if it
is colored and sugared and perhaps carbonated. Does somebody
check the water that goes into that as well? Are there
different standards there? The second point I would make on, I
think it is Santa Clara, the junior high students, my
understanding is that the FBI may be involved in investigation
there so it might be more of a tampering issue. Is that
correct?
Mr. Stupak. They are involved but no one has reached a
conclusion whether it is tampering.
Mr. Walden. Right. I understand. I wasn't trying to jump to
a conclusion. Thank you, Mr. Chairman.
Mr. Stupak. OK. You bet. That is a good segue into our
first panel. Let me introduce our first panel of witnesses with
Mr. Joseph Stephenson, who is director of National Resources
and the Environment at the Government Accountability Office. We
have Dr. Joshua Sharfstein, who is the principal deputy
commissioner at the U.S. Food and Drug Administration, Ms. Jane
Houlihan, who is the senior vice president for research at the
Environmental Working Group, and Mr. Joseph K. Doss, who is the
president of the International Bottled Water Association.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that you have the right under the
rules of the House to be advised by counsel during your
testimony. Do you wish to be represented by counsel? Mr.
Stephenson.
Mr. Stephenson. No.
Mr. Stupak. Dr. Sharfstein, Ms. Houlihan? No. OK. Then I am
going to ask you to please rise and raise your right hand to
take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect that the witnesses have
replied in the affirmative. You are now under oath. We will now
hear 5-minute opening statement from our witnesses. You may
submit a longer statement for the record and would be included
in today's hearing. Mr. Stephenson, we will start with you.
TESTIMONY OF JOHN STEPHENSON, DIRECTOR, NATURAL RESOURCES AND
THE ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE; JOSHUA M.
SHARFSTEIN, DEPUTY COMMISSIONER, U.S. FOOD AND DRUG
ADMINISTRATION; JANE HOULIHAN, SENIOR VICE PRESIDENT FOR
RESEARCH, ENVIRONMENTAL WORKING GROUP; AND JOSEPH K. DOSS,
PRESIDENT, INTERNATIONAL BOTTLED WATER ASSOCIATION
TESTIMONY OF JOHN STEPHENSON
Mr. Stephenson. Thank you, Mr. Chairman and Mr. Walden. I
am pleased to be here today to discuss the quality and safety
of bottled water and its environmental impacts.
Over the past decade, the per capita consumption of bottled
water in the United States has more than doubled from 13.4
gallons per person in 1997 to 29.3 gallons per person in 2007.
That is over 200 bottles a year for every man, woman and child
and an $11 billion plus market. With this increase come several
questions and concerns over bottled water's quality and safety.
My testimony is based upon the report that we are issuing to
the committee today which is going to be publicly released.
In summary, we found that FDA's safety and consumer
protections are less stringent for bottled water than
comparable EPA protections for tap water. While FDA's standards
for bottled water generally mirror the standards for nearly all
of the 88 contaminants covered by EPA's national primary
drinking water regulations, there is one notable exception,
DEHP, which is a plasticizer used to soften plastic, which has
been linked to reproductive and liver problems and increased
cancer risk. It has been regulated by the EPA in tap water
since 1992 but FDA deferred action on DEHP in a rule published
in 1996 and has yet to either adopt a standard or publish a
reason for not doing so, even though the statutory deadline for
acting was more than 15 years ago. Since DEHP is used in food
packaging as well as bottled water, this is a broader issue
that FDA is still studying. Nevertheless, our report recommends
that FDA expeditiously promulgate a DEHP standard for bottled
water.
More broadly, we found that FDA, unlike EPA, does not have
the statutory authority to require bottlers to use certified
laboratories for water quality tests or to report test results,
even if violations of the standards are found. Most tests are
done by the bottlers themselves. Several states have
requirements to safeguard bottled water that exceed those of
FDA but are still less comprehensive than for tap water. In
addition, while FDA bottled water labeling requirements are
similar to labeling requirements for other foods, they provide
consumers with far less information about the source and
quality of water than what EPA requires of public water systems
under the Safe Drinking Water Act. For example, public water
systems must annually provide consumer confidence reports that
summarize water quality information about the water sources,
detected contaminants and compliance with national primary
drinking water regulations as well as information on the
potential health effects of certain contaminants. FDA does not
require bottled water companies to provide similar information.
In a study mandated by the 1996 amendments to the Safe Drinking
Water Act, FDA concluded that it was feasible for the bottled
water industry to provide the same type of information to
consumers that public water systems must provide. However, the
agency was not required to act on its findings and has yet to
do so.
A survey of 50 States and the District of Columbia showed
that consumers have misconceptions about bottled water,
believing that it is safer and healthier than tap water. We
also found that information comparable to what public water
systems are required to provide to consumers of tap water was
available for only a small percentage of the 83 bottled water
labeled we examined, companies we contacted or company Web
sites we reviewed. We believe that consumers would benefit from
better information on the quality and safety of bottled water,
and our report also recommends that FDA implement the results
of this study to accomplish this.
In examining the environmental effects of bottled water, we
found that only about 25 percent of water bottles are recycled
and that the remaining 75 percent are discarded in municipal
landfills where they never decompose and essentially remain
forever. While this is over 900,000 tons of plastic annually,
it represents less than 1 percent of municipal waste.
Another issue is the amount of energy used to manufacture
and transport bottled water. Another study estimates the energy
use at 5.8 megajoules per liter. At the current rate of
consumption, this is the equivalent of the energy used by 4.7
million households for a year and is 1,000 to 2,000 times the
energy used for tap water. We also found that groundwater
extraction for bottled water facilities in selected areas and
that Michigan and other States have passed laws to minimize the
impact of stream levels and wetlands.
Finally, I would note that some of our bottled water
findings are indicative of FDA's overall food safety oversight
problems that led to GAO's designating it a high-risk area in
January 2007 and again in 2009 when we called for a fundamental
reexamination of the federal food safety system. We believe
that FDA's lack of authority and resources to effectively
regulate bottled water should be part of that reexamination.
Mr. Chairman, that concludes the summary of my statement
and I will be happy to answer questions at the appropriate
time.
[The prepared statement of Mr. Stephenson follows:]
Mr. Stupak. Thank you, Mr. Stephenson.
Dr. Sharfstein, would you like to make your opening
statement?
TESTIMONY OF JOSHUA M. SHARFSTEIN
Dr. Sharfstein. Thank you very much. We appreciated the GAO
report, and I especially appreciate that he finished with
exactly 2 seconds left. I was watching. I have never seen that
before.
Good morning, Mr. Chairman and members of the subcommittee.
I am Dr. Joshua Sharfstein, the principal deputy commissioner
of the Food and Drug Administration of the Department of Health
and Human Services. I want to thank the committee for your work
on a wide range of health issues and for the opportunity to
discuss FDA's regulation of bottled water today.
As has been mentioned, bottled water and tap water are
regulated by two separate agencies. FDA regulates bottled water
while the EPA regulates tap water, also referred to as
municipal water or public drinking water. EPA has regulations
on the production, distribution and quality of public drinking
water including source water protection, operation of drinking
water systems, contaminant levels and reporting requirements.
The Food, Drug, and Cosmetic Act provides FDA with
regulatory authority over food and as part of that, bottled
water that is introduced into interstate commerce. Under the
Food, Drug, and Cosmetic Act, manufacturers are responsible for
producing safe, wholesome and truthfully labeled food products.
It is a violation of the law to introduce into interstate
commerce adulterated or misbranded products.
FDA has established specific regulations for bottled water
in the Code of Federal Regulations. These regulations include
standard identity regulations that define different types of
bottled water such as spring water versus mineral water and
standard quality regulations that establish allowable levels
for chemical, physical, microbial and radiological
contaminants. FDA has established Good Manufacturing Practice
regulations for the processing and bottling of bottled drinking
water. Labeling and GMP regulations for foods in general also
apply to bottled water. Federal law requires FDA to set similar
standards for bottled water as exist for municipal water or
explain why they should not apply. FDA has established such
standards for more than 90 contaminants and in some cases such
as for lead or copper, the FDA limits are stricter for bottled
water than for municipal water. And another point to make in
this regard is that the way that the testing is done is
different. For example, take the lead standard. Any test that
is high is violative when that is done on FDA-regulated bottled
water; for the municipal water only a percentage of the samples
is above a certain level. The municipal water supply failed
that. So they are allowed to have certain failures and not have
it as a failure for the municipal water supply. So it just
illustrates that there is a different approach that is taken in
a few contexts.
FDA monitors and inspects bottled water products and
processing plants as part of the general food safety program.
Inspections occur approximately once every 1 to 3 years. The
agency inspects violative firms more frequently, depending on
the number, significance and recurrence of violations. FDA's
field offices follow up on consumer and trade complaints and
other leads on potentially violative bottled water products. As
for other types of food, FDA periodically collects and analyzes
samples of bottled water. Samples of foreign bottled water
offered for entry may be collected and tested to determine if
they are in compliance with the laws and regulations, and labs
may test the water for microbial, radiological or chemical
contamination.
In recent years, FDA has promulgated a number of quality
standards for bottled water in conjunction with EPA. Most
recently, on May 29, 2009, FDA published a final rule to
require that bottled water manufacturers test source water and
finished bottled water products for total coliform organisms
and to prohibit distribution of products containing any E.
coli, an indicator of fecal contamination. FDA is also
requiring that before a bottler can use source water from a
source that has tested positive for E. coli, the bottler must
take appropriate measures to rectify or eliminate the cause of
the problem, and the bottler must keep records of such actions.
In general, FDA's oversight of bottled water, I think can
be described as successful. The agency is aware of no major
outbreaks of illness or serious safety concerns associated with
bottled water over the past decade. FDA is aware the GAO report
released today highlights a number of issues that the agency
faces in regulating bottled water. FDA has worked with GAO to
provide information and assist with their investigation.
Let me address some of the issues that GAO has raised, and
let me say that while I do believe that FDA's oversight has
been generally successful, I also believe that there is room
for improvement. First, GAO found that FDA has not yet set a
standard for the phthalate known as DEHP. This was contemplated
in 1996 but the Administration at the time did not pursue this
because of a legal issue we could discuss further if you want
known as prior sanction. We are now revisiting this decision
and intend to pursue a DEHP standard as anticipated under the
law.
Second, GAO found that FDA labeling regulations for bottled
water provided for less information about the sources and
quality of water than required by FDA for municipal systems.
FDA has found that it would be feasible for manufacturers of
bottled water to provide such information to consumers.
However, the Food, Drug and Cosmetic Act does not provide a
mechanism to require bottlers to make that information
available so Congress would have to take additional action.
Third, GAO expressed concern that FDA cannot require the
submission of results to the agency on tests conducted by
bottled water manufacturers. This is a fair point and a part of
the oversight of water and food in general that should be
strengthened. In fact, it would be strengthened by the food
safety legislation that the committee is showing so much
leadership on.
Fourth, GAO has pointed out that FDA does not have specific
authority to mandate the use of certified laboratories. This is
also a reasonable point, and FDA does require the use of
methods that are at least as sensitive as FDA's methods but the
food safety legislation passed by the committee would also be
extremely helpful here.
I would also mention that the food safety legislation
provides for food safety plans, hazard analyzes and preventive
controls that will complement FDA's Good Manufacturing
Practices for bottled water facilities and generally strengthen
the system of oversight for bottled water, and for foreign-
produced bottled water, the Act would require importers to
register with FDA, comply with Good Importer Practices and give
FDA the authority to require certification as a condition of
importation.
So we will continue to work with this committee on the
legislation, which we think is very important, and I am pleased
to be here and look forward to your questions.
[The prepared statement of Dr. Sharfstein follows:]
Mr. Stupak. Thank you, Doctor.
Ms. Houlihan, would you pull that mic over.
TESTIMONY OF JANE HOULIHAN
Ms. Houlihan. Mr. Chairman and members of the subcommittee,
I am Jane Houlihan, senior vice president for research at
Environmental Working Group. We are a nonprofit research and
advocacy organization in Washington, D.C. Thank you for holding
this hearing.
Today we are releasing an 18-month survey of labels and Web
sites for 188 bottled waters. Here is what we found. Consumers
spent about 1,900 times more for bottled water than for tap
water yet they often have no way to learn essential facts about
what is actually in the bottle. Only two of 188 bottled waters
make public three basic facts routinely disclosed by local tap
water utilities. These are the specific name and location of
the water source, purification methods and chemical pollutants
that remain in the water after treatment. These two brands are
Ozarka Drinking Water and Penta Ultra-Purified Water, the only
two of 188 doing so.
Bottled water companies are not required to make these
basic facts public, and here is the reason: they enjoy a
regulatory holiday under the federal Food, Drug and Cosmetic
Act with near-complete latitude on what, if any, information to
share with consumers. In contrast, every one of the Nation's
52,000 municipal water suppliers produces an annual water
quality report giving its water source and pollutant testing
results as required under the Safe Drinking Water Act. EPA
calls these reports the centerpiece of consumers' right to know
about water quality.
This double standard is unfair to consumers who have a
right to know what is in the water they buy. Surveys show that
over half of bottled water drinkers choose it because they are
worried about the safety of their tap water. They believe it is
free of contaminants. They do it for their health. But in too
many cases, consumers have no way to check if the purity they
are looking for is what they are actually getting.
So where does the water come from? Our survey found that 30
percent of bottled waters provide no information whatsoever
about their water source on the label but 37 percent fully
divulge both the name and location of their water source, and
the remaining 33 percent give generic information like spring
or deep aquifer. If you could look at figure 1 in your packet,
please, this is a brand that is doing the right thing. It is
Great Value. It is called in your figure a smaller brand. It is
not in the top 10 but it is actually distributed by Walmart.
You will see on the label the source clearly indicated as
municipal supply, Fort Worth, Texas, so you know exactly where
this water comes from. You will also see the treatment method
on this label, reverse osmosis. Let us look at the next figure
by way of contrast. On the other end of the spectrum is Dasani.
On this label, you will see that the product is pure and it is
crisp and it has a fresh taste but nowhere on this label will
you find the source of that water. Dasani is one of 30 percent
of the brands not giving any information on source along with
Whole Foods, Food Lion, CVS, Kroger store brands and many other
brands.
How is bottled water purified? Bottled water companies are
not required to disclose what, if any, methods they use to
purify their water. Municipal water suppliers aren't required
to disclose this information either but most of them do. We
found that 44 percent of bottled waters provide no treatment
information on labels. One-third provide no information on
labels or Web sites.
If you look at figure 2 in your packet, you will see a
label for Ozarka. This is a Nestle brand that is actually doing
the right thing. You will see on this label the water comes
from the Houston municipal water supply, but it doesn't stop
there. It is further treated by reverse osmosis, carbon
filtration, microfiltration and ozonation. Now, for contrast,
let me read to you what you will see on a Fiji label. ``The
purest water comes from the purest clouds. Our rainfall is
purified by trade winds as it travels across the Pacific Ocean
to the islands of Fiji,'' and that is all the information you
will see on treatment on that label, and Fiji is one of the 60
percent of bottled waters that print marketing claims of purity
from among those waters that don't label their treatment
methods. Consumers have no way to know if the claims are true.
What pollutants are in bottled water? Every tap water
utility publishes an annual water quality report listing all
their results for the year but only 18 percent of bottled
waters do the same. Those that do include all eight domestic
Nestle brands. Those that don't include Aquafina, which is a
Pepsi brand, and figure 3 of your packet. Without data,
consumers are left with marketing claims, and these are
extensive. You have heard Poland Springs, a man who lived 52
additional years after drinking the water. Mountain Valley
Springs became known as a remedy for the treatment of gout,
rheumatism and other diseases. Evian claims its water is a
symbol of health, general well-being. Valdix water is extremely
pure but they don't publish a test report. And finally,
Aquamantra's water resonates with the energy and frequency of
well-being. When you pay a premium price for bottled water, you
deserve more than just claims. We recommend that bottled water
labels and Web sites disclose the same information that the law
requires of municipal water utilities and that this disclosure
be mandatory. Consumers have a right to know where their
bottled water comes from, how or if it is treated and the
pollutants it contains.
Thank you for your time.
[The prepared statement of Ms. Houlihan follows:]
Mr. Stupak. Thank you.
Mr. Doss, your opening statement, please, sir.
TESTIMONY OF JOSEPH K. DOSS
Mr. Doss. Chairman Stupak, Ranking Member Walden and
members of the subcommittee, my name is Joe Doss. I am
president and CEO of the International Bottled Water
Association. I appreciate very much this opportunity to discuss
the regulation of bottled water.
Bottled water, whether in retail-size packages or in larger
containers used in home and office water coolers, is a safe,
healthy, convenient beverage. It is comprehensively regulated
as a packaged food product at both the federal and State level,
and as with other packaged food and beverages, bottled water
must meet FDA's general food regulations which include
extensive labeling requirements for ingredients, the name and
place of business of the manufacturer, packer or distributor,
the product's net weight, and if required, nutrition labeling.
In addition, FDA has promulgated separate standards, as we have
heard, separate standards of identity including labeling
requirements that identify the type of bottled water, standards
of quality and good manufacturing practices specifically for
bottled water. Federal law requires FDA bottled water
regulations to be as protective of the public health as EPA
standards for public drinking water systems, and to that end,
FDA has established bottled water standards for quality for
more than 90 substances. Most FDA bottled water quality
standards are the same as EPA's maximum contaminant levels for
public water systems. The few differences in regulated
substances are because they are not found in bottled water or
they are regulated under another provision of law such as FDA's
food additive program.
If a container of bottled water has a contaminant that
exceeds an FDA standard, this fact must by law be disclosed on
the label. Failure of a bottled water container to meet the
standards of quality and to be properly labeled can subject it
to recall by the company and enforcement action by FDA. If a
bottled water product source is a public water system and the
finished bottled water product does not meet the FDA standard
of identity for purified or sterile water, that product label
must disclose the fact that it comes from a public water
source.
It is also important to note that the courts have held that
FDA's jurisdiction over food and beverages extends not only to
those products that move in interstate commerce but to those
products sold within a single State if they are using packaging
materials that have moved in interstate commerce such as the
bottle, the caps or the labels, and that is the case for almost
every bottled water sold in the United States. In addition,
Congress has created a statutory presumption of interstate
commerce for all FDA-regulated products including bottled
water.
Now, while the current laws regulating bottled water
products protect the public health, IBWA members and others in
the food industry have recently worked with the Energy and
Commerce Committee to update the food safety laws. IBWA
supports a risk-based inspection system that would require
inspections of all food facilities every 6 months to 3 years, a
requirement for all food manufacturers to conduct a hazard
analysis and establish and maintain preventive controls which
all IBWA members already do as a condition of membership in
granting FDA authority to mandate recall under circumstances
where a food product presents an imminent threat of serious
adverse health consequences or death.
IBWA supports a consumer's right to clear, accurate and
comprehensive information about the bottled water products they
purchase. As I mentioned, all packaged food and beverages
including bottled water are subject to extensive FDA labeling
requirements that provide consumers with a great deal of
product quality information. In addition, virtually all bottled
water products include a phone number on the label that
consumers can use to contact the company. In fact, IBWA
petitioned FDA in 2001 to require all bottled water labels to
include a phone number on the label. IBWA believes that the
most feasible way to consumers to obtain information not
already on the label is through a request to the bottler. In
addition, consumers can go to the IBWA Web site to obtain
contact information or water quality information for all IBWA
member brands.
Consumers have many options when choosing which bottled
water brand to drink. If a bottled water company does not
provide them with the information that they want, he or she can
choose another brand of bottled water. That is not the case
with tap water. Consumers cannot choose which public water
system is piped into their homes, and that is a fundamental
issue: consumer choice.
Unfortunately, many people want to make this out to be a
bottled water versus tap water issue. We just don't see it that
way. If people are drinking water, whether it is tap or
bottled, that is a good thing and consumers should be free to
choose. In fact, 75 percent of consumers who drink bottled
water also choose to drink tap water. IBWA supports investments
to improve the U.S. public drinking water system in order to
maintain the highest quality of water for all citizens. And
with the increase in diabetes, obesity and heart disease rates
in the United States, any actions that would discourage
consumers from drinking bottled water are not in the public
interest. Throughout the years, bottled water companies have
always responded to the need for clean, safe drinking water
after natural disasters such as hurricanes, floods and forest
fires, and in emergency situations such as terrorist attacks
and boil alerts. However, the bottled water industry cannot
exist only for disaster response. The vast majority of bottled
water companies in the United States are primarily family owned
and operated small business that depend on a viable commercial
market to provide the resources necessary to respond in
emergency situations. In fact, 90 percent of IBWA's members
have gross sales of less than $10 million a year.
In summary, bottled water is a safe, healthy, convenient
good product that is comprehensively regulated at the federal
and State level. IBWA stands ready to assist the subcommittee
as it considers this very important issue. Thank you for
considering our views.
[The prepared statement of Mr. Doss follows:]
Mr. Stupak. Well, thanks. We will start with questions, and
thank you all for your comments.
Mr. Doss, let me ask you this. Is it true 80 percent of the
water bottlers are part of your organization, about 80 percent?
Mr. Doss. I am sorry?
Mr. Stupak. Water bottlers in this country, they belong to
your organization?
Mr. Doss. I would say we probably represent 75 percent of
the actual facilities.
Mr. Stupak. Is Dasani, Coca-Cola, are they part of your----
Mr. Doss. Dasani is not a member of the association.
Mr. Stupak. How about Nestle?
Mr. Doss. Nestle is a member.
Mr. Stupak. OK. And how about Aquafina? That is Pepsi,
right?
Mr. Doss. That is not a member.
Mr. Stupak. So are those the three biggest, Coke, Pepsi and
Nestle?
Mr. Doss. The largest companies.
Mr. Stupak. So two of the three are not part of your
organization?
Mr. Doss. That is correct.
Mr. Stupak. Your standards, which track many of the things
we recommended and GAO and the others, that is voluntary
standards you try to have your member comply with?
Mr. Doss. IBWA has always tried to, you know, have the
highest possible safety standards so we have a mandatory
requirement for our member, and if they don't meet those
standards, then they cannot be a member of the International
Bottled Water Association.
Mr. Stupak. Do you do anything on the advertising then? I
mean, we have seen these crazy----
Mr. Doss. No, advertising is not an issue that we deal
with. Obviously that is a case-by-case situation where there
are State and federal laws that would allow companies to be--
action to be brought against them for deceptive or misleading
advertising, so we don't do anything in that regard.
Mr. Stupak. OK. So like Aquamantra about these mantras
inherently penetrate the molecular structure of the water, you
guys don't condone any of that?
Mr. Doss. It is not something--the association does not
deal with advertising issues. That is something that would be
left to the State and federal authorities.
Mr. Stupak. Well, the company went on to say that it
consulted, and I use the word ``consulted'' because that is
what it said on the Web site, with a Dr. Marura Emoto who wrote
a book called Hidden Messages in Water, and the company said
that he showed us the basic principles of quantum theory
whereby the molecular structure of water was changed by a Zen
Buddhist monk's thoughts. Based on this premise, Aquamantra
uses the design on its labels to affect the molecular structure
of California natural spring water to make it more refreshing
and wholesome. Is there any water studies that a Zen monk can
change the molecular structure of water?
Mr. Doss. Well, I can't speak to what that company has
found. I just can't speak to that. I don't know that they are a
member of IBWA so I can't comment on what information they may
have about what they say on their label or other materials.
Mr. Stupak. Dr. Sharfstein, have you seen anything quite
like this? Do you think those should be part of the labeling of
bottled water, Zen Buddhist monks' thoughts that can change the
structure of water?
Dr. Sharfstein. I would be highly skeptical.
Mr. Stupak. But, you know, we have seen it, and Ms.
Houlihan pointed out and a couple others, these are just sort
of like fantastical claims. Are they legal? Can they do it
underneath your misbranding or false advertising?
Dr. Sharfstein. Well, we will definitely look into this
case. In general, misbranding pertains to whether people are
claiming to treat disease. That is the big one. That is where
we put our priority. If people are saying you drink this water
and it cures your cancer, then people may not pursue cancer
treatment.
Mr. Stupak. So like Mr. Ricker of Poland Springs who had a
miraculous recovery and lived nearly 52 years and it is good
for liver and kidney diseases, is that----
Dr. Sharfstein. Well, there were two that you--you know,
the one with historical fable. I don't know if that is
exactly----
Mr. Stupak. That is Mr. Ricker.
Dr. Sharfstein. But the other one where you said used in
clinical----
Mr. Stupak. Clinical tests, Philadelphia, St. Louis.
Dr. Sharfstein. That one I think we would like to see. I
mean, that to me strikes me as pretty, you know, worth our
evaluating. I am not familiar with that. But I think that would
definitely fall into something we would look closely at.
Mr. Stupak. How about the other one? The makers of H20M
claim that they play music and sounds at their bottling
facility that charge the water with special vibratory
frequencies? Would that be misadvertising?
Dr. Sharfstein. I am not a musician but I would still
express skepticism about that one, and I think that, you know,
we have--the misbranding provision is really about things that
we focus on we really think are going to pose a public health
threat, a claim like that, and you know, the issue about
whether it treats kidney or liver disease, this really does
raise that issue.
Mr. Stupak. You know, in tab 13 is that chart again, and we
might want to put it back up on the board there. And the two
reports by GAO and Environmental Working Group talk about the
regulations, and you mentioned a little bit in yours too. If
the bottlers discovered dangerous contaminants of water, they
don't have to alert the public. Unlike municipalities, bottlers
don't have to use certified labs. Water bottlers generally are
not required to provide information about test results, the
source of their products. You know, take Dasani here. We
mentioned them today, and I have this bottle that was put on
the airplane when I fly back and forth so I grabbed it with me
as I was reading my testimony. When I go through and read it,
you know, their claims aren't too outrageous. It is enhanced
with minerals for a pure, fresh taste that can't be beat, and
then you go to www.makeyourmouthwater.com. That is out there a
little bit but it says bottled by CCDA Waters LLC, Millersburg,
Pennsylvania, but then underneath it they have CT and then the
symbol for number, 992, then they have NV 07354, NYSHD
certificate 173 and then they have another one, L, but CT,
would that be Connecticut? NV, would that be Nevada? New York
State Health Department, I take it, would be New York. It
doesn't say anything about sources or anything, so you don't
know where this water really came from, Nevada, Connecticut,
New York or Pennsylvania.
Dr. Sharfstein. I could not decipher that for you.
Mr. Stupak. Mr. Doss, can you help out on that, these
markings?
Mr. Doss. I can't say for sure because I obviously don't--I
am not familiar with that brand but it may be that all of those
states require the product to be registered like other food
products do within the State. If you are going to sell products
within a State, I think all food products tend to have those
registration information on the bottles.
Mr. Stupak. So you would have to figure out--the last one
is probably a lot number. You would have to go through and
figure out your lot number to try to figure out where it came
from, right, and whether Nevada, Connecticut, New York or
Pennsylvania, or Coca-Cola in Atlanta, Georgia, because that
address is on there too. Really, a consumer has no way of
knowing, and this is one of the big bottlers.
Mr. Doss. Again, I can only tell you I think that is what
that refers to.
Mr. Stupak. Mr. Walden.
Mr. Walden. Thank you very much, Mr. Chairman.
Just like any food product regulated by the FDA, if
dangerous contaminants are in the bottled water, it is
considered adulterated by the FDA, correct, Doctor?
Dr. Sharfstein. That is correct.
Mr. Walden. And it violates the law if it is sold to
consumers?
Dr. Sharfstein. People can go to jail if they do it.
Mr. Walden. And if we are worried about some of these
claims on the label, isn't that really also under the
jurisdiction of the FTC, the Federal Trade Commission, on false
advertising and labeling?
Dr. Sharfstein. You know, I will have to get back to you. I
don't know if I can answer that. I think we do have certain
jurisdiction there and I am not sure about the FTC.
Mr. Walden. I would assume that they would but I don't know
that for a fact but it is something we ought to look at because
it would be helpful if they were here today and the EPA was
here today and perhaps somebody from Coca-Cola as well since
they are not represented on this panel but we are singling them
out.
Dr. Sharfstein. One thing I might want to mention is, in
just a couple of months FDA is going to launch----
Mr. Walden. Is your mic on, by the way?
Dr. Sharfstein. Yes.
Mr. Walden. OK.
Dr. Sharfstein. In just a couple months, FDA is going to
launch the reportable food registry that was part of
legislation that Congress passed, and when that happens, we are
anticipating September, companies will have to notify FDA if
there is a product release that could pose a serious risk to
health. So some of the gap will be filled by that but we really
think, you know, the passage of the food safety legislation is
necessary to really close that.
Mr. Walden. Yes, we are hopeful that that can be brought up
on the--Mr. Chairman, has that been scheduled for House Floor
consideration yet?
Mr. Stupak. Not yet. We are still working on the final
touches.
Mr. Walden. OK. In your testimony, Doctor, you discussed
new FDA testing requirements for bottled water to include
testing source water for total coliforms and establish a zero
tolerance for E. coli. Does the EPA require testing for
coliforms in tap water and did the EPA establish a zero
tolerance level for E. coli?
Dr. Sharfstein. Give me one second. I have some information
on that right here. I was curious about that also.
Mr. Walden. Because I think you made the case on lead, that
you have zero tolerance for lead in bottled water but EPA
allows a certain----
Dr. Sharfstein. I think it illustrates the point that it is
just a little different, the systems. My understanding is that
public water systems are required to collect monthly total
coliform samples throughout their distribution systems and that
if they are positive they must be tested for E. coli. For a
system collecting more than 40 samples per month, if more than
5 percent are positive, that triggers a violation. If it less
than 40 samples per month, then one positive sample triggers a
violation. So, you know, for FDA, bottled water, if there is
any violation that kicks in for municipal, it has to be certain
percentage of the tests violative for it to trigger a
violation. So the standards are slightly different. I hope I
was able to explain that clearly enough. They do a whole bunch
of tests----
Mr. Walden. Are they more stringent under your regulations
or the EPA regulations?
Dr. Sharfstein. It is----
Mr. Walden. Or is it just different?
Dr. Sharfstein. They are different. I mean, you know----
Mr. Walden. Because I know here in the District of
Columbia, I think I am correct in saying this, that we all went
many years drinking the tap water believing it to be safe only
to discover that they hadn't really fully disclosed the amount
of lead that was coming into the water through the pipes, and
so I don't know if you ran into that in Baltimore when you were
health commissioner there, but as I recall you advocated to
people to buy it and it would be safer to drink bottled water.
Dr. Sharfstein. Well, not for the population of Baltimore
because the municipal water supply in Baltimore we felt very
comfortable with but----
Mr. Walden. But for public school children?
Dr. Sharfstein. Public school children. That is right. In
fact, I advised the school superintendent to turn off all the
drinking fountains in the Baltimore City public schools because
of problems that they were having with lead.
Mr. Walden. And to go to bottled water.
Dr. Sharfstein. And to go to bottled water across the
system. It turned out to be cheaper also, given the expense of
testing the municipal water because of the old buildings and
the problems they had with the pipes in the school. So, you
know, I certainly as a health commissioner, I think there are
certain scenarios where, for example, after certain types of
disruptions of the water supply, the water can be unsafe for a
period of time and we recommended that people buy bottled water
or boil it.
Mr. Walden. Thank you.
Mr. Doss, a question about this notion that consumers are
wanting to know what it is in their bottled water. While I want
to know that it is safe when I drink it, I am not sure I am
going to chase down what spring it came out of or well, as long
as I know it is safe. How many inquiries do you get through
your association of people who say I want to know the
ingredients, I want to know--I mean, when I take water out of
my place here in D.C., there is no label on the tap that tells
me all this stuff. I wouldn't know where to go in the D.C.
system to even find out, and frankly, as long as it is safe, I
don't care. How much of this is the case? How many people are
rushing to you and calling your folks saying hey, I demand to
know where this water came from?
Mr. Doss. At IBWA, the association has hardly gotten any
comments, any questions from consumers. I have talked to some
of my members including our large members and our small- and
mid-sized members, and they get very few requests. Now, I will
say----
Mr. Walden. And how do they handle those requests?
Mr. Doss. They provide them with the information.
Mr. Walden. Do they disclose?
Mr. Doss. If they want testing results, if they want source
information, whatever they ask for, you know, in our opinion,
that is what they should provide, and that is, our bottom line
is, that if a consumer has a question, we believe they have the
right to have that information. The real issue is how to best
provide that information. I think that is the distinction here
and that was related a minute ago. These are two different
systems. Bottled water is a packaged food product in a very
different distribution system than tap water. So there are
necessarily some differences in the way you might want to
provide the information, and as far as the overall safety is
concerned, again, they both have to be safe. There are
different ways that you get to that goal.
Mr. Walden. Because I don't think in a soft drink bottle
they disclose where the liquid source comes from, right?
Because they put water in a cola beverage, right? Is that
right, Doctor?
Dr. Sharfstein. Yes.
Mr. Walden. Isn't that the number one ingredient, is water,
in these beverages we all drink? And the last time I checked,
nobody is saying tell me where the water came from that is in
there. It is not required to be on those labels, is it?
Mr. Doss. And that is why----
Mr. Walden. So you are kind of being singled out.
Mr. Doss. Bottled water is a food product so we follow the
rules that are in place.
Mr. Walden. Is cola a food product?
Dr. Sharfstein. Cola is a food product and it is not
subject to the Good Manufacturing Practices that exist
specifically for bottled water, so there is a----
Mr. Walden. So is there less oversight on our soda drinks
from the FDA's perspective?
Dr. Sharfstein. Maybe I wouldn't use the word ``oversight''
but I would say there is definitely more regulations and----
Mr. Walden. On which?
Dr. Sharfstein. On bottled water.
Mr. Walden. Than on cola products? And I am not picking on
cola versus uncola versus, you know, the new cola versus
whatever. I am just talking soft drinks.
Dr. Sharfstein. That is correct.
Mr. Walden. So there is less oversight--well, I will use
the term ``oversight'' but in terms of food safety issues----
Dr. Sharfstein. Right, and there are Good Manufacturing
Practices that apply to foods generally that apply to colas,
and someone will tap me if I am getting this totally wrong, but
I understand that the bottled water has a whole set of
regulations that are really just for bottled water, and it
relates to the fact----
Mr. Walden. Commodity-specific----
Dr. Sharfstein. Right.
Mr. Walden [continuing]. Regulations which don't exist for
soft drinks?
Dr. Sharfstein. Right.
Ms. Houlihan. Can I also say that one difference between
bottled water and soda is also that people choose bottled water
because they think it is healthier and safer than----
Mr. Walden. Yes, but that is not----
Ms. Houlihan [continuing]. In a lot of cases, and that is
not the reason they are choosing colas. So I think that----
Mr. Walden. Yes, but the question--whether they choose it
or not, the question I thought you were getting at is,
consumers have the right to know the source of the ingredients
in the bottle, the labeling and all that. I mean, I want to
know if--I may think a soda product is better than bottled
water.
Ms. Houlihan. Water is very different from other kinds of
food products. It makes up more than half of our body and we
are advised to drink at least eight----
Mr. Walden. Right, because it helps remove toxins and
everything else.
Ms. Houlihan. Exactly, and so people are choosing bottled
water in particular, not colas, because there is a perception
that it is safer and healthier than tap water, and I think that
is why it is being singled out here over other foods because of
the special place that it holds in people's minds. Also,
because it is almost 2,000 times more expensive than tap water
and people----
Mr. Walden. How much more expensive is a soda drink over
tap water?
Ms. Houlihan. Maybe a similar amount, but people are making
really tough choices right now about their budgets and so
bottled water is part of that.
Mr. Walden. And I have almost doubled over my time.
Mr. Stupak. No, that is all right. We will come back
another time but I want to get to Mrs. Christensen for
questions.
Mrs. Christensen. Thank you, Mr. Chairman. I just want to
go over the contaminant disclosure issue again so I am clear.
According to the new reports released today, it appears that
consumers have access to a lot more information about
contaminants in tap water than they do about contaminants in
bottled water in answer to some of the questions previously
asked.
Mr. Stephenson, under current law, municipal water
authorities have to notify the public within 24 hours when they
detect contaminants such as E. coli above prescribed levels in
tap water. Is that correct?
Mr. Stephenson. That is right.
Mrs. Christensen. And they have to send that notice over
broadcast media or in warnings posted in conspicuous locations?
Mr. Stephenson. Yes, there are very specific requirements
on how you report those.
Mrs. Christensen. But if a bottled water company ran the
same tests on its water and found the same level of E. coli, a
level that both EPA and FDA say is dangerous to human health,
they don't have to tell the FDA or EPA or the public?
Mr. Stephenson. Or the State. Well, some States require it
but not the FDA.
Mrs. Christensen. A few States require it but generally no?
Mr. Stephenson. Excuse me?
Mrs. Christensen. Generally they don't have to report it?
Mr. Stephenson. Generally, they don't.
Mrs. Christensen. Now, under current law, municipal water
systems are also required to issue annual consumer confidence
reports that disclose any contamination problems, the likely
source of that contamination, potential health effects of that
contamination and information about the system's susceptibility
to future contamination, correct?
Mr. Stephenson. Yes.
Mrs. Christensen. But bottled water companies are not
required to make similar disclosures to the public?
Mr. Stephenson. That is true. We currently don't have the
authorities to make that requirement.
Mrs. Christensen. Dr. Sharfstein, this is a striking
disparity in the information available to consumers. We learn
about dangerous contaminants in our tap water through broad
public announcements within 24 hours but we may never learn
about the dangerous contaminants in bottled water. Did you say
that you supported a requirement to have the bottled water
companies disclose test results showing contamination above the
federal levels?
Dr. Sharfstein. Actually, starting in September, we think,
that requirement will take effect for contamination that poses
a risk to the public.
Mrs. Christensen. Is it enough to have the companies report
their lab reports or should there be certified labs and should
the labs be required to tell FDA when a positive result is
found? Isn't that more reliable?
Dr. Sharfstein. I think it is a very important question. I
think there are two questions there, the certified lab and then
whether labs should be required to report.
Mrs. Christensen. Right.
Dr. Sharfstein. So for certified labs, I think FDA would
like to have authority to require labs if we think that that is
important for a particular product, and I think that because of
the broad preventive authority that this new legislation that
has been moving through the House would give, we would be able
to do that.
The second question of requiring labs to report to FDA is a
little bit more complex because there are so many tests that
are done.
Mrs. Christensen. Just the positive ones.
Dr. Sharfstein. Right. I understand. The concern that is
expressed there is whether or not it inhibits the private
sector from testing at all. If they have a good testing program
in place where there are identifying and keeping things out of
the system, you know, should they be reporting every single
positive, which ones should get reported. Those are questions
that are a little bit more complex because you could be
drowning, and if you are thinking not just for water but all
the different foods, all the different tests, we don't want to
inhibit companies from doing their own testing if they have
good preventive plans in place. We want to not be missing the
forest for the trees in terms of all the information coming to
us. So that question of how much to require, where to get it
from is sort of more complex issue that we would probably look
at, you know, in a particular industry, a particular situation
like, you know, certain types of tests we probably would want
to know because they would be so serious.
Mrs. Christensen. And earlier this year, the subcommittee
held two oversight hearings on salmonella poisoning in peanut
products that caused multiple deaths and dozens of illnesses,
and we learned that the Peanut Corporation of America received
positive tests for salmonella and was not required to disclose
them to anyone, and FDA didn't have the access to those results
and couldn't access them until people fell ill by invoking
another law, the bioterrorism law, and so the same legal
loophole applies to bottled water companies. Although the
municipal water authorities are required to disclose their test
results, FDA cannot compel bottled water companies to disclose
theirs.
So Ms. Houlihan, if a bottled water company tests its water
and finds dangerous levels of E. coli, as far as you
understand, is that required to disclose those results to the
public?
Ms. Houlihan. As far as I understand, that is the case. We
found a lot of bottled water brands that are posting, 18
percent of the brands that we looked at that are posting full
water quality test reports online, and we think 100 percent of
companies should be doing that and letting people know right
away about contamination.
Mrs. Christensen. I am not really--even though I made a
reference to peanut butter, I am not in any way suggesting that
the water issue is similar. But one important lesson that we
learned is that sometimes disreputable companies have warning
signs long before major problems arise because the systems are
faulty, and if federal or State officials had access to that
testing data, they might be able to flag small problems before
they become big ones.
Mr. Doss, your organization represents, I think you said
about 75 percent of the bottled water industry. Do you support
a requirement that bottled water companies make their test
records available to the FDA during routine inspections?
Mr. Doss. We do.
Mrs. Christensen. And I am sure Dr. Sharfstein already
answered that question. I guess I am out of time right now and
I will just hold for a second round.
Mr. Stupak. Thank you.
Mr. Burgess for questions, 5 minutes.
Mr. Burgess. Thank you, Mr. Chairman. I apologize for being
gone during your testimony and the earlier questioning. Can
anyone tell me, if bottled water has a certain standard, what
about our cola drinks? Are those bottles held to the same
standard as bottled water?
Dr. Sharfstein. So cola drinks are considered food and
there are food Good Manufacturing Practices that they are held
to but cola drinks are not held to the bottled water Good
Manufacturing Practices which are sort of in addition to the
general Good Manufacturing Practices.
Mr. Burgess. To the best of anyone's knowledge, there is no
difference in the way any of these compounds would leach out of
the plastic into liquid phase whether it be water or cola
drinks. Is that correct?
Dr. Sharfstein. Yes, I don't know if I know enough to
answer that question. I do think that the point that is there,
you know, from a food safety perspective. You know, there is
not a--from a food safety perspective, water has a whole
additional set of regulations compared to cola. It really
depends on--and, you know, public health, you are saying
compared to what. If you compare bottled water to cola, it has
got a whole additional set of regulations. If you compare
bottled water to municipal water, then there are certain
disclosure requirements of municipal water that don't apply to
bottled water. So it is sort of just your vantage point, but
from a food safety perspective, you know, there is a whole
additional set of regulations that apply to bottled water
compared to cola.
Mr. Burgess. Well, what about the water that is
manufactured and sold with caffeine added to the water? Does
that fall under the foodstuff or is that a water?
Dr. Sharfstein. That is not a water.
Mr. Burgess. That is not a water?
Dr. Sharfstein. Yes, I think--and somebody is going to tap
me if I get this wrong but I am pretty sure that it is not a
water. It depends. I think some of those may be--people may be
attempting to market them as dietary supplements and other
things but what they are actually marketed as is a whole
separate discussion, but I don't think they are considered a
water if you put extra caffeine in.
Mr. Burgess. It just really underscores the complexity of
the process that you have to deal with.
Now, let me ask the GAO, on the report that two people to
inspect the $11 billion water industry, and 4 years ago the FDA
changed the risk assessment for bottled water from low risk to
high risk, so the question then comes, how many inspectors
should be required? If two are not enough, what is our limit?
We will be doing the agriculture appropriations bill this
afternoon which will have the funding for the Food and Drug
Administration in it. How do we know that we have got the right
number of inspectors so that we can then know that we have the
right appropriation attached to the FDA?
Mr. Stephenson. That is a good question, and we don't have
a precise number just for this segment of FDA's overall
responsibility. We have said designating food safety a high-
risk area over the past 2 years that the resources are
inadequate to do the job right now, and we have pointed out
from a broader standpoint that food safety is spread over a
number of different agencies and of those agencies, FDA seems
to get the smallest proportion of the budget yet it has 80
percent of the responsibility. So I don't know whether two is
right or four is right or six is right just for bottled water.
All we are just doing is stating a fact, that that is how many
FTAs are currently dedicated to inspecting bottled water
facilities.
Mr. Burgess. And that in fact does not seem to be a
sufficient number?
Mr. Stephenson. It does not seem to be a sufficient number,
given the number of bottled water facilities.
Mr. Burgess. Also in your testimony, you note that three-
quarters of the water bottles produced in the United States in
2006 were recycled. Do we know about the rates of recycle for
other beverages?
Mr. Stephenson. I think it is probably similar for all
plastic bottles. With bottled water being a growing share of
the market, there are more bottles dedicated to water than soda
percentage-wise.
Mr. Burgess. So numerically, there are more in the
environment----
Mr. Stephenson. Right, and this isn't a volume problem, as
we noted. It is less than 1 percent of what is going into a
landfill. Nevertheless, they never decompose and they stay
there forever, and recycling is a good thing in general.
Mr. Burgess. And I would agree with that.
Dr. Sharfstein, in the GAO report it states that the FDA
currently assigns two people yet 4 years ago the Food and Drug
Administration changed the risk assessment from low to high
risk, so again, I would ask the question, how many inspectors
should now be assigned to oversee the Code of Federal
Regulations as it relates to bottled water?
Dr. Sharfstein. I am not sure that is right, that we
changed it to high risk. I think that in general compared to
other foods, we considered bottled water in the lower risk
side. I think that there are two issues. One is the frequency
of inspection and the other is all the things that go with
inspections, and one of the key things we talked about is just
knowing who is making bottled water, and we have a hard time
under the current food safety laws really understanding that
because by law, people can register on paper and the category
is called soft drinks and waters, so everyone is sort of thrown
in together so we don't have a very good idea--we don't have as
good an idea as we would like to have or we should have exactly
who is making it. That is sort of the first step to have, like,
you know, a solid system. And then we would like the ability to
require preventive plans and, you know, all the key basic steps
there, and then you put inspections as part of that strategy.
But just thinking of inspections alone with the rest of the way
it is, it is probably going to leave some opportunities for
strengthening the system off the table if you are just thinking
of inspection alone which is why we would like the parts of the
law giving us access to records, giving FDA the ability to
require preventive plans, certified labs if we think necessary,
other things like that.
Mr. Burgess. Let me ask you a question in the time I don't
have remaining, and it is not fair to ask you this but I will
do it anyway. We are going to vote on the agriculture
appropriations bill today or tomorrow. Is the number we have in
the bill for the Food and Drug Administration, do we have the
right number there?
Dr. Sharfstein. Yes. The President's budget and what came
out of committee is a historic increase and I think there is no
question the Administration responded very strongly to GAO's
finding this would be a high risk and putting a lot more
resources into food safety, and if we get that combined with
additional authority, I think we will be able to strengthen the
system considerably.
Mr. Burgess. And just for the record, Mr. President, the
beautiful campus that they occupy is actually part of the GSA
budget so none of your food safety dollars are going to build
that lovely campus which we are all so proud of. I will yield
back.
Mr. Stupak. Thanks, Mr. Burgess.
Let us go another round of questions. Dr. Sharfstein, if we
do testing and if they have to report their positive results,
wouldn't after a while if you see a continued positive results
for E. coli or something from a plant that indicates you have a
problem, we have to get there or at least increase inspections,
like the peanut butter one with the salmonella. We had report
after report of problems but no one ever received a report and
no one ever knew, at the FDA, at least, what was going on
there.
Dr. Sharfstein. I agree with you. FDA has to respond to
problems very aggressively and has got to be able to follow up
with manufacturers that aren't meeting standards and if
necessary shut them down, and, you know, in recent weeks we
have taken action against some firms----
Mr. Stupak. But you wouldn't know unless you received
positive results, I mean, unless you received the results.
Somewhere, someone at the FDA has to receive results and look
at them, right?
Dr. Sharfstein. Well, it could be that we got a complaint
and we investigated. It could be testing that FDA does, and FDA
does do some testing. So we can find out problems. We could
have somebody call us and say there is a problem with this
company, and so that leads us to investigate. But once we find
the problem, I think it is important to really follow up until
that problem is clearly resolved.
Mr. Stupak. Well, how about for those bottlers who use
municipal water as their source? Wouldn't it make sense to
require them to post a link to the required EPA testing results
because they have to do it once a year? Wouldn't that make
sense to require them to--25 percent, I think, Ms. Houlihan was
in your report, 25 percent of the bottlers use tap water, so
why wouldn't we just require them to post their Web site?
Dr. Sharfstein. Right. I can totally understand why that
would make sense, why consumers might be interested in that.
But the thing for FDA is, the standard that we have for putting
something on the label is that it would have to be misleading
without it, and so we can't--you know, we use that to say that,
you know, something has got to be there or it is misleading
without it, and that is a hard thing to put that, you know, to
kind of file that in that category. So that is not to say we
wouldn't support it but whether we could do it under our
misleading, you know, authority, that we think is questionable
and that it might require a different authority.
Mr. Stupak. It is misbranding authority that you have?
Dr. Sharfstein. Yes, the misbranding authority. The basic--
if we were to do it, and this would--you know, what standard
would we have to meet, and it would be that it is misleading
without it, and, you know, we don't require it for other types
of foods. You know, would it really be misleading consumers not
to have that, and that is a hard standard for us to reach.
There may be a better way for Congress to achieve that.
Mr. Stupak. Mr. Stephenson, if I may, on page 22 of your
report you referred to a poll conducted by Water Research
Foundation that approximately 56 percent of bottled water
drinkers cite safety and health as the primary reason they
sought an alternative to tap water. So is it fair to say that
the number one reason people are buying bottled water is
because they think it is safer and healthier than tap water?
Mr. Stephenson. Well, there is that poll and several other
research studies that have concluded that, although convenience
is a top reason as well.
Mr. Stupak. Well, what bothers me about that is the
perception that bottled water is healthier than tap water, in
many instances, bottled water is nothing more than tap water.
The Natural Resources Defense Council, they estimated, as I
said, 25 percent of bottled water is just tap water in bottles.
Sometimes it is treated, sometimes it is not. So I guess my
question is, and Ms. Houlihan, I think you cited in your
report, is that accurate that 25 percent of the bottled water
is just tap water in a bottle?
Ms. Houlihan. Those are the numbers that are publicly
available, and I think it is a big question as to whether it is
even more than that because in so many cases we just don't have
the information on what the source actually is and we found
almost a third of all bottled waters have no information on
their label.
Mr. Stupak. But if they take it from tap water and do
something like reverse osmosis or something, then they don't
have to claim it is tap water, right?
Ms. Houlihan. That is right, and there is a provision that
requires that bottled waters be labeled as from a municipal
supply if they have not undergone any additional treatment, but
any treatment that is, according to FDA, quote, suitable,
allows that bottled water manufacturer not to use that label
and just to call it this is a purified water without giving
people information on what the treatment processes actually
were.
Mr. Stupak. Well, like I said, I got this on the airplane
yesterday. Does Coca-Cola use municipal water for its Dasani
bottled water?
Ms. Houlihan. You can't tell from the label. There is no
information at all on the water source for that product.
Mr. Stupak. How about Pepsi there that Dr. Burgess is
drinking, the Aquafina bottled water? Does that come from a
municipal source?
Ms. Houlihan. Aquafina, we have that label in one of the
examples, if you could pull that up. So on the label, it is
labeled as from a municipal supply for Aquafina. It doesn't
name the municipal supply, which is what so many other bottled
waters are choosing to do.
Mr. Stupak. But do we know if they do any further treatment
or anything of it? Would it have to be on there?
Ms. Houlihan. It doesn't have to be labeled at all, and we
found 44 percent of all labels don't provide any information on
treatment.
Mr. Stupak. Mr. Doss, if Aquafina was part of your
organization, I understand it is not, but if it was, would the
have to put on there whether they further treated or would they
just put down municipal source?
Mr. Doss. No, they wouldn't, and I think the issue here is
one maybe of misunderstanding. Purified bottled water, which is
what Dasani is and what Aquafina is, is not just tap water in a
bottle.
Mr. Stupak. Correct. Something else happens to it.
Mr. Doss. When water comes in from a municipal source, it
goes through reverse osmosis, it goes through UV light, it goes
through ozonation and then in a sanitary condition is placed in
a bottle. Now, those purified waters must meet the U.S.
pharmacopoeia standard for purified or sterile water. If it
dose not, then that label must disclose in that bottle that it
comes from a municipal source. So in that case, that water
because it doesn't list it as from a municipal source, meets
the U.S. pharmacopoeia standard for purified or sterile water,
and that is the big difference, and that goes to the sourcing
of the water. It would be not--to list that this source was the
Dayton whatever county municipal water, that water is quite
different once it gets in that bottle than when it started out,
and that is the distinction here.
Mr. Stupak. OK, let me ask you this. Let us go back to
Dasani then. And again, I am reading the label right here on
what I got here. It says ``noncarbonated, crisp, fresh taste.
Dasani is filtered through a state-of-the-art purification
system and enhanced with minerals for a pure, fresh taste that
can't be beat.'' And then if you go on the other side of the
label, it says purified water, magnesium sulfate, potassium
chloride, salt, and then it has as asterisk, ``adds a
negligible amount of sodium,'' then it has a cross on it and it
says ``minerals added for taste, purified by reverse osmosis.''
So to get that clean, crisp taste, are the chemicals they are
adding then magnesium sulfate, potassium chloride, salt and
sodium or is it other chemicals?
Mr. Doss. I can't speak to Dasani specifically but what is
done sometimes is that the water comes in from a municipal
source, it is purified by reverse osmosis and other treatments
and then minerals are added back for taste. That is what they
are disclosing. Again, I can't speak to that specific label but
in general that is oftentimes what happens.
Mr. Stupak. OK. I guess my time is up.
Mr. Walden, questions?
Mr. Walden. Thank you.
First of all, what the chairman cited, are those chemicals
or minerals?
Mr. Doss. I believe they are minerals that have been added
for taste, and that is why they disclose it on the label. They
are meeting the labeling requirements. They are making sure
that they are informing those who buy it that this is a
purified water with minerals added back.
Mr. Walden. And if they added other things into the water,
would they have to disclose that?
Mr. Doss. I believe they would. It then is a question of
the standard of identity for bottled water, which we talked
about which specifically says if you are spring water, you have
to do this, if you are purified water, you have to do that. So
what----
Mr. Walden. So there are already rules that say that?
Mr. Doss. There are rules that say exactly what you must do
if you want to say you are a purified water, a spring water, an
artesian water, well water.
Mr. Walden. All right.
Mr. Doss. If you then add something else to the water, then
for labeling purposes you would probably--and this is where
FDA--I will have to make sure we can get back to you on this
specifically but I think in that case, FDA would say you need
to then make sure you are saying this is purified water with
minerals added back, and I think that is why they do it.
Mr. Walden. Dr. Sharfstein, do you know or do your folks
know if that is correct?
Dr. Sharfstein. The question is, what you are allowed to
put back in?
Mr. Walden. Not what you are allowed to put back in but
that which you put back in, do you have to disclose on the
label?
Dr. Sharfstein. I am getting a yes, it is required.
Mr. Walden. So it is already required? If I am a bottler of
water and if I go through reverse osmosis and the UV and all
that and then I add things back in, I have to put that on the
label?
Dr. Sharfstein. That is what I am understanding.
Mr. Walden. OK. I want to ask about the DEHP issue. In your
testimony, you state the FDA has decided to move forward on
making a decision on DEHP. Can you elaborate on this and tell
us when we can expect a ruling? That is actually what I hear.
If I hear anything about bottled water, it is about this
discussion about what is in the plastic.
Dr. Sharfstein. This is where it gets a little bit
confusing, but basically in the mid-1990s when this was
originally done and this particular chemical was deferred. The
reason it was deferred is because it had been marketed prior to
1958 and had a special grandfather-like provision as a food
additive, and it was thought that it was in plastic and
therefore this provision of the law that we are talking about
conflicted with another provision of the law. Our understanding
has changed since that time. In fact, we don't believe that it
is being used in water bottles or water caps right now, and as
a result of that, the concern that existed--and I am a
pediatrician and not a lawyer--basically the legal conflict
that was of concern in the mid-1990s is not of concern now and
that we can move forward and basically testing whether or not
there is a reason to--there has to be an affirmative reason not
to have the same standard as municipal water so, you know, my
presumption would be that we will move forward with the
standard for DEHP like we have for all the other contaminants.
What held it up before was really the grandfather legal issue,
and I think that that may not apply anymore and we can move
forward.
Mr. Walden. But I want to get to sort of the heart of the
matters for the people I represent. You are telling me that
plastic in the cap here doesn't have the phthalate?
Dr. Sharfstein. In our communications with industry, as I
understand, we do not believe that this is regularly used in--
--
Mr. Walden. Mr. Doss, can you speak to this issue?
Mr. Doss. I can. It is my understanding that none of the
plastic containers used for bottled water contain DEHP at all,
not the PET, not the polycarbonate, not the HDPE. So none of
the bottled water containers contain any DEHP. However, the
International Bottled Water Association for purposes of parity
several years ago, we have a standard in our model code that is
exactly the same as the EPA, more for parity reasons, but none
of the plastic containers used for bottled water contain DEHP.
Mr. Walden. From your knowledge, does that apply also to
Dr. Burgess's Pepsi bottle there and other bottles used for
sodas?
Mr. Doss. If they are using PET, which I believe most are,
if they are using polycarbonate or HDPE, which are the three
primary uses for all beverage products, then there is no DEHP
in them.
Dr. Sharfstein. So the DEHP issue is really, is it in the
water separately just because it is in the environment and, you
know, that----
Mr. Stupak. Is there a number that you use for DEHP like
PET has a number 1 on it, and that is what this one is here.
But there is usually a symbol. Is there a symbol that if you
use DEHP in a plastic----
Dr. Sharfstein. I will have to get back to you on that.
Ms. Houlihan. Can I also add----
Mr. Walden. Go ahead. I actually have another question,
though, I want to get to.
Ms. Houlihan. The food contact notifications that EPA has
approved show at least 100 different other kinds of plastic
additives that could leach into the water, so this is a problem
that is much bigger than DEHP.
Mr. Stupak. Go ahead, Mr. Walden.
Mr. Walden. I just wanted to get to another point because
we are so focused, and I realize that is the focus of the
hearing is on bottled water and where that water comes from and
all of that, but I am sitting here thinking, if I buy orange
juice in a carton that is made from concentrate, what percent
of that is water? It has to be a huge percent, right? Because
we are adding water in and then the concentrate. And if the
issue here is the quality of the water and the source of the
water going into what we consume, then it seems to me we are
kind of myopic here just looking at bottled water because
somebody doesn't like bottled water or presumes that it has a
higher sort of threshold in our minds about purity. I would
suggest that a lot of us drink orange juice thinking that is
better than perhaps bottled water because you get other--no
offense, but you get other things with it, and yet I am
thinking 80 percent, 90 percent of what I am getting in the
carton of orange juice unless it is, you know, fresh squeezed
only, not from concentrate, is probably water. And so from the
FDA's standpoint, do you look at the water that goes into that?
Dr. Sharfstein. That is part of what makes food safe is the
water and they need to meet food safety requirements, and----
Mr. Walden. And that is the same thing you apply to the
bottled water, right?
Dr. Sharfstein. It is more we apply to the bottled water
because we----
Mr. Walden. OK.
Dr. Sharfstein. So as I was saying before, a lot of this is
compared to what--if you are comparing bottled water to other
foods or other foods that contain water, there are additional
regulations that apply. If you are comparing it to municipal
water, then there is more disclosure on municipal water than
there is on bottled water.
Mr. Walden. Well, I----
Dr. Sharfstein. It is just your point of comparison.
Mr. Walden. Yes, but I guess the question would be, where
is that disclosure? I mean, I have never even--at least there
is something on this label. In my hometown of Hood River, we
have it out of a spring but I don't get a notice on my tap or
on my water bill, or here in the District of Columbia, for
heaven's sake, I mean, what it runs through to come out of my
tap is scary. That is why I put a filter on the end and then
refilter it in another deal and, you know, all of that. So
anyway, I am over my time. I am done. Thank you.
Mr. Stupak. So you get from a municipal water supply and
you don't get a notice every year? We get a letter, seriously.
Mr. Walden. Probably. And I rush out to my mailbox to read
it.
Mr. Stupak. OK.
Mr. Walden. And, you know, it is like the sewer notice I
get here. It tells me that when it rains they inflate these
inflatable things to keep the sewage from rushing out into the
Potomac unless it rains too much and then they deflate them
because they cause too much problems. But that is a whole other
issue.
Mr. Stupak. No, we don't want them releasing untreated
sewage in our waters, that is for sure.
Mrs. Christensen.
Mrs. Christensen. Thank you, Mr. Chairman.
Mr. Stephenson, I note that in your report the surveys were
done in the 50 States and the District of Columbia. Any reason
why the territories are not included or are they generally not
included in surveys done by GAO?
Mr. Stephenson. No, no particular reason, just the
methodology we chose.
Mrs. Christensen. But they are not generally excluded
just----
Mr. Stephenson. No.
Mrs. Christensen [continuing]. That in this particular----
Mr. Stephenson. No, a limited amount of time, a limited
amount of resources dictated 50 States and the District of
Columbia.
Mrs. Christensen. And Dr. Sharfstein, in your testimony you
say that FDA has broad authority over food that is introduced
or delivered in interstate commerce. So if it is just within a
state or within a territory, FDA doesn't have any jurisdiction
or do you work with the States then and the territories?
Dr. Sharfstein. That actually is a pretty broad statement
because if the bottle comes from outside the State or the cap
comes from outside the State, even if it is just sold within
the State, it counts as interstate, and there is a presumption,
I understand, that it would be interstate, but in theory there
might be products that could be challenged, our authority over
them, although I am not aware that we heard about a problem
that we haven't been able to get to either directly or through
the State.
Mrs. Christensen. Mr. Stephenson, we have talked a lot
about whether bottled water is safer and healthier and there is
disagreement on that but there is no disagreement on the fact
that bottled water uses more energy to produce and deliver. On
page 26 of your report, there is a quite amazing statistic
where you refer to a study by the Pacific Institute which
examined how much energy it takes to bring bottled water from
different locations throughout the world to L.A., and in your
report this is what it says. ``The Institute estimated that the
total energy required to bring a typical one-liter bottle of
water weighing about 38 grams to a consumer in Los Angeles
would typically range from about 1,100 to 2,000 times the
energy cost of producing tap water.
Mr. Stephenson. That is true.
Mrs. Christensen. So if I drink a single bottle of Evian or
Fiji or some other bottled water, which I may not ever drink
again, from overseas, I could be using up to 2,000 times more
energy than if I just walked over to my sink and filled up a
glass?
Mr. Stephenson. That is true. The import bottled water
accounts for a very small percentage of the total bottled water
but that is true.
Mrs. Christensen. I see. OK. The study cited in the GAO
report also describes how transporting these bottles can be the
single biggest cost. According to that study, transportation
energy costs can be as high as 57 percent of the total energy
costs for spring water bottled in France, transported overseas
by cargo ship and transported by rail from the eastern United
States to Los Angeles.
Mr. Stephenson. That is correct.
Mrs. Christensen. Your report also has some other findings
related. For example, you concluded that most plastic water
bottles are discarded rather than recycled.
Mr. Stephenson. Yes, we estimate 25 percent are recycled,
so 75 percent are discarded.
Mrs. Christensen. So Ms. Houlihan, how did we get here? Why
do consumers pay so much, hundreds of times more for bottled
water, taking thousands of times more energy to produce?
Ms. Houlihan. You heard some of the marketing claims that
are used by the industry and I think a lot of people are under
a misperception that bottled water must be safer than tap
water. A lot of people believe that it is free of contaminants.
In fact by law, it is not required to be any safer than tap
water. When we tested 10 major brands of bottled water, we
found 38 different pollutants, everything from disinfection
byproducts to radioactive isotopes, even traces of Tylenol and
fertilizer residues. So one thing that we need when it comes to
the bottled water industry is just more daylight, information
for consumers on where that water comes from, how it is treated
and what is in it.
Mrs. Christensen. I think it is really important for the
information to be there so that people can make knowledgeable
judgment.
I certainly understand that bottles are convenient, but if
we are going to use them, isn't there a better way than going
into the landfill. This bottle of water is bottled in Virginia
and is transported just a few miles from here to the Capitol
and it is biodegradable. Mr. Doss, you represent the bottled
water companies. How many of them are using biodegradable
bottles?
Mr. Doss. I am not sure exactly how many are using
biodegradable bottles but I will say that as a general
statement that bottled water companies like other food industry
companies are trying to do whatever they can to reduce their
environmental footprint. Obviously, going to bottles such as
those is one way of doing it. We have made significant efforts
to lightweight the bottled water containers. Anyone who drinks
bottled water knows these days they are much lighter weight
which uses less plastic. We also have some of our companies
that are using recycled content, less virgin materials. So
bottled water is trying to do what it can to reduce the
environmental footprint, but I think it is important to
recognize that bottled water is just one of thousands of food
products on the market in plastic, and in fact, we are only
one-third of 1 percent, as reported in the GAO report, of the
entire waste stream in the United States so I think that any
efforts to reduce the environmental impact of packaging has to
focus more broadly on all consumer goods.
Mrs. Christensen. Absolutely. Thank you for your answers.
Mr. Stupak. Thank you.
Mr. Burgess, let us get 5 minutes in before we have to go
for votes.
Mr. Burgess. Great. Thank you.
Dr. Sharfstein, just to follow up a little bit on what Mr.
Walden was talking about on the lawsuit with the phthalate DEHP
that has been held up. I think Mr. Stupak referenced it has
been 15 years in the making. You are now prepared to issue a
ruling in September. Do I understand that correctly, on DEHP?
The FDA is prepared to go ahead with that ruling now or is
that----
Dr. Sharfstein. So there is questions whether we set a
standard for bottled water, and our intent is to proceed with
setting a standard for bottled water. That is just a matter of
preparing the standard, getting it going. If we come across
some reason why this doesn't apply to bottled water at all, we
are permitted to make the statement that it doesn't apply to
bottled water at all but it is not obvious to us there is such
a compelling reason at this point, so we would anticipate then
going forward and setting a standard. So at that point is just
as long as it takes to do. What is in the law, and this gets,
you know, there is a 180-day standard in the law which is that
if EPA sets the standard, FDA needs to set a standard at least
180 days before so that it can take effect at the same time as
the EPA standard. But with this one where they waited so long
because of this legal thing, that is sort of out the window. It
doesn't really apply because the EPA's standard went into
effect so long ago. So really, we would just like to do it in a
reasonable time frame.
Mr. Burgess. And at this point, any preview, any look ahead
as to what that standard may be?
Dr. Sharfstein. Sure. It would just be the--if we were to
do it, it would be the same standard that EPA has unless we had
a really good reason otherwise, but that would be the
assumption, just like we have done for almost all the other
contaminants, the same standard as EPA.
Mr. Burgess. Mr. Chairman, on the issue of the high risk,
low risk, apparently there was a ruling issued by the FDA in
2005 in the risk assessment, and I have a copy of that. With
your permission, we will make that available to the committee
for its consideration and adding it to the record.
And then finally, let me just ask a question about
recycling, and really this is for everyone on the panel, about
the compounds leaching out of the plastic in greater amounts in
recycled materials than native or first-run materials. So is
that a real concern for us to have? Are there going to be
different standards for the recycled bottles or should there be
different standards? Do consumers need to be aware of any
difference between a recycled bottle and a first-run bottle?
Ms. Houlihan. We looked at FDA reviews of additives in
plastic and found that there are over different compounds that
could leach out of plastic, so the question you have raised is
a very important question and we think not only do recycled
bottles need to be more closely inspected and tested with
regard to that but also new bottles, what is coming out of the
plastic into waters, and that kind of testing is not required.
We fully support the greater rates of recycling in industry.
That is just a smart move overall.
Mr. Burgess. Is there another secondary use for the
recycled plastic water bottle other than re-creating another
plastic water bottle? Can they be used in building materials or
is there any other use for these bottles?
Ms. Houlihan. That is a fabulous question, and I think we
are creative enough in this country to come up with other uses
that don't involve direct contact with water.
Mr. Burgess. Mr. Doss, do you have an opinion?
Mr. Doss. I don't know anything specifically about the
issue you just raised but I do know that FDA has to clear all
contact packaging materials. So if FDA clears it, then the
manufacturer is able to use it and they have made the
determination that they are safe to use.
Mr. Burgess. So we come to Dr. Sharfstein.
Dr. Sharfstein. There has got to be a standard of safety.
Whether it is recycled or not recycled, there has got to be a
standard of safety, and so that is what FDA enforces, and
understanding in light of, you know, new evidence that comes
out about the particular substances and the latest science and
the different concerns people have, FDA's job is to weigh that,
but at the end of the day, it has to be a standard of safety
and it has got to apply no matter what is in the package.
Mr. Burgess. So where are we right now with the issue of
recycling? Should consumers be concerned about buying bottled
water in a recycled product? Are you testing these products
currently, or even are there any available?
Dr. Sharfstein. Well, we test the water, you know. When we
test water, it could be from a recycled bottle or not, but I am
not aware of any special concerns for recycled plastic but I
think if there are concerns people have they should share them
with the agency.
Mr. Burgess. And I guess I don't really even know enough to
know whether these recycled materials are then broken down and
reconstituted or do we just simply wash out the bottle and put
a new cap on it. But, I mean, obviously the push is to recycle
so we are going to be seeing more of these products on our
shelves and in our stores.
Dr. Sharfstein. I think you are illustrating why the job is
so challenging because products change and FDA has to be up on
them so we can enforce the same basic safety standards.
Mr. Burgess. Thank you, Mr. Chairman.
Mr. Stupak. Thanks, Mr. Burgess.
Just one last question and we will close the hearing. Mr.
Stephenson, in your GAO report that we talked about today about
consumer confidence reports, and in 1996 Congress directed the
FDA to assess the feasibility of providing bottled water to
consumers with the functional equivalent of a consumer
confidence report, and according to your GAO report that is
released today, on August 25, 2000, FDA concluded that it would
be feasible to provide consumers with some of the information
contained in the consumer confidence report directly on a
bottle label and access the remaining information through an
address or phone number, and that is tab number 3 there in the
document. Is that correct?
Mr. Stephenson. Yes, that is right.
Mr. Stupak. So Mr. Doss, any reason why your organization
would object to that or do you think we should have a consumer
confidence report for bottled water?
Mr. Doss. Well, as I think was reported in their study,
they did say it was feasible. They didn't exactly say what was
feasible to put on the label. I think they were quite skeptical
of putting some of the contaminants, et cetera on the label
because it would just clutter the label. Now, as I said before,
I think that the bottom line for us that consumers ought to be
able to get information and we think that a telephone number,
call the company and request that information is the best way
to do it and almost all bottled waters currently as well as
other food products have a phone number at least that a
consumer could call the company and say could you send me the
information and that information should be sent, and if it
isn't, I would say go find another product to buy.
Mr. Stupak. So you don't mind the phone number but you
don't want any other information?
Mr. Doss. We don't.
Mr. Stephenson. Mr. Chairman, I think there needs to be
some specificity in what is going to be required in those
confidence reports. When were checking labels and Web sites, it
was very difficult to get the kind of information we were----
Mr. Stupak. Sure. Your report didn't say put the whole
report on the bottle.
Mr. Stephenson. It doesn't have to be on the label.
Mr. Stupak. Just that some information should be on there
and there should at least a phone number to back it up if you
want further information.
Mr. Stephenson. That is right.
Mr. Stupak. Well, that concludes all of our questioning. I
want to thank all of our witnesses for coming today and for
your testimony.
The committee rules provide that members have 10 days to
submit additional questions for the record. That concludes our
hearing. This meeting of the subcommittee is adjourned.
[Whereupon, at 12:00 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]