    [Senate Hearing 109-741]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 109-741

                       S. 3128: THE NATIONAL UNIFORMITY
                                  FOR FOOD ACT

    =======================================================================

                                    HEARING

                                     OF THE

                        COMMITTEE ON HEALTH, EDUCATION,
                              LABOR, AND PENSIONS
                              UNITED STATES SENATE

                           ONE HUNDRED NINTH CONGRESS

                                 SECOND SESSION

                                       ON

    EXAMINING S. 3128, TO AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT TO
       PROVIDE FOR UNIFORM FOOD SAFETY WARNING NOTIFICATION REQUIREMENTS

                                   __________

                                 JULY 27, 2006

                                   __________

     Printed for the use of the Committee on Health, Education, Labor, and
                                    Pensions

      Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                                     senate

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              COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                       MICHAEL B. ENZI, Wyoming, Chairman

    JUDD GREGG, New Hampshire            EDWARD M. KENNEDY, Massachusetts
    BILL FRIST, Tennessee                CHRISTOPHER J. DODD, Connecticut
    LAMAR ALEXANDER, Tennessee           TOM HARKIN, Iowa
    RICHARD BURR, North Carolina         BARBARA A. MIKULSKI, Maryland
    JOHNNY ISAKSON, Georgia              JAMES M. JEFFORDS (I), Vermont
    MIKE DeWINE, Ohio                    JEFF BINGAMAN, New Mexico
    JOHN ENSIGN, Nevada                  PATTY MURRAY, Washington
    ORRIN G. HATCH, Utah                 JACK REED, Rhode Island
    JEFF SESSIONS, Alabama               HILLARY RODHAM CLINTON, New York
    PAT ROBERTS, Kansas

                   Katherine Brunett McGuire, Staff Director

          J. Michael Myers, Minority Staff Director and Chief Counsel

                                      (ii)

                                C O N T E N T S

                                   __________

                                   STATEMENTS

                            THURSDAY, JULY 27, 2006

                                                                       Page
    Enzi, Hon. Michael B., Chairman, Committee on Health, Education,
      Labor, and Pensions, opening statement.........................     1
    Burr, Hon. Richard, a U.S. Senator from the State of North
      Carolina, opening statement....................................     2
        Prepared statement...........................................     4
    Feinstein, Hon. Dianne, a U.S. Senator from the State of
      California, opening statement..................................     6
        Prepared statement...........................................     7
    Boxer, Hon. Barbara, a U.S. Senator from the State of California,
      opening statement..............................................     9
        Prepared statement...........................................    10
    Chambliss, Hon. Saxby, a U.S. Senator from the State of Georgia,
      opening statement..............................................    13
        Prepared statement...........................................    14
    Roberts, Hon. Pat, a U.S. Senator from the State of Kansas,
      opening statement..............................................    15
    Stadtlander, William, Owner, Homestat Foods, Dublin, Ohio........    19
        Prepared statement...........................................    21
    Hutt, Peter Barton, Senior Counsel, Covington and Burling,
      Washington, DC.................................................    23
        Prepared statement...........................................    24
    Murano, Elsa A., Dean, College of Agriculture and Life Sciences,
      Texas A&M University, College Station, TX......................    30
        Prepared statement...........................................    32
    Hubbard, William K., Former Associate Commissioner for Policy,
      Food and Drug Administration, Chapel Hill, NC..................    36
        Prepared statement...........................................    38

                              ADDITIONAL MATERIAL

    Statements, articles, publications, letters, etc.:
        Senator Kennedy..............................................    52
        Senator Hatch................................................    53
        Senator Jeffords.............................................    54
        Senator Nelson...............................................    54
        Leslie G. Sarasin............................................    55
        Thomas R. Frieden............................................    56
        Benjamin Cohen...............................................    59
        Response to Questions of Senator Jeffords by Panel II........    86
        Response to Questions of Senators Enzi, Kennedy, and Reed by
          William Stadtlander........................................    87
        Response to Questions of Senators Enzi, Kennedy, Harkin,
      Reed, and
          Clinton by:
            Peter Barton Hutt........................................    90
            Elsa A. Murano...........................................   109
        Response to Questions of Senators Enzi, Kennedy, Harkin, and
          Reed by William K. Hubbard.................................   111
        Letters of Support...........................................   116
        Letters of Opposition........................................   123

                                     (iii)

                       S. 3128: THE NATIONAL UNIFORMITY
                                  FOR FOOD ACT

                                  ----------

                            THURSDAY, JULY 27, 2006

                                           U.S. Senate,
           Committee on Health, Education, Labor, and Pensions,
                                                        Washington, DC.
        The committee met, pursuant to notice, at 10:00 a.m. in
    Room SD-430, Dirksen Senate Office Building, Washington, DC.,
    Hon. Michael B. Enzi, chairman of the committee, presiding.
        Present: Senators Enzi, Burr, Isakson, Feinstein, Boxer,
    Chambliss, and Roberts.

                       Opening Statement of Senator Enzi

        The Chairman. Good morning and welcome to this hearing on
    food safety standards and warning requirements. Today's hearing
    will help the committee understand how the National Uniformity
    for Food Act might affect food safety across our Nation. In
    looking at foods, we see that nutrition labeling is nationally
    uniform, health claims are nationally uniform, and allergen
    labeling is nationally uniform. As a result, consumers have
    consistent science-based information about these products. Yet
    warning labels and other notifications vary from State to
    State. How do I as a consumer use these different warnings to
    make good decisions in food choices? What do I do if benefit
    information is always the same but the risk information is
    different, depending on where I live? Can a loaf of bread be
    more dangerous in California than the same loaf in Wyoming or
    Massachusetts? The bill before us today, the National
    Uniformity for Food Act, would create a uniform, national
    system of food safety standards and warning requirements. The
    bill would create this system by preempting State laws
    regarding food warning labels and tolerances. The bill provides
    that where FDA has acted by setting a safety standard for a
    food ingredient, the States would adopt and enforce the same
    standard. If FDA has not set a safety standard for a particular
    substance in food, the States would remain free to set and
    enforce their own standards. The bill would also provide for
    national uniformity in product warnings. States would not be
    permitted to require a warning in labeling, advertising, or any
    other form of public communication if that warning differs from
    that imposed under Federal law. States would remain free to
    issue their own public warnings under State laws. Under the
    bill, a State with the requirement that differs from a related
    Federal requirement could petition the FDA either to adopt the
    requirement as a national requirement or exempt it from the
    requirement of uniformity. FDA's decisions on State petitions
    would occur only after public input. The bill before us seeks
    consistency in substantive standards between State and Federal
    requirements. It does not address how requirements are
    enforced. The State requirements and authorities for handling
    potentially hazardous foods, sanitation, date marking and
    related issues would not be effected by the legislation. The
    bill also would preserve the authority of the States to act if
    a food presents an imminent hazard. Today the States inspect
    most food manufacturing establishments. This bill would not
    change the partnership between FDA and State authorities in
    food safety. In fact, just last week, FDA announced a program
    to create uniform standards for the multi-level inspection
    program. FDA worked with State food regulators to create the
    draft uniform standards. This is exactly the sort of thing that
    should be happening. When it comes to drugs, we've been talking
    a lot lately about how important it is to weigh risks and
    benefits together. Senator Kennedy and I agree on this, yet
    while half of all Americans take at least one prescription drug
    daily, every one of us eats daily. So we're all affected by the
    actions that our Federal and State Governments take in
    regulating food safety standards. The bill before us raises
    important questions and here are just a few: Why should we
    weigh risks and benefits together when it comes to drugs but
    separately by State when it comes to food? Why should we charge
    the FDA with regulating the positive information about foods
    but leave decisions about warnings and tolerances to the
    States? And do consumers really benefit from the 50-state
    hodge-podge of different warnings and labelings on these
    products? I hope this hearing will help us answer these
    questions as we consider the National Uniformity for Food Act
    and I appreciate our colleagues who are here to testify today.
    I have to apologize, I have to go to a mark-up of the Small
    Business Committee. We've got a couple of small business issues
    in Wyoming since that is all we have in Wyoming--small
    businesses.
        So I'll turn the gavel over to Chairman Burr.

                       Opening Statement of Senator Burr

        Senator Burr [presiding]. Thank you, Mr. Chairman. I want
    to thank you before you leave for holding this hearing on
    uniformity and I want to welcome our colleagues. This is the
    way it is supposed to work. I sponsored this legislation in the
    105th Congress. I never dreamed that I would be in this
    institution, the U.S. Senate, but I also never dreamed that it
    would take this long to bring what I thought was common sense
    legislation to this country.
        I believe consumers should be able to make informed
    decisions about foods they purchase. As a Nation, we have
    uniform nutrition labeling and with S. 3128, we would have
    uniform warning labels as well. This legislation provides for a
    national, uniform and scientific approach to food safety
    regulation and it provides for consideration of State Food
    Safety requirements as national requirements.
        This food uniformity legislation has been carefully crafted
    over many years to help ensure our system of food regulation
    remains the gold standard of the world. Currently, the Food and
    Drug Administration is widely recognized as the preeminent food
    regulatory agency. This bill we discuss today will build on
    that strength and help make our food regulatory system even
    stronger.
        The intention behind this uniformity legislation is quite
    simple. It is to provide strong and consistent national
    regulations to ensure the quality of our country's food supply.
    Right now, our system of food regulation involves actions not
    just by the FDA but States and localities as well. Each of
    those entities has an important role to play in ensuring the
    quality and the safety of our food supply.
        Historically, the FDA has established standards to
    determine when food is safe and has established national
    requirements for food labeling. The FDA conducts some
    inspections of food facilities and participates in standard
    setting that occurs at a multinational level. State and local
    governments have historically inspected food facilities, in
    fact, often under a contract with the FDA and they play an
    important role in shellfish and dairy product safety, in
    retail, local restaurants and food service safety.
        This uniformity legislation preserves and protects these
    important roles. Let me be clear. S. 3128 does not change any
    of these roles and functions, but I believe inconsistent, often
    conflicting and often nonscience-based requirements and
    warnings imposed at the State or local level--those also not
    supported by the FDA--create confusion for consumers and
    unnecessarily increase production costs for thousands of food
    manufacturers across the country.
        In order to simplify the process, the bill provides for a
    single national standard on food adulteration and a system of
    determining whether food labels should bear particular warning
    labels. Clearly, we should rely on the FDA to make the final
    determination as to when food is adulterated and when food
    should bear a warning statement.
        When a warning about food is supported by science and it is
    necessary to help consumers make informed decisions about the
    foods they purchase and consume--that warning should be applied
    to the food items sold in all 50 States. This bill achieves
    that result. I would respectfully suggest that if food is safe
    to be sold in one State or 20 States or 30 States, it should be
    safe in all 50 States. Likewise, if a warning is needed, surely
    that warning should be shared with consumers in all 50 States.
        The concept of a national system for food adulteration,
    including warnings, is not new. In fact, the absence of
    uniformity between Federal and State food systems is an
    exception. For example, current law provides for uniformity in
    the regulation of meat and poultry products, pesticide
    residues, nutrition labeling, health claims and standards of
    identity. The uniformity bill before us is built on many years
    of uniform food regulation experience.
        As I've said before, States play an important role in
    enforcing food safety requirements. States do this through
    inspection of food facilities and embargoing contaminated
    products. Under this legislation, States will continue to be in
    charge of inspections to enhance basic sanitation requirements
    in places such as restaurants, retail food stores, shellfish
    processors, and dairy farms. Recognizing this important role,
    unlike other uniformity bills considered by Congress, S. 3128
    enables States to petition the FDA to consider potential
    Federal requirements of any food adulteration requirements
    under the State law that, on the date of enactment, does not
    have a Federal counterpart and in this proposed process the
    State requirement remains in effect. Let me repeat that.
    Remains in effect until the FDA takes action on the State
    petition. Not only does the legislation provide for uniformity
    but it also includes a predictable process by which all
    existing State Food Adulteration requirements can be considered
    for adoption at the Federal level by the FDA.
        I believe S. 3128 will ensure that food sold in this
    country is subject to a single contemporary standard that will
    benefit consumers. Again, I thank our colleagues for their
    willingness to come and at this time, the Chair recognizes the
    Senator from Kansas, for any statement you might like to make.
        [The prepared statement of Senator Burr follows:]

                       Prepared Statement of Senator Burr

        Thank you, Chairman Enzi and Senator Kennedy, for holding a
    hearing on S. 3128, the National Uniformity for Food Act. I am
    proud to be the lead sponsor of S. 3128. I have sponsored
    legislation on this issue since the 105th Congress. I can
    assure you that back then I did not know I would be a member of
    the Senate HELP Committee participating in a hearing on this
    bill in the 109th Congress!
        I believe consumers should be able to make informed
    decisions about the foods they purchase. As a Nation, we have
    uniform nutrition labeling, and with S. 3128 we would have
    uniform warning labeling as well. This legislation provides for
    a national, uniform, and scientific approach to food safety
    regulation and it provides for consideration of State food
    safety requirements as national requirements as well.
        This food uniformity legislation has been carefully crafted
    over many years to help ensure our system of food regulation
    remains the gold standard of the world. Currently, the Food and
    Drug Administration is widely recognized as the pre-eminent
    food regulatory agency. The bill we are discussing today will
    build on that strength and help make our food regulatory system
    even stronger.
        The intention behind this uniformity legislation is simple.
    It is to provide for strong and consistent national regulations
    to ensure the quality of our country's food supply. Right now
    our system of food regulation involves actions not just by the
    FDA, but States and localities as well. Each of those entities
    has an important role to play in ensuring the quality and
    safety of our food supply.
        Historically, the FDA has established standards to
    determine when food is safe and has established national
    requirements for food labeling. The FDA conducts some
    inspections of food facilities and participates in standard
    setting that occurs at a multinational level. State and local
    governments have historically inspected food facilities (in
    fact, often under contract with the FDA), and play an important
    role in shellfish and dairy product safety, and retail, local
    restaurant and food service safety.
        This uniformity legislation certainly preserves and
    protects these important roles. Let me be very clear--S. 3128
    does not change any of these roles and functions. But I believe
    inconsistent, often conflicting, and nonscience-based
    requirements and warnings imposed at the State or local level--
    those also not supported by the FDA--create confusion for
    consumers and unnecessarily increase production costs for
    thousands of food manufacturers across our country.
        In order to simplify the process, the bill provides for a
    single national standard on food adulteration and a system of
    determining whether food labels should bear particular warning
    statements. Clearly, we should rely on the FDA to make the
    final determination as to when food is adulterated and when
    food should bear a warning statement.
        When a warning about food is supported by science and is
    necessary to help consumers make informed decisions about the
    foods they purchase and consume, that warning should be applied
    to that food item sold in all 50 States. This bill achieves
    that result. I would respectfully suggest that if food is safe
    to be sold in one State, or 20 States, or 30 States, it should
    be safe in all 50 States. Likewise, if a warning is needed,
    surely that warning should be shared with consumers in all 50
    States.
        The concept of a national system for food adulteration,
    including warnings, is not new. In fact, the absence of
    uniformity between the Federal and State food systems is an
    exception. For example, current law provides for uniformity in
    the regulation of meat and poultry products, pesticide
    residues, nutrition labeling, health claims, and standards of
    identity. The uniformity bill before us is built on many years
    of uniform food regulation experience.
        As I have said before, States play an important role in
    enforcing food safety requirements. States do this through
    inspections of food facilities and embargoing contaminated
    products. Under this legislation, States will continue to be in
    charge of inspections to enforce basic sanitation requirements
    in places such as restaurants, retail food stores, shellfish
    processors, and dairy farms. Recognizing this important role,
    unlike other uniformity bills considered by Congress, S. 3128
    enables States to petition the FDA to consider potential
    Federal requirements of any food adulteration-related
    requirement under State law that, on the date of enactment,
    does not have a Federal counterpart. And, in this proposed
    process, the State requirement remains in effect until FDA
    takes action on the State petition. Not only does the
    legislation provide for uniformity, but it also includes a
    predictable process by which all existing State food
    adulteration requirements can be considered for adoption at the
    Federal level by the FDA.
        I believe S. 3128 will ensure that food sold in this
    country is subject to a single contemporary standard that will
    benefit consumers. Again, I thank the Chairman for having this
    hearing today. Thank you and I look forward to the witnesses'
    testimony.
        Senator Roberts. Mr. Chairman, I know that there are
    Senators on the panel who have time schedules as I do and I'm
    going to reserve my statement. I want to thank you for yours
    and I want to thank you for your leadership in this regard but
    I hope I can be recognized after the panelists make their
    statements. I know they are eager to go on to their other
    duties so I will yield at this time.
        Senator Burr. Does the Senator from Georgia have----
        Senator Isakson. I would like to publicly acknowledge the
    hard work over four Congresses, by the Senator from North
    Carolina on this issue. I appreciate his dedication to it and
    appreciate the members of the Senate being here to testify
    today.
        Senator Burr. I'd like to welcome our three distinguished
    colleagues to the committee today, Senator Saxby Chambliss of
    Georgia, Senator Barbara Boxer from California, and Senator
    Diane Feinstein from California. I appreciate all of your
    longstanding interest in food uniformity, your willingness to
    appear before the committee and as would be a southern custom,
    we would start with our Senator from California, Senator
    Feinstein.

                     Opening Statement of Senator Feinstein

        Senator Feinstein. Thank you very much, Mr. Chairman. I
    appreciate the committee holding this hearing. I appreciate my
    colleague from California being here. Mr. Chairman, I must say
    that both of us are strongly opposed to this bill as is our
    Governor, Governor Schwarzenegger and others. I believe this
    bill would have a very deleterious effect on the people that we
    represent and that's 37.2 million Californians. I think it has
    to be looked at, that California is as big in population as 21
    States and the District of Columbia put together. It is a huge
    consumer market and 17 years ago, the State passed an
    initiative known as Proposition 65. It passed with 63 percent
    of the vote and the product of 65 was to impose separate and
    distinct warning requirements for known carcinogens in consumer
    products. I must say that since that time, having been in
    public life, I have never had a single complaint from anybody
    about Proposition 65 and I very much doubt that my colleagues
    has either. There is strong bipartisan opposition to these
    proposed measures. Not only our Governor but the Governors of
    seven other States, the attorneys general of 39 States, the
    Association of Food and Drug Officials, the State Departments
    of Agriculture, Consumers Union and Rumors National Consumer
    and Environmental groups oppose pre-empting State and local
    Food Safety requirements. This legislation would pre-empt over
    200 of these Food Safety State laws and regulations nationwide
    and they would impede States and localities from enacting and
    implementing food safety regulations stronger than those
    required by the Federal Government, even if that authority is
    needed to respond quickly to an incident, such as an act of
    bioterrorism. This bill is a major assault on California's
    initiative and it would cancel out major benefits under the law
    that protects California consumers from cancer-causing
    chemicals to lead and arsenic poisoning.
        Let me give you a few examples. This year, the State used
    Proposition 65 to stop Pepsi from selling soda bottles with
    leaded labels, which can cause birth defects and cancer. With
    respect to lead in ceramic tableware, California required clear
    warnings for lead that leeches from ceramic tableware into food
    and beverages. The marketplace has responded. Now these
    ceramics have disappeared from shelves. Lead and calcium
    supplements--makers of calcium supplements such as Tums and
    Rolaids, agreed to reduce levels of lead contamination in their
    products. This result was reached without posting warnings that
    might have discouraged women from taking calcium. Leaded
    crystal, fully leaded crystal, especially when used for storage
    of beverages, leeches substantial amounts of lead. California
    requires point of sale signs while FDA has provided a consumer
    advisory. Mercury in fish--California requires that information
    be posted in stores where fresh fish is sold, warning pregnant
    women about the high levels of mercury in seafood and it would
    no longer be able to do so. As you can see, this bill, in just
    these ways that I've elucidated, undermines California's
    Proposition 65 and this is not the first assault on California
    law. Earlier, similar efforts to overturn Proposition 65 and
    pre-empt State and local food safety laws, have been opposed by
    people on both sides of the isle. For example, the Reagan
    administration conducted an economic analysis of the impact of
    Proposition 65 in 1988, which the first President Bush
    concurred with and that found that industry's claims that
    Proposition 65's financial burden ``vast overstate the
    potential impact on producers.'' Mr. Chairman, I think what I
    want to say is that on behalf of my colleague, Senator Boxer
    and I, if this bill were to come to the floor, we would use
    every parliamentary device available to us to stop it. We both
    strongly oppose this bill. Thank you very much.
        [The prepared statement of Senator Feinstein follows:]

                    Prepared Statement of Senator Feinstein

        Mr. Chairman, thank you very much for holding this hearing
    today.
        I hope that this hearing--the first to be held on this
    issue--will clarify the major negative impact of establishing
    uniform requirements for food safety warning labels nationwide.
        This legislation effectively cancels strong food safety
    laws approved by State and local governments, such as
    California's Proposition 65 (``Safe Drinking Water and Toxic
    Enforcement Act'') enacted into law 17 years ago by 63 percent
    of Californians.
        This Senate bill (S. 3128), like the house-passed bill,
    undermines hundreds of important food safety laws across the
    country. And it sets a dangerous precedent undermining States'
    rights.
        There is strong bipartisan opposition to these proposed
    measures. Governors of eight States, including Governor
    Schwarzenegger, Attorneys General of 39 States, the Association
    of Food and Drug Officials, State Departments of Agriculture,
    Consumers Union and numerous national consumer and
    environmental groups oppose preempting State and local food
    safety requirements.
        This Senate bill would:

         Preempt over 200 food safety State laws and
    regulations nationwide.
         Impede States and localities from enacting and
    implementing food safety regulations stronger than those
    required by the Federal Government, even if that authority is
    needed to respond quickly to an incident such as an act of
    bioterrorism.
         Threaten laws passed by California and at least
    eight other States limiting the sale of sodas and junk food in
    public schools aimed to promote healthy eating habits for
    children.
        In September 2005, Governor Schwarzenegger signed two bills
    (one bill which takes effect in July 2007) restricting certain
    foods and beverages from being sold in California's public
    schools so that children are not exposed, for example, to such
    high levels of sugar in their food and beverages that
    contribute to the major issue of child obesity.
         Prohibit States, like California, to issue their
    own mercury warnings to pregnant women about the significant
    risks from high levels of mercury in seafood such as swordfish
    and shark. California requires that signs be posted in grocery
    stores where fresh fish is sold warning pregnant women about
    the high levels of mercury in seafood and would not be able to
    continue to post these warning signs that protect consumers.
         Force States to petition the FDA to maintain
    important food safety laws, imposing major financial burdens on
    the financially-strapped FDA and States. The Center for Science
    in the Public Interest estimates it will cost FDA at least $120
    million to process the expected 300 waiver requests just for
    Proposition 65 (i.e. waivers for lead in calcium supplements
    and arsenic in bottle water).

        This bill is a major assault on California's Proposition 65
    and would cancel out major benefits under the law that protect
    California consumers from cancer causing chemicals to lead and
    arsenic poisoning.

        Here are just a few examples:

         This year, the State used Proposition 65 to stop
    Pepsi from selling soda bottles with leaded labels which can
    cause birth defects and cancer.
         Lead in ceramic tableware: California required
    clear warnings for lead that leaches from ceramic tableware
    into food and beverages.
        The marketplace responded. Now these ceramics have
    disappeared from shelves.
         Lead in Calcium Supplements: Makers of calcium
    supplements, such as Tums and Rolaids, agreed to reduce levels
    of lead contamination in their products. This result was
    reached without posting warnings that might have discouraged
    women from taking calcium.
         Leaded crystal: Fully leaded crystal, especially
    when used for storage of beverages, leaches substantial amounts
    of lead. California requires point-of-sale signs, while FDA has
    provided a consumer advisory.
         Mercury in fish: California requires that
    information be posted in stores where fresh fish is sold
    warning pregnant women about the high levels of mercury in
    seafood and it would no longer be able to do so.

        As you can see, this bill significantly undermines
    California's Proposition 65. This is not the first assault on
    the California law.
        Earlier similar efforts to overturn Proposition 65 and
    preempt State and local food safety laws have been opposed by
    people on both sides of the aisle.
        For example, the Reagan administration conducted an
    economic analysis of the impact of Prop 65 in 1988--which the
    first President Bush administration later concurred with--that
    found industries claims of Prop 65's financial burden to
    ``vastly overstate the potential impact on producers.''
        State and local governments should have the right to
    protect their citizens. Consumers deserve to know if the
    product they are purchasing may cause them harm.
        The bottom line is this: Congress should NOT approve
    legislation that threatens hundreds of critical food safety
    laws across the country and puts at risk the health and safety
    of all Americans.
        Thank you Mr. Chairman.
        Senator Burr. Thank you for your willingness to speak.
        Senator Feinstein. I might be excused and I thank my
    colleague for allowing me to go earlier. I have a judiciary
    mark-up.
        Senator Burr. We understand.
        Senator Boxer.

                       Opening Statement of Senator Boxer

        Senator Boxer. Thanks so much, Mr. Chairman and I have a
    hearing in Foreign Relations with Ambassador Bolton and so I
    will also have to bolt after my statement. Thank you so much
    for allowing us to speak here. I know it is not a happy time
    for you to hear two colleagues lead off in opposition to a bill
    you really care about so in advance, let me say that I respect
    your view but we are in strong disagreement because, as Senator
    Feinstein has said, we view this legislation as a direct threat
    to California's Food Safety and Consumer Rights and their
    protections. Our people were heard at the ballot box. This
    isn't our opinion, this is the opinion--Republicans, Democrats,
    Independent voters, our Republican Governor--we're all united
    against this bill and that is why we are so, just letting you
    know right now, today, that I know you've fought long and hard
    for this but the fight is not over because we think this bill
    will roll back essential food safety laws and in essence,
    prevent State and local authorities from enacting food safety
    regulations. Our State is a national leader in ensuring food
    safety. We have more people than any other State by far, as was
    pointed out. We've got more kids, we've got more sick people,
    we've got more vulnerable populations and therefore, we have
    stepped out in our State, again Californians passing Prop 65
    with 63 percent of the vote, one of the most popular
    initiatives we've ever had on our ballot in terms of pulling
    people together. It is interesting because really, the act of--
    it doesn't force anything. It just says to the manufacturer,
    let us know what is in your product and then people will decide
    and if you have high levels of arsenic in your bottled water,
    then people have a right to know and guess what? They're not
    going to buy that product and that's why this has been so
    successful, because we believe in the people's right to know
    and if the people know, they'll buy the safest products and it
    has worked really, really well. We don't want to go back to the
    days when our consumers were in the dark about dangerous
    contaminants in their food. Now, I know your response is,
    ``Well the Federal Government will do just as good a job.''
    That hasn't been proven to be the case and I want to talk about
    lead in candy. Senator Chambliss leaned over and said, ``Wow!
    That looks awful good.'' And it does look awful good. This is
    candy with lead in it, dangerous lead and I want to show you a
    picture.
        It just shows you how much I love you! Here we go. This is
    a photograph of lead-tainted candy being given to little
    children and they are having such a wonderful time eating this
    dangerous candy and in our State, we outlawed this. The Federal
    Government has no such law. It could have had. It doesn't have
    it and I want to tell you about what this does to children.
    Lead is a dangerous toxin. It attacks the nervous system
    causing behavior problems, learning disabilities, seizures and
    even death. Children are at the greatest risk. The State of
    California, as I said, has a law to reduce lead in candy along
    with the State of Illinois and we know New York City has it. We
    believe if this bill becomes law, these important protections
    will be threatened and we could have kids eating bowls of this
    candy and unfortunately ingesting lead. Parents won't know any
    better. They trust their government would act but the fact is,
    we haven't acted here in the Federal Government, to ban this.
    We also in California have addressed other issues of arsenic,
    mercury in fish, lead in places Senator Feinstein mentioned, in
    gold and glassware and PCBs in salmon. We've also passed
    innovative State protections to combat childhood obesity by
    ensuring that public schools provide our children with healthy
    food: juice, milk and water rather than soda and it was a big
    fight in California but we did this and all of you know now
    that childhood obesity is likely to lead to an epidemic of
    diabetes later in life. So we are out there moving forward and
    we think this legislation will set us way back. Now, what I
    want to show you then, is another chart that gives you a sense
    of this bill and you know this better than I do, but if a State
    wants to be able to get around this bill, they have quite a
    maze to go through in order to get around this bill. We're
    going to use this to show our colleagues on the floor, it is
    just a bureaucratic nightmare. It is a petition process that
    just is not going to work for our State.
        Mr. Chairman, I'd ask that the rest of my statement be
    placed in the record and since this is my sum-up time.
        [The prepared statement of Senator Boxer follows:]

                      Prepared Statement of Senator Boxer

        Thank you, Mr. Chairman for allowing me to speak today on
    an issue of great importance to people in my State of
    California, and to people in every State across the Nation.
        I am here today to voice my strong opposition to S. 3128,
    the National Uniformity for Food Act.
        This legislation poses a direct threat to California's food
    safety and consumer right-to-know protections, including
    Proposition 65.
        The bill would roll back essential food safety laws and
    prevent State and local authorities from enacting food safety
    regulations that act as a safety net and fill in critical gaps
    in Federal law.
        And for a State like California, which is a national leader
    in ensuring food safety, this legislation is particularly
    harmful, threatening laws that protect the most vulnerable
    among us, including pregnant women and children.
        Californians passed Proposition 65 in 1986 with 63 percent
    of the vote because they wanted to know if dangerous
    contaminants were in their food and drinking water, and they
    knew such a law would encourage food manufacturers to provide a
    safer product--because who wants to buy bottled water with an
    arsenic warning label?
        For more than 20 years, this simple combination of consumer
    education and market forces has reduced exposure to dangerous
    substances in food throughout California.
        But now, California's State food safety laws are under
    attack from special interests, who would keep consumers in the
    dark about dangerous contaminants in their food and water.
        Why? Because of claims that food safety regulations may cut
    into profits.
        Rather than looking at a picture like this (Chart--photo of
    children eating lead candy), and being disgusted at the sight
    of innocent children eating candy contaminated with lead, these
    special interests see dollars signs.
        Lead is a dangerous toxin that attacks the nervous system,
    causing behavioral problems, learning disabilities, seizures
    and death, with children at greatest risk.
        If this legislation becomes law, the Food and Drug
    Administration could do away with State laws prohibiting lead-
    infested candy from being sold in our supermarkets, and
    uninformed consumers will be the worse for it.
        The State of California already has a law to reduce lead in
    candy, along with the State of Illinois and New York City. If
    this bill becomes law, these important State and local
    protections will be threatened.
        Once again in convenience stores and at family picnics,
    children could see bowls like this full of enticing treats, and
    reach for them as a child would reach for a snickers bar or
    Hershey's kiss.
        And unfortunately most parents won't know any better,
    because they trust that their government would not allow
    children to eat candy with high levels of lead. Unfortunately,
    the Federal Government does not have a requirement in place
    that would ensure children are protected from dangerous levels
    of lead in candy. This simple fact alone answers the question
    of why we need a State safety net.
        In addition to addressing the issue of lead in candy,
    Californians have acted to reduce arsenic in bottled water,
    mercury in fish, lead in plates, bowls, and glassware, and
    polychlorinated biphenyls (''PCBs'') in salmon.
        Californians have also passed innovative State protections
    to combat childhood obesity by ensuring that public schools
    provide our children with healthy foods, juice, milk and water
    rather than soda.
        The dangerous and bureaucratic process in S. 3128 that
    would in theory allow the Federal Government to consider
    allowing State protections to continue not only wastes scarce
    resources, but provides little hope of success. [Chart on S.
    3128's Petition Process]
        There is widespread opposition to efforts to eliminate
    State food safety and consumer right-to-know protections.
    Numerous State, public health, scientific, labor, environmental
    and other public interest groups have objected to the H.R.
    4167, the House version of S. 3128, as well as the bill at
    issue in this hearing. I would like to place these letters into
    the record to accompany my statement.

        [Editor's Note: The letters of opposition may be found in
    Additional Material.]
        Don't let the nice title, ``National Uniformity for Foods
    Act'', fool you. This legislation poses a threat to the health
    of Americans in every State in the Union.
        Senator Boxer. I'm going to just read a few of the groups
    that oppose this legislation: the National Association of State
    Departments of Agriculture, the National Association of Food
    and Drug Officials, Consumer Federation of America, United
    Steel Workers, Consumers Union, Center for Science in the
    Public Interest, National Environmental Trust, Physicians for
    Social Responsibility, Attorneys General in 39 States and
    territories, including California, New York, Hawaii, Alaska,
    Arizona, Connecticut, Delaware, Idaho--it goes on and on and
    interestingly, the North Carolina Consumers Union opposes this
    as well. The bottom line is, Mr. Chairman, I know that your
    aims and that of my colleagues are good. I have no question
    that your aims are good and your intentions are good but it is
    the practical impact of this. Coming from a State that is way
    out in front on food safety, we don't want to go back and our
    people don't want us to go back. This is not partisan and
    that's why Senator Feinstein and I are here. We so appreciate
    the chance to speak with you very directly. You're direct,
    we're direct. We know we have disagreements and honorably, we
    will debate those differences. Thank you very much.
        Senator Burr. Senator Boxer, thank you. Your full statement
    will be a part of the record.
        Senator Boxer. Thank you.
        Senator Burr. I'll take this opportunity as I introduce my
    colleague from Georgia, to also put up a chart.
        That chart is a chart of Prop 65.
        Senator Boxer. Sure.
        Senator Burr. If you will, it's over here.

        Senator Boxer. Well, ours is prettier. Ours is in better
    color.
        Senator Burr. We didn't have the money, you know, too----
        [Laughter]
        Senator Boxer. I know you spent the entire Federal surplus.
        Senator Burr. Small thing here. We just had a copy machine.
    That's the only thing we had.
        Senator from Georgia.

                     Opening Statement of Senator Chambliss

        Senator Chambliss. Well, as usual, I hate to follow my
    friend from Kansas. Thank you Mr. Chairman, Senator Isakson,
    Senator Roberts, I appreciate the opportunity to share my views
    with you on S. 3128, the National Uniformity for Food Act. As
    Chairman of the Senate Committee on Agriculture, Nutrition and
    Forestry, I engage in this debate from a unique perspective.
    The Senate Agriculture Committee oversees a significant portion
    of America's food safety system and the Federal food safety
    functions over which the committee has jurisdiction, have long
    employed uniform standards to protect public health.
        The U.S. Department of Agriculture's Food, Safety and
    Inspection service is responsible for the safety of meat,
    poultry and egg products, both domestic and imported. It
    enforces uniform standards through the authority granted to the
    USDA by the Federal Meat Inspection Act, the Poultry Products
    Inspection Act, and the Egg Products Inspection Act.
        USDA isn't the only agency charged with enforcing national
    uniformity. There are many other areas where Congress has
    decided that national uniform standards are warranted. These
    areas include nutrition labeling, allergens, pharmaceuticals,
    and medical devices, just to name a few. For example, the Food
    Quality Protection Act, a State may not set tolerance levels
    for pesticide residues that differ from national levels unless
    the State petitions the Environmental Protection Agency for an
    exception.
        I support the National Uniformity for Food Act because it
    will not only remove unnecessary and costly impediments to
    interstate commerce but even more importantly, it will provide
    consumers with clear and useful information.
        The bill that you have drafted will ensure that consumers
    have access to the same accurate, science-based information
    regardless of where they live. It will eliminate consumer
    confusion and bolster confidence in the safety of our food
    supply by placing our Nation's food safety in the hands of the
    U.S. Food and Drug Administration, the world's leading food
    safety agency. In addition, this bill will streamline the
    regulatory process by creating a single process for
    establishing food safety standards and warning labels for
    packaged foods under the authority of the FDA.
        States traditionally have played a strong role in the
    formulation of our Nation's food safety policy and that will
    not change under this bill. Under this legislation, States will
    continue to have authority for enforcements, sanitation
    inspections at local restaurants, licensing and the protection
    of public health in the event of a food emergency or a
    terrorist attack.
        States will also be able to continue their constant
    communication and information sharing with the FDA when it
    comes to food safety. A unique provision in the bill allows any
    State to petition the FDA to keep its existing State law or
    elevate that standard to the National level, following a
    thorough review of the entire body of scientific evidence. In
    fact, no State law would disappear upon the enactment of this
    bill. States would have 180 days to petition the FDA under the
    provision I just outlined. If the FDA fails to act on a State
    petition, then that State law would remain in effect.
        With the world's safest food supply, every American
    benefits from uniform food safety standards. The National
    Uniformity for Food Act builds on that record of success by
    extending the same approach used by the USDA and other
    regulatory agencies to the FDA. This is not only a common sense
    approach but it assures every American that the food they enjoy
    is regulated by strict, national standards meant to ensure
    their health and well-being.
        I would like to commend Chairman Enzi and you, Senator Burr
    and the other members of this committee, for holding this
    hearing today. It is important to debate this issue in a public
    forum so that American consumers understand our goal is to
    strengthen and harmonize food safety efforts in this country.
    It is rather ironic that at the international level, we
    actively pursue the goal of harmonizing food safety standards
    yet we still debate this issue at home. The National Uniformity
    for Food Act provides us with an opportunity to bring a long-
    needed, common sense approach to the regulation of packaged
    foods. I urge the members of this committee as well as the rest
    of our Senate colleagues, to support this bill and I thank you
    very much for letting me share these thoughts with you.
        [The prepared statement of Senator Chambliss follows:]

                    Prepared Statement of Senator Chambliss

        Thank you Mr. Chairman. I appreciate the opportunity to
    share my views on S. 3128, the National Uniformity for Food
    Act. As Chairman of the Senate Committee on Agriculture,
    Nutrition and Forestry, I engage in this debate from a unique
    perspective. The Senate Agriculture Committee oversees a
    significant portion of America's food safety system, and the
    Federal food safety functions over which the committee has
    jurisdiction have long employed uniform standards to protect
    public health.
        The U.S. Department of Agriculture's Food Safety and
    Inspection Service is responsible for the safety of meat,
    poultry, and egg products, both domestic and imported. It
    enforces uniform standards through the authority granted to the
    USDA by the Federal Meat Inspection Act, the Poultry Products
    Inspection Act and the Egg Products Inspection Act.
        USDA isn't the only agency charged with enforcing national
    uniformity; there are many other areas where Congress has
    decided that nationally uniform standards are warranted. These
    areas include nutrition labeling, allergens, pharmaceuticals,
    and medical devices to name a few. For example, under the Food
    Quality Protection Act, a State may not set tolerance levels
    for pesticide residues that differ from national levels unless
    the State petitions the Environmental Protection Agency for an
    exception.
        I support the National Uniformity for Food Act because it
    will not only remove unnecessary and costly impediments to
    interstate commerce but even more importantly it will provide
    consumers with clear and useful information.
        The bill will ensure that consumers have access to the same
    accurate, science-based information regardless of where they
    live. It will eliminate consumer confusion and bolster
    confidence in the safety of our food supply by placing our
    Nation's food safety in the hands of the U.S. Food and Drug
    Administration, the world's leading food safety agency. In
    addition, this bill will streamline the regulatory process by
    creating a single process for establishing food safety
    standards and warning labels for packaged foods under the
    authority of the FDA.
        States traditionally have played a strong role in the
    formulation of our Nation's food safety policy, and that will
    not change under this bill. Under the legislation, States will
    continue to have authority for enforcement, sanitation
    inspections at local restaurants, licensing, and the protection
    of public health in the event of a food emergency or a
    terrorist incident.
        States will also be able to continue their constant
    communication and information-sharing with the FDA when it
    comes to food safety. A unique provision in the bill allows any
    State to petition the FDA to keep its existing State law or
    elevate that standard to the national level following a
    thorough review of the entire body of scientific evidence. In
    fact, no State law would disappear upon the enactment of this
    bill. States would have 180 days to petition the FDA under the
    provision I just outlined. If the FDA fails to act on a State
    petition, then that State law would remain in effect.
        With the world's safest food supply, every American
    benefits from uniform food safety standards. The National
    Uniformity for Food Act builds on that record of success by
    extending the same approach used by the USDA and other
    regulatory agencies to the FDA. This is not only a common sense
    approach, but assures every American that the food they enjoy
    is regulated by strict, national standards meant to ensure
    their health and well-being.
        I would like to commend Chairman Enzi and the members of
    this committee for holding this hearing today. It is important
    to debate this issue in a public forum so that American
    consumers understand our goal is to strengthen and harmonize
    food safety efforts in this country. It is rather ironic that
    at the international level we actively pursue the goal of
    harmonizing food safety standards, yet we still debate this
    issue at home.
        The National Uniformity for Food Act provides us with an
    opportunity to bring a long-needed, common sense approach to
    the regulation of packaged foods.
        I urge the members of the committee, as well as the rest of
    my Senate colleagues to support this bill. Thank you very much.
        Senator Burr. Mr. Roberts.

                      Opening Statement of Senator Roberts

        Senator Roberts. Well, I would never dismiss the Senator
    from Georgia. I'd let him ride off into the sunset if he
    wishes.
        Mr. Chairman, thank you for holding this hearing today on
    the National Uniformity Food Act. This bill, as others have
    said, is an important piece of legislation. Quite frankly, we
    should have passed this a long time ago. I'm very pleased to
    have been a lead sponsor of this bill in the past. I'm pleased
    to be joining Senator Burr and I am his shotgun rider or wing
    man, as of this time around and I think we ought to dispel some
    concerns and some news, as the Chairman has indicated, about
    this bill. We discussed this for a long time but recent events,
    Mr. Chairman, in the food industry and the courts show us that
    the time for debate has passed. It is time for us to do our
    jobs and bring uniformity to the food safety tolerances and the
    warning label systems for consumers nationwide. I just don't
    understand why you have--you don't have food safety concerns in
    49 States but you do in one. I guess that means the consumers
    in the other States are undergoing a real problem or a real
    concern. I want to emphasize that facts can be stubborn things.
    The thing that occurred to me about--whoop! Put that candy back
    up there.
        Audience Member. OK.
        Senator Roberts. Let me have that candy!
        Audience Member. Only if you promise not to eat it.
        [Laughter]
        Senator Roberts. All right. This has been tested in the lab
    and it contains high levels of lead. Can you tell what the
    tolerance is in regards to how much food a young child would
    have to eat in terms of candy before it would become a real
    problem? That's the thing, it seems to me, that is important
    because that would be important for every State and every
    consumer and every parent.
        Audience Member. One piece.
        Senator Roberts. One piece of this particular candy?
        Audience Member. A child would exceed the daily limit based
    on----
        Senator Roberts. On California standards?
        Audience Member. That's correct, but they are not----
        Senator Roberts. Well, the thing that I remember so well is
    when we were talking about this--is this candy for sale in all
    49 States? So it's unsafe in all 49 States? No, it's unsafe in
    California but it's not unsafe in all 49 States, is that right?
        Audience Member. I'm sorry. Essentially, the Federal
    Government, the FDA has a tolerance proposed but they don't
    have an enforceable standard and have not actually fulfilled a
    gap----
        Senator Roberts. So it is an enforcement issue with the
    FDA, not the tolerance?
        Audience Member. They don't have enforceable requirements.
        Senator Roberts. No enforceable requirements? Well, if this
    is being sold in 49 States, let me go back to my one example I
    at least know something about because on the floor of the
    House, when we were considering this 15 years ago and I was
    asking people why pancake flour in Pennsylvania was okay but
    pancake flour in California wasn't and even had a demonstration
    of flipping pancakes but that's another whole story.
        We got the example of domenicide which was used to control
    pests in regards to the production of peanuts and the argument
    was that obviously domenicide was a carcinogen in certain
    amounts and if you raised it to certain levels, it is a real
    problem. So I ask about the tolerance level on how many peanuts
    a person would have to eat every day to reach the tolerance
    level set by the critics of the FDA and it turned out to be 600
    pounds of peanuts a day. That's a lot of peanuts. Now, I knew
    several members in the Congress at that time that I would have
    liked to have fed 600 pounds of peanuts a day but that was not
    an option. So I think we ought to at least use some common
    sense.
        I am distressed to learn about the enforcement thing in
    terms of an enforcement mechanism but I think we have to look
    at this in this world of parts per trillion. There is a little
    bit of something in everything and you have to have a cost-
    benefit risk and you have to have a sound science risk and 49
    States do, with the FDA. Not California.
        The fact of the matter is, this legislation does not
    propose taking some unprecedented step in food and consumer
    safety; rather as many of our witnesses will testify today, the
    legislation simply intends to add national uniform standards
    for food safety tolerances and warning labels. Now what am I
    talking about? We've already got uniform requirements for meat
    and poultry products, nutrition labeling, allergen labeling,
    pesticide tolerances and medical devices.
        Your bill, sir. Passed the Ag Committee in 2000. Now it's
    here where obviously you'd have jurisdiction and this debate
    should take place, don't misunderstand me. I just don't think
    it should be to one committee and then we go to the floor. Why
    shouldn't we also have them on the tolerance and warning label
    front, I just don't understand that. I think the FDA can do the
    job. This issue has always been focused largely on the
    tolerance and warning discrepancies between the rest of the
    United States and California. Not unusual and largely as a
    result of Proposition 65, as has been referred to by my friends
    and colleagues. But let me just state that there are a lot of
    people in California, if I can find my list, who are for this
    bill, Senator. The California Chamber of Commerce, the
    California Farm Bureau Federation, California Grocer's
    Association, California League of Food Processors, California
    Manufacturers and Technology Association, California/Nevada
    Soft Drink Association and the California Restaurant
    Association. I do not think these people are interested in the
    business of poisoning any family or any youngster or for that
    matter, anybody.
        We found on the California Attorney General's Web site that
    if you take a look at Proposition 65 settlement dollars paid in
    private cases, including attorney fees, you'll see that the
    total amount for 2000 to 2005 was about $57 million. About $40
    million of it, 70 percent, went to attorney fees. More
    significantly, the total civil penalties only averaged about
    $885,000 over a 6-year period.
        So I think you can see that there are other factors in
    regards to opposition to this legislation. I don't think we
    need to look any further to understand the need for this
    legislation than the prepared testimony of Mr. Bill Stadtlander
    today. Bill, if I've mispronounced your last name, I apologize.
    Here is a man who has produced a product that the FDA has
    determined can be labeled, and I'm quoting, ``heart healthy,
    bone healthy, may reduce the risk of certain types of cancer.''
    May reduce the risk of certain types of cancer but the State of
    California says, in that regard that the product that Bill
    would like to sell, is that naturally occurring Acrylamide
    may--may cause cancer. He is now being subjected to a multi-
    million dollar lawsuit because his product does not contain a
    label saying that the State of California believes his product
    could--could, may cause cancer. Forty-nine other States, Bill--
    why don't you bring your company to Kansas? Where are you?
        [Laughter]
        You know, Dodge City will give you a special deal. We'll
    make you Marshall. We'll give you the land--well, I'm maybe a
    little out of line there but at any rate, think about it. But
    at any rate, I think it is time to bring common sense to our
    food safety tolerance and warning label policies. Mr. Chairman,
    I thank you again for holding this hearing. Pardon my sort of
    wanderings here or being rather irascible in regards to this
    but 15 years we've tried to get uniform and we've done it on so
    many other different things, as I've said. Pesticides,
    allergens, nutritional labeling, pesticides in 1996,
    nutritional labeling in 1990, allergens 2004. As science has
    progressed in this parts per trillion, or even more than that
    in terms of technology. I think we can do the job. I think the
    FDA can do the job and I certainly would support funding in
    regards to enforcement practices. So I thank you again for
    holding the hearing. I urge my colleagues to help us move
    forward in ensuring this legislation is enacted as of this year
    if possible. I yield whatever time I have remaining, which is
    probably none.
        Senator Burr. All right, I thank the Senator from Kansas
    for his work in the past and his work today. The Chairman also
    said that it is his understanding that the FDA is in the
    process of issuing, probably before the end of the year, a
    regulation as it relates to lead in candy. Were this to be the
    law today, California, in this particular case, because there
    was no Federal standard, would petition the FDA as it related
    to lead in candy. Until the FDA acted on that petition, this
    would be the letter of the law in California. We would not
    alter California's regulation of lead in candy and clearly,
    there is the opportunity that California may object with what
    the FDA came out with or in fact, California's experience might
    guide the FDA as to what that regulation should look like. But
    I think clearly, the point needs to be made that passing this
    bill would not in any way, shape or form, affect what
    California has done as it relates to lead in candy. The Chair
    would recognize Senator Reed if he has any opening remarks. He
    does not, then the Chair would call up the second panel. On our
    second panel is William Stadtlander, who has been president and
    CEO, owner of Homestat Farms, Limited since creating the
    company in 2001. The company is based in Dublin, Ohio and makes
    the hot cereals Maypo, Wheatena and Maltax as well as G.
    Washington Seasoning and Broth. Prior to creating Homestat
    Farms, Mr. Stadtlander worked at Abbott Laboratories for 21
    years and served for 9 years as Vice President, Corporate
    Officer for the Ross Division of Abbott Labs. Mr. Stadtlander
    will discuss the impact of nonuniform food safety laws on his
    small business. In addition, Mr. Peter Barton Hutt is a Senior
    Counsel in the Washington, D.C. law firm of Covington and
    Burling, specializing in food and drug law. He began his law
    career practicing with the firm in 1960 and except for his 4
    years in the Government, has continued at the firm ever since.
    From 1971 to 1975, he was the Chief Counsel for the Food and
    Drug Administration. Mr. Hutt will discuss the history of food
    regulation and why establishing uniformity in food adulteration
    regulations and warning notifications is an important step
    forward. Welcome, Mr. Hutt.
        Senator Roberts. Mr. Chairman, could I make a point?
        Senator Burr. Yes.
        Senator Roberts. I'm the candy man here again. You folks
    have to get a better example here, more up to date because this
    is pretty old stuff and it is hard to read the label but this
    candy is from Mexico and I think maybe this is a trade issue or
    certainly an inspection issue for products coming in from
    Mexico to California. And I would agree, I wouldn't eat this
    stuff. This looks like it is about 2 or 3 years old.
        Senator Burr. I'm confident our second panel might be able
    to share some insight on that candy as well. In addition, Dr.
    Elsa Murano----
        Senator Roberts. Jack, do you want some candy?
        [Laughter]
        Senator Burr. Dr. Elsa Murano is the former Undersecretary
    of the USDA. She is currently the Vice Chancellor and Dean of
    Agriculture and Life Science at Texas A&M University and
    Director of the Texas Agricultural Experiment Station. Prior to
    being appointed Undersecretary for Agriculture for Food Safety
    by President George Bush in 2001, Dr. Murano was a Professor in
    the Department of Animal Science at Texas A&M and holder of the
    Sadie Hatfield Professorship in Agriculture. Dr. Murano will
    discuss why food adulteration regulations need to be based on
    sound science. And before his recent retirement, Mr. William
    Hubbard advised the Commissioner of Food and Drugs on agency
    policy, coordinated the development of the agency rulemaking,
    directed the agency's congressional relations and legislative
    activities and oversaw the planning and evaluation functions of
    the Food and Drug Administration. He was also a principal
    representative of the agency with the Secretary of Health and
    Human Services, other members of the Cabinet, Governors and
    other senior officials of several States and with the White
    House. Mr. Hubbard will discuss the FDA's activities on food
    safety and the agency's interaction with States and I might
    also add--I understand you are now a resident of North
    Carolina. We're delighted to have you there.
        Mr. Hubbard. Thank you, Mr. Chairman. I'm a native of the
    State and while those others down east are not as sophisticated
    or probably intelligent as those of you up in the Piedmont, we
    do appreciate your concerns, Mr. Burr.
        Senator Burr. Thank you, Mr. Hubbard. We will start with
    Mr. Stadtlander.

               STATEMENT OF WILLIAM STADTLANDER, OWNER,
                       HOMESTAT FOODS, DUBLIN, OH

        Mr. Stadtlander. Thank you, Mr. Chairman.
        Senator Burr. And I would ask all of you to make sure the
    mics are on and that you pull them close enough so everybody
    can hear.
        Mr. Stadtlander. Thank you, Mr. Chairman. My name is Bill
    Stadtlander. I own a small company, Homestat Farm, which makes
    Maypo, Wheatena and Maltex hot cereals. Homestat Farm was
    formed in October 2001, when I purchased these brands as well
    as G. Washington Seasoning and Broth, from ConAgra Grocery
    Products. My company is located in Dublin, Ohio and we have a
    manufacturing facility in Highspire, Pennsylvania, where our
    cereals are manufactured. We work with BCTGM Local 464.
    Homestat Farm is a small company. Our annual sales are $4.5
    million. We employ about 20 people. Although I am a small
    company, I pay good wages to my employees. I pay 85 percent of
    their health insurance, have a pension plan for union employees
    related to their years of service. I spent more than 25 years
    working for food and consumer products companies, many of those
    years making nutritious foods. I created Homestat Farm because
    I wanted to continue to offer, as my slogan says, healthy
    nutrition for those you love.
        The Wheatena story, which is the subject of a lawsuit right
    now in California, is what I am here for. The Wheatena story
    goes back a long way to 1879, when a small bakery owner on
    Mulberry Street in lower New York City, roasted whole wheat,
    ground it, sold it in packages branded Wheatena. That is pretty
    much what Wheatena remains today: a toasted wheat product with
    a unique taste and lots of healthy fiber, 25 percent more than
    the leading brand. Health experts now recognize that fiber is
    essential to a healthy diet. The FDA food pyramid and
    nutritionists across the world recommend eating high fiber
    diets and whole grains to maintain good health and to reduce
    both the risk of heart disease and some types of cancers. A
    healthy way for a person to start the day is to have a high-
    fiber breakfast. Wheatena provides that. People may disagree
    about what foods are healthy and which are not but I've never
    heard anyone dispute that Wheatena is a high-fiber, healthy
    food. Nevertheless, I have been sued by a trial lawyer in
    California who claims that because Wheatena--like hundreds of
    other cooked or heated foods--contains a naturally occurring
    by-product of the cooking process, I should have provided a
    Prop 65 cancer warning to Wheatena customers. What is this by-
    product? It is Acrylamide, a substance produced whenever foods
    that have starch are browned.
        It's not just Wheatena that Acrylamide is found in, it's in
    whole grain breads and cereals such as Cheerios, Corn Flakes,
    Raisin Bran, Granola, Rice Krispies, and Shredded Wheat. It is
    found in crackers and cookies, toast and pastries. It is found
    in roasted nuts, prunes, grilled asparagus, to just name a few.
    Coffee also has Acrylamide. I'm told about 40 percent of the
    food people consume today have Acrylamide in it.
        I am in compliance with all Federal laws, including NLEA
    labeling and health claims and I know now that the FDA actually
    says there should not be warnings on foods just because they
    contain Acrylamide but this lawyer claims that California law
    is otherwise. It is extremely difficult as a small businessman,
    to keep up with potentially 50 different State laws regarding
    ingredients and warnings.
        Although I sell approximately $70,000 worth of Wheatena in
    California each year, California's Prop 65 allows this trial
    lawyer to sue me for millions of dollars. Food safety agencies
    around the world have been studying the Acrylamide issue
    intensively since the substance was first discovered in food 4
    years ago and none of them found any significant health risks
    or recommended any Acrylamide warnings. But that does not stop
    the lawsuit against me, which I have to spend thousands of
    dollars to defend.
        I understand that those who oppose the National Uniformity
    for Food Act claim it will gut the Nation's food safety laws. I
    do not believe that is true but I do know they will prevent a
    State from trying to dictate food policy to the rest of the
    country and giving bounty hunter lawyers a financial plug to
    make me think twice about selling Wheatena in that State. As a
    result of the California lawsuit, I have a real dilemma in that
    State. I am selling a product that reduces the risk of cancer
    but the lawyers claim I have to either remove the product from
    the market or put a cancer warning on it. A cancer warning on a
    product that nutritionists agree reduces cancer risk all
    because Acrylamide in Wheatena, even though the same Acrylamide
    is in lots of other foods with a lot fewer health attributes.
        Wheatena is a healthy, all-natural, toasted wheat hot
    cereal that has been on the market since 1879. The Federal
    Government has very rigorous procedures for determining health
    claims a food product can make and Wheatena is in the minority
    of foods that are allowed three different health claims: heart
    healthy, bone healthy and may reduce the risk of certain types
    of cancer. Even though the FDA specifically determined that
    Wheatena may reduce the risk of cancer, California wants foods
    that contain Acrylamide, including whole grain breads and
    cereals, to have a warning that the product may cause cancer,
    even when no other regulatory party in the world believes
    warnings are required for Acrylamide at this time. Are you
    confused? I am and consumers are sure to be confused if Federal
    guidelines say a product may reduce the risk of certain cancers
    followed by a California warning that it may cause cancer.
        The combination of the litigation costs and potentially
    pulling out of the State of California is enough to jeopardize
    my small business when I believe I am selling a very healthy
    cereal. Because of the real risk to my business, I am fully
    supportive of the National Uniformity for Food Act that
    provides for national uniform food safety standards and warning
    requirements. The basic rationale is for one, uniform,
    scientifically sound food safety standard rather than a
    patchwork of 50 different State laws. I want to thank the
    committee for allowing me to speak here today and I urge you to
    quickly pass this bill.
        [The prepared statement of Mr. Stadtlander follows:]

                   Prepared Statement of William Stadtlander

        My name is Bill Stadtlander and I own a small company, Homestat
    Farm, which makes Maypo, Wheatena and Maltex--hot cereals which, as
    many mothers have said to their children, are good and good for you.
    Homestat Farm was formed in October 2001 when I purchased these brands,
    as well as G. Washington's Seasoning and Broth, from ConAgra Grocery
    Products. My company is located in Dublin, Ohio and we have a
    manufacturing facility in Highspire, PA. where our cereals are
    manufactured. We work with BCTGM Local 464.
        Homestat Farm is a small company. Our annual sales are $4,500,000--
    all in the United States--with sales of $70,000 of Wheatena in
    California.
        We have 3 full-time employees and 3 part-time consultants in our
    Dublin office which are new jobs that were created when I bought the
    business. In our manufacturing facility, we have 2 full-time employees
    in administration and 10 full-time union employees.
        Although I am a small company, I pay good wages to my employees, I
    pay 85 percent of their health insurance, and I have a pension plan for
    the union employees related to their years of service.
        I spent more than 25 years working for food and consumer product
    companies, many of those years making nutritious foods. I created
    Homestat Farm because I wanted to continue to offer (as my slogan says)
    ``Healthy Nutrition for Those You Love.''
        I do not know how many on this committee had Wheatena growing up,
    but I did, and I did not want to see Wheatena disappear. The Wheatena
    story goes back a long way--to 1879, when a small bakery owner on
    Mulberry Street in lower New York City roasted whole wheat, ground it
    and sold it in packages branded Wheatena. That's pretty much what
    Wheatena remains today: a toasted wheat product, with unique taste, and
    lots of healthy fiber--25 percent more than the leading brand.
        Health experts now recognize that fiber is essential to a healthy
    diet. The FDA food pyramid and nutritionists across the world recommend
    eating high fiber diets and whole grains to maintain good health and to
    reduce both the risk of heart disease and some types of cancers. A
    healthy way for a person to start the day is to have a high fiber
    breakfast--Wheatena provides it.
        And Wheatena promotes health in other ways:

         It is Calcium fortified to help keep bones strong.
         It has, as I said, 25 percent more fiber than the leading
    brand of hot cereal.
         It is 100 percent natural, toasted whole wheat, rich in
    bran, protein and wheat germ.
         It is cholesterol free, low in fat, low in sugar, low in
    sodium and fortified Kosher by the Orthodox Union.

        People may disagree about what foods are healthy and which are not.
    But I have never heard anyone dispute that Wheatena is a high fiber,
    healthy food. In fact, one of the most vocal consumer activist groups
    engaged in advocating for good nutrition, the Center for Science in the
    Public Interest (CSPI), lists Wheatena as a good source of whole grains
    in ``Nine Weeks to a Perfect Diet'' on its Web site.
        Nevertheless, I have been sued by a trial lawyer in California who
    claims that because Wheatena--like hundreds of other cooked or heated
    foods, contains a naturally occurring by-product of the cooking
    process, I should have provided a Proposition 65 cancer warning to
    Wheatena customers. What is this by-product? It is acrylamide--a
    substance produced whenever foods that have starch are browned. It is
    not just Wheatena. Acrylamide is found in whole grain breads and
    cereals such as Cheerio's, Corn Flakes, Raisin Bran, Granola, Rice
    Krispies, and Shredded Wheat; it is found in crackers and cookies,
    toast and pastries; and it is found in roasted nuts, prunes, and
    grilled asparagus to name just a few. I am told that about 40 percent
    of the food people consume has acrylamide in it.
        Apparently, acrylamide is one of the chemicals California has
    listed as requiring a cancer warning under its law. I am told that this
    requirement was adopted when people thought acrylamide existed only in
    synthetic form and was used in large quantities in industrial settings.
    I make food products and I try my best to keep up with food
    regulations. But nobody thought of this Prop 65 listing as applying to
    food. So I wasn't even aware of Prop 65 until I received notice of the
    lawsuit. I am in compliance with all Federal laws including NLEA
    labeling and health claims. And I know now that FDA actually says there
    should not be warnings on foods just because they contain acrylamide.
    But this lawyer claims that California law is otherwise. It is
    extremely difficult as a small businessman to keep up with potentially
    50 different State laws regarding ingredients and warnings.
        Although I sell only approximately $70,000 worth of Wheatena in
    California each year, California's Proposition 65 allows this trial
    lawyer to sue me for millions of dollars. Food safety agencies around
    the world have been studying the acrylamide issue intensively since the
    substance was first discovered in food 4 years ago, and none of them
    have found any significant health risk or recommended any acrylamide
    warnings. But that does not stop the lawsuit against me, which I have
    to spend thousands of dollars defending.
        In the meantime, I understand that the same CSPI that love
    Wheatena, is leading the charge against the National Uniformity for
    Food Act, claiming it will ``gut'' the Nation's food safety laws. I do
    not believe that is true, but I do know that it will prevent a State
    from trying to dictate food policy to the rest of the country, and
    giving ``bounty hunter'' lawyers a financial club to make me think
    twice about selling Wheatena in the State.
        As a result of the California lawsuit, I have a real dilemma in
    that State. I am selling a product that reduces the risk of cancer. But
    to limit the lawyer's claims, I have to either remove the product from
    the market or put a cancer warning on it--a cancer warning on a product
    that nutritionists agree reduces cancer risk--all because of acrylamide
    in Wheatena, even though that same acrylamide is in lots of other foods
    with a lot fewer health attributes.
        Wheatena is a healthy all natural toasted wheat hot cereal that has
    been on the market since 1879. The Federal Government has very rigorous
    procedures for determining the health claims a food product can make
    and Wheatena is in the minority of foods that are allowed three
    different health claims: (1) Heart Healthy; (2) Bone Healthy; and (3)
    May reduce the risk of certain types of cancer.
        Even though FDA specifically determined that Wheatena may reduce
    the risk of cancer, California wants foods that contain acrylamide--
    including whole grain breads and cereals--to have a warning that the
    product may cause cancer, even when no other regulatory body in the
    world believes warnings are required for acrylamide at this time. Are
    you confused? I am. And consumers are sure to be confused if Federal
    guidelines say a product may reduce the risk of certain cancers
    followed by a California warning that it may cause cancer.
        The alternative of a different label for one State than for the
    remaining 49 States is virtually impossible to implement because food
    chains and wholesalers pull from the same warehouse for different
    States and diverters move products around the country. Another
    possibility is to have a separate label with a different UPC code and
    carry duplicate inventory to conform to individual State requirements
    which is expensive and potentially confusing.
        The combination of the litigation costs and potentially pulling out
    of the State of California are enough to jeopardize my small business
    when I believe I am selling a very healthy cereal that has been on the
    market for more than a century and is widely recommended by
    nutritionists.
        Because of the real risk to my business, I am fully supportive of
    The National Uniformity for Food Act that provides for national,
    uniform food safety standards and warning requirements. The basic
    rationale is for one uniform, scientifically sound food safety standard
    rather than a patchwork of 50 different State laws. I understand that
    uniformity already exists for nutrition labels and for meat, poultry
    and eggs, and I believe that system works very well.
        I want to thank the committee for allowing me to speak here today,
    and I urge you to quickly pass this bill.

        Senator Burr. Thank you, Mr. Stadtlander.
        Mr. Hutt. Welcome.

            STATEMENT OF PETER BARTON HUTT, SENIOR COUNSEL,
                COVINGTON AND BURLING, WASHINGTON, D.C.

        Mr. Hutt. Mr. Chairman and members of the committee, I am
    Peter Barton Hutt, Senior Counsel at the Washington, D.C. law
    firm of Covington and Burling. I have practiced and taught food
    and drug law for my entire professional career. From 1971 to
    1975, I served as Chief Counsel for the Food and Drug
    Administration. I am the co-author of the casebook used to
    teach food and drug law throughout the country and since 1994,
    I have taught a full course on this subject each year at
    Harvard Law School. Mr. Chairman, I'm not from North Carolina
    but my younger daughter does teach at Duke Law School and
    enjoys it greatly. S. 3128 balances the need for a strong
    national law to assure safe food for all our citizens, wherever
    they may live, with the right and duty of each State to protect
    its own citizens from harm. It recognizes the primary
    jurisdiction of FDA to provide uniform requirements for safe
    and properly labeled food throughout the country, enforced by
    both Federal and--and I emphasize--State officials as well. It
    would be impossible to maintain a national food market of each
    of the 50 States who are free to impose their own separate food
    safety and food warning requirements. But at the same time, the
    States must be given the right to collaborate with FDA in
    assuring that appropriate national requirements are imposed and
    the States should take the predominant role in public
    protection where uniquely local matters are involved. This
    legislation accomplishes both of these objectives. Let me hit
    just the highlights of this legislation. There is no impact on
    State administrative procedures in this bill. There is no
    impact on State enforcement power and there is no impact on
    State inspections of food manufacturers. States can fully
    enforce any State food law that is the same as the Federal food
    law. Nothing in the bill, nothing at all, disrupts the
    longstanding Federal/State partnership in food safety. No
    existing food safety program is weakened. Traditional local
    food sanitation matters are not subject to national uniformity
    under the bill. Thus, regulation of milk production, shellfish
    and restaurants is not under the bill. Economic adulteration is
    also excluded, thus the illegal addition of water or other
    adulterates to milk, juice, honey, cider vinegar or maple
    syrup, in order to deceive the public, are not included within
    the legislation. Now, in contrast, there are inherently
    national matters for which uniformity is essential to an
    orderly and free national marketplace. Regulation of the safety
    of food ingredients, color additives and packaging components
    must be consistent in every jurisdiction in the country in
    order to permit our free market economy to thrive. But even
    then, as S. 3128 explicitly confirms the authority of the
    States to enforce their identical State laws regardless whether
    FDA does or does not take action itself. But provisions of S.
    3128 that relate to food warnings are narrowly limited to
    actual warnings and not to a large number of their types of
    statements relating to food. Thus, the legislation does not
    apply to directions for use such as keep refrigerated or to
    descriptions of the origin of a food such as farm-raised fish.
    Now, the Center for Science in the Public Interest erroneously
    asserts that more than 200 State laws will be affected by S.
    3128. In fact, all but a handful of the State laws cited by
    CSPI are not affected by the legislation in any manner
    whatsoever. The most notable State law that would be affected
    by S. 3128 is, of course, California's notorious Proposition 65
    that Bill has just described. This law has resulted in a
    veritable torrid of warnings as well as major litigation about
    the applicability to various food products in spite of numerous
    FDA letters opposing the warnings that California has required.
    For those nonuniform State laws and regulations that have
    already been enacted and are currently in effect, the State may
    petition for an exemption from uniformity or for a national
    standard. These existing State laws stay in place, as everyone
    recognizes, as long as it takes the FDA to rule on the
    petitions. Finally, there will be no flood of State petitions.
    Only six State exemption petitions have ever been submitted to
    FDA under the National Uniformity provisions of the Nutrition
    Labeling and Education Act of 1990. Not one exemption petition
    has been submitted by a State in the last 13 years. I'll be
    happy to answer any questions, Mr. Chairman.
        [The prepared statement of Mr. Hutt follows:]

                    Prepared Statement of Peter Barton Hutt

        Mr. Chairman and members of the committee, I am Peter Barton Hutt,
    senior counsel at the Washington, D.C. law firm of Covington & Burling.
    I have practiced and taught food and drug law for my entire
    professional career. From 1971 to 1975, I served as chief counsel for
    the Food and Drug Administration. I am the coauthor of the casebook
    used to teach food and drug law throughout the country and since 1994 I
    have taught a full course on this subject each Winter Term at Harvard
    Law School. My curriculum vita is attached to this testimony.
        I appear today in support of S. 3128, the National Uniformity for
    Food Act. This legislation balances the need for a strong national law
    to assure safe food for all our citizens, wherever they may live, with
    the right and duty of each State to protect its citizens from harm. It
    recognizes the primary jurisdiction of FDA to provide consistent and
    uniform requirements for safe and properly labeled food throughout the
    country, enforced by both Federal and State officials. It would be
    impossible to maintain the national food market that we have come to
    demand if each of the 50 States imposed its own separate food safety
    and warning requirements. At the same time, the States must be given
    the right to collaborate with FDA in assuring that appropriate food
    safety and warning requirements are imposed and, where uniquely local
    matters are involved, to assume the predominant role in public
    protection. This legislation accomplishes these dual objectives.
        It is fitting that, on this the 100th anniversary of our first
    national food and drug law, the Congress is considering legislation
    that strengthens the authority and responsibility of FDA to regulate
    the safety and labeling of the entire food supply. Our country has
    moved well beyond the day when most food was locally produced and
    consumed. Now, food that has been grown, produced, and packed all over
    the world is sold in every State. Different standards and warnings
    imposed on food in one State but not in others impedes commerce,
    confuses consumers, and increases the cost of food without commensurate
    benefit.
        Consumers are entitled to assurance that the food they purchase and
    consume, whether for themselves or for their families, is safe. Whether
    it be a container of milk, a box of cereal, or a bottle of juice, the
    decision whether that food is safe ought to be applied consistently
    from State to State. Disparate standards and warnings--the current
    circumstance which S. 3128 addresses--does not facilitate informed
    decisionmaking by consumers about the foods that they choose to
    consume.
        Let me provide an example of this point. There has been
    considerable recent discussion and controversy about regulation
    regarding mercury in fish. No one seriously questions that pregnant and
    nursing women and young children should limit their consumption of fish
    known to be relatively high in mercury. At the same time, the health
    benefits of eating fish (low fat, high protein, and an abundant source
    of omega-three fatty acids) are also well known. The challenge for
    health and safety regulators is thus to provide advice to consumers
    that properly balances the risks and benefits of fish consumption.
        In 2004, the Food and Drug Administration and the Environmental
    Protection Agency did just that. The two agencies issued a
    comprehensive advisory to consumers that is scientifically based and
    carefully drawn to encourage consumption of fish while also permitting
    consumers--especially those most at risk--to avoid fish with relatively
    high levels of mercury. Nevertheless, one State, California, has taken
    a contrary position that focuses on the risk of mercury while
    minimizing or ignoring the benefits of eating fish.
        The position California has taken is contrary to the public health.
    Several months ago, the highly regarded Tufts Health and Nutrition
    Letter reported on a study done at the Harvard School of Public Health.
    That study concluded that government warnings about mercury in fish did
    more harm than good because they caused consumers to avoid fish and
    thus to deprive themselves of the health benefits of fish in return for
    a negligible reduction in risk due to avoidance of mercury. Several
    studies have compared the risk of exposure to mercury with the benefits
    of omega-three fatty acids in terms of the risk of stroke and coronary
    heart disease and relative to prenatal development. The conclusion of
    those studies is clear: the health benefits to the pubic of consuming
    fish outweigh the risks from mercury.
        The mercury in fish matter demonstrates the need for regulators to
    speak with one voice and to apply sound science to reach a conclusion
    that gives consumers a basis to make informed and sound choices about
    the food they consume. We do consumers a disservice when we perpetuate
    a system that allows inconsistent, indeed contradictory, standards to
    be applied and warnings to be issued in some places in the country
    which are at odds with the science-based conclusions that regulators
    with national responsibility have reached after thorough and careful
    consideration of the available scientific data and information.
        S. 3128 would properly and effectively ensure that the standards to
    be applied and the warnings to be issued are based on sound science and
    consistent throughout the country.
        The Congress has repeatedly exercised its Constitutional authority
    to regulate interstate commerce in the food and drug arena by enacting
    legislation that provides for uniformity in food and drug regulation.
    The legislation before the committee today is not novel, unique, or
    unprecedented. National Uniformity exists for meat and poultry products
    under the Federal Meat Inspection Act and the Poultry Products
    Inspection Act, both of which are administered by the U.S. Department
    of Agriculture. When the Congress enacted the Nutrition Labeling and
    Education Act in 1994, it provided for national uniformity for
    nutrition labeling, health claims, nutrient content claims, ingredient
    labeling, standards of identity and numerous other aspects of food
    labeling. Congress has also provided national uniformity for pesticide
    regulation, medical devices, and cosmetic and over-the-counter drug
    product labeling.
        In 1990, Congress enacted the Nutrition Labeling and Education Act
    (NLEA) which amended the Federal Food, Drug, and Cosmetic Act (FD&C
    Act) to modernize food labeling. As part of that legislation, Congress
    included Section 403B of the FD&C Act, 21 U.S.C. 343-1, to require
    national uniformity for most aspects of food labeling. Two areas of
    food regulation were not included under the 1990 national uniformity
    provisions: (1) the food safety provisions of the FD&C Act and (2) food
    warnings. The National Uniformity for Food Act is intended to address
    these two important areas, in order to assure that food is safe
    throughout the Nation and that, whenever some form of warning is
    appropriate, it will be provided in every part of the country.
        It is a conspicuous anomaly that a statutory requirement for
    national uniformity does not currently exist for food safety and food
    warnings for products regulated by FDA. The absence of uniformity in
    these areas is an historic accident that cannot be explained by
    fundamental differences between food safety and all of the other areas
    in which the Congress has provided for consistent and uniform
    regulation. Under the food safety related provisions of the FD&C Act,
    FDA has extensive statutory authority to establish standards for the
    adulteration of foods, establish tolerances or other limits for
    environmental contaminants in food, determine whether food additives,
    color additives and other categories of food ingredients are safe, and
    establish standards for the safe processing and packaging of foods. One
    cannot explain the absence of national uniformity for food safety and
    food warnings by claiming that the authority of the States to regulate
    food is more extensive than the authority that the Congress has given
    to FDA.

                      SUMMARY OF MAIN FEATURES OF S. 3128

        The legislation divides food safety into two categories: (1)
    traditional local matters that have long been the subject of city,
    county, and State regulation and (2) inherently national matters for
    which a consistent policy throughout the country is essential to a
    nationwide market.
        The pending legislation does not include traditional local food
    safety matters within the requirement for national uniformity. For
    example, there are three areas of local food sanitation that have long
    been handled by cooperative Federal/State/industry/academia programs:
    milk production (a program begun in 1923), seafood (begun in 1925), and
    regulation of restaurants, vending machines, and retail food stores
    (begun in 1935). All three of these areas largely involve food
    sanitation and administrative procedures that are excluded from
    national uniformity. Similarly, the economic adulteration provisions of
    the law that have long been handled at the local level are also
    excluded from national uniformity. For example, the illegal addition of
    water or other adulterants to milk, juice, honey, or maple syrup in
    order to deceive the public are not included within this legislation.
    Because each uniquely takes place in a local jurisdiction and
    regulation has no impact upon a nationwide market, there is no need for
    national uniformity in order to preserve the ability of the food
    industry to serve the entire country. As a practical matter, moreover,
    the cooperative programs that have long been used in these areas assure
    widespread uniformity in food sanitation and economic adulteration
    requirements that has served the public so well for decades.
        In contrast, there are inherently national matters for which
    national uniformity is essential to an orderly and free national
    marketplace. Regulation of the safety of natural and synthetic food
    ingredients, color additives, and packaging components must be
    consistent in every jurisdiction in the country in order to permit our
    free market economy to thrive. If differing standards and requirements
    were adopted in each State, and specific ingredients were regarded as
    safe in some States but not in others, there would be economic chaos.
    Thus, national uniformity is applied under this legislation to all of
    these inherently national aspects of food regulation, with three
    exceptions which are addressed later in this testimony.
        I now turn to the provisions of S. 3128 and describe briefly how
    these provisions would operate if enacted. Because there has been so
    much misinformation circulated about S. 3128 (and H.R. 4167, the
    version of the legislation that passed the House of Representatives), I
    also address the major criticisms of the legislation that I conclude
    are without merit.
        S. 3128 contains four main features:

         Uniformity for food safety regulation
         Uniformity for food safety warnings
         Implementation of the legislation and the process for
    consideration of State requirements
         Specific exemptions

        I will address each of these features in turn.
    Uniformity for Food Safety Regulation
        Section 2(a) of S. 3128 provides for uniformity in food safety
    regulation. The bill would do this by amending the existing uniformity
    provision in Section 403A of the FD&C Act (21 U.S.C. 343-1). The bill
    sets forth 10 sections of Federal food safety law under which the vast
    majority of Federal food safety regulation arises and provides that
    State requirements that are the counterpart to these 10 sections must
    be identical. The 10 sections of Federal law that are included in the
    bill relate to adulteration of food, food and color additive
    regulation, regulation of contaminants in food, emergency permits for
    low acid canned food, and animal drugs used in food producing animals.
        The bill defines ``identical'' broadly to encompass many State
    requirements that are not literally identical. As defined in Section
    2(a)(4)(c)(1), ``identical'' means that the language of the State law
    is ``substantially the same'' as the Federal provision and that any
    differences in language do not ``result in the imposition of materially
    different requirements.'' This definition is unique. Ordinarily when
    the Congress enacts legislation to create uniformity it merely requires
    that State law be identical to Federal law. The language in S. 3128,
    however, accommodates differences in the wording of State and Federal
    requirements that do not affect the meaning of the respective
    provisions.
        The premise of this provision of S. 3128 strikes me as
    straightforward: the basic provisions of law--whether Federal or
    State--under which the safety of the food supply is regulated, ought to
    be the same. If a State were to apply different standards to
    determining, for example, whether a food was adulterated, than other
    States or the Federal Government, interstate commerce in food would be
    chaotic.
        The notion that underlying food and drug law at the Federal and
    State levels should be the same is not new. The food and drug laws of
    virtually every State are patterned after the Model State Food and Drug
    Bill which was developed to foster uniformity. The Model State Bill
    was, in turn, patterned after Federal law. For example, Section
    402(a)(1) of the FD&C Act, 21 U.S.C. 342(a)(1), has contained the basic
    food safety standard for 100 years. It provides that a food is
    adulterated if it contains any added poisonous or deleterious substance
    which may render the food injurious to health. This very same provision
    is found in the laws of all 50 States.
        In point of fact, there are very few differences between Federal
    and State food safety laws, which is why I am puzzled that this
    provision of S. 3128 has generated so much discussion. With some
    exceptions, including notably Proposition 65 in California, existing
    differences between Federal and State food safety law are few and
    generally of a minor nature.
        Section 2 of S. 3128 also contains provisions to clarify the
    ability of the States to enforce their identical State laws even in
    circumstances in which FDA has not or does not take enforcement action.
    Thus, under Section 2(a)(4)(c)(2) and (3), a State may enforce its
    identical State food safety law as it deems appropriate if FDA has not
    by regulation or final guidance applied Federal law to the matter in
    question. If there is an FDA regulation or final guidance, however, the
    State may still enforce its identical law, but it must conform that
    enforcement to the FDA regulation or final guidance. Finally, if FDA
    has formally considered a regulation or guidance and affirmatively
    concluded not to adopt one (where, for example, there is insufficient
    scientific evidence to support the adoption of a tolerance by
    regulation), then the State must abide by that FDA decision.
        In my experience, State and local officials routinely consult with
    the FDA when they encounter a food safety problem and they will
    continue to do so under S. 3128. S. 3128 carefully preserves the
    ability of State officials to use the various enforcement tools
    available to them under State law to remove potentially dangerous food
    from the marketplace. It imposes no additional requirement to consult
    with FDA or to obtain the concurrence of FDA to take action. S. 3128
    will help to ensure that, regardless whether it is a State or a Federal
    official deciding whether a food is safe, the standard applied to that
    food will be the same.
    Uniformity for Food Safety Warnings
        The provisions of the national uniformity legislation that relate
    to food warnings are narrowly limited to warnings, and do not apply to
    a large number of other types of statements relating to food. For
    example, the legislation does not apply to directions for use such as
    ``keep refrigerated,'' or to descriptions of the origin of a food such
    as ``free-range-chicken'' or ``farm-raised fish.'' It does not cover
    specialized laws found in many States that require that the term
    ``honey'' can only be used for a food that consists solely of honey, or
    that the term ``maple syrup'' can only be used if the product is made
    solely from the sap of the maple tree, or that ``cider vinegar'' must
    be made solely from apple cider. None of these is in the nature of a
    warning. Finally, the legislation itself excludes non-warning statutes
    and regulations relating to freshness dating, open date labeling, grade
    labeling, a State inspection stamp, religious dietary labeling, organic
    or natural designation, returnable bottle labeling, unit pricing, a
    statement of geographical origin, and dietary supplement regulation.
    None of these involve safety warnings and thus are explicitly excluded
    from the statute. One type of safety warning--a consumer advisory under
    the FDA Food Code relating to the risk of eating raw or undercooked
    food--has also been explicitly excluded from the legislation because it
    is already recommended on a national basis by FDA.
        Thus, there are dozens of State statutes and regulations that are
    excluded from the legislation because they are essentially local in
    nature and do not in any way relate to food safety.
        The national uniformity legislation focuses exclusively on food
    safety warnings. It prohibits a State from imposing any such warning
    that is in addition to or different from a warning imposed by FDA, in
    order to assure that the same information on food safety is provided to
    citizens in every part of the country.
        Section 2(b) of S. 3128 provides for uniformity in food warnings.
    Under that section, States would not be permitted to impose on the food
    industry a requirement to communicate a ``notification requirement for
    a food that provides for a warning'' unless there is a Federal warning
    and the State warning is identical. States would remain free, however,
    to issue their own warnings to citizens of their States, even if there
    is no Federal label warning or if the State-issued warning contradicts
    a Federal warning.
        In order for the warning uniformity language to apply, the State
    requirement must be (1) a notification requirement (2) that contains a
    warning and (3) is imposed on the food industry.
        I am familiar with a report issued by the Center for Science in the
    Public Interest that asserts that nearly 200 State laws will be
    affected by S. 3128 (or the House counterpart). I have examined this
    report and conclude, as have others who have studied it in detail, that
    the CSPI report is incorrect. The CSPI report is incorrect because,
    while it collects numerous examples of State food laws or regulations,
    it assumes erroneously that the uniformity legislation will affect them
    without examining the language of the legislation to determine if that
    is so. For example, there are numerous State laws listed in the CSPI
    report that contain notification requirements for such things as ``keep
    refrigerated,'' or ``farm-raised,'' or that restrict the use of certain
    terms on food products unless certain conditions are met (Massachusetts
    law on halibut and Connecticut law on honey). None of these State laws
    are affected by the uniformity legislation because they are
    notification requirements but not warnings. S. 3128 makes it perfectly
    clear that it reaches only notification requirements that contain food-
    related warnings.
        The most notable State law that would be affected by S. 3128 is
    California's Proposition 65. Proposition 65 was adopted in California
    in 1986 under the State's initiative process. It was promoted as a law
    to ensure the safety of the State's drinking water. As we have come to
    know, Proposition 65 is considerably broader. Under Proposition 65, the
    State maintains a list of chemicals ``known to the State of California
    to cause cancer or reproductive toxicity'' and makes it illegal to
    ``expose'' anyone to a listed chemical without providing a warning.
    California has listed more than 750 chemicals under Proposition 65. The
    law has resulted in a veritable flood of warnings in restaurants, bars,
    grocery stores, hotel lobbies, and elsewhere, as well as major
    litigation about its applicability to various food products.
        Proposition 65 provides for substantial monetary penalties for
    violations ($2,500 per violation per day). In addition to the Attorney
    General, Proposition 65 may be enforced by private persons, which has
    given rise to lawyers who bring private Proposition 65 suits because,
    if successful, they receive not just attorneys fees, but a portion of
    the penalty imposed.
        These suits are expensive to defend and risky to litigate because
    of the financial exposure involved. Many companies, faced with a
    Proposition 65 lawsuit, have elected to reformulate their products to
    remove or reduce the substance in the food that creates the legal
    exposure, rather than engage in protracted litigation.
        Some have characterized these reformulations as ``success stories''
    and as demonstrating that, under Proposition 65, action has been taken
    at the State level to make food safer in situations where the FDA has
    not acted. This argument cannot be sustained.
        Under Proposition 65, chemicals in food are determined to present a
    significant risk by using a vastly different approach to risk
    assessment than that used by FDA and EPA. When assessing the potential
    risk to human health from a chemical shown to cause cancer in animal
    studies, for example, FDA and EPA calculate an upper limit on the risk
    as one potential additional cancer per 1 million persons. California,
    however, used a standard of one additional cancer per 100,000 persons.
    Further, in estimating the potential exposure of a person to a
    chemical, California assumes exposure 24/7 for 70 years. FDA and EPA,
    estimate exposure conservatively, but not constantly throughout one's
    lifetime, as is done under Proposition 65.
        The result of the approach to assessing risk under Proposition 65
    is that significant risk is asserted where it does not exist. Thus, the
    claims that Proposition 65 has resulted in safer food are often not
    correct. If a food contains a chemical in a small quantity such that
    the risk from exposure to it is negligible, forcing the manufacturer
    either to lower the level of the chemical in the food or to face costly
    and uncertain litigation and adverse publicity does not make the food
    less risky. Proposition 65 creates the illusion of safer food while
    simultaneously creating a proliferation of warnings that can only cause
    consumers to believe that ``everything is unsafe.''
    Implementation of the Legislation and Process For Consideration of
            State Requirements
        For both food safety requirements and safety warning requirements,
    the national uniformity legislation divides State laws and regulations
    into two categories: (1) those already existing as of the date of
    enactment of the legislation and (2) those that are the subject of
    State action after the legislation goes into effect.
        For those State laws and regulations that have already been enacted
    and are currently in effect, the legislation provides for a 2-year
    process for FDA consideration as to whether the requirements can be
    justified on the basis of sound science or whether they cannot
    withstand close scrutiny. If a State wishes to abandon a requirement,
    it need do nothing further. If the State desires to continue enforcing
    the requirement, it can petition FDA either for an exemption from
    national uniformity or to adopt the State requirement throughout the
    country. Following a 2-year public process, FDA will make a decision
    based on sound science. That decision may also be appealed to the
    courts. At every stage of this process, the States will be intimately
    involved. If FDA fails to take action as required by the legislation,
    provisions authorize the courts to force the agency to do so. State
    requirements that are the subject of State petitions to FDA remain in
    effect until FDA takes action on the petition, however long that may
    take.
        For future State safety requirements and warnings, there are three
    mechanisms by which a State may adopt provisions that do not conform to
    national uniformity. First, a State may petition FDA for an exemption
    from national uniformity in order to address a local problem. Second,
    the State may petition for a national standard that would impose a
    requirement throughout the country, in order to address a nationwide
    problem. Third, the State may act immediately in order to address an
    imminent hazard to health, for example, an issue of bioterrorism.
        For all three of these areas, the legislation explicitly provides
    that FDA must expedite consideration of any requirement relating to a
    cancer risk or to the safety of pregnant women and children. Again the
    courts are empowered to force FDA to take action if the agency fails to
    do so.
        Some have suggested that FDA will be overwhelmed with petitions
    under the petition process set forth in the legislation for existing
    State requirements. I will be very surprised if this were the case.
    First, as noted earlier in this testimony, there are likely to be very
    few State requirements in effect on enactment that will be affected by
    the legislation. Of the 196 State requirements in the CSPI report, in
    reality only 11 would be affected. Second, to the extent that States
    submit petitions to FDA out of caution, FDA will be able to address
    this summarily and without substantial expenditure of resources.
    Finally, to the extent that FDA is not able to resolve petitions in the
    time periods set forth in the legislation, State requirements will
    remain in effect.
    Food Bioterrorism
        The national uniformity legislation fully recognizes valid concern
    about the potential for bioterrorism through intentional poisoning of
    the food supply. First, States retain all of the enforcement
    authorities that exist under State law. Second, as already noted, any
    State can act immediately under the imminent hazard provision of the
    legislation in the event of food bioterrorism. Third, the entire bill
    will not go into effect unless and until the Secretary of HHS certifies
    to Congress, after consultation with the Department of Homeland
    Security, that implementation will pose no additional risk to the
    public health or safety from terrorism attacks.

                                   CONCLUSION

        The national uniformity legislation explicitly reinforces the
    unique and important role of State officials in enforcing food safety
    requirements. The legislation provides, for example, that it does not
    affect State administrative procedures or enforcement powers. The
    legislation explicitly confirms that States can enforce, at any time,
    local laws and regulations that are the same as the requirements of the
    FD&C Act. And States can at any time issue their own food safety
    warnings to their citizens, even if the State warnings do not conform
    to FDA policy. Thus, States retain substantial authority to protect
    their citizens. In this way, national uniformity is reconciled with the
    fundamental right and duty of a State to protect the public from unsafe
    food.
        The national uniformity legislation represents a balanced approach,
    incorporating both the need for a consistent and coordinated approach
    to food safety and food warnings throughout the country, while
    retaining the authority of States to take the lead on local issues, to
    collaborate with FDA to assure appropriate national regulatory
    requirements, and to cooperate in a comprehensive enforcement system
    that will protect the public in every jurisdiction throughout the
    country.

        Senator Burr. Thank you, Mr. Hutt.
        Dr. Murano.

     STATEMENT OF ELSA A. MURANO, DEAN, COLLEGE OF AGRICULTURE AND
        LIFE SCIENCES, TEXAS A&M UNIVERSITY, COLLEGE STATION, TX

        Dr. Murano. Thank you. My name is Dr. Elsa Murano. I am the
    Dean of the College of Agriculture and Life Sciences at Texas
    A&M University, Director of the Texas Agricultural Experiment
    Station and Vice Chancellor of Agriculture for the Texas A&M
    University system. Mr. Chairman, I am a food microbiologist by
    training, holding a Master's and Ph.D. degrees from Virginia
    Tech in Anaerobic Microbiology and Food Science and Technology.
    In the 1990s, I was Professor of Food Microbiology at Iowa
    State University and then at Texas A&M University.
        From 2001 to 2004, I served as Undersecretary for Food
    Safety at the U.S. Department of Agriculture, where I was
    responsible for developing the policies and programs
    implemented by the Food Safety and Inspection Service or FSIS.
    This public health agency is believed to be the premier public
    health agency in the world, with FDA as a close second. This
    public health agency is charged with ensuring that the Nation's
    commercial suppliers of meat, poultry and egg products is safe,
    wholesome and correctly labeled and packaged. While
    Undersecretary, I was also responsible for representing the
    U.S. Government on the Codex Alimentarius Commission, which is
    an international organization that develops food standards
    guidelines and codes of practice to protect the health of
    consumers, ensure fair trade practices and promote coordination
    of all food standards at the international level.
        Mr. Chairman, S. 3128 would provide a national approach for
    establishing food safety tolerances and inserting warning
    information on the label and related materials for packaged
    foods. The bill would assure a consistent approach to labeling
    information for all 50 States. The proposed law is not a new
    concept as we have heard already this morning. National
    uniformity already exists for most of the U.S. food supply and
    many other products. The laws under which I operated as
    Undersecretary for Food Safety at the USDA are a good example.
    Besides my representing a new concept, S. 3128 is designed to
    ensure that the public is protected and well informed without
    impacting the fundamental food safety laws at the Federal or
    State level or affecting any enforcement authority at the State
    or Federal level. It is through cooperation that exists between
    Federal and State agencies that these activities are carried
    out. A good example of this cooperation is the Food Code. The
    FDA, the Center for Disease Control and Prevention and FSIS all
    contribute to the Food Code to make sure it addresses control
    for risk factors that the Government has identified as causing
    outbreaks of food borne illness. The Code provides food control
    authority at all levels of government, a scientifically sound
    technical and legal basis for regulating the retail and food
    service segment of the industry. In fact, according to the FDA,
    local, State, tribal and Federal regulators use the FDA Food
    Code as a model to develop or update their own food safety
    rules and to be consistent with national food regulatory
    policy. As a trained researcher, as a scientist, I understand
    how science can be used to determine the true risk posed by
    food-borne hazards. As Undersecretary, I put this back on to
    use, applying the scientific principle of hazard analysis,
    epidemiology, risk assessment and statistical sampling in order
    to develop policies that would reduce the risk of illnesses
    such as those caused by E. coli or 157H7, Listeria
    monocytogenes, among others. As a result, the number of
    illnesses caused by these pathogens was reduced by 42 percent
    and 40 percent respectively, as reported last year by the CDC.
    At the USDA, our scientific experts work very hard to develop
    the underlying data used in risk assessments, incorporating
    research also from the entire scientific community, which
    resulted in these public health improvements. Establishing a
    uniform national system will put food safety in the hands of
    the Nation's top food scientists and food safety experts, such
    as those at the USDA and just like USDA, the FDA is best
    positioned to assure that these scientists and experts are
    brought together, whether they come from Federal Government,
    State government or academia. There are few issues that are
    important to point out when applying science. First, science
    sometimes can be misinterpreted by people without sufficient
    expertise. In the area of food safety, a range of different
    interpretations leading to different advice or warnings in
    different States would be obviously problematic. The benefit of
    a national uniformity approach is that it will bring the best
    scientists together to address issues of public health
    significance, thereby helping to determine how best to
    communicate to consumers in all 50 States. Second, sometimes
    obtaining results via the scientific process can take time and
    all the answers to our questions may not be available as
    quickly as we want them to be. In these cases, the Federal
    agencies, as well as the States, have the authority and the
    capability to step in and protect the American public. The
    proposed law includes an eminent hazard authority that would
    retain the authority of the State's health regulators to take
    protective actions on a local basis. Third, sometimes a safety
    issue appears locally, not nationally but because we have a
    national food supply, an action taken locally may not help all
    consumers. If there is a true safety issue, State authorities
    should bring it to the attention of the Federal agencies so
    that it can be confirmed and together, they can take a national
    approach to protect all U.S. consumers. The proposed law
    provides a process to establish national standards in order to
    protect all consumers, not just some. Fourth, on occasion, the
    data will show that a safety issue could truly be local and
    advice or warnings should be provided to consumers in that
    area. The proposed law recognizes this and allows for an
    exemption from national uniformity when a safety issue is
    demonstrated to be unique to a specific State.
        So Mr. Chairman, S. 3128 would provide a national approach
    for establishing food safety tolerances and warning label
    requirements that are consistent in all 50 States.
    Incidentally, this objective is also consistent with activities
    the U.S. Government has been engaged in for international food
    standards. As I mentioned in my opening statements, while at
    USDA, one of my responsibilities was to represent the United
    States as a member Nation of the Codex Alimentarius Commission.
    Allow me to quote very briefly from a Codex document on the
    harmonization of food standards internationally to emphasize
    the value of national uniformity here in the United States,

              ``With respect to the ever-increasing global market, in
            particular, the advantages of having universally uniform food
            standards for the protection of consumers are self evident.''

        It is not surprising, therefore, that the agreement on the
    application of sanitary and pseudo sanitary measures and the
    agreement on technical barriers to trade both encourage the
    international harmonization of food standards. As I think
    Senator Roberts said, it would be ironic for us to be
    supporting harmonization internationally and then here at home,
    allow and even encourage individual States to impose their own
    labeling requirements. In closing, it is incumbent upon those
    who are charged with protecting public health to avail
    themselves with the best data, obtained with the best
    scientific methodology and analyze using sound scientific
    principles in order to provide consumers with the most accurate
    information that can effectively reduce, if not eliminate,
    risks. Federal agencies like the FDA are charged with such a
    mandate and are best equipped to implement it on a nationwide
    basis in order to protect the health of Americans and every one
    over 50 States. In a world in which confusion and
    misinformation can provide either a false sense of security or
    create unwarranted fears in consumers, uniform tolerances and
    labeling requirements as provided by the proposed bill simply
    makes sense. Thank you, Mr. Chairman.
        [The prepared statement of Dr. Murano follows:]

                      Prepared Statement of Elsa A. Murano

        My name is Dr. Elsa Murano, and I am the Dean of the College of
    Agriculture and Life Sciences at Texas A&M University, the Director of
    the Texas Agricultural Experiment Station, which is the agency in the
    State of Texas charged with conducting research in agriculture and the
    life sciences, and the Vice Chancellor of Agriculture for the Texas A&M
    University System. I am a food microbiologist by training, and hold a
    Masters and Ph.D. degree from Virginia Tech in Anaerobic Microbiology
    and Food Science & Technology. During the 1990s, I was professor of
    food microbiology at Iowa State University and then at Texas A&M
    University, where I taught and conducted research in food safety. I am
    very familiar with the scientific process of arriving at solutions to
    problems in food safety, having published dozens of peer-reviewed
    scientific papers, book chapters, and monographs. At Texas A&M, I also
    served as Director of the Center for Food Safety, in charge of research
    in this important area.
        From 2001 to 2004, I served as Undersecretary for Food Safety at
    the U.S. Department of Agriculture (USDA), where I was responsible for
    developing the policies and programs implemented by the Food Safety and
    Inspection Service, or FSIS. This public health Agency is charged with
    ensuring that the Nation's commercial supply of meat, poultry, and egg
    products is safe, wholesome, and correctly labeled and packaged. This
    duty is not limited to domestically produced products, but it also
    extends to ensuring the same for products that are imported from other
    countries. As Undersecretary for Food Safety, I was also responsible
    for representing the U.S. Government at the Codex Alimentarius
    Commission, an international organization created in 1963 by FAO and
    WHO which develops food standards, guidelines and codes of practice to
    protect the health of consumers, ensure fair trade practices, and
    promote coordination of all food standards at the international level.
        As I mentioned, my experience in government was principally with
    USDA-regulated products. However, having worked very closely with my
    counterpart, the Commissioner of the Food and Drug Administration
    (FDA), I can assure you that the same principles we applied at USDA to
    ensure that the products we regulated were safe, wholesome, and
    appropriately labeled, are also employed by FDA for the foods they
    regulate.
        S. 3128 would provide a national approach for establishing food
    safety tolerances and inserting warning information on the labels and
    related materials for packaged foods. The bill would thus assure a
    consistent approach to labeling information for all 50 States. As
    others have pointed out, the proposed law is not a new concept--
    national uniformity already exists for most of the U.S. food supply and
    many other products. In fact, Congress has repeatedly established
    uniform requirements for nutrition labeling, allergen labeling,
    standards and labeling of meat and poultry products, prescription
    drugs, medical devices and pesticide tolerances. The laws under which I
    operated as Undersecretary for Food Safety at USDA are a good example.
    The Federal Meat Inspection Act states that:

              ``Marking, labeling, packaging, or ingredient requirements in
            addition to, or different than, those made under this chapter
            may not be imposed by any State or Territory or the District of
            Columbia with respect to articles prepared at any establishment
            under inspection.'' [21 U.S.C. 678]

        Similarly, in the Poultry Products Inspection Act the Congress
    established uniformity in labeling:

              ``Marking, labeling, packaging, or ingredient requirements
            (or storage or handling requirements found by the Secretary to
            unduly interfere with the free flow of poultry products in
            commerce) in addition to, or different than, those made under
            this chapter may not be imposed by any State or Territory or
            the District of Columbia with respect to articles prepared at
            any official establishment in accordance with the requirements
            under this chapter . . .''[21 U.S.C. 467e]

        As I mentioned before, Congress has on these and many previous
    occasions established nationally uniform requirements for labeling, and
    with good reason. Uniformity in labeling would provide a consistent
    national approach to addressing food safety issues and communicating
    effectively with American consumers important information to safeguard
    their health.
        As mentioned previously, S. 3128 focuses on food safety tolerances
    and warning statements for packaged foods. The bill is designed to
    ensure that the public is protected and well-informed, without
    impacting the fundamental food safety laws at the Federal or State
    level, or affecting any enforcement authority at the State or Federal
    level. In fact, it is impressive to note just how much actual or de
    facto uniformity already exists between the FDA and the USDA and the
    State authorities responsible for food safety. The proposed bill does
    not impact such uniformity at all. For example, the FDA and the State
    Public Health Officials cooperate through the National Conference on
    Interstate Milk Shipments to establish milk sanitation standards and
    procedures for testing and evaluation, thus assuring the safety of the
    Nation's milk supply. FDA and the States cooperate similarly on seafood
    safety. Similarly, FSIS cooperates with States that like to conduct
    their own inspections so that the food safety systems they use are
    equivalent to those used by the Federal agency.
        Another area of cooperation between Federal agencies and their
    cooperation with State and local food safety authorities is the Food
    Code. The FDA, the Centers for Disease Control and Prevention (CDC) and
    the USDA's Food Safety and Inspection Service (FSIS) have all
    contributed to the Food Code to make sure it addresses controls for
    risk factors that the Government has identified as contributors to
    outbreaks of food-borne illnesses, and includes actions designed to
    strengthen the inspection process and improve food safety as product
    moves from the plant to the consumer. The Food Code is updated
    regularly taking into account current science, emerging food safety
    issues, and imminent health hazards related to food safety.
        The Code provides food control authorities at all levels of
    government, a

            ``. . . scientifically sound technical and legal basis for
            regulating the retail and food service segment of the industry
            (restaurants and grocery stores and institutions such as
            nursing homes). Local, State, tribal, and Federal regulators
            use the FDA Food Code as a model to develop or update their own
            food safety rules and to be consistent with national food
            regulatory policy.'' [http://www.cfsan.fda.gov/dms/
            foodcode.html#get05, accessed July 24, 2006.]

        The Association of Food and Drug Officials (AFDO) has reported that
    48 of the 56 States and territories--or 86 percent representing 79
    percent of the U.S. population--have adopted their own food codes
    modeled on the Food Code.
        In fact, the Food Code was, and continues to be, very useful to
    USDA and its efforts with State food safety authorities to assure a
    safe food supply, as it no doubt is for FDA. In my opinion there is
    nothing in proposed S. 3128 that would limit, restrict or compromise
    the Food Code or the State or territorial codes modeled on it. Nor can
    I see anything that would impact FDA's or USDA's other cooperative food
    safety programs with the States.
        As a trained researcher, I understand how science can be used to
    determine the true risk posed by food-borne hazards. As Undersecretary,
    I put this to use, applying the scientific principles of hazard
    analysis, epidemiology, risk assessment, and statistical sampling in
    order to develop policies that would reduce the risk of illnesses such
    as those caused by E. coli O157:H7, Listeria monocytogenes, among
    others. As a result, the number of illnesses caused by these pathogens
    was reduced by 42 percent and 40 percent, respectively, as reported
    last year by the CDC.
        In 2003, application of the scientific principle of risk assessment
    provided me with the information I needed to develop science-based
    regulations that would virtually eliminate the risk of exposure to the
    mad cow disease agent. This assessment, conducted by Harvard
    University, showed that banning brain and spinal cord from animals
    older than 30 months from the food supply would present the greatest
    protection to human health. We quickly developed regulations that
    banned such materials. A follow-up analysis conducted to determine the
    effect of our policies showed that indeed, actions we took in 2003
    virtually eliminated the risk of exposure to this agent.
        At USDA, our scientific experts worked very hard to develop both
    the underlying data used in risk assessments, incorporating research
    from the entire scientific community, and the scientific models on
    which they are based. At the same time, they continue to pursue
    measures designed to reduce acute and chronic risks to public health.
    Establishing a uniform national system will put food safety in the
    hands of the Nation's top food scientists and food safety experts. Just
    like USDA, the FDA is best positioned to assure that these scientists
    and experts are brought together, whether they come from Federal
    Government, State Government, or academia.
        As you have no doubt seen, science is not always absolutely certain
    or complete, and as a result it can be interpreted differently by
    different people. In the area of food safety a range of different
    interpretations, leading to different advice or warnings in different
    States, is obviously problematic. The benefit of a national uniformity
    approach is that it will bring the best scientists together to address
    issues of public health significance, thereby helping to determine how
    best to communicate to consumers in all 50 States.
        It is important to point out that simple warning statements may not
    always be appropriate. Sometimes the science is complex and different
    population groups may be affected differently than others, and
    sometimes an ineptly worded warning statement could cause people to
    avoid certain foods and miss real benefits. This is another reason why
    it is better to have safety issues thoroughly evaluated on a national
    basis before warning statements are considered.
        Sometimes, obtaining results via the scientific process can take
    time and all the answers to our questions may not be available as
    quickly as we want them to be. In these cases, the Federal agencies as
    well as the States have the authority and the capability to step in and
    protect the American public. The proposed law includes an Imminent
    Hazard Authority that would retain the authority of the States' health
    regulators to take the same protective actions on a local basis.
        In other instances, there may be preliminary results that may seem
    to contradict existing data. In these cases, Federal agencies like FDA
    and USDA are best positioned to protect all consumers, given their
    significant resources, experience, and expertise that can be brought to
    bear in reviewing the entire body of scientific evidence in order to
    issue food safety regulations that will actually protect public health.
        Sometimes a safety issue appears locally, not nationally. But
    because we have a national food supply, an action taken locally may not
    help all consumers. If there is a true safety issue, State authorities
    should bring it to the attention of the Federal agencies so that it can
    be confirmed and together they can take a national approach to protect
    all U.S. consumers. The proposed law provides a process to establish
    national standards in order to protect all consumers, not just some.
        Similarly, on occasion, the data will show that a safety issue
    could truly be local, and advice or a warning should be provided to
    consumers in that area. The proposed law recognizes this and allows for
    an exemption from national uniformity when a safety issue is
    demonstrated to be unique to a specific State.
        Again, S. 3128 would provide a national approach for establishing
    food safety tolerances and warning label requirements that are
    consistent in all 50 States. This objective is also consistent with
    activities the U.S. Government has been engaged in for international
    food standards. As I mentioned in my opening statements, while at USDA
    one of my responsibilities was to represent the United States as a
    member Nation of the Codex Alimentarius Commission. In establishing
    this international organization, the Food and Agriculture Organization,
    the World Health Organization, and the member countries felt that

            ``. . . if all countries harmonized their food laws and adopted
            internationally agreed standards, such issues would be dealt
            with naturally. Through harmonization, they envisaged fewer
            barriers to trade and fewer barriers to trade and freer
            movement of food products among countries, which would be to
            the benefit of farmers and their families and would also help
            to reduce hunger and poverty. [Understanding the Codex
            Alimentarius, Rome, 2005 edition, p. 29]

        The Codex, through the agreement of the participating countries,
    sets standards with the dual purpose to assure consumer safety and to
    facilitate international trade in food. These standards cover, among
    other topics, specific foods, food ingredients and additives, food
    hygiene procedures, and food labeling.
        Allow me to quote from a Codex document on the harmonization of
    food standards internationally to emphasize the value of national
    uniformity here in the United States:

              With respect to the ever-increasing global market, in
            particular, the advantages of having universally uniform food
            standards for the protection of consumers are self-evident. It
            is not surprising, therefore, that the agreement on the
            Application of Sanitary and Phytosanitary Measures (SPS
            Agreement) and the Agreement on Technical Barriers to Trade
            (TBT Agreement) both encourage the international harmonization
            of food Standards. [Understanding the Codex Alimentarius, Rome,
            2005 edition, Preface]

        Codex has also commented on the potentially significant problems
    that may occur if countries went their separate ways in setting
    standards and tolerances:

              A principal concern of national governments is that food
            imported from other countries should be safe and not jeopardize
            the health of consumers or pose a threat to the health and
            safety of their animal and plant populations. Consequently,
            governments of importing countries have introduced mandatory
            laws and regulations to eliminate or minimize such threats. In
            the area of food, animal and plant control, these measures
            could be conducive to the creation of barriers to intercountry
            food trade. [Understanding the Codex Alimentarius, Rome, 2005
            edition, p. 29]

        It would be ironic for us to be supporting harmonization
    internationally and then here at home allowing, or even encouraging,
    individual States to impose their own labeling requirements.
        In closing, it is incumbent upon those who are charged with
    protecting public health to avail themselves of the best data, obtained
    with the best scientific methodology, and analyzed using sound
    scientific principles, in order to provide consumers with the most
    accurate information that can effectively reduce, if not eliminate,
    risks. Federal agencies like FDA are charged with such a mandate, and
    are best equipped to implement it on a nationwide basis, in order to
    protect the health of Americans in every one of our 50 States. In a
    world in which confusion and misinformation can provide either a false
    sense of security, or create unwarranted fears in consumers, uniform
    tolerances and labeling requirements, as provided by the proposed bill,
    simply make sense.

        Senator Burr. Thank you, Dr. Murano.
        Mr. Hubbard.

    STATEMENT OF WILLIAM K. HUBBARD, FORMER ASSOCIATE COMMISSIONER
       FOR POLICY, FOOD AND DRUG ADMINISTRATION, CHAPEL HILL, NC

        Mr. Hubbard. Thank you, Mr. Chairman.
        Senator Burr. Push the button, Bill.
        Mr. Hubbard. Thank you, Mr. Chairman. I have submitted
    written testimony, which I will not, in the interest of time,
    read. I'll just make a few brief remarks, if I may. I cannot
    speak formally for the FDA, as you know I have been retired,
    but I think I can give you some of the viewpoints from the
    point of view of the FDA. If I slip up and say we in talking
    about the FDA, please forgive me as old habits die hard.
        Uniformity is a word to go and I would like to say more
    about that. Let me divide my comments up into three points. The
    premise behind the bill, interpretation of the bill and the
    effects of the bill and various implementation by the FDA of
    the bill. First of all, the premise, as you know, is that
    uniformity does not exist and the conflicts are rampant. The
    States and the FDA are very good partners and they've worked
    closely together over the years to develop a relatively
    seamless food safety enforcement system that I believe works
    very well. There, in fact, is great consistency now and
    inconsistencies--they have arisen, I think, have been
    relatively minor and generally get resolved by scientists
    working out the issues. In fact, in my 20 years of working on
    this issue, I've never had a consumer tell me he was confused
    by State labels that differ from Federal or I've never gotten a
    letter. The industry has often said that and I think that there
    are specific examples of where particular companies have had a
    problem and we heard one today but there has been very little
    evidence of a negative impact, is my view. I served on the
    Regan panel that looked extensively at this. I think they, in
    fact, weren't assigned the kind of inconsistency the industry
    alleged and after a very lengthy study, concluded that there
    just wasn't the sort of impact that was being alleged. That was
    repeated again in the Bush administration, repeated again in
    the Clinton administration. There has just been no adverse
    impact at the level that I think people often say. And the
    conclusion of all of these public officials over the years is
    that there has not been an adverse effect, impact and the
    action should be taken only if a serious problem does emerge.
    So to some extent, Mr. Chairman, I feel that this is a bill
    with a solution in search of a problem.
        Only--pushed the bill into effect so I will not at all go
    into the provisions of the bill. There is voluminous
    documentation that I hope you've not attempted to read about
    all of these points that have been made today, between the
    industry and the opposing groups. They are obviously opposed. I
    think the fact that you have a consensus among State Attorneys
    General, Food and Drug officials in the States, consumer
    interest groups, that this will have very negative impacts. I
    think it is something to listen to. But I am particularly
    concerned that there are vast differences of opinion about what
    the language even does or what it means and that--intent of
    Congress before this bill proceeds. Please don't raise this
    ambiguity that clearly exists between the competing parties.
    Nail all of the FDA scientists or the courts. I would beg you
    to look very closely at the differences of opinion and try to
    get those resolved because they are diametrically opposed and
    someone is right or someone is wrong or there is truth in the
    middle and I don't know which is which.
        Last, I don't believe the FDA can implement this bill, Mr.
    Chairman. The food program of the FDA has undergone tremendous
    budget cuts in recent years. They've gone from being able to do
    35,000 inspections of food facilities in 1972 to perhaps 5,000
    today. When Proposition 65 was enacted, there were perhaps
    100,000 imports of food coming to the United States. There will
    soon be 10 million coming into the United States. You took the
    lead on a very important bioterrorism bill that included a
    registration provision. FDA now has 200,000 registrants
    domestically and perhaps another 100,000 foreign. That's
    300,000 food firms that they should be looking at and they can
    look at 5,000 a year. So to put on that system an additional
    burden of taking on State responsibilities, I am very concerned
    about. The FDA headquarters' staff that want to do this work,
    if this bill passes, has been reduced by 10 percent in just the
    last 2 years and is going down further. Overall, the food
    program at FDA, which includes--has lost hundreds of people
    since 1903 alone, at a time in which the Congress is saying
    worry more about bioterrorism. Be more active. I am very
    concerned about that. The program is weaker than at any time
    since the 1960s and the President's budget commands FDA to
    further reduce the food safety effort and put it over into
    terrorism, a worthy goal. But Dr. Murano mentions that the meat
    program has preemption. I think if the FDA got nine times more
    staff, as USDA does, including stackers, I think they would be
    very willing to say to you, we can do it now. But I don't think
    that's in the cards. When you've got an agency that has such
    pervasive regulatory influence over a problem such as the meat
    program or when you take a food label in the FDA, preemption, I
    believe, is appropriate because you have an area where the
    States will not inflate and the Federal Government came in to
    no votes and took control and I think that is a good idea. In
    the case of food safety, the States were doing this long before
    the FDA was created.
        Last, I'll point out this petition process. Mr. Hutt may be
    right but certainly the Congressional Budget Office says there
    will be many petitions. I must tell you that the call petition
    process of the FDA is broken. They have a backlog of over 200
    petitions now. Last year, they were able to get nine done. The
    backlog actually grows every year. If S. 3128 passes, the FDA
    can't implement it, Mr. Chairman. They cannot do it. If the CEO
    is correct and they'll get 200 petitions, virtually the entire
    food headquarters staff will drop everything else and do
    nothing but review these petitions. If the food industry is
    right, that there will be 300 of these petitions, they will
    drop everything and do nothing but this and still fail and of
    course, this is not a subjective determination. I can tell you
    objectively, they will fail massively in implementing a bill
    like this or they will be forced to simply tell you no, we
    can't do it and to stand there and do nothing.
        Either way, that is a very bad outcome for the public
    health and for the agency. So, in sum, Mr. Chairman, while
    consistency is a worthy goal, I think the bill appears to be
    unjustified by the current circumstances. It is lacking clarity
    about its extent and effects as we see from these differing
    opinions and I truly believe, Mr. Chairman, that it is
    impossible to regionally implement by the FDA under current
    circumstances and current resource levels. Thank you for your
    attention.
        [The prepared statement of Mr. Hubbard follows:]

                    Prepared Statement of William K. Hubbard

        Thank you, Mr. Chairman, for inviting me to present views today on
    S. 3128, The National Uniformity for Food Act of 2006. I am William K.
    Hubbard, and until recently was an official of the Food and Drug
    Administration. I retired in 2005 after 33 years of Federal service,
    the last 14 of which were as an Associate Commissioner at the FDA. The
    issue of national uniformity for food safety laws was one in which I
    was involved repeatedly over the years, as successive Presidential
    Administrations sought FDA advice when they examined this issue.
        Let me begin by observing that protecting citizens from unsafe food
    is a quintessential governmental function. Even before the creation of
    the United States, individual States (then colonies) were establishing
    laws protecting the public from hazards that could be intentionally or
    mistakenly placed in food sold in the marketplace. That role grew as
    commerce in food expanded, until, a century ago, in 1906, Congress
    determined that a Federal food safety role should be established as
    well, in the forms we know today as the Food and Drug Administration
    and the Agriculture Department's meat inspection program. With this
    addition of a Federal food safety structure, State and Federal food
    safety officials have become closely allied partners in protecting our
    citizens from unsafe food--sharing scientific data about potential
    risks to foods, cooperating on inspecting food manufacturing
    facilities, responding to outbreaks of foodborne illness, removing
    hazardous food from the market, and devising similar regulatory
    structures for overseeing the safety of the food supply.
        Together, State and Federal health officials have developed a
    modern, science-based infrastructure that, along with the hard work and
    dedication to high standards of food producers, has given Americans a
    food supply of unparalleled abundance, affordability, quality,
    nutritional variety, and safety. There is no doubt that this system has
    served the Nation well, and that State and Federal food safety programs
    have not only co-existed, but have evolved to protect our citizens
    using essentially the same scientific standards, regulatory mechanisms
    and statutory constructs. Indeed, most States, in an effort to
    harmonize with the judgment of Congress, have enacted food and drug
    laws identical or quite similar to the provisions of the Food, Drug and
    Cosmetic Act (the principal source of FDA's food safety authority).
    There have, over the years, been occasional instances in which FDA and
    State determination about product safety (and their concomitant public
    warnings) have differed. But those instances have been relatively rare,
    and generally have been worked out amicably among the scientists
    involved. There certainly has not been the sort of mass conflict and
    confusion that would warrant a fundamental undermining of the strong
    Federal/State partnership that currently exists. And the States have
    served the valuable function at times of being the first to identify a
    health risk and, through their actions to protect their own citizens,
    have alerted the FDA, so that it could extend such protections
    nationally.
        The issue before the committee today, of course, is whether
    Congress should preempt the laws of the States, in deference to the
    regulatory role of the FDA. There are certainly examples where Congress
    has done so. For example, USDA has meat inspectors in every
    slaughterhouse while that facility is processing meat, and a separate
    State function would be redundant. When Congress required all foods to
    bear nutrition labeling in 1990, it judged that a single Federal
    standard was appropriate, as the States had no separate nutritional
    labeling requirements at that time and FDA was authorized to create a
    strong, enforceable national standard. Most recently, Congress
    established standards for labeling the 8 major food allergens, and gave
    those preemptive effect.
        However, in the case of contaminants in the food supply, Congress
    has never done so, and the circumstances are much different. The
    States' role in protecting against adulterated foods long pre-dates the
    creation of the FDA, and the FDA's ability to adequately oversee such
    potential threats to the food supply is inadequate today and growing
    weaker each year. So it is ironic that at this time Congress would be
    considering legislation that would remove a valuable food safety tool,
    and perhaps provide incentives to further weaken FDA. Let me explain
    the basis for those conclusions.
        In 1972, FDA's food program constituted approximately one-half of
    the FDA's efforts, in terms of the agency's resource allocation. Today,
    it is about one-quarter, even though FDA has little more staff than it
    had in the 1970s. Likewise, 34 years ago, FDA conducted 35,000
    inspections of food manufacturing facilities. This year, they will do
    perhaps 5,000. The volume of food imports from overseas is approaching
    10 million per year, and the number that FDA inspectors physically
    examine is in the single digit thousands--making it virtually certain
    that any given food shipment will enter the United States with no FDA
    inspection. I could provide many more similar statistics, all of which
    paint a picture of an FDA regulatory structure that is under-resourced,
    under-staffed, and essentially incapable of meeting the growing demands
    to oversee food production, food additives, cosmetics, dietary
    supplements, nutrition labeling, foods produced from biotechnology,
    foodborne disease outbreaks, dangerous new pathogens that infect food,
    pesticides, and the many other responsibilities of that program. And,
    most recently, the President has proposed diverting traditional food
    safety resources toward protecting the Nation against terrorism threats
    to the food supply--a worthy effort, but one that will force FDA to
    rely even more on State food safety efforts.
        Yet S. 3128, in the name of ``uniformity,'' would remove FDA's
    partner in protecting against food adulteration, and throw even more
    responsibilities at the agency--in effect, moving problem solving from
    a source that has proven to be an effective complement to Federal
    authorities to one that cannot accept more responsibility and will thus
    be ineffective. Further, because the States' ability to deter
    adulterated foods would be weakened, and with FDA the only alternative,
    producers of food about which safety concerns have been raised would
    have incentives to maintain a weak FDA.
        FDA's resource shortfalls beg for a focus on the mechanism embodied
    in S. 3128 to permit the States to act against adulterated food. The
    bill would create a petition process whereby a State wishing to
    maintain an existing standard, or create a new one, would petition FDA
    either for an exemption from preemption or to create a uniform,
    national standard. This provision is simply impracticable. First, FDA
    has shown demonstrably that resource constraints prevent it from
    processing the flow of citizen petitions that it currently receives. In
    fact, the agency slips further behind each year in its handling of
    citizen petitions; there is now a backlog of over 200 citizen petitions
    in the queue for response in the food program alone, many dating back
    several years; and that program managed to respond to only 9 petitions
    in all of 2005. Adding yet another flood of petitions to this already-
    overwhelmed system would merely build in additional failure.
        But I can describe an even more dismal prospect regarding FDA's
    ability to respond to the petitions envisioned by S. 3128. The
    Congressional Budget Office assumes that FDA will receive at least 200
    State petitions during the first year after the bill's enactment, and
    that it will cost $400,000 to review each petition. So FDA would be
    required to spend $80 million to answer those petitions--for no
    discernible public health gain. Mr. Chairman, the entire budget for
    salaries and expenses of the scientists in FDA's headquarters food
    program is under $100 million, so this bill, if enacted, would
    essentially mean that the food program would need to cease all other
    functions except for the review of State petitions, if it were to make
    a sincere effort to comply with Congress's charge. If the industry's
    prediction, that FDA would receive over 300 petitions from California
    alone, is correct, the effort to address the petitions would require
    more resources than the agency's food program possesses, meaning that
    FDA could not accomplish the goal even if ALL food headquarters staff
    were assigned only to petition review. Or, if FDA chose not to engage
    in this decimation of the agency's food safety programs, it could be
    forced to basically ignore the statute, thus setting the stage for
    great confusion, potentially endless lawsuits, and a vacuum in both
    State and Federal protection against food adulterants.
        I would add that it is very unclear what the bill preempts. The
    dispute between the food industry and others--whether the State
    Attorneys General, State food safety officials, or the Center for
    Science in the Public Interest--about the number of laws preempted is a
    good indicator of that ambiguity. There is a very real question whether
    most State enforcement actions will be met with a rejoinder that the
    action is preempted by this bill. Resolving such disputes through the
    courts will add significantly to State enforcement costs and inevitably
    reduce the volume of enforcement the States can undertake. Obviously,
    FDA will not have resources to take up any slack.
        The bill does not give preemptive effect only to requirements
    imposed by FDA by regulation. Instead, it appears to completely
    eliminate State safety notifications, whether the FDA has acted or not.
    In terms of enforcing State safety standards themselves, the bill
    starts at the top, broadly preempting State safety requirements unless
    they are identical to Federal requirements. It then allows States to
    enforce only those State requirements that are identical to existing
    FDA requirements, or even guidances, which are non-binding FDA
    advisories to industry. Localities, such as New York City, are
    apparently preempted from enforcing their own requirements. While
    preemption focused on circumstances when FDA has made a well-
    reasoned determination can make sense, it is difficult to see a problem
    that supports such a broad preemption. Further, the bill would not
    require that FDA step in (even if it had the resources) and replace
    State and local laws that might be necessary, further exacerbating the
    vacuum in safety oversight that the bill would create.
        In conclusion, Mr. Chairman, when a well resourced FDA has been
    able to examine a potential health risk in food, bringing to bear the
    best scientific data and analytical ability, and resulting in the
    establishment of a reasoned determination--whether to bless a
    substance's safety, to require safety warnings to consumers, or to ban
    the substance--it would be reasonable to consider whether that
    determination should be dispositive for the entire Nation, and whether
    States should second guess such a carefully reasoned disposition.
    However, until and unless FDA is given the resources and ability to
    deal with any and all questions about the safety of food constituents,
    I believe that the existing Federal/State cooperative relationship has
    passed the test of time in its effectiveness and ability to work
    together to protect our citizenry. Not only does the current system
    work well, but there is little evidence of a problem now that would
    justify the broad preemption envisioned by the bill, and no reason to
    believe that there will be a problem in the future. The vast majority
    of State attorneys general agree with that conclusion, as do the
    States' food and drug officials, and virtually all consumer interest
    groups. That practical consensus of opposition to S. 3128 should be
    seen as a significant cautionary message about this bill. Adding in
    FDA's absolute inability to implement this bill in any reasonable
    fashion should raise those caution flags even higher.
        Thank you for giving me the opportunity to comment on this
    important matter.

        Senator Burr. Bill, thank you. It is the intent of the
    Chair to recognize the Senator from Georgia first for questions
    but let me say, from 1995 to 1997, the FDA, as we worked on FDA
    modernization, said we can't absorb that type of change. Well,
    we did it and we went from, I believe, eight applications
    approved in 1997 to 81 in 1998. What we found was that
    sometimes when you find a system that is broken, our
    responsibility is to fix it. I don't think that is a suggestion
    that we didn't take on FDA modernization or that the FDA
    shouldn't exercise what is their mission and their
    responsibility as it relates to food safety. I think that if
    there is one individual and certainly we have one today, it's
    probably fairly easy for Mr. Stadtlander to say, ``You know,
    it's not worth selling cereal in California. I'm just going to
    pull the damn thing off the shelf.'' But it's not just losing
    $70,000-$80,000 worth of revenue. In his case, it is a multi-
    million dollar lawsuit that he has to defend, so to suggest
    that there is not an impact, I think, is to ignore what's going
    on. We've got ample time with the few members that are here to
    explore a number of different areas and I'll take the
    opportunity to do that with all of you. But I do want to
    recognize the Senator from Georgia first, for a line of
    questions.
        Senator Isakson. Well, thank you, Senator Burr and I
    apologize to the panelists for missing your live testimony but
    I had to go cast a vote in the Small Business committee. My
    experience in the private sector is not with the processing of
    food. I was in the construction and housing industry. By
    California standards, caused problematic issues even in that
    because California would have a standard, for example, in terms
    of suspended particles in the air and you'd get a lawsuit going
    and somebody would go find the California standard and you'd
    get sued in Georgia for not meeting a California standard even
    though it didn't apply because it was by that State. So it cost
    me and I got involved in one of those one time, it caused me to
    think of a few things and Mr. Hutt, again I apologize. I didn't
    hear your testimony but you're an attorney and I'm assuming
    that when you have a variety of different standards or an
    inconsistency of standards nationwide, that the practical
    effect of those inconsistencies for the mass producer of almost
    any product ends up being a lot of litigation. Is that correct
    or am I wrong?
        Mr. Hutt. You have only two options. Either you meet the
    toughest standard in the entire Nation or yes, you are subject
    to numerous lawsuits.
        Senator Isakson. Mr. Stadtlander, I read part of your
    testimony with regard to the product, Wheatena?
        Mr. Stadtlander. Yes, right.
        Senator Isakson. OK. And you produce your product
    uniformly, I guess, at a production facility, is that correct?
        Mr. Stadtlander. Yes, sir.
        Senator Isakson. So, in the case of this product, because
    of the Acrylamide or whatever that element was, you then,
    because of the California standard, just not sell in
    California? Or do you have to go into a separate processing
    facility or labeling facility? Tell me how you deal with that.
        Mr. Stadtlander. Wheatena, as well as 40 percent of the
    food that people in this room consume, would have Acrylamide as
    a byproduct, so it is impossible to sell these products without
    having Acrylamide because it is a byproduct of toasting.
    Otherwise, you'd be eating raw wheat or oats. As soon as you
    cook them--and it can be cooked at home, it doesn't need to be
    done by a manufacturer--you end up with Acrylamide. So the
    first answer to your question, it is impossible for the vast
    majority, 40 percent of what you're eating, to remove
    Acrylamide. That's the first thing. So the options are warning
    people on 40 percent of the food supply, that it may cause
    cancer, negating or confusing consumers when the Federal
    Government is saying I may reduce the risk of cancer because of
    high fiber content. So this package, to conform to California
    law, would say, may reduce the risk of cancer, Federal law and
    may cause cancer, California law. That's what I would be
    selling on the marketplace. It doesn't work that way. The other
    thing is, in terms of California saying this works, the 40
    percent of the food supply that so-called may cause cancer
    because of Acrylamide, which is strictly California--the rest
    of the world has reviewed this and no one is coming to that
    conclusion of warning people on food supply. You end up with
    suits. So the suit I'm involved in right now, is the law firm
    says, we're suing because you didn't warn consumers. If you
    give me $250,000, I'll go away. I'm saying I'm not doing it.
    I'm selling a healthy product so California is still to be
    resolved because the 40 percent of the food supply that has
    Acrylamide is not warning consumers today that it may cause
    cancer. That's why the court is backed up with suits because
    manufacturers are saying, I can't remove it and I'm not going
    to label it or I can't label it strictly for the State of
    California and 49 other States are going to have a cancer
    warning on my product. Manufacturers are not going to do that.
        Senator Isakson. So Acrylamide is a natural occurring
    element we cannot control?
        Mr. Stadtlander. Exactly right, including if you toasted
    something at home. So it's not just manufacturers. I'm saying
    what you'd be doing is not selling ovens any more because you
    create Acrylamide anytime you'd put a starch product in your
    cooking facility.
        Mr. Hutt. And that's not the only instance of naturally
    occurring substances that the California Proposition 65 applies
    to. There are suits on mercury in fish, which is naturally
    occurring, the lead in calcium, which is naturally occurring,
    the cancer-causing substances every time you grill a steak,
    charcoal broiled steak, every one in the country produces
    carcinogens and there are lawsuits on that. There is no end to
    this type of litigation in California.
        Senator Isakson. Well, that was the reason. And again, I'm
    sorry I missed both of your testimony but the reason I brought
    the question up was because in my private life, my experience
    is that when you have a lack of uniformity, all you do is open
    up people who are doing good things in honorable businesses to
    be in court all the time, spending their money trying to defend
    something. But in the case of this, you couldn't have had any
    control over it anyway. Dr. Murano, I'm sorry I missed your
    testimony but which side do you come down on as the
    distinguished Head of the College of Agriculture, I think that
    is correct.
        Dr. Murano. Yes, sir. Well, as a scientist I have to tell
    you that you've got to use science in order to make the best
    decisions possible when it comes to food safety, for sure and
    to simply say that because there is a certain substance or
    ingredient in a food that may cause adverse effects, that that
    warrants a label, is irresponsible because as I think the
    gentleman at the other table said, there are so many foods that
    contain naturally occurring substances that, given enough of a
    dose, perhaps will make an adverse effect but yet the doses
    that we're exposed to, science has not shown to cause any
    adverse effect. It makes absolutely no sense and frankly
    affects the credibility of whatever agency requires such a
    label to be put on there because consumers will soon realize
    that if there is a warning on everything, because everything
    basically has a component that potentially could be harmful if
    consumed in high enough levels, then it ceases to have an
    impact. The credibility of the agency is compromised and
    frankly, as I was mentioning in my testimony, on the
    international arena, we have to abide by good, sound science
    because if we don't, we're surely prone to be accused by other
    countries of setting up false trade barriers because we're not
    basing them on science.
        Senator Isakson. Thank you and I know my time is up but I
    did want to ask one question, Mr. Hubbard. Mr. Hubbard, do you
    think the FDA does a good job with the drug industry?
        Mr. Hubbard. Actually I do. I think it is a very good job.
    Congress has given the FDA pervasive regulatory authority over
    drugs to oversee their testing, their approval and the
    manufacturing and marketing. In fact, when California has
    attempted to step into the drug area, the FDA has been
    assertive in saying, ``Do not put a warning label on these
    products because we know these products better than you do.''
    And we have tangled with them and we have prevailed. The
    problem here is that on the third side, you have a much less
    pervasive authority, much weaker program, much less information
    and the FDA has relied traditionally upon the States to be a
    strong partner in protecting the public against unsafe foods.
        Senator Isakson. But I would assume that if the FDA had the
    authority over food like it has over drugs, they could do a
    good job.
        Mr. Hubbard. Whenever we have made a sound determination
    based on good science, about the safety of a product, whether
    to leave it on the market, take it off the market or label it,
    we have stood by that and we have told States, do not come up
    with a different answer. We have brought the science to bear
    and made the decisions and I said, we've tangle with California
    on this and I think we've prevailed. Generally we work it out
    in a scientist to scientist fashion. A few times we literally
    had to threaten them but those are occasions when FDA had the
    scientific leadership on the issue. That was not necessarily
    the case here. If I could comment on the Acrylamide, if I may.
    Acrylamide is really an example of both points of view.
    Acrylamide came as a surprise to the whole world for its safety
    risk in 2002. People have been screaming to understand what it
    means and the fact that the consensus said high levels of
    Acrylamide might cause cancer. However, it is in many, many of
    our foods and FDA has been trying to say to the industry, let's
    get it out but give them time. Let's don't scare people that
    there is an immediate risk. California has done a similar
    thing. They have stayed their rulemaking to give folks the time
    to understand that. Mr. Stadtlander is a victim of thing called
    a bounty hunter, which is a human provision they have in
    California which a trial lawyer can go to court on its own. I
    certainly hope personally that a judge will say, to the various
    food safety authorities who are looking at this, Mr.
    Stadtlander should not be punished because it is in many, many
    foods and you should not be singled out because his product has
    Acrylamide when so many others do. I will say, however,
    California put Acrylamide on their cancer warning list in the
    late 1980s so they kind of got there first and he, I think,
    started marketing his product many years later. But again, I
    don't want to defend the bounty hunter provision. There are
    some potential issues there that I think would be fair for you
    to look at.
        Senator Isakson. You ought to send that testimony to your
    lawyer. I think it will help. Thank you, Mr. Chairman.
        Senator Burr. I'm not so sure anything will help short of
    the amount of money you're going to have to pay your lawyer to
    hopefully get to a reasonable judge on the bench that makes a
    determination this shouldn't go forward. Unfortunately at the
    end of the day, it's going to cost you a lot of money. Without
    objection, I would ask that the entire testimonies of all of
    our witnesses be put into the record. It is my intent to share
    whatever time with my colleague from Georgia and if we're
    joined by any other member, to also include them. And I'm going
    to attempt to work my way down the line, if I can, and try to
    help enlighten us on not only what the current law is, what the
    language in this bill says, and how it affects current law, be
    it Proposition 65 or anything else. Let me ask you, Mr.
    Stadtlander, has any other State raised an issue, other than
    California, on Wheatena?
        Mr. Stadtlander. No.
        Senator Burr. Would it be possible to make a Wheatena box
    with a warning label just for California sales or does that,
    over and above the fact that you'd be saying contradictory
    things--lessen the chance of cancer and contributes to cancer--
    what does that challenge you to do in your distribution
    process?
        Mr. Stadtlander. From a commercial standpoint, it is
    virtually impossible if you're selling--basically, I'm selling
    in 50 different States. For me to have a separate label
    specifically for California, the chains that I sell through,
    people like Kroger, et cetera, have warehouses where they pull
    from for different States. They have diverters that buy product
    and move it across the country, so to have a label specifically
    for California would be, I don't want to say impossible, but
    extremely difficult, in the same way that chains, like the
    Krogers of the world, who normally would take a product in and
    distribute to all Krogers, so that would be one challenge. If
    you had a separate product for the State of California, and
    they ordered that separately, you would then still have
    confusion because what you would need is, the chains that
    specifically say this store is getting this product and that
    store is not going to get this product. So from a practical
    standpoint, it is impractical to virtually impossible to
    control that.
        Senator Burr. You actually described a process though,
    where a stock person in a chain grocery store could, in fact,
    have two boxes, one marked for California and one marked for
    the other 49. A minimum wage worker may make a mistake and put
    on the shelves in California through a distribution truck, a
    box not labeled for California and you as a company would then
    be liable not by a bounty hunter but by the State, once the
    State promulgated those rules, even if you were well-
    intentioned to do that, that could happen to you?
        Mr. Stadtlander. Yes.
        Senator Burr. Mr. Hutt, is Mr. Stadtlander alone?
        Mr. Hutt. He is not alone.
        Senator Burr. The only one in the country that has got this
    problem?
        Mr. Hutt. The entire food industry is endangered here
    because as he pointed out, you can't eliminate, based on
    current science, Acrylamide from food and unfortunately, if
    Bill Hubbard were running California, we would have no problem
    but he's not. And the people who he deals--or used to deal with
    in the California government agency, are not the people who are
    running this show. It's the attorney general who has political
    ambitions to go higher and it's the bounty hunters who have an
    enormous economic stake here. They've been earning millions of
    dollars based on this litigation. If you take a look at all the
    food products involved, let's talk about mercury in fish, which
    as I already pointed out, is naturally occurring.
        Senator Burr. Could you also, as you talk about mercury in
    fish, take us through the most current court case that
    manufacturers challenged and won?
        Mr. Hutt. I'd be happy to do that. The court in California
    turned back the case that was brought again by the State--not
    by a bounty hunter but by the State of California. It was
    masterminded by the office of the Attorney General and the
    court said on three separate grounds, that the State of
    California's mercury level for fish was wrong. First they said
    it was not backed up by sound science. Second, they said--and
    in fact, what they said was that the State scientific witnesses
    had no scientific credibility. It was a remarkable opinion in
    that respect. Second, they said that deference should be given,
    under the Doctrine of Primary Jurisdiction, to the views of the
    FDA because the FDA thoroughly opposed the way that California
    was trying to bring that case. And finally, they said that the
    mercury was naturally occurring. It wasn't put in there by
    humans. Mercury is prevalent throughout the environment and
    thus, for those three reasons, the court threw out the
    California case. Now, the same might happen with Acrylamide.
    But Bill is going to have to pay millions of dollars if he
    wants to litigate that case in California. The same, presumably
    I hope would happen, with regard to benzthanrozine and other
    carcinogens in steak, in chicken and in any other cooked meat,
    we don't need a warning on every piece of meat in California.
    That is not--I'm sure Dr. Murano, you would agree with that,
    from your experience at USDA. So we're talking about the entire
    food industry being at risk here. If Bill Hubbard could
    negotiate with the State officials on a science basis, none of
    this would have occurred.
        Senator Burr. Do you think the lawsuits that truly do come
    out of Prop 65 have peaked or are we going to see a
    continuation of a climb in lawsuits?
        Mr. Hutt. Well, I'm afraid that my profession, other
    members of my profession--I'm not a trial lawyer--have found a
    gold mine in California and I don't think they will stop.
        Senator Burr. Senator Feinstein, in her comments, talked
    about bioterrorism. Would S. 3128 impair the ability of a State
    to take action in the case of food bioterrorism, in your
    estimation, or any other food safety emergency?
        Mr. Hutt. There are two provisions in the law that make it
    clear that it would not, in any way, impede the State. The
    first provision says that the bill cannot go into effect at all
    unless the Department of Homeland Security certifies to the
    Department of Health and Human Services, that there would be no
    impairment of bioterrorism protection. That's the first
    provision. The second one authorizes any State to act in the
    event of an emergency, an imminent hazard to health so that
    bioterrorism is covered fully in this legislation.
        Senator Burr. One additional question, if I could. The
    Center for Science in the Public Interest released a study that
    concluded that nearly 200 State laws would be affected by the
    National Uniformity legislation. Do you agree with their
    conclusions?
        Mr. Hutt. Well, their conclusions, as I testified earlier,
    are just dead wrong. They do not read the legislation. For
    example, the sanitation--I'll just give one example--the
    sanitation provisions of the Federal Food, Drug and Cosmetic
    Act under which restaurants and shellfish and milk--those three
    are regulated. Those are not covered by national uniformity but
    CSPI keeps saying, knowing that it is untrue, that they are
    covered. Even if you take a look, for example, at the history
    of these three types of regulatory programs, the Milk Program
    that was begun 1923 by the Public Health Service, the National
    Shellfish Program that started in 1925 and the third one, the
    restaurants, in 1935. They are authorized under the Public
    Health Service Act. They are not even conducted under the
    Federal Food, Drug and Cosmetic Act and they are not subject in
    any way, shape or manner, to any form of national uniformity,
    under this legislation. The legislative history is clear and
    indeed, the statute or the bill, is clear. I agree with Bill
    Hubbard. The legislation should be clear. I don't know how it
    could be made any clearer.
        Senator Burr. Thank you. Thank you for that and I think we
    all agree that we should require more people to actually read
    the legislation before they comment on the contents and the
    effects of the legislation. Dr. Murano, has uniform regulation
    of products under the USDA been a good thing?
        Dr. Murano. It has been a great thing. It's been great when
    we were faced with outbreaks of food-borne illness, the E. coli
    in undercooked hamburger meat, for example, because we were
    able to very, very quickly, as we developed policies that could
    be enacted nationwide without any obstacles to really getting
    that implemented as quickly as one could. When we, for example,
    implemented some new policies regarding ways to avoid exposure
    to the Mad Cow Disease agent and we put policy that removed
    certain high-risk materials from the food supply, again having
    that authority to do it nationwide by virtue of one piece of
    regulation, gave us a tremendous advantage because we were able
    to not only protect the public's health, which is uppermost in
    our consideration but also had the credibility worldwide that
    what we were doing was going to be implemented nationwide and
    was going to be backed up and it was backed up by scientific
    studies, risk assessments that were conducted by Harvard
    University that had been shown, now most recently by a further
    study of the impact of our regulation to have been the most
    significant thing we could have done to prevent exposure to the
    Mad Cow Disease agent and protect the public's health.
        Senator Burr. Do you feel that there is enough evidence-
    based science behind the food-related activities in
    California's Proposition 65?
        Dr. Murano. If we take, for example, the Acrylamide
    question, since that is the one that affects the discussion
    here this morning as a good example, there is evidence
    certainly that Acrylamide may cause cancer. It has been shown
    to do so in laboratory animals. But the levels at which
    Acrylamide is naturally found in all the many foods that have
    been mentioned already, including good coffee by the way, so if
    you had coffee this morning, you consumed a little bit of
    Acrylamide but what is a little bit? A little bit, we're
    talking about microgram amounts and even less than that and the
    scientific evidence is just not there to support any claim of
    that being a hazard to human health at all whatsoever. So the
    question here is, if you have a substance in a food, naturally
    occurring or otherwise--what science does for us is it permits
    us to figure out what is the dose, the exposure level that will
    cause a detrimental effect and if that exposure level is not
    met because the amounts are so well below that tolerance level,
    then it is not a hazard to human health and it is
    misinformation to put a warning on a product simply because
    there is the presence of a certain amount. If it is below a
    tolerance level, if it is below a level that has been shown to
    cause deleterious effects, then it is not a hazard, by
    definition, by scientific definition.
        Mr. Chairman, I just wanted to add something somewhat
    unrelated to your question--and I feel compelled to do so
    because my colleague is formally from FDA as I am formally with
    the USDA--I wanted to point out when I was Undersecretary, I
    worked very closely with the Commissioner of FDA to make sure
    that if the FDA needed help or assistance--for example, in
    conducting inspections or any other function that our
    inspection force could help them with--they could deputize our
    inspectors to do so. There are Federal agencies that work for
    the good of public health and we work together and we have a
    Memorandum of Understanding and other agreements in order to be
    able to maximize the resources that we are both given. So I
    feel certain that if this legislation becomes law that the
    resources of the Federal Government would be put to use and in
    fact, if FDA needed assistance from other agencies, those
    agencies would certainly assist them.
        Mr. Hubbard. Mr. Chairman, if it is not tomorrow, in fact,
    Mr. Burr's bioterrorism bill of a couple years ago did in fact
    do that. It gave FDA the authority to deputize and that is
    working very well and I think everyone is appreciative of your
    leadership on that.
        Senator Burr. Thank you for that. I'm curious and I should
    know the answer to this but all of the products that might
    resemble yours, from the standpoint of makeup and crackers and
    other things, do they all have to have that warning or is there
    a threshold that you hit from the standpoint of what California
    set as a tolerance, that they haven't?
        Mr. Stadtlander. There is no threshold in California at
    this point in time. So any amount.
        Senator Burr. So technically--and I trust you--you are a
    microbiologist. You've got Acrylamide in coffee. Does coffee
    have to have a label in California that says may cause cancer?
        Mr. Hutt. Yes.
        Senator Burr. All coffee does?
        Mr. Hutt. Yes.
        Senator Burr. Does wine have any in it?
        [Laughter]
        Mr. Hutt. No, but I will--I'm glad you brought up that
    issue because of the concern expressed by the two Senators from
    California about lead in candy and various other--pottery,
    etcetera. What they failed to point out is that California is
    the only State that has a law that explicitly allows lead foil
    for closures of wine.
        Senator Burr. Interesting. At this time, I ask unanimous
    consent. I'm going to enter into the record a chart that shows
    for 2005, the Prop 65 settlement dollars paid in private cases,
    a total of $56 million and the breakout of the attorney fees
    from that, which is $38 million. I think it is only appropriate
    to have that in the record, matched with civil penalties,
    $5,300,000.
        [The previously referred to information follows:]

                                Proposition 65 Benefits Private Attorneys, Not the Public
    ----------------------------------------------------------------------------------------------------------------
                                                         Prop. 65
                                                        settlement                      Percent of
                                                       dollars paid                     settlement
                          Year                          in private      Attorneys'       going to          Civil
                                                       cases (incl.        fees         attorneys'       penalties
                                                        attorneys'                       fees* [In
                                                           fees)                         percent]
    ----------------------------------------------------------------------------------------------------------------
    2000............................................      $9,030,974      $5,675,457             63%        $590,712
    2001............................................       7,584,034       4,704,800           62            559,875
    2002............................................       6,443,808       3,676,455           57            325,015
    2003............................................       8,090,248       5,290,940           65            566,300
    2004............................................      15,385,638      12,656,669           82          1,857,508
    2005............................................       9,892,989       6,145,768           62          1,414,800
                                                     ---------------------------------------------------------------
        6-year Total................................     $56,427,691     $38,150,089                      $5,314,210
                                                     ---------------------------------------------------------------
        6-year Average..............................      $9,404,615      $6,358,348             65%        $885,702
    ----------------------------------------------------------------------------------------------------------------
    * In addition to attorneys' fees, ``Prop. 65 settlement dollars paid'' includes additional payments that go
      directly to the plaintiffs or are steered to organizations that work in conjunction with plaintiffs.
     SOURCE: Office of The California Attorney General, data available at http://ag.ca.gov/prop65/index.htm.

        Senator Burr. Bill, I sort of feel like you're holding up
    the whole end of the table.
        Mr. Hubbard. Thank you.
        Senator Burr. I should say thank you for your long service
    and I think over the last decade, there has been a partnership
    between Congress and the FDA to move forward and to make
    advances. You and I probably still have a long way to go and
    just under the mission of the FDA, the challenge is huge. I'm
    not sure that we all fully understand and appreciate what this
    global economy is going to produce to us and we had it first on
    drugs as we talked about harmonization with the EU and when we
    looked at the EU, which walked out and said, ``We'll just
    accept everybody's standard.'' When we went to harmonize with
    the EU and we saw that they accepted the Italian standard. We
    looked at it and said there is no way that we can operate
    within that system--we found that there is a great need for us
    to uphold that solid foot-in-the-ground gold standard that we
    had. I understand your concerns about staffing and I understand
    your concerns about budgets. Were the FDA to be charged with
    this and we addressed those staffing and budgetary issues, any
    question in your mind as to whether the FDA could do this job?
        Mr. Hubbard. Well, as I said, Mr. Chairman, I believe this
    is a reasonable approach and that had the FDA had the
    scientific wherewithal to make a judgment on food or drug or
    anything else and could bring the best science to bear, they
    would make a reasonable decision. I believe it is appropriate
    for the FDA to then say to the States, don't do anything
    different. You can require the same label that FDA or warning
    or whatever the FDA has decided and then you get the compliment
    of the States acting and I think that's your goal. I think the
    problem is that in some areas of regulation, FDA had that but,
    in this area, it does not and it is unlikely to get it anytime
    soon and the States have been able to fill the back in many
    ways and do some important things. Certainly the California
    experience has been challenging, shall I say, for industry and
    the FDA. But, I surely would hope that you wouldn't necessarily
    take a nationwide approach to one particular problem that
    perhaps has some particular eccentricities about it in
    California.
        Senator Burr. I think you stated it very clearly in the
    beginning of your written statement when you said, and I quote,
    ``Most States have enacted food and drug laws identical or
    quite similar to the provisions of the Food, Drug, and Cosmetic
    Act.'' Later you said that the bill is unclear in what it
    creates. Now, I'm sort of with you, Mr. Hutt and its not
    because I'm the author. It's because I've had an opportunity to
    read it and read it and read it. And when I do, I see that in
    the bill, if State food laws are identical in language or
    meaning to Federal food laws, the State food law remains in
    effect. I don't see how it could be any clearer than that. You
    acknowledged in your written testimony, you know, States are
    out doing this. Then, there is patchwork, there is a lack of
    consistency, some do, some don't. The real basis that this bill
    came from was not to penalize States that have actually been
    out there doing this but if the Federal standard was the same
    in language or in meaning, the State could feel confident that
    their language, in fact, stayed in effect.
        Mr. Hubbard. May I comment?
        Senator Burr. Sure.
        Mr. Hubbard. I would never question Mr. Hutt's legal
    opinions. It is rumored at the FDA that he was there to change
    the diapers of the first FDA Commissioner and so I would not
    question what he is telling you at all, but the fact that the
    majority of attorneys general, the Food and Drug officials in
    the States and so many consumer groups have also looked at this
    with their legal expertise, their statutory and legislative
    expertise, and disagreed. I guess I'm simply saying to you that
    there needs to be some effort to understand whether they are
    right or wrong and then perhaps amend your bill accordingly
    because someone is right or wrong here and I will not pretend
    to tell you who that someone is.
        Senator Burr. I can only share with you that as the author,
    it is my intent that it be applied exactly like I read it. I
    have no reason to dislike lawyers but they go through extensive
    training to look at a sentence and figure out if it really
    means something different and then lie. I think Mr. Hutt has
    had a long experience dealing with FDA, you're exactly right.
    He will outlive both of us from a standpoint of his tenure.
        Mr. Hutt. Could I, Mr. Chairman, give two examples of the
    misinterpretation and of this legislation?
        Senator Burr. Sure.
        Mr. Hutt. Recently CSPI has added two more types of State
    laws that they saw would be drastically changed and indeed, in
    effect, repealed. The first deals with State laws that require
    messages to put at bars, warning pregnant women not to consume
    alcoholic beverages. In 1976, the U.S. District Court held that
    FDA has no authority whatsoever with regard to the labeling and
    advertising of alcoholic beverages. So FDA--that all occurs
    under the Federal Alcohol Act. It does not occur under the
    Federal Food, Drug and Cosmetic Act and thus, this legislation
    has absolutely no impact at all. The FDA has no jurisdiction in
    this area. The second set of laws that they say would be
    affected deal with State and local laws that govern when food
    can be sold, particularly snacks and soft drinks, can be sold
    in schools. Those laws are, as Dr. Murano knows, solely the
    jurisdiction of USDA and they are not in any way affected by
    the Federal Food, Drug and Cosmetic Act. So all of this
    misinformation is being put out there. People are becoming
    States--are therefore doing what Bill Hubbard said, ``they're
    expressing concern for absolutely false reasons.''
        Senator Burr. Trust me when I tell you, some of us have
    been the subject of media accounts that would--the basis for
    being against the bill was because of what we did to Meat and
    Poultry. Again, as you referenced earlier, Meat and Poultry is
    not included in this and I would say this for all of you. What
    we've found is that as we've been contacted by AGs, as we've
    been contacted by State Ag Commissioners who expressed
    concerns, we said go back and read the bill and then call us
    back and tell us if you've got a problem and in many cases, not
    all--but in many cases, individuals have changed their opinion
    of the legislation because in fact, the consumer groups
    basically put out a notice that said, ``this is a bad bill.''
    Those that were being kind just said it was a bad bill. They
    didn't use the host of things that were inaccurate and I think
    as reasonable people have gone back and read it, they found
    that to be the case. I'm going to ask you one more question,
    Mr. Hubbard. You mentioned that State enforcement actions may
    be pre-empted in this bill. I wanted to point out page 5, lines
    15-23 of the bill, affirm that the State enforcement actions
    are not impacted by the bill, including notification,
    disclosure, inspection, mandatory recall, embargo, and
    detention orders. This is for my own good. Tell me where I am
    unclear.
        Mr. Hubbard. Well, I think I was reflecting the predominant
    opinion by the Attorneys General so if I'm wrong, let's go back
    and look at what their concerns are.
        Senator Burr. I appreciate your candor on that because I
    think, at the root of this, I really do, I think many of the
    concerns come from individuals who have not read the
    legislation, who have been handed, in some cases, not by their
    staffs, a Talking Point sheet that contains many things that
    are inaccurate but it has forced me to go back through the
    legislation and read it with staff to make sure that the
    clarity that existed when I read it the first few times, was in
    fact, there and that it was a misinterpretation. I would turn
    to my colleague from Georgia to see if he has any additional
    questions.
        Senator Isakson. One question. Mr. Hutt's comment about the
    wine closures in California and the exemption to the lead
    standards probably is a pretty good example of the economic
    interests of the State having an effect on the regulatory power
    of the State, which begs a question to Dr. Murano because I
    think in your answer to me, Doctor, you referred to exports of
    agricultural products. I remember the Japanese used key MOs
    basically as scare tactics to try and limit importing of
    American food products. It would seem like to me the uniformity
    of labeling would be of benefit to us from the standpoint of
    our international exports, is that correct?
        Dr. Murano. That is correct, sir and frankly, it is the TTO
    that is the world body, where you are supposed to settle
    disputes when there are disagreements of a nature and it is the
    standards that are agreed to by countries in food safety,
    through the Codex Alimentarius Commission that are used as the
    evidence and actually were the reason why the European Union
    could no longer not allow GMO products to be sold there from
    the United States and it is because it has to be based on
    science. It cannot be just an arbitrary regulation or warning
    label without basis for science because then if everyone does
    that, we'll have a chaotic situation and trade certainly can
    come to a screeching halt.
        Senator Isakson. Thank you and that's all the questions I
    have, Mr. Chairman.
        Senator Burr. Last thing, Mr. Stadtlander. Senator
    Feinstein testified to something that I have no reason to
    question the accuracy. She said that she had never heard a
    complaint from her constituents about Prop 65. If you are
    forced to pull Wheatena from the marketplace, do you think
    there is at least one person out there that likes that product
    well enough that they may complain about this?
        Mr. Stadtlander. I can make sure they complain.
        [Laughter]
        Senator Burr. I thank you for that and I will warn her
    exactly how I set her up. I would like to thank all of you for
    your willingness to be here, to share your experience, your
    knowledge and your concerns as it relates to your livelihood
    but more importantly, the safety of food and labeling for the
    American people. I think the hearing has been a great
    contribution to the debate and I think one would have to say
    that the top bullet that people should leave here with is, go
    read the bill again. Even if you think you know everything that
    is in it, go read it one more time. I am told we have no
    further questions. I ask unanimous consent that all members'
    statements be included in the record of the hearing and I also
    ask unanimous consent that the Letters of Support for S. 3128
    be included. Without objection, so ordered. Members of this
    committee may submit questions in writing for any of the
    witnesses and I would ask you to make yourself available, as we
    would appreciate a timely response to any questions. The record
    will remain open for 10 days for these questions and for
    further statements from my colleagues. Again, thank you for
    your time commitment to us and for instilling in us the
    knowledge on this issue.
        The hearing is adjourned.
        [Additional material follows.]

                              ADDITIONAL MATERIAL

                     Prepared Statement of Senator Kennedy

        Thank you, Mr. Chairman, for calling this hearing on the
    National Uniformity for Food Act, which would prohibit States
    from applying food safety laws unless they are identical to
    provisions of the Federal Food, Drug, and Cosmetic Act.
        This extreme bill is a giveaway to the food industry, and
    all Americans will pay for it with their health. Everyone
    agrees that the bill would preempt Proposition 65, the
    California law that requires warning labels on products that
    contain ingredients known to the State to cause cancer, birth
    defects, or reproductive problems. But there is little
    agreement after that.
        The food industry claims that only about a dozen State laws
    would be preempted, but the Center for Science in the Public
    Interest, with the support of many State officials, has
    identified about 200 such laws.
        For example, according to the Center, the bill would
    preempt statutes regulating the quality of milk and food served
    in restaurants in all 50 States. It would preempt laws on
    unsafe food and color additives and laws on shellfish in more
    than a dozen States. It would preempt warnings required by at
    least 18 States about the effect of alcohol consumption by
    pregnant women on their unborn children.
        In Massachusetts, the sale of dead lobster is banned,
    because it decomposes so rapidly. We can now set more stringent
    bacterial standards for milk than under FDA guidelines, and ban
    or require warnings about food or color additives that are
    considered safe under Federal law. These and potentially other
    food safety laws in Massachusetts would be preempted by S.
    3128.
        In fact, the bill is so vaguely written that we don't know
    how broad the preemption of State and local health laws would
    be. There will certainly be costly litigation on the issue.
    Otherwise, States will have to assume their laws are preempted
    and resort to the costly process in the bill to petition the
    FDA for exemptions. The Congressional Budget Office estimated
    costs of $100 million to FDA and $64 million to the States for
    these petitions over 5 years. But the estimate assumes that
    California will file one petition for Proposition 65, instead
    of one for each compound for which that law now requires a
    warning. Because determinations for each compound are obviously
    highly fact-specific, there will need to be individualized
    petitions for each one, and the CBO estimate is obviously too
    low.
        State officials across the Nation argue that their laws
    would be unfairly preempted and their efforts to improve the
    safety of food would be crippled. The legislation obviously is
    intended to benefit the food industry, regardless of its impact
    on the right of States to protect the health of their citizens.
        Even identical State laws would be limited under this bill.
    Every State enforcement action would potentially be subject to
    a Federal preemption defense, on the ground that the State is
    imposing a ``materially different'' requirement than under
    Federal law. The cases could even be removed to Federal court,
    and this is especially true when neither the FDA nor the State
    has issued a regulation setting a tolerance for a harmful
    substance in food.
        The bill would, however, allow a State to enforce when FDA
    has issued a regulation setting a tolerance level for a harmful
    substance or, if the FDA hasn't issued a regulation, when the
    State has a policy on the harmful substance, either through
    regulation or administrative decision.
        But the bill blocks the State from enforcing a policy
    rejected by the FDA. This prohibition is true even when the FDA
    rejected the policy 20 years ago and there is new science
    validating the policy.
        The bill also implies that a State may not enforce its laws
    when there is neither an FDA nor a State regulation or policy.
    In such cases, the State should be permitted to allege that a
    food contains a substance, that the substance is poisonous, and
    that it may be injurious to health. The bill implies that local
    food safety laws--such as those in New York City--may never be
    enforced, even when they are identical to Federal laws.
        The uncertainty surrounding enforcement and the hugely
    increased cost to the States of each enforcement action would
    drastically reduce the number of those actions, and could deter
    the States from even bringing them at all. We can't expect an
    under-funded FDA--which conducts only about 20 percent of
    domestic inspections and is able to inspect, at most, 2-3
    percent of imported food--to fill this gap.
        Congress shouldn't even be considering such a step,
    especially when we've all focused on strengthening the Nation's
    ability to respond to bioterrorism. Do we really want to
    prevent a State from doing more to protect its citizens from
    bioterrorism than the Federal Government does? Why disarm our
    State food safety officials--who will be our first responders
    if terrorists put anthrax in our food supply? The certification
    by the Secretary of Health and Human Services is hollow
    reassurance that this won't happen--all it indicates is that
    the authors of the bill know this is a real possibility.
        If we ever mark this bill up, the first amendment should be
    to rename it the ``Make Way for Terrorism with Foods Act.''
        Cal Dooley, the President of the Food Products Association,
    could not cite a single case in which manufacturers had to put
    two different labels on a food, let alone 50 labels. Label
    uniformity is obviously not the issue here. Yet the food
    industry wants us to cripple State efforts to enforce the
    safety of our food.
        In fact, as we all know, the industry wants to be able to
    add ingredients to food that some States feel may cause serious
    health risks, or even cancer or birth defects. Which of the
    Proposition 65 ingredients, for example, does the food industry
    want to put in our food? I hope these hearings will help us get
    to the bottom of issues like this.
        I thank the Chairman and I look forward to today's
    testimony.

                      Prepared Statement of Senator Hatch

        Mr. Chairman, I regret that a prior commitment precludes my
    attendance at this hearing today, because I am very interested
    in this legislation.
        I commend Senator Burr for his work on this important
    issue.
        Mr. Chairman, I am very sympathetic to the goals of this
    legislation. Indeed, I appreciate that differing food safety
    tolerances and warning labels among the various States can be
    disruptive to interstate commerce.
        That being said, I look forward to examining this
    legislation and its impact in more detail as the committee
    process moves forward. For example, I would like to understand
    more fully how the bill defines food, if the bill is
    significantly flexible to allow State and local authorities the
    ability to respond to emerging public health problems
    associated with foods, and if the Food and Drug Administration
    will be able to meet the timeframes established for the
    petition process.
        Thank you for holding this hearing today and for
    considering my concerns.

                     Prepared Statement of Senator Jeffords

        Mr. Chairman, thank you for this hearing and for giving
    those of us with strong reservations about S. 3128, the
    National Uniformity for Food Act of 2005, a chance to ask
    questions and receive testimony. To our witnesses, thank you
    for appearing today before this committee.
        In May, I joined 20 of my Senate colleagues in writing to
    the Senate leadership asking for, at least, some committee
    consideration of this legislation. As a former chairman of this
    committee, I appreciate, Mr. Chairman, your willingness to hold
    this hearing and proceed under regular order.
        I have heard from many Vermonters who are genuinely
    concerned with S. 3128 and its counterpart H.R. 4167. To these
    constituents, the enactment and enforcement of strong food
    safety laws are legitimate functions of State governments. As a
    former Attorney General, I agree.
        This hearing will also bring to light the growing gap
    between the many responsibilities given to the Food and Drug
    Administration (FDA) and the funding levels that fall short of
    being adequate to carry out those responsibilities. If S. 3128
    were to be enacted into law, it would exacerbate the FDA's lack
    of funding and possibly cause more problems than it is intended
    to fix.
        Again, thank you, and I look forward to the testimony of
    our witnesses.

                      Prepared Statement of Senator Nelson

        Mr. Chairman, I would like to express my support for S.
    3128 and national uniformity for our Nation's food products. I
    am proud to be an original cosponsor of this bill seeking to
    set a national standard for food safety, food safety labeling
    and put food safety in the hands of the Nation's top food
    scientists and food safety experts.
        My commitment to a safe food supply is second to none, but
    I also understand the reality that our food supply is national,
    and indeed global, in scope. Effective regulation of this
    national food supply and assurance of safe, wholesome and
    affordable food requires uniformity in food safety regulation,
    especially warnings. Because our food supply is truly national
    in scope with products made in one facility distributed and
    sold throughout the Nation, both consumers and food
    manufacturers should be able to rely on national,
    scientifically-based standards for food safety.
        I think this legislation reflects a commonsense
    understanding that consumers should have the same confidence
    about the food they consume regardless of the State they live
    in or the State in which the food is sold. Food cannot be safe
    in one State and unsafe in another and food that is safe should
    be freely sold in all States and food that is not safe should
    not be sold anywhere.
        I believe that States have an important role in making sure
    that the food supply is safe and sanitary. I think the States
    should actively cooperate with FDA to develop sensible,
    science-based requirements and to assist in the enforcement of
    these uniform, national requirements. I am convinced that S.
    3128 will facilitate the development and enforcement of uniform
    food safety and food warning requirements, while preserving the
    ability of the States to use their enforcement authorities to
    prevent the sale of unsafe foods and to remove such foods from
    the marketplace. This bill will improve the safety of the food
    supply, remove unnecessary burdens on the food industry and
    help to ensure that our food supply is as safe, wholesome and
    affordable in the future as it has been in the past.
        The National Uniformity for Food Act provides the mechanism
    for a national, uniform, and scientific approach to food safety
    regulation. The bill also provides a mechanism for considering
    State food safety requirements as national requirements. To the
    extent that there are State requirements that are stricter than
    Federal requirements, the bill ensures that all of those State
    requirements will be considered for adoption by Federal
    regulators. State authority to take action against adulterated
    food is preserved and they will still be in charge of
    inspections to enforce basic sanitation requirements in places
    such as restaurants, retail food stores, shellfish processors
    and dairy farms.
        Uniformity in food regulation is not unprecedented and
    already exists for all meat and poultry products regulated by
    the U.S. Department of Agriculture; health claims, standards of
    identity, pesticide residue tolerance, medical devices, and
    drugs regulated by the U.S. Food and Drug Administration are
    all regulated at the Federal level.
        I would like to reiterate that when a warning about food is
    supported by science and is necessary to help consumers make
    informed decisions about the foods they purchase, then the
    warning should be applied to food sold in all 50 States. Food
    cannot be safe in one State and unsafe in another, and that is
    why I am an original cosponsor of S. 3128 and I urge my
    colleagues to support this bill.

                    Prepared Statement of Leslie G. Sarasin

        The American Frozen Food Institute (AFFI) supports S. 3128,
    the National Uniformity for Food Act of 2006. S. 3128 would set
    uniform national food safety standards that will provide all
    Americans with the same high level of confidence in and
    protection with the Nation's food supply.
        On March 8, 2006, the House passed the bill (H.R. 4167)
    with a strong bipartisan vote of 283-139. Support from
    committee members during the Senate HELP Committee hearing is
    absolutely critical to this legislation becoming law this
    session.
        AFFI is the national trade association that promotes and
    represents the interests of all segments of the frozen food
    industry. The approximately 500 members of the Institute are
    engaged in the processing of frozen foods, as well as other
    functions in the frozen food supply chain. These functions
    include ingredient supply, cold storage, transportation,
    packaging, marketing and scientific research. The Institute
    fosters industry development and growth, advocates on behalf of
    the industry before legislative and regulatory entities, and
    provides additional value-added services for its members and
    for the benefit of consumers.
        AFFI has consistently endorsed policy initiatives that
    facilitate the needs of its members while maintaining core
    consumer interests. The National Uniformity for Food Act of
    2006 is not only vital to frozen food manufacturers who engage
    in interstate commerce, but ensures the promotion of accurate
    and consistent food safety information for consumers.
        The legislation provides for science-based uniform food
    safety standards and warning requirements so that Americans in
    every State are protected equally. It is common-sense
    legislation that will help consumers make educated decisions
    for themselves and their families in an ever-changing and
    confusing food labeling environment. Consumers deserve a single
    standard when it comes to food safety, and this bill will allow
    States and the Food and Drug Administration to work
    collaboratively in establishing sound food safety policies that
    benefit, rather than confuse, consumers.
        The National Uniformity for Food Act is a top priority for
    the frozen food industry. In advocating this policy, AFFI is
    mindful of concerns that States should have the opportunity to
    establish policies according to their discretion based on local
    or regional issues. However, it is important to note that the
    legislation contains provisions that give States the ability to
    petition the Federal Government to seek variances from the
    Federal standard should there be a belief that a different
    requirement is necessary or appropriate. Furthermore, issues of
    interstate commerce are appropriate topics for Federal
    policymaking.
        AFFI is enthusiastic that the National Uniformity for Food
    Act is advancing and appreciates the committee's consideration
    of this legislation, which clearly constitutes good public
    policy. AFFI urges its enactment.

             Prepared Statement of Thomas R. Frieden, M.D., M.P.H.

        The legislation being considered by this Senate Committee, S. 3128,
    represents dangerous public policy and would, if enacted, seriously
    jeopardize public safety by compromising the ability of State and local
    officials to protect their citizens from unsafe foods.
        Similar legislation was passed by the House of Representatives in
    March 2006 without public hearings, despite the strenuous opposition of
    39 State attorneys general, the National Association of State
    Departments of Agriculture, the National Conference of State
    Legislatures, the Association of Food and Drug Officials, and many
    other State and local elected and appointed officials representing
    diverse geographic and political views. I commend the Senate HELP
    Committee for holding hearings and I strongly urge that you not pass
    this legislation, noting the strong objections of national, State and
    local food safety experts who work on the front lines to ensure food
    safety. These are the individuals and institutions responsible for
    assuring the public that the food in their own neighborhoods--their
    markets, restaurants, school cafeterias and corner delis--is safe and
    unadulterated.
        As the chief health officer of the Nation's largest city, I urge
    the committee to prevent this significant nationwide diminution of food
    safety protection. Not only would it compromise traditional and
    fundamental State and local responsibilities regarding food safety, it
    would also likely prevent cities and States from taking timely action
    to protect the public in the event of a terrorist attack involving
    contaminated food. This is especially important in light of the
    increased risk of terrorism, especially in large urban areas such as
    New York City.
        S. 3128 is often described as a food-labeling bill, but it goes far
    beyond legislating uniformity of food labels. It preempts State and
    local laws and regulations that are not identical to Federal laws or
    regulations regarding adulterated food or food that ``bears or contains
    any poisonous or deleterious substance which may render it injurious to
    health.'' Thus, the act prevents State and local governments from
    enacting or enforcing their own laws and regulations bearing upon
    contaminated, adulterated or poisoned food--even when particular
    regional or local circumstances warrant, justify or require State and
    local laws, regulations and enforcement, or when State or local action
    is needed to cover areas and circumstances not addressed by Federal
    law.
        Furthermore, S. 3128 would prevent enforcement of local laws even
    when they are identical to Federal law. For New York City, whose
    population is greater and whose health department is correspondingly
    larger than that of many States, and for other large cities with
    marketplaces that serve large diverse and increasingly international
    populations, this would create extremely dangerous enforcement gaps.
    Any expectation that State or Federal Government, or any other entity,
    would or could fill these gaps is completely unrealistic. According to
    S. 3128, the States, but not local governments, could petition the
    Federal Government for an exemption, or for establishment of a national
    standard. These are not acceptable options when lives and health are
    threatened by adulterated or contaminated food in the marketplace and
    when preventing deaths or illness may depend on enforcement action
    within hours--rather than the weeks or months required for a
    bureaucratic petitioning process.
        For more than a century, assuring food safety has been a
    fundamental State and local responsibility. The highest Federal court
    in New York recognized that ``States have traditionally acted to
    protect consumers by regulating foods produced and/or marketed within
    their borders.'' [Grocery Manufacturers of America v. Gerace, 755 F.2d
    993, 1003 (1985)]. State and local agencies conduct more than 80
    percent of the food safety and enforcement activities in the country's
    marketplaces and food service establishments.
        This proposal is an unwarranted intrusion on traditional State and
    local governments' inherent police powers and responsibilities to act
    to protect the public health. If enacted, it will create endless
    confusion and costly litigation around what constitute ``identical
    laws,'' causing delays in removing contaminated food from circulation.
    It will prevent cities such as New York from acting when the Federal
    Government has not addressed, or has not adequately regulated, a
    dangerous food contaminant. Furthermore, it can be interpreted as
    preempting State action even when the Federal Government has not
    established a standard. This would be a particular problem for cities
    such as New York, where each day potentially dangerous food products
    from all over the world find their way into the local food supply.
        The bill's language and its sponsors suggest that there exists a
    comprehensive body of Federal laws and standards that should be applied
    uniformly across States, such that State and local responsibilities are
    unneeded or duplicative. New York City's experience informs us that the
    reality is far different, and in fact often quite the opposite of what
    is being suggested. Time and time again, we have sought clear Federal
    standards to address adulterated food products that have been directly
    linked to illnesses, but have found either no standards, or
    unenforceable guidelines. A recent example is the discovery of lead in
    certain imported candy in New York City. The lack of adequate or
    enforceable Federal standards led to enactment of a local law banning
    the sale of lead-containing candy in New York City. This law could be
    preempted and unenforceable if S. 3128 were enacted.
        The bill is dangerously ambiguous. Although the bill's proponents
    have stated that under the proposed law, States would be free to
    regulate ``in the void''--that is, to regulate when the Federal
    Government has no existing standards--they have also stated the
    following:

              ``Where States have existing requirements without a Federal
            counterpart and those State requirements `protect an important
            public interest that would otherwise be unprotected,' the
            State's petition will be found by FDA to be well taken. Where
            States have requirements without Federal counterpart and those
            State requirements cannot be justified as contributing to the
            safety of the food supply, the State requirements will
            ultimately not be sustained.''

        These statements seem completely inconsistent with authorizing
    States to regulate in the void. Further, it appears that what would be
    contemplated is for the State to submit a petition in order for the
    necessary determinations to be made.
        The longstanding authority of States and localities to regulate the
    safety of the food provided to their own citizens, particularly in
    areas such as food preparation in food service establishments, must be
    preserved. For example, this law would preempt various State statutes
    such as those that require food establishments that sell alcoholic
    beverages to post a sign warning pregnant women about the risk of birth
    defects. This is just one example of the very type of activities that
    must continue to remain within the purview of State and local
    government regulation.
        In the event of a terrorist attack involving deliberate poisoning
    or contamination of food, the proposed law could cause serious delays
    while public health officials consult, deliberate and debate to
    determine whether a relevant ``identical'' State and Federal law and
    standard exists. If no relevant Federal standard were found to exist,
    would a State be expected to petition the Federal Government for a
    determination of imminent hazard authority before action could be
    taken? This petitioning process is not only cumbersome and time-
    consuming, but, as discussed previously, only a State, and not a
    locality, is an eligible petitioner. These are not acceptable
    scenarios, particularly in view of the heightened threat of terrorism
    in New York City.
        Enactment of S. 3128 would have serious consequences for the
    enforcement of New York City's Health Code, which has historically
    regulated food safety in more than 20,000 local restaurants and food
    service establishments and which provides the authority to seize and
    embargo any unsafe food. With Federal support and encouragement, the
    city has developed a state-of-the-art disease surveillance system
    capable of detecting food-borne and other illnesses early on. Yet S.
    3128 could prevent the city from using its authority under its Health
    Code to act on critical information gathered from this system, because
    it would eliminate local authority to remove adulterated food from
    stores or restaurants. Accompanying this testimony is an attachment
    entitled New York City's position on S. 3128, The National Uniformity
    for Food Act of 2005, which contains additional examples of important
    enforcement actions the New York City Department of Health and Mental
    Hygiene has taken over past decades that would have been preempted, had
    S. 3128 been in effect.
        The effect of S. 3128 would be to prevent States and localities
    from legislating on health-related matters affecting their citizens, a
    result that more than 100 years ago the U.S. Supreme Court recognized
    was not intended in the conferring upon Congress the regulation of
    commerce. [See Sherlock v. Alling, 93 U.S., 99, 103 (1876).]
        I believe that if members of this committee consider carefully the
    opinions of the many national, State and local organizations who
    collectively represent substantial expertise in food and safety and the
    law and who have raised fundamental concerns about the serious
    consequences of this legislation, you will reach the conclusion that
    this bill should not be enacted into law.
        I appreciate the opportunity to provide these comments and thank
    the committee members for your attention to these concerns. I would be
    happy to discuss my comments in person or provide any additional
    information you might request.
                                     ______

                                   Attachment

        New York City's Department of Health and Mental Hygiene (NYC DOHMH)
    is responsible for supervising and regulating the food supply in New
    York City. [New York City Charter  556(x)(9)] Food service
    establishments in New York City are licensed and regulated by the
    Department in accordance with Article 81 of the New York City Health
    Code. The Department is also authorized by existing local law to seize,
    embargo or condemn food that is adulterated or otherwise constitutes a
    danger to public health. [New York City Health Code  3.03(a) and
    71.22] These authorities are essential public health tools that the
    city has used for many decades to protect its citizens. City health
    officers must be able to continue this critical public health activity,
    especially in light of New York City's disproportionate risk for future
    acts of terrorism, including the threat of deliberate contamination of
    food. Following are examples of actions the city has taken and that
    could be preempted by S. 3128 or be subject to legal challenges,
    creating dangerous delays and costly litigation. The law in such
    critical areas of public health should not be left unsettled and
    unclear. The authority to act needs to be unequivocal.

         NYC DOHMH issued a warning to city residents to avoid
    eating certain candies and food products made in Mexico that had been
    found to contain lead. Based on its authority under the Health Code and
    in cooperation with New York State authorities, NYC DOHMH inspected and
    tested these products. These actions, along with actions by other
    States and localities, resulted in a voluntary recall by a candy
    manufacturer. However, under this bill, if the manufacturer had not
    voluntarily taken this action, the city would have been preempted from
    taking enforcement action to remove candy from the market because there
    were no enforceable FDA safety standards regarding lead in candy.
         Because any increase in lead exposure to New York City's
    children is a serious public health concern, the New York City Council
    subsequently adopted a law banning sale of candy products containing
    lead. This action was prompted by concerns about the inadequacy of
    Federal regulatory efforts to set allowable safety limits for lead in
    food products and stop contaminated products from entering the country.
         NYC DOHMH linked certain imported cheeses to infection by
    Mycobacterium bovis, a form of tuberculosis found in cattle; 35 cases,
    including the death of an infant, were attributed to M bovis
    tuberculosis. The city monitored certain markets to assure that no
    contaminated cheese was sold, and would have relied upon its local
    Health Code authority to seize or embargo such products had they been
    discovered
         NYC DOHMH used its powers under the city's Health Code to
    embargo certain herbal products after several cases of adult lead
    poisoning were confirmed among residents who used these products.
    Although there were National Academy of Science recommendations about
    tolerance levels, there were--and continue to be--no specific Federal
    standards. In previous years, NYC DOHMH had also ordered the cessation
    of sale of an herbal tea that contained high concentrations of lead and
    arsenic. While an amendment in the House-passed version of S. 3128
    exempts regulation of dietary supplements, it is unclear whether food
    products containing dietary supplements would be similarly exempted.
         Following a sewage back-up in a manufacturing
    establishment in which specialty desserts and candies were made, NYC
    DOHMH used its powers under the city's Health Code to order the owner
    to cease production and thoroughly clean the processing area. NYC DOHMH
    embargoed and ultimately destroyed the contaminated products.
         NYC DOHMH, under the authority in the City Charter and the
    Health Code, ordered the surrender of shellfish that had been
    identified as the source of several cases of cholera.
         Recent New York City Health and Nutrition Examination
    Survey (HANES) data revealed that mercury levels are elevated in the
    Asian population. NYC DOHMH is currently examining reasons behind these
    elevated levels. The investigation may reveal certain food staple
    products or traditional remedies commonly used by Asians to be the
    source. However, if the act becomes law, NYC DOHMH will be unable to
    remove these products from the market.

                      Prepared Statement of Benjamin Cohen

    ``In all that we do, our purpose will be to strengthen the family by .
    . . promoting decisionmaking at the level closest to the people--our
    communities, counties, schools districts and, most importantly, our
    homes.'' (emphasis added) (Mission Statement of Senator Michael B. Enzi
    for Senate Committee on Health, Education, Labor, and Pensions (on wall
    of Room 835 Hart Senate Office Building))

        On behalf of its 800,000 members in the United States, the Center
    for Science in the Public Interest \1\ is pleased to submit this
    testimony in strong opposition to the National Uniformity for Food Act,
    S. 3128, which was introduced by Senator Richard Burr on May 25, 2006.
        The fallout from this thermonuclear attack on California's
    Proposition 65 could be the destruction of hundreds of other State and
    local food safety and labeling laws in every State (including six from
    North Carolina) (see attached table).\2\ This destruction would occur
    even though Cal Dooley, President of the Food Products Association,
    admitted in March 2006 (according to a USA Today editorial opposing the
    bill) that he could not ``cite a single instance in which manufacturers
    have to put two different labels on a [food] product, let alone 50.''
    \3\ (emphasis in original)

                                  INTRODUCTION

        S. 3128 does not mention Proposition 65. Instead, it preempts any
    State or local food safety or labeling law--with the exception of
    returnable bottle labeling and 10 other specific categories \4\--that
    is not ``identical'' to a requirement of the Food and Drug
    Administration (``FDA''). S. 3128 (but not its companion bill, H.R.
    4167) would allow any State ``policy such as a State regulation or an
    administrative decision, that is based on a State law that contains a
    requirement that is identical to'' the adulteration requirement in
    section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act \5\
    (``FFDCA'') if the FDA has not issued ``a regulation or adopted final
    guidance'' on this matter. S. 3128 does not, however, identify which
    State laws, if any, are protected by this vague provision.\6\ Moreover,
    it certainly does not shield local government laws and may only protect
    State regulations--rather than State statutes.
        A State can ask the FDA to waive this preemption by filing a
    petition. For State or local laws passed after the legislation is
    enacted, the State or local law--with the exception of one dealing with
    an ``imminent hazard''--cannot take effect until the FDA grants the
    waiver; for State or local laws in effect on the day the legislation is
    enacted, the law remains in effect until the FDA denies the request for
    a waiver (which must be submitted within 180 days after enactment). The
    FDA may grant the waiver if the FDA determines that the State or local
    law ``protects an important public interest that would otherwise be
    unprotected'' and ``would not unduly burden interstate commerce.'' \7\
        In its February 2006 analysis of the companion House bill, H.R.
    4167, the Congressional Budget Office (``CBO'') estimated that roughly
    200 petitions for existing laws and an additional 40 petitions for
    future laws could be filed with the FDA and that--at a cost of about
    $400,000 per petition--it would cost the FDA about $100 million (over 5
    years) to process these petitions.\8\ This new burden on the FDA comes
    at a time when the number of FDA employees devoted to food issues has
    fallen steadily by 10 percent over the last 4 years (from 3,167 in
    fiscal year 2003 to 2,843 in fiscal year 2006).\9\
        There has been a rising tide of bipartisan opposition to this
    legislation. Attorneys General of 37 States, Governors of 8 States
    (California, Delaware, Illinois, Iowa, Michigan, New Jersey, New
    Mexico, and Oklahoma), food safety officials in 7 States (Colorado,
    Florida, Georgia, Michigan, New York, Washington, and Wisconsin), and
    food safety officials in New York City and Baltimore have told Congress
    they oppose H.R. 4167.\10\ The Association of Food and Drug Officials,
    the National Association of State Departments of Agriculture, numerous
    consumers groups and environmental organizations, the Humane Society of
    the United States, and labor unions also oppose the legislation.\11\ As
    the Attorneys General put it, ``under this bill, States would be
    forbidden from adopting their own policies, even if the Federal
    Government had not acted in a particular area or adopted a particular
    warning . . . this bill would strip State governments of the ability to
    protect their residents through State laws and regulations relating to
    the safety of food and food packaging.'' \12\
    I. The Ambiguity of the National Uniformity for Food Act Would Lead to
            Much Litigation About Its Scopes As Even the Food Industry is
            Uncertain As to Which State Laws It Threatens
        The CBO said ``the scope of the State and local regulations that
    would be affected by the legislation is ambiguous.'' \13\
        On April 24, 2006 Cal Dooley, the President and CEO of the Food
    Products Association, and C. Manly Molpus, the President and CEO of the
    Grocery Manufacturers of America, held a press conference; they were
    joined by Stuart M. Pape, an attorney with the Washington law firm of
    Patton Boggs, and John W. Bode, an attorney with the Washington law
    firm of Olsson, Frank and Weeda. In their summary statement they claim
    that H.R. 4167 affects only 11 State laws,\14\ but in their
    accompanying (unsigned) detailed table they concede that at least 26
    laws are preempted.\15\ Five of these are food labeling laws:
    California's Proposition 65, laws in Connecticut and Michigan requiring
    warning of a possible allergic reaction to bulk foods containing
    sulfites, a Maine law requiring a warning on the risks of eating smoked
    alewives, and a Nevada law requiring a warning in restaurants and other
    food establishments that sell alcoholic beverages of the risks, to
    pregnant women of drinking alcoholic beverages. The others are food
    safety laws: food additive laws in 16 States; milk safety laws in
    Massachusetts, Michigan, and Nebraska; and laws in Michigan and
    Virginia banning the use of sulfites in restaurants and other food
    service establishments.
        We, however, have identified at least 220 State and local laws that
    are threatened by S. 3128 (see attached table). We have also identified
    at least 240 State and local laws that are threatened by H.R. 4167 (see
    attached table). Our estimates are conservative, as--with a few
    exceptions--they ignore both State regulations (as distinct from State
    statutes) and food safety and labeling requirements of the more than
    87,000 local governments.
        This uncertainty about the scope of the legislation will, of
    course, lead to litigation in both State and Federal courts.
    II. The Food Industry Concedes That California Would Have to File About
            300 Petitions With the FDA to Preserve the Requirements of
            Proposition 65 if Congress Were to Pass the National Uniformity
            for Food Act, Thereby Forcing the FDA to Spend About $120
            million Just on These Petitions
        The food industry concedes that California's Proposition 65 would
    be preempted by this legislation.\16\ Proposition 65--passed by
    referendum in 1986--requires a warning when a product contains a
    chemical that may cause cancer or birth defects if the amount of the
    chemical is above a certain threshold. California has established
    ``safe harbor'' ceilings for about 270 carcinogens and about 25
    chemicals causing reproductive toxicity.\17\ Some--such as lead--have
    long been known to be present in some foods. Others--such as acrylamide
    and benzene--have only recently been discovered to be in foods.
        The food industry admitted at its April press conference that in
    order to preserve these ``safe harbors'' California would have to file
    a separate petition for each chemical that may be in a food--as the
    science for each chemical and the impact of the required warning on
    interstate commerce would differ for each chemical. Thus, California
    would likely have to file about 300 waiver petitions in order to
    preserve its ability to enforce these Proposition 65 safe harbors.
    Using CBO's estimate of $400,000 per petition, the FDA would have to
    spend $120 million to handle these Proposition 65 petitions.
    III. The Food Industry Concedes that at Least 17 States Would Have to
            File Petitions With the FDA to Preserve Their Law That Allows
            the State to Establish a Ceiling for a Food Additive That is
            More Protective of Public Health Than One Established by the
            FDA
        At least 17 States--Alabama, California, Colorado, Florida, Hawaii,
    Illinois, Indiana, Kansas, Maryland, Massachusetts,\18\ Montana, New
    Hampshire, North Dakota, Oregon, South Carolina, Texas, and Utah--have
    a law that authorizes the State to adopt standards for unsafe food and
    color additives that are more protective of human health than those the
    FDA has set.
        The food industry concedes that these laws would be preempted by
    this legislation, but asserts this preemption would be of no
    ``practical effect'' because the State has never used this
    authority.\19\ Even if this assertion were true, there may come a time
    when the State may want to use its authority because the FDA has not
    acted, and so each State would have to ask the FDA for a waiver in
    order to preserve the option of using these laws in the future.
    IV. The Food Industry Has Not Refuted the Argument of State Food Safety
            Officials That at Least 100 State Laws Governing the Safety of
            Milk, Restaurant Food, and Shellfish or Fish Are Threatened by
            S. 3128
        S. 3128 (at page 2, lines 7-21) amends the FFDCA to preempt any
    State or local requirement that is not ``identical'' to 10 sections of
    the FFDCA. Of particular relevance here, the State or local law must be
    identical to subsection 402(a)(1) and section 406 of the FFDCA.
    Subsection 402(a)(1) provides, in pertinent part, that a food is
    adulterated if it ``contains any poisonous or deleterious substance
    which may render it injurious to health,'' and in order ``to protect
    the public health'' section 406 directs the FDA to set a ceiling for
    the amount of any poisonous or deleterious substance that can be added
    to a food if such substance is required to produce the food.
        The Wisconsin Secretary of Agriculture, Trade and Consumer
    Protection told Congress that his lawyers had examined H.R. 4167 and
    concluded that it ``would severely hinder Wisconsin's ability to
    protect citizens from contaminated foods.'' \20\ He went on to point
    out that ``there are no Federal laws governing the inspection and
    regulation of grade A milk production for interstate commerce,
    shellfish harvester and processors, or regulation of retail food
    establishments like grocery stores and restaurants.'' (emphasis in
    original) \21\ The Florida Commissioner of Agriculture and Consumer
    Services told Congress, after having H.R. 4167 examined by his lawyers,
    that H.R. 4167 would ``place at risk our . . . programs for milk, dairy
    and shellfish.'' \22\ New York's Commissioner of Agriculture and
    Markets told Congress that ``food inspection enforcement laws relating
    to grade A milk, grocery stores and shellfish would be preempted'' by
    H.R. 4167.\23\
        In order to fill the gaps in the FDA's regulations,\24\ every State
    has a law to ensure the safety of milk and a law to ensure the safety
    of food served in restaurants, cafeterias, nursing homes, and other
    food service establishments. At least 16 States have a law to ensure
    the safety of shellfish, and Arizona has a law to ensure the safety of
    farm-raised fish. About 88 percent (100 of these 116 laws) are clearly
    threatened by S. 3128 (see attached table).\25\
        The food industry claims that these laws--with the exception of
    milk safety laws in Massachusetts, Michigan, and Nebraska--are not
    affected by this legislation because they deal with food ``sanitation''
    rather than with food adulteration.\26\
        The Association of Food and Drug Officials rejects this argument.
    It told Congress ``Proponents of this bill emphasize that H.R. 4167
    does not impact State sanitation laws, and thus, will not impact State
    programs. Nothing could be further from the truth. States perform
    sanitation inspections in an effort to assist food businesses in
    preventing contamination or adulteration of products, but one of the
    States' critical complementary functions is to take action when these
    preventive measures fail . . . If enacted, H.R. 4167 would
    significantly impede resolution of the unsafe conditions and removal of
    contaminated foods from the human food supply. Sanitation and
    adulteration are not identical, but rather complementary. . . . While
    proponents [of H.R. 4167] argue that programs such as the cooperative
    milk and shellfish programs are not at risk our attorney, along with 11
    other State attorneys, read the bill quite differently.'' \27\
    (emphases added)
    V. S. 3128 Threatens at Least Ten Other Food Safety Laws (Including
            Bans on Lead in Candy) of at Least Nine States and New York
            City That Fill Gaps in the FDA's Regulations
        There are at least 10 State and local government food safety laws
    (in addition to the milk, restaurant, and shellfish laws discussed
    above) that fill gaps in the FDA's current requirements and are not
    part of a State's general food safety law. California has a law
    limiting the amount of lead in candy and a law dealing with the
    adulteration of wine. Illinois has a law limiting the amount of lead in
    food. Maine, Mississippi, and Utah have laws governing the safety of
    honeybees.\28\ New York has a law prohibiting the combined amount of
    lead, cadmium, mercury, and hexavalent chromium in any package from
    exceeding 100 parts per million. New York City has a law banning lead
    in candy. Texas has a regulation setting a minimum chlorine residual
    level in water that is being hauled. Virginia has a law banning
    sulfites in foods served in restaurants and other food service
    establishments.
        Consider, for example, lead in candy. In 1995 the FDA told the
    candy industry--via an unenforceable guidance document \29\ rather than
    through a regulation--that the FDA would consider enforcement action
    against candy with lead levels exceeding 0.5 parts per million
    (``ppm''). In May 2005 the New York City Council determined that ``lead
    poisoning is linked to many adverse health effects among children . . .
    [and] that certain candy products have been discovered to contain
    dangerously high levels of lead.'' \30\ So New York City banned the
    sale of candy products containing lead. In October 2005 Governor
    Schwarzenegger signed a California law limiting the amount of lead in
    candy to the amount that cannot be avoided by good agricultural,
    manufacturing, and procurement practices. Perhaps in reaction to these
    two bans, in December 2005 the FDA urged the candy industry to reduce
    the maximum amount of lead from 0.5 ppm to 0.1 ppm; the FDA explained
    that this new guidance ``describes the Agency's current thinking on a
    topic and should be viewed only as recommendations.'' \31\ In June 2006
    Illinois's Governor signed a law banning the sale of food (and other
    items) containing lead in excess of 0.06 percent of the weight of the
    food. The National Uniformity for Food Act threatens these laws of New
    York City, California, and Illinois and, if enacted, would leave
    children and other consumers of candy protected only by the FDA's
    ``recommendation'' to the candy industry.
    VI. The Food Industry Concedes that the Legislation Threatens the Laws
            of at Least 17 States Requiring That Establishments Selling
            Alcoholic Beverages Post A Sign Warning Pregnant Women About
            the Risks of Birth Defects from Drinking Such Beverages
        The FDA shares jurisdiction over alcoholic beverages with the
    Alcohol and Tobacco Tax and Trade Bureau of the Department of the
    Treasury.\32\
        The food industry concedes that the legislation would preempt
    Nevada's law requiring that establishments selling alcoholic beverages
    post a sign warning pregnant women of the risks of drinking such
    beverages.\33\ At least 16 other States--Alaska, Arizona, Delaware,
    Georgia, Kentucky, Minnesota, Missouri, Nebraska, New Hampshire, New
    Jersey, New Mexico, New York, South Dakota, Tennessee, Washington, and
    West Virginia--have similar laws. (These State laws complement the
    Congressional requirement that bottles of alcoholic beverages carry
    such a warning.)
    VII. The National Uniformity for Food Act Threatens at Least 32 Other
            Food Labeling Laws in at Least 26 States and a County
        The legislation provides that a State or local government may not
    require any ``notification'' for ``a food that provides for a warning
    concerning the safety of the food'' unless it is ``identical'' to a
    notification requirement of the FDA.\34\ The legislation goes on to say
    that ``the term `warning' . . . means any statement, vignette, or other
    representation that indicates, directly or by implication, the food
    presents or may present a hazard to health or safety.'' (emphasis
    added).\35\
        There are at least 31 State food labeling laws in 26 States \36\
    that the food industry claims are not affected by the legislation.\37\
    However, it is clear that these laws are ``warnings'' within the broad
    meaning of H.R. 4167 and S. 3128 because ``directly or by
    implication,'' as the bills state, they may be about health or safety--
    and so they are threatened by S. 3128 and H.R. 4167. For example,

         Alaska requires the labeling of genetically modified fish
    or fish products. Many consumers believe that such fish would be less
    safe than fish that has not been genetically modified.
         At least four States require disclosure on whether fish
    are farm raised: Alaska (salmon), Arkansas (catfish), Louisiana
    (catfish), and Mississippi (catfish). Certain farm-raised fish may
    contain elevated levels of PCBs or other contaminants.
         At least three States--New Hampshire, New York, and
    Vermont--have statutes that require that a food labeled as ``maple
    syrup'' consist only of maple syrup. By contrast, the FDA permits a
    product labeled as ``maple syrup'' also to contain salt, chemical
    preservatives, and defoaming agents.\38\ Consumers may believe that
    such an additive-containing product is less healthy than pure maple
    syrup.
         At least 10 States--Connecticut, Georgia, Iowa, Minnesota,
    Montana, Nevada, New York, Ohio, Pennsylvania, and Washington--have
    laws requiring that a food labeled as ``honey'' be only honey. Such
    honey labels may be challenged as preempted by the legislation under
    the guise that these restrictions are an implied warning to consumers
    who believe that natural food is healthier than foods that contain
    artificial sweeteners and flavorings, or highly refined sugar.
         Los Angeles County requires restaurants to display letter
    grade reports on what the county's inspectors found about the safety of
    the food in the restaurant.
    VIII. The Legislation Threatens Laws Passed by at Least Nine States
            That Restrict the Sale of Sodas and Certain Foods and Beverages
            in Schools in Order to Promote the Health of Children
        In September 2005 Governor Schwarzenegger signed two bills
    restricting what foods can be sold in California's schools. SB 12
    requires local school districts to prohibit, beginning July 2007, the
    sale of certain foods and beverages. SB 965 requires local school
    districts to prohibit the sale of certain beverages during various
    times, depending on whether it is an elementary school or a middle or
    junior high school. The California legislature determined in section 1
    of SB 12 that the ingredients in certain foods, including added sugar
    in soft drinks, contribute to the ``growing epidemic of overweight
    children,'' which is ``putting growing numbers of California children
    at risk for type 2 diabetes, hypertension, heart disease, and cancer.''
        Laws in at least eight other States--Arizona, Arkansas,
    Connecticut, Indiana, Kentucky, Louisiana; North Carolina,\39\ and West
    Virginia--also restrict the sale of sodas and other foods and beverages
    in public schools.\40\
        The FDA has broad power to restrict the sale of any food that, in
    the words of section 402(a)(1) of the FFDCA, contains a ``deleterious
    substance which may render it injurious to health.'' Section 406 of the
    FFDCA authorizes the FDA to issue regulations to limit the amount of a
    deleterious substance as the FDA ``finds necessary for the protection
    of public health.'' Section 409(a) of the FFDCA directs the FDA to
    establish conditions under which a food additive may be safely used. As
    discussed above, S. 3128 amends the FFDCA and provides, in pertinent
    part, that ``any requirement [of any State or political subdivision of
    a State] for a food described in section 402(a)(1), . . . 406, [and]
    409'' is preempted unless the State or local government's requirement
    is identical to a requirement of the FDA.\41\
        As the FDA has not used its broad legal powers to issue any
    regulations restricting the sale of foods, including soft drinks
    containing added sugar or artificial sweeteners, to children, the laws
    of these nine States restricting sales in schools could be preempted by
    S. 3128 and H.R. 4167.\42\
      conclusion: congress should not tamper with the federal-state food
       safety partnership that the food industry admits is not now broken
        More than 70 years ago Supreme Court Justice Louis D. Brandeis said
    ``It is one of the happy incidents of the Federal system that a single
    courageous State may, if its citizens choose, serve as a laboratory;
    and try novel social and economic experiments without risk to the rest
    of the country.'' \43\ For decades the food safety partnership among
    the FDA, the States, and local governments has worked well. As
    discussed above, Cal Dooley, President of the Food Products
    Association, admitted to USA Today in March 2006 that he could not
    ``cite a single instance in which manufacturers have to put two
    different labels on a [food] product, let alone 50.'' \44\ (emphasis in
    original) Congress should not tamper with this partnership merely
    because the food industry thinks there may be an unspecified problem in
    the future.

    Attachment: Examples of State and local food safety and labeling laws
    and regulations threatened by either H.R. 4167 (as passed by the House
    of Representatives on March 8, 2006) or S. 3128, the National
    Uniformity for Food Act.

                                     Notes

        1. The Center for Science in the Public Interest, a nonprofit
    organization based in Washington, DC., is supported by about 900,000
    members in the United States and Canada who subscribe to its Nutrition
    Action Healthletter. CSPI has been working to improve the Nation's
    health through better nutrition and safer food since 1971.
        2. This July 2006 table reflects criticisms by the food industry of
    a March 2006 table. My CSPI colleagues Hilary Kennedy and Samantha
    Williams were of great help in the preparation of these tables.
        3. USA Today (March 27, 2006) at 12A.
        4. The other exempt categories are ``freshness dating, open date
    labeling, grade labeling, a State inspection stamp, religious dietary
    labeling, organic or natural designation, . . . unit pricing, a
    statement of geographic origin, dietary supplements, or a consumer
    advisory relating to food sanitation that is imposed on a food
    establishment, or that is recommended by the Secretary, under part 3-6
    of the [Model] Food Code issued by the Food and Drug Administration,''
    the Centers for Disease Control, and the U.S. Department of
    Agriculture. H.R. 4167, page 14, lines 9-25 and S. 3128, page 14, lines
    12-23. The Model Food Code is published periodically and deals with
    more than consumer advisories; it can be used by State and local
    governments in establishing their own regulations to ensure the safety
    of food served in restaurants, schools, hospitals, nursing homes, and
    other food service establishments.
        5. This exception also applies to nine other enumerated parts of
    the FFDCA that deal with any poisonous or added deleterious substance
    added to food (subsection 402(a)(2)), a food container that contains a
    poisonous or deleterious substance (subsection 402(a)(6)), irradiated
    food (subsection 402(a)(7)), the safety of color additives in foods
    (subsection 402(a)(c)), emergency permits (section 404), tolerances for
    poisonous ingredients in foods (section 406), the safety of food
    additives (section 409), the safety of new animal drugs (section 512),
    and the safety of color additives in foods, drugs, devices, or
    cosmetics (subsection 721(a)). See S. 3128 at page 3, lines 5-12.
        6. For example, in North Carolina it might refer to regulations
    adopted pursuant to the North Carolina Food, Drug, and Cosmetic Act
    (``NCFDCA''). North Carolina General Statutes, Chapter 106, Article 12,
    sections 106-120-106-145. However, other important North Carolina food
    safety laws--such as those dealing with the safety of milk, food eaten
    in restaurants and other food service establishments, and shellfish,
    are not part of the NCFDCA and so are threatened by S. 3128.
        7. H.R. 4176 at page 10, lines 1-13 and S. 3128 at page 10, lines
    1-10. The courts will, of course, strike down any State or local food
    safety or labeling law that unduly burdens interstate commerce. For
    example, more than 60 years ago the U.S. Supreme Court held that a
    Madison, Wisconsin ordinance requiring that all pasteurized milk be
    bottled at an approved pasteurization plant located within a five mile
    radius of the center of Madison violated the Commerce Clause of the
    U.S. constitution. Dean Milk Co. v. City of Madison, 340 U.S. 349
    (1951). See also Granholm v. Heald, 544 U.S. 460 (2005) (Michigan and
    New York laws banning out-of-state wineries from selling directly to
    consumers violate the Commerce Clause).
        8. H.R. Rept. 109-379, 109th Cong. 2d Sess. (February 28, 2006) at
    11.
        9. FDA, Office of Management and Budget Formulation and
    Presentation, ``Foods'' www.fda.gov/oc/oms/ofin/budget/2007/pdf/
    3consolidatednarrative.pdf (visited May 1, 2006).
        10. March 1, 2006 letter of National Association of Attorneys
    General; April 18, 2006 letter of Governor Arnold Schwarzenegger; March
    2, 2006 letter of Governor Rod R. Blagojevich; March 7, 2006 letter of
    Governor Ruth Ann Minner, Governor Tom Vilsack, Governor Jennifer M.
    Granhohn, Governor Jon S. Corzine, Governor Bill Richardson, and
    Governor Brad Henry; January 30, 2006 letter of Colorado Commissioner
    of Agriculture; February 14, 2006 letter of Florida Commissioner of
    Agriculture and Consumer Services; March 24, 2006 letter of Georgia
    Commissioner of Agriculture; February 17, 2006 letter of Michigan
    Director of Agriculture;
    March 1, 2006 letter of New York Commissioner of Agriculture and
    Markets; February 27, 2006 letter of Washington Assistant Director of
    Agriculture; December 12, 2005 letter of Wisconsin Secretary of
    Agriculture, Trade and Consumer Protection; April 21, 2006 letter of
    Baltimore Commissioner of Health; July 10, 2006 letter of New York City
    Commissioner of Health and Mental Hygiene. Many of these letters are
    available at http://www.house.gov/waxman/issues/health/food_safety_hr
    4167.htm and http://www.house.gov/waxman/issues/health/food_safety_hr_
    4167_letters_oppostion.htm.
        11. See, e.g., January 16, 2006 letter of Association of Food and
    Drug Officials; June 1, 2006 letter of National Association of State
    Departments of Agriculture. These and other letters opposing H.R. 4167
    are available at http://www.house.gov/waxman/issues/health/
    food_safety_hr_4167.htm and http://www.house.gov/waxman/issues/health/
    food_safety_hr_4167_letters
    _opposition.htm.
        12. March 1, 2006 letter of National Association of Attorneys
    General at 1.
        13. H.R. Rept. 109-379, 109th Cong. 2d Sess. (February 28, 2006) at
    11.
        14. National Uniformity for Food Coalition press release (April 24,
    2006) www.uniformityforfood.com/coalitionrelease042406pressconf.pdf.
        15. Analysis of State Laws Cited in CSPI Report Shredding the Food
    Safety Net (hereafter cited as Pape-Bode paper).
    www.uniformityforfood.org/statelawanalysis
    summarydetails.pdf. The Pape-Bode paper deletes the first six pages of
    our March 2006 report, thereby making it appear that we were presenting
    the maximum number of laws--rather than examples of laws--that are
    threatened by H.R. 4167. The full text of our report--Shredding the
    Food Safety Net, A Partial Review of 200 State Food Safety and Labeling
    Laws Congress is Poised to Effectively Kill with H.R. 4167 (Center for
    Science in the Public Interest and Natural Resources Defense Council
    March 2006)--is available at www.cspinet.org/new/pdf/shredding.pdf.
        16. Pape-Bode paper at 4.
        17. www.oehha.ca.gov/prop65/pdf/Augt2005statusreport.pdf (visited
    May 1, 2006). California has identified about 770 chemicals that cause
    cancer or reproductive toxicity. www.oehha.ca.gov/prop65/prop65_list/
    files/060906p65single.pdf (visited July 19, 2006).
        18. In 1988 the Massachusetts Supreme Court rejected a challenge by
    the food industry to the Massachusetts statute whereby the
    Massachusetts Department of Public Health had set a ceiling for
    daminozide residue in processed apple products that was lower than what
    the FDA had established. Processed Apples Institute, Inc. v. Department
    of Public Health, 402 Mass. 392 (1988).
        19. See, e.g., Pape-Bode paper at 4.
        20. December 12, 2005 letter of the Wisconsin Secretary of
    Agriculture, Trade and Consumer Protection at 1.
        21. Id. at 2.
        22. February 14, 2006 letter from Florida Commissioner of
    Agriculture and Consumer Services at 2.
        23. March 1, 2006 letter of New York Commissioner of Agriculture
    and Markets at 2.
        24. The FDA prohibits the interstate shipment of both contaminated
    shellfish and unpasteurized milk. 21 CFR 1240.60 and 1240.61. However,
    its regulations do not deal with ensuring the safety of milk or
    shellfish within a State. The FDA has no regulations governing the
    safety of food in restaurants and other food service establishments.
        25. Sixteen milk safety, restaurant safety, and shellfish safety
    laws in Alaska, Kentucky, Massachusetts, Michigan, Missouri, Nebraska,
    Ohio, Wisconsin, and Wyoming may not be threatened by S. 3128 because
    in these States these laws are part of the State law that resembles the
    FFDCA.
        26. See, e.g., Pape-Bode paper at 1.
        27. January 16, 2006 letter from Association of Food and Drug
    Officials at 1, 2.
        28. At a press conference on March 7, 2006 the Attorney General of
    Utah said he opposed the legislation, in part because, in his opinion,
    it threatened Utah's honeybee safety law.
        29. James T.O. Reilly, Food and Drug Administration, 2nd ed. (2005)
    volume 1 at 4-71-4-72 (``Guidelines have the legal status of advisory
    opinions, which are merely an indication of policy directions . . .
    guidelines are legally unenforceable--rather a list of desires than of
    mandates . . .'') (footnotes omitted). See 21 CFR 10.90(c).
        30. New York City Law No. 49 (May 19, 2005).
        31. www.fda.gov/bbs/topics/NEWS/2005/NEW01284.html. (visited March
    1, 2006).
        32. See, www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg510-450.html.
    (visited July 6, 2006)
        33. Pape-Bode paper at 21.
        34. H.R. 4167 at page 4, lines 11-22 and S. 3128 at page 4, lines
    8-19.
        35. H.R. 4167 at page 5, lines 9-13 and S. 3128 at page 5, lines 5-
    9.
        36. Alaska requires both the labeling of farm-raised salmon
    products and the labeling of genetically modified fish or fish
    products. Arkansas requires a label that catfish be labeled as ``farm-
    raised,'' ``river or lake,'' ``imported,'' or ``ocean.'' California
    requires labels to disclose both if the food contains more than \1/2\
    percent alcohol and if a food is perishable when not refrigerated.
    Connecticut, Georgia, Iowa, Minnesota, Montana, Nevada, New York, Ohio,
    Pennsylvania, and Washington each have a law governing when ``honey''
    can be on the label of a food. Delaware requires that carbonated
    beverages containing artificial sweeteners be labeled as dietetic. Iowa
    also has a law governing when a food can have on the label the word
    ``sorghum.'' Louisiana has a law requiring that any catfish product be
    labeled as farm-raised or naturally produced. Maine has laws requiring
    disclosure of whether fresh produce has had a post-harvest treatment
    and whether apples have been exposed to controlled atmosphere. Maryland
    has a law requiring disclosure of whether a ``fresh'' food has been
    previously frozen. Massachusetts has a law governing the labeling of
    halibut. Minnesota also has a law governing the labeling of various
    types of wild rice. Mississippi requires any catfish product to be
    labeled as ``farm-raised,'' ``river or lake,'' or ``ocean.'' New
    Hampshire, New York, and Vermont have laws requiring that maple syrup
    be made solely from the sap of the maple tree. New York also requires a
    label to disclose whether a frozen food has previously been offered for
    sale in unfrozen form. North Carolina has a law governing the labeling
    of milk used in summer camps. Oregon has a law requiring that food that
    has been ``salvaged'' have a label stating that fact. Rhode Island has
    a law requiring disclosure of whether uncooked fish or shellfish have
    ever been frozen and a law governing the labeling of closed packages of
    apples. South Dakota requires a food label to disclose whether the food
    contains chloroform and various narcotics. Wisconsin has a labeling law
    governing the age of cheese made in Wisconsin.
        37. See, e.g., Pape-Bode paper at 2. Depending on the particular
    State labeling law, the food industry gives one of three reasons why it
    is not affected by H.R. 4167: (1) the label is not a ``warning'' as
    defined in the bill, (2) the label deals with what the industry calls
    ``economic adulteration'' (a term that does not appear either in the
    National Uniformity for Food Act or the FFDCA), or (3) there is no
    comparable FDA requirement (even though for other State labeling
    requirements--such as Proposition 65--the industry says the law is
    preempted although there is no comparable FDA requirement).
        38. 21 CFR 168.140(b).
        39. The North Carolina law also bans the sale of foods containing
    trans fatty acids from partially hydrogenated vegetable oils.
        40. For further discussion of State efforts to restrict the sale of
    certain foods and beverages in schools, see School Foods Report Card
    (CSPI June 20, 2006) available at http://cspinet.org/new/pdf/
    school_foods_report_card.pdf.
        41. S. 3128 at page 2, lines 7-21.
        42. These State laws are not part of the State law resembling the
    FFDCA.
        43. New State Ice Co. v. Liebmann, 285 U.S. 262, 311 (1932)
    (dissenting opinion).
        44. USA Today (March 27, 2006) at 12A.

                                     ______

                   Questions of Senator Jeffords to Panel II

        Question 1. I am concerned that S. 3128 would undermine Vermont's
    food labeling laws, particularly those that control what may or may not
    be labeled as maple syrup. Some testimony states that S. 3128 would
    only affect State warnings that address the safety of food. On most
    containers of Vermont maple syrup, the word ``pure'' is used, and is
    widely understood, to indicate an absence of impurities or pollutants.
    According to S. 3128, a ``warning'' is a direct or implied indication
    of a food's risk to health or safety. Would S. 3128, should it become
    law, prohibit Vermont from regulating what is considered ``pure?''
        Answer 1. Response not available.

        Question 2. In Vermont, maple syrup must be ``100 percent maple
    syrup which is entirely produced within the State of Vermont.''
    According to the FDA, however, maple syrup may contain one or more
    ``optional ingredients,'' including salt or chemical preservatives, as
    long as the optional ingredient is ``safe and suitable.'' Since the FDA
    allows other ingredients to be present in maple syrup, and since this
    bill prohibits State food laws that result in ``materially different
    requirements,'' would S. 3128 override Vermont's higher standards?
        Answer 2. Response not available.

        Question 3. When the FDA uses ``safe and suitable'' to describe a
    food ingredient, as it does with optional ingredients allowed for maple
    syrup, it seems that a judgment on that ingredient's healthfulness has
    been made. If S. 3128 prohibits States from issuing warnings about food
    safety, would this judgment by the FDA on an optional ingredient's
    healthfulness affect Vermont's ability to regulate the labeling of
    maple syrup or other maple products?
        Answer 3. Response not available.

      Response to Questions of Senator Enzi, Senator Kennedy, and Senator
                          Reed by William Stadtlander

                           QUESTIONS OF SENATOR ENZI

        Question 1. Your product, Wheatena, bears an FDA-approved health
    claim to the effect that Wheatena may help reduce the risk of cancer.
    At the same time, if I understand the situation correctly, you are
    being sued in California for failure to warn that your product contains
    a substance that causes cancer. Do I have that right?
        Answer 1. Exactly right. The health benefits of whole grain cereals
    like Wheatena are well established. Indeed, the reason that Wheatena
    can make these claims is that FDA has rigorously reviewed the data and
    determined that fiber-rich whole grain foods like Wheatena may help
    reduce the risk of cancer.

        Question 2. What would happen to your company and your employees if
    you had to pay out the $250,000 to settle the California Prop 65 law
    suit? What are your other options? Couldn't you just decide not to sell
    your product in California?
        Answer 2. Homestat Farm is a small company. Having to pay that kind
    of money to settle a lawsuit would have a huge impact on my ability to
    continue offering healthy products to consumers and jobs to my
    employees.
        As I understand them, my options in this litigation are to pay to
    settle these claims or to pay my attorneys to defend me in court. Since
    Proposition 65 puts the burden on defendants, winning this case (and
    I'm confident that I will win) will cost a tremendous amount of money
    that will be lost to my company forever because I can't get it back
    from the people who are bringing these claims against me.
        These costs won't necessarily go away even if I agreed to put a
    cancer warning on my product or to pull the products off California
    shelves. In fact, I'm told that some plaintiffs (even the California
    Attorney General) could sue me if someone sold the product in
    California without my authorization, even if I tried my best to prevent
    that from happening.
        Therefore, I could be forced to put a warning on the product,
    regardless of where it is sold. Aside from the injury to my business,
    that warning could discourage consumers in all 50 States from eating
    these products and deprive them of these well established benefits, all
    in order to give warnings about miniscule amounts of a naturally
    created chemical that poses little or no risk to people.

        Question 3. In your testimony, you stated that Wheatena has been
    sold since 1879. Have you changed the way you make Wheatena since it
    was first marketed? If you have not, doesn't that suggest there has
    been acrylamide in Wheatena for over 100 years?
        Answer 3. Wheatena is and always has been a pure and simple
    product--toasted wheat. Of course, people have been eating roasted,
    toasted, and baked wheat- and grain-based products for hundreds if not
    thousands of years. Since these basic cooking methods create
    acrylamide, you're right that it's been part of the human diet all of
    that time.
        In addition, calcium has been added for building strong bones.

                          QUESTIONS OF SENATOR KENNEDY

        Question 1. Wheatena.--You state on page 3 of your testimony that
    ``FDA specifically determined that Wheatena may reduce the risk of
    cancer.'' This statement surprises me, because FDA health claims don't
    typically identify a specific food product, but instead talk about food
    types, or foods that contain certain substances, usually as part of a
    certain diet, as reducing the risk of a disease.
        For example, a health claim under 21 CFR 101.76 relates the risk of
    cancer to low fat diets rich in fiber-containing grain products,
    fruits, and vegetables. The health claim under 21 CFR 101.77 is
    similar: it relates the risk of heart disease to diets low in saturated
    fat and cholesterol and rich in fruits, vegetables, and grain products
    that contain some types of dietary fiber, particularly dietary fiber.
        Could you please provide the committee with a copy of, or citation
    to, the document in which FDA ``specifically determined that Wheatena
    may reduce the risk of cancer?''
        Answer 1. FDA has specifically determined that fiber-rich grain
    products are components of a healthy diet associated with a reduced
    risk of cancer. 21 CFR  101.76(a)(2). Wheatena is a fiber-rich grain
    product.
        There are many other cereals as components of a healthy diet that
    reduce the risk of cancer.

        Question 2. Status of Acrylamide.--The following are some
    statements from the FDA Action Plan for Acrylamide in Food, March 2004
    (http://www.cfsan.fda.gov/dms/acrypla3.html):

              ``[A]crylamide is a potential human carcinogen and
            genotoxicant, based on high-dose animal studies, and a known
            human neurotoxicant.''
              ``Acrylamide causes cancer in laboratory animals in high
            doses. As a result, acrylamide is considered a potential human
            carcinogen. However, it is not clear whether acrylamide causes
            cancer in humans at the much lower levels found in food.
            Scientists have conducted epidemiological studies of people
            exposed to acrylamide in the workplace and through the diet.
            The studies did not show increased cancer risk with acrylamide
            exposure. However, these studies do not rule out the
            possibility that acrylamide in food can cause cancer because
            they have limited power to detect this effect. Also, we do not
            have enough information to rule out the possibility that subtle
            effects can occur on the developing nervous system at
            acrylamide doses lower than those that have been studied so far
            in animals and humans.''
              ``In June 2002, the World Health Organization (WHO) and the
            Food and Agriculture Organization (FAO) convened an expert
            consultation on acrylamide. The consultation, in which three
            FDA experts participated, concluded that the presence of
            acrylamide in food is a major concern, and recommended more
            research on mechanisms of formation and toxicity. Both the WHO/
            FAO consultation and the FDA have recommended that people
            continue to eat a balanced diet rich in fruits and vegetables.
            The WHO/FAO consultation advised that food should not be cooked
            excessively, i.e., for too long a time or at too high a
            temperature, but also advised that it is important to cook all
            food thoroughly--particularly meat and meat products--to
            destroy foodborne pathogens (bacteria, viruses, etc.) that
            might be present.''

        The FDA Web site (http://www.cfsan.fda.gov/dms/acrydata.html) also
    includes reports on its sampling of foods with acrylamide, and FDA
    tested Wheatena three different times as having 1057, 689, and 467 ppb
    acrylamide. Although some foods had higher levels than these--some
    considerably higher--most foods tested had much lower levels.
        Considering these statements and assuming there were foods that
    provided the nutritional benefits of Wheatena that contain less
    acrylamide than does Wheatena, do you believe that a consumer could
    reasonably choose to eat the other foods and not eat Wheatena? How do
    you think a consumer who might consider these statements relevant to a
    decision to eat Wheatena or not should be informed of such statements?
        Answer 2. As FDA has pointed out, people who are frightened away
    from eating certain foods because of an acrylamide warning will not
    necessarily substitute foods that are more wholesome or healthful. In
    the case of Wheatena, they almost certainly would not (since there
    aren't many more healthful foods around).
        Wheatena offers the following nutritional benefits:

         All Natural, High Fiber (25 percent more fiber than the
    leading brand), Low fat, Cholesterol free, Sodium Free, Calcium
    fortified;
         Wheatena is Heart Healthy, Bone Healthy and May reduce the
    risk of cancer;

        Healthy whole grain cereals, breads and bagels contain acrylamide.
        More importantly, the numbers you mention are expressed in parts
    per billion--these amounts are extremely small. FDA has said that the
    levels of acrylamide present in foods as the result of cooking do not
    warrant a change in diet. Differences between the levels present in my
    products and others on the market are therefore so insignificant that
    they simply do not provide any meaningful information regarding
    differences in actual risk. These warnings don't help consumers choose
    one product over another based on a comparison of such small numbers,
    they do the opposite--they mislead.
        The levels of acrylamide in Wheatena are smaller than the FDA
    reports based on our testing through an independent lab. In addition,
    Wheatena was tested in raw form versus mixed with a liquid to make hot
    cereal and Wheatena's serving size is 24 percent greater than other hot
    cereals.

        Question 3. Acrylamide Labeling.--In your testimony on page 2, you
    say, ``I know now that FDA actually says there should not be warnings
    on foods just because they contain acrylamide.'' I'm not aware of any
    statement to that effect from the agency--certainly not a formal
    advisory opinion. Would you please submit for the record any
    information that you have suggesting the FDA took a formal position on
    the issue, including any written statement from FDA?
        Answer 3. Representatives of FDA have twice written to government
    agencies in California indicating that Proposition 65 warnings on foods
    based on acrylamide are unwarranted and may confuse consumers or
    conflict with Federal policy. The first was a July 14, 2003 letter from
    acting director Lester Crawford to the director of the California
    Environmental Health Hazard Assessment. This view was recently
    reiterated in a March 21, 2006 letter from the FDA's Dr. Terry Troxell
    to the California Deputy Attorney General Ed Weil.

        Question 4. Regulations adopted under Proposition 65 provide that a
    warning need not be given for a chemical that causes cancer where
    ``sound considerations of public health'' support using a standard more
    favorable to businesses.

        1. Were you aware of this provision prior to your testimony?
        2. Have you done anything to raise this issue in your case?
        3. Do you plan to follow-up on this provision and potentially use
    it in the future?

        Answer 4. I am aware of this provision, and it is among the
    defenses that make me confident that the claims in the lawsuit against
    my company are without merit. However, proving it will require me to
    hire expert witnesses to develop a risk assessment and to engage in a
    ``battle of experts'' with the plaintiff if my case goes to trial.
    These things are enormously expensive, particularly for a small
    business such as mine.

                           QUESTIONS OF SENATOR REED

        Question 1. Food Manufacturing Facility Inspections.--As a food
    manufacturer, you are inspected regularly by a variety of different
    State and Federal agencies. How often are you inspected by State
    entities and how often does the FDA come to inspect your manufacturing
    sites presently?
        Answer 1. I can not speak to either State or Federal inspections
    prior to my ownership of Homestat Farm, however, in the nearly 5 years
    of ownership the FDA has conducted one inspection resulting in the FDA
    inspector stating the facility ``looked good.'' While I am in
    compliance with State requirements, no State inspection has taken place
    since I have owned the company.

        Question 2. Acrylamide.--I understand that acrylamide is a
    naturally occurring substance contained in Wheatena as well as numerous
    other products consumed by millions of Americans. Does the amount of
    acrylamide contained in Wheatena differ from similar products? Does the
    California law or its regulations specify a particular threshold for
    consumption of acrylamide, and if so, how does Wheatena measure up to
    that standard?
        Answer 2. As I've stated, there are differences between the
    concentrations found in one food product or another (and between one
    sample and another of the same food product). However, because the
    numbers are so small, the differences between them are immaterial and
    do not provide a sound basis for choosing between one product and
    another.
        The appropriate warning threshold for acrylamide in foods is one
    that is supported by sound considerations of public health. For all of
    the reasons I've discussed here and in my testimony before the
    committee, I am confident that sound considerations of public health
    support a warning threshold that does not require warnings that could
    scare people away from foods that they have been eating for hundreds of
    years without ill effect.
        Acrylamide is a naturally occurring substance and is in
    approximately 40 percent of the food people consume. Many of these
    products are considered healthy by the FDA and nutritionists. Toasters,
    microwaves and ovens all create acrylamide when starches and
    carbohydrates are cooked. In addition, coffee contains acrylamide. As a
    result of small quantities of naturally occurring acrylamide in food,
    and the total percent of foods with acrylamide I do not believe there
    should be any acrylamide warning.

    Response to Questions of Senator Enzi, Senator Kennedy, Senator Harkin,
             Senator Reed, and Senator Clinton by Peter Barton Hutt

                           QUESTIONS OF SENATOR ENZI

        Question 1. How do you respond to the charges that suggest State
    officials have the primary responsibility for protecting the food
    supply and that this legislation would impair their ability to ensure
    the safety of the food supply?
        Answer 1. Under the Federal Food and Drugs Act of 1906 and then the
    Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, Congress has
    entrusted to FDA the primary responsibility for protecting the
    nationwide food supply for the past 100 years. Under State and local
    food and drug laws, State and local officials are given the primary
    responsibility for protecting the food supply within their own local
    jurisdictions. Thus, regulation of the food supply necessarily requires
    a cooperative and collaborate approach between Federal and State
    officials. In order to have a nationwide food supply, one nationwide
    policy must be established to govern both the labeling and the safety
    of our food. That policy can then be implemented at both the Federal
    and State levels. Permitting every State and local jurisdiction to have
    their own conflicting and inconsistent rules would destroy interstate
    commerce in food and directly violate the intent of Congress in
    establishing FDA with primary jurisdiction over nationwide food issues.
        As the National Uniformity for Food Act recognizes, however, there
    are food issues that are essentially local in nature. These include, as
    examples, regulation of milk, shellfish, and restaurants. That is the
    reason why the National Uniformity for Food Act excludes these type of
    local activities from the requirement of national uniformity. The
    cooperative Federal/State/industry/academic programs that cover these
    local issues will not in any way be affected. It is only nationwide
    issues that are subject to the requirement of national uniformity, and
    the legislation makes it clear that every State and local jurisdiction
    will retain full authority to enforce compliance with nationwide policy
    on a local level.

        Question 2. Your testimony mentioned that there were only six
    petitions for an exemption under NLEA. What process did NLEA use for
    petitions? It has been suggested that the Citizen Petition process
    would be used under the National Uniformity for Food Act, but I don't
    see that requirement anywhere in the legislation. Could FDA use a
    different process?
        Answer 2. As enacted by the Nutrition Labeling and Education Act
    (NLEA) of 1990, Section 403A(b) of the FD&C Act provides that a State
    or political subdivision may petition FDA for an exemption from
    national uniformity. FDA has by regulation established a form in 21 CFR
    10.30(b) for all citizen petitions, regardless of the subject matter.
    Because the NLEA did not specify any particular form to be used for an
    exemption petition, the form established by FDA in 21 CFR 10.30(b) was
    used for the six submitted petitions. It is reasonable to anticipate
    that FDA would use the same form for exemption petitions under the
    National Uniformity for Food Act. The process that FDA uses in
    considering such petitions is also established by FDA in its
    administrative regulations set forth in 21 CFR Subpart B. FDA could
    lawfully adopt a different process if it chose to do so, but it is
    standard FDA practice to use the forms and procedures set forth in 21
    CFR Part 10 except in unusual circumstances where a more detailed or
    targeted petition may be appropriate.

        Question 3. There has been considerable disagreement about the
    number of State laws that would or would not be preempted by this
    proposed legislation. I have heard numbers ranging from 11 to 240.
    While I have heard a lot of back and forth about which number is right,
    and whether a particular law would or would not be preempted, I have
    not heard anything definitive about the sources of the confusion. For
    example, some have suggested the definition of ``identical'' is
    unclear. Others have indicated that the problem lies with
    distinguishing between a State law and a State regulation. Please
    discuss what you believe to be the sources of disagreement and
    confusion in this debate, and any suggestions or recommendations to
    clarify the proposed language.
        Answer 3. There are a number of reasons for the disagreement
    regarding the number of State laws that would be affected by the
    National Uniformity for Food Act.
        First, the people who oppose the legislation argue that it would
    affect a very large number of State laws, hoping that this will give
    strength to their argument. They contend that the bill is ambiguous and
    thus could have a very broad impact on State laws. On not one occasion,
    however, have these critics ever suggested ways that the language could
    be improved and clarified. Their strategy, instead, is simply to repeat
    vague allegations and not to respond to requests for specific details.
        Second, an analysis of the list of 240 State laws that would
    supposedly be affected by the legislation demonstrates in detail why in
    fact only 11 State laws would be affected. The proof of the validity of
    this analysis lies in the fact that the critics who have put forth the
    list of 240 State laws have been unable to respond substantively to the
    analysis which shows their list to be inaccurate. If their list was
    accurate, they would have responded.
        Third, the definition of the word ``identical'' is a good example.
    In response to criticism that this word was not defined, Senator Burr
    added a specific definition in order to make clear that it requires
    only that the State law be substantially the same as the Federal law
    and that any differences in language do not result in the imposition of
    materially different requirements. Nonetheless, the critics continue to
    say the provision is ambiguous--but, importantly, offer no clarifying
    language. The purpose of the critics is simply to oppose the
    legislation, not to offer meaningful clarifying language.
        Fourth, the problem does not lie with distinguishing between a
    State law and a State regulation. A State regulation cannot exceed the
    authority granted by a State law. Because a State regulation only
    implements a State law, the National Uniformity for Food Act refers
    only to the State laws themselves and not to the various regulations
    promulgated to implement them.
        Fifth, the only suggestion I have to clarify the proposed language
    would be for the committee to request all of the critics of the
    legislation for their suggestions to clarify the language of the bill
    in order to implement--not change--the stated purpose of the
    legislation. I believe this would quickly reveal that the purpose of
    the critics is to defeat the legislation, not to clarify it.
        Sixth, part of the confusion is also caused by the fact that
    critics either do not read or do not wish to understand the clear words
    of the bill. For example, William Hubbard, who appeared before the
    committee and initially criticized the legislation, later admitted that
    he had not read the bill at all. He relied upon the March 1, 2006
    letter from the National Association of Attorneys General raising
    concerns about 10 specific examples of State laws that would be
    affected. I am attaching an analysis of those 10 examples which
    demonstrates that none of them is valid. NAAG simply failed to conduct
    the research and analysis necessary to understand the provisions of the
    legislation.

                        National Uniformity for Food Act

     ANALYSIS OF CONCERNS RAISED BY THE NATIONAL ASSOCIATION OF ATTORNEYS
                        GENERAL LETTER OF MARCH 1, 2006

        In a letter dated March 1, 2006, the National Association of
    Attorneys General (NAAG) raised 10 specific concerns about H.R. 4167,
    the National Uniformity for Food Act, which would amend the current
    national uniformity provisions of the Federal Food, Drug, and Cosmetic
    Act (FD&C Act). A close review of these 10 concerns, however, reveals a
    serious misunderstanding of the impact of the National Uniformity for
    Food Act on the authority of States to regulate the food supply. The
    following analysis corrects the record and demonstrates that the
    National Uniformity for Food Act would have none of the consequences
    that were erroneously alleged in the NAAG letter.
        1. Mercury in fish.--The NAAG letter states in two places that the
    national uniformity legislation would prevent a State from requiring a
    consumer warning with respect to the mercury content in tuna fish. The
    letter fails to point out that FDA has determined--and sent a letter to
    California explicitly stating its determination--that there is no valid
    scientific or public policy basis for such a warning. On April 7, 2006,
    the San Francisco Superior Court issued an opinion in California v.
    Tri-Union Seafoods, LLC concluding that mercury is naturally occurring
    throughout the environment, that it does not present a significant
    human risk at the levels involved, that the FDA determination to handle
    the matter through consumer advisories rather than safety warnings must
    be given deference in California, and therefore that there is no legal
    basis for the consumer warnings proposed by the State. Accordingly, the
    example of mercury in fish simply reinforces the legal and factual
    basis for the National Uniformity for Food Act.
        2. Arsenic in drinking water.--The NAAG letter states that the
    national uniformity legislation would remove the authority of a State
    to require a warning about the level of arsenic in drinking water. This
    is incorrect, because the national uniformity legislation does not
    involve the regulation of drinking water in any way. The legislation
    only covers food regulated by FDA. Regulation of drinking water is
    handled by EPA, not FDA. Accordingly, consumer warnings about arsenic
    in drinking water are not affected by the national uniformity
    legislation. Research has uncovered no State law requiring a consumer
    warning about arsenic in drinking water.
        3. Lead in cans used to package food.--The NAAG letter states that
    the national uniformity legislation would prevent a State from
    requiring consumer warnings about the lead content in cans used to
    package food. This is incorrect, because FDA banned lead soldered food
    cans more than a decade ago. 21 CFR 189.240. FDA also banned lead foil
    for wine bottles a year later. 21 CFR 189.301. California is the only
    State that has an explicit law permitting the continued use of lead
    foil for wine bottle closures.
        4. Arsenic in bottled water.--NAAG argues that the National
    Uniformity for Food Act takes away from the States the authority to
    require consumer warnings about arsenic in bottled water. This is
    incorrect, because FDA regulates the amount of arsenic permitted in
    bottled water under a standard of identity promulgated by the agency.
    21 CFR 165.110(4)(i)(A). Under the national uniformity provisions of
    the Nutrition Labeling and Education Act of 1990, this FDA standard of
    identity is already subject to national uniformity. 21 U.S.C. 343-
    1(a)(1).
        5. Lead in ceramic tableware.--The NAAG letter contends that the
    national uniformity legislation would prevent a State from requiring
    consumer warnings about lead in ceramic tableware. Following a landmark
    court decision holding that FDA has jurisdiction over lead in ceramic
    tableware, the agency has established and enforced stringent
    regulations and action levels governing the migration of lead from food
    utensils and ceramic ware, 21 CFR 109.16, and has determined that the
    trace amounts of lead that do migrate are safe and should not be the
    subject of consumer warnings.
        6. Alcohol in candy.--The NAAG letter contends that a State will be
    precluded from consumer warnings about the alcohol content of candy
    within its jurisdiction. This is incorrect, for two separate reasons.
    First, the provisions regarding the regulation of alcohol in candy,
    under Section 402(d) of the FD&C Act, 21 U.S.C. 342(d), explicitly
    state that each State is permitted either to ban or permit the use of
    alcohol in candy. Second, the national uniformity legislation does not
    cover this provision of the FD&C Act. Thus, the pending legislation
    would not change current law with respect to the authority of a State
    to require a consumer warning about the alcohol content of candy within
    its own borders. Research has uncovered no State law that requires such
    a warning.
        7. The fat and oil content of a food.--The NAAG letter states that
    the national uniformity legislation would take away the right of a
    State to require a consumer warning about the fat and oil content of
    food. This is also incorrect, for three reasons. First, to the extent
    that the NAAG letter relates to the labeling of the content of fat and
    oil in food, the national uniformity legislation does not cover this
    subject. The labeling of food ingredients and nutrients is subject to
    national uniformity that was enacted by Congress in the Nutrition
    Labeling and Education Act of 1990, 21 U.S.C. 343-1(a). Second, to the
    extent that the NAAG letter relates to regulating the safety of the
    content of fat and oil in food, because FDA has no specific regulation
    governing these matters States would be free to impose safety
    limitations under their own State statutes in compliance with new
    section 403A(c)(3) unless and until FDA issued its own contrary
    determination. Third, to the extent that the NAAG letter relates to
    consumer safety warnings about the safety of fat and oil in food, new
    section 403B(a)(3) explicitly preserves the right of any State to issue
    any consumer warning that it determines appropriate although it cannot
    require the food industry to disseminate such warnings unless it
    obtains FDA approval of a local exemption or a new national standard.
    Research has uncovered no State law governing the safety or consumer
    warnings relating to the fat and oil content of food.
        8. Post-harvest pesticide application to fruits and vegetables.--
    The NAAG letter argues that the national uniformity legislation would
    take away the authority of a State to require consumer warnings about
    post-harvest pesticide applications to fruits and vegetables. This is
    incorrect, because FDA has no statutory authority to establish
    pesticide tolerances or require consumer warnings about pesticide
    residues. EPA has sole jurisdiction over pesticides, under Section 408
    of the FD&C Act, 21 U.S.C. 346a, and this provision is not covered by
    the National Uniformity for Food Act. National uniformity has already
    been established for pesticides under the Food Quality Protection Act
    of 1996, 21 U.S.C. 346a(n). Accordingly, the national uniformity
    legislation has no impact on the authority of a State to require
    warnings about post-harvest pesticide applications to food.
        9. False claims of health benefits.--The NAAG letter states that
    the national uniformity legislation would eliminate the ability of a
    State to regulate false claims relating to the health benefits of food.
    This is incorrect, because the national uniformity legislation only
    covers safety warnings, and does not in any way relate to claims for
    the health benefits of food. Congress enacted national uniformity
    governing claims for the health benefits of food as part of the
    Nutrition Labeling and Education Act of 1990, 21 U.S.C. 343-1(a)(5).
    Accordingly, the current legislation has no impact on this matter.
        10. Inadequate warnings for children.--Finally, the NAAG letter
    argues that the national uniformity legislation will prevent a State
    from imposing adequate warnings for children with respect to food
    products. The letter gives no specific examples of appropriate warnings
    that are not already required by FDA, and cites no State law or
    regulation that imposes such warnings. The NAAG letter also fails to
    recognize that new section 403B(c)(3)(C) of the legislation would grant
    expedited consideration by FDA to any State petition for a local
    exemption or a national standard governing warnings that could affect
    the health of children. Thus, the pending legislation fully recognizes
    the importance of any appropriate warnings to protect the health of
    children.

                          QUESTIONS OF SENATOR KENNEDY

        Question 1. Implied Warnings.--Under the bill, a warning includes a
    statement ``that indicates, directly or by implication,'' that the food
    presents or may present a hazard to health or safety.
        In a notice published in the Federal Register in February 1994, FDA
    stated:

            ``[T]he concept would better be formulated as `from cows not
            treated with rbST' or in other similar ways. However, even such
            a statement, which asserts that rbST has not been used in the
            production of the subject milk, has the potential to be
            misunderstood by consumers. Without proper context, such
            statements could be misleading. Such unqualified statements may
            imply that milk from untreated cows is safer or of higher
            quality than milk from treated cows. Such an implication would
            be false and misleading.''

        Farm-raised salmon has more PCBs than wild salmon. Therefore, by
    the reasoning FDA applied to statements about mild from rbST treated
    cows, a statement that salmon is farm-raised implies that the fish may
    be less safe than wild salmon, and is a warning under this bill. Do you
    agree? If not, why not? Please explain what ``by implication'' means?
    Why won't a food industry lawyer at least be able to argue that ``farm-
    raised'' is an implied statement about safety?
        Answer 1. Under the National Uniformity for Food Act, not all
    statements regarding the origin or composition of food are subject to
    national uniformity. Simple statements that provide information to
    consumers without in any way stating or implying that the food presents
    or may present a hazard to health or safety are not included within
    this legislation. Thus, a statement that is not in the nature of a
    warning is not covered by the legislation.
        Your question raises two examples: ``From cows not treated with
    rbST'' and ``farm-raised salmon.'' Taken by themselves, without a
    negative context, neither of these statements is in the nature of a
    warning. For the same reason, ``contains no caffeine'' on a soft drink
    or any other of a large number of other ``avoidance''statements do not,
    by themselves, inherently imply a warning. An avoidance statement is
    intended to appeal to people who, for whatever reason, do not wish to
    ingest a given type of substance or product. People have widely
    variable reasons for preferring substances or food products, wholly
    apart from safety reasons. Providing truthful, accurate, and
    nonmisleading information about food is therefore useful to consumers
    who wish to be able to make informed decisions in the marketplace.
        Any of these types of avoidance statements can, on the other hand,
    quickly be turned into safety warnings if the context is different. If
    the statement about rbST were conjoined with safety concerns or if the
    issue of PCBs were directly raised with regard to farm-raised salmon--
    or if the safety of caffeine is questioned in conjunction with a
    statement that a soft drink contains no caffeine--the result would be a
    warning. Thus, this legislation unequivocally preserves the right of a
    consumer to obtain accurate and nonmisleading information about the
    composition of the food supply without confusing consumers about
    warnings that are not imposed on a national basis.

        Question 2. Preemption Defense.--Under the proposed section
    403A(c)(1) in the Federal Food, Drug, and Cosmetic Act (page 2 of the
    bill), every time language in a State requirement does not use exactly
    the ``same language'' as the comparable provision under the Federal
    Food, Drug, and Cosmetic Act, a food company lawyer will be able to
    argue that the State provision is not ``substantially the same
    language'' or that the ``differences in language . . . result in the
    imposition of materially different requirements,'' especially when
    there is no FDA standard for the substance at issue.
        In fact, a food company lawyer would likely be committing
    malpractice not to use a preemption defense in such a State enforcement
    action following passage of S. 3128 if his or her client wanted him or
    her to do so. Food company lawyers would even potentially try to remove
    the cases to Federal court. How do you respond?
        Answer 2. The FD&C Act is filled with broad and general terminology
    that is designed to achieve the statutory purpose. Indeed, there is no
    regulatory statute in American history for which this is not true. For
    example, Section 402(a)(1) of the FD&C Act states that a food is deemed
    adulterated if it bears or contains ``any poisonous or deleterious
    substance which may render it injurious to health.'' Section 403(a)(1)
    of the FD&C Act states that a food is deemed to be misbranded if its
    labeling is ``false or misleading in any particular.'' The language in
    these two provisions is far broader and less clear in its scope and
    impact than is the definition of ``identical'' in the National
    Uniformity for Food Act. In fact, the statutory terms for adulteration
    and misbranding are not defined at all, whereas the statutory term
    ``identical'' is defined in a very clear and precise way. A State
    statute will be deemed identical if it uses substantially the same
    language and there is no materially different requirement. Compared to
    other provisions in the FD&C Act, the intent is extremely clear and the
    courts should have no difficulty whatever in implementing it.

        Question 3. Guidance Documents.--Section 701(h) of the Federal
    Food, Drug, and Cosmetic Act states that guidance documents are ``not
    binding on the Secretary'' and requires that guidance documents
    indicate their ``nonbinding nature.''
        S. 3128 doesn't change that guidance documents aren't binding on
    FDA or the industry. But it says that guidance documents are binding on
    States and localities, because they may only enforce a State
    requirement when it ``conforms'' to an FDA guidance.
        Under this bill, a company is not required to comply with a
    guidance document but a State can only act if it is alleging that the
    company hasn't complied with the guidance. Could you please explain why
    a State or locality should be bound by a guidance document that binds
    neither the FDA nor a food company?
        Answer 3. There are two answers to your question.
        First, if there is no FDA regulation or guidance, a State is
    entirely free to implement a statutory provision that is identical to
    the same provision in the FD&C Act in any way that it believes is
    justified. Thus, a State requirement imposed under a State statute
    identical to the Federal statute is completely lawful unless FDA has
    taken a contrary position in a regulation or guidance.
        Second, Section 701(h) of the FD&C Act explicitly states that
    guidance documents ``present the views'' of FDA on matters under its
    jurisdiction. It requires FDA to ensure that agency employees do not
    deviate from such guidances without appropriate justification and
    supervisory concurrence. Thus, as FDA has often said, guidance
    documents represent the enforcement position of the agency. The agency
    deviates from them only on rare occasions and under unusual
    circumstances.
        FDA guidance documents therefore represent national policy. They
    establish tolerances for food contaminants that the agency intends to
    enforce in court and related food safety and labeling positions that
    represent national policy established by the agency designated by
    Congress as the primary regulatory agency for our nationwide food
    supply.
        Although a guidance is not legally binding in the way that a
    statute or regulation is binding, it nonetheless represents FDA
    enforcement policy. It is rare that a company would willfully violate
    such a guidance. It is an informal substitute for a formal regulation.
    FDA uses guidances rather than regulations in situations where the
    formal procedures now required for promulgating regulations make that
    form of policy statement infeasible. A guidance represents FDA
    nationwide policy, however, and thus States should follow it or should
    petition FDA to change it. If States were permitted to ignore FDA
    guidance, FDA would be required to promulgate many more regulations in
    order to assure national uniformity, thus making regulation far more
    costly and difficult.

        Question 4. Seafood HACCP.--In 1995, the FDA issued final
    regulations under both section 402(a)(1) and 402(a)(4) of the Federal
    Food, Drug, and Cosmetic Act to ensure the safe and sanitary processing
    of fish and fishery products, known as Seafood HACCP, for Hazard
    Analysis and Critical Control Point.
        S. 3128 gives preemptive effect to section 402(a)(1) and it gives
    no preemptive effect to section 402(a)(4). So what is the effect of the
    HACCP regulations, which were issued under both of these statutory
    requirements? It seems that any State that has a safety standard of any
    sort related to fish, including shellfish, is preempted by this FDA
    regulation, because those State standards are obviously not identical
    to the FDA HACCP regulation. In any case, there is some real ambiguity
    here that a food industry lawyer could exploit, isn't there?
        Answer 4. The seafood HACCP regulations codified in 21 CFR Part 123
    are unquestionably directed at the safety of seafood, to implement
    Section 402(a)(1) of the FD&C Act. As often occurs, FDA included the
    sanitation provisions of section 402(a)(4) as additional statutory
    justification for these regulations. Even if FDA had not cited section
    402(a)(4), however, all of the regulatory requirements in part 123
    would be fully justified. Accordingly, to the extent that any State
    enacts a competing or different seafood HACCP regulation, it could not
    lawfully be enforced. This would be true whether the State law sought
    to increase or reduce the seafood HACCP requirements. Thus, consumers
    throughout the country are assured of a comprehensive, nationally-
    applicable HACCP regulation protecting the safety of seafood products.
        You ask whether any State that has a safety standard of any sort
    related to fish is preempted by this regulation. The answer is that in
    some circumstances it would be and in some circumstances it would not.
    Such a State law would be subject to national uniformity if it
    attempted to reduce or increase safety requirements addressed by part
    123. If it addressed other issues relating to fish, however, national
    uniformity would not apply. For example, the National Shellfish
    Sanitation Program (NSSP) is not subject to national uniformity. The
    NSSP program has been implemented for years under the authority of the
    Public Health Service Act, not the FD&C Act. And the National
    Uniformity for Food Act explicitly provides that shellfish warnings
    established under the Food Code are not subject to national uniformity.
    Thus, there is no ambiguity on what aspects of FDA regulations
    governing seafood are and are not subject to the pending legislation.

        Question 5. Preemption of Proposition 65.--Mr. Hutt, on page 6 of
    your written testimony, you say that it is a ``conspicuous anomaly''
    and an ``historic accident'' that there is not uniformity for foods, as
    there is for other products, such as nonprescription drugs, cosmetics,
    nutrition labeling, and pesticides. You seem to think the main point of
    this bill is to pre-empt California's Proposition 65. It is therefore
    interesting to note that both the Reagan and Bush I administrations
    opposed preemption of Proposition 65. It is therefore not an
    ``accident'' that Proposition 65 is not preempted.
        Nor is it an anomaly, as consideration of the preemptive actions of
    Congress makes clear. When Congress gave preemptive effect to FDA's
    regulation of over-the-counter drugs, cosmetic packaging and labeling,
    pesticides, and nutrition labeling, it always protected Proposition 65.
        Sections 751 and 752 of the Federal Food, Drug, and Cosmetic Act,
    as added in 1997, include the following provision:

              ``This section shall not apply to a State requirement adopted
            by a State public initiative or referendum enacted prior to
            September 1, 1997.''

        In fact, Congress added this provision to protect California's
    Proposition 65 from preemption.
        Similarly, paragraph (8) of the pesticide preemption provision,
    section 408(n) of the Federal Food, Drug, and Cosmetic Act, says:

              ``Nothing in this Act preempts the authority of any State or
            political subdivision to require that a food containing a
            pesticide chemical residue bear or be the subject of a warning
            or other statement relating to the presence of the pesticide
            residue in or on such food.''

        Again, Congress protected Proposition 65 from preemption.
        Finally, section 6(c)(2) of the Nutrition Labeling and Education
    Act states:

              ``The amendment made by subsection (a) and the provisions of
            subsection (b) [both of which provided for preemption of
            certain State laws] shall not be construed to apply to any
            requirement respecting a statement in the labeling of food that
            provides for a warning concerning the safety of the food or
            component of the food.''

        Once again, Congress protected Proposition 65.
        With respect to prescription drugs, Congress has never given
    preemptive effect to FDA regulation. It is true that Congress gave
    preemptive effect to FDA regulation of medical devices in section 521
    of the Federal Food, Drug, and Cosmetic Act, but the effect of this
    provision is still being debated, and besides, it was passed in 1976,
    before the citizens of California adopted Proposition 65 by referendum
    in 1986. It cannot be argued that Congress explicitly intended section
    520 to preempt a proposition that California had not yet adopted.
    Certainly, as the Senate author of the 1976 medical device legislation,
    it was not my intent to preempt Proposition 65 (nor any State product
    liability claims, for that matter).
        You argue that Congress should preempt Proposition 65 because you
    suggest it has done so in the past, when in fact Congress has not.
    Please comment.
        Answer 5. I have not stated, and I do not believe, that the ``main
    point'' of this legislation is to preempt California Proposition 65.
    The purpose of the legislation is to establish national policy
    regarding food safety in general and food warnings in particular. It is
    intended to make certain that every citizen of our country, wherever
    located, has access to the same safe and wholesome food that is clearly
    and conspicuously labeled with whatever warnings are appropriate.
    Uniformity in food warnings is uniquely important because of the
    consumer confusion that would result if each State imposed its own
    separate and different system of warnings.
        The lack of uniformity in regulating food under the FD&C Act is
    indeed an anomaly. When the Association of Official Agricultural (now
    Analytical) Chemists (AOAC) was formed in 1884, its constitution stated
    that the objectives were ``to secure, as far as possible, uniformity in
    legislation . . . and uniformity and accuracy in the methods and
    results'' of analysis. When the Association of Food and Drug Officials
    (AFDO) was formed in 1897, the constitution of the new organization
    stated that its purpose was ``to promote uniformity in legislation and
    rulings.'' In 1898, the Chief of the USDA Food Laboratory (which later
    became part of FDA) stated that national legislation was needed
    because, ``By no other means can we hope to secure laws uniform in
    their scope, requirements and penalties.'' The Director of the Bureau
    of Chemistry of the New York State Department of Health stated in 1903
    that ``uniformity in our food laws is much to be desired.'' Indeed, the
    House Report on the Food and Drugs Act of 1906 stated that:

              ``The laws and regulations of the different States are
            diverse, confusing, and often contradictory. . . . One of the
            hoped-for good results of a national law on the subject of pure
            foods is the bringing about of a uniformity of laws and
            regulations on the part of the States within their own several
            boundaries.''

        Similarly, the 1935 Senate Report on the legislation that
    ultimately became the FD&C Act of 1938 expressly recognized the
    importance of enacting legislation that would result in greater
    uniformity between Federal and State requirements.
        Your question does not reflect the fact that numerous laws have
    been enacted by Congress to achieve national uniformity in the
    regulation of food products as well as in the regulation of other
    products subject to FDA jurisdiction. These laws include the statutes
    that govern meat, poultry, and eggs, the packaging and labeling
    requirements for all food, and the misbranding provisions for food
    enacted under the Nutrition Labeling and Education Act of 1990. It also
    includes such other areas as medical devices. Most recently national
    uniformity was included in the Food Allergy Labeling and Consumer
    Protection Act of 2004, which you supported.
        As you point out, California Proposition 65 was excluded from three
    other provisions of law. These provisions were the result of political
    compromise in order to expedite pending legislation. They represent
    extremely unwise public policy. In effect, they permit one State to
    dictate food safety requirements for the rest of the country. The
    mistakes made in that prior legislation should not be repeated.

        Question 6. Local Requirements.--I'd like you to explain why the
    bill completely preempts localities from enforcing local requirements,
    even those that are identical to Federal requirements.
        Paragraphs (2), (3), and (4) of the proposed section 403A(c) (pages
    2 and 3 of the bill) say when a State or political subdivision of a
    State may or may not enforce a State law, but they don't say when the
    law of a political subdivision may be enforced. Similarly, the proposed
    section 403B(a)(3) (page 5) permits States to act under certain State
    authorities, but it doesn't say that a locality may act under its own,
    comparable authorities.
        Proposed section 403B(b) (pages 6-9) provides for the review of
    preempted State requirements, but not preempted local requirements.
    Proposed section 403B(c) (pages 9-12) allows States to petition for
    exemptions and national standards, but not localities. Proposed section
    403B(d) (pages 12-14) gives States a so-called imminent hazard
    authority, but not localities.
        S. 3128 completely preempts local laws that are not identical to
    Federal requirements, and it blocks localities from enforcing local
    laws that are identical. Why?
        Answer 6. The National Uniformity for Food Act does not completely
    preempt localities from enforcing local requirements that are identical
    to Federal requirements.
        Section 403B(a)(1) explicitly provides that any political
    subdivision of a State may enforce a local food safety warning that is
    identical to a Federal warning. Section 403A(c) also explicitly
    provides that a political subdivision of a State may enforce a State
    law that contains a requirement that is identical to a Federal
    requirement. I am unaware of any situation where a local jurisdiction
    within a State has enacted a law governing food safety that is
    identical to the Federal law but for which there is no comparable State
    law. Your question does not identify any such situation, nor has AFDO
    or other interested organizations stated that this has ever occurred.
    Perhaps that is the reason why Senator Burr has not covered this
    hypothetical situation in the legislation.
        Nonetheless, there is a simple answer to this hypothetical
    question. If the local jurisdiction has identified a provision of
    Federal law governing food safety that has no State counterpart and has
    enacted its own identical provision on a local level, it will be quite
    simple for that local jurisdiction to persuade the State to enact it
    into State law. Once that is done, it may be enforced by both State and
    local officials.
        Finally, the National Uniformity for Food Act funnels all State
    issues relating to FDA review, petitions for exemption, national
    standards, and imminent hazard action, through the appropriate State
    officials rather than through each individual local jurisdiction, for
    several reasons. First, as already stated, no one has thus far
    identified the type of local laws that you hypothesize in this
    question. Second, it is sound public policy to require each State to
    coordinate whatever petitions may be appropriate within its own
    jurisdiction, rather than to have a variety of viewpoints expressed by
    different local authorities. For the same reasons that uniformity is
    appropriate at the Federal level on nationwide issues, it is equally
    justified at the State level on statewide issues. Assuming that there
    are local laws governing food safety that are not applicable on a
    statewide basis, the State has an interest in assuring both that those
    laws are appropriate and that they should be advanced either as an
    exemption or as a national standard.

        Question 7. The Effect of Proposition 65.--On pages 14-15 of your
    testimony, Mr. Hutt, you state that California's Proposition 65 ``has
    resulted in a veritable flood of warnings in restaurants, bars, grocery
    stores, hotel lobbies, and elsewhere, as well as major litigation about
    its applicability to various food products.''
        The implication of this statement is that Proposition 65 has
    resulted in warnings on signs or placards in various places of business
    in California, but not actual warnings on food labels. A bit later on
    page 15, you concede that many companies have reformulated their foods,
    rather than engage in litigation (or, implicitly, place a warning on
    their food products).
        First, there is obviously no burden on food manufacturers of a
    requirement that signs be posted at points of sale in California.
    Please respond.
        Second, you obviously think that certain substances reduced as
    ingredients or reformulated out of foods because of Proposition 65
    should be reintroduced or increased in levels in foods. Please list
    each substance for which a warning is required under Proposition 65
    that is in your view improperly excluded from food or reduced in levels
    in food. Provide all substantiating science for your views.
        Third, you state on page 16 of your testimony that ``the claims
    that Proposition 65 has resulted in safer food are often not correct.''
    By implication, sometimes such claims are correct. Please list each
    substance that Proposition 65 has properly reduced in, or excluded
    from, foods, making them safer.
        Answer 7. As you point out, I have testified that California
    Proposition 65 ``has resulted in a variable flood of warnings in
    restaurants, bars, grocery stores, hotel lobbies, and elsewhere, as
    well as major litigation about its applicability to various food
    products.'' Your question implicitly agrees with that statement. I also
    testified that FDA has disagreed both with Proposition 65 itself and
    with its applicability to several food products. Your question does not
    disagree with that testimony. Thus, the real issue is whether this
    ``flood of warnings''--which has occurred in only 1 of 50 States in our
    country and has not occurred anywhere else in the rest of the world--
    represents sound public policy.
        Your question implies that, because warnings have not been placed
    on food labels and companies have simply reformulated in order to avoid
    litigation rather than because of any concern about the safety of their
    products, there is no impact on the food industry or on consumers. This
    is wrong. There has been a major impact on the food industry and on
    consumers. Forcing industry to promulgate warnings in California, even
    if not on food labels, has a large impact on the food industry as well
    as on consumers. First, it undermines the credibility and authority of
    one of our most important Federal agencies, the Food and Drug
    Administration. Second, it leads to enormous public concern about
    issues that FDA and the rest of the world have determined do not
    represent a significant health hazard. Third, it undermines our
    nationwide food distribution system. Fourth, it forces food companies
    either to engage in protracted expensive litigation in California (like
    the recent tuna fish litigation) or else cave in to private bounty
    hunters who have no interest in food safety but rather are focused on
    extorting fines from food companies.
        The recent tuna fish litigation responds to all three of your
    specific questions. In California v. Tri-Union Seafoods, LLC (April 7,
    2006), the San Francisco Superior Court issued an opinion concluding
    that mercury is naturally occurring throughout the environment, that it
    does not present a significant risk at the levels involved, that the
    FDA determination to handle the matter through consumer advisories
    rather than safety warnings must be given deference in California, and
    therefore that there is no legal or policy basis for the consumer
    warnings sought by the State. That decision illustrates the burden on
    food manufacturers involved under signs posted at points of sale in
    California, the existence of substances in food for which California
    would require a warning even when FDA determines that no warning is
    appropriate, and the false illusion that is created that any reduction
    in substances like mercury will necessarily make the food safer. The
    California court decision details the scientific evidence demonstrating
    the lack of harm from existing mercury levels in fish. The court
    determined that the testimony offered by the State was not credible.
    Yet manufacturers were forced to spend millions upon millions of
    dollars in defense of a case that should never have been brought. This
    is but one example where FDA has opposed a warning that would be
    required under Proposition 65, but it is the only one that has thus far
    been litigated with respect to food products.

        Question 8. Status of State Requirements Subject To a Petition.--On
    page 17 of your testimony, you state: ``State requirement that are the
    subject of State petitions to FDA remain in effect until FDA takes
    action on the petition, however long that takes.'' The proposed section
    403B(b)(2), on page 6 of the bill, says that if a State submits a
    petition within 180 days after the date of enactment of the bill, ``the
    notification of food safety requirement shall remain in effect in
    accordance with subparagraph (C) of paragraph (3).'' Paragraph (3)(C)
    of the proposed section 403B(b) says in clause (I) that the State
    requirement stays in effect until FDA denies the petition, which makes
    sense. Clause (II) says the State requirement stays in effect until FDA
    approves the petition, which makes no sense: Shouldn't the State
    requirement remain in effect after the petition is granted?
        Answer 8. Sections 403B(b)(3)(C)(i)(I) & (II) provide that a State
    requirement that is the subject of a petition submitted to FDA within
    180 days after the date of enactment shall remain in effect until
    either FDA denies the petition or, if the petition is approved, the
    effective date of the final rule promulgating an exemption or national
    standard, except that there is no applicable ending date if the final
    rule does not establish any condition regarding the State law
    provision. The State requirement remains in affect after the petition
    is granted, except to the extent that the FDA determination modifies
    the State requirement in some respect. Accordingly, there is no need to
    revise this provision of the National Uniformity for Food Act.

        Question 9. Number of Petitions for Proposition 65.--On page 18,
    you suggest that the number of State petitions will be small. Everyone
    agrees that the bill would preempt Proposition 65 and presumably also
    every warning with respect to a substance in food required under it.
    California could of course petition FDA to create an exemption for
    Proposition 65 itself.
        Do you believe that FDA could grant an exemption from preemption
    for Proposition 65? If it could, would each of the current food warning
    requirements under Proposition 65 be preserved from preemption, or not?
        If FDA weren't to grant an exemption for Proposition 65, or if such
    an exemption wouldn't preserve each of the Proposition 65 food
    warnings, isn't it reasonable to assume that California would pursue a
    petition for each such food warning? How many such warnings are there?
    Please list each one. Would you agree that each such petition would
    require FDA scientists to review an extensive scientific record, and
    that FDA action on such petitions could not be addressed ``summarily?''
        Answer 9. Sections 403B(b)(1) & (2) provide that the State may
    petition within 180 days after the date of enactment with respect to
    any State food safety warning ``that expressly applies to a specified
    food or food component'' and ``that does not meet the uniformity
    requirement.'' A petition by California to create an exemption for all
    of Proposition 65 would therefore violate this provision and could not
    lawfully be granted. California could, of course, file separate
    petitions regarding safety warning requirements that are imposed under
    Proposition 65 for each specified food or food component. Any such
    petition would be required to demonstrate the scientific basis for the
    warning. As I have already noted above, FDA has opposed Proposition 65
    generally and the specific warnings for food products that have been
    the subject of potential or actual litigation thus far. It is highly
    doubtful that responsible toxicologists in California would conclude
    that the types of warnings that FDA has opposed can be justified on a
    scientific basis. Indeed, it is unclear that responsible scientists
    would be able to mount a persuasive argument that cancer and
    reproductive toxicity warnings under Proposition 65 should be applied
    to any significant items in the food supply. Once the rules of science
    are imposed, rather than the arbitrary political determinations set
    forth in Proposition 65, the number of petitions is likely to be
    extremely small. In fact, it is not clear that even a single petition,
    backed by a strong scientific rationale, could be prepared for any
    Proposition 65 food safety warning.
        I fully agree that any California petition relating to a food
    safety warning that is backed by substantial scientific data would be,
    and should be, treated very seriously by FDA. Under no circumstances
    could it be summarily dismissed. The length and depth of any scientific
    analysis by FDA will, of course, depend upon the length and depth of
    the scientific analysis presented in a State petition.

        Question 10. Alcohol-Pregnancy Warnings.--At the food industry's
    April 24, 2006, press conference, the industry conceded that H.R. 4167
    threatened Nevada's law requiring that food establishments selling
    alcoholic beverages post a sign warning pregnant women of the risk of
    drinking such beverages (Analysis of State Laws Cited in CSPI Report
    Shredding the Food Safety Net, www.uniformityforfood.org/
    statelawanalysissummarydetails.pdf at 21). I believe at least 18 States
    have such requirements. How do you explain this discrepancy with your
    testimony that such warnings would not be preempted?
        Answer 10. It is clear that State laws requiring food
    establishments selling alcoholic beverages to post a sign warning
    pregnant women of the risk of drinking alcoholic beverages is not
    subject to the National Uniformity for Food Act. The National
    Uniformity for Food Act only applies to food that is subject to the
    jurisdiction of FDA under the FD&C Act. In Brown-Forman Distillers
    Corp. v. Mathews, 435 F. Supp. 5 (W.D.Ky. 1976), the District Court
    held that alcoholic beverages are exempt from the labeling requirements
    of the FD&C Act. Alcoholic beverage labeling is instead subject to the
    sole jurisdiction of the Federal Alcohol Administration Act, which is
    administered by the Alcohol and Tobacco Tax and Trade Bureau (ATTTB,
    formerly BATF). ATTTB also has exclusive jurisdiction over the
    advertising of alcoholic beverages, and FDA does not have jurisdiction
    over the advertising of any food that is subject to the National
    Uniformity for Food Act. Accordingly, the State laws referenced in your
    question are not covered by the National Uniformity for Food Act and
    are not in any way affected by this legislation. I did not attend the
    press conference that you reference and have no information about what
    was said at that time.

        Question 11. Number of Laws Preempted.--The same document
    identified 26 State laws that would be threatened by the House bill,
    whereas you state on page 18 of your testimony that only 11 would be
    affected. Please explain the discrepancy.
        Answer 11. I base the statement in my testimony that only 11 State
    laws would be potentially affected by the National Uniformity for Food
    Act on the April 24, 2006 analysis of State laws cited in the CSPI
    Report ``Shredding the Food Safety Net.'' That analysis explicitly
    identifies the 11 State laws that would be affected. My own review of
    that analysis confirms that conclusion. Perhaps the discrepancy occurs
    because a number of State statutes authorize the State to adopt
    tolerances for food additives and color additives that are more
    protective of human health than the applicable FDA tolerances. I do not
    include those statutes in my analysis because no State has ever taken
    action under one of these provisions in the 48 years that they have
    been in existence.

        Question 12. Meaning of ``Requirement''.--I would like you to
    clarify what a ``requirement'' is under the bill. You seem to suggest
    that individual phrases can be preempted, leaving the remaining
    provisions of a State requirement that is ``identical'' to a Federal
    Requirement in effect. Yet there is nothing in the bill language to
    suggest that this is what ``requirement'' means.
        Consider two examples. First is Chapter 94, Section 13 of the
    General Laws of Massachusetts, which provides for rules for milk and
    raw milk products. It consists of three sentences. The first of these
    gives the State the authority to issue rules and regulations with
    respect to milk and milk products. The second sentence requires that
    these rules be consistent with FDA's Grade ``A'' Pasteurized Milk
    Ordinance, and adds a proviso that the State may impose more stringent
    bacterial and temperature standards. The third sentence provides for
    fines for violations of the regulations.
        So what is the State requirement here? The food industry seems to
    argue that these provisions should be spliced up into various phrases
    and that only the proviso in the second sentence would be preempted,
    yet I see nothing in S. 3128 that compels this result. Indeed, it would
    seem that S. 3128 would allow the requirement at issue to be the entire
    section. The entire provision is by no means identical to anything in
    the Federal Food, Drug, and Cosmetic Act, and would therefore be
    preempted. At a minimum, it would seem that the entire second sentence
    must be preempted. The bottom line is that there is at least a
    reasonable argument that all of section 13 is preempted by S. 3128,
    which would leave Massachusetts with no authority to enforce safe
    standards for milk products.
        There is a similarly troubling ambiguity with respect to
    Massachusetts laws governing the safety of pesticides, food additives,
    and color additives. The relevant provisions are found in Chapter 94,
    Section 186. The second Paragraph relating to foods includes
    subparagraphs (2) (pesticides), (3) (food additives), and (4) (color
    additives) that say a substance adulterates a food if it is unsafe
    under the corresponding provisions of the Federal Food, Drug, and
    Cosmetic Act, with a proviso clause that the State may, by regulation,
    prohibit pesticides, food additives, and color additives deemed safe
    under Federal law. So is just the proviso preempted, or are all three
    provisions preempted entirely? There appears to be nothing in the
    language of S. 3128 to clarify the issue, which is arguable either way.
    Please comment.
        Answer 12. The term ``requirement'' is explicitly defined in
    Section 403B(g)(1) of the National Uniformity for Food Act. It is
    defined to mean a mandatory action or prohibition established under the
    FD&C Act or the Fair Packaging and Labeling Act or by a regulation or a
    court order. Thus, you are correct that the part of a State statute
    that is identical to a Federal statute would remain in effect, but the
    part that is not identical would no longer be effective (assuming that
    it is not the subject of a State petition and FDA acceptance).
        Your example of the Massachusetts law relating to milk and raw milk
    products is not applicable. Beginning in 1923, the Pasteurized Milk
    Ordinance (PMO) and Code were developed by the Public Health Service
    under the Public Health Service Act, not the FD&C Act. FDA at one time
    contemplated codifying the PMO in regulations under the FD&C Act, but
    abandoned this approach at the request of State officials. Thus, the
    PMO continues to be implemented under the Public Health Service Act,
    which is not subject to the provisions of the National Uniformity for
    Food Act. If at some point in the future FDA were to implement the PMO
    under the FD&C Act, rather than the Public Health Service Act, the
    following analysis would result. The State would continue to have full
    authority to issue rules and regulations with respect to milk and milk
    products that are identical with the PMO. The State would no longer
    have authority to impose more stringent bacterial and temperature
    standards than those required by FDA, but could petition FDA for an
    exemption or a national standard adopting the Massachusetts
    requirements. Because nothing in the National Uniformity for Food Act
    affects enforcement mechanisms, Massachusetts would continue to be able
    to impose fines for violations. This analysis is completely consistent
    with the statutory definition of the term ``requirement,'' which
    unambiguously refers to a mandatory action or prohibition and not to an
    entire statutory provision. Your analysis is incorrect because it does
    not refer to the statutory definition of ``requirement'' in the
    National Uniformity for Food Act.
        The second part of your question refers to Massachusetts laws
    governing the safety of pesticides, food additives, and color
    additives. First, the National Uniformity for Food Act does not cover
    pesticides. Section 408 of the FD&C Act, which governs pesticides, is
    not one of the provisions that is made subject to this legislation. The
    Food Quality Protection Act of 1996 governs national uniformity for
    pesticides. Accordingly, the rules governing national uniformity for
    pesticides were enacted by Congress 10 years ago.
        With respect to food additives and color additives, as I have
    pointed out above, neither Massachusetts nor any other State has ever
    utilized the authority to promulgate regulations for food additives or
    color additives differing from the FDA regulations, in the past 48
    years. Indeed, States do not bother to promulgate specific food
    additive or color additive regulations identical to those adopted by
    FDA. This is an area where States appropriately have deferred to FDA
    for the past 5 decades. Nonetheless, in light of the statutory
    definition of the term ``requirement,'' it is clear that States would
    retain their authority to issue food additive and color additive
    regulations identical to those promulgated by FDA, and to enforce those
    requirements, under the National Uniformity for Food Act. It is only
    the proviso in the State laws authorizing different regulatory
    requirements that would be subject to national uniformity.

        Question 13. Conforms.--Please explain the meaning of the word
    ``conforms'' in the proposed section 403A(c)(2) of the bill (page 3),
    especially in light of Processed Apples Institute v. Department of
    Public Health, 522 N.E.2d 965 (1988). Why doesn't that case compel the
    preemption of both the second paragraph on foods of Chapter 94, Section
    186 and Section 192?
        Answer 13. Section 403A(c) contains provisions that confirm the
    authority of both a State and a political subdivision to enforce any
    requirement in a State or local law that is identical to a requirement
    in the Federal law. If FDA has promulgated a regulation or guidance
    relating to that requirement, the State or local government must
    conform its requirement to the Federal requirement. If FDA has not
    promulgated a regulation or guidance, the State or local government may
    implement the identical provision in any way that it believes
    appropriate.
        The term ``conforms'' in Section 403A(c)(2) has its customary
    English meaning, i.e., the State requirement must be in accord or
    agreement with the Federal requirement. Once again, because of the
    statutory definition of the term ``requirement,'' which makes it clear
    that it refers to a specific action or prohibition and not to a
    sentence or entire section, the meaning of ``conforms'' is very clear.
    If the Federal and State statutes are identical, it is the specific
    State requirement and not the entire statutory provision that must
    conform to the Federal regulation or guidance.
        Nothing in the Processed Apples Institute decision indicates a
    contrary interpretation of the National Uniformity for Food Act. That
    decision arose in a context where the court concluded that the State
    had the authority to ban the pesticide completely. That situation could
    not arise under the National Uniformity for Food Act. The court in that
    case reasoned that, if the State could impose a complete ban, it could
    also take the lesser action of imposing a more stringent tolerance.
    Because the National Uniformity for Food Act expressly prohibits a
    complete ban, that court's reasoning could not be applicable, and
    conformity would be given its common and clear meaning.

        Question 14. No FDA or State Regulation.--The proposed section
    403A(c) allows a State or locality to enforce a State (but not a local)
    requirement identical to a Federal requirement when FDA has issued a
    regulation or guidance and the State or locality enforce the Federal
    regulation or guidance (paragraph (2)), and when FDA has not issued a
    final regulation or guidance and the State has its own ``policy'' such
    as a regulation or ``administrative decision'' (paragraph (3)). S. 3128
    doesn't say what a State or locality can do when neither the FDA nor
    the State have a regulation, guidance, or ``policy'' in place.
        It seems to me the better reading is that a State or locality may
    not enforce in that instance, and, at a minimum, it is clear that a
    food industry lawyer will be able to argue that the enforcement action
    is not permitted under the bill. This seems to me a particular concern
    when neither FDA nor a State may have anticipated a substance that
    terrorists have put in food. Please respond.
        Answer 14. Section 403A(c)(3) governs when a State and the FDA are
    operating under an identical statute, FDA has taken no action in the
    form of a regulation or guidance on a particular issue, and the State
    wishes to enforce its State law in a particular way. For example, let
    us assume that the State determines that a contaminant in the food
    supply violates the ``poisonous or deleterious substance'' provision in
    both the Federal and the State law, and FDA has expressed no opinion on
    the matter. Under those circumstances, the State is completely free to
    take action unless and until FDA takes its own action in the form of a
    regulation or guidance and makes a different determination. The State's
    ``policy,'' under this hypothetical, consists of the determination that
    the contaminant represents a ``poisonous or deleterious substance'' at
    the level involved. Indeed, it would be impossible for the State to
    take any form of action until it had reached the policy position that
    the particular level of the contaminant that is involved constitutes a
    ``poisonous or deleterious substance.'' If, as you suggest, the
    contaminant has been placed in the food by terrorists, it is
    unquestionable that both FDA and the State would act, and in fact the
    State would act under the imminent hazard provisions of the National
    Uniformity for Food Act.

        Question 15. Aborted FDA Action.--The proposed section 403A(c)(4)
    blocks a State or locality from enforcing a policy rejected by FDA. If
    FDA has rejected a tolerance of X for substance Y, it seems clear that
    the State may not enforce the tolerance of X. What about twice X? X
    plus a tenth X? X plus a hundredth X? It is entirely unclear what this
    provision means. Suppose FDA rejected the policy 10 years ago, and
    since that time new science supports the tolerance of X for substance
    Y. Why should a State be prohibited from enforcing it? What if the new
    science supports a tolerance of one tenth or one hundredth X? Why
    should the State be blocked from acting until FDA has acted?
        Answer 15. FDA is constantly reviewing contaminants and ingredients
    in the U.S. food supply, and adopting formal and informal
    determinations regarding the level at which a given contaminant is and
    is not a hazard to public health. The hypothetical posed in your
    question is not realistic. FDA does not determine that a particular
    level of a contaminant or ingredient is safe and therefore all levels
    are safe. In almost all instances, it determines the upper limit of
    safety, so that anything above that limit would not be regarded as
    safe. Thus your examples of contamination at levels in excess of the
    FDA tolerance are easily answered. If FDA has said that X level is
    safe, the simple answer is that in virtually all instances FDA has
    determined either that this level is the upper limit of safety or that
    some higher level is the upper limit and that this level falls within
    it. It would be extremely unusual for FDA to make a safety
    determination about a particular level and to stop at that point
    without further analysis. If a State believes that FDA has in fact done
    this, it is a simple matter for the State to discuss it with FDA in
    order to obtain clarification, or to submit a petition for an exemption
    or a national standard.
        Without doubt, all regulatory standards are worthy of review and
    reconsideration as time progresses. You ask what should be done if FDA
    rejected a tolerance for a contaminant 10 years ago and new science now
    supports such a tolerance. The National Uniformity for Food Act
    anticipates exactly this type of circumstance. The State should then
    discuss the matter with FDA and submit a petition for exemption or,
    undoubtedly more appropriate, a new national standard. If the science
    demonstrating the toxicity of the contaminant is compelling, and the
    hazard is very serious, the State may utilize the imminent hazard
    provision as well.
        You ask why a State should be prohibited from simply adopting
    whatever contaminant level it wishes, without regard to the FDA
    determination. The answer to this is very clear and compelling.
    Tolerances for food contaminants must be established on a national
    level, not a local level, if we are to maintain a nationwide market in
    food. If every State were to adopt its own tolerances in the light of
    new scientific data, there would be chaos in the marketplace. It is
    precisely for this reason that Congress delegated to FDA primary
    authority to deal with nationwide food safety problems. This
    legislation simply permits that delegation to have its intended
    purpose.

                          QUESTIONS OF SENATOR HARKIN

        Question 1. Exemption From Preemption.--The proposed section
    403B(f) exempts from preemption certain types of State required
    notifications such as open date labeling, religious dietary labeling,
    organic or natural designation, and statements of geographic origin,
    among others. Please explain why such exemption is needed for each of
    the particular exemptions contained in this subsection. What provisions
    in the bill imply that these sorts of provisions are preempted absent
    the exemption? Does the clear exemption for these specific State-
    required notifications create the implication that all other State-
    required notifications are preempted?
        Answer 1. The State laws you identify in Section 403B(f)(1)--open
    date labeling and so forth--are not food safety provisions, are not
    food warnings, and would not be covered by the legislation even without
    the specific statutory exemption. I am told that Senator Burr included
    them in the legislation because critics persisted in using each one of
    these types of State required notifications as an example of State laws
    that would be preempted by this legislation. Even though that was a
    demonstrably incorrect interpretation of the bill, Senator Burr
    apparently felt that it was easier to put in a specific exemption in
    order to cut off this erroneous criticism. There would be no way to
    interpret the legislation to imply that these sorts of provisions are
    preempted absent the exemption. Thus, this specific exemption for these
    types of non-warning statements does not create an implication that
    other similar non-safety statements are subject to national uniformity.

        Question 2. Scope of the Bill.--Mr. Hutt, you state in your
    testimony that Proposition 65 is the overarching problem that
    necessitates this uniformity legislation. But you also state that
    ``existing differences between Federal and State food safety law are
    few and generally of a minor nature.'' Can you please explain how you
    reconcile your opinions on this matter, which seem somewhat at odds
    with one another?
        In addition, if Proposition 65 is the problem that needs to be
    addressed, can you tell me if there are there alternative and more
    circumscribed means by which to address these matters? Is it possible
    to create a mechanism by which to avoid the kind of situation in which
    Mr. Stadtlander finds himself without such broad preemption?
        Answer 2. As I have stated in response to a question from Senator
    Kennedy, the main purpose of this legislation is to assure a cohesive
    national approach to food safety. It is not directed primarily or
    exclusively at Proposition 65.
        In 1997, Congress directed USDA to fund a study by the National
    Academy of Sciences to evaluate our current food safety system in the
    United States. The Institute of Medicine undertook this study and
    produced its report in 1998. The report found that ``Federal activities
    are not well integrated with State and local activities'' and called
    for a ``national food safety plan'' that would ``integrate Federal,
    State, and local food safety activities.'' As the report recognized,
    ``officials at all levels of government must work together in support
    of common goals of a science-based system.'' The report emphasized the
    need for statutory authority ``to integrate State and local activities
    regarding food safety into an effective national system.'' The
    President's Council on Food Safety, which President Clinton established
    in August 1998 in response to the Institute of Medicine report,
    strongly endorsed this approach. President Clinton's Council issued its
    own report in March 1999 stating that Federal and State food safety
    agencies ``have expertise and resources that, when combined in an
    integrated program, would significantly enhance the impact of food
    safety programs.'' The Council's report concluded that there needs to
    be ``public assurance that State and local activities are integrated
    with, and an extension of, the Federal responsibility in order to
    assure consistency, accountability, and above all, enhanced consumer
    protection.'' This legislation provides the critical element to assure
    an integrated national food safety program.
        As I said in my testimony, existing differences between Federal and
    State food safety laws are few and generally of a minor nature. This
    means that there will be no wholesale revocation of existing food
    safety laws. Most are presently identical to the Federal law, and thus
    may continue to be enforced under the provisions of this legislation.
    It is only the few that differ substantially from Federal law that will
    no longer be enforceable.
        Merely addressing California Proposition 65 would not meet the
    mandate of President Clinton's Food Safety Council. A comprehensive
    national food safety system is needed in order to assure maximum
    consumer protection, and this legislation provides for just such a
    system.

        Question 3. Multiple Labels.--With regard to warning labels and
    notification requirements, supporters of this bill, have complained
    about a patchwork quilt of food safety warnings required by different
    States. Yet I have not yet seen a specific food product that contains
    multiple labels--one required by Federal law and another required by
    State law. Can you provide me with such an example or multiple
    examples?
        Answer 3. I did not testify that food safety warnings have appeared
    in food labeling. Rather, I said that they appear ``in restaurants,
    bars, grocery stores, hotel lobbies, and elsewhere.'' None of these
    warnings are required in any other State or by FDA or by any other
    country in the world. Obviously, the ingredients required to be the
    subject of a warning in California are not unsafe in California and
    safe in 49 other States. There is a strong need to rationalize safety
    decisions in order not to confound the public.
        For example, a law suit was brought under Proposition 65 to require
    a warning regarding the natural lead content of calcium in dietary
    supplement products. The industry had only two options. Either it could
    spend millions of dollars litigating the issue, with the always
    uncertain result in a California court, or it could cave in and find a
    way to use only low lead calcium in California. At no time did FDA
    suggest that the lead content in calcium deserved a warning.
    Nonetheless, the industry concluded that it was less expensive to find
    a low-lead source of calcium for California than it was to litigate the
    matter. In the view of FDA, this entire process did not in any way
    advance the health and safety of consumers. It disrupted the dietary
    supplement industry and cost them millions of dollars, for no public
    health reason.

        Question 4. Warning vs. Notification.--On the issue of what
    constitutes a warning, there is some disagreement. The Center for
    Science in the Public Interest asserts that nearly 200 State laws would
    be affected by this legislation. Mr. Hutt, you have reviewed the CSPI
    report on this matter and believe that the CSPI report is incorrect
    because it doesn't distinguish between ``warnings'' and
    ``notification.'' You state that if one looks only at warnings and not
    at notifications more broadly, that the number of State laws affected
    would be significantly less. You also state that S. 3128 clearly
    pertains only to notification requirements that contain food-related
    warnings and not notification more broadly.
        However, I am unclear as to whether the term ``warning,'' as
    defined by the bill, is nearly as clear as has been asserted. The bill
    says that ``warning,'' used with respect to a food, means any
    statement, vignette, or other representation that indicates, directly
    or by implication, that the food presents or may present a hazard to
    health or safety.
        Do you see any uncertainly under this definition, especially the
    ``by implication'' portion? Can you explain to me more precisely the
    legal import and effect of this ``by implication'' language? Why it is
    important to have the ``by implication'' language included in the bill
    at all?
        By way of example, what if a State adopts a requirement that grass-
    fed beef be labeled as such? Directly, this may be only a notification.
    But what if research definitively shows that grass-fed has health
    benefits relative to grain-fed beef. By implication, wouldn't a grass-
    fed beef notification then become a warning regarding grain-fed beef?
    Perhaps this isn't the best illustration. My point is not to comment on
    grass-fed beef or the state of science pertaining to it, but to ask
    whether the definition of warning in the legislation is altogether
    clear.
        Answer 4. As I have said in response to your first question above,
    the National Uniformity for Food Act covers only notifications that are
    in the nature of a warning, and does not cover notifications that do
    not state or imply a safety problem.
        You have asked why it is necessary to impose national uniformity
    both for direct warnings and for implied warnings. The answer is clear.
    If only direct warnings were subject to national uniformity, it would
    be very simple to convert them into implied warnings and thus escape
    national uniformity. Let us take the example of farm-raised fish. State
    laws that require farm-raised fish to be so labeled are not subject to
    national uniformity because, as I have pointed out in response to
    question No. 1 from Senator Kennedy, this type of statement is merely
    an ``avoidance'' claim. Some people prefer wild fish to farm-raised
    fish because they prefer ``natural'' food. Companies are entitled to
    give this type of information on the source of the fish so that
    consumers can satisfy their own personal eating preferences.
        If a State were to decide that it wanted to discourage the sale of
    farm-raised fish (because it could be in an ocean State's interest to
    encourage the sale of wild fish), it could easily devise a statement
    such as ``farm-raised fish contain PCBs.'' It would not include the
    required use of the term ``warning'' and would not allege the lack of
    safety of the product. It would, however, clearly imply that there was
    a significant safety issue. Accordingly, it is important to harmonize
    implied as well as direct food safety warnings throughout the country.

        Question 5. Cost-Benefit Analysis.--Issues like food safety often
    involve cost-benefit analyses. Are you aware of any cost-benefit
    analysis showing the costs and benefits of a single national regulatory
    scheme as envisioned under S. 3128 compared to the costs and benefits
    under the current relationship?
        Answer 5. Both the Report of the Institute of Medicine and the
    Report of President Clinton's Food Safety Council strongly recommended
    a nationally integrated food safety system. They argued that a
    coordinated national regulatory scheme such as that envisioned under
    the National Uniformity for Food Act would increase efficiency and
    maximize consumer benefit. I am not aware whether they conducted formal
    cost-benefit analyses in reaching their conclusions, but it seems very
    clear that a single national food standard, enforced uniformly by every
    Federal, State, county, and city regulatory agency, will be far more
    efficient than a patchwork of requirements of the type that now exist.

        Question 6. National Response to Local Issues.--Right now, State
    and local officials are not preempted from taking action when food-
    related health concerns arise that are limited to their jurisdictions.
    How can we be sure that a national regulatory regime will: (a) be able
    to respond in a timely fashion to what is a local concern; and (b) be
    willing to respond to localized issues, when other matters will compete
    for limited Federal resources?
        Answer 6. The National Uniformity for Food Act balances the need of
    the Federal Government to assert primary jurisdiction over national
    issues and the right of State and local governments to take primary
    responsibility for local issues. The legislation explicitly excludes
    such food sanitation matters as regulation of milk, seafood, and
    restaurants, which are quintessential local issues. Moreover, local
    food safety officials will always be authorized under the National
    Uniformity for Food Act to take immediate enforcement action under
    their own State provisions that are identical to Federal law in order
    to address local concerns promptly. And if those localized issues
    present a serious health hazard, the State may act immediately under
    the imminent hazard authority in this legislation. Thus, the National
    Uniformity for Food Act explicitly provides for several ways in which
    State and local officials can immediately respond to localized food
    safety problems.

        Question 7. Imminent Hazard Authority.--Could you please explain
    the imminent hazard authority to me more fully? First, explain to me
    the legal definition and standing of the term ``imminent hazard'' as
    well as the term ``adverse health consequences.'' Are these terms
    defined in statute, regulations, or guidance or, alternatively, have
    they been further explicated in existing case law?
        If a State determines that there is an imminent hazard, why is it
    necessary for them to notify FDA and to determine if FDA has or has not
    initiated enforcement action on the matter? And how do you envision
    that this process would operate? Would a State have to receive word
    from the FDA that they are not initiating enforcement? How long would a
    State have to wait to determine whether or not the FDA has initiated or
    plans to initiate enforcement action? And if there is truly an imminent
    hazard that requires immediate action by State authorities, is this
    process of notification, waiting, and clarification truly the best
    process, in terms of expediency and therefore, in terms of human
    health?
        Answer 7. The imminent hazard provision in section 403B(d) is
    patterned on two other provisions in the FD&C Act: (1) the imminent
    hazard provision for new drugs in Section 505(e) of the FD&C Act and
    (2) the standard of ``serious adverse health consequences'' that is
    used in Sections 515(e)(3), 518(e)(1), and 522(a) of the FD&C Act and
    in a number of FDA regulations. Thus, both of these statutory terms
    have substantial FDA precedent.
        For example, the term ``imminent hazard'' is defined in 21 CFR 2.5
    and has been the subject of judicial interpretation in the decision in
    Forsham v. Califano, 442 F. Supp. 203 (D.C.D.C. 1997). The term
    ``serious adverse health consequences or death'' has similarly been
    defined by FDA in 21 CFR 810.2(1) & 814.3(1). Thus, these are not new
    or undefined terms.
        Under the imminent hazard provision in the legislation, once the
    State notifies FDA and determines that FDA has not already initiated
    enforcement action, it may immediately take its own action. It need not
    wait another minute. No clarification by FDA is needed. The State must
    later submit a petition to FDA relating to the matter, but in the
    meanwhile it can take whatever action is necessary in order to address
    the imminent hazard. Thus, the type of delay and confusion that you
    envision is explicitly avoided under the legislative provisions.
        As you know, the imminent hazard provision applies only where the
    State action conflicts with the uniformity provisions of the
    legislation. If the State wishes to take emergency action under a State
    law that is identical to the Federal law and there is no contrary FDA
    regulation or guidance, the State may proceed immediately without
    consulting FDA.

        Question 8. Restaurant Labeling.--This country has now required
    food manufacturers to provide nutrition information on packaged foods
    for about 15 years. I think most people agree that the nutrition
    information provided on packaged foods has been successful. Americans
    appreciate the information and rely on it to make informed choices
    about what they eat.
        However, more and more, Americans spend their food dollars away
    from home, mostly in restaurants. As a result, individuals who have
    good nutrition information when cooking at home are totally in the dark
    when they go out to a restaurant. That's why I've proposed a bill that
    would require chain restaurants to provide basic nutrition information
    (calories, salt, fat, trans fat) on standard menu items at the point of
    sale.
        I'm hopeful that Congress will take up and pass my bill for
    restaurant nutrition labeling. But if it doesn't happen, there is
    always the possibility of a State or a municipality passing a similar
    law on restaurant labeling. If a State were to pass a law that required
    chain restaurants to provide nutrition information on calories, salt,
    fat, and trans fat at the point of sale, would such a law, in your
    view, be preempted by passage of the proposed National Uniformity
    legislation?
        Alternatively, what if, in addition to the required information on
    calories, salt, fat, and trans fat, a State or municipality required
    restaurants to also post the following notice, ``The National Academy
    of Sciences has concluded that trans fats provide no known benefit to
    human health and recommends that consumption of trans fats be as low as
    possible.'' Would such a notification be preempted by passage of S.
    3128?
        Answer 8. Congress established the current statutory provisions
    regarding national uniformity for nutrition labeling in the Nutrition
    Labeling and Education Act of 1990. The National Uniformity for Food
    Act does not in any way deal with nutrition labeling, whether on food
    packages or in restaurants.
        You ask whether a State requirement that a restaurant post a notice
    that ``the National Academy of Sciences has concluded that trans fats
    provide no known benefit to human health and recommends that
    consumption of trans fats be as low as possible'' would be subject to
    national uniformity under this legislation. In my opinion, such a
    notice would be an implied safety warning. In contrast, a simple
    restaurant statement that a food ``contains trans fats'' without an
    implication that they are unsafe, like the ``avoidance'' claim that a
    product ``contains no trans fats,'' would not be subject to uniformity.
    I believe that this is consistent with my response above to your
    question number 4 and illustrates why implied as well as direct food
    warnings are properly covered by the National Uniformity for Food Act.

        Question 9. School Nutrition Standards.--In testimony before the
    committee, you raised the issue of State and local laws regarding
    school food sales. In particular, these are laws that govern what and
    when food can be sold at schools, especially unhealthy foods such as
    soft drinks and snack foods. Your assertion, which I hope is correct,
    is that because school nutrition issues are typically governed by USDA
    rather than the FDA, then these State and local laws would not be
    preempted by S. 3128.
        But other than the simple argument that school nutrition is
    traditionally the purview of USDA, are there other substantive reasons
    why S. 3128 wouldn't or couldn't be applicable to State and local
    school nutrition laws? Is there, for instance, any case law that you
    can cite that would further support this assertion? Wouldn't it still
    be possible that someone could challenge such laws by arguing that S.
    3128, if passed, has preempted them?
        Furthermore, if areas that are traditionally the jurisdiction of
    USDA wouldn't be affected by this bill, why is it that organic
    designations, which are the purview of USDA, are specifically preempted
    by the proposed section 403B(f) of S. 3128? Does the clear exemption of
    organic, even though it is traditionally governed and regulated by the
    Department of Agriculture, create the implication that all other
    requirements are therefore affected, even those that are under the
    purview of USDA? Is it possible that someone could cite this language
    in an action challenging State school nutrition laws following passage
    of S. 3128?
        Answer 9. State and local laws regarding school food sales are not
    subject to national uniformity under this legislation. The FD&C Act has
    no provision authorizing FDA to permit or prohibit the type of food
    sold in schools. The laws that govern such programs--the National
    School Lunch Act and the Child Nutrition Act of 1966--are under the
    jurisdiction of USDA, not FDA, and are not in any way included under
    the FD&C Act. Accordingly, it is absolutely clear that the National
    Uniformity for Food Act has no impact of any kind on these laws.
        It is not just a matter that school nutrition is ``traditionally''
    the purview of USDA. It is the clear legal situation that school
    nutrition matters do not fall within the FD&C Act. Rather, they fall
    within the two specific statutes referred to above that are separate
    and distinct from the FD&C Act and that are not included in the list of
    statutory provisions to which the National Uniformity for Food Act
    applies. Thus, the fact that State and local laws regarding school food
    sales are not affected by the National Uniformity for Food Act is a
    matter of statutory law, not a matter of simple tradition. It would be
    impossible for anyone seriously to suggest that the National Uniformity
    for Food Act applies to State and local laws regarding school food
    sales, because the laws administered by USDA are not listed as subject
    to uniformity under Section 403A or Section 403B as they are written
    under the pending legislation.
        The matter of organic labeling, however, is an entirely different
    matter. As I have noted in response to your question No. 1, Section
    403B(f)(1) included nonsafety food statements as a specific exemption
    only because critics of the legislation persisted in erroneously
    contending that otherwise they would be subjected to national
    uniformity. In short, the provision was included for absolute clarity
    in order to avoid giving critics yet another erroneous reason for
    attacking the legislation.
        You are correct that it was USDA who was given the statutory
    authority to develop an organic food certification program under the
    Farm bill of 1990. Because FDA has jurisdiction under the FD&C Act over
    all food labeling statements, however, FDA is charged with enforcing
    the USDA requirements for organic food labeling, even though it is USDA
    who promulgates the implementing regulations. Thus, this is quite
    different from the school nutrition programs. Quite simply, FDA has no
    jurisdiction over school nutrition programs, has not been delegated by
    Congress with any authority with respect to school nutrition, and has
    never in its entire history taken any action with respect to school
    nutrition. FDA has jurisdiction over the safety and labeling of the
    entire food supply, but does not have authority to determine which safe
    and properly labeled food may be sold in local school systems.

                           QUESTIONS OF SENATOR REED

        Question 1. FDA Guidance Documents Versus State Food Safety Laws.--
    The Federal Food, Drug, and Cosmetic Act (Section 701(h)) states that
    guidance documents are ``not binding on the Secretary'' and requires
    that guidance documents indicate their ``nonbinding nature.'' This bill
    doesn't change the fact that guidance documents aren't binding on FDA
    or the industry. But it says that guidance documents are binding on the
    States and localities, because they may only bring an enforcement
    action when it ``conforms'' to the guidance. As a practical matter, a
    company is not required to comply with a guidance document but the
    State can only act if it is alleging that the company hasn't complied
    with the guidance. Would any of you care to comment on whether this
    makes any sense?
        Answer 1. Senator Kennedy has raised the identical question. My
    response follows.
        There are two answers to your question. First, if there is no FDA
    regulation or guidance, a State is entirely free to implement a
    statutory provision that is identical to the same provision in the FD&C
    Act in any way that it believes is justified. Thus, a State requirement
    imposed under a State statute identical to the Federal statute is
    completely lawful unless FDA has taken a contrary position in a
    regulation or guidance.
        Second, Section 701(h) of the FD&C Act explicitly states that
    guidance documents ``present the views'' of FDA on matters under its
    jurisdiction. It requires FDA to ensure that agency employees do not
    deviate from such guidances without appropriate justification and
    supervisory concurrence. Thus, as FDA has often said, guidance
    documents represent the enforcement position of the agency. The agency
    deviates from them only on rare occasions and under unusual
    circumstances.
        FDA guidance documents therefore represent national policy. They
    establish tolerances for food contaminants that the agency intends to
    enforce in court and related food safety and labeling positions that
    represent national policy established by the agency designated by
    Congress as the primary regulatory agency for our nationwide food
    supply.
        Although a guidance is not legally binding in the way that a
    statute or regulation is binding, it nonetheless represents FDA
    enforcement policy. It is rare that a company would willfully violate
    such a guidance. It is an informal substitute for a formal regulation.
    FDA uses guidances rather than regulations in situations where the
    formal procedures now required for promulgating regulations make that
    form of policy statement infeasible. A guidance represents FDA
    nationwide policy, however, and thus States should follow it or should
    petition FDA to change it. If States were permitted to ignore FDA
    guidance, FDA would be required to promulgate many more regulations in
    order to assure national uniformity, thus making regulation far more
    costly and difficult.

        Question 2. Definition of ``identical'' in S. 3128.--Mr. Hutt, you
    contend that most State laws will not be preempted by S. 3128 because
    they will not have to exactly mirror the FDA standard. It is estimated,
    however, that anywhere between 11 and 200 State and local laws would be
    preempted by S. 3128. Won't the fact that identical means something
    other than identical under this bill just result in a battle in the
    courts to define what ``identical'' actually means?
        Answer 2. It is extremely unlikely that there will be any
    significant litigation regarding the scope of the term ``identical'' as
    set forth in new section 403A(c)(1) of the National Uniformity for Food
    Act, for several reasons. First, the definition is much clearer than
    most definitions in the FD&C Act. It unambiguously states that it does
    not require identical language, just the imposition of identical
    requirements. It also explicitly excludes procedural requirements, and
    section 403B(a)(3) explicitly excludes enforcement requirements.
        Second, the 11 State laws that will be impacted by the National
    Uniformity for Food Act are unlikely to be the subject of State
    petitions. A review of these State statutes shows that most are
    obsolete or represent minor deviations from existing FDA requirements
    and are unlikely to survive rigorous scientific analysis.

                          QUESTIONS OF SENATOR CLINTON

        Question 1. Local Agencies and Food Safety.--As you state in your
    testimony,

              ``States must be given the right to collaborate with FDA in
            assuring that appropriate food safety and warning requirements
            are imposed and, where uniquely local matters are involved, to
            assume the predominant role in public protection.''

        However, S. 3128 only allows States, not local governments, to
    petition the Federal Government for exemptions or to establish a
    national standard. Furthermore, State governments are allowed to act
    when the Federal Government has not set a standard, but local
    governments are not allowed to take such action.
        In New York City, a proactive local government, has identified and
    addressed hazards for which Federal regulation does not exist. For
    example, when imported candies contaminated with lead were found in New
    York City, a city law was enacted banning the sale of such products.
        In addition, New York City recently embargoed certain imported
    herbal products that contained lead after several cases of adult lead
    poisoning were confirmed among residents who used these products. This
    action was taken despite the fact that there were--and continue to be--
    no specific Federal standards about adult tolerance levels for adult
    lead poisoning.
        Given these facts, how can we ensure that food uniformity will not
    constrain this important local role? Under the restrictions of S. 3128,
    how can localities respond rapidly to products that pose an imminent
    hazard to their population and do not affect the entire State?
        Answer 1. Senator Kennedy has raised the identical question. My
    response follows. The National Uniformity for Food Act does not
    completely preempt localities from enforcing local requirements that
    are identical to Federal requirements.
        Section 403B(a)(1) explicitly provides that any political
    subdivision of a State may enforce a local food safety warning that is
    identical to a Federal warning. Section 403A(c) also explicitly
    provides that a political subdivision of a State may enforce a State
    law that contains a requirement that is identical to a Federal
    requirement. I am unaware of any situation where a local jurisdiction
    within a State has enacted a law governing food safety that is
    identical to the Federal law but for which there is no comparable State
    law. Your question does not identify any such situation, nor has AFDO
    or other interested organizations stated that this has ever occurred.
    Perhaps that is the reason why Senator Burr has not covered this
    hypothetical situation in the legislation.
        Nonetheless, there is a simple answer to this hypothetical
    question. If the local jurisdiction has identified a provision of
    Federal law governing food safety that has no State counterpart and has
    enacted its own identical provision on a local level, it will be quite
    simple for that local jurisdiction to persuade the State to enact it
    into State law. Once that is done, it may be enforced by both State and
    local officials.
        Finally, the National Uniformity for Food Act funnels all State
    issues relating to FDA review, petitions for exemption, national
    standards, and imminent hazard action, through the appropriate State
    officials rather than through each individual local jurisdiction, for
    several reasons. First, as already stated, no one has thus far
    identified the type of local laws that you hypothesize in this
    question. Second, it is sound public policy to require each State to
    coordinate whatever petitions may be appropriate within its own
    jurisdiction, rather than to have a variety of viewpoints expressed by
    different local authorities. For the same reasons that uniformity is
    appropriate at the Federal level on nationwide issues, it is equally
    justified at the State level on statewide issues. Assuming that there
    are local laws governing food safety that are not applicable on a
    statewide basis, the State has an interest in assuring both that those
    laws are appropriate and that they should be advanced either as an
    exemption or as a national standard.
        You specifically refer to a New York City law banning the sale of
    imported candies contaminated with high levels of lead. In that
    instance, FDA also took enforcement action directly to prevent
    importation of lead-contaminated candies under the prohibition of
    poisonous or deleterious substances in Section 402(a)(1) of the FD&C
    Act. New York State law contains an identical prohibition. Accordingly,
    under the provisions of new Section 403A(c)(3) of the National
    Uniformity for Food Act New York City would be fully authorized to
    enforce the State law provisions banning these lead-contaminated
    candies. The same is true in the situation of imported herbal products
    with high levels of lead. Where there is no specific Federal standard,
    New York City may enforce the State law prohibiting poisonous or
    deleterious substances because that law is identical to the Federal
    law. Thus, this is an excellent example of the collaboration and
    cooperation among Federal, State, and local food regulatory agencies
    that I emphasized in my testimony before the committee.

        Question 2. Compensation for Testimony.--Did you or your law firm
    receive compensation for the testimony you gave to the HELP Committee
    on Thursday July 27, 2006? Please outline the amount of your
    compensation together with the details of what companies, groups,
    associations, or other parties provided that compensation.
        Answer 2. I am told that the staff of the HELP Committee asked the
    Grocery Manufacturers Association to suggest the names of experts in
    the area of FDA regulation of food safety. GMA suggested me because I
    have spent the past 45 years practicing food and drug law both as Chief
    Counsel for FDA and in private practice, I teach food safety law at
    Harvard Law School each Winter Term, and I am the co-author of the
    casebook used to teach this subject at law schools throughout the
    country. It was the HELP Committee that extended an invitation for me
    to testify. I will be paid by GMA for the amount of time I spent
    preparing for the hearing, testifying before the committee, and
    responding to these questions, at my standard billable rate. At this
    moment I do not know the amount of compensation that will be involved.

    Response to Questions of Senator Enzi, Senator Kennedy, Senator Harkin,
              Senator Reed, and Senator Clinton by Elsa A. Murano

                           QUESTIONS OF SENATOR ENZI

        Question 1. I am told that under this legislation, States and
    localities retain their enforcement authorities and the ability to set
    food safety standards where FDA hasn't. Furthermore, States would
    continue to conduct inspections, use their embargo and other
    enforcement authorities. Do you see anything in the bill that will
    prevent the States from doing the things they now do in terms of food
    safety?
        Answer 1. It is extremely important that the States retain their
    inspection, embargo, and other enforcement authorities. The National
    Uniformity for Food Act does not cover procedural authority states that
    it does not cover inspection, recall, civil orders, embargo, detention,
    or court proceedings. I support these provisions. I can find nothing in
    the bill that will prevent the States from doing the things they do now
    in terms of food safety.

        Question 2. In your testimony, you discussed how when you were
    Undersecretary, USDA worked with FDA on inspections and could be
    deputized under Memoranda of Understanding to help FDA. This sounds
    sensible to me. Do you think it makes sense to expand this approach?
        Answer 2. Both USDA and the States have at times been deputized to
    assist FDA, by conducting inspections, analyzing products, and
    undertaking other related regulatory work. This has been going on for
    decades, and I support continuing it and expanding it in the future.

                          QUESTIONS OF SENATOR KENNEDY

        Question 1. Proposition 65.--Which of the ingredients requiring a
    warning under Proposition 65 do you think should be put back into food,
    or added to food at higher levels? On which ingredients did California
    get it right? Please provide a complete list of each class of
    substances.
        Answer 1. To my knowledge, only one food warning case has been
    litigated under Proposition 65. That case would have required a warning
    for mercury levels where FDA has determined that a warning is not
    appropriate. This is, I believe, a sufficient answer to your question.
    I do not have a complete list of all substances for which warnings have
    been sought, nor am I familiar with the negotiations that have taken
    place. I am aware that FDA has opposed warnings that have been sought
    under Proposition 65. In my opinion, California should follow the lead
    of FDA in food safety matters, and should not try to set the rules for
    the entire country.

        Question 2. USDA-FDA.--How does Federal preemption on meat
    inspections justify preemption on the FDA side of things, when USDA is
    in the plant inspecting basically 24/7 and FDA gets to a food plant to
    inspect perhaps every 5-10 years?
        Answer 2. The justification for continuous factory inspection for
    meat does not exist when it comes to the kind of processed food that
    FDA regulates. USDA oversees the slaughter of live animals. FDA does
    not. Instead, FDA focuses on issues of food toxicology in determining
    whether safety warnings are appropriate. Accordingly, national
    uniformity makes as much sense for FDA safety decisions as it does for
    USDA safety decisions.

                          QUESTIONS OF SENATOR HARKIN

        Question 1. Exemption From Preemption.--The proposed section
    403B(f) exempts from preemption certain types of State required
    notifications such as open date labeling, religious dietary labeling,
    organic or natural designation, and statements of geographic origin,
    among others. Please explain why such exemption is needed for each of
    the particular exemptions contained in this subsection. What provisions
    in the bill imply that these sorts of provisions are preempted absent
    the exemption? Does the clear exemption for these specific State-
    required notifications create the implication that all other State-
    required notifications are preempted?
        Answer 1. I agree with you that these particular exemptions are not
    needed. I asked why they are there and was told that they were put
    there to appease critics who insisted that otherwise the types of State
    laws identified in that provision could possibly be included within
    national uniformity. Since none of these State laws involves a safety
    warning, they clearly would not be included under the bill even if this
    section were not a part of the legislation. I do not believe there is
    any implication that other non-safety State-required notifications are
    subject to national uniformity.

        Question 2. Multiple Labels.--With regards to warning labels and
    notification requirements, supporters of this bill, have complained
    about a patchwork quilt of food safety warnings required by different
    States. Yet I have not yet seen a specific food product that contains
    multiple labels--one required by Federal law and another required by
    State law. Can you provide me with such an example or multiple
    examples?
        Answer 2. I have asked the same question, and I have been told that
    the food industry prefers to put any required food safety warnings on
    store posters rather than on labels. We are therefore unlikely to see
    any food labels that contain a safety warning imposed by State law but
    not required by Federal law.

        Question 3. Cost-Benefit Analysis.--Issues like food safety often
    involve cost-benefit analyses. Are you aware of any cost-benefit
    analysis showing the costs and benefits of a single national regulatory
    scheme as envisioned under S. 3128 compared to the costs and benefits
    under the current relationship?
        Answer 3. I have undertaken no research to determine whether cost-
    benefit analyses of a single national regulatory scheme have been
    performed. It is common sense, however, that one national safety
    standard, as contrasted with numerous State standards, will be far more
    effective and efficient. We do not need a study to understand that. It
    is instructive that the European Union has adopted a common market in
    food, and has abandoned its centuries-old balkanized approach of
    individual country regulations, precisely in order to obtain the
    benefits of a single standard that the National Uniformity for Food Act
    would confirm.

                            QUESTION OF SENATOR REED

        Question. USDA Meat Inspections Versus FDA Inspections.--How many
    inspectors does the USDA have to conduct meat inspections? How many
    inspectors does the FDA have for the thousands of food products under
    its jurisdiction? How does Federal preemption on meat inspections
    justify preemption on the FDA side of things, when USDA is in the plant
    inspecting basically 24/7 and FDA gets to a food plant to inspect every
    5-10 years?
        Answer. USDA has about 9,000 meat inspectors, because of the
    Federal statutory requirement of continuous factory inspection over the
    slaughter of live animals. Comparing USDA inspection of the slaughter
    of live animals with FDA inspection of processed food is like comparing
    apples and oranges. The two have nothing in common. USDA must be
    concerned with the safety of each individual animal. FDA is concerned
    with the safety of ingredients, which can be used in thousands of
    different types of products. Thus, while USDA focuses on one animal at
    a time, FDA can cover thousands of food products by reviewing just a
    single ingredient. For this reason, the two agencies properly conduct
    their statutory responsibilities in extremely different ways.

                          QUESTION OF SENATOR CLINTON

        Question. AFDO and the Food Code.--As you stated in your testimony,
    48 of the 56 States and territories have adopted their own food codes
    from the Food Code. You draw parallels between this code and the
    National Uniformity for Food Act.
        According to your testimony,

            ``there is nothing in proposed S. 3128 that would limit,
            restrict or compromise the Food Code or the State or
            territorial codes modeled on it . . . [nor] anything that would
            impact FDA's or USDA's other cooperative food safety programs
            with the States.''

        It stands to reason that if this statement were true, the National
    Uniformity for Food would enjoy the support of the organizations that
    support the Food Code.
        However, the Association of Food and Drug Officials (AFDO), the
    non-profit organization whose mission is to foster ``uniformity in the
    adoption and enforcement of food, drug, medical devices, cosmetics and
    product safety laws and regulations,'' is opposed to H.R. 4167, the
    House companion of S. 3128. In a letter to the House of Representatives
    last January the AFDO addresses ``serious concerns'' regarding H.R.
    4167 and its impact on State sanction laws and programs. The AFDO calls
    the bill ``a disastrous step backwards in ensuring the safety of our
    Nation's food supply.''
        Considering the AFDO fully supports the Food Code but stands in
    opposition to the National Uniformity for Food Act, how do you justify
    your argument that the two are somehow equal? What differences exist
    between the Food Code and the food uniformity legislation?
        Answer. The Food Code began with a cooperative program undertaken
    in 1935 by the Public Health Service in cooperation with State health
    officials. It encompasses food service, vending, and retail food store
    sanitation. It is a cooperative program with the States, and it is not
    affected in any way by the National Uniformity for Food Act. In fact,
    over the past 70 years the Food Code and its predecessor programs have
    fostered uniformity in these areas that are uniquely the responsibility
    of local health officials, and I expect that this will continue. I
    regret that AFDO has seen fit to oppose the National Uniformity for
    Food Act. This opposition seems to go against the stated mission of
    this important organization. I see no difference between the Food Code
    approach and the National Uniformity for Food Act. Both are consistent
    with the mission of AFDO.

    Response to Questions of Senator Enzi, Senator Kennedy, Senator Harkin,
                     and Senator Reed by William K. Hubbard

                          QUESTIONS FROM SENATOR ENZI

        Question 1. On what basis do you conclude that such a large number
    of petitions would be submitted? Mr. Hutt testified that many of the
    State laws that were listed as vulnerable to preemption were not even
    under the FDA's jurisdiction. How do you respond to this?
        Answer 1. I based my conclusion on the assumptions made by the
    Congressional Budget Office, which I understand is charged with guiding
    legislators in gauging the impact of proposed legislation. The food
    industry is on record as saying that there will be more petitions
    coming to FDA than the CBO estimated. Whomever is correct, it appears
    that there will likely be many petitions addressed to the FDA under the
    bill, and even a much smaller number than estimated will result in
    significant budgetary problems for the FDA.

        Question 2. The Congressional Budget Office scored a similar House
    bill, H.R. 4167 at $100 million over 5 years, using an estimated cost
    of $400,000 per petition, 240 petitions and associated regulatory costs
    of about 4.2 percent. You have suggested that FDA could not accommodate
    such responsibilities in its current budgetary state. I, too, am
    concerned about FDA's budget. However, if we stipulate to CBO's model
    for the cost per petition and the add-on for any regulatory actions,
    but take the lower number of 11 laws preempted, we would come up with a
    cost estimate for this bill of a little under $5 million. Could FDA
    handle that?
        Answer 2. A $5 million estimate would assume that only about 20
    petitions would be received by FDA in the first year. It is difficult
    to conceive of so small a number of petitions, given the large number
    of contaminants that California alone has listed under Proposition 65.
    It might be useful to ask that State how many petitions it would expect
    to submit. Further, even if California submitted just one petition to
    cover the hundreds of contaminants it has regulated under Proposition
    65, FDA would be forced to undertake the same expensive process for
    assessing those contaminants as it would if the State had submitted a
    separate petition for each hazardous substance.
        Given FDA's precarious budget situation in its foods program, even
    a $5M reallocation would be difficult for the agency to accommodate. In
    essence, it would mean the assignment of perhaps 40 to 50 scientists
    away from their public health mission to the review of petitions, for
    no discernible public health gain.

        Question 3. Dr. Murano's testimony discussed how when she was
    Undersecretary, USDA worked with FDA on inspections and USDA staff
    could be deputized under agreements between the two agencies to help
    FDA. You indicated that deputization worked in combating bioterrorism.
    Why wouldn't it work here?
        Answer 3. The Bioterrorism Act authorized FDA to ``commission''
    officials from other regulatory agencies with like missions to assist
    FDA in its food safety oversight role--in essence, to empower those
    agencies, where FDA determined it appropriate, to share FDA's
    regulatory authority. For example, FDA has already commissioned Customs
    officials who can assist in inspecting imported foods. However, the act
    also required FDA to reimburse agencies for such commissioning efforts
    where necessary, so there would need to be funding to allow USDA staff
    to review petitions, if the purpose of this question is to inquire
    about USDA doing petition review under the uniformity legislation.
    Moreover, the meat inspectors that were under Dr. Murano's supervision,
    while highly trained in their particular field, would not likely have
    the scientific expertise to review the safety of contaminants that
    would be the subject of uniformity petitions. Indeed, Congress
    recognized that fact by assigning to FDA the principal authority to
    approve new food additives, including those used in meat production. If
    the question is aimed more at suggesting that USDA inspectors would
    pick up any slack caused by FDA's inspection reduction due to their
    having to reallocate inspectors to petition review, such reallocations
    would not likely occur. Petition review would need to be done by the
    scientists in FDA's headquarters food program, who would be best
    qualified to conduct petition review.

                          QUESTIONS OF SENATOR KENNEDY

        Question 1. FDA Inspections.--State officials, from attorneys
    general to public health and agriculture officials, have expressed
    concern that S. 3128 will disrupt their authority to inspect and
    enforce the safety of food. States presently conduct 80 percent of all
    domestic food inspections. Does it unsettle you that S. 3128 might
    disrupt these inspections? What resources could FDA bring to bear to
    replace lost State inspections?
        Answer 1. FDA would have no resources to make up for lost State
    efforts. Indeed, States do far more now than FDA does to enforce food
    safety laws, and much of that enforcement is directly on FDA's behalf.
    If States are allowed to continue their inspections, as S. 3128
    contemplates, but not enforce the standards that those inspections are
    intended to enforce, as S. 3128 appears to intend, it would be logical
    to assume that States would simply stop inspecting altogether in many
    instances. The result would be a significant diminution of food safety
    protection nationwide.

        Question 2. Petitions.--How do you think the FDA will be able to
    afford the hundreds of millions of dollars it will take to implement S.
    3128 over the next 5 years, when its budget is currently being cut?
        Answer 2. The agency will not be able to afford to implement S.
    3128. If enacted, and if FDA were to make a sincere effort to implement
    it, I believe S. 3128 would force FDA to reallocate most of the efforts
    of its headquarters scientists to petition review, for no discernible
    public health gain. FDA's food budget needs to be doubled, not
    drastically cut, as is already happening (and which would be
    exacerbated by S. 3128).

        Question 3. Implied Warnings.--Under the bill (page 5, paragraph
    (B)), a warning includes a statement ``that indicates, directly or by
    implication,'' that the food presents or may present a hazard to health
    or safety. Because farm-raised salmon has more PCBs than wild salmon,
    isn't a statement that salmon is farm-raised a warning under this bill?
        Answer 3. FDA has interpreted similar circumstances in the past as
    implied warnings. For example, when some States expressed their
    intention to require that milk resulting from the use of the hormone
    BST in milk cows bear a notification of that fact, FDA concluded that
    consumers would view that notification as a warning. A farm-raised
    salmon notification could easily be assumed to refer to fish that
    contained higher levels of PCBs or a wild salmon notification could
    refer to fish that contained higher levels of mercury. So viewed, these
    notifications would be preempted by S. 3128.

        Question 4. State Embargoes.--Given what you know about how State
    embargo is used, including in coordination with FDA, what is your view
    of the restrictions on such embargo authority under the proposed
    section 403B(a)(3)?
        Answer 4. Currently, State health officials can detain or
    ``embargo'' a food that they believe posed a health risk, by
    essentially demanding that the food be held pending sampling or other
    examination to affirm its safety. The Bioterrorism Act of 2002
    attempted to give FDA detention authority as well, but so many
    procedural requirements were imposed that the authority is essentially
    unused and impractical. S. 3128 preserves various State authorities--
    including embargo and detention authorities--but only when they
    ``involve food adulteration under a State statutory requirement
    identical to a food adulteration requirement under this Act.'' So the
    bill seems to result in diminution of States' current detention
    authority, an authority that States have often used to deal with
    critical food safety threats. If the intention is to retain current
    State embargo authority, any ambiguity on this point should be
    explicitly removed.

        Question 5. Imminent Hazard.--What is your reaction to how the
    imminent hazard provision in proposed section 403B(d)? Is it at all
    realistic to think that a State can use this provision to respond
    quickly to a food emergency?
        Answer 5. The very term ``imminent hazard'' implies a public health
    threat that must be addressed with alacrity. Under S. 3128, a State
    wishing to use its imminent hazard authority would first be expected to
    ask the FDA to deal with the issue (and perhaps engage in the
    development of a scientific standard). Such a process would not allow
    expeditious solution of an imminent hazard, and thus would be a
    negative public health provision.

                          QUESTIONS OF SENATOR HARKIN

        Question 1. Exemption From Preemption.--The proposed section
    403B(f) exempts from preemption certain types of State required
    notifications such as open date labeling, religious dietary labeling,
    organic or natural designation, and statements of geographic origin,
    among others. Please explain why such exemption is needed for each of
    the particular exemptions contained in this subsection. What provisions
    in the bill imply that these sorts of provisions are preempted absent
    the exemption? Does the clear exemption for these specific State-
    required notifications create the implication that all other State-
    required notifications are preempted?
        Answer 1. I am not a lawyer, but it appears to me that by clearly
    listing certain things that are not preempted, one is left with the
    impression that everything else is not exempted from preemption. So,
    yes, I agree with you that the clear exemption for these specific
    State-required notifications create the implication that all other
    State-required notifications are preempted.

        Question 2. Scope of the Bill.--Can you comment on the scope of the
    bill compared to the scope of the problem? Most importantly, are there
    alternative and more circumscribed means by which to address these
    matters? Is it possible to create a mechanism by which to avoid the
    kind of situation in which Mr. Stadtlander finds himself without such
    broad preemption?
        Answer 2. The bill's scope certainly implies that there is a major,
    nationwide problem with consumer confusion and excessive costs to the
    food industry. Such a problem has not, to my knowledge, been shown. Mr.
    Stadtlander, however, certainly finds himself in a bind, due to the so-
    called ``bounty hunter'' provision embodied in Proposition 65, which
    allows private parties to sue if the State has not taken action. On the
    one hand, Mr. Stadtlander's cereal is alleged to contain much higher
    levels of acrylamide than other cereals, and public health officials at
    international, national, and State levels are trying to lower
    acrylamide levels in food across the board; so some would argue that
    Mr. Stadtlander needs whatever urging possible to change his production
    processes so as to lower acrylamide levels in his food. On the other
    hand, California is engaged in a process to address acrylamide in all
    foods, and, as I testified at the hearing, I would hope that the judge
    in Mr. Stadtlander's case would defer further action on his case until
    his product can be brought under the auspices of the State (and
    Federal) actions that will be taken more broadly to lower acrylamide
    levels.

        Question 3. Multiple Labels.--With regards to warning labels and
    notification requirements, supporters of this bill, have complained
    about a patchwork quilt of food safety warnings required by different
    States. Yet I have not yet seen a specific food product that contains
    multiple labels--one required by Federal law and another required by
    State law. Can you provide me with such an example or multiple
    examples?
        Answer 3. The food industry has long feared that individual State
    actions will result in differing State labeling requirements that will
    impose massive costs on them with regard to the distribution and
    labeling of their products. In theory, their fears are legitimate.
    However, States have acted responsibly on such matters, such
    conflicting and confusing labels on foods have generally not appeared,
    and thus the substantial consumer confusion and production costs have
    not been seen. The Reagan administration conducted a lengthy study
    looking for such adverse effects, and did not find them (and those
    conclusions were affirmed by the first Bush and Clinton
    administrations. If Congress believes those examinations are no longer
    up to date, perhaps a better course than pursuing this legislation at
    this time would be to sponsor another, independent, examination to
    determine if such costs are being incurred.

        Question 4. Warning vs. Notification.--On the issue of what
    constitutes a warning, there is some disagreement. The Center for
    Science in the Public Interest asserts that nearly 200 State laws would
    be affected by this legislation. Mr. Hutt has reviewed the CSPI report
    on this matter and states that the CSPI report is incorrect because it
    doesn't distinguish between ``warnings'' and ``notification.'' He
    argues that if one looks only at warnings and not at notifications more
    broadly, that the number of State laws affected would be significantly
    less and also asserts that S. 3128 clearly pertains only to
    notification requirements that contain food-related warnings and not
    notification more broadly.
        However, I am unclear as to whether the term ``warning,'' as
    defined by the bill, is as clear as has been asserted. The bill says
    that ``warning,'' used with respect to a food, means any statement,
    vignette, or other representation that indicates, directly or by
    implication, that the food presents or may present a hazard to health
    or safety.
        Do you see any uncertainty under this definition, especially the
    ``by implication'' portion? Can you explain to me more precisely the
    legal import and effect of this ``by implication'' language? Why is it
    important to have the ``by implication'' language included in the bill
    at all?
        By way of example, what if a State adopts a requirement that grass-
    fed beef be labeled as such? Directly, this may be only a notification.
    But what if research definitively shows that grass-fed has health
    benefits relative to grain-fed beef. By implication, wouldn't a grass-
    fed beef notification then become a warning regarding grain-fed beef?
    Perhaps this isn't the best illustration. My point is not to comment on
    grass-fed beef or the State of science pertaining to it, but to ask
    whether the definition of warning in the legislation is altogether
    clear.
        Answer 4. It appears that there is indeed ambiguity in whether a
    notification is a safety warning. FDA concluded years ago that the
    proposed ``notification'' by some States that some milk might contain
    the animal hormone BST was, in fact, a ``warning,'' as it implied that
    such milk might pose a safety risk (if the milk cow had been given BST
    to promote milk production). Similarly, a ``grass-fed'' beef
    notification would/could be felt to imply that the beef cattle were
    free of beef hormones commonly used in beef cattle husbandry. Thus,
    under that view, the term ``grass-fed'' would be an implied warning and
    covered by S. 3128.

        Question 5. Cost-Benefit Analysis.--Issues like food safety often
    involve cost-benefit analyses. Are you aware of any cost-benefit
    analysis showing the costs and benefits of a single national regulatory
    scheme as envisioned under S. 3128 compared to the costs and benefits
    under the current relationship?
        Answer 5. I served on a Reagan administration task force, led by
    the President's Council of Economic Advisors that was charged in the
    late 1980s with carefully examining the costs of Proposition 65 and
    similar State initiatives. Despite a long and detailed search for
    excessive costs imposed on the food industry resulting from consumer
    confusion and conflicting State labeling and warning requirements, that
    analysis concluded that the costs were only theoretical and that
    preemptive action to address State food safety warnings should be
    considered only if substantial costs were to actually occur. The
    Administrations of G.H.W. Bush and Bill Clinton also studied the issue
    and reached the same conclusions as the original Reagan study--that
    preemption was not warranted absent clear, proven negative effects on
    the food production system.

        Question 6. State Innovation.--States and local regulatory efforts
    have often put State and local actors out ahead of Federal agencies in
    discovering more efficient and effective means to accomplish the goal
    of public protection. Enacting a single, national regulatory scheme may
    mean the loss of these resources and of State and local innovation. How
    can we be sure that a single Federal system will lead to the most
    effective and efficient approaches to ensuring better public health?
        Answer 6. As I said in my formal testimony at the committee's
    recent hearing on this matter, the States have been a valuable
    complement to Federal food safety protections, and have often taken the
    lead in identifying public health threats that they have brought to the
    attention of Federal officials. That synergistic system should be
    protected and nurtured, and I fear that S. 3128 will have the opposite
    effect, by weakening the ability of States to protect their citizens
    (and thus to some extent remove the ``canary in the coal mine'').
    Preemption can be quite appropriate where the States have not taken
    action in the past, such as with allergen and nutrition labeling for
    processed foods. But States have a long, distinguished, and effective
    history in food safety, which should not be undermined.

        Question 7. Imminent Hazard Authority.--Could you please explain
    the imminent hazard authority to me more fully? First, explain to me
    the legal definition and standing of the term ``imminent hazard'' as
    well as the term ``adverse health consequences?'' Are these terms
    defined in statute, regulations, or guidance or, alternatively, have
    they been further explicated in existing case law?
        If a State determines that there is an imminent hazard, why is it
    necessary for them to notify FDA and to determine if FDA has or has not
    initiated enforcement action on the matter? How do you envision that
    this process would operate? Would a State have to receive word from the
    FDA that they are not initiating enforcement? How long would a State
    have to wait to determine whether or not the FDA has initiated or plans
    to initiate enforcement action? If there is truly an imminent hazard
    that requires immediate action by State authorities, is this process of
    notification, waiting, and clarification truly the best process, in
    terms of expediency and therefore, in terms of human health?
        Answer 7. S. 3128 appears to require a State to come to the FDA
    before it can act upon an identified ``imminent hazard,'' which is
    generally meant to refer to a public health threat that needs prompt
    and decisive action. Forcing a State to present its evidence to the
    FDA, then perhaps await FDA's procedural efforts to regulate the
    ``hazard,'' would deprive the State of its ability to promptly protect
    its citizens. Thus, it is difficult to see how the ``imminent hazard''
    authority would, in fact, be what it claims to be.

        Question 8. Restaurant Labeling.--This country has now required
    food manufacturers to provide nutrition information on packaged foods
    for about 15 years. I think most people agree that the nutrition
    information provided on packaged foods has been successful. Americans
    appreciate the information and rely on it to make informed choices
    about what they eat.
        However, more and more, Americans spend their food dollars away
    from home, mostly in restaurants. As a result, individuals who have
    good nutrition information when cooking at home are totally in the dark
    when they go out to a restaurant. That's why I've proposed a bill that
    would require chain restaurants to provide basic nutrition information
    (calories, salt, fat, trans fat) on standard menu items at the point of
    sale.
        I'm hopeful that Congress will take up and pass my bill for
    restaurant nutrition labeling. But, if it doesn't happen, there is
    always the possibility of a State or a municipality passing a similar
    law on restaurant labeling. If a State were to pass a law that required
    chain restaurants to provide nutrition information on calories, salt,
    fat, and trans fat at the point of sale, would such a law, in your
    view, be preempted by passage of the proposed National Uniformity
    legislation?
        Alternatively, what if, in addition to the required information on
    calories, salt, fat, and trans fat, a State or municipality required
    restaurants to also post the following notice, ``The National Academy
    of Sciences has concluded that trans fats provide no known benefit to
    human health and recommends that consumption of trans fats be as low as
    possible.'' Would such a notification be preempted by passage of S.
    3128?
        Answer 8. When the Nutrition Labeling and Education Act was enacted
    by Congress in 1990, it preempted States from imposing separate
    nutrition labeling requirements on packaged foods (correctly, in my
    judgment, as States had not been active in that area and national
    standards were appropriate). But the act also exempted restaurants,
    including so-called ``fast food'' and other chain restaurants, from
    nutritional labeling. Thus, States presumably have the authority to
    require nutrition labeling for restaurants, and there is a public
    health justification for doing so for restaurants with standard menu
    items (and, indeed, most fast food chain restaurants do so voluntarily
    now, with varying degrees of public display). However, if notification
    of such food constituents as trans fats were required by States, and
    considered ``warnings,'' then it would be logical to assume that the
    States would be preempted from requiring such notifications.

        Question 9. School Nutrition Standards.--Mr. Hutt, in his testimony
    before the committee, raised the issue of State and local laws
    regarding school food sales. In particular, these are laws that govern
    what and when food can be sold at schools, especially unhealthy foods
    such as soft drinks and snack foods. Mr. Hutt's assertion, which I hope
    is correct, is that because school nutrition issues are typically
    governed by USDA rather than the FDA, then these State and local laws
    would not be preempted by S. 3128.
        But other than the simple argument that school nutrition is
    traditionally the purview of USDA, are there other substantive reasons
    why S. 3128 wouldn't or couldn't be applicable to State and local
    school nutrition laws? Is there, for instance, any case law that you
    can cite that would further support this assertion? Wouldn't it still
    be possible that someone could challenge such laws by arguing that S.
    3128, if passed, has preempted them?
        Furthermore, if areas that are traditionally the jurisdiction of
    USDA wouldn't be affected by this bill, why is it that organic
    designations, which are the purview of USDA, are specifically preempted
    by the proposed section 403B(f) of S. 3128? Does the clear exemption of
    organic, even though it is traditionally governed and regulated by the
    Department of Agriculture, create the implication that all other
    requirements are therefore affected, even those that are under the
    purview of USDA? Is it possible that someone could cite this language
    in an action challenging State school nutrition laws following passage
    of S. 3128?
        Answer 9. I am not a lawyer, and am certainly not familiar with
    case law on this issue. But I would agree with you that the exemption
    for organic descriptors creates the impression that other USDA-related
    items may be covered by S. 3128, including State school lunch
    requirements.

                           QUESTIONS OF SENATOR REED

        Question 1. Previous Administrations have rejected Food
    Uniformity.--Is it true that previous Administrations have considered
    the issue of Federal standards for food uniformity and rejected it?
    Could you please elaborate on which Administrations contemplated food
    uniformity and their reasons for maintaining the current State food
    safety framework?
        Answer 1. The administrations of Presidents Reagan, G.H.W. Bush,
    and Clinton explicitly examined this issue and rejected it, concluding
    that preemption of State food safety standards was not warranted absent
    a showing of significant adverse economic effects caused by conflicting
    State requirements (which they concluded did not exist).

        Question 2. Disruption of State Efforts.--States presently conduct
    80 percent of all domestic food inspections. State inspection
    authorities generally understand the intricacies of the local food
    industries. For instance, seafood and shellfish in particular are big
    business in my little State. Under this bill, responsibility for
    inspection and oversight of these local manufacturers would fall under
    the authority of FDA officials. Does it unsettle you that S. 3128 might
    disrupt these inspections, especially as the Federal Government will
    not be able to step in?
        Answer 2. I would not read S. 3128 as specifically preempting a
    State's ability to inspect food processors. However, if a State could
    not set or enforce its food safety standards, as contemplated by S.
    3128, why would they continue to inspect? Accordingly, the only
    inspection system would be the FDA's. Let me give you an example of
    what that would mean. FDA now has over 200,000 registrants of food
    producers, each and every one of which should be inspected with some
    regularity (even if only every year or two). This year, FDA will
    conduct about 5,000 inspections. This means that a food producer in a
    given State would be inspected only once every 40 years by the FDA. So,
    the practical effect of removing State inspections would be eliminating
    the likelihood that a given food processor would ever be inspected.
                                     ______

                               Letters of Support

                    National Black Chamber of Commerce,
                                          Washington, DC 20036,
                                                          July 3, 2006.
    Hon. Bill Frist,
    Senate Majority Leader,
    Washington, DC 20510.

    Re: S. 3128, National Uniformity for Food Act of 2006

        Dear Majority Leader Frist: The National Black Chamber of Commerce
    joins the U.S. Chamber of Commerce, the Grocery Manufacturers
    Association and many other organizations in support of the National
    Uniformity for Food Act of 2006, S. 3128. This bill is to amend the
    Federal Food, Drug and Cosmetic Act to provide for uniform food safety
    warning notification requirements, and for other purposes. This is
    consistent with the NBCC philosophy that mainstreaming regulation
    avoids needless costs and bureaucracy. This will benefit American
    citizens as well as businesses.
        Under the current system, food regulations are composed of
    different and sometimes contradictory requirements. This imposes
    unnecessary complexity and cost on makers of food throughout the United
    States. By bringing a uniform code to our industry, the legislation
    represents a major step forward in assuring consumer confidence in the
    food they buy for their families.
        As you know, the House of Representatives overwhelmingly supported
    their version of this bill by a vote of 283 to 139. Your support of
    this bill when it hits the floor will be very appreciated by the 1.4
    million Black-owned businesses which we represent.
                Sincerely,
                                               Harry C. Alford,
                                                     President and CEO.
                                     ______

                     U.S. Hispanic Chamber of Commerce,
                                          Washington, DC 20037,
                                                         June 19, 2006.
    U.S. Senate,
    Washington, DC 20510.

        Dear Members of the U.S. Senate: On behalf of the 2 million
    Hispanic-owned businesses in the country, we are writing to you to vote
    YES on S. 3128, the ``National Uniformity for Food Act of 2006.'' This
    important piece of legislation will establish a single standard for
    food safety, helping consumers, families and businesses in an ever-
    changing and currently confusing food labeling environment.
        Under the current system, food regulation is composed of a variety
    of different and sometimes inconsistent requirements. This
    ``patchwork'' of different State laws adopting different regulatory
    requirements on identical food products is confusing to consumers and
    burdensome for businesses that distribute products across State lines.
    This imposes unnecessary complexity and cost on food producers and
    distributors throughout the United States. By bringing a uniform code
    to our industry, the National Uniformity for Food Act represents a
    major step forward in assuring that there are rational, scientifically-
    based and consistent standards in all 50 States.
        The National Uniformity for Food Act also takes a measured approach
    to national uniformity for food labeling by providing a mechanism for a
    thorough, orderly review of existing State regulations that may differ
    from Federal regulations. By granting States the ability to have the
    Federal Government adopt their State standard, this bill carefully
    balances the need for uniformity while respecting the important role
    State and local governments have in ensuring the safety of the food
    supply.
        Once again, the United States Hispanic Chamber of Commerce strongly
    urges you to support S. 3128, the National Uniformity for Food Act of
    2006, if you have any questions, please feel free to contact me at
    (202) 842-1212.
                Sincerely,
                                            Michael L. Barrera,
                                                     President and CEO.
                                     ______

           Wyoming Retail Merchants Association (wrma),
                                            Cheyenne, WY 82003.
    Hon. Michael B. Enzi,
    U.S. Senate,
    Washington, DC 20510.

        Dear Senator Enzi: On behalf of the Wyoming Retail Merchants
    Association, I am writing to urge you to cosponsor and support S. 3128,
    the ``National Uniformity for Food Act of 2006.'' Senators Richard Burr
    (R-NC), Pat Roberts (R-KA), and Ben Nelson (D-NE) introduced the
    legislation on May 25, 2006. On March 8, the House passed the
    legislation (H.R. 4167) with a strong bipartisan vote of 283-139. I
    urge you to cosponsor this critical piece of legislation.
        The legislation provides for science-based uniform food safety
    standards and warning requirements so that Americans in every State are
    protected equally. It is common-sense legislation that will help
    consumers make educated decisions for themselves and their families in
    an ever-changing and confusing food labeling environment. Consumers
    deserve a single standard when it comes to food safety, and this bill
    will allow States and the FDA to work collaboratively in establishing
    sound food safety policies that benefit--not confuse--consumers.
        The ``National Uniformity for Food Act'' is top priority for
    Wyoming Retailers. It recognizes that it makes no sense to have
    different States adopting different regulatory requirements for
    identical food products. This legislation will instead provide
    consumers with a single set of consistent, science-based food safety
    regulations for food products sold in all 50 States.
        Successful passage of the ``National Uniformity for Food Act'' is
    absolutely critical. We urge you to make its passage a top priority.
                Sincerely,
                                                 Lynn Birleffi,
                                                    Executive Director.
                                     ______

                                     State of Nebraska,
                        Office of the Attorney General,
                                             Lincoln, NE 68509,
                                                        April 19, 2006.
    Hon. Ben Nelson,
    U.S. Senate,
    Washington, DC 20510.

    Re: H.R. 4167--Food Labeling Legislation

        Dear Senator Nelson: I am writing to urge you to support The
    National Uniformity for Food Act when it is introduced in the Senate.
    Last month, 39 Attorneys General signed a NAAG letter to Congress
    urging you to oppose the House bill, H.R. 4167, which passed in the
    House by a large and bipartisan margin on March 8. I respectfully
    disagree with my colleagues regarding the effect of the bill and
    believe it would establish a consistent, science-based framework to
    ensure the security and safety of our food supply.
        I am satisfied that H.R. 4167 in its current form will not
    compromise the ability of State and local officials to act decisively
    when faced with a food safety threat of any kind. Rather, the bill
    fosters consistency in the regulation of our food supply and ensures a
    framework in which State Attorneys General and our State agriculture
    and health officials will remain unencumbered and effective in
    protecting consumers.
        Attorneys General across the country are generally protective of
    States' rights. However, food label warnings seem to be one area in
    which it makes sense to have a national standard. I do not believe that
    food manufacturers that ship their food all around the world should be
    required to potentially develop a different label for each State in the
    union. H.R. 4167 recognizes and preserves the essential role that
    States play in the day-to-day business of ensuring a safe food supply.
    For example, the bill would keep all existing State warning
    requirements in place while States petition the U.S. Food and Drug
    Administration (FDA) and both a public comment period and transparent
    review process are completed.
        A similar petition procedure is also established for warnings
    requirements that are not currently the subject of State law. Expedited
    review is specifically required for petitions involving notifications
    relating to cancer, reproductive or birth defects, or that furnish
    information to parents that allows them to limit a child's exposure to
    cancer-causing agents, or reproductive or developmental toxins.
        It is noteworthy that the bill specifically applies only to
    mandated warning statements. Nothing in H.R. 4167 infringes upon the
    right of any State agency or official to share food safety concerns
    (e.g., public education campaign) with their citizens. The sum of the
    parts of H.R. 4167 that address warning statements ensures that States
    participate in, and the Federal Government ultimately sets, national
    food safety policy. A close reading of the proposed legislation
    confirms that this balance would be achieved by H.R. 4167.
        Certain food safety and adulteration provisions of the Federal
    Food, Drug, and Cosmetic Act are also subject to national uniformity
    under the bill, with several important limitations. is my understanding
    that nearly all States have food statutes comparable to the food safety
    and adulteration provisions of Federal law that are covered by the
    bill. The bill is not likely to have any practical impact on the
    content or application of such State food laws. Separately, I would
    note that H.R. 4167 completely excludes--and thus would not affect the
    Federal and corresponding State provisions that are most often relied
    upon by State and local inspectors to seize, embargo or otherwise take
    immediate action against unsafe food (e.g., food held under unsanitary
    conditions, product unfit for food).
        Where State food safety and adulteration law is the same as the
    Federal, States are only restricted in adopting adulteration-related
    requirements that are already the subject of an FDA regulation or
    ``final guidance'' as that term is defined by Federal regulation. If
    there is no FDA regulation or ``final guidance,'' States would be free
    to apply their food safety laws to a circumstance as they see fit.
        Finally, the bill, once enacted, cannot become effective until the
    U.S. Department of Health and Human Services, in consultation with the
    U.S. Department of Homeland Security certifies to Congress that
    implementation of the new law would pose no additional risk to public
    health or safety from terrorist attacks on the food supply. State and
    local officials remain on the front-line in protecting our food supply
    and their rapid response is left intact under H.R. 4167. Accordingly,
    this office does not foresee any significant changes in how State and
    local officials protect consumers.
        I urge your support for the Senate version of H.R. 4167, when
    introduced. The plain language of the bill suggests that a proper
    balance between uniform, consistent Federal food safety policies and
    requirements can be achieved without compromising the critical role
    States play day-in and day-out in the marketplace.
                Sincerely,
                                                   Jon Bruning,
                                                      Attorney General.
                                     ______

                              Bimbo Bakeries USA, Inc.,
                                     Fort Worth, TX 76155-2861,
                                                         June 28, 2006.
    Hon. Michael B. Enzi,
    U.S. Senate,
    Washington, DC 20510.

        Dear Senator Enzi: On behalf of Bimbo Bakeries USA, Inc., I am
    writing to urge you to support S. 3128, the ``National Uniformity for
    Food Act of 2006.'' Senators Richard Burr (R-NC), Pat Roberts (R-KS),
    and Ben Nelson (D-NE) introduced the legislation on May 25, 2006. On
    March 8, the House passed their version of this legislation (H.R. 4167)
    with a strong bipartisan vote of 283-139. I urge you to support this
    critical piece of legislation.
        S. 3128 provides for science-based uniform food safety standards
    and warning requirements so that Americans in every State are protected
    equally. It is common-sense legislation that will help consumers make
    educated decisions for themselves and their families in an ever-
    changing and confusing food labeling environment. Consumers deserve a
    single standard when it comes to food safety, and this bill will allow
    States and the FDA to work collaboratively in establishing sound food
    safety policies that will benefit--not confuse--consumers.
        The ``National Uniformity for Food Act'' is a top priority for the
    baking industry. This critical legislation recognizes that it makes no
    sense to have different States adopting various regulatory requirements
    for identical food products. S. 3128 will instead provide consumers
    with a single set of consistent, science-based food safety regulations
    for food products sold in all 50 States.
        Successful passage of the ``National Uniformity for Food Act'' is
    absolutely critical to Bimbo Bakeries USA, Inc. and our employees. I
    urge you to make its passage a top priority.
        Thank you in advance for your consideration of my request to
    support S. 3128.
                Sincerely,
                                            Joe T. Dangelmaier,
                                   Senior Vice President of Operations,
                                               Bimbo Bakeries USA, Inc.
                                     ______

           National Association of Manufacturers (NAM),
                                     Washington, DC 20004-1790,
                                                         July 13, 2006.
    Hon. Michael B. Enzi,
    U.S. Senate,
    Washington, DC 20510.

        Dear Senator Enzi: On behalf of the National Association of
    Manufacturers (NAM), I urge you to cosponsor and strongly support S.
    3128, the National Uniformity for Food Act.
        The National Uniformity for Food Act will create national, uniform
    standards for food safety labeling. Under current policy, there could
    be 50 or more labeling standards, causing logistical and distribution
    inefficiencies and, potentially, drawing concerns from our
    international trading partners about labeling being used as a non-
    tariff barrier to trade. Thus, S. 3128 is an appropriate congressional
    exercise of the Constitution's Interstate Commerce Clause.
        Some State officials have wrongly argued that their citizens will
    lose protections if S. 3128 becomes law. Actually, States will retain
    their ability to contribute to food safety information by petitioning
    to have their current and new standards approved by the FDA. If a
    petitioned standard is warranted, all consumers nationwide would
    benefit rather than just the citizens of certain States.
        Your cosponsorship of and support for S. 3128 would be appreciated.
    Please let me or Larry Fineran, the NAM's vice president for legal and
    regulatory reform, know if you have any questions or need additional
    information. Mr. Fineran can be reached at (202) 637-3174 or
    lfineran@nam.org.
                Sincerely,
                                                   John Engler,
                                                     President and CEO.
                                     ______

                                     State of Arkansas,
                                State Capitol Building,
                                        Little Rock, AR, 72201,
                                                        April 17, 2006.
    Hon. Mark Pryor,
    Hon. Blanche Lincoln,
    U.S. Senate,
    Washington, DC 20510.

        Dear Senator Pryor and Senator Lincoln: I am contacting you to ask
    for your support for legislation that has been introduced in the Senate
    that would provide national, uniform food safety standards and warning
    requirements for food. The National Uniformity for Food Act passed the
    U.S. House of Representatives on March 8th by a vote of 283-139 with
    bipartisan support.
        If approved by the Senate, States could petition the U.S. Food and
    Drug Administration (FDA) to adopt their food safety standards and
    warning requirements nationally. If approved by the FDA, food
    manufacturers would incorporate the requirements, thus providing all
    consumers nationwide with the same information.
        This is an opportunity for Congress to embrace a measure that would
    ensure critical safety information about food products delivered to
    consumers nationwide in a simplified fashion. Arkansas consumers
    deserve more than a mixed message when it comes to important
    information regarding food safety.
        I have spent a great deal of time in recent years looking at
    wellness and obesity issues in America. Maintaining a consistent
    labeling system is important to all our citizens. This policy will also
    protect Arkansas-based food manufacturers from having to deal with the
    logistical nightmare of 50 labels for each product sold in the United
    States.
        Maintaining consumer confidence in food safety is an important
    goal. The National Uniformity for Food Act is a step in the right
    direction. For this reason, I respectfully ask for your support on this
    measure.
                Sincerely yours,
                                                 Mike Huckabee,
                                                              Governor.
                                     ______

           Chamber of Commerce of the United States of
                                               America,
                                     Washington, DC 20062-2000,
                                                         June 13, 2006.

        To the Members of the United States Senate: The U.S. Chamber of
    Commerce, the world's largest business federation representing more
    than 3 million businesses and organizations of every size, sector, and
    region, strongly urges you to consider cosponsoring S. 3128, the
    National Uniformity for Food Act, a similar version of which recently
    passed the House with strong bi-partisan support. This legislation
    would amend the Federal Food, Drug, and Cosmetic Act by extending
    national uniformity to food safety and warning label laws.
        With the enactment of this legislation, national uniformity would
    be extended to one of the very few areas where it has been lacking:
    food safety and warning labeling. Meat and poultry regulations,
    nutritional labeling, and pesticide tolerance standards are all
    regulated at the Federal level. Food safety and warning label
    requirements, on the other hand, have been governed by a ``patchwork
    quilt'' of State and local regulations. This collection of inconsistent
    requirements is burdensome for food businesses and confusing for
    consumers.
        The National Uniformity for Food Act takes a commonsense, measured
    approach to achieving national uniformity for food safety and warning
    label requirements, striking an appropriate balance between national
    and State interests. The legislation provides ample time for review and
    harmonization of preexisting State rules, and establishes procedures
    under which States can opt out of uniformity requirements. Furthermore,
    this legislation does not impact the States' inspection and enforcement
    authority over food safety and warning label requirements.
        With the increase in new food sources from overseas, thousands of
    new products introduced each year by domestic manufacturers, and faster
    communications and transportation, the need for a national food safety
    system is greater today than it was even 10 years ago. Consumers should
    not have to endure conflicting standards that declare an identical food
    product safe in one State, but hazardous in another.
        The Chamber strongly urges you to consider cosponsoring S. 3128,
    the National Uniformity for Food Act, and looks forward to a hearing on
    this bill in the near future.
                Sincerely,
                                               R. Bruce Josten,
                                              Execitive Vice President,
                                                    Government Affairs.
                                     ______

          International Dairy Foods Association (IDFA),
                                                         July 25, 2006.
    Hon. Michael Enzi,
    Chairman,
    Committee on Health, Education, Labor, and Pensions,
    U.S. Senate,
    Washington, DC 20510.
    Hon. Edward Kennedy,
    Ranking Member,
    Committee on Health, Education, Labor, and Pensions,
    U.S. Senate,
    Washington, DC 20510.

        Dear Chairman Enzi and Ranking Member Kennedy: On behalf of the
    International Dairy Foods Association, I am writing to ask for your
    support of the National Uniformity for Food Act, S. 3128, which was
    referred to the Senate Health, Education, Labor, and Pensions Committee
    (HELP) in March. This important bill would create a uniform, national
    system that recognizes the role of State and local governments in the
    regulation of food products and integrates them into the national
    system.
        The International Dairy Foods Association (IDFA) represents the
    Nation's dairy manufacturing and marketing industries and their
    suppliers, with a membership of 530 companies representing a $90-
    billion a year industry. IDFA is composed of three constituent
    organizations: the Milk Industry Foundation (MIF), the National Cheese
    Institute (NCI) and the International Ice Cream Association (IICA).
    IDFA's 220 dairy processing members run more than 600 plant operations,
    and range from large multi-national organizations to single-plant
    companies. Together they represent more than 85 percent of the milk,
    cultured products, cheese and frozen desserts produced and marketed in
    the United States.
        We ask you to consider the following points when the HELP Committee
    hears S. 3128 on Thursday, July 27. Current individual State
    regulations create an unwieldy national patchwork of standards, which
    oftentimes confuse consumers about the food they eat and the beverages
    they drink. Under the current system, food regulation is composed of a
    variety of different and sometimes inconsistent requirements. S. 3128
    seeks to harmonize these differences to achieve a more uniform and
    national system. Consistency in labeling is vital to dairy processors
    that sell their products in multiple States and want to provide the
    clearest information to American consumers.
        This legislation provides for science-based uniform food safety
    standards and warning requirements so that Americans in every State are
    protected equally. Under the bill, the Federal requirements would take
    effect gradually and provide for thorough review of existing State
    regulations. The bill allows for the States to petition the Food and
    Drug Administration to adopt their regulations as national requirements
    or exempt them from national uniformity. This legislation would not
    undo current safety regulations, as opponents have claimed, for
    products such as milk.
        Congress has repeatedly recognized the importance of uniformity in
    food regulation. The Nutrition Labeling and Education Act (1990), the
    Food Quality Protection Act (1996), the Poultry Products Inspection Act
    and the Meat Inspection Act are examples of policies containing
    uniformity provisions. The House has already acted on this important
    legislation and passed the bill with a strong bipartisan vote of 283-
    139.
        I urge you to join the list of cosponsors of S. 3128, the National
    Uniformity for Food Act, and ultimately vote ``yes'' on this critical
    legislation. Feel free to contact me directly for more information at
    (202) 737-4332.
                Sincerely,
                                                    Chip Kunde,
                                                 Senior Vice President,
                                      Legislative and Economic Affairs.
                                     ______

      Hispanic Association on Corporate Responsibility
                                                (HACR),
                                          Washington, DC 20005,
                                                         June 22, 2006.
    Hon. Bill Frist,
    Majority Leader,
    U.S. Senate,
    Washington, DC 20510.

        Dear Senator Frist: On behalf of the Hispanic Association on
    Corporate Responsibility (HACR), one of the most influential advocacy
    organizations in the Nation representing 14 national Hispanic
    organizations, I am writing to urge you to support S. 3128, the
    ``National Uniformity for Food Act of 2006.'' Senators Richard Burr (R-
    NC), Pat Roberts (R-RA), and Ben Nelson (D-NE) introduced the
    legislation on May 25, 2006. On March 8, the House passed the
    legislation (H.R. 4167) with a strong bipartisan vote of 283-139.
        This legislation recognizes that it makes no sense to have
    different States adopting different regulatory requirements on
    identical food products. S. 3128 will instead provide consumers with a
    single set of consistent, science-based food safety regulations for
    food products sold in all 50 States.
        Under the current system, food regulations are composed of
    different and sometimes contradictory requirements. This imposes
    unnecessary complexity and cost on makers of food throughout the United
    States. These costs are most often passed on to consumers. By bringing
    a uniform code, the legislation represents a major step towards
    ensuring consumer confidence in the food they buy for their families.
        S. 3128 takes a measured approach to national uniformity for food
    by providing a mechanism for a thorough, orderly review of existing
    State regulations that may differ from Federal regulations. By granting
    States the ability to have the Federal Government adopt their standard,
    this bill carefully balances the need for uniformity while respecting
    the important role State and local governments have in ensuring the
    safety of the food supply.
        Founded in 1986, HACR is one of the most influential advocacy
    organizations in the Nation representing 14 national Hispanic
    organizations in the United States and Puerto Rico. Our mission is to
    advance the inclusion of Hispanics in corporate America at a level
    commensurate with our economic contributions. To that end, HACR focuses
    on four areas of corporate responsibility and community reciprocity:
    employment, procurement, philanthropy, and governance.
        Once again, we urge you to support this legislation. Thank you for
    your time and consideration.
                Sincerely,
                                                Carlos F. Orta,
                                                     President and CEO.
                                     ______

         Council for Citizens Against Government Waste,
                                          Washington, DC 20036,
                                                         June 19, 2006.
    U.S. Senate,
    Washington, DC 20510.

        Dear Senator: On behalf of the more than 1.2 million members and
    supporters of the Council for Citizens Against Government Waste
    (CCAGW), I urge you to support S. 3128, the ``National Uniformity for
    Food Act of 2005.'' S. 3128 would harmonize inconsistent State
    requirements by providing national, uniform food safety standards and
    warning requirements.
        Under the current system, States may impose different, and
    sometimes contradictory, regulations. This imposes unnecessary
    complexity and cost on food processors and manufacturers throughout the
    United States. These costs are most often passed on to consumers. In
    addition, taxpayers in the various States bear the burden for
    administration of these unnecessary and duplicative regulations.
        It does not make sense to have States adopting different regulatory
    requirements on identical food products. S. 3128 will provide consumers
    with a single set of consistent, science-based safety regulations for
    food products in the entire country. The legislation provides that
    where the Food and Drug Administration (FDA) has established a safety
    standard, the States would adopt and enforce the same standard. If the
    FDA has not set a safety standard for a particular food ingredient, the
    States would remain free to set and enforce their own standards.
        The National Uniformity for Food Act takes a measured approach by
    providing a mechanism for a thorough, orderly review of existing State
    regulations that may differ from Federal regulations. By providing
    States with the ability to petition for adoption at the Federal level
    any existing State food safety or warning requirements, the legislation
    carefully balances the need for uniformity while at the same time
    recognizing the role that State and local governments have in ensuring
    the safety of the Nation's food supply.
        Any votes on S. 3128 will be among those considered in CCAGW's 2006
    Congressional Ratings.
                Sincerely,
                                              Thomas A. Schatz,
                                                             President.
                                     ______

                             Letters of Opposition

        California League of Conservation Voters, California League for
    Environmental Enforcement Now, CALPIRG, Center for Food Safety, Center
     of Science in the Public Interest, Coalition for Clean Air, Consumer
    Action, Consumer Federation of California, Consumers Union, Environment
     California, Environment Law Foundation, Environmental Working Group &
      EWG Action Fund, Friends of the Earth, GotMercury.Org, Greenpeace,
      Healthy Children Organizing Project, National Environmental Trust,
       Natural Resources Defense Council, Oceana, Physicians for Social
    Responsibility, Sierra Club, Union of Concerned Scientists, U.S. Public
                  Interest Research Group, United Steelworkers
                                                          June 7, 2006.
    U.S. Senate,
    Washington, D.C. 20510.

        Dear Senator: On behalf of our millions of members and supporters,
    we strongly urge you to support the safety of America's food supply by
    opposing and refusing to cosponsor the so-called ``National Uniformity
    for Food Act of 2005,'' S. 3128. This legislation, more appropriately
    labeled the ``State Food Safety Preemption Act,'' tinkers with--but in
    some respects is actually worse than--the hastily-passed House food
    safety preemption bill, H.R. 4167.
        For example, the Senate bill explicitly deletes the House's
    provision--adopted on the floor as the Wasserman-Shultz amendment by a
    vote of 253-168--allowing States to retain warnings to pregnant women
    and parents about the significant risks to the brains of fetuses and
    young children from high levels of mercury in certain kinds of fish.
    Consumer Reports (published by Consumers Union) just published an
    article on the risk of mercury in tuna, which we have attached to this
    letter. The U.S. Food and Drug Administration (FDA) warns on its Web
    site that pregnant women and young children should avoid certain fish
    due to high mercury levels, but under S. 3128 State-required warnings
    about these risks--even one identical to the Federal FDA warning--would
    be preempted.
        In this and many other ways, S. 3128 undermines public health
    protection. The Senate bill makes other minor changes to the House
    legislation, but none alter the fundamental thrust of the bill, which
    is to stop States from protecting their citizens from dangers in the
    food supply when the Federal Government is not doing so. This bill has
    been introduced repeatedly for many years, yet no public hearings have
    been held on it, and we are confident it cannot withstand public
    scrutiny.
        The vast majority of editorial writers, State officials,
    environmental, consumer, health, labor and other groups strongly oppose
    this problematic legislation (see attached). For example, State and
    local food safety officials and 39 Attorneys General have weighed in
    against the House bill because it would nullify critically-important
    consumer and health protections and right-to-know requirements.
    Similarly, at least eight governors, including Governor Schwarzenegger,
    oppose the bill. The preempted State and local rules protect consumers
    by filling the gaps left by the understaffed and underfunded FDA.
    States would no longer have the authority to provide important
    protections for the public, such as shellfish, milk, and egg safety
    standards--unless the FDA grants a State waiver. This seriously
    undermines food safety and offends longstanding principles of
    federalism. Preemption of State food safety laws is opposed by the
    National Association of State Departments of Agriculture and the
    Association of Food and Drug Officials (AFDO). AFDO points out that
    this bill, if enacted, ``will effectively eliminate our Nation's
    biosecurity shield, and will undermine our whole food safety and
    biosurveillance capability.''
        The waiver process of the legislation would impose huge financial
    burdens on the financially-strapped FDA and States. The CBO estimated
    that this legislation would require the FDA to spend $100 million (over
    5 years) reviewing over 240 waiver requests. Moreover, States would
    incur substantial legal and technical expenses in seeking an FDA
    waiver. These Federal and State resources could be better used in
    promoting food safety.
        We urge you to oppose this rollback of State and local food safety
    programs.
                Sincerely,

        Susan Smartt, Executive Director, California League of Conservation
    Voters; Joseph H. Guth, J.D., Ph.D., Executive Director, California
    League for Environmental Enforcement Now; Emily Clayton, Public Health
    Advocate, CALPIRG; Will Rostov, Senior Attorney, Center for Food
    Safety; Benjamin Cohen, Senior Staff Attorney, Center of Science in the
    Public Interest; Tim Carmichael, President and CEO, Coalition for Clean
    Air; Linda Sherry, Director of National Priorities, Consumer Action;
    Richard Holober, Consumer Federation of California; Susanna
    Montezemolo, Policy Analyst, Consumers Union; Rachel L. Gibson,
    Environmental Health Advocate & Staff Attorney, Environment California;
    James R. Wheaton, Esq., President, Environment Law Foundation; Bill
    Walker, Vice President/West Coast, Environmental Working Group & EWG
    Action Fund; Sara Zdeb, Legislative Director, Friends of the Earth; Eli
    Saddler, JD, MPH, MA, Public Health Analyst, GotMercury.Org; Rick Hind,
    Legislative Director, Greenpeace; Neil Gendel, Project Director,
    Healthy Children Organizing Project; Karen Steuer, Vice President,
    National Environmental Trust; Erik Olson, Advocacy Center Director,
    Natural Resources Defense Council; Ted Morton, Legislative Director,
    Oceana; Will Callaway, Legislative Director, Physicians for Social
    Responsibility; Ed Hopkins, Director of the Environmental Quality
    Program, Sierra Club; Susan Prolman, J.D., Washington Representative,
    Union of Concerned Scientists; Anna Aurillio, Legislative Director,
    U.S. Public Interest Research Group; Roxanne D. Brown, Legislative
    Representative, United Steelworkers.

        [Editor's Note: Due to the high cost of printing, previously
    published materials submitted by witnesses are not reproduced. The
    article, ``Mercury in Tuna'' may be found at ConsumerReport.org.]
                                     ______

                   U.S. Public Interest Research Group,
                                          Washington, DC 20003,
                                                           May 4, 2006.

        Dear Senator: On behalf of the 30 State Public Interest Research
    Groups (PIRGs) across the country, we are writing to urge you to oppose
    the National Uniformity for Food Act, which passed the House on March
    8. This bill, as passed by the House, would nullify at least 200
    effective State and local food safety and right-to-know requirements,
    leaving a critical gap in the food safety net that protects public
    health and consumer choice.
        This bill does not establish uniform food safety and labeling
    requirements; instead, it simply eliminates proven food safety and
    labeling standards that are more protective than Federal standards,
    even when the Federal Government has done nothing. In effect, the bill
    asks American consumers to trust that an increasingly unresponsive and
    under-funded Federal bureaucracy will enact adequate food safety and
    labeling standards that fully inform and protect them. Unfortunately,
    this often is not the case.
        In the absence of adequate Federal regulations, numerous State and
    local governments have passed strong laws designed to safeguard public
    health, ensure a safe supply of food, and give consumers the
    information they need and deserve. Laws at risk of preemption include
    milk safety and restaurant sanitation standards in all 50 States;
    shellfish safety standards in 16 States; laws in 17 States requiring
    bars and liquor stores to post signs warning pregnant women of the
    effects of drinking alcohol; laws in 15 States allowing the States to
    enact stricter standards for food additives; and scores of laws that
    require food manufacturers to truthfully label their products.
        In addition to nullifying proven food safety laws already on the
    books, this bill would forever tie the hands of States and
    municipalities on a range of emerging food safety issues, whether or
    not the Federal Government has addressed public health concerns.
        Federal legislation preempting State law would affect dozens of
    States, but the law that started the food industry's crusade is
    California's Proposition 65. In 1986, California voters approved
    Proposition 65, which requires warning labels on products containing
    chemicals known to cause cancer or birth defects. Consumers have the
    right to know if their food contains dangerous chemicals, and States
    and localities have the right to provide this information in the
    absence of strong Federal standards. Although critics of Proposition 65
    say varying State standards pose a burden to food manufacturers, past
    administrations have dismissed this claim. When asked by the food
    industry to preempt California's law, President George H.W. Bush's
    administration concluded in 1989 that ``no Federal preemptive action--
    either by regulation or otherwise--is warranted.'' The Reagan-Bush
    administration came to the same conclusion, and this is why Governor
    Arnold Schwarzenegger of California has opposed this bill.
        Although the bill provides States with a limited opportunity to
    petition the Food and Drug Administration (FDA) to keep State laws on
    the books, the petition process is slow, uncertain, and expensive. In
    fact, the Congressional Budget Office estimates that this bill would
    cost FDA at least $100 million over a 5-year period. FDA does not have
    the staff or financial resources to absorb these costs. In fact, the
    number of full-time FDA employees dealing with food safety has fallen
    steadily from 3,167 in fiscal year 2003 to 2,843 in fiscal year 2006;
    the president's proposed fiscal year 2007 budget for FDA would further
    reduce that number to 2,757.
        Eight Governors, 39 Attorneys General, the National Conference of
    State Legislatures, National Association of State Departments of
    Agriculture, Association of Food and Drug Officials, and others from
    both political parties have come out in sharp opposition to this bill,
    as it would usurp power from those best-positioned to serve as the
    first line of defense against threats to our food supply: States and
    localities. Oppose the National Uniformity for Food Act to preserve the
    State and local laws so critical to the safety of our food supply.
                Sincerely,
                                                  Anna Aurilio,
                                                  Legislative Director.
                                     ______

                                     State of New York,
                 Department of Agriculture and Markets,
                                                         March 1, 2006.

        Dear Member of New York State Delegation: I am writing to express
    my concern for H.R. 4167, the National Uniformity for Food Act, as
    currently written. This bill could make it more difficult for States
    like New York with strict food safety regulations to protect our food
    supply.
        As you know, the current food safety regulatory system in the
    United States is the shared responsibility of local, State and Federal
    partners. Local and State agencies currently perform approximately 80
    percent of the food safety work across the Nation and Federal agencies
    often seek assistance from local/state partners in dealing with
    imminent health hazards. Therefore, it is imperative that States have
    the right to act quickly to enact laws and issue rules that address
    local and statewide public health concerns that cannot be anticipated
    or are not adequately addressed nationally.
        In addition to preempting State laws relating to food safety
    warnings, H.R. 4167 would require States to change their laws to be
    identical to the Federal Food, Drug, and Cosmetic Act (FDCA).
        If this proposed legislation is enacted, the Association of Food
    and Drug Officials anticipates the following:

        State enforcement action related to adulterated food or misbranding
    would be open to challenge. Variations in language currently exist
    between many of New York's food laws, relating to adulterated food and
    additives, and the respective Federal counterpart. Under this proposed
    legislation, States will be required to seek clarity to determine if
    New York laws are ``identical'' to Federal law through an appeals
    process with the U.S. Food and Drug Administration (FDA). During this
    process, the States' enforcement attempts to ensure food safety and
    security will be open to legal challenge by anyone who violates State
    food safety provisions. This fact is problematic at a time when the
    Nation is forced to address current problems such as ``mad cow''
    disease (State food safety laws cover adulterated animal feed), unsafe
    food or food ingredients, and possible terrorist threats to the
    Nation's food supply. If passed into law, H.R. 4167 has the potential
    to deregulate food safety requirements at a time when quick food safety
    action could prove crucial to protecting the public. In the past, FDA
    has typically acted months after a food safety concern has occurred
    where New York State has taken action quickly to protect our consumers.
        New York State's ability to enforce food safety laws would be
    hampered. Currently, there is very limited food inspection and
    corrective action taken in New York by Federal authorities. The New
    York State Department of Agriculture and Markets has coordinated over
    1,000 food recalls in the past 3 years. If H.R. 4167 is passed, the New
    York law authorizing the quarantine or seizure of misbranded or
    adulterated food could be unenforceable. Due to the broad wording
    relating to the ``construction'' provision in this proposed Federal
    law, New York could be left without any means to keep contaminated food
    from entering the Nation's food supply.
        Food inspection enforcement laws relating to grade A milk, grocery
    stores and shellfish would be preempted. Currently there are no Federal
    laws governing the inspection and regulation of grade A milk production
    for interstate commerce, shellfish harvesters and processors, or
    regulation of retail food establishments like grocery stores and
    restaurants. By failing to specifically reference these code sections
    in the bill, States are left to assume that State regulations, relating
    to inspection and enforcement of these programs, may be preempted
    because there are no Federal laws governing these program areas. These
    food safety areas would then be left unregulated.
        For the above reasons, I ask you to work with us to amend H.R. 4167
    to ensure that New York's strong food safety programs remain intact so
    that our food supply remains as safe as possible. Please let me know if
    we can provide any additional information or assistance.
                Sincerely,
                                            Patrick H. Brennan,
                                                          Commissioner.
                                     ______

      The National Association of State Departments of
                                           Agriculture,
                                          Washington, DC 20005,
                                                          June 1, 2006.
    Members of the U.S. Senate.

        Dear Senators: The National Association of State Departments of
    Agriculture (NASDA) is writing to express our strong opposition to S.
    3128, the National Uniformity for Food Act. NASDA represents the
    commissioners, secretaries and directors of agriculture in the 50
    States and four territories, and we are partners in the Nation's food
    safety system.
        The State Departments of Agriculture are very concerned that this
    legislation goes far beyond its stated purpose of providing uniform
    food safety warning notification requirements and greatly expands
    Federal preemption under the Food, Drug and Cosmetics Act. This
    preemption would seriously compromise our ability to enact laws and
    issue rules in numerous areas of food safety. Specifically, we believe
    the bill as currently written threatens existing State food safety
    programs and jeopardizes State/Federal food safety cooperative programs
    such as those related to Grade A milk, retail food protection, and
    shellfish sanitation. We simply disagree with recent analyses which
    claim that State laws and regulations will not be undermined by this
    legislation.
        Our current food safety regulatory system is the shared
    responsibility of local, State and Federal partners. Approximately 80
    percent of food safety inspections in the United States are completed
    at the State and local level. It is imperative that States retain their
    traditional right to address local and statewide public health concerns
    that cannot be anticipated or are not adequately addressed nationally.
    The preemption embodied in this legislation is broad, vague and
    sweeping. It calls into question the authorities of State and local
    laws that address adulterated foods, animal feed, and antiterrorism and
    other food defense programs. It will leave a critical gap in the safety
    net that protects consumers.
        We are dismayed that Congress has not held any hearings on these
    important issues, especially since the legislation would radically
    change the traditional allocation of power between States and the
    Federal Government. NASDA urged the House of Representatives to hold
    hearings on similar legislation, and we were extremely disappointed
    when this did not happen. We call on the Senate to hold hearings before
    taking further action on S. 3128 and to seek full input from State and
    local partners in our food safety system.
        NASDA would welcome the opportunity to discuss ways the legislation
    could be amended to achieve its intent without dismantling critical
    food safety regulatory programs at the State and local level. We
    respectfully request that you oppose S. 3128 until these critical
    issues are fully addressed.
                Sincerely,
                                        J. Carlton Courter III,
                                                      President, NASDA,
                       Commissioner, Virginia Department of Agriculture
                                                   & Consumer Services.
                                     ______

                                  The City of New York,
               Department of Health and Mental Hygiene,
                            Office of the Commissioner,
                                            New York, NY 10013,
                                                        April 11, 2006.
    Hon. Hillary Clinton,
    U.S. Senate,
    Washington, DC 20510.

        Dear Senator Clinton: I am writing to advise you of the very
    serious impact that enactment of H.R. 4167, the ``National Uniformity
    for Food Act,'' would have on public health and safety in New York
    City. We join a broad spectrum of groups, including attorneys general
    and State agriculture commissioners, who strongly oppose this bill.
        This act would encroach upon State and local governments' inherent
    power to act to protect the public health of their citizens. Moreover,
    by preempting local authority to seize, embargo and condemn adulterated
    food, it would seriously undermine the ability of New York City and
    other localities to respond immediately to the threat of terrorist
    activity affecting the food supply. Enactment of this bill, which
    passed the House of Representatives without public hearings, would have
    serious consequences that may not be intended or clearly understood by
    some of its proponents. I urge you to request that the appropriate
    Senate committees hold hearings and carefully review its impact. The
    bill, in its present form, should not be adopted by the Senate.
        This legislation would go far beyond regulation of food labeling.
    It preempts State and local governments from enforcing laws regarding
    adulterated food that are not ``identical'' to Federal laws, creating a
    serious obstacle to our ability to protect the public from dangerous
    conditions that the Federal Government has not yet regulated. The power
    to act on local authority is of particular importance to New York City
    and other localities with multicultural populations that create a
    market for imported specialty foods and products. These products may be
    rare and unique to certain nationalities and cultures, and often
    present hazards that have not been anticipated or adequately addressed
    either by State or national governments. For example, when imported
    candies contaminated with lead were found in the city, a city law was
    enacted banning the sale of such products, because Federal regulatory
    efforts had been inadequate to stop these contaminated products from
    entering the country.
        In addition, the bill may prevent local governments from enacting
    and enforcing even laws ``identical'' to Federal law. The definition of
    ``identical'' in section 403A refers to a law ``of a State or a
    political subdivision'' that uses ``substantially the same language as
    the comparable provision'' under H.R. 4167, and where ``any differences
    in language do not result in the imposition of materially different
    requirements.'' This language by itself would create endless
    challenges, confusion, and litigation as to whether any given law meets
    the ``identical'' standard. Moreover, while the definition refers to
    local as well as State laws, the operative provision states only that a
    ``State or political subdivision of a State may enforce a State law''
    meeting the ``identical'' standard; there is no provision for enforcing
    a local law which meets that standard. This inconsistency in the
    drafting of the statute creates serious doubt about the ability of
    local governments to enforce a wide range of laws concerning food
    safety. New York City, which has had a longstanding and critical role
    in protecting its residents from adulterated food, is particularly
    impacted by this legislation.
        New York City has a comprehensive body of law regarding food
    safety, and the city's Department of Health and Mental Hygiene has the
    primary responsibility for these matters in the city. These activities
    are at the very core of the mission of local health departments and
    must be preserved, especially in view of New York city's
    disproportionate risk for future terrorist attacks, including the
    threat of deliberate contamination of our food supply.
        As the Supreme Court stated more than 125 years ago in Sherlock v.
    Ailing, 93 U.S. 99, 103 (1876),

              ``In conferring upon Congress the regulation of commerce, it
            was never intended to cut the States off from legislating on
            all subjects relating to the health, life and safety of their
            citizens, though the legislation might indirectly affect the
            commerce of the country.''

        As recent events have proven, local governments are ultimately
    responsible for the safety of their citizens, and must continue to have
    the necessary tools to fulfill this responsibility.
        Enclosed is an analysis of the impact of this bill on New York
    City, as well as news articles and letters from other public officials
    and experts expressing concerns about this legislation. I appreciate
    your continued interest in this critical issue.
                Sincerely,
                               Thomas R. Frieden, M.D., M.P.H.,
                                                          Commissioner.
                                     ______

         New York City Position on H.R. 4167, The National Uniformity
                              for Food Act of 2005
        New York City strongly opposes this legislation. If enacted, H.R.
    4167, by preempting local authority to seize, embargo and condemn
    adulterated food, would seriously undermine the ability of New York
    City and other localities to protect citizens from unsafe food and to
    respond immediately to the threat of terrorist activity affecting the
    food supply.
        New York City's Department of Health and Mental Hygiene (DOHMH) is
    responsible for supervising and regulating the food supply in New York
    City. [New York City Charter  556(a)(9)]. Food establishments in New
    York City are licensed and regulated by DOHMH in accordance with
    Article 81 of the New York City Health Code.
        DOHMH is also authorized by existing local law to seize, embargo or
    condemn food that is adulterated or otherwise constitutes a danger to
    public health [New York City Health Code  3.03(a) and 71.11]. These
    authorities are essential public health tools that DOHMH has used for
    many decades to protect the citizens of New York City. DOHMH must be
    able to continue this critical public health activity, especially in
    light of New York City's disproportionate risk for future terrorist
    attacks, including the threat of deliberate contamination of our food
    supply.
        The following are examples of actions that New York City's DOHMH
    has taken and that would be preempted by H.R. 4167 or be subject to
    legal challenges that would result in dangerous delays and costly
    litigation. Law in such critical areas of public health should not be
    left unsettled and unclear. The authority to act needs to be
    unequivocal.

         In March 2005, DOHMH linked certain imported cheeses to
    infection by Mycobacterium bovis, a form of tuberculosis found in
    cattle; 35 cases, including the death of an infant, were attributed to
    M. bovis tuberculosis. The city monitored certain markets to assure
    that no contaminated cheese was sold.
         In December 2005, DOHMH used its powers under the city's
    Health Code to embargo certain imported herbal products that contained
    lead or mercury after several cases of adult lead poisoning were
    confirmed among residents who used these products. Although there were
    National Academy of Science recommendations about tolerance levels,
    there were--and continue to be--no specific Federal standards. In
    previous years, DOHMH had also ordered the cessation of sale of an
    herbal tea that contained high concentrations of lead and arsenic.
    While an amendment in the House-passed version of H.R. 4617 exempts
    regulation of dietary supplements from preemption, it is unclear
    whether food products containing dietary supplements would be similarly
    exempted.
         In October 2005, following a sewage backup in a
    manufacturing establishment in which specialty desserts and candies
    were made, DOHMH used its powers under the city's Health Code to order
    the owner to cease production and thoroughly clean the processing area.
    DOHMH embargoed and ultimately destroyed the contaminated products.
         In August 2004, DOHMH issued a warning to city residents
    to avoid eating certain candies and food products made in Mexico that
    had been found to contain lead. DOHMH, based on its authority under the
    Health Code, and in cooperation with New York State authorities,
    inspected and tested these products. These actions, along with actions
    by other States and localities, resulted in a voluntary recall by a
    candy manufacturer. Because any increase in lead exposure to New York
    City's children is a serious public health concern, the New York City
    Council subsequently adopted a law banning sale of candy products
    containing lead. This action was prompted by concerns about the
    inadequacy of Federal regulatory efforts to set allowable safety limits
    for lead in food products and stop contaminated products from entering
    the country.
         In 1999, reports of food-related illnesses were traced to
    salmonella bacteria in cheese blintzes prepared and sold by a local
    retail food manufacturer. DOHMH used the power of the Health Code to
    order the retailer to cease production of the blintzes and to destroy
    all contaminated products.
         In 1991, DOHMH, under the authority of the City Charter
    and the Health Code, ordered the surrender of shellfish that had been
    identified as the source of several cases of cholera.
                                     ______

      KEY PROVISIONS OF H.R. 4167 THAT WOULD IMPACT NEW YORK CITY'S FOOD
                                 SAFETY PROGRAM

        The bill amends 21 USCA  343-I, the National Uniform Nutrition
    Labeling Act. The proposed amendments, however, go well beyond
    regulation of labeling. The bill would prevent a State or locality from
    enforcing requirements for adulterated foods that are also regulated by
    Federal law when the State or local requirement is not ``identical'' to
    a Federal requirement. This invites litigation about whether a State or
    local requirement meets the ``identical' standard and will thereby
    seriously undermine the ability of State and local governments to
    enforce laws of great importance to public safety.
        It is unclear whether a State or locality would continue to have
    any authority to act regarding adulterated food in the absence of a
    Federal requirement addressing the relevant type of adulteration. An
    amendment to section 2 of the bill seemingly authorizes States and
    localities to act in some such cases, but the amendment is made to a
    section that still refers to enforcement of a State law that is
    ``identical'' to a requirement in Federal law, thereby creating
    confusion about whether an ``identical'' Federal requirement is a
    prerequisite to State or local action. Denying State and local
    governments the ability to protect their citizens from threats in the
    food supply that the Federal Government has not addressed is clearly
    not in the public interest.
        Section 403A(c)(2) of H.R. 4167 establishes circumstances under
    which a State or political subdivision of a State may enforce a State
    law regarding adulteration, and says nothing about enforcement of a
    local law, even though the definition of ``identical'' laws does refer
    to laws of a political subdivision as well as to laws of a State. New
    York City has a comprehensive body of city law regarding food safety.
    Given New York City's population, which includes citizens from every
    part of the world, the unique cultural and ethnic foods that are
    imported and consumed by these populations, and New York City's
    disproportionate risk for future attacks or deliberate contamination of
    food, enforcement of local law must be recognized. Many imported
    specialty foods may present public health hazards that have not been
    anticipated or adequately addressed either by State or national
    governments. Local governments, as first responders, would be in the
    best position to quickly identify, investigate and remove harmful
    products from the local food supply.
        Section 403B(a)(3) of the bill is also of great concern to DOHMH.
    This provision states that section 403B should not be construed to
    prevent a State from embargoing adulterated food pursuant to a State
    requirement identical to a Federal food adulteration requirement, but
    again fails to recognize the need of a locality to take such action, or
    to act pursuant to a local law. These activities (i.e., seizure,
    embargo of adulterated food) are at the very core of the mission of
    local health departments and must be preserved, not preempted.
        H.R. 4167 attempts to address the threat of an imminent hazard by
    explicitly allowing States--but again, not localities--to impose
    requirements for adulterated foods or take action that would otherwise
    violate the proposed uniformity requirement in  403B(a), but only upon
    satisfying various conditions (for example, submission of a petition).
    This process would be unduly burdensome and is unreasonable in
    situations involving an imminent threat to public health, when
    immediate action is necessary. New York City's health authority must be
    able to protect its citizens without having to comply with additional
    layers of bureaucracy.
        Immediately after 9/11, DOHMH intensified its surveillance for
    food-related illnesses because of concern about the potential for
    terrorist activity involving the food supply. If the provisions of H.R.
    4167 had been in effect at that time, the city would likely have been
    powerless to embargo potentially harmful food, even if our surveillance
    system had detected a serious threat. We have strengthened and enhanced
    that system, and it is now a model for the Nation. However, this
    legislation, if enacted, would compromise our ability to use our model
    system to respond quickly and preserve the public health.
        Enactment of H.R. 41671, which passed the House of Representatives
    without public hearings, will have serious consequences that may not be
    intended or clearly understood by some of its proponents. I urge you to
    request that the appropriate Senate committees hold hearings and
    carefully review its impact. The bill, in its present form, should not
    be adopted by the Senate.
                                     ______

       State of Connecticut, Department of Agriculture,
                            Office of the Commissioner,
                                            Hartford, CT 06106,
                                                        August 4, 2006.
    Hon. Christopher Dodd,
    Putnam Park,
    100 Wethersfield, CT 06109.

        Dear Senator Dodd: I am writing to you on behalf of Governor Roll
    to urge your rejection of S. 3128 ``National Uniformity for Food Act of
    2006.''
        The Connecticut Department of Agriculture (CT DOA) has the
    following concerns regarding S. 3128, known as the ``National
    Uniformity for Food Act of 2006'':

         Potential preemption of State and local food safety
    authority particularly in the area of dairy products including yogurt
    and cheese, more specifically locally produced product, and locally
    grown and harvested shellfish, all of which CT DOA regulates.
         CT DOA has concerns about the economic impact the passage
    of this bill may have on its local producers of dairy product and
    shellfish in terms of new or additional labeling requirements and also
    Connecticut Grown promotional labeling.
         CT DOA is uncertain about the impact of the bill on intra-
    state commerce for example labeling of Connecticut grown/produced food
    products at Connecticut farmers' markets.

        At this point in time, we are not convinced that this bill is in
    the best interests of, primarily Connecticut's agricultural industry,
    and secondarily, the citizens of the State of Connecticut.
        It is my understanding that the Connecticut Department of Consumer
    Protection also has concerns and you may be hearing from them in a
    separate communication.
        It is for these reasons I urge your careful consideration and
    rejection of S. 3128. Thank you for the opportunity to comment.
                Sincerely,
                                              F. Philip Prelli,
                                                          Commissioner.
                                     ______

             National Association of Attorneys General,
                                          Washington, DC 20002,
                                                         March 2, 2006.

        Dear Members of Congress: On March 1, 2006, we sent to you a sign-
    on letter by 37 Attorneys General in opposition to H.R. 4167, the
    ``National Uniformity for Food Act.'' Attorneys General Wayne Stenehjem
    of North Dakota and Malaetasi M. Togafau of American Samoa would like
    to join their colleagues in supporting this issue, so attached is the
    revised letter which includes their signatures. Thus, a total of 39
    Attorneys General have signed on to the March 1 letter.
                Sincerely,
                                                    Lynne Ross,
                                                    Executive Director.
                                     ______

             National Association of Attorneys General,
                                          Washington, DC 20002,
                                                         March 1, 2006.

        Dear Members of Congress: We write to urge you to oppose the
    ``National Uniformity for Food Act,'' H.R. 4167, 109th Cong. (2005)
    which undercuts States' rights and consumer protection. This bill,
    which the House Energy and Commerce Committee approved on December 15,
    2005, would preempt all existing and future State and local food
    labeling requirements that expressly or indirectly imply that a
    particular food or its packaging ``presents or may present a hazard to
    health or safety'' unless identical to Food and Drug Administration
    requirements. Indeed, under this bill, States would be forbidden from
    adopting their own policies, even if the Federal Government had not
    acted in a particular area or adopted a particular warning. Important
    consumer warnings dealing with mercury in fish, arsenic in drinking
    water, and lead in cans are just a few examples of States food labeling
    requirements that would be eviscerated by this bill.
        Food safety has been largely a matter of State law and oversight
    for well more than a century. State and local agencies perform more
    than 80 percent of food safety work, with Federal agencies often
    seeking their assistance. There is nothing in the public record showing
    that Federal uniformity in this area provides a greater level of
    protection to consumers or is in the public interest. Indeed, although
    this bill would radically change the traditional allocation of power
    between the States and the Federal Government, it has never been the
    subject of public hearings.
        This bill would strip State Governments of the ability to protect
    their residents through State laws and regulations relating to the
    safety of food and food packaging. Some of the more obvious state-level
    warnings that almost certainly would be challenged include consumer
    warnings about mercury contamination of fish, arsenic in bottled water,
    lead in ceramic tableware, the alcohol content in candies, the content
    of fats and oils in foods, and post-harvest pesticide application to
    fruits and vegetables. Unscrupulous merchants could contend that this
    bill immunized their false claims of health benefits ascribed to their
    products from State prohibitions or remedies such as laws barring
    deceptive advertising of food. The same could occur with regard to
    inadequate warnings regarding a child's use of a product.
        While H.R. 4167 provides States with a limited opportunity to
    petition the Federal Government for authorization to take action in a
    particular area, the petition process is slow, expensive and uncertain,
    and certainly is no substitute for allowing States their traditional
    role of taking action on their own to protect consumers. The bill would
    create a new Federal bureaucracy dedicated to evaluating, judging and
    even invalidating proposed State and local laws, a startling change in
    State-Federal relations in the food safety area.
        Without question, the target of this bill is California's
    Proposition 65, which was approved by California voters by initiative
    in 1986 and provides consumers with health and safety information
    concerning foods they may purchase and eat. There is no evidence that
    this popular initiative has harmed consumers or merchants.
        The Association of Food and Drug Officials, an organization
    comprised of State regulators with responsibility for ensuring food
    safety since 1896, strongly opposes this bill and, on January 16, 2006
    wrote:

            passage of this bill would undermine proven consumer protection
            programs . . . [t]he preemption provisions are broad, vague and
            sweeping and will likely dismantle the authority of State and
            local laws that address adulterated foods--which include food
            laws, dairy laws, animal feed laws, other agricultural
            commodity laws, anti-tampering laws, anti-terrorism laws, etc.:

        Letter from Association of Food and Drug Officials regarding H.R.
    4167 to the Honorable Mike Rogers, January 16, 2006 (copy attached).
        We need all levels of government to work together to protect food
    safety. State and local governments are often the first line of defense
    when problems emerge. Prohibiting State and local leadership and action
    in this area is a serious mistake. We respectfully request that you
    oppose H.R. 4167.
                Sincerely,

        Eliot Spitzer, Attorney General, New York; Mark J. Bennett,
    Attorney General, Hawaii; David W. Marquez, Attorney General, Alaska;
    Malaetasi M. Togafau, Attorney General, American Samoa; Terry Goddard,
    Attorney General, Arizona; Bill Lockyer, Attorney General, California;
    Richard Blumenthal, Attorney General, Connecticut; Carl C. Danberg,
    Attorney General, Delaware; Robert Spagnoletti, Attorney General,
    District of Columbia; Lawrence Wasden, Attorney General, Idaho; Lisa
    Madigan, Attorney General, Illinois; Tom Miller, Attorney General,
    Iowa; Greg Stumbo, Attorney General, Kentucky; Charles Foti, Attorney
    General, Louisiana; G. Steven Rowe, Attorney General, Maine; J. Joseph
    Curran, Jr. Attorney General, Maryland; Tom Reilly, Attorney General,
    Massachusetts; Mike Cox, Attorney General, Michigan; Mike Hatch,
    Attorney General, Minnesota; Jim Hood, Attorney General, Mississippi;
    Jeremiah W. Nixon Attorney General, Missouri; Mike McGrath, Attorney
    General, Mississippi; George J. Chanos; Attorney General, Nevada; Kelly
    Ayotte, Attorney General, New Hampshire; Zulima V. Farber, Attorney
    General, New Jersey; Patricia A. Madrid, Attorney General, New Mexico;
    Wayne Stenehjem, Attorney General, North Dakota; W.A. Drew Edmondson,
    Attorney General, Oklahoma; Hardy Myers, Attorney General, Oregon;
    Patrick Lynch, Attorney General, Rhode Island; Henry McMaster, Attorney
    General, South Carolina; Larry Long, Attorney General, South Dakota;
    Paul G. Summers, Attorney General, Tennessee; Greg Abbott, Attorney
    General, Texas; Mark Shurtleff, Attorney General, Utah; William H.
    Sorrell, Attorney General, Vermont; Darrell V. McGraw, Jr. Attorney
    General, West Virginia; Peg Lautenschlager, Attorney General,
    Wisconsin; Pat Crank, Attorney General, Wyoming.
                                     ______

         Association of Food and Drug Officials (AFDO),
                                                York, PA 17402,
                                                      January 16, 2006.
    U.S. House of Representatives,
    Washington, DC 20515.

        Dear Representative: I am writing on behalf of the Association of
    Food and Drug Officials (AFDO) to express serious concerns regarding
    H.R. 4167, ``The National Uniformity for Foods Act of 2005'' introduced
    by Congressman Mike Rogers (MI-8). Originally introduced in the 108th
    Congress as H.R. 2699, the bill's stated purpose is to amend the
    Federal Food, Drug and Cosmetic Act (FFDCA) to provide for uniform food
    safety warning notification requirements--and for other purposes. It is
    the phrase ``for other purposes'' that alarms members of AFDO. The
    legislation has been reviewed by attorneys for 11 State food safety
    programs, and unfortunately, all of the reviews are unanimous in their
    conclusion that the bill will preempt States and local food safety and
    defense programs from performing their functions to protect citizens.
        You may have already received some information concerning this
    bill's impact from its proponents. This information claims that State
    regulators, and organizations such as AFDO, are erroneous in their
    legal evaluation of the bill. However, in addition to AFDO's attorney,
    attorneys in 11 States, after careful review of this bill (as H.R.
    2699), have reached similar conclusions regarding its severe negative
    impacts to State programs. While it is not uncommon for legal
    authorities to differently interpret the meaning of a given law,
    because this disagreement is so profound and has such far-reaching
    implications, it is imperative to amend this bill and clearly specify
    Congress' intent to address solely food labeling. I urge you to oppose
    this bill until these differences can be resolved in Congress, and not
    leave it to the courts to decide while public health is put at risk.
        Proponents of this bill emphasize that H.R. 4167 does not impact
    State sanitation laws, and thus, will not impact State programs.
    Nothing could be further from the truth. States perform sanitation
    inspections in an effort to assist food businesses in preventing
    contamination or adulteration of products, but one of the States'
    critical complementary functions is to take action when these
    preventive measures fail. Whether food becomes contaminated by
    accident, intent, or act of nature, it is critical that States retain
    their authorities to contain and remove food from the marketplace.
    Because we believe that H.R. 4167 compromises these authorities, it is
    our belief that the impact of this legislation is huge. If enacted,
    H.R. 4167 would significantly impede resolution of the unsafe
    conditions and removal of contaminated foods from the human food
    supply. Sanitation and adulteration are not identical, but rather
    complementary, and if public health is to be protected, States must
    retain their authority to respond to contaminated (adulterated)
    products--without seeking Federal permission.
        Please take note that FDA has adopted few adulteration standards
    for microbial contamination. While some guidance has been issued in the
    form of Action Levels, adulteration is frequently determined on a case-
    by-case basis. With States' rulemaking authority in question under H.R.
    4167, States cannot take action unless they first confer with FDA and a
    determination is made, or unless the State concurrently petitions FDA.
    In 2001 alone, States took action in over 45,000 separate instances to
    embargo or remove adulterated foods from the market place. No
    additional resources have been provided to FDA to undertake such review
    of these petitions, and again--this is an issue that extends well
    beyond uniform labeling.
        A vote in support of H.R. 4167 puts at risk the health and
    wellbeing of all our citizens. While proponents argue that programs
    such as the cooperative milk and shellfish programs are not at risk,
    our attorney, along with 11 other State attorneys, read the bill quite
    differently. These are cooperative programs. The milk program, based on
    the Pasteurized Milk Ordinance (PMO), is written under the auspices of
    the Public Health Service Act. In order to participate in either
    program, a State must first demonstrate clear authority in adulterated
    foods--and this authority is lost under H.R. 4167. Under this bill, a
    State cannot have ANY law, not just a food law, which is not identical
    to the FFDCA.
        Please note the differences in language between this ``uniformity
    bill'' and Section 11 of S. 3, the ``National Biodefense Act of 2005'',
    which specifically states its intended uniformity applies to the
    labeling of drugs. AFDO does not oppose uniform food labeling; however,
    H.R. 4167 extends its reach well beyond this, and because of its
    ambiguity, it would be a disastrous step backwards in ensuring the
    safety of our Nation's food supply.
        Again, with so much at risk, I urge you to oppose this bill and to
    call for hearings to better delineate the impact and issues that are
    clouded by the broad, vague, sweeping language that comprises H.R.
    4167. AFDO representatives would appreciate and welcome an opportunity
    to discuss our concerns with you and your staff.
        Thank you in advance for your thoughtful consideration of our
    concerns. Should you or your staff have any questions, please do not
    hesitate to contact me at (850) 488-0295 or Mr. Cameron Smoak,
    Assistant Commissioner, GA Department of Agriculture at (404) 656-3627.
                Sincerely,
                                    Marion F. Aller, DVM, DABT,
                                                             President.

        [Whereupon, at 12:08 p.m., the hearing was adjourned.]