[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 
[email protected].
            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.]

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