[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]



 H.R.------, THE ``U.S. AGRICULTURAL SECTOR RELIEF ACT OF 2012,'' AND 
         H.R.------, THE ``ASTHMA INHALERS RELIEF ACT OF 2012''

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

                                HEARING

                               BEFORE THE

                    SUBCOMMITTEE ON ENERGY AND POWER

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED TWELFTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 18, 2012

                               __________

                           Serial No. 112-168


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]




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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

JOE BARTON, Texas                    HENRY A. WAXMAN, California
  Chairman Emeritus                    Ranking Member
CLIFF STEARNS, Florida               JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky                 Chairman Emeritus
JOHN SHIMKUS, Illinois               EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania        EDOLPHUS TOWNS, New York
MARY BONO MACK, California           FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon                  BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska                  ANNA G. ESHOO, California
MIKE ROGERS, Michigan                ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina   GENE GREEN, Texas
  Vice Chairman                      DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma              LOIS CAPPS, California
TIM MURPHY, Pennsylvania             MICHAEL F. DOYLE, Pennsylvania
MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California         TAMMY BALDWIN, Wisconsin
CHARLES F. BASS, New Hampshire       MIKE ROSS, Arkansas
PHIL GINGREY, Georgia                JIM MATHESON, Utah
STEVE SCALISE, Louisiana             G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio                JOHN BARROW, Georgia
CATHY McMORRIS RODGERS, Washington   DORIS O. MATSUI, California
GREGG HARPER, Mississippi            DONNA M. CHRISTENSEN, Virgin 
LEONARD LANCE, New Jersey            Islands
BILL CASSIDY, Louisiana              KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky              JOHN P. SARBANES, Maryland
PETE OLSON, Texas
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

                                 _____

                    Subcommittee on Energy and Power

                         ED WHITFIELD, Kentucky
                                 Chairman
JOHN SULLIVAN, Oklahoma              BOBBY L. RUSH, Illinois
  Vice Chairman                        Ranking Member
JOHN SHIMKUS, Illinois               KATHY CASTOR, Florida
GREG WALDEN, Oregon                  JOHN P. SARBANES, Maryland
LEE TERRY, Nebraska                  JOHN D. DINGELL, Michigan
MICHAEL C. BURGESS, Texas            EDWARD J. MARKEY, Massachusetts
BRIAN P. BILBRAY, California         ELIOT L. ENGEL, New York
STEVE SCALISE, Louisiana             GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington   LOIS CAPPS, California
PETE OLSON, Texas                    MICHAEL F. DOYLE, Pennsylvania
DAVID B. McKINLEY, West Virginia     CHARLES A. GONZALEZ, Texas
CORY GARDNER, Colorado               HENRY A. WAXMAN, California (ex 
MIKE POMPEO, Kansas                      officio)
H. MORGAN GRIFFITH, Virginia
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)

                                  (ii)








                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Ed Whitfield, a Representative in Congress from the 
  Commonwealth of Kentucky, opening statement....................     1
    Prepared statement...........................................     3
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     4
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     7
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, opening statement....................................     8
    Prepared statement...........................................    10
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................    11
Hon. Bobby L. Rush, a Representative in Congress from the State 
  of Illinois, opening statement.................................    15
Hon. Lois Capps, a Representative in Congress from the State of 
  California, opening statement..................................    15

                               Witnesses

Russ Costanza, Owner, Russell Costanza Farms.....................    19
    Prepared statement...........................................    22
Scott M. DiMare, Vice President and Director of Farm Operatons, 
  DiMare Ruskin, Inc.............................................    28
    Prepared statement...........................................    30
David D. Doniger, Policy Director, Climate and Clean Air Program, 
  Natural Resources Defense Council..............................    38
    Prepared statement...........................................    40
Michelle Castellano Keeler, Vice President, Mellano & Company....    59
    Prepared statement...........................................    61
Mark Murai, President, California Strawberry Commission..........    70
    Prepared statement...........................................    73
Jason Shandell, Vice President and General Counsel, Amphastar 
  Pharmaceuticals, Inc...........................................   152
    Prepared statement...........................................   155
Monica Kraft, Professor of Medicine, Duke University; President, 
  American Thoracic Society; and Director, Duke Asthma, Allergy 
  and Airway Center..............................................   162
    Prepared statement...........................................   165
Chris Ward, Former Chairman, Board of Directors, Asthma and 
  Allergy Foundation of America..................................   171
    Prepared statement...........................................   173
Edward W. Kerwin, Senior Medical Director, Allergy and Asthma 
  Center of Southern Oregon......................................   177
    Prepared statement...........................................   179

                           Submitted Material

Letter, dated February 29, 2012, from Mr. Burgess to President 
  Barack Obama, submitted by Mr. Burgess.........................     5
Letter, dated July 17, 2012, from Nancy Sander, President and 
  Founder, Allergy & Asthma Network Mothers of Asthmatics, to Mr. 
  Whitfield, submitted by Mr. Barton.............................    12
Letter, dated July 17, 2012, of Eric Larson, Executive Director, 
  San Diego County Farm Bureau, to Mr. Whitfield, submitted by 
  Mr. Bilbray....................................................    18
Article, dated 2012, ``Moving away from methyl bromide: Political 
  economy of pesticide transition for California strawberries 
  since 2004,'' Journal of Environmental Medicine, submitted by 
  Mr. Rush.......................................................   102
Letter, dated July 17, 2012, from Larry Jacobs, Farm Fuel Inc., 
  to Mr. Whitfield and Mr. Rush, submitted by Mr. Rush...........   111
Letter, undated, from Jim Cochran, President, Swanton Berry 
  Farms, to Mr. Whitfield and Mr. Rush, submitted by Mr. Rush....   113
Letter, dated July 14, 2012, from Albert S. Marulli, Agricultural 
  Trade Services, to Mr. Upton, submitted by Mr. Whitfield.......   116
Letter, dated July 17, 2012, from Kelly Covello, President, 
  Almond Hullers & Processors Association, to Mr. Upton, 
  submitted by Mr. Whitfield.....................................   117
Letter, dated July 12, 2012, from Bob Stallman, President, 
  American Farm Bureau Federation, to Mr. Upton, submitted by Mr. 
  Whitfield......................................................   120
Letter, dated July 12, 2012, from Albert P. Keck, Chairman, 
  California Dates Commission, to Mr. Upton, submitted by Mr. 
  Whitfield......................................................   121
Letter, dated July 16, 2012, from Carl Eidsath, Technical Support 
  Director, California Walnut Commission, to Mr. Upton, submitted 
  by Mr. Whitfield...............................................   123
Letter, dated July 16, 2012, from John L. Hoblick, President, 
  Florida Farm Bureau Federation, to Mr. Upton, submitted by Mr. 
  Whitfield......................................................   125
Letter, dated July 10, 2012, from Reginald L. Brown, Executive 
  Vice President, Florida Tomato Exchange, to Mr. Upton, 
  submitted by Mr. Whitfield.....................................   126
Letter, dated July 17, 2012, from Charles T. Hall, Jr., Executive 
  Director, Georgia Fruit & Vegetable Growers Association, to Mr. 
  Upton, submitted by Mr. Whitfield..............................   128
Letter, undated, from John C. Holzinger, Holzinger Flowers, Inc., 
  to Mr. Whitfield, submitted by Mr. Whitfield...................   129
Letter, dated July 16, 2012, from Robert Y. Harper, President, 
  Hopkinsville Milling Company, to Mr. Upton, submitted by Mr. 
  Whitfield......................................................   131
Letter, dated July 16, 2012, from C.B. Knappen III, President, 
  CEO, Knappen Milling Company, to Mr. Upton, submitted by Mr. 
  Whitfield......................................................   132
Letter, dated July 13, 2012, from Elizabeth Elwood Ponce, Co-
  Owner, Lassen Canyon Nursery, Inc., to Mr. Upton, submitted by 
  Mr. Whitfield..................................................   134
Letter, dated July 16, 2012, from Dennis Rochford, President, 
  Maritime Exchange for the Delaware River and Bay, to Mr. Upton, 
  submitted by Mr. Whitfield.....................................   140
Letter, undated, from Fred Leitz, Jr., None Better Fruits and 
  Vegetables, to Mr. Upton, submitted by Mr. Whitfield...........   141
Letter, dated July 17, 2012, from Arthur Loeffler, President, 
  Star of the West Mining Co., to Mr. Upton, submitted by Mr. 
  Whitfield......................................................   144
Letter, dated July 16, 2012, from Michael Wootton, Senior Vice 
  President, Sunkist, to Mr. Upton, submitted by Mr. Whitfield...   145
Letter, dated July 11, 2012, from Eric Nissen, Vice President, 
  Sunshine State Carnations, Inc., to Mr. Whitfield, submitted by 
  Mr. Whitfield..................................................   147
Letter, dated July 11, 2012, from Eric Nissen, Vice President, 
  Sunshine State Carnations, Inc., to Mr. Rush, submitted by Mr. 
  Whitfield......................................................   148
Letter, dated July 13, 2012, from Mike Miguel, Director of 
  Industrial and Environmental Process Applications, Sunsweet 
  Growers, Inc., to Mr. Upton, submitted by Mr. Whitfield........   149
Letter, dated July 13, 2012, from Miriam Borja-Fisher, Western 
  Industries, to Mr. Upton, submitted by Mr. Whitfield...........   151
Discussion Draft of HR --------, the ``U.S. Agricultural Sector 
  Relief Act of 2012,'' submitted by Mr. Whitfield...............   201
Discussion Draft of HR --------, the ``Asthma Inhalers Relief Act 
  of 2012,'' submitted by Mr. Whitfield..........................   209
Letter, dated October 28, 2011, from Nancy Sander, President and 
  Founder, Allergy & Asthma Network Mothers of Asthmatics, et 
  al., to Honorable Pat Roberts and Honorable Jim DeMint, U.S. 
  Senate, submitted by Mr. Rush..................................   213
Letter, dated November 28, 2011, from Mark Salyer, Executive Vice 
  President and General Manager, Teva Respiratory, to Lisa 
  Jackson, Administrator, Environmental Protection Agency, 
  submitted by Mr. Rush..........................................   217
Letter, dated December 12, 2011, from Dave Stirpe, Executive 
  Director, The Alliance for Responsible Atmospheric Policy, to 
  Margaret A. Hamburg, Commissioner, Food and Drug 
  Administration, submitted by Mr. Rush..........................   219
Letter, dated July 17, 2012, from Alpha-1 Association, et al., to 
  Mr. Whitfield and Mr. Rush, submitted by Mr. Rush..............   223
Statement, dated July 18, 2012, of Maureen Hardwick, Secretariat, 
  International Pharmaceutical Aerosol Consortium, submitted by 
  Mr. Rush.......................................................   225
Letter, dated November 17, 2011, from Bob Corcuera, Category 
  Manager-Health Care, Kinney Drugs, to Cynthia Giles, Assistant 
  Administrator, Office of Enforcement and Compliance Assurance, 
  Environmental Protection Agency, submitted by Mr. Whitfield....   229
Letter, dated November 22, 2011, from Kevin N. Nicholson, Vice 
  President, Government Affairs and Public Policy, National 
  Association of Chain Drug Stores, to Cynthia Giles, Assistant 
  Administrator, Office of Enforcement and Compliance Assurance, 
  Environmental Protection Agency, submitted by Mr. Whitfield....   231
Letter, dated December 8, 2011, from Ronna B. Hauser, Vice 
  President, Policy & Regulatory Affairs, National Community 
  Pharmacists Association, to Cynthia Giles, Assistant 
  Administrator, Office of Enforcement and Compliance Assurance, 
  Environmental Protection Agency, submitted by Mr. Whitfield....   233
Letter, dated December 30, 2011, from Cynthia Giles, Assistant 
  Administrator, Office of Enforcement and Compliance Assurance, 
  Environmental Protection Agency, to Bart Stupak, Attorney for 
  Amphastar and Armstrong Pharmaceuticals, Venable LLP, submitted 
  by Mr. Whitfield...............................................   236
Statement, dated July 18, 2012, of Regina McCarthy, Assistant 
  Administrator for the Office of Air and Radiation, 
  Environmental Protection Agency, submitted by Mr. Whitfield....   238

 
H.R.------, THE U.S. AGRICULTURAL SECTOR RELIEF ACT OF 2012, AND H.R.--
              ----, THE ASTHMA INHALERS RELIEF ACT OF 2012

                              ----------                              


                        WEDNESDAY, JULY 18, 2012

                  House of Representatives,
                  Subcommittee on Energy and Power,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:20 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. Ed 
Whitfield (chairman of the subcommittee) presiding.
    Members present: Representatives Whitfield, Shimkus, 
Walden, Terry, Burgess, Bilbray, Scalise, Olson, McKinley, 
Gardner, Griffith, Barton, Upton (ex officio), Rush, Sarbanes, 
Dingell, Engel, Green, Capps, and Waxman (ex officio).
    Staff present: Anita Bradley, Senior Policy Advisor to 
Chairman Emeritus; Allison Busbee, Legislative Clerk; Cory 
Hicks, Policy Coordinator, Energy and Power; Heidi King, Chief 
Economist; Ben Lieberman, Counsel, Energy and Power; Mary 
Neumayr, Senior Energy Counsel; Jeff Baran, Democratic Senior 
Counsel; Phil Barnett, Democratic Staff Director; and Caitlin 
Haberman, Democratic Policy Analyst.
    Mr. Whitfield. I would like to call this hearing to order 
this morning. This morning, we will be focused on two pieces of 
legislation: the U.S. Agricultural Sector Relief Act of 2012 
and the Asthma Inhalers Relief Act of 2012. Our friends on the 
other side of the aisle are not here yet. They have been 
delayed except for Mrs. Capps of California, so the way we will 
proceed is that I will give my 5-minute opening statement. 
Then, I will call on the chairman of the full committee, Mr. 
Upton, to give his 5 minutes. And by then, we believe Mr. 
Waxman will be here and then if Mr. Rush is not here, I think 
Mrs. Capps is going to give an opening statement. So you all 
have to listen to the Republicans for about 10 minutes first 
before we hear the other side.

  OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

    As I said, we are holding a legislative hearing on the U.S. 
Agricultural Sector Relief Act of 2012 and the Asthma Inhalers 
Relief Act of 2012. Both bills relate to Title VI of the Clean 
Air Act, specifically, the Montreal Protocol. This 
international environmental treaty seeks to phase out the use 
of ozone-depleting substances. One of the substances to be 
phased out is the fumigant methyl bromide. And basically, it 
has been phased out except for certain critical use exemptions.
    Now, this substance is used by many agricultural groups 
around the country, those who grow eggplant, flowers, peppers, 
strawberries, used in milling companies and so forth. And while 
many of these farmers have been able to switch to substitutes 
for certain purposes--for example, sulfuryl fluoride--we now 
discover that EPA wants to ban sulfuryl fluoride, the 
substitute. So we think that that does provide a problem.
    And I might also add that this methyl bromide is very 
important--I think I indicated this earlier--in milling 
operations. So it is also critical uses that the U.S. 
Agricultural Sector Relief Act sets out a process to allow 
limited but continued availability of methyl bromide. And we 
want to set that out clearly in the statute.
    I would also like to just say a brief word about the Asthma 
Inhalers Relief Act. This bill simply allows the CFC inhalers 
already manufactured before the ban to be sold or distributed 
providing a temporary supply for those asthmatics who would 
like the option to purchase this. So it is a limited amount. It 
has already been manufactured. It is just sitting on the 
shelves and there are many people out there who have requested 
the ability to continue to use this over-the-counter medicine 
for their asthma condition. So that is the purpose of this 
legislation.
    At this time I would like recognize the gentleman from 
Texas, Mr. Burgess, for 2 minutes and 35 seconds.
    [The prepared statement of Mr. Whitfield follows:]

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OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. I thank the chairman for the recognition.
    You know, this past January 1, a common over-the-counter 
emergency asthma inhaler was taken off the pharmacy shelves due 
to an international treaty agreement known as the Montreal 
Protocol. Now, asthma sufferers who find themselves awakened at 
2:00 a.m. with an unexpected attack and who don't have other 
medicines in the home don't have immediate access to an inhaler 
and they are forced to undergo a time-consuming and expensive 
emergency room visit, or worse yet, stay up the rest of the 
night using the accessory muscles of breathing, wondering if 
they are going to live through the experience.
    A replacement inhaler has been before the Food and Drug 
Administration's approval board for some time, but the FDA has 
taken no action to allow for another over-the-counter inhaler 
to be available for consumers. When the January 1, 2012, ban 
went into effect, people expected that its replacement would be 
available. They did not expect disruption to health services 
for asthma patients. But this is not the case. Because of the 
Food and Drug Administration's intransigence, asthmatics 
currently do not have an over-the-counter remedy when they have 
an unexpected attack, especially if that attack happens when 
they are traveling and they don't have access to their regular 
medicines.
    However, there is a fairly simple solution. The 
Environmental Protection Agency has within its authority to 
ability to waive the ban on the over-the-counter epinephrine 
meter-dosed inhaler to allow the existing stock to be sold, at 
least until a replacement can be approved. Yet, despite 
multiple letters to the EPA and in fact to the President of the 
United States and questions during committee hearings, the EPA 
remains unresponsive to the plight of millions of asthmatics.
    Why does EPA refuse to grant a waiver? I simply cannot tell 
you because they will not tell me. It is because of their 
refusal, EPA's refusal to account for the health and safety of 
asthma patients that we are in the predicament that we are in 
today. We have got a straightforward piece of legislation--
require the EPA to grant a waiver to allow for the sale of 
remaining stock, which otherwise would be wasted on the shelves 
of storage facilities where it sits, allowing perfectly good 
inhalers to sit unused when patients need them really cries out 
for remedy. The miniscule amount, I mean miniscule amount, of 
chlorofluorocarbons that exist in the over-the-counter inhalers 
will have a negligible effect on the hole in the ozone, 
especially considering the limited supply left.
    The Environmental Protection Agency should be on the side 
of patients and consumers. In this case, it is not. 
Administrator Lisa Jackson and President Obama need to stop 
this senseless war on asthmatics.
    And I will yield back my time.
    Oh, Mr. Chairman, I would ask for unanimous consent to 
provide for the record a copy of the letter I sent to the 
President of the United States on February 29 of this year 
asking for this waiver.
    [The information follows:]

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    Mr. Whitfield. At this time, I would recognize the 
gentleman from California, Mr. Waxman, for his 5-minute opening 
statement.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you, Mr. Chairman.
    In the 1970s, scientists warned that manmade chemicals were 
depleting the stratospheric ozone, which protects our planet 
from harmful ultraviolet rays from the sun. In response, 
governments around the world acted to address the threat. At 
first, we acted unilaterally taking steps such as banning CFCs 
from hairspray. Then, we entered into the Montreal Protocol to 
ensure that all the nations of the world were working together 
to solve the problem. The Montreal Protocol is widely 
recognized as a tremendously successful international 
environmental agreement. As a result of the protocol, global 
emissions of the gases are a small fraction of their 1990 
levels. And if we continue to comply with the protocol and 
enforce the Clean Air Act, the ozone layer is expected to 
recover later this century.
    But this progress cannot be taken for granted. Legislation 
like we are considering today would undermine the effectiveness 
of the Montreal Protocol. The first bill we are considering 
would increase the use of methyl bromide, a pesticide that is a 
powerful ozone-depleting chemical. Methyl bromide has been 
banned since 2005, but there is a mechanism in the law for 
critical use exemptions.
    Each year, growers apply for exemptions. EPA analyzes those 
applications with the help of USDA and the U.S. Government 
requests critical use exemptions under the Montreal Protocol. 
This process is working. Since 2005, the level of critical use 
exemptions requested by the United States and granted through 
the Montreal Protocol has decreased dramatically. That is 
exactly what is supposed to happen.
    California's strawberry growers are the largest remaining 
user of methyl bromide. They have been predicting for years 
that these reductions in methyl bromide would ruin their crops, 
but according to a recent study, ``the years of declining 
methyl bromide use have been years of rising yields, acreage, 
exports, revenues, and market share for California growers.''
    This bill reverses the progress that has been made on 
methyl bromide. Instead of requiring growers to justify 
continued use of methyl bromide, the bill reverses the 
presumption. It would require EPA to accept growers' requests 
unless EPA can prove they are unnecessary. The bill also 
freezes into law an outdated list of approved critical uses. As 
a result, sectors that have completely phased out the use of 
methyl bromide during the last 7 years would be permitted to 
use methyl bromide again. Incredibly, even golf courses would 
once again be allowed to seek critical use exemptions. And the 
bill creates a gaping emergency event loophole.
    I also have concerns about the Primatene Mist bill. 
Primatene Mist is an over-the-counter epinephrine inhaler from 
the 1960s. It was phased out at the end of 2011 and has been 
off the shelves for over 6 months. The bill would put Primatene 
Mist back on the shelves to its manufacturer could sell off its 
remaining inventory. A long list of physician, patient, public 
health, and industry groups strongly oppose the bill. Medical 
and public health organizations don't want Primatene Mist back 
on the market because they say it is not safe or recommend it 
for treating asthma. Physician groups are concerned that the 
bill will result in patient confusion and companies that made 
the necessary investments to develop CFC-free inhalers argue 
that the bill would unfairly provide special treatments to a 
single company.
    Mr. Chairman, we should be looking at these issues very 
carefully. We should be celebrating and strengthening the 
Montreal Protocol, not considering legislation to weaken it. 
And I hope we will reject the methyl bromide bill and rethink 
the Primatene Mist bill as well.
    In the last 30 seconds I just want to point out some 
history. I was here in 1977 when the first time the issue was 
raised. We were considering Clean Air Act amendments. One of my 
colleagues was able to dissuade the committee from doing 
anything on CFCs because he said it had not been proved beyond 
a reasonable doubt that CFCs were harmful, and therefore, 
Congress didn't act. We finally did act and we acted first and 
then went to complete and international agreement. It is 
exactly the kind of thing we ought to do with carbon emissions. 
We ought to be looking at that issue and dealing with it, not 
denying the science, which is where we are now today in the 
Congress of the United States.
    I thank the chairman for allowing me to exceed my time by 
22 seconds.
    Mr. Whitfield. Thank you.
    At this time, I recognize the chairman of the full 
committee, Mr. Upton, for 5 minutes.

   OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Upton. Well, thank you, Mr. Chairman.
    Over the last several decades, environmental quality has 
improved significantly, and our goal is to maintain that 
progress without imposing unnecessary burdens on our economy or 
the American people. And that is why we have consistently 
advocated for regulatory common sense and balance. And that is 
what we are going to talk about today--two sensible proposals, 
I believe, that ensure environmental rules do not impose 
unnecessary hardships.
    Congress examined and addressed ozone depletion through the 
1990 Clean Air Act amendments, which provide the framework of 
the U.S. participation in the Montreal Protocol treaty. As a 
result, the use of CFCs as refrigerants in air-conditioners and 
refrigerators has been sharply curtailed. And other ozone-
depleting substances have also been restricted.
    For the most part, the transition to the substitutes has 
gone well, but there are two exceptions that we hope to address 
through targeted legislation. One deals with the crop fumigant 
methyl bromide, which was widely used in agricultural 
applications until it was included on the list of ozone-
depleting compounds. For many crops and uses there are adequate 
substitutes, and as a result, methyl bromide use is down by 90 
percent. But for some crops, methyl bromide is still needed 
because viable alternatives are not yet available.
    And to address that issue, I am pleased that Michigan 
farmer Russ Costanza has joined us today. Russ grows peppers, 
eggplant, squash, tomatoes, cucumbers back on his farm in 
Sodus, Michigan, and he employs 125 folks. And we need to hear 
him out because his message is that of many farmers throughout 
the country who doubt whether they can remain in business 
without continued access to methyl bromide. The U.S. 
Agricultural Sector Relief Act would allow farmers like Russ to 
keep using methyl bromide on a limited basis.
    While one bill provides relief to farmers, the other 
provides relief to patients with asthma. The over-the-counter 
asthma inhalers containing CFCs, most commonly marketed as 
Primatene Mist, have been banned because they use very small 
amounts of CFCs as propellants. But no non-CFC over-the-counter 
inhalers are available at this time, leaving asthmatics without 
an over-the-counter option. The Asthma Inhalers Relief Act 
would allow for the remaining inventories of this inhaler, 
which were available in the U.S. for more than 40 years, to be 
temporarily sold or distributed without penalty.
    So on behalf of the American people, we are working to 
ensure reasonable environmental protections and we are doing so 
while avoiding unnecessary harm. The two bills at issue today 
satisfy those obligations.
    And I yield to the chairman emeritus, Mr. Barton, the 
balance of my time.
    [The prepared statement of Mr. Upton follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
   OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Barton. Thank you, Chairman Upton. And thank you, 
Chairman Whitfield and Mr. Rush, for holding this hearing. We 
may have already done it, but I would like to welcome back 
former Congressman Bart Stupak, who is in the audience and a 
distinguished former member of the committee. We are glad to 
have you, Bart.
    I support the U.S. Agricultural Sector Relief Act of 2012 
and I tend to support the Asthma Inhaler Relief Act of 2012 
also, although I have got some concerns about that piece of 
legislation.
    Methyl bromide is essential as an agricultural fumigant. 
There are some alternatives for agricultural uses, but methyl 
bromide is still needed for others where there doesn't appear 
to be a viable alternative. Under the Montreal Protocol, we 
have seen a considerable decrease in the critical use 
exemptions since 2005. This bill is important not only for 
American jobs but as a matter of national security as well.
    In terms of the Asthma Inhaler Relief Act, Dr. Burgess has 
got a well intended piece of legislation. I am going to put 
into the record, Mr. Chairman, by unanimous consent, a letter 
from the Allergy and Asthma Caucus and the Mothers of 
Asthmatics. Their president and founding member is in the 
audience today, Nancy Sander, and we are glad to have you, too, 
Nancy, here.
    Their group has got very legitimate concerns about Dr. 
Burgess' bill, and I have worked with them and put them in 
touch with Dr. Burgess to try to alleviate some of those 
concerns. I think it is important that Americans have an over-
the-counter alternative to a prescription inhaler. And that is 
basically what Dr. Burgess's bill intends to do. The letter 
that I will ask unanimous consent to put in the record at the 
end of my statement, Mr. Chairman, does say that there is an 
alternative. There is a handheld bulb nebulizer that is 
available over-the-counter, and that is one reason I have some 
concerns about Dr. Burgess' bill.
    With that, I would ask unanimous consent to put a letter 
dated July 17, 2012, from the Allergy and Asthma Network 
Mothers of Asthmatics, into the record and then yield back the 
balance of my time.
    Mr. Whitfield. Without objection, it will be entered.
    [The information follows:]

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    Mr. Whitfield. At this time, I would like to recognize the 
gentleman from Illinois, ranking member of the subcommittee, 
Mr. Rush, for a 5-minute opening statement.

 OPENING STATEMENT OF HON. BOBBY L. RUSH, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    Mr. Rush. Well, thank you, Mr. Chairman.
    Mr. Chairman, in keeping in line with the majority party's 
overall agenda of bypassing, overriding, and curtailing the 
Clean Air Act, as well as any and all regulations that may 
hamper industry profits regardless of the health or 
environmental benefits that those rules were designed to 
protect, we are here yet again holding this hearing on the 
Agricultural Sector Relief Act and the Asthma Inhalers Relief 
Act of 2012.
    My Republican colleagues, Mr. Chairman, continue to ignore 
the fact that the U.S. has set more than 40,000 high 
temperature records this year and that the last 12 months have 
been the hottest ever recorded in U.S. history. And the fact 
that more than 113 million Americans are living under extreme 
health advisories, while the USDA has declared a Federal 
disaster area in more than 1,000 countries covering 26 States 
also does not seem to concern the majority party.
    Mr. Chairman, while the country literally burns around us, 
I can't believe that we are here today holding yet another 
hearing on two issues of far less importance to most Americans 
other than a few industry lobbyists.
    Today, fully 2/3 of the country is experiencing extreme 
drought and 30 percent of the Nation's corn crop is in poor or 
very poor condition. While at the same time, water levels of 
four of the five Great Lakes have plummeted due to high 
evaporation rates and insufficient rainfall. We are still here 
having hearings on two not very important bills to the majority 
of the American people.
    Mr. Chairman, I ask this committee to not to deal with 
these two bills but to deal with a different kind of drought, 
the drought of laws that come from the inaction of this 
subcommittee. While even all the heat-related and fire-related 
and the atrocities that are occurring to farmers of our Nation, 
to the consumers of our Nation, the two bills before us would 
only serve the interests of select industries by rolling back 
gain we have made under the Montreal Protocol.
    The Montreal Protocol is widely recognized as a 
tremendously successful international environmental agreement, 
and in 2009 became the first of its kind to achieve universal 
ratification by every country in the world. Mr. Chairman, let 
us get on to some real business.
    And with that, I yield a minute, the balance of my time, to 
Mrs. Capps of California.

   OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mrs. Capps. I thank my colleague for yielding to me. And I 
want to focus a few comments on the methyl bromide bill, a very 
important issue to my constituents.
    I represent some of the very best strawberry and cut flower 
growers in the country, and just a couple of weeks ago, I was 
invited by the Strawberry Commission of California to meet with 
them in Santa Maria to discuss this exact issue. We met in the 
midst of the strawberry fields. While I have seen firsthand the 
tremendous progress in finding alternatives to methyl bromide, 
I have also seen firsthand why methyl bromide is still a 
necessity to many if not most strawberry growers.
    I am proud to say that many of the flower farmers in my 
district like June and Rene Van Wingerden of Ocean Breeze Farms 
and Lane Devries of Sun Valley Floral no longer use methyl 
bromide because they have pioneered innovative new methods that 
are effective. But let us be clear. These alternatives don't 
work for everyone and they don't work in every situation. And 
the cost of the disease our growers face are very real, very 
threatening. During my recent visit, I saw firsthand the 
impacts of charcoal rot in some fields in Santa Maria, as well 
as other diseases. They can literally shut down an operation 
hurting not only the growers but also their workers and the 
local economy.
    I must add that agriculture is a growing force of my 
congressional district, strawberries are the number one crop, 
and these local economies stretch far and wide in central and 
southern California, including the local economies of my 
colleague, Mr. Bilbray, I know.
    So it is very important that this issue be addressed but I 
am, I must say, Mr. Chairman, disappointed that we are going to 
be back here in just a very few hours to mark up this 
legislation without hearing from the administration or really 
adequate time to fully consider the testimony of our witnesses. 
I am pleased to say that one is from the Strawberry Commission 
in California. It is a very important issue that should not be 
rushed through the legislative process.
    That being said, I do look forward to hearing the witness 
testimony and working toward a solution on this matter. And I 
yield back. Thank you, Mr. Rush.
    Mr. Whitfield. Thank you, Mrs. Capps.
    And I will say that while we did invite EPA to testify, 
they were unable to be here, but they have submitted a pretty 
detailed statement for the record relating to these two bills. 
And this will be part of the record, so thank you.
    We have two panels of witnesses this morning and I would 
like at this time to call up the first panel of witnesses. And 
on that panel we have five people. First, we have Mr. Russell 
Costanza, who is the owner of Russell Costanza Farms. Number 
two, we have Mr. Scott DiMare, who is vice president and 
director of farm operations, DiMare Ruskin, Inc. We have Mr. 
David Doniger, who is no stranger to our committee, and he is 
the policy director of Climate & Clean Air Program at the 
Natural Resources Defense Council. And I would like to call on 
Mr. Bilbray to introduce our next witness, please.
    Mr. Bilbray. Thank you, Mr. Chairman.
    Chairman Whitfield, thank you for holding this hearing on 
this very important issue, especially to certain segments of 
our society and economy.
    Methyl bromide is a critical application, as my colleague 
from California said, in certain situations, limited but 
critical in those limited. And I wish to ask for unanimous 
consent to enter into the record a letter supporting the U.S. 
Agricultural Sector Relief Act.
    Mr. Whitfield. Without objection.
    [The information follows:]

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    Mr. Bilbray. It is my honor to introduce Michelle Keeler. 
She is one of our panelists today. Ms. Keeler, I apologize for 
the un-San Diego weather that you have to endure at this time. 
I hope you understand what a sacrifice those of us in 
California who serve in Congress do every day, OK, at least 
during the summer.
    Mr. Chairman, Ms. Keeler is vice president of Mellano & 
Company. It is a prestigious family-owned business that 
specializes in cut flower growing in the sunny San Diego/
Carlsbad area and right along the coast. As you are driving up 
Highway 5, you can see the hillsides filled with her products 
and the beauty that has been appreciated by the community.
    The company prides itself in progressive ideas of cut 
flowers. Many of them have been developed as an industry-wide 
standard as improved logistics in growing techniques. These 
achievements have utilized pre-cooling allowing flowers to be 
shipped with optimum freshness.
    Mr. Chairman, let me point out that when Mrs. Keeler 
speaks, she is not just speaking about her endeavor to keep a 
family business alive, to keep American jobs in America, but as 
a former California Coastal Commissioner, I want to remind 
everybody, too, that the California Coastal Commission has 
determined that Mrs. Keeler's operation is a cultural heritage 
that needs to be preserved. It is actually mandated in the 
Coastal Act's enforcement that she keep her production of 
flowers in this area.
    And Ms. Keeler, I want to welcome you to California and 
welcome your ability to enlighten those of us in Washington of 
the challenges you face on the West Coast.
    Mr. Whitfield. Thank you. And welcome, Ms. Keeler.
    And the final witness in the first panel will be Mr. Mark 
Murai, who is the president of the California Strawberry 
Commission. And we appreciate your being here.
    I will be calling on each one of you to give a 5-minute 
opening statement and on the table there are a couple of little 
small boxes that have colors red, yellow, and green. And when 
you get to red, we hope you will be finished, but if not, we 
will let you go over for a brief period of time.
    So Mr. Costanza, we will recognize you first and you are 
recognized for 5 minutes to give an opening statement. And make 
sure your microphone is turned on as well. Thank you.

  STATEMENTS OF RUSS COSTANZA, OWNER, RUSSELL COSTANZA FARMS; 
     SCOTT M. DIMARE, VICE PRESIDENT AND DIRECTOR OF FARM 
   OPERATIONS, DIMARE RUSKIN, INC.; DAVID D. DONIGER, POLICY 
  DIRECTOR, CLIMATE AND CLEAN AIR PROGRAM, NATURAL RESOURCES 
 DEFENSE COUNCIL; MICHELLE CASTELLANO KEELER, VICE PRESIDENT, 
   MELLANO & COMPANY; AND MARK MURAI, PRESIDENT, CALIFORNIA 
                     STRAWBERRY COMMISSION

                   STATEMENT OF RUSS COSTANZA

    Mr. Costanza. Well, thank you. And thank you for the 
warning because it takes me about 6-1/2 minutes to read this 
and I am going to skip over some of this keeping this in mind. 
OK.
    First of all, I want to thank each and every one of the 
members for allowing me this opportunity to speak before you 
today and represent my farm, my workers in the State of 
Michigan.
    My name is Russ Costanza. I grew up on our family farm. I 
am the owner of Russell Costanza Farms. My wife and I 
established our farm in 1976 with 10 acres. Today, we have 
grown that farm with our two kids and their families to over 
500 acres of peppers, eggplant, squash, tomatoes, and 
cucumbers. Our farm is labor-intensive. Over the years, we have 
grown from my wife and I doing all the work on the farm to 125 
farm workers. Sadly, the inability to use methyl bromide and 
the lack of a truly viable alternative is threatening our 
family and our remaining workers' livelihood.
    Mr. Whitfield. Would you mind just moving the microphone a 
little closer?
    Mr. Costanza. I am usually a little loud anyway.
    Methyl bromide is a fumigant that controls insects, 
nematodes, pathogens, and weeds, and we use the fumigant on our 
farm to treat the soil prior to planting. Fumigation with 
methyl bromide allows us to grow a higher quality crop with 
increased yields and provides more onetime effective pest 
control than any other alternative product.
    Methyl bromide has allowed us to treat our fields and 
cultivate abundant, high quality, high demand produce. This 
year, however, we were not granted any critical use exemptions 
for methyl bromide. Without any CUEs, the only way to use 
methyl bromide is to purchase dwindling stocks of the chemical 
that were produced prior to 2005. Such stocks are not readily 
available and are cost prohibitive. I currently have enough 
methyl bromide to last through one or perhaps two growing 
seasons for eggplant only, but after that, I do not know how I 
will be able to continue to produce adequate crops.
    I used to be able to purchase methyl bromide for about $1 a 
pound. Today, the cost averages $9 a pound. It costs over $800 
an acre to use methyl bromide. Between the scarcity and high 
cost, it is impossible to compete with inexpensive, quality 
produce from other countries whose growers are able to legally 
use methyl bromide. Further, the quality of our produce will 
deteriorate due to the lack of methyl bromide use, further 
eroding our ability to compete with foreign growers in our own 
markets.
    While we have a limited supply of methyl bromide available 
for eggplant, we cannot use methyl bromide for our other crops. 
Due to the loss of quality and yields associated with these 
crops, we have experienced decreased profits for our remaining 
workers and our farm. Our dwindling profits also mean a loss of 
tax revenue for local, State, and Federal governments.
    Our family and our workers pride ourselves on providing 
high quality and affordable food to U.S. consumers and to 
making a meaningful contribution to our country's economy. 
Unfortunately, our ability to do this is diminishing due to the 
lack of methyl bromide and an effective, affordable 
alternative.
    Our farm has spent a great deal of money and effort seeking 
viable alternatives to methyl bromide. In 2005, staff from the 
EPA Chicago office was invited to tour our farm. They came, 
observed our operation, how we worked, and how methyl bromide 
was used. We demonstrated how methyl bromide increased our 
yield of our eggplant and pepper crops. These increased yields 
and lack of effective alternatives were documented through the 
research conducted on our farm with Michigan State University 
on all methyl bromide alternatives. We donated the land, the 
manpower, and the resources to research the efficiency of 
alternatives on eggplant. Sadly, we did not find any 
affordable, usable replacement.
    Due to the weather in Michigan, we have a narrow window of 
time before planting in which we can apply a fumigant. We 
cannot wait an additional 2 or 3 weeks to reenter the field 
prior to planting, as was required by iodomethane, Midas, and 
some other alternatives, or we would lose our market window. 
Further, Midas is no longer being sold in the United States.
    For my Michigan operation, methyl bromide is truly the only 
treatment option available. And then we will go on with a study 
from Michigan State University. Our circumstances are dire, 
which I am very appreciative of the committee. I and other 
Michigan growers are facing an emergency situation on our 
farms, and for that reason, I am grateful that the legislation 
includes the provisions related to the emergency use of methyl 
bromide under certain circumstances.
    The law must allow for flexibility when a planned, 
affordable alternative is no longer an option or another 
unanticipated event occurs. While I understand that EPA is the 
lead organization in making CUE recommendations to the parties, 
I appreciate that the legislation includes consultation with 
the U.S. Department of Agriculture. Because of its close 
working relationship with growers, the USDA and extension 
agents are best equipped to determine when an emergency 
situation exists. The Department's role in this process is 
critical.
    I cannot overstate the importance of access to methyl 
bromide for my farm operation and my fellow Michigan growers. 
We are facing a crisis and need relief. I am hopeful that 
Congress will pass the Act of 2012 and the EPA and USDA will 
quickly implement a process to allow for limited emergency 
exemptions when circumstances exist.
    Thank you very much for your leadership in addressing this 
critical issue for myself and other Michigan growers.
    [The prepared statement of Mr. Costanza follows:]

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    Mr. Whitfield. Well, thank you, Mr. Costanza.
    And Mr. DiMare, you are recognized for 5 minutes.

                  STATEMENT OF SCOTT M. DIMARE

    Mr. DiMare. Thank you, Mr. Chairman.
    Mr. Whitfield. Be sure and turn your microphone on and move 
it up close.
    Mr. DiMare. Thank you, Mr. Chairman. Ranking Member, the 
rest of the committee, I want to thank you for having me here 
today. My name is Scott DiMare. I am a director of farm 
operations for a family business that is over 80 years old. I 
am a third-generation farmer. We are based in Ruskin, Florida. 
We farm tomatoes. I employ about five to six hundred people. 
And we are here to talk about methyl bromide for emergency use.
    With rising costs, we have a cost of about $2,500 to $3,000 
an acre to lay our plastic mulch and do our fumigation process 
before we ever put a plant in the ground. Methyl bromide is the 
foundation for our operation. It allows for uniformity and 
consistency, which is key in our industry. It kills soil-borne 
diseases, pests, and weeds. The idea is to sterilize the ground 
before you plant it. We used to call methyl bromide idiot-
proof. And basically, it is not a reckless term; it is how we 
view under all conditions--and the key being all conditions, 
OK, because the rest of the alternatives that we will talk 
about are very sensitive to soil, moisture, temperature, and so 
forth, whereas methyl bromide worked uniformly across the board 
under all conditions.
    Furthermore, with the tools that we have available today, I 
feel pretty confident that we have reduced any if not all 
emissions. And among those tools we use are a Raven computer, 
which is on the tractor, which precisely turned on and off the 
system, allows for no leakage. We are also using the VIF or 
high barrier films, which reduce the emissions down to 
virtually nothing.
    And let us just talk about the alternatives for a minute. 
We have made numerous capital investments over the years. We 
have known the phase-out was coming. For many years, we have 
tried to be ahead of the curve by being proactive in trying the 
number of different alternatives that are available. As Mr. 
Costanza mentioned earlier, one of the tools that we had has 
been taken away--Midas--which I felt was one of the most 
comparable or efficacious products out there but still had its 
limitations.
    But be that as it may, we have the alternatives that are 
there, and among them, we cannot use them in certain areas 
because of groundwater issues. In the other areas we can use 
them, we still have many unresolved issues and most of them are 
attributed to weather. Soil conditions, soil temperature mainly 
being wet or cold, does not allow for the dispersion of the 
product, which again brings us to the point where we have an 
unpredictable situation. As a farmer, we can control only so 
many things. And what we do before we lay our plastic mulch is 
crucial. And once we do that, we are at the hands of Mother 
Nature. And we can't control the weather. In Florida we live in 
a subtropical climate. With these alternatives, the plant-back 
periods are up to 2 months that I have to have this plastic 
sitting out there with nothing being grown because of the fact 
that it is damaging to the crop because we don't know what the 
result is going to be, whereas methyl bromide in the past we 
had a maximum of a 2-week leeway time. That is a huge risk that 
we have created.
    OK, we have got, as I told you, $3,000 in the ground before 
we ever put a plant in the ground. You got leeching of 
fertilizer, you got more weed control issues, herbicides, 
weeding by hand, which is very labor-intensive for that extra 
month-and-a-half period. We got tropic storms. We have laid 
hundreds of acres before and been wiped out by storms. The 
longer time you have between your planting periods, the more 
risk you have, the higher your cost is going to be. And with 
methyl bromide we didn't have that.
    I guess, you know, when all is said and done, you know, 
this comes down to a need of a product that we I feel need, 
must have, in order to clean up some of these situations that 
we have. Since the phase-out of methyl bromide, we have an 
increasing incidence of soil-borne diseases. You can see it 
getting worse every year behind methyl bromide and it is going 
to continue to get worse. We have, you know, Fusarium, Fusarium 
crown rot, southern blight, which we never had. Fusarium I have 
in fields this year that I have never had before ever. Weeds, 
nutsedge is getting out of control and, you know, again these 
are things that we never had issues with when we had methyl 
bromide.
    I just again appeal to you to use some good foresight and--
it is a tool that we need. Thank you.
    [The prepared statement of Mr. DiMare follows:]

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    Mr. Whitfield. Thank you very much.
    And Mr. Doniger, you are recognized for a 5-minute opening 
statement.

                 STATEMENT OF DAVID D. DONIGER

    Mr. Doniger. Thank you very much, Mr. Chairman and Mr. 
Rush.
    Protecting the ozone layer is a huge bipartisan public 
health success story. The treaty was signed under Ronald Reagan 
and it has had the support of four Presidents since then. The 
phase-out of ozone-destroying chemicals, including methyl 
bromide, is saving literally millions of Americans and tens of 
millions of people around the world from death and disease, 
from skin cancer, cataracts, and immune diseases. And it is 
also savings farmers billions of dollars in avoided ultraviolet 
light, ultraviolet radiation crop damage.
    Now isn't the time to tamper with the Protocol or the Clean 
Air Act. I won't mince words. By slowing or actually reversing 
the transition from methyl bromide, this bill will lead to more 
skin cancers, more cataracts, more immunological disease. It 
will benefit a number of growers who have profited by abusing 
the critical use exemption for more than a decade. Some of the 
people now seeking relief now haven't even asked for critical 
use exemptions for years. Thousands of other farmers growing 
other crops will suffer more crop losses as a result.
    Now, the treaty and the Clean Air Act already allow for 
well supported exemptions and no one is suggesting that the 
pursuit of exemptions under existing law isn't possible. This 
has been done for 7 years and well supported exemptions have 
been forwarded by the U.S. and granted by the parties. But this 
industry has dragged its feet on replacing this dangerous 
compound. No other industry has had more time or more leeway to 
transition away from dangerous ozone-destroying chemicals.
    The U.S. is responsible for more than 90 percent of all 
methyl bromide exemptions. Every other strawberry- and tomato-
growing country with California-like growing conditions or 
Florida-like growing conditions--including Italy, Spain, 
Greece, and Australia--has ended use of methyl bromide. There 
is a lot of concern expressed over the years about competition 
from Mexico. Mexican growers use less methyl bromide per acre 
than their California counterparts, and Mexico will end the use 
of methyl bromide entirely this year.
    California strawberry growers have done very well during 
this whole experience. Strawberry acreage is up despite ground 
rules that countries would not use methyl bromide on expanded 
acreage. Yields are up, grower prices are up, crop values are 
up.
    U.S. critical use exemptions have been coming down. 
California strawberries are now the only field use for which 
the U.S. still seeks exemptions. And there are several other 
structural and commodity uses. Together they amount to about a 
little more than 400 tons. That is significantly down from 
10,000 tons 7 years ago. And as I said, there is an opportunity 
to keep asking for well supported exemptions. There is also a 
stockpile of 1,200 tons, three times the requests now being 
made.
    This bill would do reckless damage in three ways. First, it 
would permanently define as critical uses all of the uses that 
were deemed critical in 2005 even though the vast majority of 
those uses don't use methyl bromide anymore. Why would we make 
golf course turf grass a critical use again? It makes no sense 
to freeze into law the utterly out-of-date list from 2005.
    Second, the bill relieves the applicants of the need to 
show why they need exemptions. Doesn't it make sense that if 
you are asking for an exemption for a banned product, you 
should explain why and you should produce the data that shows 
that you need it? Some people do that and some people make the 
case. Some people's case is convincing and the U.S. makes the 
application and the other parties agree to it. Other people 
don't even ask. Some people make exemption requests that can't 
even get past first base.
    So EPA under this bill would bear the burden of saying why 
any wish list shouldn't be forwarded to the parties. And this 
is actually going to backfire for the applicants because it 
actually helps the U.S. to win approval for the exemptions to 
show that it has exercised judgment and discipline in framing 
its requests and hasn't mechanically asked for everything that 
domestic applicants may have wanted.
    Lastly, the bill would blast an enormous loophole into the 
Clean Air Act and our pesticide safety laws by allowing any 
individual user to write his own ticket for up to 20 tons of 
methyl bromide per farm simply by asserting the existence of an 
``emergency.'' There could be hundreds of emergency exemptions 
per year, totaling up to 2,000 tons, the 2011 critical use 
amount.
    The testimony today illustrates the abuse that this 
emergency exemption would provide where some witnesses are 
saying, well, we just needed to go in and ``clean up'' problems 
for which we didn't get critical use exemptions. So it is just 
an alternate route to write your own critical use exemption.
    This is a bad bill. It is an unneeded bill. It would harm 
public health, harm other farmers, and indeed it would even 
harm the farmers it is intended to help because it would make 
it even more difficult to get critical use exemptions through 
the current process. The current process is working and this 
committee should leave well enough alone. Thank you.
    [The prepared statement of Mr. Doniger follows:]

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    Mr. Whitfield. Thank you, Mr. Doniger.
    At this time, Ms. Keeler, you are recognized for a 5-minute 
opening statement.

            STATEMENT OF MICHELLE CASTELLANO KEELER

    Ms. Keeler. Thank you.
    As Congressman Bilbray stated, my family grows cut flowers 
in the San Diego area of California where we employ over 200 
employees. We farm approximately 400 acres at any given time, 
have over 50 varieties of flowers growing on our farm. Unlike 
other farms, you have to picture our farm sort of like a 
patchwork quilt because we just don't have one product; we have 
several products. So you might have 2 acres of tulips next to 
10 acres of lilies next to 20 acres of myrtle, so there is all 
kinds of things taking place. And each of those squares is 
constantly changing in terms of the crops, cultivating times, 
diseases, pests, irrigation needs, and the market demands.
    We are very concerned by EPA's arbitrary cuts of our 
allocations with no real burden of evidence showing a feasible 
or technical alternative exists for certain crops. We are also 
concerned about situations that are emerging on our farms 
requiring emergency cleanup applications of methyl bromide.
    As a grower, we have a limited number of tools in our 
toolbox, and when you take a tool away from us, it puts 
pressure on the remaining tools. And when you leave us with 
only weak tools, we become as weak as the tools are. As soon as 
these tools become useless, we have to walk away, and sadly, 
many growers are starting to walk away from growing their 
crops.
    Please understand, we are using alternatives whenever 
possible, and in some instances, they work for a short time. 
But then issues start to pop up. A good example is nut grass. 
We have been using alternatives such as Telone, chloropicrin, 
and Vapam, and while they did a decent job for a little while 
of knocking down the nut grass, it never eliminated it and 
after a few years these popped back up and take over our crop. 
We then find ourselves applying excessive amounts of these so-
called alternatives. So not only are we compounding the use of 
alternative chemicals, we are also finding now later on that 
there is a detrimental effect to our crops, which forces us to 
prematurely disk under our flowers and we are disking under our 
investment as well. A periodic application of methyl bromide is 
more effective and we believe it is safer.
    We also have difficulty in the cut flower industry because 
we can't fit our growing practices into one neat formula due to 
this ever-changing patchwork quilt that I described earlier. In 
these squares we have perennials, annuals, bulb crops, seed 
crops, and shrubs. Our crops at Mellano & Company can have a 
planting value of $60,000 an acre, and some of these perennial 
crops will be in the ground from anywhere from 5 to 25 years. 
We can't afford to put plants like this that are this expensive 
into dirty soil. We also can't predict when in that 5 to 25 
years we will be replanting this crop based on issues that pop 
up. So periodic applications--it is difficult for us to fit 
into an application process because it is not every year. It 
might be in 5 years; it might be in 8 years.
    The cut flower industry has converted many, many crops over 
to alternatives, but in a few instances, alternatives do not 
exist. This year, the cut flower industry submitted a similar 
application to EPA as in the previous few years. However, EPA 
determined we had no need and submitted nothing to the 
international body. We understand EPA assumed methyl iodide 
would be a drop-in replacement for our entire industry despite 
the fact that we provided scientific information showing that 
methyl iodide was not useful to California growers. We can't 
afford for EPA to make assumptions in our dynamic industry 
about our growing practices without understanding our industry 
first. Not only is methyl iodide not a replacement in 
California, the manufacturer withdrew sales of that compound in 
the U.S., so now, what does our industry do?
    The United States agricultural community has complied with 
the CUE requirements where no alternatives exist, despite the 
fact that this process is cumbersome, time-consuming, and 
costly. We are willing to do so because in a few instances, we 
still need this strong tool in our toolbox, yet our 
applications continue to be arbitrarily reduced without any or 
inadequate scientific explanation. So now we are left with weak 
tools or with nothing at all.
    I personally cannot understand why EPA can so easily make 
these cuts. Every miniscule cut that they make means so much to 
our survival and so little in the grand scheme to the other 
parties. Why is our government hurting us? And we are being 
hurt. In the floral industry, many growers, including my 
family, is cutting back on our crop mix to a very limited 
number of varieties to ensure that we have access to the proper 
growing tools. This means fewer varieties available and 
certainly nothing new in the marketplace. Thus, other 
developing countries are taking on these varieties and 
providing them to the consumer, which begins the decline of our 
business.
    People are in pain. Our family farm is in pain. And it is 
something that Congress can do something about. Please reaffirm 
the CUE process beyond 2014, ensure that EPA protects its 
American growers with scientifically sound reasoning, and make 
available the tools we need to grow our crop, especially in 
emergency rescue and cleanup situations. Thank you.
    [The prepared statement of Ms. Keeler follows:]

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    Mr. Whitfield. Thank you, Ms. Keeler.
    And Mr. Murai, you are recognized for 5 minutes.

                    STATEMENT OF MARK MURAI

    Mr. Murai. Good morning, Mr. Chairman. Chairman Whitfield, 
Ranking Member Rush, and members, thank you for holding a 
hearing on this very important issue. My name is Mark Murai and 
I am a third-generation strawberry farmer and president of the 
California Strawberry Commission, representing all of 
California's strawberry growers, shippers, and processors.
    Farmers lead the way in the world to find alternatives. The 
United States has eliminated over 90 percent of ozone-depleting 
products and the ozone layer is healing faster than predicted. 
As we all know, legacy fluorocarbons, CFCs, from a variety of 
consumer products such as plastics, foam, solvents, and fire 
extinguishers----
    Mr. Whitfield. Sorry. You can continue.
    Mr. Murai [continuing]. Are the largest impact on the ozone 
layer. Because these legacy fluorocarbons have a long life, the 
scientists forecast it will be another 39 years before the 
ozone layer is fully restored. But methyl bromide can also 
impact the ozone layer, and I am proud to say the strawberry 
farmers have taken this seriously. We have innovative new 
farming techniques such as drip fumigation and employed new 
technologies such as emission reduction measures to reduce our 
methyl bromide imprint.
    California strawberry farmers are also leaders in organic 
production methods. These farmers grow more organic 
strawberries than all other 49 States combined. In fact, nearly 
1 out of 5 California strawberry farmers grows both organic and 
conventional.
    By combining all of these approaches, California strawberry 
farmers transition to non-methyl bromide alternatives faster 
than any other strawberry farmers in the world. And 
unfortunately, we have learned that there are still some 
diseases that can only be treated by methyl bromide.
    In the late '90s, I made the decision to phase down my 
farm's use in methyl bromide ahead of the official 2005 
deadline. I was past chairman of our Research Committee and an 
officer of the Commission, so I believed my family's farm 
should demonstrate that using alternatives were feasible. I was 
confident; I was cavalier. The first year, the yields looked 
comparable. The second year, my new plants didn't look so good, 
a little peaked. And by the third year, my field was dying 
before I picked my first berries. Calling your banker is a 
difficult call to make having to explain your field is dying, 
and notwithstanding a miracle, I would not be able to pay back 
my crop loan that year. And by the way, I need to borrow more 
money for next year's planting in a few months. That is a tough 
call to make.
    But the worst part was telling my family that we are deep 
in the hole and our soil is now contaminated with disease. That 
is a tough thing for a farmer to swallow. So farmers need clean 
soil.
    As you can see in my written testimony, I am not alone in 
my experience. After multiple years of repeated use of 
alternatives, we learned that alternatives do not work on all 
the soil-borne diseases. In 2008, we saw the emergence of new 
diseases that resulted in widespread crop failure.
    The CUE process needs to be improved. In 2011, a new 
fumigant called methyl iodide was approved for use in 
California. Everyone thought the fumigant would be an effective 
treatment for these tough soil-borne diseases. EPA immediately 
rushed to try and force farmers to use methyl iodide. EPA 
stated, ``our 2013 critical use nomination assumes an 
aggressive transition rate to methyl iodide of 7 percent per 
year between now and 2013 and resulting in a reduction of 21 
percent.'' When I heard this, I could hardly believe my ears. 
Doesn't EPA know about the community concerns in California? We 
specifically made a trip to EPA to show news clips and 
newspaper articles to give them a flavor of what we were going 
through back in California and how our communities and State 
and legislators were in an uproar around this compound. There 
was an obvious disconnect between DC and our farming 
communities. And we believed at best our transition, if this 
product was registered, would be at a rate of maybe 1 to 2 
percent and that was aggressive.
    Well, 4 months ago, the manufacturer decided that this 
controversy was too big and they cancelled methyl iodide in 
California. We immediately advised EPA and asked that they 
restore the 21 percent but they did not take any action to 
request a supplemental CUE for 2013. I wanted to believe our 
government would work to ensure that our critical needs were 
met within the rules of the treaty, but this has not happened. 
At every turn, there is always another arbitrary reason our 
application should be cut. This is just not right. Our farmers 
have followed all the rules, but now EPA doesn't want to follow 
the rules. They should substantiate their new reasons with data 
standards that we are held to. I should be able to go back and 
tell our growers that the system is fair, the interpretations 
are correct, and we should all just live with it, but I can't.
    The new science report on methyl bromide CUEs, perhaps what 
is most frustrating is that nobody seems to be following the 
science. Scientists have always described methyl bromide as 
quickly dissipating in about 1 year and having a relatively 
smaller impact compared to other ozone-depleting products. The 
newest scientific assessment by NOAA, NASA, UNEF, WMO, and the 
EU concludes the ozone layer is improving faster than predicted 
due to legacy products that were required by 39 years to fully 
restore the ozone layer and continued use of methyl bromide 
will add less than 73 days to the 39 years. More specifically, 
the report stated, ``the scientific assessment of ozone 
depletion 2010 is the product of 312 scientists from 39 
countries of the developed and developing world who have 
contributed to its preparation and review, 191 scientists 
prepared the report, and 196 scientists participated in the 
peer-review process''--196. They said methyl bromide 
``continuing critical use exemptions at the approved 2011 level 
indefinitely would delay the return of the equivalent effective 
stratospheric chlorine 1980 levels by .2 percent of a year.
    Mr. Whitfield. Mr. Murai, your testimony is very 
interesting and you have gone over considerably, so if you 
would try to summarize it here, we would appreciate it.
    Mr. Murai. Sorry about that.
    So what is the benefit to the economy of allowing continued 
use of methyl bromide while the California Department of Food 
and Agriculture commissioned an economic study and they said if 
there is no methyl bromide and no methyl iodide, the California 
communities will lose over $1.5 billion annually and more than 
23,000 jobs annually.
    So if all the scientists and economists are accurate and 
the environmental impact of continued use of methyl bromide 
CUEs would just add no more than 73 days to a 39-year schedule 
while the economic downside for not allowing this would be $58 
billion and 897,000 jobs over those same 39 years, I just ask 
please bring some common sense to this issue and restore our 
CUE. Thank you for your time.
    [The prepared statement of Mr. Murai follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr. Whitfield. Thank you.
    And I thank all of you for your testimony.
    At this time, we will have some questions for you and I 
will recognize myself for 5 minutes of questions.
    Mr. Murai, Mr. Doniger in his testimony said that 
California strawberry growers have led the pack in coming to 
Congress playing the hardship violin. And he said that your 
growers have done very well, you have increased your yields, 
you have increased the strawberry acreage, and that you all are 
doing very well. But from what you said, that doesn't sound 
like that is the case. Now, have you increased your yields? 
Have you increased your acreage or----
    Mr. Murai. Yields have increased and it has barely kept us 
floating. The margins are razor thin. I think the economic 
studies only show one side of the story, and I don't think I 
would even really be here if we were doing well, right?
    Mr. Whitfield. Yes.
    Mr. Murai. I think this is a priority and an important 
issue because the growers are in a risky situation, very 
difficult to plant. The bankers are even asking about what are 
you doing to ensure----
    Mr. Whitfield. How much do you borrow to put out a crop?
    Mr. Murai. It is about $20 to $22,000 per acre per year.
    Mr. Whitfield. And what about you, Ms. Keeler?
    Ms. Keeler. At the high end, we are at $60,000, so between 
$20 and $60,000 depending on the varieties. I----
    Mr. Whitfield. Per acre.
    Ms. Keeler. Per acre.
    Mr. Whitfield. And Mr. DiMare?
    Mr. DiMare. The operating costs alone are around $10,000 an 
acre. That doesn't include harvesting or land cost or anything 
like that.
    Mr. Whitfield. Mr. Costanza?
    Mr. Costanza. Our operating cost per acre is between $10 
and $12,000 an acre per year.
    Mr. Whitfield. Yes. Now, from my understanding, it is very 
difficult to obtain a critical use exemption for methyl 
bromide, is that correct, Mr. Costanza?
    Mr. Costanza. Yes. In our case, we were told we were going 
to have Midas to use this year.
    Mr. Whitfield. OK. What about you, Mr. DiMare? Have you 
tried to get a critical use exemption?
    Mr. DiMare. Yes, it is an exhausting process.
    Mr. Whitfield. Ms. Keeler?
    Ms. Keeler. Yes, we have been part of the process from the 
beginning. And like I said earlier, it is a very time-consuming 
process, and private sector, we are doing a tremendous amount 
of research looking for these alternatives. There seems to be 
this idea that we are not doing this research looking----
    Mr. Whitfield. Right.
    Ms. Keeler [continuing]. For alternatives and we just want 
this simple free ticket for methyl----
    Mr. Whitfield. Right.
    Ms. Keeler [continuing]. Bromide. It is not an easy 
process.
    Mr. Whitfield. Yes. Mr. Murai?
    Mr. Murai. Yes, Mr. Chairman, every year.
    Mr. Whitfield. Yes. Mr. Doniger mentioned that in other 
countries, Mexico, Italy, so forth, that they are using less 
methyl bromide and being quite successful. What would be your 
reaction or statement or comment about that? Or do you have any 
information about it, any of you?
    Ms. Keeler. In our industry, I can comment to that. Mexico 
produces some pretty unsophisticated flowers, so they have no 
need for it. And my family immigrated from Italy and we still 
have some connections there, and in the EU, the same thing is 
happening there. The EU is off-shoring a lot of their flowers 
over to Africa. And so like we are seeing flowers going down to 
the South American countries. The Italian growers are getting 
rid of the same products we are getting rid of for the same 
problem----
    Mr. Whitfield. Yes.
    Ms. Keeler [continuing]. And they are being grown in Africa 
for some of those countries.
    Mr. Whitfield. You know, one of the common things that 
seems to be coming through a lot of hearings that we have is 
that we are hearing a lot of concerns about EPA that many 
people in various businesses dealing with EPA view them almost 
as an adversary. And I would just like to ask you, do you view 
EPA as a partner trying to help solve a problem or do you view 
them as an adversary?
    Mr. Murai. Well, the actions result in an adversarial 
result. I would say we work closely and try to collaborate and 
really flesh the data out. You know, like Mr. Doniger said, we 
want to put up a nomination that is credible and we are using 
the best data.
    Mr. Whitfield. Yes.
    Mr. Murai. And so I think we try to have a collaborative 
effort but there is nobody listening over there.
    Mr. Whitfield. So you feel it is an adversarial 
relationship, is that correct?
    Mr. Murai. Yes, at times----
    Mr. Whitfield. Ms. Keeler, what about you?
    Ms. Keeler. Yes, like Mr. Murai, I hate to use that word 
because we have been trying to work with them and so we are all 
going to this international body together----
    Mr. Whitfield. Yes.
    Ms. Keeler [continuing]. But at the end when our 
application just gets denied and we don't really get the 
scientific research of why our crops were denied, it is----
    Mr. Whitfield. OK. Mr. DiMare----
    Ms. Keeler [continuing]. Hard to say we work together.
    Mr. Whitfield [continuing]. What about you?
    Mr. DiMare. I feel basically the same way they do. We try 
to work in concert with them----
    Mr. Whitfield. Mr. Costanza, how do you feel?
    Mr. Costanza. I invited EPA out to our farm----
    Mr. Whitfield. Yes.
    Mr. Costanza [continuing]. And their minds were made up 
before they got there.
    Mr. Whitfield. OK.
    Mr. Costanza. They didn't want to hear what we had to say.
    Mr. Whitfield. OK.
    Mr. Costanza. They didn't want to see what we had to show 
them.
    Mr. Whitfield. Now, without methyl bromide and this methyl 
iodide, is there something else you can use?
    Mr. DiMare. Well, it depends on where you are at in the 
country. Even in the State of Florida we have from one end to 
the other Telone cannot be used in south Florida because of the 
groundwater issue----
    Mr. Whitfield. Yes.
    Mr. DiMare [continuing]. But we do use that as one of the 
alternatives in other places----
    Mr. Whitfield. Yes.
    Mr. DiMare [continuing]. As well as others. Methyl iodide 
that they are talking about is gone in the U.S. It is off the 
shelf. They have taken it away so that is not an alternative 
anymore.
    Ms. Keeler. And some of those alternatives have different 
buffer requirements, so for us in San Diego you can't really 
picture a farm like out in the middle of Iowa.
    Mr. Whitfield. Yes.
    Ms. Keeler. We have houses and industry coming right up to 
us. So buffer zones, township caps put a lot of limitations 
on----
    Mr. Whitfield. Well, my time is expired but I mean it is 
pretty clear that all four of you feel like methyl bromide is 
essential and that is my impression.
    Mr. Rush, I recognize you for 5 minutes.
    Mr. Rush. Well, and thank you, Mr. Chairman.
    Mr. Doniger, somehow I am feeling like I am a registration 
clerk at heartbreak hotel when I listen to the testimony of 
some of the witnesses here. And, first of all, you raised your 
finger up because you wanted to react or respond to something 
that I think Ms. Keeler said. Is there something that you 
wanted to respond to?
    Mr. Doniger. Well, I wanted to make one point in connection 
with the issue of whether the relationship with EPA is 
adversarial. If anything from the environmental perspective I 
see the EPA bending over backwards to service these 
applications, to consider these applications. I thought they 
were grossly too large in the beginning. The numbers have come 
down. That is true. But I would offer you one factoid to think 
about. To my knowledge, there has not been one lawsuit filed 
against EPA for denying these applications. There has not been 
one agricultural association or individual grower who has taken 
EPA to court over these supposedly too-small allocations. What 
other industry hasn't sued EPA? It is very hard to take the 
matter that seriously if that is the situation we have. I mean 
I don't want to encourage these guys to sue EPA but everybody 
does.
    Mr. Rush. This industry is one of EPA's favorite 
industries, then, whether they are being adversarial.
    Let me just move on. What are some of your biggest concerns 
with the definition of critical use in the discussion draft 
that is before us today?
    Mr. Doniger. Well, the most serious problem is the--the two 
problems are, one, putting into law a list of critical uses. 
The idea is supposed to be dynamic, that some uses would start 
out being critical, and then as alternatives were found, they 
would no longer be critical and they would drop off the list. 
And that in fact is what has happened. Now, some of the growers 
can have concerns about individual decisions but that is the 
way it is supposed to work. You work your way to alternatives 
and then that use is no longer a critical use exemption. So why 
would we go back to the original list?
    The second thing is how is it going to work now? A grower 
can write on a piece of paper I need x tons. I don't have to 
tell you why. I don't have to give you any information or 
evidence about what I tried and whether it works and so on. It 
is now up to you, EPA, to tell me why I don't need that many 
tons and you would have the obligation, EPA, to go abroad to 
the other countries and say this is what my guys say they need. 
So where is the support for it? The reason that the exemptions 
have been granted--and more than 88 percent, I think, 
nominations have been granted--is that the U.S. comes in 
frankly with a bulldozer of a case for each one. And that 
starts with the growers being challenged frankly to come up 
with a very convincing case, that they have tried all the 
alternatives, that they don't work in these particular 
situations and thus the methyl bromide is still needed. When 
you get a case that is sound, the nominations are forwarded and 
the nominations are granted.
    Mr. Rush. Do you share my concerns with the provision of 
the bill that would shift the burden of proof to the EPA and 
that a requested use of the exemption is unwarranted?
    Mr. Doniger. Yes, I mean that is what I am saying leads to 
the counterproductive result because if the U.S. goes to the 
other parties and says this is the piece of paper I got. I 
don't have any scientific backup or I don't have the full 
backup I used to have, but my guys say they need it so I say I 
need it. It is not a very persuasive case. And it is more 
likely to lead to the nominations being turned down than the 
current situation.
    Mr. Rush. How would this bill impact the Clean Air Act in 
your opinion?
    Mr. Doniger. Well, right now, the Clean Air Act allows for 
the critical use exemptions and that is the process under which 
the nominations have been made for the last seven years and the 
requests have been made by the government to the treaty parties 
and that is the process that is working. The folks here are 
concerned, some of them, that, gosh, there is some expense 
involved, there is some work involved in making the 
applications. And even the best applications you only get, you 
know, roughly 90 percent of them approved by the parties.
    Remember that all the other strawberry-growing and tomato-
growing countries in the western world have stopped using 
methyl bromide. So they look at these applications and say what 
is going on? Why can't the U.S. do what we do in Australia, 
Greece, Italy, Spain with respect to strawberries and tomatoes? 
And it is a tough sell. So if EPA doesn't get the full dossier 
of data from the growers, they are not going to be able to make 
that sale and I don't think they should make that sale.
    Mr. Whitfield. Gentleman's time is expired.
    At this time, I recognize the gentleman from Oregon, Mr. 
Walden, for 5 minutes.
    Mr. Walden. Mr. Chairman, thank you. And I want to thank 
our panel of witnesses, appreciate your testimony and the 
answers to the questions the subcommittee has posed.
    Mr. Murai, do you want to take what the gentleman just 
said, so when it comes to dealing with strawberries and all, 
what is your take on what he just said about the international 
situation and be able to explain why every other country 
doesn't use methyl bromide and we need to?
    Mr. Murai. I think those growers need a process that they 
can come to a hearing like this and voice their opinions, 
because I visited those growers and they are under extreme 
pressure of disease. They are exporting strawberry-growing to 
Morocco. They are exporting the problem rather than dealing 
with it in their own community and that is what our California 
strawberry growers are trying to do. We are trying to deal with 
it in our own community but the rules keep changing every page 
we turn. And that is what we want. We need transparency, we 
need accountability, we need data coming back that shows the 
argument coming back, not just arbitrary. The process is 
broken. I don't want to say we are adversaries but it is broken 
and it needs to be fixed. I want to go back to my growers and 
say this is the way it is, guys, or ladies. This is the way it 
is. But I can't say that with conviction because I know how 
broken it is.
    Mr. Walden. I appreciate that. You know, methyl bromide has 
obviously been used in nursery crops in Oregon. It is a nursery 
business, of course, one of our biggest in Oregon. I know they 
had a big outbreak of potato cyst nematode in Idaho recently. 
And while they don't usually use methyl bromide for potatoes, 
it has been successfully used against potato cyst nematode, 
which, as you know, can just wreak havoc on potatoes if it gets 
away from them. And I know the industry is conducting research 
to find alternatives but none have been found to date. Can any 
of you speak to the potato side of the world and what happens 
in that respect?
    Mr. Murai. I can't speak to the potato crop but I would 
only add that the strawberry industry went through the same 
types of mass destruction. And what we are trying to do is 
provide food for the world with a consistent supply of healthy 
nutritious food, and I think we go to school and we learn the 
newest techniques and we try to innovate----
    Mr. Walden. Um-hum.
    Mr. Murai [continuing]. To try to avoid mass destruction of 
crops. We don't need to go back to the potato famine days. Why 
do we have to revisit that where people are suffering? That is 
not what our intent is, and as farmers, we want to feel good 
about what we do and provide that food and we will work within 
the rules. But the rules and the structure and the process must 
be corrected.
    Mr. Walden. And can you elaborate on the efforts that have 
been undertaken by the strawberry sector to identify potential 
alternatives?
    Mr. Murai. We have invested over $10 million over the last 
15 years to look at steaming the soil using anaerobic soil 
disinfestations. We are looking at growing strawberries in 
substrate, peat moss, coconut coir, but there are other issues 
around that. How sustainable is that when our strawberry 
industry would use up the North American supply of peat moss in 
1 year? Or steaming takes 21 hours to steam an acre of 
strawberries right now. How much fossil fuel is needed, how 
much emissions are needed to steam one acre? You know, 20 
hours.
    Mr. Walden. How many acres do you have in production, 
strawberries in California?
    Mr. Murai. Thirty-eight thousand acres in California.
    Mr. Walden. That is a lot of steaming.
    Mr. Murai. And the----
    Mr. Walden. Or you could just try and grow them here where 
we have steam all the time, or at least today, or a lot of hot 
air.
    Mr. Murai. The funny part is you have to soften the water 
before you put it through the steamer. So we have to have a 
water softener on the road with the long hose that takes it to 
the big steaming machine, and the steaming machine creeps 
along, inches, and covers 1 acre in 21 hours.
    Mr. Walden. So what does that mean to your cost, your 
ability to compete?
    Mr. Murai. There is not enough time in the year to put your 
crop in.
    Mr. Walden. So I guess the question is how do these other 
countries grow strawberries without using methyl bromide? Do 
they just have different pests and different issues?
    Mr. Murai. They are trying to grow in substrate. If you go 
into like northern European areas, they are growing in a lot of 
the coconut coir ----
    Mr. Walden. I see.
    Mr. Murai. --but even that is becoming controversial there. 
So, you know, you move to one solution but it creates other 
problems.
    Mr. Walden. Got it.
    Mr. Murai. And I think that is where we need a 
comprehensive look and a realistic look, right?
    Mr. Walden. Yes, I appreciate that. I know my time is 
expired. I grew up on a cherry orchard and represented a lot of 
ag interests in Oregon, farmers and ranchers that just feel 
like there is a whole onslaught out of the Federal Government 
that is going to shut down our way of life in the West and 
especially on the farms.
    Mr. Murai. We are California farmers and we want to stay in 
California.
    Mr. Walden. Yes. Well, we Oregonians want you to stay in 
California. It has been an issue dating back--no, I am just 
kidding. Yes, but----
    Mr. Murai. That is a good one.
    Mr. Walden [continuing]. We want you to come up and spend 
your money in Oregon, then go back. Thank you. Thanks for your 
testimony.
    Mr. Whitfield. Mrs. Capps, you are recognized for 5 minutes 
for questions.
    Mrs. Capps. Well, thank you, Mr. Chairman.
    As my colleague knows, I was trained as a nurse in Oregon 
and I moved to California so, you know, I guess it can go both 
ways, just an aside. And actually, I want to thank you because 
I know this is not the same as standing in the fields, but we 
are getting close to getting the feeling of what the various 
challenges are to complying with regulations that I believe in 
with all my heart but that are complicated and need to have a 
discussion. If you can't be there to smell the strawberries and 
see for ourselves what the peppers are like in the fields, we 
need this kind of discussion. We need this back-and-forth and 
this give-and-take.
    And I was going to continue the same line with you, Mr. 
Murai. I have got two Californians here I am going to pick on 
for my time. I know growers have put millions of dollars into 
developing alternatives to methyl bromide. Could you continue 
this explanation of why your growers are putting so many 
valuable resources into finding these alternatives? And you are 
not doing it just because of the Montreal Protocol. It is not 
just that.
    Mr. Murai. I think we are trying to improve and innovate 
our practices to be an example for the world. And the 
regulatory environment and the environmental laws are very 
strict in California. It is a whole other layer, and I believe 
that is what the world bodies don't understand is the sovereign 
power within California to have those laws, but the California 
growers will meet that challenge. We have invested our 
resources, we have put in a lot of time, we have lost a lot of 
crop----
    Mrs. Capps. Um-hum.
    Mr. Murai [continuing]. In this time frame and we have had 
a lot of hurt. And I think that is why we believe in what the 
Montreal Protocol is doing and we want to be part of the 
solution, but we also have to understand if there are 
exemptions due to critical use, they should be recognized and 
held to a standard as the applicant is doing. So if there is a 
change in the nomination put forth to the United Nations 
unbeknownst to the California strawberry growers and in our 
application, we should understand why they are doing that and 
what data backs that up.
    Mrs. Capps. OK. Ms. Keeler, would you agree that the flower 
growers are similarly committed to phasing our methyl bromide 
and finding alternatives?
    Ms. Keeler. Absolutely. I can only repeat what Mr. Murai 
just said. Our industry is absolutely committed. We have a much 
more dynamic industry with so many different crops and 
varieties, so there has been a tremendous amount of research 
that maybe something works in one crop, we try it in a 
different crop. We have actually teamed up with the strawberry 
growers. We share our information----
    Mrs. Capps. Yes.
    Ms. Keeler [continuing]. University, private sector, we put 
in so much research into this. And like Mr. Murai said, we want 
to cooperate. We believe in the Montreal Protocol.
    Mrs. Capps. Well, as Mr. Murai told me before, you are 
there, you breathe the air, your families are suffering 
whatever health consequences there are to whatever you put into 
the soil.
    I wanted to move on if I could--I didn't mean to interrupt 
you--but Mr. Murai, you mentioned the CUE process, which I am 
going to expand on just briefly. When the critical use 
exemption process is working, growers get the methyl bromide 
they need while you also phase out its use and incentivize the 
development of viable alternatives. No matter how well 
designed, however, no complex international system can fully 
anticipate every issue that may come up down the road, and that 
is why we always need to be looking at ways to improve and 
adapt the system to the current needs of its stakeholders while 
still moving forward, ultimately achieving its original goals.
    Mr. Murai, I am aware of several fields in Ventura County, 
California, which is in my district, that have had some issues 
transitioning to Telone. And I know that California has banned 
certain alternative chemicals like methyl bromide for its 
cancer-causing and water-polluting qualities, yet EPA has not 
responded accordingly. Perhaps, Mr. Murai, you could expand on 
that just a little, touch on the types of flexibility and 
coordination that could be built into the current system to 
help prevent these problems in the future.
    Mr. Murai. Well, we are very intentional on maximizing the 
alternatives that are available within the law and we explain 
that in our application every year. And what changes, though, 
sometimes when you are using some of these alternatives, they 
don't do a thorough enough job. And so in order for a family 
farm not to abandon their land, they need to be able to have a 
way to clean that soil up and make it healthy again. And, you 
know, in this global economy, we are moving products back and 
forth and think new pests are coming in, new diseases, and 
there has got to be a mechanism. The authors of the protocol 
were very smart and that is why they wrote it in the critical 
use exemption because they anticipated there might be critical 
needs.
    Mrs. Capps. Could I ask for time to ask one further 
question? I know I have used my time.
    Mr. Whitfield. Yes, your time has expired.
    Mrs. Capps. All right.
    Mr. Whitfield. Thank you.
    Mrs. Capps. Thank you.
    Mr. Whitfield. At this time, I would like to recognize the 
gentleman from Texas, Mr. Barton.
    Mr. Barton. Mr. Chairman, my questions are for the second 
panel, so I am----
    Mr. Whitfield. OK.
    Mr. Barton [continuing]. Going to defer or yield back.
    Mr. Whitfield. Then I recognize the gentleman from 
California, Mr. Bilbray.
    Mr. Bilbray. David, would you upgrade me on the latest 
status? We are talking strawberries and I know we have had a 
conflict and have consistently had a conflict between EPA and 
ag on importation of certain issues. What alternative to methyl 
bromide has the ag people put on importation of strawberries, 
the fumigation of those fruits? Do you know----
    Mr. Doniger. I think you are asking, Congressman, about 
quarantine of pre-shipment?
    Mr. Bilbray. Yes.
    Mr. Doniger. And I am not sure I precisely understand your 
question----
    Mr. Bilbray. We have run into----
    Mr. Doniger [continuing]. And I am not sure I know the 
answer.
    Mr. Bilbray. You know, when I was working the Air Resources 
Board when I got over here we had this big conflict because the 
accord we were trying to follow but then we had the Federal 
Government mandating the use of methyl bromide as a condition 
of importing certain fruits----
    Mr. Doniger. Right.
    Mr. Bilbray [continuing]. And vegetables.
    Mr. Doniger. So one of the problems in that field, which is 
outside the scope of this bill, is double-dosing where the 
importing country requires the treatment even though it may 
have been treated on the way out of the exporting country. So I 
think there has been some progress made in reducing that kind 
of double-dosing.
    Mr. Bilbray. But they are still looking at methyl bromide 
as being their----
    Mr. Doniger. Well, this is an area where sulfuryl fluoride 
may be quite promising and----
    Mr. Bilbray. Maybe, but, you know, I----
    Mr. Doniger. No, I mean more than that. It is almost ready 
to be approved as a substitute for methyl bromide in certain 
quarantine uses. And sulfuryl fluoride was mentioned in the 
beginning if I may----
    Mr. Bilbray. No, no, no, no, wait, wait a minute.
    Mr. Doniger. I just want to make sure people----
    Mr. Bilbray. Let me double back----
    Mr. Doniger [continuing]. Understand that NRDC is opposed 
to the withdrawal of the tolerances for sulfuryl fluoride.
    Mr. Bilbray. OK. My biggest concern is that we have known 
since the early '90s there was a conflict between our mandated 
procedures in one department and a treaty that we were agreeing 
to in another. And it has been at least 15 years, if not 20 
years, we still haven't kind of put that together.
    Mr. Doniger. The treaty doesn't cover quarantine and pre-
shipment.
    Mr. Bilbray. OK.
    Mr. Doniger. I believe it should but it doesn't. So there 
are no restrictions on quarantine and pre-shipment use of 
methyl bromide under the treaty.
    Mr. Bilbray. OK. I appreciate you clarifying that. It is 
frustrating to me to see the government that says this is so 
essential that we reduce the use and everything else.
    And Mr. Chairman, you know, my family has been personally 
affected by diseases directly related to the ozone issue. So I 
really believe, you know, this is a concern. But it is a 
reasonable application of the concept. I think any law, no 
matter how good intentioned, if there isn't a reasonable 
application, there is going to be major problems of not only 
unforeseen adverse impact but also unforeseen inefficiency in 
acquiring the original goal. And that is one of the things I 
want to address.
    And Dave, why I asked you about that is that we talk about 
priorities in the Federal Government but it isn't reflected by 
our actions at getting to go. We always love to say no. It is 
easier to say no. But getting to go, getting to an alternative 
answer, we know what is bad but getting to what we are willing 
to say is good takes 20 years at a time that we are saying the 
ozone is being depleted as we speak, people are going to be 
dying, but don't ask me to rush to finding a viable 
alternative. And I think there is an obligation that those of 
us in the system, if we want to claim the moral high ground 
like some members on this committee love to do, that we are 
saving lives and we are avoiding this and that, we have more of 
a responsibility than just saying no. We have a real obligation 
to find a yes and doing it quicker than 20 years down the pike.
    Mr. Doniger. Well, the one thing I think we can all agree 
on is that there has been--all of the witnesses here can agree 
on--is there has been a lot of progress in phasing down methyl 
bromide. If you had this hearing 5 years ago--actually, you did 
have this hearing 5 years ago--the crisis of impossibility of 
terrible impact was at the then current level where we are now 
down some 80 or 90 percent below that. And that is why the 
critical use exemption process is there. If the case can be 
made, the exemption should be granted.
    Mr. Bilbray. I just worry we are quick here to put 
regulations on to outlaw stuff and we are not quick here at 
creating the vehicles to create an opportunity to make that 
product obsolete. In other words, just outlawing something is 
not answering the problem. The problem is identifying the 
problem and then finding an alternative answer to be able to 
move things forward without the social economic impacts and the 
health impacts that may be related.
    Mr. Doniger. There has been a fair amount of USDA research 
and we would have supported there being more to help the 
growers find these alternatives.
    Mr. Bilbray. Well, I would just say 20 years is pretty 
slow.
    Mr. Whitfield. The gentleman's time is expired.
    At this time, I recognize the gentleman from Louisiana, Mr. 
Scalise, for 5 minutes.
    Mr. Scalise. Thank you, Mr. Chairman, appreciate you having 
this hearing on these two bills that----
    Mr. Whitfield. Mr. Scalise, I am sorry. I didn't see Mr.--
--
    Mr. Scalise. Oh, I will yield to the gentleman from 
Michigan.
    Mr. Whitfield. OK, you go ahead and then I will come back 
to Mr. Dingell. Thank you.
    Mr. Scalise. All right. Thank you, Mr. Chairman. I thank 
the former chairman, the gentleman from Michigan.
    As we are talking about strawberries, I, you know, 
represent a city called Ponchatoula, and the Ponchatoula 
strawberries I would argue are the plumpest, juiciest, most 
bright red. We could probably have a taste test and we would 
both enjoy it. But, you know, I look at these new regulations 
and, you know, really have concern about what it is going to 
mean to those strawberry farmers in Ponchatoula just as it is a 
concern to those of you in whether it is California, Michigan, 
all across the country. Do you all have any estimates on how 
many jobs are at risk if this industry is threatened with the 
inability to use methyl bromide? I will just start with you, 
Mr. Costanza, and we can go down. Any kind of estimates on job 
losses that may be in play?
    Mr. Costanza. On our farm presently we have about 125 
employees. I am 30 employees short for harvest. We are leaving 
product in the field. In the local economy in the State and 
Federal level, there is about four jobs for every farm worker I 
have on the farm. So the economic impact across the country if 
we are out of business is dramatic.
    And I would like to mention that I have been to your 
district and I have visited some of your growers, Anthony 
Liuzza being one of them----
    Mr. Scalise. I know him well.
    Mr. Costanza [continuing]. Looking for an alternative to 
use other than methyl bromide.
    Mr. Scalise. And what have you all been able to come up 
with?
    Mr. Costanza. Nothing. We need a product that is affordable 
and that will produce----
    Mr. Scalise. And effective.
    Mr. Costanza [continuing]. A crop that the public demands. 
Now, these European countries, they will accept a lower quality 
berry. Americans won't accept that quality. So----
    Mr. Scalise. And it is my understanding that under the 
protocol, developing nations are exempt from this. They don't 
even have to comply what is being imposed on you, but a 
developing country that competes against you would not have to 
comply, is that correct?
    Mr. Costanza. My understanding that is correct but the 
other thing is accountability. How are you going to account for 
what goes into Mexico from China? How are you going to account 
for what goes into some of the European countries from China? 
How are you going to account for what goes into Morocco? 
Because they produce a lot of methyl bromide in China because 
we pay for the plant to be built.
    Mr. Scalise. Yes. And then that would be just more jobs 
outsourced, exported that we lose that go to foreign countries.
    I want to ask Mr. Murai, because you represent the 
California growers, if you can give me any kind of estimates on 
jobs as well, kind of similar questions as I was asking Mr. 
Costanza. I am not sure if you have met Mr. Liuzza as well but 
he is a good man.
    Mr. Murai. Our California Department of Food and 
Agriculture commissioned an economic study with the University 
of California Davis, and their latest numbers show that without 
methyl bromide and without methyl iodide now, they are 
anticipating California communities would lose over $1.5 
billion annually and more than 23,000 jobs annually.
    Mr. Scalise. How many jobs?
    Mr. Murai. Twenty-three thousand.
    Mr. Scalise. Just in California that would be lost?
    Mr. Murai. Just California coastal communities.
    Mr. Scalise. OK, thank you.
    Mr. DiMare, if you can answer the same question?
    Mr. DiMare. I can't speak from a study standpoint on the 
data or statistics but just from our own perspective, on the 
one farm location that we have where I am at in central Florida 
is about 5 to 600 people, but for the whole company we are in 
the thousands. We employ thousands of people.
    Mr. Scalise. OK. And then Ms. Keeler.
    Ms. Keeler. I don't have specifically those numbers. I 
could get them to you. The California cut flower industry is a 
$10 billion industry from farm to florist, so it is a pretty 
big industry. Our farm alone employs over 200 people for 400 
acres. But I could get the stats to you afterwards.
    Mr. Scalise. OK. And then we don't have any kind of 
indirect jobs. You know, we are looking at this regulation. 
Unfortunately, if this was the only one, you could kind of 
isolate it and deal with it, but we have seen time and time 
again it is far from this one. We have already seen job losses 
in other industries due to EPA coming out with regulations that 
do nothing to address the problems they are concerned about. I 
mean if you are concerned about carbon emissions, jobs that are 
being sent overseas from greenhouse gas regulations, those 
countries where we lose our jobs to, they emit even more 
carbon.
    You know, you look at this, you know, the farms, it is 
going to go to developing countries. These jobs will go to 
developing countries that under definition can still use the 
product. And so you just cost American jobs. You do nothing to 
reduce usage of the product. And again, it is one more 
regulation that makes no sense. I know we have got legislation 
that we passed called the REINS Act that tries to rein in some 
of these radical regulations.
    But I know I am out of time. I appreciate the discretion, 
Mr. Chairman, and I yield back.
    Mr. Whitfield. The gentleman's time is expired.
    Mr. Doniger, you want to make a comment.
    Mr. Doniger. I would just like to correct the record on a 
couple of points. 1) Mexico is ending its use of methyl bromide 
this year, 3 years before the obligation. They have an 
obligation under the protocol to end it in 2015. They are 
ending it in 2012.
    Mr. Scalise. I don't know if you are correcting the record 
because other witnesses are shaking their head no.
    Mr. Doniger. Well, I am sorry. That is fact. The second 
fact I want to correct is that the United States didn't pay for 
or contribute in any way to the production capacity of China 
from methyl bromide, and it is because of this treaty that 
their production and use is also coming down. The treaty 
protects Americans because it controls the dangerous chemicals 
and the impact on the stratosphere around the world. We cannot 
protect our people by ourselves. That is why we need----
    Mr. Scalise. Can Mr. DiMare respond? Because it looks like 
he disagrees----
    Mr. Whitfield. Well, now, the time is up but I am just 
going to make one other comment. You had asked the question 
about jobs and Mr. Murai in his testimony pointed out I believe 
that the California Department of Agriculture said without 
methyl bromide, that there would be a loss of 23,000 jobs 
annually, is that correct?
    Mr. Murai. Yes.
    Mr. Whitfield. OK. At this time I recognize the gentleman 
from California, Mr. Waxman, for 5 minutes.
    Mr. Waxman. Thank you, Mr. Chairman, and thank you, Mr. 
Dingell, for allowing me to ask my questions.
    Mr. Doniger, the whole idea of the protocol international 
agreement is that we are not going to give an advantage to 
other countries. We are going to require everybody to reduce 
what is a threat to all of us in this planet. And in the case 
of CFCs, U.S. acted unilaterally and then moved forward. I 
sometimes think if we had that problem today, we would probably 
treat it the way we are treating greenhouse gases. They are not 
doing anything, we are not going to do anything. Cost us jobs? 
Well, we are not going to allow that to happen. And of course 
the result is every day we hear about another drought 
destroying the crops and I am sure more crops are being 
destroyed by the drought which I think has to do with global 
warming and climate change than the issue that we are 
discussing today, which is an important one but a very narrow 
one.
    The bill freezes an outdated list of approved critical 
uses. As a result, sectors that have completely phased out the 
use of methyl bromide during the last 7 years would be allowed 
to use methyl bromide again. Incredibly, as I understand it, 
even golf courses would once again be allowed to seek critical 
use exemptions.
    Let me ask, does anyone on the panel think that we should 
amend the Clean Air Act to allow sectors that have completely 
eliminated the use of methyl bromide to start using it again? 
No one? Do you think that we ought to allow sectors of our 
economy that have completely eliminated the use of methyl 
bromide to start using it again?
    Mr. Murai. Yes, because they were eliminated under false 
pretenses of an alternative being available and that 
alternative has been now taken off the market.
    Mr. Waxman. I see. What alternative has been taken----
    Mr. Murai. Methyl iodide.
    Mr. Waxman. I see. So you would let them--we would go back 
and allow methyl bromide----
    Mr. Murai. For critical use exemption----
    Mr. Waxman. For critical use exemption.
    Mr. Murai [continuing]. Under the critical use exemption 
process.
    Mr. Waxman. Well, do you think it makes sense to have a 
critical use exemption to allow golf courses--to allow the turf 
grass to be preserved with methyl bromide?
    Mr. Murai. I think if it is under the law, if it is within 
the law, it is within the law.
    Ms. Keeler. And I think that is what Congresswoman Capps 
was asking earlier when she was talking about the flexibility 
and her time ran out. I can't speak to golf courses. That is 
not my area. But in some areas we thought we found an 
alternative in a certain crop and we tried it, and this is our 
commitment to the protocol. But sometimes you try something new 
and after 3, 4, 5 years, you find out there is a problem. A new 
disease develops. Something you thought was taking place 
didn't. So I think what Mr. Murai is saying if there is 
adequate information for a critical use exemption, whether it 
is golf courses, strawberries, flowers, that is how the 
protocol was written.
    Mr. Waxman. Mr. Murai, the California strawberry growers 
are by far the largest remaining users of methyl bromide in the 
United States. I know you have concerns with the amount of 
methyl bromide available to your industry, but do you really 
think that this legislation is the most constructive way to go 
about addressing these concerns?
    Mr. Murai. I think there could be several approaches and I 
think this has probably gotten to a point where we were so 
frustrated that we needed people to listen. We tried to 
collaborate with EPA. We tried to introduce what we best 
thought best information, put forth a package of application 
for the critical use exemption. If they could tell us otherwise 
based on data, then, you know what, that is how it is. But they 
weren't providing that data back, Congressman, and that is what 
bothered me about the system is when you can make a cut based 
off methyl iodide and now methyl iodide is gone, so what 
happens now with all the CUEs that have gone by the wayside 
because of this alternative? There needs to be some resolution 
to that.
    Mr. Waxman. But I am concerned----
    Mr. Murai. There are no alternatives coming off the shelf 
ready for the field.
    Mr. Waxman. I am concerned about the provision of the bill 
that would allow growers to obtain methyl bromide without a 
critical use exemption for so-called emergency events. This 
could create a big loophole that would allow for the use of 
large quantities of additional methyl bromide. Mr. Doniger, my 
understanding is that a Montreal Protocol decision allows for 
the use of methyl bromide in true emergencies. Do you know how 
many times this emergency event provision has been invoked?
    Mr. Doniger. Yes, it has been invoked twice and they were 
true emergencies, once by Canada and once by Australia. It was 
not a routine thing and that is what this bill would allow. 
Emergencies would become routine. It would be like every time 
you don't have enough money in your bank account, you just 
declare an emergency and write another check.
    Mr. Waxman. Well, Ms. Keeler, in your testimony you argue 
that growers should be allowed to develop an emergency cleanup 
process that will allow you to go into your fields every few 
years and use methyl bromide to clean up any pests or diseases 
that have developed, is that right?
    Ms. Keeler. What I was referring to, in our industry we 
have perennials we have to take out of the fields when certain 
diseases pop up. So we don't have situations in many of our 
crops where it is an every-year process. So the way that the 
protocol is set up in the application process, it is very 
difficult for us to fit in because we aren't scheduled.
    Mr. Waxman. So it is not an emergency. It is the opposite 
of emergency. They are planned, routine use of methyl bromide 
without a critical use exemption.
    Ms. Keeler. Well, I am referring to a cleanup process that 
would allow us to go in and clean those fields up when----
    Mr. Waxman. Mr. Doniger, what do you think of that idea?
    Mr. Doniger. Well, I think if this problem of not needing 
it every year, you figure that out, you build that into the 
critical use exemptions. If the case can be made for it, that 
is what the critical use exemption process is for. The 
committee is approaching this as though there is no exemption 
and we need to create one. Actually, there is one already and 
it is working. We don't need to enlarge it.
    Mr. Waxman. Well, Mr. Murai doesn't think it is working.
    Mr. Murai. I think it has worked well for a while and I 
think lately in the last 2, 3 years it has gotten very tenuous 
because there hasn't been a real listening to what is really 
happening in the field. And so when we come to EPA with our 
package to demonstrate the need, it is very easily put forth, 
here is what you can do. In this case, methyl iodide was put 
forth and you are going to transition 21 percent in 3 years. I 
don't think so but OK. That went away. Now, there is no 
restoration for any of the crops that were dependent on methyl 
iodide based on EPA's aggressive nature with that product.
    Mr. Waxman. So you think EPA is not being reasonable in 
deciding when emergency event should take place and this 
exemption should be allowed?
    Mr. Murai. Yes, I believe they are not being reasonable and 
I believe the rules change at every corner. And that is where I 
want to be able to go back to our growers and say, hey, the 
process is the process and it is correct, it is transparent, 
their interpretations are right on the science, and it is fair 
and we have to live with it. But I can't honestly go back to my 
growers and speak with conviction that that is the process 
right now. And that is what I am talking about today is that 
this process needs to be corrected.
    Mr. Waxman. OK, thank you.
    Thank you, Mr. Chairman.
    Mr. Whitfield. At this time, I recognize the gentleman from 
Virginia, Mr. Griffith, for 5 minutes.
    Mr. Dingell. Mr. Chairman, I thank you for your courtesy. I 
am sorry.
    Mr. Whitfield. Go ahead, Mr. Griffith.
    Mr. Griffith. Thank you, Mr. Chairman. I do appreciate 
that.
    Mr. DiMare, a couple times Mr. Doniger has said that Mexico 
is outlawing the use this year or ending the use this year of 
methyl bromide, and each time you have indicated at least with 
your body language that you didn't agree with that, so I am 
giving you an opportunity now to explain what disagreement is 
with that or other statement regarding the use in other 
countries of methyl bromide you might have disagreed with Mr. 
Doniger on.
    Mr. DiMare. Well, you know, I don't know that that is 
written into law there, but I will believe that when I see it.
    Mr. Griffith. Trust but verify, is that what you are 
saying?
    Mr. DiMare. I am sorry?
    Mr. Griffith. Are you saying trust but verify?
    Mr. DiMare. That is correct.
    Mr. Doniger. It is a commitment that Mexico has made under 
the Multilateral Fund, which is part of the Montreal Protocol 
and it is in writing. It is referenced in my testimony.
    Mr. Griffith. I understand.
    Mr. Doniger. And it is firm.
    Mr. Griffith. I think what Mr. DiMare is saying, though, 
that illegal drug trafficking takes place, you know, on both 
sides of the border. It is written into law but he will believe 
that they stop using methyl bromide when he sees it because he 
is not sure they are going to follow the law. I understand what 
you are saying but I understand what he is saying, too.
    Mr. Doniger. It is harder to get methyl bromide than it is 
to get illegal drugs.
    Mr. Griffith. And that is what, apparently, even the people 
who want to use it legally are saying and it is one of the 
reasons we need the bill is that it is harder to get methyl 
bromide than it is to get the illegal drugs. And they have got 
a concern and they are hoping that maybe it can be a little 
easier so they can use this substance legally and 
appropriately.
    Along those lines, Mr. Doniger, is there anything in this 
bill that would force the EPA or the State Department out of 
compliance with the protocol?
    Mr. Doniger. I think what would happen, Congressman, is 
that if the United States went forward with unsupported 
applications, they would be turned down. And that would be the 
normal operation of the protocol but it wouldn't be a good 
result for my colleagues here on this panel. They want the 
nominations to succeed, not to fail because they weren't 
supported.
    Mr. Griffith. But inherently there is nothing in this bill 
that would put us out of----
    Mr. Doniger. Yes, actually, I believe the emergency 
exemptions provision would be grossly out of line with the 
protocol and freezing the critical use list, you know, 
permanently at the 2005 list would be contrary to the protocol.
    Mr. Griffith. All right. And if I might ask Ms. Keeler and 
others who have talked about this, and feel free to jump in, 
because I am not as familiar with methyl bromide, I don't know 
what happened that made methyl iodide--what were the negative 
effects that we decided as a country to take methyl iodide out 
of the mix--either one of you--as a potential fix for using 
methyl bromide?
    Mr. Murai. I think methyl iodide was identified as an 
effective fumigant but the science on health effects was 
debated and there were two sides of the science. And it was 
deemed a cancer-causing agent and so it caused definite uproar 
in the communities. And as growers, we were just as sensitive 
to that and we believed that the process of science and 
examination should go forward. And so we weren't resting on 
that product as being the replacement for methyl bromide and 
that is what we tried to articulate back to EPA is that we 
aren't convinced this will be the tool for California or the 
Nation.
    Mr. Griffith. And then am I also hearing the testimony 
correctly when I was listening to your opening statements, the 
four of you that are in production of various types of 
vegetables or fruits that to replace the methyl bromide you are 
using a lot more pesticides and things that would get into the 
water supply? Is that accurate? And Mr. Costanza, you want to 
comment on that?
    Mr. Costanza. When using methyl bromide eliminates a lot of 
sprays across the field that we are going to have to do with 
methyl bromide. As far as Midas is concerned, I am concerned 
about my workers because it is not worker-friendly, whereas 
methyl bromide is easier to work with and it is less risky to 
my employees. But one of the biggest worries I had about Midas 
was the fact that it could affect my workers more than anything 
else. But this was the replacement the EPA gave us, said we 
were going to have, and then that is gone. So they promised us 
that we would have a drop-in replacement. And the reason I am 
here is because we don't. If somebody has got a magic wand here 
that I could use, I don't want methyl bromide. But you don't 
have a replacement.
    You know, if I need a blood transfusion today and I am A 
positive and you don't have A positive and you give me 
something else, you are going to kill me. But with methyl 
bromide it worked. And my customers demand the product that it 
produced. My employees liked the product because it yielded 
more fruit. And they get paid an incentive on volume. They made 
more money. So why don't produce it? The chain stores are going 
to go to where it is if they have to import it. It doesn't 
matter if it comes from--you know, you could fly anything 
anywhere from the world today. You know, I have got Chinese 
product in the stores in my hometown. My grandson was eating 
Chinese-produced diced pears, not American, Chinese. We don't 
need that. We can do it here. But all you are doing is 
eliminating jobs and exporting the production to other 
countries. Give me a break.
    Mr. Whitfield. The gentleman's time is expired.
    At this time I recognize the gentleman from Michigan, Mr. 
Dingell, for 5 minutes.
    Mr. Dingell. Thank you.
    I am very sympathetic with the witnesses here. I am very 
much concerned about their views and their need for a 
pesticide, but I have a feeling that we are like the surgeon 
who conducted a superb operation in which the patient died. I 
don't see here, Mr. Chairman, EPA. They have a story to tell. 
Where are they? I don't see here the Department of Agriculture. 
I don't see here others who could tell us whether there are 
substitutes or why those substitutes are available or not 
available.
    I note here as I am looking at it the annual critical use 
exemption summary. I don't know whether the panel has seen this 
or not but it shows a continuing decline in the exemption that 
has been given by the folks up at the Montreal Protocol. It 
started out they were getting about 10,000 tons and it is down 
now to less than 2,000 tons. My concern here is that every time 
we have seen this, it has gone down and down and down but I 
don't see any real prospect of getting relief through the 
Montreal Protocol. If I look, they have consistently been below 
what the farmers have requested and they have not given the 
amount that the farmers say they need.
    And we are going to take this legislation to the floor 
after virtually no hearings. We have had a panel and I am sure 
the panel are most respectable of folks in their fields, but we 
haven't heard a word from the government agencies. Frankly, I 
am in the view we ought to have EPA up here and let us find out 
what the facts are from EPA's view. I am in the view we ought 
to hear from Department of Agriculture. Let them tell us what 
is the need but I don't see that. So we are going to take this 
bill to the floor, probably pass, and then when it passes it 
goes to Senate. And it is going to sink out of sight.
    And if it doesn't sink out of sight in the Senate, it is 
probably not going to be signed by the President and it is 
going to be opposed with utmost diligence by the 
environmentalists, and I don't think this committee is going to 
afford the relief that quite frankly our agriculture community 
needs. I don't think that we are going to see them get the 
opportunity to have new pesticides that will address the 
concerns of our farmers. And I see us lining up if the dire 
predictions I hear today are to be realized, I see just nothing 
but trouble coming from this legislation. And I see under the 
legislation the farmers tell EPA what they go to the Montreal 
Protocol with and the Montreal Protocol takes a look at it and 
says, well, we are just not going to do that. So the farmers 
walk away and the farmers got nothing and there is no methyl 
bromide or anything else that is available to help our farmers 
with their problem.
    So we are giving our farmers the most successful operation, 
but when we are done, the patient is going to fall off the 
table and he is going to die. And we are going to have a huge 
fight on the floor and everybody is going to get all torn up, 
but the farmers aren't going to get the relief that they need 
or they want. And to me that is not only bad policy but it is 
very bad legislating and it is going to leave this committee 
quite frankly looking kind of whoosh because we really didn't 
do the job that we should have done in terms of having an 
intelligent bunch of hearings where we heard the witnesses.
    And, you know, I warned about this in earlier times. I 
remember one morning Chairman Staggers brought in the swine flu 
bill and we had a great big hearing on swine flu and my friend 
John Moss, who was a member of the committee, and I, we said 
this is a hell of a way to do business. We don't have the 
vaguest idea what this is going to do. So we had a magnificent 
program for the production of vaccine. We produced a hell of a 
lot of vaccine. We absorbed liability for everything from the 
building burning down while the patient was in it to being 
raped or assaulted in the parking lot. And lawyers said oh, my, 
isn't this wonderful? So they rushed out and had swine flu 
seminars at which they told everybody how to sue the 
government. We wound up with about $7 billion of liability. 
They developed this wonderful inoculant but they never found 
the damn disease and they never found the virus. And the 
government got about a $7 billion liability and the trial 
lawyers had a wonderful time and made lots and lots of money.
    I am not going to say that that is what is going to happen 
here but I think we are working most diligently to create red 
faces on the members of this committee, and I just hope, Mr. 
Chairman, that you will slow down and you will bring in the 
witnesses from the Department of Agriculture, witnesses from 
EPA, and maybe somebody else and let us find out why they are 
not producing what our agriculture needs and exposing them to 
what looks like is the work product of a snake oil salesman.
    I yield back the balance of my time.
    Mr. Whitfield. Thank you very much. I might add, Mr. 
Dingell, that we do have a document from the EPA making 
comments on this particular legislation, even though they are 
not here today. But we do have comments from them.
    At this time----
    Mr. Dingell. If you want EPA up here, they will come and 
the committee will support you. And if you want the Department 
of Agriculture up here, they will come and the committee will 
support you. And that is the way to do the business. Let us 
find out----
    Mr. Whitfield. We don't want to sit around and subpoena 
them every time we ask them. We try to work with them and----
    Mr. Dingell. Did you invite them, Mr. Chairman?
    Mr. Whitfield. We did invite them, absolutely.
    Mr. Dingell. And did you get on the phone and say we want 
to have you up here? I have run committees for about 20 years 
and I am somewhat knowledgeable----
    Mr. Whitfield. We contacted them one month ago about this 
hearing.
    Mr. Dingell. I never had any trouble getting anybody in 
here. I have watched my Republican colleagues waiving subpoenas 
and throwing them around here like confetti, and they don't get 
anything done. But it is fairly simple, let them know, By the 
Great Horn Spoon, you are coming and we are going to have you 
up here.
    Mr. Whitfield. See, our goal is to accumulate the esteem 
and respect that you have so that when we ask them, next time, 
they will show up immediately.
    Mr. Rush. Mr. Chairman, with all due respect I have to join 
in here with Mr. Dingell. You know, here we have this hearing 
and we are going to finish maybe these hearings by 1:30, maybe 
2:00. And then at 4:00 the markup starts. You know, that is not 
enough time. I think that if we delay this pending markup, I 
will certainly join in with you and I am sure Mr. Waxman would 
and the chairman of the full committee would. We would join 
with you if you want to do a telephone call, request that the 
EPA appears before a hearing we could schedule tomorrow 
morning, I am sure we would be able to do that--or the 
following day. But just to rush pell-mell into a markup less 
than probably 2 hours after a hearing on this obviously very 
important matter in your opinion, I think that is ludicrous on 
its face.
    And so I would strongly suggest and recommend that you 
consider postponing your markup until we are able to get EPA 
and USDA here so they could have some testimony from the 
departments.
    Mr. Whitfield. Mr. Rush, you and I both know that whether 
Democrats are in control or Republicans are in control, there 
are times when the other party does not agree with the 
procedure. There were a lot of things, for example, about the 
healthcare procedure bill we didn't agree with, and I have a 
number of letters. I have farmers talking to me all the time, 
milling companies all the time about methyl bromide, the 
importance of methyl bromide. And we have this panel of 
witnesses that reflects the agriculture community, reflects the 
environmental groups, and we are going to intend to have 
opening statements today at 4:00. And I guess the markup is 
scheduled for tomorrow at 10:00.
    Mr. Rush. But Mr. Chairman, why the hurry? Why do we have 
to hurry up and get this done? Why----
    Mr. Whitfield. We are trying to be responsive to the 
agriculture community----
    Mr. Rush. I would like to have the opportunity to invite, 
along with yourself, along with Mr. Waxman, along with Mr. 
Upton, to request that the EPA appear before the markup. I 
would like to have that opportunity and I would respectfully 
request that we be given an opportunity. Mostly Democrats and 
the Republicans send invitation over the phone, however you 
want to send it, email it, asking them to show up for a hearing 
before we go into a markup.
    Mr. Whitfield. Now, have you had the opportunity to read 
their comments on this bill?
    Mr. Rush. Mr. Chairman, I want to ask them questions. I 
want them sitting right there at that table so that we can have 
a vigorous debate or discussion and ask questions and ask them 
some important questions that I and other members of the 
committee want to get some answers to. The departments need to 
be here.
    Mr. Whitfield. Well, we invited them and you know what, I 
would be happy to join with you, Mr. Waxman, and we can sit 
down with EPA between the subcommittee markup and the full 
committee markup and we can ask them all the questions you 
would like to ask them.
    Mr. Rush. It should be public and every member of this 
committee should have that opportunity.
    Mr. Whitfield. We will invite the public in.
    Mr. Rush. And in fact, Mr. Chairman, I don't know why we 
can't delay the markup for 24 hours if necessary so that we can 
be responsible and have some real deliberative discussions with 
the administration, with the EPA, and Department of 
Agriculture. I don't see what----
    Mr. Whitfield. So you prefer to do it on Friday instead of 
tomorrow?
    Mr. Rush. Yes, and we can do it on Friday. I don't have any 
reason why that isn't OK, but we need to get the EPA and the 
Department of Agriculture at the witness table.
    Mr. Whitfield. Well, listen, I really do thank you and Mr. 
Dingell for your comments. And like I said, we will make sure 
that you get a copy of this. And like I said, I would be happy 
to join you all in having EPA come up and talk to us, but we do 
believe that this is an important issue. A lot of jobs are at 
stake.
    And at this time I think, Mr. Olson, you are the only one 
who hasn't asked questions, so I recognize Mr. Olson from Texas 
for 5 minutes.
    Mr. Olson. And I thank the chair. And welcome to our 
witnesses. I appreciate your time and your expertise this 
afternoon.
    One of the largest annual festivals back home in Texas 22 
is the Strawberry Festival in Pasadena, Texas. It just was 
completed this past May and so because of those strawberries, 
American strawberries, strawberry production in America is 
important to me. Beyond strawberries, I am concerned about some 
of the comments you made, Mr. Doniger. You essentially said 
that citizens who are impacted by the loss of methyl bromide 
have an avenue to have their objections heard, and that is a 
lawsuit suing the EPA. That apparently is how the NRDC sees a 
remedy for people who are impacted by loss of methyl bromide. 
But I am curious if the people working on the farms think a 
lawsuit is a viable alternative.
    So my first question is for you, Mr. Costanza, and I will 
work down to the other three. Do you have the money, the time, 
and the resources to sue the EPA?
    Mr. Costanza. No. When I was using methyl bromide on the 
other crops, I was paying a lot higher income tax. My employees 
were paying a lot higher income tax than they are now. So both 
my employees and myself, our incomes have been reduced because 
we are not using methyl bromide. And to sue the EPA, where am I 
going to get this kind of money from? You know, we are a family 
farm. Our margins are 2, 3 percent.
    Mr. Olson. So a lawsuit is not a viable alternative for 
yourself?
    Mr. Costanza. Not unless you got some money.
    Mr. Olson. We got a spending problem here in Washington, 
see. No, we don't have the money, sir.
    Same question to you, Mr. DiMare. Do you have the time, 
money, and resources to sue the EPA?
    Mr. DiMare. We are in the business of farming. We are not 
in the business of suing people. We are just looking for an 
alternative that is viable. If methyl bromide is the only 
product, this will not be disputed. The only product out there 
that did kill all the pathogens that it killed, all the weeds 
that it killed, all the alternatives that are out there are 
lesser, OK, which increases our cost, decreases our yield, 
which is not a productive way to do business.
    Mr. Olson. And probably lose jobs as well, just like----
    Mr. DiMare. Well, the jobs will follow, yes. As we know it, 
the type of farming we do will go under.
    Mr. Olson. Ms. Keeler, same question for you, ma'am. Do you 
have the time, money, resources to sue EPA?
    Ms. Keeler. No, we barely have profit margins. I have to 
repeat what Mr. Murai said earlier and we appreciate the 
opportunity to be here to tell you our story. It should be not 
an adversarial situation with EPA. We in our government should 
have a conversation about what is going on on our farms. We 
don't expect you all to know how to run a flower farm. That is 
what we do. But we can come here and tell you and tell EPA how 
that is taking place and the struggles that we have.
    And Mr. Murai made a wonderful comment earlier. Italy, 
Greece, they don't have the opportunity to come and talk to 
their governments. At the very first international meetings 
that I attended, I actually went and talked to the Italians and 
the French because we know what they are growing. And we 
basically said how are you guys going to grow these cut flower 
products without methyl bromide? And they said we are not. The 
EU came to us and told us this is what the EU is agreeing to. 
There was no discussion. The Italians were on a vacation and 
all these international locations at the meetings because there 
was nothing for them to talk about.
    So, no, we don't have the money, no, we don't want to sue 
EPA. We want to be here, discuss with you, discuss with EPA and 
follow the CUE process the way it is laid out and get our 
allocations when necessary.
    Mr. Olson. Thank you. And finally, for you, Mr. Murai, 
being a strawberry man, very special to my heart with the 
passing of the Strawberry Festival, so I mean again, same 
question. Do you have the time, resources, money to sue EPA?
    Mr. Murai. Our time and resources should be invested in 
researching alternatives to methyl bromide. That is where our 
efforts should be. And the process just broke down. It needs to 
get fixed. People need to listen, get their boots dirty, and 
clean their ears out because it is just not computing. And we 
are not making things up. It is based on real data, real 
science, and I think the EPA really needs to prove to all of us 
that they have legitimate reasons for reducing our nominations 
or eliminating them.
    Mr. Doniger. So instead what these folks are doing is 
coming to you at no small expense and asking you to change the 
law, not to get EPA to carry out the law but to change the law, 
to tilt the playing field in their direction. All I am saying 
is there is an existing law and an existing process. Let us 
make it work. It does work in my opinion. And use all the tools 
that people have under existing law. If we change it----
    Mr. Olson. Mr. Doniger, with all due respect, sir, the four 
panelists sitting next to you disagree completely with that 
statement there. I mean EPA is hurting their business, is 
killing their jobs, and again that is not EPA's role. I mean 
again we need to get the Federal Government off the peoples' 
backs and let the American people grow their products, create 
jobs in this country. That is the biggest challenge we have 
right now.
    I guess one more question for you, last one, Mr. Costanza.
    Mr. Costanza. I don't want the EPA to change their rules. I 
just want them to do what they told me they were going to do. 
They were going to get me a viable, affordable alternative and 
they have not. So until they give me a viable, affordable 
alternative, give me the CUEs.
    Mr. Doniger. Mr. Costanza hasn't even requested one----
    Mr. Costanza. That is not correct.
    Mr. Doniger [continuing]. Since 2007.
    Mr. Costanza. No, that is not correct.
    Mr. Olson. Well, we will settle that later, gentlemen.
    Again, one commonsense thing from Mr. Murai----
    Mr. Costanza. We are in the process of doing it now.
    Mr. Olson. Dirt on the boots, wax out of the ears, that is 
how we get through this problem. Thank you. I yield the balance 
of my time.
    Mr. Whitfield. OK. Time is expired.
    That concludes questions for the first panel. We appreciate 
all of you being here and talking to us about----
    Mr. Rush. Chairman, I ask unanimous consent to insert three 
items related to methyl bromide into the record. And one is a 
recent article from the Journal of Environmental Medicine 
citing that the California strawberry industry is experiencing 
rising crop yields while methyl bromide use declines. And there 
are also two letters from the California growers describing 
their success with alternatives to methyl bromide.
    Mr. Whitfield. Well, without objection.
    [The information follows:]

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    Mr. Whitfield. And then we have some additional letters 
from millers and Agricultural Trade Services, Almond Processing 
Association, the American Farm Bureau, California Date 
Commission, California Walnut Commission, Florida Farm Bureau, 
Florida Tomato Exchange, Georgia Fruit & Vegetable Growers, 
Holzinger Flowers, Inc., Knappan Milling Company, Lassen 
Nursery, Maritime Exchange for the Delaware River and Bay, None 
Better Fruits & Vegetables, Star of the West Milling Company, 
Sunkist, Sunshine, Sunsweet, and Western Industries. Without 
objection, so ordered.
    [The information follows:]

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    Mr. Whitfield. At this time I would like to call up the 
second panel of witnesses for testimony on the Asthma Inhalers 
Relief Act of 2012. On that panel we have Mr. Jason Shandell, 
who is general counsel and secretary, Amphastar 
Pharmaceuticals. We have Dr. Monica Kraft, who is the professor 
of medicine at Duke University, president of the American 
Thoracic Society, and director of the Duke Asthma, Allergy, and 
Airway Center. We have Dr. Edward Kerwin, who is senior medical 
director, Allergy & Asthma Center of Southern Oregon. And we 
have Mr. Chris Ward, who is the former chairman of the Board of 
Directors of the Asthma and Allergy Foundation of America.
    And I would like at this time call on Mr. Walden for the 
purpose of introducing Dr. Kerwin.
    Mr. Walden. Thank you very much, Mr. Chairman. It is my 
honor to introduce Dr. Edward Kerwin, an allergy, asthma, and 
clinical research physician who traveled from Oregon out here 
today. We appreciate your being here. Dr. Kerwin founded the 
Allergy & Asthma Center of Southern Oregon in 1997, and prior 
to that, practiced in the area since '93.
    Today, he is going to provide the committee with insight on 
his years of experience as a physician serving patients in and 
around Medford, Grants Pass, Klamath Falls, and Ashland. In 
addition to his role as health provider, Dr. Kerwin is a 
leading clinical trial investigator on issues that we will 
discuss today. He authored over 25 medical publications on 
allergy and asthma, and even previously worked for NASA on 
solar energy technology and space antenna projects in the '80s. 
So maybe Mr. Olson will be back and we can talk NASA antennas.
    He is active in multiple professional trade associations, 
even finds time to participate in the Medford Rotary Club. And 
after this hearing he will be able to add testifying before 
Congress to his long and impressive rsum. And with that, Mr. 
Chairman, we thank you for having Dr. Kerwin invited to testify 
today.
    Mr. Whitfield. We have got a meeting in here for just a 
minute, but Dr. Burgess is going to go on and get the opening 
statements started and then we will be right back.
    Mr. Burgess [presiding]. So again, welcome to our 
witnesses. We will first hear from Mr. Jason Shandell, 5 
minutes for opening statement, please.

   STATEMENTS OF JASON SHANDELL, VICE PRESIDENT AND GENERAL 
    COUNSEL, AMPHASTAR PHARMACEUTICALS, INC.; MONICA KRAFT, 
  PROFESSOR OF MEDICINE, DUKE UNIVERSITY, PRESIDENT, AMERICAN 
THORACIC SOCIETY, AND DIRECTOR, DUKE ASTHMA, ALLERGY AND AIRWAY 
CENTER; CHRIS WARD, FORMER CHAIRMAN, BOARD OF DIRECTORS, ASTHMA 
AND ALLERGY FOUNDATION OF AMERICA; AND EDWARD M. KERWIN, SENIOR 
 MEDICAL DIRECTOR, ALLERGY AND ASTHMA CENTER OF SOUTHERN OREGON

                  STATEMENT OF JASON SHANDELL

    Mr. Shandell. Thank you. Good afternoon and thank you for 
this opportunity to testify. I am Jason Shandell, Vice 
President and General Counsel for Amphastar Pharmaceuticals, 
which is the parent company of Armstrong Pharmaceuticals. We 
are grateful to the Members and professional staff of the 
Energy and Commerce Committee for their assistance in helping 
us to hopefully distribute the remaining units of Primatene 
Mist. We strongly believe that allowing Americans to have 
access to Primatene Mist is better than leaving it to expire in 
a warehouse in California.
    Primatene Mist, an epinephrine inhaler with CFC as 
propellant was developed by Wyeth Labs in July 2008. Primatene 
Mist is approved for temporary relief of occasional symptoms of 
mild asthma. There are at least 2 to 3 million loyal Primatene 
Mist users in the U.S.
    When our company purchased Primatene Mist brand in 2008, we 
knew it would be going off the market and that there were 
technical challenges in creating an epinephrine inhaler without 
CFCs. This is referred to as Primatene HFA. We accepted the 
challenge, and in fact, we have developed Primatene HFA and we 
are targeting to file a new drug application with the FDA in 
the fourth quarter of this year.
    Because Primatene Mist was removed from the market on 
January 1, 2012, there is currently no over-the-counter inhaler 
for asthmatic patients on the U.S. market. An individual who 
previously used Primatene Mist must now pay to see a doctor and 
then buy a prescription inhaler that costs four to five times 
more than Primatene Mist.
    We have received thousands of inquiries from users of 
Primatene Mist who are desperate for availability of an over-
the-counter inhaler. Unfortunately, these inquiries have also 
cited two possible deaths because of the lack of such an over-
the-counter inhaler, and I have these emails here.
    Last December, we submitted a request to the EPA to allow 
for the sale of the remaining units of Primatene Mist based on 
public health and economic interests. The public health 
interest is growing since the untreated and undertreated asthma 
patient population is largely comprised of uninsured, 
economically disadvantaged black and Hispanic communities. This 
includes a large number of women and children. Without 
Primatene Mist, those asthmatics who have no insurance, they 
may have to seek care in emergency rooms, which can take many 
hours and cost thousands of dollars.
    The company's request for enforcement discretion was denied 
by the EPA on December 30, 2011, citing that it would not be in 
the public interest to allow for the sale of the remaining 
units of Primatene Mist. Since the EPA did not address the 
economic factors raised in our original request, we again 
requested enforcement discretion from the EPA on January 4, 
2012. The 2008 Final Rule stated that removing Primatene Mist 
from the market will cost consumers between $300 million to 
$1.1 billion. That is based on 2007 estimates. The cost to the 
Federal Government and taxpayers for Medicare and Medicaid 
could run as high as $75 million in each program, not to 
mention the severe financial burden that an emergency room bill 
can place on a family.
    We have not received a response from the EPA on this 
subsequent request based on economic concerns.
    Amphastar understands that Members of Congress have also 
written to the EPA expressing their concerns, and they have not 
received any response from the EPA as far as I can tell. The 
company has repeatedly asked why Primatene Mist was pulled from 
the market when actually there are two prescription drug 
inhalers that also use CFC as their propellants and they have 
been allowed to stay on the market through December of 2013. No 
one from EPA has ever explained why these two inhalers, with 
CFC, are allowed to remain but Primatene Mist is not.
    Primatene Mist has been on the market for almost 50 years 
and has a safe and effective track record. To remove Primatene 
Mist from the market because it contains CFC with no over-the-
counter replacement inhaler jeopardizes the health and safety 
of the 2 to 3 million Americans that have relied on this 
product for many years.
    Amphastar believes in putting people over profits, and 
throughout our efforts, we have offered to distribute all of 
the remaining units of Primatene Mist as a donation to public 
health clinics. This offer has been rejected by the government. 
We are not interested in profiting from the sale of the 
remaining inventory. Therefore, we hereby commit that we will 
donate all the net profits from the sale of the remaining units 
of Primatene Mist to charity.
    Amphastar believes in its product, Primatene Mist. It 
should be available in the United States over-the-counter so 
individuals who are suffering from asthma and depend on this 
product can enjoy instant relief when they experience asthma 
symptoms such as shortness of breath. We sincerely believe that 
there must be a readily available over-the-counter inhaler for 
Americans who have difficulty accessing a doctor to obtain a 
prescription and cannot afford to pay four to five times more 
for a prescription inhaler.
    In closing, let me again thank the members of this 
committee, specifically Dr. Michael Burgess and also 
Congressman Mike Ross and your professional staff for holding 
this hearing. Our goal is to get the remaining units of 
Primatene Mist out of the warehouse and into the hands of the 
American people.
    Thank you.
    [The prepared statement of Mr. Shandell follows:]

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    Mr. Burgess. I thank the gentleman for his testimony.
    Dr. Kraft, you are recognized 5 minutes for testimony, 
please.

                   STATEMENT OF MONICA KRAFT

    Ms. Kraft. Very good, thank you. I would like to thank the 
committee for allowing me to speak to you today.
    I am Dr. Monica Kraft, and I am a professor of medicine at 
Duke University and currently the president of the American 
Thoracic Society. This is a specialty society made up of about 
16,000 physicians who are pulmonologists with an interest in 
obviously respiratory issues, critical care physicians, and 
sleep physicians. So I also direct the Duke Asthma, Allergy, 
and Airway Center and have been involved in both research and 
care of patients with asthma. And my group and I have over 140 
publications along these lines.
    So it is with this professional scientific background that 
I come to you today to present testimony on the behalf of the 
American Thoracic Society on this issue of restoring 
epinephrine inhalers back to the U.S. marketplace. It is my 
strongly held view and the view of the American Thoracic 
Society that returning these inhalers to the U.S. market even 
for a limited time is ill-advised. But this view isn't just 
shared by me or my societies. It is also shared by several 
other societies, including the American Academy of Pediatrics, 
two asthma and allergy societies, and two respiratory therapy 
societies. So we are not unique in this view.
    Now, when we think about asthma we think of it as a very 
common disease. It affects between 5 and 10 percent of the 
population, so most of us know someone with asthma. We also 
have this perception--this is at least what I hear from 
people--that asthma is relatively mild and not a problem when 
actually I certainly take care of patients with very severe 
disease who die of their asthma. And one of the reasons that is 
is because the airways are red and swollen in asthma so they 
become narrowed. And it is somewhat like breathing through a 
straw. So really the mainstay of therapy is anti-inflammatory 
therapy like inhaled corticosteroids. You may have heard of 
that.
    We also use bronchodilators, which dilate the airways and 
we use this combination together. And in more severe asthma we 
may need to use oral steroids like prednisone or adopt other 
strategies such as focusing our allergic symptoms, which are 
very big triggers of asthma.
    So I am here to tell you that healthcare professionals play 
a really critical role in the management of asthma in that we 
form partnerships with our patients to get them not only the 
best combination of medications that they need that are safe 
and effective but also to educate them so that they can control 
their disease.
    So the takeaway message is the majority of cases asthma can 
be managed and patients with the appropriate therapy can live 
full and active lives.
    But I would say to you today that epinephrine is not one of 
those medications considered safe. So I am coming to you from a 
safety perspective. So epinephrine is a nonselective 
bronchodilator. So yes, it dilates. It bronchodilates. That is 
good, but it also has other effects, primarily cardiac that is 
very concerning to me and my colleagues. This can lead to 
excessive cardiac stimulation, heart rate, that can lead to 
heart attacks, especially in the older patients or those folks 
who have heart disease. And sometimes we don't always know who 
has heart disease.
    Now, for years, the medical community has recognized the 
dangerous side effects of epinephrine in the treatment of 
asthma and recommended against its use. The American Medical 
Association has urged warning labels. They have encouraged FDA 
to consider removing inhaled epinephrine. They have requested 
studies to really determine does it contribute to increased 
asthma morbidity and mortality.
    Now, I would be interested in hearing more about these 
deaths that we just heard mentioned in the last testimony 
because in speaking to my colleagues in emergency medicine--and 
my husband runs the emergency department at the University of 
North Carolina Chapel Hill--and my colleagues at Duke, their 
perception is since Primatene Mist has been off the market, 
there have been fewer severe exacerbations. And so we 
hypothesize that in fact patients are now getting the care that 
they need.
    We have a mechanism to take care of those patients who are 
uninsured, those underrepresented minority patients. I live in 
Chapel Hill. I see patients from Durham. We have a very 
significant contingent of underserved patients that we take 
care of at our institution. And we can provide them with the 
right medication. So I don't necessarily think it is all about 
access.
    So furthermore, the guidelines that put forth the treatment 
of asthma do not mention epinephrine as a viable option for 
treatment and I want to make sure that that is clear. The 
National Asthma Education and Prevention Program, put together 
by our own National Institutes of Health here in Washington, 
the U.S., have emphasized that inhaled medications are critical 
for asthma therapy but not epinephrine.
    So the American Thoracic Society strongly encourages any 
patient who is using over-the-counter medications like 
Primatene Mist to seek care from a provider and there are ways 
that these patients can get help. And I am a strong advocate, 
again, for allowing patients to learn how to take care of their 
own asthma and manage their disease because it is really all 
about putting the power in the hands of the patient and 
teaching them what they need.
    So if one of the goals of today's hearing is to discuss the 
pros and cons of enacting legislation to permanently or 
temporarily restore inhaled epinephrine for the treatment of 
asthma to the U.S. market, if the intent is to restore a safe 
and effective medication, I think that is a laudable cause but 
it is misinformed. Inhaled epinephrine is not safe for the 
treatment of asthma and no current clinical practice guideline 
calls for the use of epinephrine.
    If the legislative intent is to provide access to an 
inexpensive drug for the treatment of asthma, then I think that 
is laudable but misdirected. In my opinion and that of my 
society and other societies, the epinephrine's risk outweigh 
its benefits.
    And lastly, I am concerned about the message we are sending 
to patients. We spent a lot of time preparing patients for this 
transition when Primatene Mist was being taken off the market, 
moving towards approved asthma therapies that are effective and 
safe, and I worry that putting Primatene Mist back on the 
market, even temporarily, may send a confusing message.
    I would like to propose that Congress should be considering 
ways to increase patient access to healthcare professions who 
can work with patients to find an effective combination of 
drugs to control asthma. We should not be abandoning patients 
with serious medical conditions like asthma to self-diagnosis 
and self-medication with less-effective drugs that have known 
side effects.
    So I hope this committee will keep the view of the American 
Thoracic Society in mind as it considers legislation on inhaled 
epinephrine for the treatment of asthma. I thank you for the 
opportunity to speak to you today.
    [The prepared statement of Ms. Kraft follows:]

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    Mr. Burgess. Time is expired.
    Mr. Ward, recognized 5 minutes for the purposes of an 
opening statement.

                    STATEMENT OF CHRIS WARD

    Mr. Ward. Thank you, Dr. Burgess, members of the committee, 
for your invitation to speak today. My name is Chris Ward. I 
live here in Washington, DC, and I am past chairman of the 
volunteer Board of Directors of the Asthma and Allergy 
Foundation of America, and I have had asthma all my life. When 
I was a child, there were very few choices for treating my 
asthma. I have been fortunate, however, that more and better 
asthma treatments have come into use. I have also been 
fortunate to be under the care of an allergist, a specialist in 
the care of patients with asthma, since childhood when I was 
diagnosed. Now that there are a variety of safe, effective 
medications from which to choose to treat my asthma, I am a 
grateful beneficiary.
    Making the epinephrine bronchodilators, Primatene Mist or 
others, available over-the-counter may give patients a false 
sense of security. I know that from a personal perspective. If 
patients use this medication to achieve short-term control of 
asthma, which is a chronic disease, when long-term control is 
warranted, asthma is a chronic disease and short-term symptom 
relief may lull patients into a false sense of security and 
think they have no need to follow up with a healthcare 
practitioner physician.
    Asthma patients need professionals who can recognize levels 
of asthma control and recommend the most appropriate, effective 
medication to achieve control. Left on their own--I as well as 
other patients and a lot of us know that with medication over-
the-counter, that patients can get into trouble. Sound public 
policy should provide patients with opportunities to get 
appropriate treatment directed by skilled professionals. Having 
access to epinephrine bronchodilators over-the-counter may put 
patients at risk if they delay getting an appropriate diagnosis 
and effective treatment to keep their asthma in control.
    Some may argue that in the case of an asthma attack, 
patients need to be able to go to a drugstore or a market and 
buy an over-the-counter inhaler like Primatene Mist or other 
epinephrine inhaler. Should we recommend, however, that someone 
who is having an asthma emergency go to a store to buy a device 
rather than calling 9-1-1 or going to an emergency room or 
hospital? If patients need unplanned refills or replacement 
devices, they can contact their prescriber or even get those 
medications prescribed for them by a physician in an emergency 
room and then follow up otherwise.
    Another assumption that may prove false is that patients of 
low-income need these medications because they are low-cost. I 
grew up in an area of the country where there were a lot of 
low-income patients, and I certainly was not a child of means. 
While the price of Primatene Mist may be lower than the total 
cost or co-pay for more effective bronchodilators, the relief 
from these epinephrine devices does not last as long. Thus, the 
long-term control and long-term cost is actually higher.
    Over-the-counter access to this product may seem to erase 
the cost of visiting a prescriber. However, over-the-counter 
bronchodilators can promote self-diagnoses, and we are all 
subject to those kinds of self-treatment sometimes, which is 
particularly unsafe for the symptoms of asthma because it can 
be deadly. With proper diagnoses and treatment, people can 
control their asthma symptoms, avoiding high-cost interventions 
like emergency department visits and hospitalizations. Cutting 
out care by a qualified medical practitioner could be dangerous 
for the patient and costly to the healthcare system.
    The decision to withdraw Primatene Mist from the U.S. 
market was made years ago. Lifting the ban may now lead to 
confusion. There will be little opportunity to inform patients 
about the nature of the change and to urge them to seek care 
from a professional if they think they have asthma. I have 
worked with professionals like Dr. Kraft many years of my life 
in the industry of healthcare and life sciences, worked for 
pharmaceutical companies and other healthcare organizations. I 
have also been a volunteer as a volunteer leader of the Asthma 
and Allergy Foundation of America, and I know that asthma is a 
serious chronic condition, and I know what a difference 
effective treatment can make and even as a child with very few 
available to me, I was very fortunate.
    I urge you, for all asthma patients, to reject an attempt 
to re-release an epinephrine inhaler to the market as an over-
the-counter product. Again, I thank all the members of the 
committee for inviting me here to testify today.
    [The prepared statement of Mr. Ward follows:]

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    Mr. Burgess. I thank the gentleman for his testimony.
    Dr. Kerwin, you are recognized for 5 minutes for an opening 
statement.

                 STATEMENT OF EDWARD M. KERWIN

    Mr. Kerwin. Thank you very much to the committee and the 
subcommittee for inviting me to testify.
    As Congressman Walden explained, I am an allergy 
researcher, asthma researcher. I have conducted over 300 
clinical trials with over 200 new state-of-the-art medicines 
for asthma and I care for 10,000 asthma patients. And I trained 
with Monica. I will say that I am a member of the American 
Thoracic Society, a fellow of the American College of Allergy, 
and the American Academy of Allergy and never once have those 
organizations polled me or any of their general membership on 
the issue of Primatene.
    Now, my comments today briefly----
    Mr. Burgess. I am sorry, sir. Your microphone popped. Could 
you make that statement again? I missed it.
    Mr. Kerwin. I thought the microphone was on. I wanted to 
just state that I am a member of the American Thoracic Society 
for the last 10 years, a fellow of the American College of 
Allergy, and the American Academy of Allergy and never once 
have those organizations polled myself or any others of the 
general membership on the issue of Primatene and the safety of 
Primatene. So what I will tell you is these organizations are 
speaking on behalf of the administrative doctors working there 
but not on behalf of the general membership.
    Now, what I want to say is that I think we live in a 
difficult era in science and culture. There are major 
scientific advances happening all the time, and I will just say 
that that is how I spend 90 percent of my time, doing clinical 
research with some of the latest, most advanced medicines for 
asthma. Science tells us CFCs can be harmful to the ozone layer 
and they do need to be removed gradually over time and that has 
happened with hairsprays and air conditioners and 
refrigerators. And I am happy to say that there are many new 
HFA medications that are available for asthma. So science is 
moving forward. We hope that there will be an HFA Primatene 
perhaps within a year.
    But I have to say that there are also many issues of 
practicalities that critically need to be considered when any 
new law is implemented. And science cannot just be implemented 
as a blanket process. It has to be implemented in a rational 
way.
    Asthma, as you have heard, is a disease that strikes in the 
middle of the night, and I don't know many private practice 
doctors who are going to be available 24/7 if you suddenly need 
a prescription medicine. Asthma occurs at your 4th of July 
picnic and it is going to occur when you visit your least 
favorite relatives who have five cats at home. Asthma may 
affect your college daughter when she moves into a basement 
apartment that has mold in it. It may occur when you get out 
and run a 5K or a 10K running race, and it will hit you when 
you come to visit me in Oregon where we have horse farms and 
hay farms.
    What I need to make clear is that despite all of the 
science, which I am happy to discuss endlessly, Primatene Mist 
is a first aid situation kind of medicine. The reason it is 
over-the-counter is that there need to be immediate access, 
immediate use medicines available to children, poverty-stricken 
patients, elderly people who have acute airway disease. It is 
similar to choking where a Heimlich maneuver is needed. It is 
similar to a bee sting where Benadryl can be picked up at any 
convenience store. We need regular access to emergency 
medicines.
    Now, the American Thoracic Society and others may say you 
can get albuterol HFA but I challenge them that is simply not 
true. There are many, many Americans who have no insurance, 
they have no doctor, they have no prescriptions. They cannot 
simply get albuterol HFA.
    The best analogy that comes to my mind is basically a life 
vest or a life raft on a ship. We have all seen the Titanic 
movie. We know what happens if there are not enough life vests 
or life rafts. Now, we have seen the Costa Concordia ship. The 
question is should all the life vests be locked up where only 
the ship's doctor or the ship's captain has the key? That 
simply does not make sense for a medicine that can be 
lifesaving for poor people in inner cities.
    I am going to end by reading a brief poem. This is a little 
over the top but this is the poem engraved on the bottom of the 
Statute of Liberty, a little excerpt that says, ``Give me your 
tired, your poor, your huddled masses yearning to breathe free, 
The wretched refuse of your teeming shore. Send these, the 
homeless, tempest-tost to me, I lift my lamp beside the golden 
door!'' Now, what that means really is that we live in a 
country where there are many people who don't have 
opportunities to see fine and wonderful doctors. They need some 
temporary relief medicines. Scientifically, we are all in favor 
of HFA over-the-counter medicines, but there are none.
    So I would ask the committee to consider extending the use 
of Primatene. It is the only available rescue medicine for up 
to 30 million Americans who don't have healthcare.
    Thank you.
    [The prepared statement of Mr. Kerwin follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr. Burgess. The gentleman's time is expired.
    We thank all witnesses for their testimony. I am going to 
start with myself.
    If I was sitting down there, I would complain to the 
chairman that we don't have the EPA here and we don't have the 
Food and Drug Administration here because really that is who 
needs to be at this hearing. And I do want to thank all of you. 
I mean this has been difficult for me because I just simply did 
not understand what in the hell was going on. You have got the 
EPA saying the Montreal Protocol says we have got to take this 
stuff off the market. The FDA is saying, yes, yes, we are 
working on a replacement; we are going to get to it. But it 
just wasn't happening and I couldn't get anyone to answer my 
questions. Lisa Jackson, Gina McCarthy were not only 
dismissive, they were derisive. Dr. Hamburg at the EPA just 
simply evaded the question but now I understand. There is a 
contingent of people who do not think that epinephrine belongs 
as part of the armamentarium for treating asthma. OK.
    Dr. Kraft, have you talked to the FDA about the withdrawal 
of epinephrine as an asthma therapy? I mean it has been around 
for 50 years. Presumably it was approved at some point. So have 
you provided testimony or documentation to the FDA on this 
subject?
    Mr. Kraft. What I have done is we have been involved as a 
society in looking at----
    Mr. Burgess. So the answer to the question is no, you have 
not----
    Mr. Kraft. No, I have not talked to them directly other 
than offline. So you won't find any documented testimony. One 
thing I would like to put forth, however----
    Mr. Burgess. Well, could you provide us those things that 
you have sent to them offline? You have communications?
    Mr. Kraft. And I am just being told the ATS other than 
myself personally has commented on the transition process.
    Mr. Burgess. OK, so you will----
    Mr. Kraft. We can provide that.
    Mr. Burgess. On the transition process, but I mean look, if 
you want a drug withdrawn from the market--and this happens all 
the time--I mean you go to the FDA and say we have post-market 
surveillance. This stuff is as bad as key tech. This stuff is 
as bad as--I forgot what the anti-inflammatory was----
    Mr. Kraft. VIOXX.
    Mr. Burgess. VIOXX. And things happen.
    Mr. Kraft. Sure.
    Mr. Burgess. Have you done that?
    Mr. Kraft. We can provide you with--absolutely. We have 
been to the FDA. We have two issues actually if you permit me 
to----
    Mr. Burgess. Well, what did the FDA tell you?
    Mr. Kraft [continuing]. Speak. We have issues on--there is 
a CFC issue. To be honest, I am here today as a physician 
caring for patients. I am really here for the patients' safety 
piece because we have been calling for the removal of inhaled 
epinephrine well before Montreal Protocol really became an 
issue.
    Mr. Burgess. Right. So that is the issue that you are 
coming to discuss today, but the hearing is on the Montreal 
Protocol and the CFC prohibition preventing asthmatic 
patients----
    Mr. Kraft. Right.
    Mr. Burgess [continuing]. From having a rescue inhaler.
    Mr. Kraft. Absolutely. So----
    Mr. Burgess. And I am speaking to you not just as a Member 
of Congress. I am also a physician. I am also an asthma 
patient----
    Mr. Kraft. Right.
    Mr. Burgess [continuing]. And I use over-the-counter 
epinephrine metered-dose inhalers and I have for some time. I 
use them as part of the rescue phenomenon that we have all 
heard talked about, and yes, OK. I am a doctor. I can go down 
to the all-night pharmacy and write my own prescription for 
albuterol. But if I get trapped in a situation without an 
inhaler, it happened to me in Chicago at an NRCC fundraiser a 
few years ago. The hotel put me in a room where somebody had 
been smoking. So at 2:00 in the morning, guess what? I can't 
breathe. So I got two options. I can stay up the rest of the 
night holding onto the chair using the accessory muscles of 
respiration and have a sleepless night or I can go down to the 
front desk clerk and say where is your nearest 24-hour 
pharmacy? He says one block over, two blocks up. I say thank 
you very much, take my life in my hands, walk across the 
streets of Chicago at 2:00 in the morning, but a rescue inhaler 
is available to me.
    Mr. Kraft. Right.
    Mr. Burgess. And I could do this without being a physician, 
just being a regular Joe you can go and get that but not 
anymore. And this is the difficulty that I have is you have the 
product in the warehouses. If you are really concerned about 
CFCs, if this is really about the hole in the ozone, what is 
going to happen to those canisters? I mean at some point they 
degrade to the point where they blow up I guess. I mean I don't 
know. I don't know what the lifecycle is of one of those 
things. But the CFC is going to go into the environment. So 
what are we preventing here? Are we going to go put them in 
Yucca Mountain and entomb them in concrete so that they don't 
ever get out? I mean I don't even know how much CFC we are 
talking about here.
    But it is just preposterous that we are having this 
argument around CFC, around the propellant under the Montreal 
Protocol when really your beef is with epinephrine and we 
should have the FDA here and you should be asking them----
    Mr. Kraft. I agree.
    Mr. Burgess [continuing]. To explain what studies have you 
done? Why do you still allow this stuff to be sold? And I would 
have some questions for them about that as well. But no one 
would answer my questions. Can you understand the frustration? 
I have had Lisa Jackson here at this table and she just looks 
at me like I am nuts. I have had Gina McCarthy and she laughs 
that I am even concerned about this.
    Mr. Kraft. Um-hum.
    Mr. Burgess. Margaret Hamburg won't even answer the 
question. Can you understand why there is such frustration with 
this?
    Mr. Kraft. I do.
    Mr. Burgess. And at the same time I am getting these same 
letters from constituents, Doc, how come I can't go buy this 
stuff anymore? How come you took it away from me? How come you 
know better than I do about what is best to treat my asthma? It 
is not just breathing through a straw; it is breathing through 
a straw that is packed full of cotton. I mean this----
    Mr. Kraft. Absolutely.
    Mr. Burgess [continuing]. You know, Mr. Ward. I mean this 
is a dreadful set of symptoms to have visited upon someone. You 
have got a rescue inhaler. If the issue is that it is not a 
satisfactory pharmacologic agent, let us work on getting 
albuterol over-the-counter----
    Mr. Kraft. I agree.
    Mr. Burgess [continuing]. And I will just share with you my 
personal preference is CFC is a much better propellant----
    Mr. Kraft. Right.
    Mr. Burgess [continuing]. Than HFA. HFA is for wimps. CFC 
delivers the right dose at the right time.
    I am going to yield to the ranking member of the 
subcommittee.
    Mr. Kraft. Would I be permitted to answer?
    Mr. Burgess. Oh, please.
    Mr. Kraft. Thank you. So I agree with your frustration. I 
can understand that. If I were your doc, I would make sure you 
had three separate albuterol inhalers. I would have you put one 
in your briefcase, I would have you put on in the glove box of 
your car, and I would have you put one in your wife's purse to 
make sure that you always have albuterol with you. So that is 
the first part.
    Mr. Burgess. I do that, but the best-laid plans don't 
always work out. And sorry that I wasn't prepared that night 
but it happens. It happened on a flight into Dulles where, you 
know, I didn't have an inhaler. I had a long cab ride back. Oh, 
my lands, I am really in trouble. I asked the cabdriver, would 
you stop at a pharmacy and let me pick up a rescue inhaler so I 
am not sitting here in the backseat of your cab suffocating----
    Mr. Kraft. Right.
    Mr. Burgess [continuing]. And he was happy to accommodate 
me. I mean those are real-world situations and they happen all 
the time. My wife will likely not carry one in her purse for 
me, but I do have one in my glove box. I do have one in my 
backpack. I don't carry a briefcase but, yes, I have got them 
scattered all over my life----
    Mr. Kraft. OK.
    Mr. Burgess [continuing]. But sometimes I wander away from 
them. I will let you respond.
    Mr. Kraft. OK, thank you. The other issue is regard over-
the-counter. There actually is a movement going on to start 
talking about over-the-counter bronchodilators that are safe. 
It is still in the very early stages. It is somewhat 
controversial because we are still on the same issue where we 
want to make sure that practitioners interact with their 
patients to be able to educate them on the principles of asthma 
and know what combinations of medications work best for them.
    So I don't know if you are aware of that or not. So I 
wanted to just put that forth as something that is in the 
works. If we are really focusing on this over-the-counter 
piece, I think there is a thoughtful way to consider over-the-
counter medications for asthma that aren't necessarily 
Primatene Mist per se.
    I am also a critical care physician and I have seen more 
patients coming into my intensive care unit with their 
Primatene Mist inhaler clutched to their chest with a severe 
asthma exacerbation on a ventilator. And I don't see that when 
they are on proper therapy. We have seen a much lower incidence 
of really severe asthma exacerbations because of people getting 
in with their docs, getting on anti-inflammatory inhalers. 
Because I worry this reliance on going down to the drugstore 
and getting Primatene Mist and not being on something daily for 
asthma--because it is about redness and swelling of the airways 
is a problem.
    Mr. Burgess. We need to go to Mr. Rush. I don't want you to 
be concerned for my health and safety. I do have an ADVAIR 
inhaler and I do use it----
    Mr. Kraft. Well, I am.
    Mr. Burgess [continuing]. Regularly. But there are times 
when you need that extra boost.
    And I will yield to Mr. Rush, 5 minutes for questions.
    Mr. Rush. Well, thank you, Mr. Chairman. Mr. Chairman, I 
was headed along the same path. I think you might have 
inadvertently--didn't mean any harm--mentioned the fact that 
you took your life in your hands by walking outside of a hotel 
in Chicago and I really take offense to that. But I have been 
working on this issue of asthma for quite a while and it is a 
real acute concern of mine and it has been and always will be 
because it disproportionately impacts my community. In the year 
2000, Congress passed the Asthma Reduction Act, which 
incorporated aspects of a bill that I sponsored into the 
Children's Health Act of 2000. And it came along and I still am 
very much concerned about the issue of asthma. And I have to 
say I am somewhat torn but I have to come down on the side of 
my constituents.
    Mr. Chairman, a month and a half ago I had a pastor at a 
church and the person who is one of my--not my key person at 
the church--had asthma and I think you might recall I had to go 
and bury him. And he was a member of my church and he was an 
asthmatic patient and he died of congestive heart failure. But 
he was an asthmatic patient also. And his memory keeps 
overpowering me and overwhelming me even now. And he was under 
a doctor's care. But now, many, many people who are my 
constituents, I have one of my long-time staff members is an 
asthmatic patient. Every Tuesday she takes half a day off and 
this has been going on for years. She goes to the doctor to get 
the shots that I have seen her go into crisis situation on more 
than one occasion.
    And I know that the science and the goodhearted folks--but 
I just have to say to Dr. Burgess, I think that this 
legislation that you come up with, I don't like the fact that 
we have to do this, but I just don't see, given the absence of 
any other approach that this Congress can make, I don't see how 
we can avoid it. I for one just find that there are too many of 
my constituents who don't have access to healthcare, who don't 
have a doctor, and who even think it would take too much time 
right now if they would be able to do--they just don't have the 
wherewithal. They are missing so many elements keeping them 
from living productive lives, and asthma is becoming more and 
more of an issue. It is probably one of the leading health 
issues in my community.
    And I hear the arguments but I think that this Primatene 
should be allowed back on a temporary basis, understanding what 
the problems are with it, what the short-term solution might 
mean to other long-term issues--I haven't addressed the long-
term issues. But I don't see the solution to these issues. I 
don't see that being eminent and overnight, reality, because it 
has to do with access to healthcare. And this Congress, we have 
tried to address it but we can't agree on what access to 
healthcare really means to the American people. I know my time 
is expired. I had some questions but I just had to get out what 
I had to say about this particular issue.
    I yield back.
    Mr. Whitfield. Well, thank you, Mr. Rush.
    At this time, I recognize the gentleman from Texas, Mr. 
Barton, for 5 minutes.
    Mr. Barton. Thank you, Mr. Chairman.
    When I go to Chicago, which I don't do very often, I just 
carry around Bobby Rush-is-my-friend cards and I have never had 
a problem on the streets of Chicago. I just show them that card 
and they say what can we do for you? They just couldn't be 
friendlier.
    So when Dr. Burgess indicated he was going to introduce 
this bill, I was encouraging of him introducing the bill. You 
know, but this goes under the heading of no good deed goes 
unpunished because apparently a lot of the people in the 
asthmatic community are fairly opposed to his bill.
    My first question would be to the panel. Each of you 
indicate you support the bill, oppose the bill, or are neutral 
on the bill. Just start and go right down the line.
    Mr. Shandell. Yes, I definitely support the bill. I find it 
ironic that these third parties are now raising safety issues 
when this really was an environmental issue. Primatene Mist has 
been around for half a century.
    Mr. Barton. So you support the bill?
    Mr. Shandell. I support the bill.
    Mr. Barton. I don't need the editorial right now.
    Mr. Shandell. I support the bill.
    Mr. Barton. OK. Dr. Kraft?
    Mr. Kraft. I oppose the bill. Am I allowed to say anything?
    Mr. Barton. Well, in a minute.
    Mr. Kraft. OK.
    Mr. Barton. Right now, we have got one for and one against.
    Mr. Kraft. All right.
    Mr. Barton. Mr. Ward?
    Mr. Ward. As a patient, I think I would oppose the bill----
    Mr. Barton. Oppose the----
    Mr. Ward [continuing]. As it is currently constructed.
    Mr. Barton. As it is currently constructed, OK.
    And Dr. Kerwin?
    Mr. Kerwin. And I definitely support the bill----
    Mr. Barton. Support the bill.
    Mr. Kerwin [continuing]. Only alternative out there for 
people who don't have a doctor right next to----
    Mr. Barton. So we are two to two. We have two for and two 
against. That is not bad. I mean, you know, that is a tie. In 
this committee, the tie goes to the sponsor of the bill.
    So my next question, Primatene Mist, if it were allowed to 
be sold over-the-counter, the existing stocks, what would that 
cost an individual who just walked in and purchased it? What 
would it----
    Mr. Shandell. I can answer that. So we sell to the 
retailers who then mark up, but we will not raise the price of 
Primatene. As I said, we will donate all the profits. So based 
on the past sales, we are looking at about $20 at the retail--
--
    Mr. Barton. If it were allowed to be sold, it would be 
around $20?
    Mr. Shandell. Correct.
    Mr. Barton. Now, if I don't have it and I have to go to a 
doctor and get a prescription, what does that prescription cost 
for the equivalent amount of dosages?
    Mr. Shandell. Well, the prescription itself let us not 
forget the doctor's bill but the actual inhaler is $110.
    Mr. Barton. OK, Dr. Kraft, you have got----
    Ms. Kraft. I would like to respectfully disagree. Yes, 
there are places where in fact it is $120. If you look, which I 
just did today, not in Canada, $30----
    Mr. Barton. Thirty dollars.
    Ms. Kraft [continuing]. You can find----
    Mr. Barton. You can get----
    Mr. Kerwin. Well, I will just have to say that having 
practiced allergy and asthma care for 20 years, there is 
nowhere in my State of Oregon where you can get albuterol 
inhaler HFA for less than $60 to $70 a canister.
    Mr. Barton. All right. So----
    Mr. Kerwin. So that is the fact----
    Mr. Barton. We are----
    Ms. Kraft. Well, I guess I practice in a part of the 
country that is a little less----
    Mr. Barton. We are all in agreement that the prescription 
is going to be somewhat more expensive. If you are an informed 
consumer like Dr. Kraft, you can get it much less expensively, 
but there is nowhere you can get it for the same price. That is 
fair?
    Now, the next question--which of you a medical doctor, 
which of the two doctors? So we have two medical doctors. This 
is great because you are on each side of the issue. What is 
wrong with allowing the sale of the existing stocks and use 
that as an emergency but also have your prescription where you 
get the treatment regime that actually seems to be more 
effective? What is wrong with that, Dr. Kerwin?
    Mr. Kerwin. Well, thank you for making that point. That is 
exactly the kind of care we think Americans should get. Like 
Dr. Burgess does, they should see a doctor, they should get 
educated about their asthma, they should reduce their allergy 
exposures, they should get anti-inflammatory inhalers, and they 
should have access to Primatene just for emergencies. I live in 
a rural State. Many patients in southern Oregon live 50 miles 
from the nearest doctor. That is quite common. Certainly, 100 
miles from an emergency room. We believe there is a role for 
Primatene or epinephrine or any over-the-counter inhaler. I 
would support over-the-counter albuterol but it is not----
    Mr. Barton. My time is about to expire.
    Dr. Kraft, my friends at the Allergy and Asthma Network 
Mothers of Asthmatics point out that there is a product 
manufactured by Nephron Pharmaceutical that is a handheld bulb 
nebulizer. What does that cost? And is that effective?
    Ms. Kraft. That is epinephrine also is my understanding and 
so I do not know the cost of that. But I would like to comment 
on your first statement----
    Mr. Barton. I mean that would take care of the Montreal 
Protocol issue I think because it is a handheld. It doesn't use 
a CFC.
    Ms. Kraft. Right. The issue I see is that Primatene has 
been around for 50 years, so that is one issue that people like 
to bring up. I would argue that 50 years ago we didn't have a 
lot of particularly effective asthma therapies. So that is all 
there was. Now, we do.
    Now, I am also in favor of over-the-counter options for 
asthma and that is actually, as I was mentioning earlier, that 
is in the works at the FDA.
    Mr. Barton. Well, it has been in the works for----
    Ms. Kraft. Well----
    Mr. Barton [continuing]. A number of years.
    Ms. Kraft [continuing]. Actually, I think there have been 
hearings. It is actually heating up quite vigorously and we are 
right in there part of it as supportive with thought.
    Mr. Barton. Well, my time is expired and I appreciate the 
chairman's courtesy.
    Ms. Kraft. OK.
    Mr. Whitfield. The gentleman's time is expired.
    Mr. Barton. I do think Dr. Burgess has a good idea here. If 
we can work with the community so it is not two to two, we may 
have a bill that actually goes somewhere.
    Mr. Whitfield. At this time, I will recognize the gentleman 
from California, Mr. Waxman, for 5 minutes.
    Mr. Waxman. Thank you, Mr. Chairman.
    Obviously, if you have two on each side, it doesn't produce 
a tie; it just means it is a balanced presentation and that is 
always a good idea so we hear both sides of the issue.
    But I am going to ask about the health effects of all of 
this. Dr. Kraft, you are the president of the American Thoracic 
Society and a recognized expert on asthma. And there is a long 
list of medical and public health organizations who have raised 
concern about the over-the-counter epinephrine inhalers. In 
your testimony, you said epinephrine inhalers like Primatene 
Mist are not a safe treatment for asthma and are not 
recommended by expert guidelines. Why is that?
    Ms. Kraft. You are absolutely right. That is true. The 
reason is it is the compound itself, the chemical epinephrine. 
It is nonselective. So yes, it can bronchodilate, so that is 
the good news, but it has effects on other organs. And the 
major concern is cardiac, excessive cardiac stimulation and can 
lead to myocardial infarction, heart attack in patients who 
have heart disease. And that is really the concern. I am not 
against over-the-counter medications for asthma necessarily if 
done in a thoughtful way. I think that this particular 
medication is concerning. And there have been voices for many 
years calling for the removal of this particular agent because 
of the dangers and the side effect profile. That is really 
where we are sort of coming from today.
    Mr. Waxman. But it is not easy for FDA to take a drug off 
the market. Do you know what the standard of proof is? I assume 
it is pretty tough.
    Ms. Kraft. I am sorry. Repeat that question, please.
    Mr. Waxman. Has FDA tried to take it off the market? Is it 
something that FDA should take off the market?
    Ms. Kraft. You mean Primatene?
    Mr. Waxman. Yes.
    Ms. Kraft. Well, it has been off the market for 6 months 
because of----
    Mr. Waxman. But did they ever move to take it off the 
market?
    Ms. Kraft. There have been calls from the American Medical 
Association----
    Mr. Waxman. Um-hum.
    Ms. Kraft [continuing]. To the FDA to consider it. But I 
think it is a difficult situation because the question is can 
we look at alternatives and can we improve access to care for 
patients----
    Mr. Waxman. Um-hum.
    Ms. Kraft [continuing]. So that they can actually get the 
right medications. So I like the idea of having something 
available for patients but I would argue let us make it the 
best medication and a safe medication.
    Mr. Waxman. Well, Dr. Kerwin argues in his testimony that 
Primatene Mist is necessary for an emergency situation where 
someone suffering from asthma does not have a prescription 
medication. He says people would die or could die without it. 
What do you think in a potentially life-threatening situation, 
should asthmatics use Primatene Mist?
    Ms. Kraft. I have actually seen the ramifications of using 
it in an emergency situation and relying upon it to improve 
asthma symptoms. And the issues--it is very short-term in terms 
of its action and the excessive additional side effects of the 
cardiac piece actually, in my opinion, is not a safe 
alternative. So I would actually recommend--and we have done 
this in the community that I practice--we have the ability for 
patients to get albuterol very easily and to have access to 
emergency departments and follow up with us so they can get the 
medications they need. And we have a big community program in 
Durham for this purpose exactly to help the underserved because 
I think that is who we are talking about today, those patients 
who don't have the access that perhaps the rest of us do.
    Mr. Waxman. Well, I take seriously when the health 
professionals take a point of view that something is not safe, 
particularly if it is--this bill would go to extraordinary 
lengths to put it back on the market. It is not on the market 
now. If I were convinced, however, that it is necessary, then I 
would say fine. Let us keep it out there. But I don't think we 
have got to push legislation to put a product back on the 
market in the face of such strong opposition by public health 
and physician organizations.
    Am I correct that public health and physician organizations 
take the same point of view you do?
    Ms. Kraft. Yes, many.
    Mr. Waxman. Now, I want to go into the question of how fair 
this is to the company. The company obviously wants to sell the 
product that they still have and they are not going to pursue 
it after that. The initial proposal by FDA was to phase out the 
drug and it was agreed upon it would be December 31, 2010. 
Armstrong submitted comments to FDA requesting it be extended 1 
year, and FDA granted Armstrong's request for a 1-year 
extension. Isn't that right, Mr. Shandell?
    Mr. Shandell. Yes. I would like to address that because----
    Mr. Waxman. Well, I just want your answer because----
    Mr. Shandell. Yes, that is correct.
    Mr. Waxman. No, my understanding is that about a dozen 
other types of inhalers containing CFCs were phased out before 
Primatene Mist. That includes the albuterol phase-out in 2008 
which involved moving millions of asthmatics to new 
treatments----
    Mr. Shandell. Which was our product as well.
    Mr. Waxman [continuing]. Only two CFC-based inhalers remain 
to be phased out, and both are scheduled to be taken off the 
market at the end of 2013. So Primatene Mist was actually 
phased out several years later than many other types of 
inhalers. Would it be fair to them to have you come back on the 
market when they----
    Mr. Shandell. Well, that is what I would like to address 
because, you know, this is an environmental issue regarding 
CFC. It is not a safety issue because otherwise----
    Mr. Waxman. Well, this is not a safety question that I am 
asking. I am just asking you in basic fairness----
    Mr. Shandell. Well, yes, the----
    Mr. Waxman [continuing]. If other companies follow the 
rules----
    Mr. Shandell [continuing]. Fairness question is that we 
have been working with FDA since 2007 for HFA Primatene. So 
obviously the FDA believes in Primatene because we have spent 
tens of millions of dollars on clinical trials and we are 
looking to get an approval next year. So obviously----
    Mr. Waxman. No other company----
    Mr. Shandell [continuing]. New drug applications----
    Mr. Waxman [continuing]. Came back and said we are not----
    Mr. Shandell. And the only reason we are----
    Mr. Waxman. Excuse me, sir.
    Mr. Shandell. Yes.
    Mr. Waxman. I have already exceeded my time but I get to 
ask the questions.
    Mr. Shandell. Sure.
    Mr. Waxman. And other companies phased out--not other 
company was allowed to come back and sell off its remaining 
inventory after the phase-out date. Isn't that right?
    Mr. Shandell. That is correct. No other company is over-
the-counter so there is no----
    Mr. Waxman. What difference does it makes if it is over-
the-counter or prescription?
    Mr. Shandell. Because if you don't have a prescription, you 
can't afford insurance, you have no choice.
    Mr. Waxman. That is a different issue but a drug to be 
extended and allowed to come back and sell off the----
    Mr. Shandell. We have a million units remaining----
    Mr. Waxman [continuing]. Inventory.
    Mr. Shandell. We don't need to sell the inventory. We are 
advocating on behalf of our customers who have been complaining 
saying that people have died actually. So we are just coming 
out not for money. We are saying, look, let the million be 
sold. We are really interested in getting HFA approved so there 
is an over-the-counter. In terms of fairness, there are two 
prescriptions that are still not the market with CFC and nobody 
has answered why those are allowed to stay if it is an 
environmental issue and not a safety issue.
    Mr. Whitfield. Gentleman's time is expired.
    I will recognize myself for 5 minutes of questions now.
    We have a situation here where we have in storage some 
Primatene Mist. This legislation relates only to that. This is 
a product that has been used 40, 50 years, was accepted by 
people who used it and obviously people benefitted from it or 
they wouldn't continue to buy it. We have a lot of letters or 
emails here from people--``I just spent my last $200 on my son 
at a doctor's appointment for asthma medicine and will no 
longer be able to go to the doctor's'' because Primatene Mist 
is gone. We have a lot to that effect. I understand a genuine 
concern about, oh, this is not safe for people, and Dr. Kraft, 
you have said that this is not a safe treatment. There are side 
effects. There are cardiac problems with it. And now, Dr. 
Kerwin, would you reply to that comment that Dr. Kraft made?
    Mr. Kerwin. Yes, I would be delighted to reply to that. You 
know, Primatene was released and approved by the FDA either in 
1957 or 1963, and at that time, the approval process was less 
rigorous than it is now. So Primatene has been what we would 
call a grandfathered medicine that has been out for many, many 
years. Every drug company is required to collect safety reports 
if there is any episode where a drug fails a patient or where 
they die for any reason that could be related to the drug. And 
my understanding is Amphastar has received no complaints of 
patients who have had life-threatening cardiac problems or 
other what we call serious adverse events with this medicine. 
It is truly unfair to say that it is not a safe drug. That is 
100 percent speculative. The way safety is assessed is through 
a clinical trial process, and epinephrine in the HFA form is 
going through a very careful and rigorous FDA-authorized safety 
process.
    Mr. Whitfield. Thank you. I might----
    Mr. Kerwin. Safety is roughly parallel. It is slightly more 
cardiac stimulating.
    Mr. Whitfield. I mean I can understand in Durham that there 
may be a program developed that really addresses this emergency 
need, but there are lots of places in the country that do not 
have programs like that. And from my personal perspective, I 
don't see what is wrong with giving patients a choice. If it is 
available and they want it for a period of time, why not?
    But I would like to yield the balance of my time to Dr. 
Burgess.
    Mr. Burgess. Well, Mr. Chairman, I would just reiterate the 
observation that we are here today having this hearing. The 
legislation has been introduced essentially because two Federal 
agencies decline to be truthful with the committee. And that is 
the real tragedy here. Yes, we should have the EPA here. They 
should be answering the question why are there two prescription 
products that are continuing to use CFCs still sold, not 
affected under the ban? We should hear from the FDA. Have you 
had post-market surveillance data on inhaled epinephrine 
products that lead you to believe that it is unsafe?
    But instead, we have got this mishmash, this backdoor 
banning of a product that has been approved for 50 years on 
which people depend under the Montreal Protocol. I mean this 
really makes no sense. If we are really frightened of the CFC 
in those remaining canisters that Mr. Shandell has secreted 
away somewhere, I submit that we ought to reopen Yucca Mountain 
and take them deep into the Earth and entomb them in cement 
like we would radioactive waste.
    But those canisters are eventually going to degrade, pop 
open, and the CFC floats over the Antarctic and widens the hole 
in the ozone. At least that is what we are led to believe that 
this small amount of CFC is going to lead to all sorts of 
global calamities.
    Dr. Kerwin, look, I have been in the ICU when a young 
patient has died from an aspirin overdose. I mean that is 
tragic, the acidosis that accompanies like 24, 36 hours later. 
Everybody thinks the kid is out of the woods and then he dies. 
So we know people can die from over-the-counter products. Yet, 
people take aspirin all the time for headaches. Would it make 
sense that we told people if you have a headache, you really 
shouldn't take aspirin anymore. Come to the emergency room, let 
us give a CAT scan to make sure you are not dying of a brain 
tumor and then we will get you something. I mean that is kind 
of what we are saying here, isn't it?
    Mr. Kerwin. I would say that the principle of having 
medicines available over-the-counter is sort of a twofold 
principle. One is America was settled by frontiers people who 
came out to many of the big States and they didn't have a 
doctor on their Oregon Trail wagon train. So we live in a 
country where people have a fundamental right to try to treat 
themselves first before they take the radical step of seeing a 
doctor. The second thing I would say is medicines over-the-
counter are designed in order to help the many even if overuse 
of the medicine or misuse might harm a few. And I think 
Tylenol, 20 pills of that can hurt your liver. Benadryl, 20 
pills of that could put you in a car crash, and yes, 20 puffs 
of epinephrine might make your heart race. But these medicines 
are consistent with the values that patients should have a 
right to treat themselves initially and they should then seek 
better medical care.
    Mr. Burgess. Well, Mr. Chairman, I will just close with the 
observation that we should require the two Federal agencies 
involved--Environmental Protection Agency and the Food and Drug 
Administration--to come before this committee and be honest 
with us for a change, none of this hide-the-ball, oh, it is a 
Montreal Protocol thing. If there is a danger to inhaled 
epinephrine, then why the hell has the FDA not prevented it? We 
have been through this round and round with the FDA where they 
say, oh, we know that something is dangerous but we can't 
prevent it being sold. That is nonsense. That is their job. 
That is what they are there to do. If they have post-market 
surveillance that says inhaled epinephrine multi-dose inhalers 
are damaging to people's health, they owe it to this committee 
to come here and share that with us.
    Mr. Whitfield. At this time, I would like to recognize the 
gentleman from Michigan, Mr. Dingell, for 5 minutes.
    Mr. Dingell. I thank you for your courtesy. And I would 
like to ask these questions of Mr. Shandell, yes or no.
    It is my understanding that there are 1.2 million units of 
Primatene Mist remaining in inventory, is that correct?
    Mr. Shandell. Yes, approximately.
    Mr. Dingell. Now, is this remaining inventory being stored 
under safe and proper conditions?
    Mr. Shandell. Yes, it is.
    Mr. Dingell. You are sure of that?
    Mr. Shandell. Yes.
    Mr. Dingell. When will the remaining inventory expire?
    Mr. Shandell. It expires at varying times, mostly in August 
of 2013.
    Mr. Dingell. OK.
    Mr. Shandell. Starting in January.
    Mr. Dingell. The remaining inventory has been stored 
properly and has not yet expired. Do you know the reason or do 
you have reason to believe then that any of the remaining 
inventory is unsafe for use by patients?
    Mr. Shandell. No, we do not. It should be very safe for 
patients----
    Mr. Dingell. Does anybody at the table have any reason to 
believe that the storage of the remaining inventory of 
Primatene Mist is creating an unsafe product? Yes or no?
    Ms. Kraft. I just had a question on the expiration. It is 
January to August of '13, right?
    Mr. Dingell. Well, is anybody down there going to sit there 
and tell me that this Primatene Mist is going to be unsafe when 
it is put on the market if it is so?
    Ms. Kraft. Based on the way it is stored, sir?
    Mr. Dingell. Based on any fact. Yes or no. It is a yes-or-
no question. You should have no trouble doing it.
    Ms. Kraft. Yes. Then I would say yes.
    Mr. Dingell. You believe it is unsafe?
    Ms. Kraft. Yes.
    Mr. Dingell. Why?
    Ms. Kraft. For the reasons that I stated previously. It has 
nothing to do with storage. I think they have been storing 
their product----
    Mr. Dingell. Do you have knowledge of this or is this 
supposition?
    Ms. Kraft. That it is unsafe? I have had personal 
experience with patients who have taken it and had severe 
asthma--I am talking about safety from a mechanism perspective.
    Mr. Dingell. Thank you very much for that unhelpful 
response.
    Now, according to your testimony, Mr. Shandell, there have 
been between 2 and 3 million Primatene Mist users. If Amphastar 
is allowed to distribute and sell the remaining inventory of 
Primatene Mist, how would your company do so equitably?
    Mr. Shandell. Yes, we will do it equitably. We will not 
raise the price from what it was previously. We also, as I have 
stated, this is for the goodwill of our customers. We are not 
looking to make any profit here, so we will actually donate all 
the net profits to charity. And I really want to go back to 
people are saying that this is an unsafe drug, then why has the 
FDA been working with us since 2007 for an HFA version?
    Mr. Dingell. May I persist in my questions?
    Mr. Shandell. Yes, sure.
    Mr. Dingell. Is there any reason to fear that pharmacies 
may not be willing to restock Primatene Mist for any reason?
    Mr. Shandell. There is some concern to that but if it is as 
sought after as we believe by our customers, they can always 
get it online by CVS.com. There are----
    Mr. Dingell. So there is the fear that they would refuse to 
stock it?
    Mr. Shandell. No. Well, there is some fear on the shelf 
life stocking----
    Mr. Dingell. Yes or no?
    Mr. Shandell. Yes. Yes.
    Mr. Dingell. You have no reason?
    Mr. Shandell. I have no----
    Mr. Dingell. You have no fear that the customers would 
refuse to stock this if it is put back on the market?
    Mr. Shandell. I believe that there is a strong demand for 
it.
    Mr. Dingell. All right. Now, in order to assure the proper 
education of patients regarding the phase-out of Primatene 
Mist, these inhalers were packaged with labeling noting that 
Primatene Mist would no longer be available after December 31, 
2011, and encouraged patients to talk to your doctor or 
pharmacist about other asthma medicines. How is your company 
going to address potential confusion that will be caused among 
your patient population when these inhalers become again 
available?
    Mr. Shandell. Yes. This message is on the box. If we are 
allowed to sell the remaining inventory, such units will be 
moved to our subsidiary. They will be relabeled to eliminate 
this statement and then released by quality assurance.
    Mr. Dingell. All right. Now, I have another question. There 
are two remaining prescription products containing CFCs that 
are not being phased out until 2013. These products are 
Combivent CFC, which contains albuterol and ipratropium bromide 
in combination; and Maxair, which contains pirbuterol. These 
two drugs are subject of the separate rulemaking that was 
financed on April 14, 2010. It seems to me that this tells me 
that FDA and EPA didn't feel that there was a significant 
problem with regard to the carrying medium that they have in 
your product. Is that right?
    Mr. Shandell. Yes. I have never received clarity as to why 
the prescriptions are still out----
    Mr. Dingell. All right. Thank you. My time has expired.
    Mr. Chairman, your courtesy is much appreciated. I would 
ask that the chair would be supportive of me. I am going to 
send a letter down to FDA asking a number of questions. And I 
am going to ask that the FDA would respond, and if they are 
slow, I am going to look to you for your assistance in seeing 
to it that they are properly responsive.
    Mr. Whitfield. Thank you.
    Mr. Dingell. Thank you, Mr. Chairman.
    Mr. Whitfield. We would be happy to assist in any way 
possible.
    At this time, I would like to recognize the gentleman from 
New York, Mr. Engel, for 5 minutes.
    Mr. Engel. Thank you, Mr. Chairman. And I don't think I 
will take 5 minutes because I think we have a vote on the 
floor, and a lot of the questions have been asked.
    But there are a lot of swirling issues here. I am co-chair 
of the Asthma and Allergy Caucus and I have worked with the 
asthma and allergy advocacy community for many years, and I 
have been surprised by their strong opposition to allowing 
Primatene Mist to continue to be sold. I signed a letter in 
January asking Commissioner Hamburg to allow the remaining 
units of Primatene Mist to be sold past the December 31, 2011, 
deadline.
    I mean I think there have been good points on both sides, 
but I really want to ask Mr. Shandell. What is in it for you? 
Tell me what is in it for you. You are not going to make a 
profit on it because you are going to donate everything to 
charity. You mentioned your company offered to distribute all 
the remaining units as a donation to public health clinics and 
the offer was rejected. So if you are not going to make a 
profit, why are you fighting so hard to get another exception--
--
    Mr. Shandell. Yes.
    Mr. Engel [continuing]. From FDA and EPA?
    Mr. Shandell. It is a good question because it is rare to 
see corporations not doing something for profit, but we are a 
private company in California. We are founded in science and 
this is a discontinued product. It is not in our sales forecast 
and we could walk away. However, we have received thousands of 
complaints from our customers who just don't understand why 
they cannot access this. So we really are advocating on behalf 
of our customers.
    Mr. Engel. I think I am going to leave it there, Mr. 
Chairman. I do have a bunch of questions but I am concerned 
about, you know, the vote. I mean the bottom line is is 
epinephrine safe? That is also a question. What do you say to 
people like Dr. Kraft who say it is not?
    Mr. Shandell. Well, see I would love to answer that because 
as a company, we receive all of the adverse events, and if 
something is significant, we are required to report it to FDA 
within 15 days. So I have talked to the departments that 
receive these adverse events and people talk about heart 
problems. We have never had any adverse event related to heart. 
All we have is glass sometimes breaks.
    Mr. Engel. Let me ask Dr. Kraft because she said before in 
her testimony that she feels it is not safe.
    Ms. Kraft. Right. I would argue that the mechanism to get 
the reports depending on when the patient has taken the 
medication and what their status is may or may not actually be 
filed. And so I worry that there is some underreporting.
    Mr. Shandell. After 50 years, nothing?
    Ms. Kraft. Also, I would like to make another statement. 
The company has done two trials to look at the HFA preparation, 
which is good. But I was interested that they didn't have a 
comparison armed with albuterol. They had a placebo armed 
with--do the patients use albuterol in the placebo arm 
presumably? Because I thought that would be a perfect situation 
to compare albuterol HFA with Primatene.
    Mr. Shandell. Thank you. Actually, we have submitted data 
to the FDA, and as I indicated, we will be submitting the new 
drug application in the fourth quarter, and we actually have 
evidence that show that albuterol actually causes more adverse 
events than our product.
    Ms. Kraft. And the question is is these are mild patients. 
I can tell from clinicaltrials.gov----
    Mr. Shandell. Correct.
    Ms. Kraft [continuing]. They are mild patients?
    Mr. Shandell. Correct.
    Ms. Kraft. So that was one of the concerns I wanted to 
bring up. I think in mild asthma a lot of things may work but 
what I worry about with having this drug available and looking 
at my more severe patients, they are often the ones who will go 
and get this medication in lieu of----
    Mr. Shandell. But it has been available for 50----
    Ms. Kraft [continuing]. Medical care.
    Mr. Shandell [continuing]. Years, and, you know, to this 
day people get good medical care but there are people that 
don't. There are people who can't afford it.
    Mr. Engel. Mr. Ward, let me ask you quickly. If Primatene 
Mist is on the market for 13 months and then it is not, what is 
the harm? Is there going to be people who are going to die in 
13 months if they----
    Ms. Kraft. Well, I think it is sort of an ethical issue. I 
am not against over-the-counter medication for asthma, nor is 
my society. I would like to have a safe and effective one out 
there for patients. And so I would actually think that this 
work being done at the FDA to put medications out there over 
the counter such as albuterol, it should continue.
    Mr. Shandell. But the work at FDA, they are working with us 
on Primatene for 5 years now.
    Ms. Kraft. But it is not approved yet.
    Mr. Shandell. It is not approved yet but we have great 
phase three trial data.
    Mr. Engel. I would love to stay longer but we are going to 
miss a vote, Mr. Chairman. So thank you and----
    Mr. Whitfield. Well, thank you. And that would conclude 
today's----
    Mr. Rush. Mr. Chairman, I just want to reiterate and 
restate my call that rather than us moving so quickly to 
markup, especially in light of this discussion, that we take 
time to invite the FDA and the EPA here so that we can get to 
the bottom of some of these outstanding questions that we have 
and get some real answers to these questions. And I want to 
reiterate my request.
    Mr. Whitfield. And Mr. Rush has asked unanimous consent to 
enter into the record various testimonies from the 
International Pharmaceutical Aerosol Consortium, various health 
groups, Alliance for Responsible Atmospheric Policy, and a 
letter from Teva Pharmaceuticals. And then we also have letters 
from the National Association of Chain Drugstores, the National 
Community Pharmacists Association, EPA, et cetera. So without 
objection, they will be entered.
    [The information appears at the conclusion of the hearing.]
    Mr. Whitfield. I want to thank all of you for being with us 
today. We appreciate your testimony very much and your concern 
about this important issue.
    And with that, this hearing is adjourned.
    [Whereupon, at 1:45 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

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