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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 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

CLIFF STEARNS, Florida 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

Vice Chairman 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

BRIAN P. BILBRAY, California 

CHARLES F. BASS, New Hampshire 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

SUBCOMMITTEE ON ENERGY AND POWER

ED WHITFIELD, Kentucky 

Chairman 

JOHN SULLIVAN, Oklahoma 

Vice Chairman 

JOHN SHIMKUS, Illinois 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MICHAEL C. BURGESS, Texas 

BRIAN P. BILBRAY, California 

STEVE SCALISE, Louisiana 

CATHY MCMORRIS RODGERS, Washington 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

H. MORGAN GRIFFITH, Virginia 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

BOBBY L. RUSH, Illinois 

Ranking Member 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JOHN D. DINGELL, Michigan 

EDWARD J. MARKEY, Massachusetts 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

CHARLES A. GONZALEZ, Texas 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

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 

Page

IV 

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 

Page

V 

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 

(1) 

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. 

2 

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:] 

3 


82531.001

Opening Statement of the Honorable Ed Whitfield 

Subcommittee on Energy and Power 

Hearing on the "U.S. Sector Relief Act," and the 

"Asthma Inhalers Relief Act" 

18,2012 

(As Prepared for Delivery) 

Today we will be 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 aspects of implementing the Montreal Protocol. This international 

environmental treaty seeks to phase-out the use of ozone depleting substances, such as the 

CFCs that were once used in refrigerators, car air-conditioners, and other products. 

One of the substances to be phased out is also the fumigant methyl bromide. While many 

farmers that once used methyl bromide have been able to switch to substitutes for certain 

purposes, for some specific uses - such as preparing the soil for growing strawberries, 

tomatoes or other crops - it is still needed. 

I might add that another application where methyl bromide is important is in milling 

operations. My congressional district is the home of the Hopkinsville Milling Company who 

supports this legislation because they say it helps them ensure that they are able to meet 

clean food regulations. As we will hear from today's witnesses, it is still needed because 

there are no adequate substitutes available. 

And it is for those critical uses that the U.S. Agricultural Sector Relief Act sets out a process 

to allow limited but continued availability of methyl bromide. 

The amounts of methyl bromide at issue won't make even a dent in the continued declines 

of ozone depleting compounds in the atmosphere, but they will make a major difference for 

thousands of struggling farmers who don't see a future without it. 

I would also like to say a word about the Asthma Inhalers Relief Act. As 1 mentioned, CFCs 

have been phased out, and a ban now also applies to the very small amounts of CFCs used 

in medical devices, including over-the-counter asthma Inhalers. While these inhalers 

represent only a fraction of one percent of global CFC emissions, there is a ban on them 

that became effective at the end of last year. 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 have them. 

I look forward to the witnesses' testimony today on these pieces of legislation. 

### 
4 

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-thecounter 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:] 

5 


82531.174

MICHAEL C. BURGESS, M.D 

l6lHD!~tRI\.l, TfJO;"S 

ENERGY AND COMMEnCE 

1'!110CO\Wll1et.S 

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OV£!'ISIOHf MlU I"'V!iSlI0ATtCltlS 

JOINT ECONOMIC COMMITTEE 

CONGRESSIONAL HEALTH CARE CAUCUS, 

CHAIRMAN 

President Barack Obama 

The White House 

1600 Pennsylvania Avenue 

Washington, D.C. 20500 

President Obama: 

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Febl11ary 29, 2012 

WAS1ll.li~JjJN.1lC QWQ;, 

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WASHINGtON, DC 205f5 

(202) 225~7712 

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FORT WORTH, TX76!19 

(al7)r}J1-84M 

As a lifetime asthma sufferer, I would like to bring to your attention an issue that has 

been of critical impo11ance to me as well as to millions of astluna sufferers across the country. 

On January 1, 2012, a common over-the-counter (OTC) emergency astiulla inhaler, Primatene® 

Mist, was forced offphol'macy shelves due to an international treaty agreement known as the 

Montreal Protocol which bans the use of chlorofluorocarbon (CFC) propellant, an ingredient in 

Primatene® Mist. Primatene® Mist is the only OTC approved inhaler for asthma symptoms 

with epinephrine as the active ingredient. 

CU1'l'ently, the Food and Dl'llg Administration (FDA) has under its review a replacement 

OTC inhaler for Primatene@ Mist. While I am concel'l1ed over the undue delay in the review of 

this medication by the FDA, my more immediate concern is over the CUll'ent lack of any 

available OTC emergency astlmm inhaler. I myself have used Primatene@ Mist 01111\1merOUS 

occasions where r have found myself in need of an emergency inhaler, and I know other asthma 

sufferers who have found themselves in tile same situation. At present, asthma sufferers who 

find themselves awake at 20m with an unexpected astluna attack, and who do not have 

immediate access to an inhaler, are faced with the costly and time-consuming task ofrllshing to 

the emergency room for a prescription in.haler, increasing healthcare costs and doing a disservice 

to asthma sufferers who have long found comfol1 in knowing that relief could be had with jllst a 

short trip to the local drug store. 

What is all the 1110re frustrating with this situation is that the OTe version ofPrimatene@ 

Mist is still available in large stocks, sitting in warehouses, unable to be sold in the U.S. FUl1hcr, 

the Envirorunental Protection Agency (EPA), which has repeatedly espoused its concem over 

asthma sufferers nationwide, has the ability to grant a waiver to tile Montreal Protocol and aHow 

the existing stock ofPrimatene® Mist to be sold. I have repeatedly approached representatives 

of the EPA, including Administrator Lisa Jackson and Assistant Adn1inistrator Gina McCarthy 

and asked them to grant such a waiver. While simultaneously pointing their fingers at claiming 
6 


82531.175

the problem lies at the feet of the FDA, they have beellunresponsive in answering why the EPA 

has thus far refused to grant a waiver to allow the existing stock ofPrimatene® Mist to be sold. 

If assisting asthma sufferers and loweling heaIthcare costs are truly a priority for YOUI' 

administration, allowing the existing stock ofPrimatene® Mist to be sold to asthma sufferers 

should be an easy decision. The small amount ofCFC propellant used in the remaining stock of 

Primatene® Mist will hardly have a negative impact on the global environment, especially when 

weighed against the health benefits of assisting asthmatics suffering from emergency attacks. 

Indeed, even ifnot used, the existing stock of this life-saving drug will simply be discarded, 

allowing the propellant to be emitted into the atmosphere without providing its knO\\~l benefit to 

asthma patients. Moreover, this is a finite number ofPrimatene® Mist inhalers which are at 

issue, as the company responsible for their manufacture has already switched over to a Montreal 

Protocol-compliant propellant currently under FDA review. 

Because of your stated commitment to helping asthma sufferers and lowering healthcare 

costs generally, and EPA's refusal to respond to calls to allow the existing stock ofPrhnatene® 

Mist to be sold, including letters from the Energy & Conullerce Conullittee which have gone 

unanswered by the EPA, I am writing to you to ask that you direct Administrator Jackson to 

review this isslle and allow Primatene® Mist to be sold until the existing stock is depleted and 

FDA is able to fully review and approve its replacement. The health and lives of millions of 

Americans are at risk until this issue can be resolved. 

/ Mi"'~1 .B~ 
7 

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. 

8 

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, 

9 

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:] 

10 


82531.002

Opening Statement of the Honorable fred Upton 

Subcommittee on Energy and Power 

Hearing on the "U,S, Agricultural Sector Relief Act," and the 

"Asthma Inhalers Relief Act" 

18,2012 

(As Prepared for Delivery) 

Over the last severa! decades, environmental quality has improved significantly. Our goal is 

to maintain that progress without imposing unnecessary burdens on our economy or the 

American people. That's why we have consistently advocated for regulatory common sense. 

And that's what we're here to talk about today two sensible proposals 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 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 usage is down by 

over 90 percent. But for some crops, methyl bromide is still needed because viable 

alternatives are not yet available. 

To address that issue, I am pleased that Michigan farmer Russ Costanza has joined us 

today. Russ grows peppers, eggplant, squash, tomatoes, and cucumbers back on his farm in 

Sodus, Michigan, and he employs 125 workers. We need to hear him out, because his 

message is that of many farmers throughout this country who doubt whether they can 

remain in bUSiness without continued access to methyl bromide. The 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 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 was available in the U.S. for more than four 

decades, to be temporarily sold or distributed without penalty. 

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 both these obligations. 

### 
11 

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:] 

12 


82531.003

July 17, 2012 

The Honorable Ed Whitfield 

Chair, Subcommittee on Energy & Power 

2368 Rayburn House Office Building 

Washington, DC 

Dear Chairman Whitfield: 

Allergy & Asthma Network Mothers of Asthmatics serves families with allergies and asthma. Founded in 

1985 by families for families, we've enjoyed a long history of bipartisan support from Congress to change 

laws and policies affecting school children with asthma and anaphylaxis, and worked with federal 

agencies such as FDA, EPA, CDC, NHLB! and NIAlD to ensure evidence-based, cost effective and patientcentered care. This collaborative effort means that today, it is possible to improve patient quality of life, 

prevent asthma and anaphylaxis deaths and suffering while reducing healthcare costs. Thank you for 

consideration of our views opposing the Asthma Inhaler Relief Act 

• The Act gives unprecedented preferential and exclusive exceptions and financial benefits to 

Armstrong Pharmaceuticals, an Amphastar Company, for the sale of one product, Primatene Mist 

(PM) under the guise of serving otherwise unmet needs of poor and uninsured patients with asthma. 

• However, PM is not recommended for the treatment of asthma in NIH/NHLBl Asthma Guidelines, the 

accepted standard for care in the U.S. (Attachment) Therefore, no Act of Congress should Cause the 

poor be subject to outdated and substandard modes of treatment. 

Primatene Mist contains a crc propellant banned through the Montreal 

191 countries since 1987 and the Clean Air Act of 1990 

• This same Montreal Protocol and Clean Air Act required all pharmaceutical manufacturers to cease 

production, distribution and sale of alhuterol inhalers containing erGs on December 31, 2008. 

• At that time, Armstrongj Amphastar was a leading manufacturer of generic albuterol and as such was 

required to cease production, distribution and sale of generic albuterol inhalers in 2008. Therefore, 

Armstrong/ Amphastar is no stranger to the Montreal Protocol, Clean Air Act or the FDA process for 

ANDA and NDA submissions. 

• Armstrong/ Amphastar plans to manufacture generic albuterol HFA inhalers as soon as patents expire 

and PM HFA inhalers upon approval which the company continues to promise Is any day now. The 

820! Greensboro Rd., Strite 300, McLean, VA 221 02 800.878.4403 w\vw.aanma.org 
13 


82531.004

company hopes to dominate both the generic albuterol and OTC asthma market according to public 

securities documents. 

• By December 31,2008,40 million patients with asthma and chronic obstructive pUlmonary disease 

transitioned to one or more of the non-CFC asthma and COPD inhalers shown on AANMA's Asthma 

Inhalers Posters. [Attachments] 

• Armstrong! Amphastar does not meet established U.S. and International criteria to determine 

essential use status or to qualify for the exemptions outlined in the Act There is no unmet need. There 

is no evidence-based data suggesting otherwise. 

Epinephrine Hand-held Bulb Nebulizer 

• In August 2011, Armstrong/ Amphastar continued to manufacture Primatine Mist knowing that saJes 

would cease on December 31, 2011. FDA required the manufacturer to post this warning on the front 

of all packaging and on their website. 

• Armstrong! Amphastar's numerous and extensive media and Internet marketing campaigns garnered 

significant and sympathetic press coverage. Yet, Armstrong! Amphastar was unable to unload 1 

million excess PM canisters that now languish in a warehouse one year later. Was this poor planning 

or strategic planning? It was one or the other and in either case, purposeful. 

• In the last quarter of 2011, the PM prices climbed upwards of $250 a canister. On this PM Facebook 

page, recent show where to buy the device for $250 a canister. Similar activities occurred 

when discontinued as 

• The "Bring Eack Primatene Mist" Facebook page was started 7 months ago by an unnamed source 

with no identity yet he!she/they coach 185 "friends" on how to badger members of Congress and 

FDA. of most "friends" on most Facebaok and of social media sites is masked 

All but two CFe metered dose inhaler products and nasal sprays have completed the eFe transition. 

Both are in compliance with US Jaw. Combivent will soon be available as an aerosol inhaler that 

requires no propellant. MaxAir's market share was so small that the manufacturer will discontinue 

the product. 

8201 Greensboro Rd .. Suite 300, McLean, VA 22102 800.878.4403 www.aanma.org 
14 


82531.005

Most new metered dose inhalers have or will soon have dose counters, the only way the patient 

knows when medication runs out and all that remains is propellant. 

Recently, Armstrong! Amphastar posted a warning to patients that there have been reports of PM 

canisters breaking or exploding if dropped since January 2012. 

• The transition was not voluntary for patients or manufacturers. No federal funds were allocated for 

patient awareness and education programs. That responsibility fell to manufacturers and nonprofit 

organizations. Manufacturers making the transition provided free drug to patients in need and some 

offered coupons to help offset the cost of higher co-pays charged by health insurance companies. 

Patients absorbed have absorbed the bulk of costs with average $10 co-pay rose to $20, $50 and $60 

per HFA inhaler. 

The Act should not be seen not an act of charity. The manufacturer will not give the drugs away and has 

no way to ensure that only poor or uninsured patients receive product. If they could, how many canisters 

would each patient be allowed to purchase? Who will tell the poor when 1 mll!ion canisters are available 

in stores or when supplies will be running low? 

What if patients don't like the HFA taste or force of spray and perceive ilto be inferior to the CFC? Will 

packaging warn consumers of the potential for glass canisters to break and cause injury? 

The Act brings confusion. Why is PM given preferential treatment while 40 million insured and uninsured 

children and adults are not? 

Asthma is a disease that is always present but not always noticed. When severe attacks occur, patients do 

not have time or luxury to think about where they stashed their inhaler last or if medication vs. 

propellant is all that remains in the canister. 

Asthma is the master deceiver, You don't wake up one day and say this will be the day I die or my two 

year old dies of asthma, It happens slowly, but the lungs fill with fluid and plug with mucus until the brain 

perceives a dangerous situation. 

Death by asthma doesn't look so scary. Just ask the father whose two year old daughter died in his arms 

as he gave her a routine nebulizer treatment. She didn't struggle, She just whispered, "I love you" and 

stared with empty eyes. 

AANMA remains ready to help patients find the care and relief they seek. We need your support to ensure 

existing cost productive protocols provide patients with patient-centered, evidenced based care that 

saves lives, kids back to school and parents back to work. It's no mystery and it's something that 

members for your consideration. 

820l Greensboro Rd" Suite 300, McLean, VA 22102 800.878.4403 
15 

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. 

16 

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. 

17 

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:] 

18 


82531.006

July 17, 2012 

The Honorable Ed Whitfield 

Chairman 

House Committee on Energy and Commerce and Subcommittee on Energy and Power 

United States House of Representatives 

2125 Rayburn House Office Building 

Washington, DC 2051,5 

Dear Chairman Whitfield, 

The San Diego county Farm Bureau supports the U.S, Agricultural Sector Regulatory Relief Act of 2012. 

The State of California and San Diego County in particular, is a leading producer of flower crops and 

strawberries in the United States. Strawberries and flowers are high value crops with significant impact 

on the agricultural economy. These two crops aye also dependent on soilsteriHzatlon for consistent 

production, Recognizing the phase out of methyl bromide, growers are looking forward to the 

establishment of viable alternatives for reliable soil sterilization. However, no alternative has yet been 

found. Until such alternatives are discovered, the need is critical for growers to have access to methyl 

bromide as a crop production tool. We thank you for addressing this important issue. 

Sincerely, 

Eric larson 

Executive Director 

Serving San Diego County Agric\11ture Since 1913 
19 

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. 

20 

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. 

21 

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:] 

22 


82531.007

Summary of Testimony of Russ Costanza on the "Agricultural Sector Relief Act of 2012" 

July 18,2012 

I am the owner of Russell Costanza Famls in Sodus, Michigan. Our farm grows about 500 acres 

of peppers, eggplant, squash, and cucumbers. The to use methyl bromide and the lack of 

any tmly viable alternatives, is threatening our family our remaining workers' livelihood. 

Methyl bromide has allowed us to trcat our fields and cultivate abundant and high quality, 

high demand produce. This year, however, we were not granted any critical use exemptions 

(CUEs) 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 available and arc cost prohibitive. Between the scarcity and high cost, it is 

to compete with inexpensive, quality produce from other countries whose growers 

are able to legally use methyl bromide. 

• While we have a limited supply ofmcthyl bromide available for eggplant, we cannot use 

methyl bromide for our other crops. Due to the lost quality and yields associated with these 

crops, we have experienced decreased profits for our remaining workers and Ollr fann. 

Our farm has spent a great deal of money and effort seeking viable alternatives to methyl 

bromide. Research conducted on our farm with Michigan State University found that without 

methyl bromide, growers can expect yield losses of 70% or more. It also concluded that other 

fumigants are not suitable for llse in coo! spring soils and do not allow growers in Michigan 

to patiicipate in the early vegetable markets that are the most profitable. 

I the provisions of "Agricultural Sector Relief Act of2012" that would extend the 

process beyond 2013. This provision is very important and helpful to growers that 

currently hold CUEs. Sadly, my operation would not benefit from such a provision because 

we have not been granted CUEs tor this year or next. 

The Environmental Protection Agency and the U.S. Department of State should pursue 

expanded CUEs for growers whose allocations were reduced due to the availability of 

iodomethane or other alternatives that are no longer options and consider new CUE requests 

for growers who may be facing new or re-emergent pest pressures. 

I strongly support the legislation's 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. We are 

facing an emergency situation on our farm and need reHef. 

• While I understand that EPII. is the lead organization in making CUE recommendations to the 

Parties to the Montreal Protocol, I appreciate that the includes consultation with 

the U.S. Dcpattment of Agriculture (USDA). Because close working relationship with 

growers, USDA and extension agents are best equipped to determine when an emergency 

situation exists. The Department's role in this process is criticaL 

Please pass the "Agricultural Sector Review Act of 20 12." 
23 


82531.008

Testimony of Russ Costanza 

Before the 

House Energy and Commerce Subcommittee on Energy and Power 

on the 

"Agricultural Sector Relief Act of 2012" 

July 18, 2012 

Thank you very much Chainnan Whitfield, Ranking Member Rush, and members of the 

subcommittee for the opportunity to testify before you today. J would also like to thank full 

committee Chairman Upton and Ranking Member Waxman for this opportunity. 

My name is Russ Costanza. I grew up on our family fann. ! am the owner of Russell 

Costanza Fanns in Sodus, Michigan. My wife and I established our farm in 1976 with 10 acres. 

Today we've grown that farm with our two kids and their families to over 500 acres of peppers, 

eggplant, squash, tomatoes and cucumbers. Our fann is labor intensive. Over the years we have 

grown from my wife and I doing all the work to over 125 farm workers. Sadly, the inability to use 

methyl bromide and the lack and any truly viable alternatives, is threatening our family and our 

remaining workers' livelihood. 

Methyl bromide is a fumigant that controls insects, nematodes, pathogens, and weeds. 

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. 
24 


82531.009

Methyl bromide is subject to phaseout under an international treaty, the Montreal Protocol on 

Substances that Deplete the Ozone Layer and the federal Clean Air Act. All production and imports 

of methyl bromide were banned in the U.S. as of January 1,2005, except for the following limited 

uses: 1) "critical" uses subject to annual exemptions granted by the Patiies and U.S. EPA; 2) 

quarantine and pre·shipment uses; and 3) "emergency" uses. 

Methyl bromide has allowed us to treat our fields and cultivate abundant and high 

quality, high demand produce. This year, however, we were not granted any critical use 

exemptions (CUEs) 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. ! lIsed to be able to purchase 

methyl bromide for about $1 per pound. Today, the cost averages $9 per pound. It costs over 

$800 per 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 arc able to 

legally use methyl bromide. Further, the quality of our produce will deteriorate due to the lack 

of methyl bromide use, fut1her 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 lost quality and yields associated with these 

crops, we have experienced decreased pronts for our remaining workers and our farm. Our 

dwindling profits also mean a loss of tax revenue to the local, state and federal governments. My 

family, our workers, and! pride ourselves on providing high quality and affordable food to U.S. 
25 


82531.010

consumers and to making a meaningful contribution to our country's economy. Unfortunately, 

our ability to do so is vanishing due to the lack of methyl bromide or an effective, affordable 

alternative. 

OUf farm has spent a great deal ofmoncy and effort seeking viable alternatives to methyl 

bromide. In 2005, staff from the EPA Chicago office was invited to take a tour of our 

farm. They came and observed our operation, how we worked and how methyl bromide was 

used. We demonstrated how methyl bromide increased the yield of our eggplant and pepper 

crops. 

The increased yields and the lack of eftective alternatives were documented through 

research on our farm conducted with Michigan State University on all methyl bromide 

alternatives, We donated the land, manpower and other resources to research the efficacy of 

alternatives on eggplant. we did not find any affordable, usable replacement. Due to the 

weather in we have a very narrow window of time before planting in which we can 

apply a fumigant. We cannot wait an additional two to three weeks to re-enter the field prior to 

planting, as was by iodornethane and some other alternatives, or we would lose our 

market window, Futher, iodomethane is no longer being sold in the United States. For my 

Michigan operation, methyl bromide is truly the only treatment option available. According to 

the study: 

• Without methyl bromide, growers can expect yield losses of 70% or more. 

e Other fumigants are not suitable for use in cool spring soils and do not allow growers in 

Michigan to participate ill the early vegetable markets that are the most profitable. 

.. Methyl bromide reduces the amount of soil microbes that infect vegetable roots and fruits 

and cause root rot, wilting, and death, 

" These damaging microbes include Verticiilium, Fusarium, and Phytophthora, Eggplant, 

melons, peppers, and tomatoes are most susceptible to these damaging soil mkrobes, 
26 


82531.011

• Two of these microbes do not respond to any fungicide. The third microbe has developed 

resistance to the most effective fungicide that is available. 

The soil microbes that harm vegetable crops do not naturally decrease to a safe level even 

when growers use long crop rotations. 

• Harsh winters do not kill these vegetable pests. 

• soil tests that can ale!1 growers to the presence of damaging soil microbes 

prior to do not exist. 

Vegetables that are adequately resistant to the damaging soil microbes have not been 

developed. Only vegetables that are susceptible to these soil microbes arc available to 

growers. 

Our circumstances are dire, which is why r am very appreciative of Chairman Whitfield, 

Chairman Upton and members of the subcommittee for your leadership in drafting methyl 

bromide legislation and in holding this I support the provisions of "Agricultural Sector 

Relief Act of2012" that would extend the CUE process beyond 2013. This provision is very 

important and helpful to growers that currently hold CUEs. Sadly, my operation would not 

benefit from such a provision because we have not been granted CUEs for this year or next. 

hope that moving lorward, EPA and the U.S. Department of State will pursue expanded CUEs 

for growers whose alloeations were reduced due to the availahility of iodomethanc or other 

alternatives that are no longer options and consider new CUE requests for growers who may be 

facing new or re-emergent pest pressures. 

I and other Michigan growers are fhcing an emergency situation on our farms and for that 

reason, I am grateful that the legislation includes provisions related to the emergency use of 

methyl bromide under cet1ain circumstances. The law must allow for flexibility when a planned 

afIordable 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 to 

the Montreal Protocol, I appreciate that the legislation includes consultation with the U.S. 

Department "",,":IlI.UI<"'" (USDA). Because ofits close working relationship with growers, 
27 


82531.012

USDA and extension agents are best equipped to detenuine 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 falm operation and 

my fellow Michigan growers. We are facing a crisis and need relief. I am hopeful that Congress 

will pass the "Agricultural Sector Review Act of2012" and that EPA and USDA will quickly 

implement a process to allow for limited emergency exemptions when circumstances merit. 

Thank you very much for your leadership in addressing this critical issue for myself and 

other jVlJ""!ll~!I growers. 
28 

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 

29 

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:] 

30 


82531.013

Testimony of Scott M. DiMare 

Vice President and Director of Farm Operations, DiMare Ruskin Inc. 

Before the U.S. House of g,p.,n .. t."p,,,t,,fi,,.,,, 

Committee on Energy and Commerce 

Subcommittee on Energy and Power 

July 2012 
31 


82531.014

Chairman Whitfield, Ranking Minority Member, Mr. Waxman, and members of the 

subcommittee, my name is Scott DiMare, I am the Vice President and Director of Farm 

Operations for DiMare, Ruskin, Inc, a family farm headquartered in Florida, We have been in 

continuous operation for over three generations with our production focused on fresh market 

tomatoes, We are part of the industry that provides a majority of the fresh tomatoes available to 

the U,S, population during the faU, winter and spring months, This industry has averaged 400 to 

600 million dollars offurm gate revenue each production season, The farms I oversee are 

located in the Ruskin/Palmetto growing region southeast of Tampa in central Florida, Our 

primary production seasons include a spring crop that is transplanted in January and February 

and a fall crop that is transplanted in late August. The success of this cropping system is highly 

dependent on the ability to control weeds, plant pathogens and nematodes through a pre-plant 

fumigation that takes place when the plastic mulch is placed in the field, Historically this was 

accomplished through the usc of methyl bromide - the subject hearings, 

It is important to note that this crop production is done at the onset ofthe crop and 

serves as the foundation for all aspects of successful crop management during the subsequent 

growing season, Prior to the regulatory phase-down on production and of me thy! 

bromide under the Montreal Protocol, the preferred fumigation treatment comprised an in-bed 

shanked aorlilcatlcm of either methyl bromide 98:2 or methyl bromide 67:33, The different 

fommlation _+', __ ,1.. .. ' bromide in combination with chloropicrin, were used dependent on the 

history of the farm and the prevalence of soil borne pathogens, These treatments were highly 

efficacious and did not require the additional of other crop protectant materials to 
32 


82531.015

ensure efficacy. The availability of methyl bromide under the current regulatory process has 

resulted in the loss of access to these formulations. 

The distribution and application of methyl bromide is highly specialized and varies by the region 

of the country. In Florida, the farm-Ieve! application of the materials is done by the grower rather 

than by custom applicators as is generally the situation in other areas of tile country. We as a 

grower community have not had access to any formulation other than 50:50 methyl bromide (50 

% methyl bromide, 50 % chloropicrin) for the past three control periods under the US Clean Air 

Act and this was limited to rates that are only marginally effective. While the regulatory process 

has identified quantities of methyl bromide as "available stocks" these reserves of the active 

ingredient are not accessible by our industry. The "available stocks" are in the channels of trade 

and it is believed that those stocks are being held by various third parties including chemical 

distributors and applicators for other !1on-agriculturaluses. 

As an active participant in the Florida Fruit and Vegetable Association and the Florida Tomato 

Exchange, we have been heavily engaged in the USDA Agricultural Research Service, 

University of Florida - Institute for Food and Sciences and commercial research for 

all of the proposed methyl bromide alternatives that have been identified over the past fifteen 

years. 

We have made major commitments and capital expenditures to test the "Three Way" system, that 

includes I ,3-dichloroporpene and chloropicrin co-applied with metam sodium; the "¥eutter Rig" 

broadcast application of I ,3-dichloropropcne followed by in-bed shanked applications of 
33 


82531.016

chloropicrin; in-bed shanked and drip applied iodomethane; and shanked in-bed applications of 

dimethyl disulfide (DMDS). The current fumigation program at the farms I manage is centered 

on the use 60, a combination of 1 ,3-dichloropropene and ctllofClpl(;nn 

In our multiyear experience this alternative program to methyl bromide is variable and 

has proven to be much more inconsistent in efficacy even when conditions appear to be nearly 

identical to those that result in acceptable levels of control. More problematic is the resurgence 

of pest populations and the overall continuous increase from year to year in specific troublesome 

pests. The primary increases are being seen in weeds as evidenced by both yellow and purple 

nutsedge, and also in the soil borne pathogen fusarium crown rot. Just as important, we are also 

seeing increase in population and corresponding impacts of root knot nematodes during the 

pnJdtlct:ion season, especially during periods of weather related stress. Attached are photographs 

from a recent tour that illustrate the level of some of the impacts during the past growing season. 

One of the problems eonfronting plastic mulched production systems in Florida is the overall 

decline in tomato plant health and vigor as production practices have shifted to the alternatives. 

It has heen observed that the general ability of the crops to withstand historical stresses, 

including weather related phenomena and low levels of pest pressure, have resulted in larger than 

anticipated impacts from both yield and quality perspectives. 

Each potential methyl bromide altemative has its own set of charaeteristics, generating its own 

impaets on the treated crop, In short, the alternatives are not uniform regarding their 

timing, rates of applieation and their comparative efficaey across the total pest spectrum 
34 


82531.017

commonly encountered that require the fumigation treatment. Methyl bromide is consistently 

reliable when used at the appropriate rates. Our experience shows us that at a certain rate, we are 

confident that application can be made relatively dose (e.g., with two weeks) of the transplanting 

date without crop injury, and we know it will be efficacious. However, the potential alternatives 

requires that they be applied with a much longer pre-planting interval. As a result the grower is 

at greater risk of some event adversely impacting the efficacy of the alternative treatment from 

the time the soil is treated until the crop is planted. 

The uncertainty alternatives have created over established tomato cropping patterns has led to 

wholesale changes in the risks associated with each tomato crop. We currently face unknowns 

surrounding the required plant back-period associated with the alternatives under the different 

conditions dictated by the seasonal aspects of our production window - continuous production 

over the fall, winter and spring months. This uncertainty has led to initiation of the 

season as much as onc and a half to two months earlier than that required when methyl bromide 

was available. This then leads to tremendously increased risk to the production system due to 

the highly variable weather conditions that occur in Florida. For the summer fumigations this 

increases the risk from tropical weather systems. During the December, January and February 

fumigation period for the spring crop, the erratic nature of cold temperatures and periodic rainfall 

disrupts the subsequent planting schedules. This is due to the inability ofthe alternatives to 

disperse properly within the bed leaving phytotoxic residues for much longer periods oftime. 

This Inability to maintain ideal conditions soil and bed conditions associated with tor the 

alternatives also leads to highly variable pest control in the subsequent or second crop. 
35 


82531.018

As an industry that is struggling to remain competitive in the globally expanding sourcing of 

fresh vegetables, we have seen our fumigation costs triple since the mainstay of our production 

system, methyl bromide, has come under regulatory restrictions dictated by the Montreal 

Protocol on Substances that Deplete the Ozone Layer and its implementation under the US Clean 

Air Act. We are encouraged by the legislation being discussed before this subcommittee today. 

While we support the goals ofbolh the Montreal Protocol and the Clean Air Act, we feel that the 

currently highly restrictive view of the U.S. obligations under the Treaty have resulted in 

unnecessary and extremely costly impacts to our industry. 

We have made significant advancements through technology and management changes to 

minimize the emissions that result from our use of the regulated substance. It is hoped that as we 

face the pressures created by the shifting pest populations on the land we fann that this 

invaluable tool will indeed be available to growers to utilize where the situation warrants. 

Thank you for your attention and llook forward to your deliberations today, I will be happy to 

answer any questions you may have. 
36 


82531.019

Photographs from Tomato Production Areas, April 2012 

Purple Nutsedge in Tomato Production Field - Approximately 21 Days Post Transplant 

(Ruskin Palmetto Production Area) 

2012 

Season of Pic-Chlor 60 Use This Fann 
37 


82531.020

Fusarium Crown rot, at tirst Harvest 

(Ruskin Palmetto Production Area) 

2012 

Season of Pic-Chi or 60 Use On This Farm 
38 

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. 

39 

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:] 

40 


82531.021

Natural Resources Defense Council 

Hearing on the U.S. Sedor Relief Act of 2012 

Subcommittee on and Power 
41 


82531.022

Protection of the ozone layer is a huge bi-partisan public health success story. The phase-out of 

ozone-destroying chemicals, indudlng 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. It is also saving farmers billions of dollars in UV-related crop losses. 

Now is not the time to tamper with the Montreal Protocol and the Clean Air Act. By slowing or even 

reversing the transition away from methyl bromide, "The U.S. Agricultural Sector Relief Act" will lead 

to more skin Cancers, more cataracts, more immunological disease. It will benefit strawberry 

growers and others who have profited by abusing the "critical use exemption" for almost a decade. 

Thousands of other farmers growing other crops will suffer more UV-related crop losses as a result. 

• Methyl bromide suppliers and users have dragged their feet on replacing this dangerous compound 

for two decades. No other industry has had more time and more leeway to transition from 

dangerous ozone-destroying chemicals. 

The United States is responsible for more than 90 percent of all methyl bromide exemptions. Every 

other strawberry- and tomato-growing country with California-like growing conditions - including 

Italy, Spain, Greece, and Australia - has ended use of methyl bromide. Mexican growers use less 

methyl bromide per acre than their California counterparts, and Mexico will end methyl bromide 

use entirely this year. 

California strawberry growers have done very well during the whole experience, according to a 

recent peer-reviewed economic study. Strawberry acreage is up 16% and yields are up 14% since 

2004 despite significant reductions in methyl bromide allocations. So are U.S. grower prices and 

total crop values. 

u.s. critical use exemptions have been coming down. California strawberries are now the only field 

use for which the U.S. is still seeking critical use exemptions. Together with several structural and 

commodity uses, the total U.s. exemption request for 2014 is down to slightly more than 400 tons. 

The bill would do reckless damage in three major ways: First, it would permanently define as 

"critical uses" all of the uses that were labeled critical in 2005, even though the vast majority no 

longer even use methyl bromide. Absurdly, the bill would make even golf course turf grass a 

"critical use." It makes no sense to freeze into law an utterly out-dated list of "critical uses." 

Second, the bill relieves applicants of the need to show why they need exemptions. They could just 

submit their exemption wish lists without any supporting data. EPA then would bear the burden of 

gathering the data to support any reduction. Absent resources and data, EPA would have little 

choice but to forward the applicants' unsupported wish lists to the parties. This would be foolish 

even from the growers' perspective. It actually helps the U.S. government win approval for 

exemptions to have shown that it has exercised judgment and discipline in framing its requests, and 

has is not mechanically asked for everything its domestic applicants may have wanted. 

Third, the bill would blast an enormous new 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 
42 


82531.023

simply by asserting the existence of an "emergency." There could be a hundreds of emergency 

exemptions per year, totaling up to 2,000 tons per year (the 2011 critical use amount). 

• This is a bad and unneeded bilL It would harm public health, harm other farmers, and indeed even 

harm the farmers it is intended to help. The process is working. This Committee should let well 

enough alone. 

2 
43 


82531.024

Thank you Chairman Whitfield and Ranking Member Rush for the opportunity to testify on 

behalf of the Natural Resources Defense Counci! on the proposed "U.s, Agricultural Sector Relief Act of 

2012," Founded in 1970, NRDC is a national nonprofit environmental organization of scientist, lawyers, 

and environmental specialists with more than 1.3 million members and online activists, served from 

offices in New York, Washington, Chicago, San Francisco, Los Angeles, and Beijing. I am policy director 

of NRDC's Climate and Clean Air Program, I have been with NRDC twice, from 1978 through 1992 and 

from 2001 to the present. In the 1990's I served as director of climate change policy in the EPA Office of 

Air and Radiation. Relevant to the topic of today's hearing, I have worked on the phase-out of ozonedestroying chemicals for more than a quarter century. 

There are few greater success stories than the global effort to phase out the ozone-damaging 

chemicals, Every American, and every citizen on this Earth, relies on the ozone layer to block dangerous 

ultraviolet radiation that causes skin cancer, cataracts, Immune disorders and other diseases. The treaty 

to protect the ozone layer, known as the Montreal Protocol, has enjoyed bipartisan support from five 

presidents beginning with Ronald Reagan. So have the ozone layer protection provisions of the Clean 

Air Act. They are saving literally millions of Americans, and tens of millions of people around the world, 

from death and disease, They are also preventing billions of dollars in UV-related crop losses and other 

economic damages. 

Yet the ozone shield is still being weakened by ozone-depleting chemicals that increase our 

exposure to dangerous UV radiation, Millions of Americans including farmers - must work everyday in 

the sun. Millions more - from school children to seniors - spend hours of their days out of doors, 

Millions of concerned parents check the UV Index and cover their kids with sunscreen before letting 

them go out in the sun. 

That brings us to methyl bromide, Methyl bromide is the most powerful ozone-depleter still in 

widespread use, All of the other more potent ozone-destroying chemicals have been successfully 
44 


82531.025

eliminated - wor!!iwide. Methyl bromide is also highly toxic, with inhalation or dermal exposure causing 

a wide range of acute and chronic effects, induding death. 

Mr. Chairman, I will not mince words. You are considering a bill to further slow the snail-like 

pace of the transition from this dangerous chemical- a bill that will lead to more skin cancers, more 

cataracts, more immunological disease, and more crop losses due to ozone-destruction and UV 

radiation, as well as more illneSS from direct exposure. Contrary to the bill's grandiose title, this bill will 

not broadly benefit "the u.s. agricultural sector." Indeed, thousands of farmers growing other crops will 

suffer more UV-related crop losses as a result Instead, this bill will benefit only a small sliver of 

strawberry growers and few others who have profited handsomely by abusing the "critical use 

exemption" for the better part of a decade. 

No industry has had more time and more leeway to transition from dangerous ozone-destroying 

chemicals than this one. The auto industry replaced CFCs in car air conditioners in less than four years. 

The electronics industry replaced ozone-depleting solvents in circuit board manufacture in less time 

than that. The air conditioning and refrigeration industry and the fire protection industry got rid of their 

potent ozone-depieters in well under a decade. Indeed, some of these industries have gone through 

two rounds of transitions to safer chemicals in the last 20 years. And all of these industries have been 

able to produce better, more energy-efficient, and more profitable products. 

But methyl bromide stands apart. The producer and the users of this chemical have dragged 

their feet on replacing this dangerous compound for two decades. let's review: 

The phase-out of methyl bromide was supposed to be completed by 2001 pursuant to the 1990 

Clean Air Act Amendments. With a decade of lead-time, growers and other users should have invested 

in developing and field testing other agents and other agricultural practices, like every other industry 

did. Their effort was minimal. And their minimal effort was rewarded by pushing the deadline back to 

2005, in conjunction with amendments to the Montreal Protocol to phase out methyl bromide world2 
45 


82531.026

wide. An post-200S exemption was allowed for so-called "critical uses," but all observers then thought 

this would be just a small percentage of historical ("baseline") methyl bromide use, just as the "essential 

use" exemptions for other ozone-destroying chemicals had been only a small fraction of their baselines. 

Indeed, other countries with comparable agricultural conditions played by those rules, 

submitting critical use exemption requests, if any at all, that reflected small fractions of their historical 

methyl bromide use levels. Only the U.S. took a different tack. In 2003, U.S. growers and others sought 

exemptions totaling same 15,000 tons, mare than 60 percent of country's baseline use in the early 

19905. The U.S. government requested more than 10,000 tons of exemptions, and nearly broke the 

back of the Montreal Protocol. For the first time in its history, the parties were unable to come to a 

consensus decision. For the first time, there was an impasse that could nat be resolved without calling 

an extraordinary meeting of the parties. 

For eight years running, the United States alone has requested more than 90 percent of all 

exemptions. Over this period, nearly every other developed nation has eliminated its need for methyl 

bromide. SpeCifically, every other strawberry- and tomato-growing country with Mediterranean-like 

growing conditions - including Italy, Spain, Greece, and Australia has moved beyond use of methyl 

bromide. Even Mexico - the California strawberry growers' only competitor - is committed to end its 

use of methyl bromide this year.' 

Throughout this period, and here again today, the California strawberry growers have led the 

pack in coming to Congress playing the hardship violin. In fact, however, California strawberry growers 

have done very well during the whole experience, according to a recent peer-reviewed economic study 

by Erin N. Mayfield and Catherine Shelley Norman, published in the Journal of Environmental 

1 "The Government of Mexico has committed to achieve the complete phase-out of MB by the end of 2012." 

United Nations Environment Programme, Executive Committee of the Multilateral Fund for the Implementation of 

the Montreal Protocol, Sixty-sixth Meeting, Montreal, 16-20 April 2012, "Project Proposal: Mexico, National 

methyl bromide phase-out plan (third tranche), '119, http://www.multiiateraifund.org/66/Engiish/l/6641.pdf. 

3 
46 


82531.027

Management.' They have expanded their strawberry acreage and increased their yields dramatically 

despite significant reductions in methyl bromide allocations: California strawberry acreage in 2010 had 

increased 83 percent over 1991 levels and 16 percent over 2004. Yields per acre in 2010 increased 29 

percent over 1991 levels and 14 percent over 2004. California's share of U.S. production also increased 

during this period, from about 80 percent in 1991 to more than 90 percent in 2010. U.S. grower prices 

and total crop values adjusted for inflation also increased during the exemption years. 

The expansion of the strawberry "creage treated with methyl bromide is extremely troubling 

because It breaks a commitment made by the U.S. government not to allow such expansion. For 

Instance, the "National Management Strategy for Methyl Bromide, United States of America, December 

2005" states: "An Important way that the United States addresses the Issue of avoiding Increases in 

MeBr use is our policy to disallow any increases in acreage or throughput that CUE applicants might 

Include in their CUE request'" This turns out to have been a hollow promise. 

The growers' complaints often center on the claim of unfair competition from Mexico. 

Throughout this period, however, Mexican growers used less methyl bromide per acre than their 

California counterparts, and Mexico, as I mentioned, has committed to stop using methyl bromide this 

year. Mayfield and Norman note that although strawberry imports from Mexico increased as the overall 

U.S. strawberry market grew, Mexico's share of total U.S. consumption did not Increase significantly, 

and U.S. growers' strawberry exports to Canada rose by almost as much as Imports from Mexico. 

Mayfield and Norman also note that the economic analysis supporting the critical use 

nomination for 2014 - an analysis prepared by the strawberry growers indicates that a range of 

alternatives to methyl bromide are effective and available at comparable cost and without yield losses. 

, E. Mayfield & C Norman, Moving away from methyl bromide: Political economy of pesticide transition for 

California strawberries since 2004, Journal of Environmental Management, Vol. 106, Pp. 93-101 (2012), available at 

http://www.sciencedirect.wm/science/artic1e/pii/S0301479712G01909, and attached to this testimony. 

3 http://www.epa.gov!ozone/mbr!downloads!MeBrNatMgmtStrat.pdl, p. 4. 

4 
47 


82531.028

Notably, these results do not depend on methyl iodide, which was withdrawn from the market by its 

manufacturer earlier this year. 

As it turns out, the industry is still sitting on a stockpile of methyl bromide made before 2005 

and stored in railroad cars in various communities around the country, Believe me, tank cars of highly 

toxic methyl bromide baking in the sun on rail sidings are not something I'd want in my community, or 

rolling through my Congressional district, yet few people know iHhey enjoy that privilege. As oftoday, 

the stockpile still exceeds 1,200 tons - three time the U.s. critical use nomination for 2014. 

Why is the stockpile important? Because the rules of the road under the treaty are that a 

country may request permission to manufacture new methyl bromide to serve critical use needs only if 

it has exhausted its stockpiles. The industry attempted to conceal that stockpile from both the public 

and the government, and this led to the U.S. government's initially misrepresenting to the other 

Montreal Protocol parties in 2003 that there would be no stockpile left in 2005. But the true stockpile, 

divulged only later in response to an NRDC lawsuit, was nearly 13,000 tons - more than the entire 

amount the U.S, claimed to need for 2005, The methyl bromide stockpile has been used - illegally, in 

our view - for crops that no longer qualify as critical uses, such as golf course turf grass, and to exceed 

the critical use limits on crops such as strawberries, Each year since 2004, the stockpile has been larger 

than the next year's total critical use request. That is true for 2013 and 2014. The deception over the 

stockpile, once revealed, almost caused the breakdown of the treaty process, and the existence of a 

continuing stockpile is still a major irritant between the parties today, 

NRDC acknowledges that the amounts of U.S. critical use exemptions have been coming down, 

however belatedly. Many growers and other users have finally taken up alternative chemicals and 

alternative pest management practices, so that we have now come to the point where the only field use 

for which a critical use nomination is still being made in 2014 is California strawberries. Together with 

several structural and commodity uses, the total U.s, exemption request is down to slightly more than 

5 
48 


82531.029

400 tons, as compared to nearly 10,000 tons in 2005. This progress, though long delayed, is noteworthy 

and must continue, Further progress is possible even in the short run, through practices such as greater 

use of impermeable films (something other countries have already adopted) and by continued adoption 

of alternatives. 

In short, the process is working. Now is not the time to tamper with the methyl bromide phaseout requirements under Montreal Protocol and the Clean Air Act. Mr. Chairman, the bill before you 

would pointlessly weaken curbs on this dangerous ozone-destroying chemical, threaten the recovery of 

the ozone layer, and further strain our relations with other countries that are already experienced with 

U.s. abuse of critical use exemptions. The bill does reckless damage in at least three major ways: 

First, the bill would permanently define as "critical uses" all of the uses that were labeled critical 

in 2005, regardless of the fact that the vast majority of those crops and applications have successfully 

transitioned to alternatives and no longer even use methyl bromide. Absurdly, the bill would make golf 

course turf grass a "critical use," even though the Bush administration's agriculture department dropped 

it from the list in 2006, Why in the world does it make sense to revive and freeze into law an utterly 

out-dated list of "critical uses"? 

Second, since growers and other applicants are seeking exemptions for a chemical that is 

otherwise already banned under both domestic and international law, and since they are in the best 

pOSition to innovate and test alternatives, they quite properly now bear the burden of showing the need 

for methyl bromide and the absence of economically practical alternatives, But the bill would turn that 

burden around. It would allow applicants to submit their wish lists for exemptions without providing 

any data in support. Even though this chemical is already supposed to be banned, the bill would then 

require EPA to shoulder the burden of developing the data to support any reduction from the growers' 

or other applicants' requests. As the growers would be quick to point out, EPA does not run farms, and 

EPA does not run alternatives testing programs. 

6 
49 


82531.030

Absent the resources and access to data, EPA would have little choice but to forward the 

applicants' wish lists to the parties for consideration, Even from the growers' perspective, this would be 

a fool's errand, It is difficult enough for the u.s. to gain approval for its out-sized exemption requests 

when it can bring a reasonably robust case forward for technical scrutiny by the other parties, It actually 

helps the U,S, win approval for exemptions to have shown that the government has exercised some 

judgment and discipline in framing its requests, and that the U,S. is not asking for everything its 

domestic applicants may have wanted, 

Third, the bill would blast an enormous new 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 

simply by asserting the existence of an emergency. "Emergency" is conveniently defined to mean any 

situation where someone wants to use more methyl bromide than is available under a critical use 

exemption, and where he declares that there is no alternative, The bill would allow a hundred 20-ton 

emergency exemptions per vear, up to a total of 2,000 tons per year (the amount of critical use 

exemptions in 2011). This would be a massive abuse of the emergency exemption provision under the 

Montreal Protocol, which has been invoked only twice so far (once by Australia and once by Canada) in 

genuine emergencies. 

Imagine, Mr. Chairman, how cool it would be to be able to withdraw more cash from the bank 

than you have in your account, just by calling it an emergency. There's another name for that: bank 

robbery. 

This is a bad bill, and an unneeded bill. it would harm public health, harm other farmers, and 

indeed even harm the farmers it is intended to help. The process is working. This Committee should let 

well enough alone. 

7 
50 


82531.031

Journal of Environmental Managemer"lt 105 (2012) 93--101 

Moving away from bromide: Political economy of pesticide transition for 

California strawberries since 2004 

Erin N. Mayfield", Catherine Shelley Norman a,b" 

ARTICLE INFO 

t. Introduction and background 

bromide 

Protocol on 

ABSTRACT 

DuPuis, 2009). In the exemption process, 

exceptions to the scheduled 2005 complete 

of the most contested uses was for strawberry 

in California where many alternatives are 

strictly or disallowed. Growers argued that none of the 

alternatives met the 'economic and technical feasibility' conditions 

of the Critical Use Exemption (CUE) rules, DeCanio ~nd Nomlan 

jhtLNlu (C5, Norman), 

@ 2012 Elsevier Lw. All rights r("served 

be met 
51 


82531.032

E.N. M~.Yfieli( c.So Norman I journal Df Environmental Matwgemenl W6 (2012) 93··101 

growers and those negotiating the CUE process on 

thefr behalf were deeply concerned that the main source of US 

of fresh strawberries, Mexico, would not be required to 

same time that California growers 

were scheduled to. The Montrea! Protocol allows delays in the 

eliminatIon of ozone substances for tess developed 

countries, and growers feared lowered trade barriers under 

NAFlA would combine with a technological 

the leading to 

domestic berries. 

dssessment of the phaseout process to date. 

2. Ex~ante analyses of economic effects and political factors 

influencing phaseout 

Economic analyses earlier in the process did not rca-ch 

it consensus regarding the impacts of phaseout. Norman 

r.elled heavily on dat.a nominations for CUEs and 

that trends demand growth fresh strawberries} .and 

Dass-tflfOlJeh of cost increases to consumers were 

increases in CA production cost.s for and, when coupled 

with increased acreage devoted to strawberry production, CA 

and net r!;'venues would increase and 

or California growers. The former field trials to estimate weed control costs. MeBr and various available alternatives but were unable to yield losses from the use of 

MeEr alternatives and concluded that acreage and thus 

supply would hav.e to significantly to raise market prices 

enough to eliminate the n{"t losses to remaining growers, The latter 

note that single annual dema.nd elasticity parameterization 

variation in seilsonaJ dem,md and supply 

Neither study considered longer-tcnn trends in [he fresh straw·· 

in California, 

the regulators side, there was concern that signifi<:ant 

exemptions would slow the 

at the expense of efforts to 

were 

the next session, 

to a level of about $20,000 

It is likely, of course, that only some of these 

S All figures ttJnverted to 2010 do1!aT$ using the (PI tm!es$ otlw!wise noted. 
52 


82531.033

EH May/ield, CS Nomwn I Journal of Elwironmenrol Monogrmf'llf WE (20J1.) 93-101 95 

p-h.:!seout of methyl bromide strawberries 

.1 rational investment for the industry, even jf the costs of 

alternative pesticides are a rel~ltively small 

profits. 

The Crittcal Use Exemption process involves stakeholders who 

use- the regulated chemical, national nominations, and recomrnend-ations or J.nalysls the Technology- and Economic Assessment PaoE'! (TEAP) of Montreal Protocol, to fin<l! 

amounts which must be by the Parties ilt 

their annual meeting. In " 

Agenql {EPA) solicits 

outcome would undermine the intent of the Parties to the 

Protocol, particularly as it could allow the use ofMeBr on fields put 

into production after the beginning of phaseout In California, 2{)a9 

repre-sented an increase ofE9%, or 7600 na, over the 1991 

ow:e are 

United States did a policy of not allowing growth in 

CUNs due to new acreage (UNEP, 2005), not that 

new acreage reliant on MeBr was not even not 

drivE' tQta! amounts of requested MeBr, and So the 

continued in (UNs for thIS sector seems to satisfy this 

domestic policy, 

While lobbying efforts are ongoing, the esc and other industry 

groups also work closely with farmers and researchers developing 

and testing MeBr-free growing methods. CSC reports research 

expendjtures of over ten million doBars to date toward this end, 

in the to mid-199O$, which 

lobbying for continued 

from continued use afMenr, CA growers have gained about $225.000 sociological issues arou[Jd 

tura! exemptions to the MeBr phaseout have been 

siwly. Clark offers an early analysis of the 

betvveen growers, state of California, and the Federal 

Badulescu and Baylis (2006) consider the harmonization of pesticide rules under NAFTA and the that that has 

the CUE process in California. 

More recently, DuPuis and 

2012) and Gareau and DuPuis 

that increasing pressure to solutions rather 

command and control ones - as evinced partly by the economic 

justification for exemptions to agreed phaseout schedules, which 

was allowed for the previously (;'stabjished 'Essential Use 

Exemptions' for other ozone substances in 

Montreal that .an on the 

credibility of estimates of private costs over estimJte'.> of 

benefits will drive decision-ma.king about exemptions the 

future, while the past a precautionary principle approach to 

the human and environmental risks -associated with ozone 

deplcting substances W<lS more important Stakeholder processes 

have hem to a significant degree by industry groups 

rather than a broader group more focused on the 

as a whole. That this mode of discourse 

for the Dngoing use 

when other countries granted early exemptions have completed 

phaseout. 
53 


82531.034

% EN, Mayfield, CS. Normon /joUnlfJl of f,:'nviromm:nto! Mmwgement 106 (2D12) 93·-101 

3. Progres.s and barriers in eliminating MeBr under the 

Montreal Protocol 

CUE process, had nonetheless reduced CUN amounts by 

2003 to 2013. Although the US has been accelerating the MeBr 

phaseout in recent years, with a large drop in the 2014 nomination, 

a complete phaseout has not been planned and it remains unclear 

when complete be achieved. 

Within the California is now the only state still 

critical use exemptions for field strawberries. Porter 

conducted a global of yields based on 

htlndreds of studies and many produce 

"statistically equivalent yields" to MeBr, and thus worked to 

undermine for related to tcchniCill feasiet aI" 2012). 

of iodomethane by the us Environmental 

ProtEction and the California Department of Pesticide 

Regulation WJS controversial due to potential publlc and occupational health hazards resulting from its use in soil 

After first denying registration of iodom.,thime 

2006, the US EPA granted iI one-year 

quickly fallowed suit by 

''''''' ........................................... .. 

1 14000 

112000 1 ,_ 

! 8000 ................. "' .......... . 

l """ 

registering the fumigant California eventually did approve the sale 

and use of iodomethane, but with restrictions more stringent than 

those imposed by the US EPA and other states. Legal challenge-s to 

the approvJI of this fmnigaot are ongoing, and an ongoing dialogue 

with respect to concerns about the registration of iodomethane 

persists between the genera! public, the US EPA, the California state 

legislature, and the risk assessment community, induding 

govemment scientists involved in assessing the risk of iodomethane. a neurotoxin and In 

early 2012, while no legal against use 

was made, the manufacturer announced that, based on an internal 

review of the fumigant and its economic in the U.S, 

4. California strawberries today 

continues for yeaTS MeBr, though yields are, 

conditions and thus man.' volatile ,lcreage. The share of California production in total domestic production ha.s also grown over 

the time period covered, and has hovered around record highs of 

88-89% since 2003. More the Fruit and Tree Nuts report 

1 :: L''=~==~;,;;;;;:~~~;;;~.;:::;;;:;:~:: 

"'''"'IJ$Area jMj 

''''''CSCANeil!Mj 

"'"""~USAfflO\,lnt !1000 kg) 

~C$CNrroUfll!lOOOk:&l 

2006 1001 2003 2Gli9 201Q lOU lO12 lOB 2014 

Fig, 1, US and Cailfornia Crit[ql U$(" NDminations, with MeEr n~que$t.~ and acreage, 
54 


82531.035

E.N. Mayfield, CS. Normon.! Journal of EnvironmellwJ Managemcnt 106 (2012) 93-·101 97 

Fig. 2. US fresh strawbe1rY prjres ;mtl dlnSl1mption. 

in California (up 7 percent from 2009) more than made up for the 

decline in harvested acres (down 3 percent), resulting in a larger 

201Ic)< 

capit3 consumption as 

seen in Fig. 2, 

We examine seasonal patterns in retaf! prices to evaluate 

about patterns of trade raised in some of the ex-ante 

discussed above. Real retail prices in june, the period 

identified by Carter et aL (2005) as most vulnerable to losses in 

a MeSf rose 5 of the 10 most for which 

data are (2000-2009). The 

prices from 200S to 2009 was 1% higher 

acreage 

deliver 

in the 

later in the SCdson, 

where strawberries come in earlier 

a domestic explanation for this 

relative prkes throughout the year, So the currently 

pattern of relatively lower April prices is consistent with the US 

market becoming mQre attractive for Mexican groWel:S wishing to 

more of the season or US growers faclng rising costs in 

pe.ak production periods. It CQuid also be that unobserved 

however, not provide strong supporting 

evidence for hypothesis that increased Mexican imports are 

intra-year changes in relative prices, Imports of fresh 

to the Unlted States. almost exclusively from Mexico, 

have indeed grown substantially, continuing a trend observed weU 

before MeBr restrictions began. They have more than doubled since 

2004 (fRS, 2011b and Table G-1. EftS, 2011a), The share of Mexican 

lmpolts in domestic consumption has changed less, 

trendin...~ slowly upward since the rnid-1980s and now around 

This !11i1Y reflect increasing retail availability and consumption in 

the Qffseasoos for domestic strawberrjes as well as increased April 

Canada is very the increase In 

gcsring th~t changing price patt~ms over .cannot be 

ascribed to trade advantages for Mexican growers seHing in 

United States. Domestic could well increase the scarcity of 

slightly dlffercnt than those 
55 


82531.036

98 E.N. Mayfieid, Cs. Normall j jO\irllal oJ i:'nvironmentnJ Mmwgemenl 106 (2012) 93~Wl 

supporting growers in 

Either of these would growers 

exporters in the domestic market While we (.annot isolate any 

of this over the short since the rules have been 

it remains clear the majority of the US market 

continues to b~ served by domestic growers. 

The MeEr alternative iodomethane has been approved fOfuse in 

Mexico .and a commercia.l launch there is pianned for 2012 (ALe. 

2010). As an Article 5 country, Mexico has until 2015 to phaseout 

MeBr under the Montreal Protoc-ol; however, the government of 

Mexico has committed to completely phas\:'out methyl bromide by 

2012 2010),9 by which point it seems that growers 

able to use iodomethanc will 

of MeBr and 

ch<lnges 10 current research 

Costs for varIous production inputs 

of course vary and be drivers of 

in international trade as with any 

th<lt changes in land use in California or 

5. California strawberry production cost estimates 

returns increased frQm 9.5 to 13,4% and then dropped to 2.2%. In the 

northernmost growing region, for 2001, 2004 and 2010 

show increasing fumigation costs 5,4 and 6.9% of total costs, 

respectively) and fluctuating net returns (6.6, 9,4 and 4.0%), These 

numbers offer some insights 1010 input and production costs, in 

suggesting weakly declining fumigation costs and 

some evidence of declining net revenues in the most 

recent years, but we note that the sample budgets are designed to 

olTer a understanding ofc:osts and revenues using current 

rather than to support rigorous economic analysis. 

CriticAl Use Nominations themselves are another source of data 

on tr.ends in production costs and revenues. The nominations 

2013 give a baseline yield rate fOT 100% 

bromide and discount it some 

control regime. detailed budgets are not 

annual CUNs for CUEs also include estimates of the 

economic impacts of MeBr as compared to a!tematives.lO These 

estimates arc developed to support the case thJt .additional 

exemptions to use MeBr in Califomia are needed to 

cant market which is a of the 

as critical, Alternatives are shown with associated yield estimates 

and implJed costs to producers fildng changed yle!ds and other 

practices. For 2006-2013 CUNs, the baseline MeBr yield estimates 

fluctuate J, bit, dropping by around 15% from 2006 to 2008 levels in 

2009·~2010 and then rising again for 2011-2013 nominations. 

per hectare are well below those reported in the 

above, typlc.ally around 40-50,000 kg! 

ha alternatives in the 30-,·40,000 range 

in earlier nomjn<'ltions, while first strJ.wbeny yields in the 

are around kgjha and the most recent 

reported is over 50,000 

The loss 

that the 

applied to the MeDr number 

altemative is only one induded in every 

metJm sodium (MS) and a mixture of Pic and MS 

were excluded from 2010 to 2009, respectively, and a mixture of Pic 

and MeBr was not added until the 2010 nominatioll. tooomethane 

M!'Br. 

n The CUN itself reports ·units'; we belicvl." these tq b-e kilDgrams based 

m:ltching With pr{'viOlls Californi.\ nomlniltions. 
56 


82531.037

EN M.:tyjle1d, CS< Norman! joumai oj Environmental Managpmen! 106 (2012) 93·~101 99 

required gmss revenues less operating costs are "difficult to 

measure and 2004-2011), Net revenues are 

sensitive to the in gross revenues of much lower 

strawberry prices even in and 

smaller net revenues produce 

nomina! coslin(TeJse 

this article was being 

Critical Use Nomination for field in was 

made public. It requests 415 metric tonnes of MeRr for field 

strawberries, a b!tover a 20% decline from the request for 20 13. The 

drop in requested acreage to be treated about 50%, 

use of MeBl' in combination with 

While the baseline 

subsequent later deliveries of crops to market growers using 

alternative practices rather than broader market 

output prices across alternatives with signifidiffering yields suggest that these economic impact estimates. assume no market responses to 

losses 

affect the 

exemptions were using substantially 

lower and simjjar or increased costs, we would expect 

market prices to rise and moderate reductions 

While we do not observe profits directly in way that we do 

acreage and revenues, it is difficult to reconcile the history of CUN 

figures for California yields and co:o;ts alternatives with the 

6. Additional drivers of change and trends 

falling in olnd 2010 (Historical income Www,cen$U$, 

goy), With a relatively short data period to t:Ontend with and 

a lack of detailed information about changes in income distrIbution 

Fig,), US fruitaod vegetable rea! retail prkes. 
57 


82531.038

100 LN. Mflyfo.!ld, [5. Norman I joumil! ofEnvirofln!f'f1tal Mmwgcm.ent 106 (2012) 93-"101 

7. Conclusion 

elin1ination of MeAr and the 

increasing success detailed in the 2014 (UN and 

other reports have bc(.'n 

recession and 

navigation of technical regulatory 

suggests that the real burdens 3ssodated 

tural practices have not kept this sector from 

growthlna 

know how lTItlCh 

continued unabated. 

Al.:trming numbers in the CUN'S sent to the Parties to the Montrea\ Protocol are not consistent with th(,' success of California 

reduced, 

to justify ongoing exemptions to support expansion rather than 

protect existing growers and growing regions. Jf all the new acres in 

productJon since 2005 are being managed profitably without MeBr. 

and existing acres are using less MeBr less often while overall and 

per acre yields <lod revenues rise steadlly, it seems we have reached 

a point where alternatives are demonstrating successes for field 

strawberries in California, 

References 
58 


82531.039

liN. Mayfield. C.S. Norman.l Journal of Environmenfal Mrmagemen1 106 (20l2) 9J-101 101 
59 

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. 

60 

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:] 

61 


82531.040

Contact: 

Lin Schmale 

STATEMENT BEFORE THE 

SUBCOMMITTEE ON ENERGY AND POWER 

ENERGY ANO COMMERCE COMMITTEE 

U.S. HOUSE OF REPRESENTATIVES 

HEARING ON 

"U.S. AGRICULTURAL SECTOR RELIEF ACT" 

submitted by 

MICHELLE CASTELLANO KEELER 

Vice President 

MELLANO & COMPANY 

SAN LUIS REY, CALIFORNIA 

on behalf of the 

SOCIETY OF AMERICAN FLORISTS 

July 18, 2012 

Society of American Florists 

(703) 83S-S7(1) 

Corey Connors 

Society of American Florists 

(703) 836·8700 
62 


82531.041

Members of the Committee, we thank you for this to present testimony on behalf of the 

U.S. floriculture industry. Continued availability of bromide to U.S. flower growers is of great 

importance to our industry, We are with the Protocol. However, our industry is 

in danger because we are not being under the terms of the Treaty. 

The Society of American Florists (SAF) is the national trade association representing the entire 

floriculture industry, a $32 billion component of the U.S, economy. Membership includes about 

10,000 small businesses, inciuding growers, wholesalers, retailers, importers and related 

organizations, located in communities nationwide and abroad. The industry produces and sells cut 

flowers and foliage, foliage plants, potted flowering plants, and bedding plants, Our products 

compete in an international marketplace, 

In crop value, nursery and greenhouse crops have surpassed wheat, cotton, and tobacco and are 

now the third-largest crop in the U,S, - behind only corn and soybeans. Nursery and greenhouse 

crop production now ranks among the top five agricultural commodities in 28 states, and among 

the top 10 in all 50 states, Growers produce thousands of varieties of cultivated nursery, bedding, 

fOliage and potted flowering plants in a wide array of different forms and sizes on 1,305,052 acres 

of open ground and 1,799 million square feet under the protective cover of permanent or temporary 

greenhouses, across the United States. 

U.S, growers, whose ability 10 compete in that international marketplace is often at stake, are very 

concerned that their rights under the Montreal Protocol be supported by the U,S. government. 

Methyl bromide is a critical management tool in many kinds of production, particularly In Florida 

and California, The combination of methyl bromide and chloropicrin has long been used to control 

weeds, nematodes and plant pathogens like Pythium, While some industries have found 

acceptable alternatives, floriculture has struggled to find an acceptable alternative despite 

substantial investments in research, The production of field-grown cut flowers, some In-ground 

shade house flowers and caladiums rely on availability of methyl bromide for economically viable 

crops. 

We greatly appreciate today's hearing, and we also greatly appreciate your introducing this 

Important legislation, the U,S, Agricultural Sector Relief Act We strongly support this bill and hope 

that Congress will move to enact it 

My testimony today will focus on four major points: 

1, The U,S. needs to be more forceful in defending the rights and needs of U,S. growers. 

EPA should not deny or reduce a Critical Use Exemption (CUE) application unless It has 

substantial evidence that there are technological and economically feasible alternatives. 

The State Department should more actively push the U.S. nomination, rather than play 

defense, 

2. We need to have assurance that the CUE process will continue after 2015, which is the 

clear intent of the treaty. 

3, EPA should work with us to establish regulations implementing the "emergency event 

e)(emption" allowed by the Protocol. We need an emergency cleanup process that will 

allow us to go into our fields every few years and clean up the pests and diseases that have 

developed during the times when we were using the less-effective alternatives. There are 

other situations, as well, where an emergency event e)(emption is appropriate. 
63 


82531.042

4. The Quarantine and Preshipment (QPS) EXemption is also clearly provided for under the 

Protocol and must continue in order to protect international trade. 

I. THE U.S. NEEDS TO BE MORE FORCEFUL IN DEFENDING THE RIGHTS AND NEEDS 

OF U.S. GROWERS'. EPA SHOULD NOT DENY OR REDUCE A CUE APPLICATION 

UNLESS IT HAS SUBSTANTIAL eVIDENCE THAT THERE ARE TECHNOLOGICAL 

AND ECONOMICALLY FEASIBLE AL TERNA TlVES. THE STATE DEPARTMENT 

SHOULD MORE ACTIVELY PUSH THE U.S. NOMINATION, RATHER THAN PLAY 

DEFENSE. 

Under Ihe terms of the Montreal Protocol, U.S. growers are enlitled to a CUE if practicable and 

economical alternatives are not available. Efforts have been made by the floral industry to find 

alternatives, and a significant market disruption would result from lack of availability of methyl 

bromide. U.S. growers have complied with the terms of Ihe treaty, but we are not receiving the 

exemptions to which we are entitled. 

Today we are faced with a political process that appears to be attempting to force U.S, growers to 

discontinue completely the use of methyl bromide despite the absence of suitable feasible 

alternatives. Without access to this necessary input, U,S. growers will be rendered noncompetitive in the global marketplace. This will force many to cease operations, killing jobs and 

causing significant harm to the local communities in which we operate at a time of great economic 

uncertainty. 

The basic CUE process works as follows: 

1. U.S. growers prepare a very detailed application for EPA, describing their efforts to find 

alternatives, the reasons why alternatives do not work, and the economic reasons why 

methyl bromide must continue to be used. 

2, EPA reviews this application ostensibly to ensure that the U.S. applications are complete 

and accurate. However, EPA as a matter of course has reduced the amounts we 

request, and we question those reductions. 

3. EPA submits the U ,So application to lhe Secretariat of the Montreal Protocol. 

4. The U.S, application and all other applications are reviewed by MBTOC and TEAP (the 

"scientific committees" of the Montreal Protocol governing body), Significant reductions 

recommended by those advisory groups again, we believe, without 

,,,,(,, •• !Ir,,, justification. 

5. While technically at the full Protocol meeting, the parties to the treaty consider and vote on 

the CUE nominations, they essentially simply adopt the recommendations of 

MBTOCffEAP. 

The U.S. cut fiower and fOliage industry has participated in the CUE process since it was 

established because it is the only meaningful way we can possibly access methyl bromide to meet 

our needs. While the Montreal Protocol deals with the phase-out of the production of methyl 

bromide, the Protocol also clearly provides for a CUE. In short, an application can be made for 

continued use of methyl bromide if efforts have been made to find alternatives. If technologically 

and economically feasible alternatives are not available, then CUE applicants should be able to 

access methyl bromide, 

Yet this provision is no! being followed in Ihe implementation of the Protocol. Despite having 

submitted CUE applications substantiating their need for the product in accordance with the 

provisions of the Protocol, U.S. growers are being forced to take arbitrary cuts In their requested 
64 


82531.043

levels, with absolutely no scientific reasoning and no justification, That is not the Protocol that the 

U,S, signed and the U,S, government must not accept it 

A. EPA's Arbitrary Reductions 

The California and Florida cut flower industry has applied for and been granted a CUE for a limited 

amount of methyl bromide in every year until this one, The applications are submitted three years 

in advance due to the lengthy review and approval process, For the past several years, the 

industry has requested about 70,5 metric tons of methyl bromide for California and over 50 metric 

tons for Florida, 

In 2009 (for 2012 use), the international treaty had approved 47 metric tons for cut flowers 

(California and Florida), In 2010 (for 2013 use), EPA's Use Nomination to the international 

body requested 47 metric tons of methyl bromide for cut flowers, In a move resulting in virtually 

zeroing out Florida due 10 the registration of the alternative methyl iodide, MBTOC recommended, 

and the parties to the Protocol approved, just 40 metric tons for cut flowers for 2013 use. This 

was a significant reduction from what the industry needs and had requested in its CUE application, 

Those reductions were made even though there were no changes in the scientific information or 

circumstances known to EPA or MBTOC, 

Cut flower producers again submitted to EPA the application for the 2014 CUE in September 

2011. However, the 2014 application submitted by EPA to the international Montreal Protocol body 

in February 2012 did not include ANY allocation for cut flowers. In fact, of the ten categories of soil 

fumigation that were approved in 2013, the U.S, nomination for 2014 included only one - that for 

field-grown strawberries, It did not include applications for the other nine: cucurbits, eggplant, 

nursery stock, fruit/nuts, cut flowers, orchard replants, peppers, straWberry runners, or tomatoes. 

The only material change in circumstances from the prior year was the registration of methyl iodide 

in California, 

EPA relied heavily on the registration of methyl iodide in California to conclude tha! methyl bromide 

would no longer be necessary, However, in our original application 10 EPA we clearly noted that 

methyl iodide at the label rate approved in California made it unlikely that the compound would be 

available or useful to California growers. Furthermore, we noted that the required buffer zones and 

the intense public opposition to the use of methyl iodide made it even more unlikely that the 

compound would be usable, Yet EPA continued to assume that methyl iodide would be a "drop-in" 

replacement for methyl bromide, ignoring the information provided in our application, 

Then, shortly after the U.S, nomination was submitted to the Montreal Protocol, the manufacturer 

of methyl iodide, Arysta, withdrew sales of that compound in the U,S, Thus, EPA's assumption 

that methyl iodid,e would be a "drop-in" replacement for methyl bromide is now completely 

invalidated, We are encouraging EPA and the State Department to submit a supplemental request 

for 2014 this coming year or early next year - but it is expected that the criteria MBTOCITEAP will 

use for reviewing the supplemental application will be even more stringent. We are making efforts 

to bolster the CUE application to EPA, but we are very concerned that our need will no! be met 

13. MellanD 8. Company 

EPA needs 10 better understand the complexity of our cropping systems and why something that 

works in one part of the world won't necessarily work for us, Simply dismissing our application by 

saying, in essence "It works in X country or state, so it should work for you" is not acceptable, 

Particularly in the case of ornamentals, the cropping systems and timing are so complex that it is 
65 


82531.044

imperative for EPA to understand and acknowledge why methyl bromide is so important to our 

operations. 

We at Mellano & Company farm over 400 acres (employing over 200 employees) and grow over 

50 different crops of flowers and greens, with upwards of 20 different varieties within each of those 

crops. Unlike other agricultural farms, you have to envision our farm as a patchwork crazy quilt, 

with each square constanlly changing in terms of crops, cultivating times, disease, pests and 

irrigation needs - and market demands. 

We cannot fit our growing practices into one neal formula because we are ever changing and 

cannot afford to let our ground sit unused and idle. We must respond quickly to market demands, 

as well as issues with pests and diseases, and have access to the tools necessary to prepare our 

land for these changes in time to produce a saleable crop. 

We will continue to work with EPA to ensure they have a clear understanding of our issues. But in 

the meantime, EPA is reducing our application amounts and we cannot afford these unscientifically 

baSed cuts. 

In addition to the factors referred to above which make the use of methyl iodide impossible, the 

other alternatives are not adequate to protect us against soil pests and diseases, despite EPA's 

assumption that they "should" work. Just because research shows that an alternative will work in 

one country of the world, or in one part of the U.S. for one crop, does not mean that that same 

alternative will work for other crops in different economic, climatic, or soil conditions. 

Our crops can have a planting value of $60,000Iacre. Some proprietary plants can cost as much as 

$40,000Iacre. \l'{e simply cannot afford to put such hi£Il:l-valull.Jlill.nts into dirty soil with the risk of 

compromising the crop. We currently have over 50 different species in production between annual 

and perennial cut flowers on our farm alone. In the state, there are many more than that. Each 

one has a different yield, cost and profitability profile. as well as a cropping system that could be 

unique to that species 

Consider these other points that apply to our farm: 

• The cost of failure is very high when applications don't work. 

• Hand-weeding is not an option in the U.S., due to the cost and to Cal-OSHA worker issues. 

• For bulb-producing plants, the second season can result in rogue plants, causing 

production and harvesting issues. 

• Drip-applied materiais on sandy, hillside farms just don't work well. On high-sand soils 

such as those at our farm, lateral movement is minimal and therefore effectiveness of dripapplied materials is restricted to a narrow strip, rather than to the whole flower bed. 

• Yield alone does not tell the whole story: plant Vigor, plant height, stem thickness are also 

important. Yield must be accompanied by good quality. 

+ Methyl bromide is now very costly up to $3300Iacre. We obviously are seeking viable 

alternatives, yet have not yet found them. 

• We have perennial crops as well as annual ones. Those perennials, depending on the 

crop, must be productive for between 5 and 25 years. Soil diseases can and will reduce 

that lifespan Significantly. We need a "clean start" QDe fumig1!!iPJl.~_few years will 

h?Jp to "cleanJ,lll" the soil to prevent car1Y9yer aD.9.1~cl,!.r:rence 9f disease, 

+ Fcr perennials, the most Important need is for disease and nematode conlrol. For annuals, 

we need disease, weed and nematode control. For some diseases, if the pathogen 

overwhelms a perennial crop the crop must be replanted, those replant acres require a very 

serious clean-up treatment before the new plants go into the ground. 
66 


82531.045

• True long-term rotations are virtually impossible to achieve, and fallowing expensive land is 

not cost-effective, 

Those points are lypical of the ones we have made, year after yeaL We do our best, in our annual 

applications to EPA, to explain why the variety and complexity of our cropping systems make it 

difficult to find alternatives to methyl bromide. Yet year after year, EPA reduces the amount we 

say we need, when they submit the U.S. application to the international body. And this year, with 

no warning and despite the fact that we thought we had provided them with all of the information 

they needed, they eliminated our application altogether, 

EPA should not deny or reduce a CUE application IInless it has substantial evidence that 

there are technological and economically viable alternatives. We ask that Congress put this 

requirement into law. 

C. MBTOCITEAP Arbitrary Reduction 

M8TOCITEAP (the "scientific advisory committees" of the Montreal Protocol) are tasked with 

reviewing CUE applications to make sure they are based on sound science, After this review, 

M8TOCITEAP makes a recommendation to the parties as to what each country's allocation should 

be. That recommendation is supposed to be based on their scientific reasoning, 

Our applications, already reduced by EPA, are presented to M8TOCITEAP. We are frustrated 

when the M8TOCITEAP recommendations are reduced further witt:lJl_o,$9?Jlliflfj!,LstificatiQEh 

The following quotation from one MBTOCITEAP report on the CUE nominations is particularly 

revealing of the unscientific and biased nature of the MBTOC decisions: 

"MBTOC assumed that an alternative demonstrated in one region of the world would be technically 

applicable in another unless there were obvious constraints to the contrary e,g,. e very different 

climate or pest complex." [Report of the TEAP, October 2004, page 5J 

This assumption is completely invalid and unjustified. This kind of "assumption" is not based on 

science, The U,S. has provided detailed Scientific information on why certain alternatives available 

to other countries will no! work in the U.S, Not only do climate and pest complexes differ, but the 

economies differ as well. An alternative, which might be economical in a developing country, may 

no! be usable in the U.S., where cost/profit margins are considerably slimmer and labor, 

enVironmental compliance, and chemical costs are very high. 

It is absolutely essential that MBTOC and TEAP be required to provide scientific justification for 

their decisions and detailed rationales of their recommended cuts to the nominating party, Without 

understanding why MBTOC and TEAP are recommending cuts, it is impossible to answer or 

defend a nomination, and we are forced to accept what can only be Classified as an arbitrary 

reduction. Our State Department cannot argue effectively on our behalf so long as this charada of 

scientific review is allowed to continue, 

D. The Negotiations at the Meeting ofthe Parties are Political, Not Science-Based 

According to the agenda, the discussion period of the international meetings is directed around the 

CUE process of the Montreal Protocol. However, the underlying agenda for most parties has 

nothing to do with the Protocol treaty terms. 

It is the clear intent of some countries, particularly the European Union representatives, to force a 

year-by-year decline in CUEs approved by the Parties. Such discussions and goals are contrary to 
67 


82531.046

the Treaty. The Treaty provides for the CUEs in cases where practicable and economical 

alternatives do not exist. The Treaty does not require that CUEs should decline year by year. 

Discussion at the international meetings imply that the U.S. applies for too much methyl bromide 

under its CUE application, and the amount should be reduced and phased out over time. Under the 

Montreal Prolocol, if no economical and feasible alternatives exist the industry can utilize the CUE 

process. 

The United States' agricultural community has complied with the CUE requirements, despite the 

fact that they are cumbersome, time-consuming and costly. Yet our applications continue, year 

after year, to be arbitrarily reduced, without any or with very inadequate scientific explanation. 

We believe that it is also noteworthy to point out the efforts that our industry has to go to in order to 

try and participate in the Protocol process to advance their nomination. For example, in Just 

considering the venues for the Meetings of the Parties under the Protocol, since 2003 those 

meetings have been held in such locations as Nairobi, Kenya, Prague Czechoslovakia, Dakar 

Senegal, New Delhi, India, Doha, Qatar, Port Ghalib, Egypt, Bangkok Thailand, and Bali Indonesia. 

These are nol the easiest or necessarily safesllocations to Iravel to. In short, we have to Iravel to 

distant lands to participate (however limited that participation is allowed to be) with governments of 

the world that hold our future In their hands. 

The foregoing does not even take into account the other meetings that are held by MBTOCITEAP 

that first will consider the US CUE nominations. The procedures of those committees are such that 

direct participation in their meetings for NGOs is essentially precluded. However, we are forced to 

live with their decisions. When we have raised these issues with the EPA and State Department, 

their response is essentially this is all controlled by the Protccol and there is nothing they can do 

other than encourage us to submit "robust" CUE applications which ostenSibly will make it more 

difficult for the advisory committees to reject or reduce the US nominated amount. You can 

imagine how unsettling this all is to us. 

The State Department should more actively advance the U.S. nomination rather than playing 

defense. 

II. WE NEED TO HAVE ASSURANCE THAT THE CUE PROCESS WILL CONTINUE 

AFTER 2015, WHICH IS THE CLEAR INTENT OF THE TREATY. 

We have now reached the point where EPA appears to be considering a complete phase-out of 

methyl bromide after 2015. That kind of complete phase-out is completely contrary to the Montreal 

Protocol, Which clearly allows use of methyl bromide after 2015 if no feasible alternatives are 

available. 

Nowhere in the Montreal Protocol is there any requirement that countries cannot avail themselves 

of the CUE process. Yet the political agenda of some of our trading partners and others involved 

in the international meetings is to push for just that - a requirement that CUE's would stop being 

issued after a certain date. 

In addition, and equally important, as circumstances change (failure of alternatives, changes in 

regulatory status, or changing a use from QPS to CUE), a methyl bromide request is 

justified under the treaty. We ask that EPA be directed recognize that increases may 

be necessary and ap propriate. 
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82531.047

We ask for legislative direction to EPA and the State Department to continue the CUE process, in 

compliance with the terms of the Montreal Protocol. 

m. EPA SHOULD WORK WITH AFFECTED INDUSTRIES TO ESTABLISH REGULATIONS 

IMPLEMENTING THE "EMERGENCY EVENT EXEMPTION" ALLOWED BY THE 

PROTOCOL. 

EPA should work with impacted industries to develop an "emergency clean-up" process thai will 

allow us to go into our fields every few years and clean up the pests and diseases that have 

developed during the times when we were using the less-effective alternatives, 

After years of trying to use methyl bromide elternatives that are less effective, and having a CUE 

amount of methyl bromide below the level we really need, we are seeing pest and disease build· 

ups in our soils. This results in reduced yields and reduced quality, EPA needs to (as is allowed 

under the treaty) work with us to develop a way for us to have methyl bromide available as an 

emergency clean-up tool, every few years, to counter this kind of buildup, 

After a few years of using alternatives to methyl bromide for soil fumigation, many of the U.S. 

growers notice a gradual (or sometimes an intense) build-up of weeds and diseases, A periodic 

"clean-up" with methyl bromide would allow us to use the alternatives during the intervening years 

without production losses yet would also allow us to keep growing our crops once the level 01 

pests and diseases in the soil has gotten to the point where the fumigalion alternatives simply can't 

get the soil clean enough, 

As noted above, Mellano & Company produces perennial crops as well as annual ones, Those 

perennials, depending on the crop, must be productive for between 5 and 25 years, Soil diseases 

can and will cut that lifespan significantly. One fumigation eve~l},'~ars __ \Nili he~~clean up" 

!bsliQiUQ.p[evenl canygver and recurrence 9f cJjgl,'l.s!", 

There are other situations in which an "emergency event" would require an exemption, For 

example, if there is no existing CUE but if a situation arises where a person who owns a farm, 

nursery, or food processing or storage facility suddenly requires fumigation and has no other 

alternatives, or if alternatives have suddenly become unavailable (as is the case with methyl iodide 

or sulfuryl floride), then an exemption for such an emergency event should be permitted. 

The Montreal Protocol specifically allows such an exemption, under Decision IX/?, and EPA must 

move to establish Leasonable regulations implementing procedures for granting emergency 

exemptions. Furthermore, the 20 tons of methyl bromide which Is the maximum authorized 

under Decision IXI7 should be the maximum on a per-farm or per-facility basis, and not a 

yearly U.S. nationwide maximum. 

IV. THE QUARANTINE AND PRESHIPMENT (QPS) EXEMPTION IS ALSO CLEARLY 

PROVIDED FOR UNDER THE PROTOCOL AND MUST CONTINUE IN ORDER TO 

PROTECT INTERNATIONAL TRADE. 

Political forces are also pushing for the elimination of the QPS exemption, Methyl bromide is an 

established and important tool used at the ports to eliminate infestations of pests. It is equally 

important as a preshipment tool in meeting quarantine requirements of international and interstate 

shipments, 

As trade increases, we are increasingly subjected to Incursions of foreign pests and diseases, 

which can cause enormous economic or environmental damage, We simply cannot afford to 
69 


82531.048

ignore the continuing need for methyl bromide as one very important 1001 in preventing those 

infestations. 

VI. CONCLUSION 

We contend that keeping methyl bromide production levels at 2011 levels would !lQ! have a 

meaningful impact on the restoration of Ihe ozone layer. and those are levels with which agriculture 

can live. Yet continuing to try to reduce methyl bromide production and use to zero will have a 

very meaningful impact on the U.S. economy and our ability to continue producing many very 

important agricultural commodities. We are continuing to try to comply with the Montreal Protocol 

as it is written, but we need your help. 

Perhaps the most troublesome aspect to this story is that while our allocation is being reduced, our 

competitors in lesser-developed countries will continue to have methyl bromide available for their 

use for several years. U.S. growers, in an increasingly international economy, need better and 

beUer tools to remain competitive. 

The U.S. industry has fulfilled the terms of the Montreal Protocol. It is in compliance. Year after 

year, we have prepared and submilted CUE requests, based on the amounts we need. However, 

both EPA and MBTOCITEAP have each year made significant, and, we believe, scientifically 

unjustified cuts to our requests. The result is that each year since this process started. our 

allocations have decreased significantly from the allocation of the previous year, and, of course, 

from our requested amount 

The State Department must defend us under the terms of the protocol or walk away. The Montreal 

Protocol does not require getting U.S. CUE allocations to "zero-use" over time. The treaty clearly 

provides that until economic and practical alternatives are found, SO long as continued research is 

being done, the industry should have CUEs. 

The United States government must support the U.S. agricultural economy in ensuring that methyl 

bromide remains available to growers, until suitable alternatives are found and can be 

implemented. We cannot simply bow to decisions whiCh appear to be predetermined and which 

will put our agricultural sector at a very significant competitive disadvantage in the international 

marketplace. 

The phase-out of methyl bromide is a critical issue for U.S. agriculture. We thank you for your 

interest and assistance in reaching a reasonable solution to what is rapidly becoming a crisis for 

many producers, and the workers they employ across the United States. 
70 

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. 

71 

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. 

72 

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:] 

73 


82531.049

U.S. HOUSE OF REPRESENTATIVES 

Testimony Before Sub Committee on 

Energy Commerce 

on Agricultural Sector Relief Act of 2012 

& 

The Inhalers ReHef Act of2012 

Mark Mural, President 

Calitbmia Strawberry Commission 

7118/2012 

Washington, D.C. 
74 


82531.050

PREPARED TESTIMONY Of MARK MURAl 

At Congressional Hearing: 

Sub Committee on Energy and Commerce 

July 18, 2012 in Washington, D.C. 

Good morning Mr. Chairman and Member. 

name is Mark Murai. I am a third-generation <;","'11,,,,.,"" farmer and president ofthe 

California Strawberry Commission. I represent all ofCaUfomia's strawberry farmers, 

and processors. 

Thank you for holding a hearing on the topic of the Montreal Protocol. It is critical that 

all of us achieve economic and environmental progress together. 

The United States has eliminated over 90% of ozone depleting products and the ozone 

layer is fhster than predictedl

. I am proud to say that strawberry fhrmers have 

taken this seriously. We have innovated new farming techniques (such as drip 

fumigation) and employed new technologies (such as emission reduction measures) to 

reduce our bromide 

Calitomia strawberry farmers are also leaders in organic production methods. These 

farmers grow more strawberries than all other 49 states combined. In fact, nearly 

one out of five California farmers also farm with organic methods. 

1 Scientific Assessment ojOzone Depleiion: 2010. National Oceanic and Atmospheric 

Administration, National Aeronautics and Space Administration, United Nations Environment 

Programme, World Meteorological European Commission 

2 
75 


82531.051

due to our eommitment, the U.S. Environmental Proteetion Ageney 

awarded California crromha'M~' farmers with the 2008 Strato'spJleric Ozone Protection 

Award for 

in the world. 

We are not 

"H'''''''Ue,more ~n·,'wl'''nrv acres to alternatives, faster than any other place 

on this success. We continue to innovate and seek alternatives. Most 

p'''~~r",p£1 our ml1rtn,~~hjn with California's EPA in research 

aimed at fi",ni"ont alternatives. As these etlorts move forward, it is essential that 

EPA a more balanced approach that recogll1Z'~S our accomplishments as well as the 

realities of 

strawoellTV farmers require clean soil, t!'ee ofhanllful fungus, and 

patl10glens. To 

Irish potato 

grasp the seriousness of soil one needs to remember the 

where an entire nation and crop ,vas decimated germ-infested soil. 

The same is true of OUT crop: in the past century, strawbelTies have been "",,,,,,,.eulv 

out disease. Notwithstanding its to the ozone, bromide revolutionized 

famJing because it cleaned the soil, protecting our and livelihoods. 

When EPA told us to replace bromide with other lUlHll!;au,,, we did so, At first, 

we switched to drip applied alternatives. However, atter multiple years use of 

the alternatives, we learned that they did not work on all of the soilborne diseases. In 

2008, we saw the emergence of new diseases that resulted in lde:sp:read crop 

The following show the impacts. 

'Dr. Tom Gordon, Professor and Chair; Department of Plant Pathology, University of California, Davis, letter to Dr. 

Dan legard. July 25, 2008. 

3 
76 


82531.052

2008, California Strawberry fields in a state of collapse ofter being treated with non-methyl bromide alternatives that 

were not effective against soil borne disease. 

The CUE Process Needs to be Improved 

In response to this new data, we submitted a request to EPA for a Critical Use Exemption 

(CUE) that would allow us to clean the soil of these diseases. We proposed that we could 

reduce methyl bromide use by using the altcmatives for several years and then cleaning 

the soil with methyl bromide once every three or four years. In other words, we proposed 

a system to rotate different treatments that would achieve both reduced usc of methyl 

bromide as wel! as clean soiL 

U nfortunatcly, the EPA responded by telling farmers to use methyl iodide instead. More 

specifically, EPA stated, "Our 2013 critical use nomination assumes an aggressive 

transition rate to methyl iodide of 7% per year between now and 2013, resulting in a 

reduction of 21 % ... ") ... However, methyl iodide registration has been canceled in 

Califllmia and the registrant has withdrawn the product. 

3 EPA Communique to the Montreal ProtocolJ via the U.s. Department of State. August 25, 2010, 

4 
77 


82531.053

We requested that EPA restore the amount of methyl bromide immediately, but they have 

not yet taken allY action to help the farmers. 

The newest scientific information by 312 international scientists sponsored by NOAA, 

NASA, UNEP, WMO, and the E.U. report that: 

.. The ozone layer is improving faster than predicted. 

.. It will require about 39 years to fully restore the ozone layer to 1980 levels. 

.. Methyl bromide C.U.E. 's will have virtually no effect on the 39 year schedule. 

More specifically, the report stated, 

" ... the Scientific Assessment of Ozone 

from 39 countries of the contributed to its 

preparation and review (191 scientists prepared the report and 196 scientists 

participated in the peer review process). " 

"Methyl bromide: Continuing critical-use exemptions at the approved 20lllevel 

indefinitely would delay the return ofEESC to 1980 levels by 0.2 year." 

In other words, indefinite use of methyl bromide at 2011 C.U.E. levels would delay 

the repair ofthe ozone layer by 73 days. 

What is the benefit of allowing continue use of methyl bromide? 

The California Department of Food and Agriculture commissioned an economic 

study by the Tni\!PI'~itv of California Davis. This report states that if there is no 

methyl bromide and no methyl iodide, California communities will lose over $1.5 

billion annually and more than 23,000 jobs annualll. 

4 Costs of Methyl/odide Non-Registration: Economic Analysis. Goodhue, Rachel, Howard, 

Peter, Howitt, Richard. California Department of Food and Agriculture. May 2010. 

5 
78 


82531.054

If all of the scientists and economists are accurate, the environmental impact of 

continued methyl bromide C.U.E.'s would add less than 73 days to a 39 year 

schedule, while the economic benefit will be $58 billion and 897,000 jobs, over 

those same 39 years. 

Please help to some common sense to this issue and restore our C.U.E. 

6 
79 


82531.055

UNIVERSITY OF CALIFORNIA, DAVIS 

Dan legard, Ph,D, 

Director of Research 

California Strawberry Commission 

Dear Dan: 

25 July 2008 

As per your request, ! am providing you with a brief summary of observations and laboratory 

results related to recent problems affecting strawberry fruit production fields in the 

OXnard/Camarillo area, In June of this year, dead and dying plants were sampled in four fields 

that received pre·pla nt bed fumigation with something other than methyl bromide. Plants from 

three of these fields were similar in that a species of Fusarium grew directly from the water 

conducting tissue (xylem) in the crown, in some cases, the same fungus was also recovered 

from petioles, It is very unusual to recover fungi from within the vascular tissue unless they are 

pathogenic. Thus, although not all tests have yet been completed, it highly likely that the 

fungus recovered from diseased strawberry plants is a vascular pathogen, Such a pathogen, a 

specialized strain of Fusarium oxysporum, is known from Japan and may have been introduced 

into California, Most likely prior use of effective fumigants prevented the pathogen from 

becoming established, In the absence of such treatments, there is a great risk that this 

pathogen will become more widespread and have a significant negative impact on strawberry 

production throughout California, 

In the fourth field, although symptoms appeared superficially similar to those in the other three 

fields, Fusarium was not recovered from any of the sampled plants. Instead, Macrophomina 

grew luxuriantly from the crown tissue of all plants, Thus, it appears that at least two different 

fungal pathogens may be responsible for the increasingly common collapse problems observed 

in Southern California, As with Fusarium it seems likely that problems caused by Macraphomina 

will become more common in the absence of recourse to effective fumigants, such as methyl 

bromide, 

Please let me know if I can provide any further information on this, 

Sincerely, 

Thomas R. Gordon 

Professor and Chair 

Department of Plant Pathology 
80 

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? 

81 

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. 

82 

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 toosmall 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 

83 

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 tomatogrowing 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. 

84 

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 

85 

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 

86 

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 

87 

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. 

88 

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 

89 

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 prodVerDate Aug 31 2005 09:19 Sep 24, 2013 Jkt 037690 PO 00000 Frm 00095 Fmt 6633 Sfmt 6633 F:\112-16~2\112-16~1 WAYNE
90 

uct 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. 

91 

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 counVerDate Aug 31 2005 09:19 Sep 24, 2013 Jkt 037690 PO 00000 Frm 00097 Fmt 6633 Sfmt 6633 F:\112-16~2\112-16~1 WAYNE
92 

tries. 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 

93 

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, 

94 

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 

95 

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 reVerDate Aug 31 2005 09:19 Sep 24, 2013 Jkt 037690 PO 00000 Frm 00101 Fmt 6633 Sfmt 6633 F:\112-16~2\112-16~1 WAYNE
96 

placement 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 

97 

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 AgVerDate Aug 31 2005 09:19 Sep 24, 2013 Jkt 037690 PO 00000 Frm 00103 Fmt 6633 Sfmt 6633 F:\112-16~2\112-16~1 WAYNE
98 

riculture 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 

99 

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? 

100 

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. 

101 

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:] 

102 


82531.101

Journal of Environmental Management 106 (2012) 93--101 

Contents 115m aV\'liisble at $ciVerse ScienceDirect 

Journal 

lourottl hom~page; www.elsevier.cQm!locateijenvman 

Moving away from methyl bromide: Political economy of pesticide transition for 

California strawberries since 2004 

Erin N. Mayfield', Catherine Shelley Norman a,b,. 

-l Depmtment 0/ Geography nnd En:Yironment~1 El'IBmeering; The johns Hopldns University, 3400 North Clwr/tfs Sb1"e~ Baltimo.rl', MD 2!Zl8. UVI. h Deprutme!!t of Ecunom(cs, The jahru HDpkins l,.Iniveni!)" 3400 N{lrt/t Cltarles S;re.ef, Baltimote, MD lU18, USA 

ARTICLE INFO ABSTRACT 

US fruit and vegetable growers using the fumigant methyl 

bromide {MeBr), scheduled for phaseout um,j.er the Montreal 

Protocol on Substances that Deplete the Ozone faced 

uncertainty about the cost and effectiveness ch.emicals and practices, and many of them applied for exemptions 

allowing continued me after the- pla.nned elimination of MeBr, This 

process was controversial so much so that the United States 

suggested that they might withdraw from the MDntreal Protocol,. 

up to that point considered a model of successful international 

environmental policy, if their nominations for exemptions were not 

granted (Gareau and DuPuis. 2009). In the exemption process, 

which allowed exceptions to the 5Cheduied 2005 complete 

phaseout date, one of the most contested uses was for strawberry 

farming, especially in California wh("fe many alternatIves are 

strictly regulated or disallow-ed. Growers argued that none of the 

alternatives met the 'economic and technic.al feasibility' conditions 

of the Critical Use Exemption (CUE) rules, De(;mio and Norman 

'" Corresponding author. Depilrtm1!nt of ('~e:graphy .and EfIVirOnlnental Engineering, The jot1O$ Hopkins University, 3400 North Charles Street <imllre,. MD 

2UlIl, USA. Tel: +1410 5165184; fax: +1 410 516 8£)96, 

~:'ma\l adclrtsmc erin<no~l.ma)l1it"!c!@8millLrom {E.N. M"yfield),. norman@' 

jhu.tdu (C.5. Norm~n). 

E!*vier Ud. All rights fll'served. 

Q 2012 Elsevier ltd, AJ1 rights reserved. 

(2005) dIscuss possible interpretatiDns of the feasibility c:rite-ria at 

length. emphasizing that it cannot mean that no changes in costs .or 

agricultural practices are required of methyl bromide users, but 

there is not a consensus: definition of precisely what standard must 

bernet. 

Currently, the m<\iority ofOJEs for methyl bromide are allocated 

to the United States,l n1l~ s.hare of field (ra.ther than nursery) 

strawberries in total exemption requests has. a!so grown; the 2014 

US field strawberries nomination was for OYer 93% of the total US 

allocation, and was exdusively for use in california, which produces 

90% of US strawberries {fRS, 2011 c), In 2007 the same share was 

only 13% and more geographically dispersed, including uses in the 

southeastern US as wen as California (USDoS. 2010, 2005, ozone, 

unep.org). Substitutes have been slower to develop in C.alifornia. 

1 For the tau st';len years rtporttd, 2007-20}3, approlll"d US CUEs ttave been 

m~re thar. 75% 0{ Mn~ATticJe 5 exemptions apptoYeO gloo<llly, so US str.awbtrry 

uses ate a significant amoulltofremainUtg globa! use of MeEk, in thl!' fit'S! year of the 

(>:.emption pnxess, US aHowa:m::~$ were a bit O'Rf 40% of tota! fiOn-Artkle 5 aHo· 

cations. For 20B, the United Stares has received over 90% of approved. (tlE 

allClwanw, Article 5 parties, which are, roughly speaking, less develcped countries, 

do not hiNt! to mmplete phaseQut until 2015, but their tQta! use peaked jf) 1998, 

and by ;ZOlO total consumption in Article 5 and nQn~Artide -5 countries wert" 

appfoxlma~ty equa1 (excluslvl1' of quarantine and pre-shipment us.es, whj(h ilre 

r£':gultted .reparatcly .. no e;t;cluded ftom tile d\$Cussion tl1foughol,lt this paper) 

(Qzone,unep.org), 
103 


82531.102

E.N. Mm'ji.e/d C£ Norman j jourmll til EflvironmellJXli Manage'JlWl1t IOU (2012) 93-101 

due to different fanning pr,llctices: and a relatively stringent regu~ 

climate that has slowed the approval of some MeBr alter·" 

The California strawberry crop is. worth more th.an $2 

bmion annually and is the 6th highest~valued fruit crop in the state, 

so while the industry is small at the nationalleve! It is economically 

significant in the region.l 

CalifOrnia growers and those negotiating the OlE process on 

their behalf were concerned that the main source of US 

of fresh would not be to 

were scheduled to. The Montreal Protocol allows delays 

elimination of ozone s.ubstances for less developed 

(ountries, and growers lowered trade barriers under 

NAFfA would combine with a technological advantage to Mexican 

growers using the fumigant. leadifig to dramatically increased 

imports of fresh strawberries and reciuc!:"d sales of and/or prices for 

domestic berries. 

This work investigates how the process of phaseout has affected 

the California field strawberry- industry and finds that management 

and regulatory dedslons at the international, national, and state 

levels have allowed California growers to maintain and enhance 

their dominance in the domestic a.nd North American market as the 

phaseout has progressed. The period between the beginning of the 

methyl bromide phaseout and the availability ofiodomethane, the 

dosest thing to a 'drop~in' substitute yet developed, for use in the 

state has been characterized by slow elimination of MeBr, rising 

acreage, yields and eonsumpti.an, improved balance of trade, 

increasing domestic market share. and rising or relatively stabJe 

prlces..lodomethane itself has recently been voluntanlywithdrawn 

from the US market, and we consider how this might affect our 

jssessment of the phaseout process to £late. 

2. Ex-ante anaiyses of economic effects and political factors 

influencing phaseout 

Economic analyses earlier in the proc.fss did not reach 

a consensus regarding the llkely impacts of phaseout Norman 

(2005) relied heavily (In data from nominations for CUEs and 

found that trEnds. in demand growth for fresh strawberries) and 

significant pass~through of cost increases to consumers were 

expected to oUJ:lAIeigh the stated negative effects of production cost 

increases associated with use of alternative fumigants, even in the 

absence of direct government support. under faIrly conservati~ 

assumptions . .and that increased conSUmer costs per household 

would be minimal, even if they were substantial in aggregate. 

Carpenter et at (2000) simulated production, consumption. and 

crop prices for methyl bromide users (e.g., California) and dIrect 

competitors (e.g., Mexico) - prior to and after the 2005 MeBT ban 

using a spatial partial-equilibrium model. To simulate post~ban 

conditions. shifts in production technology and corresponding 

changes in production costs and monthly yields were assumed.4 

Model resuits suggested that a ban, US consumers 

would pay higher prices for and consume fewer of 

them, The increased price of strawbenies would outvvefgh 

"' 2 ~h.ttP.;j!www.Glif(}t.I11;jstr4Whl!triU~om... 

J We focus on in the Us, froten berries are largely 

a tesid!-la! crop (ERS, a~ not perlshdble thls market operates 

Quite diITeflmtly. Large increases In share of pnnhll::tion going for frozen or 

otherwise processed berries might suggest qU<ility iuut's associated. with various 

changes: to fumigation pmcess('S, but we do not observe th.is: in the data, 

-'I The mOOel aSSiJmes that the best alternative ttt"hnoiogy - which is -as$illt\ed to 

be: the tf'chno!O&J' resulting 111 the highest yield per M:n: fOf tOe JDW\'steoot jX'ract'e 

- is se!el':tecL Given that the study Was wmpleted in 2000, the best t('~nolog!e$ 

pmj-Ec~ at the time dD tlOt I"l1tin!ly rorrespolld to the ajtem~tivf.!S ;ldually 

employoerl dllrlng the phaswut, 

increases in CA production costs for growers and, when coupled 

with increased acreage devoted to CA strawberry production, CA 

strawberry growers' gross and m~t revt!nues would incteas:e and 

remain stable, respectively, 

Goodhue 'tal. (2005) and Carteret.1. (2005), on the other hand, 

suggested that MeBr phaseout could cause Significant problems for 

US or California growers.. The former indudro field trials to ESt!"" 

mate weed control costs using Meer and various available a}ter~ 

natiVeS but were unable to estimate yield loss€s from the uSe (If 

MeBr alternatives directly, and -concluded that acreage and thus 

supply would have to decline significantly to raise market prices 

enough to eliminate the net losses to remaining growerS. The tatter 

note that a single annual demand elasticity parameterization 

Qbscures important vanatibR in seasonal demand and supply 

functions and can bias estimates of!oss~s dO"lrlnward. with the most 

significant Josses accruing between mid-May and early july. Their 

simulation results suggest fun~season losses of between 4 and 20% 

of revenue, with a point estimate of around 12%, exdoding r~venue 

realiz~d from lower valued crops as acr~age in strawberries decline. 

Neither study considered longer~tenn trends in the fresh straw~ 

berry market 

The design of thes:e studies reflected. concerns that Mexico, 

which provided (and continues to provide) more than 99% of 

imported fresh strawberries to the US (ERS. 2010, Table 14). was an 

ArticlE 5 country under the Montreal ProtDcol and thus not 

required. to eliminate MeBr until 2015, at which point their MeBT 

use would also have to comply with CUE standards to be permitted. 

NAJ-TA rules would make it hard to shield US growers from Mexican 

competition. Rising costs to US producers forced to transition away 

from their preferred fumigant could make Mexican imports more 

competitive over more of the year, reducing market share and 

revenues to domestic groWeT'5. Carpenter, Gianessi, and Lynch 

(2000) projected that after tile 2005 ban exemptions notwith~ 

standing in.creased acreage in Mexico devoted to strawberry 

production would be observed, and in the absence of land £md 

water constraints, Mexico would continue to increase acreage and 

displace acreage in California. 

On the regulators slde, there was; concern that significant 

exemptions would slow the phaseout and. increase lobbying efforts 

at the expense of efforts to develop and implement aiternate fumigation strategies. Using even the lowest estimate of the cost burden 

of the elimination of MeBr for CaHforni~ strawberries growers from 

Norman (Z005) of $515 ha/ye1if :suggestS that diversion of funds to 

directly unproductive rent seekIng around CUE rights could be 

significant. the 2011 industry survey indicates that 15,145 ha are 

planted in strawberries in California, and Jess than 5% of that land is 

devoted to organic production{CSC. 2011). This implies that delays in 

phaseout far conventionally grown berries could beworth mort than 

$700,000 annually (15,145 x <95 x $51 = $733,775), and any 

successfuJ efforts to secure delays- that cost less than this amount are 

profit maximizing for the industTy as a whole. 

The California Strawben:y Commission (CSC), the most active 

industry group. doubled (nominal) federal lobbying expenditures 

from $40,000 in each of 2001-2007 to $80,000 in 2008, .nd 

expenditures have remained at that level through 2010 (Center for 

Responsive Politics, 2011). State nominal lobbying expenditures 

were about $30,000 for the 2001-2002 legislative session, as ded~ 

sions about initial ruE applications were being made, and then 

dropped to around $3000 for the next session, rising for each 

subsequent legislature to a level of about $20,000 in 2009-2010 

(CalAccess. 2011). It is likely, of course, that only some of thest" 
104 


82531.103

E.N. Mayfldd. cs. NprrnCf\ / jollmcl of fnvironmenml M(lnagement 105 (2012) 93-101 

efforts were focused on preserving MeSr phaseout exemptions for 

growers.. We were not able to find evidence of significant lQbbying 

expenditures for strawberry growers in other regions. While 

lobbying expenditures are on~ indicator of lobbying efforts. the 

rapidity of regulatory movement - in this case, the reduction 

timeUrae - may also be suggestive. Th~ reduction ameiine in Ca.l~ 

ifomia has been much less aggressive than in other US regions, 

which no longer use MeBr for field strawberries, .and more broadly. 

the reduction timeUn-e in the US has been much less aggressive than 

otl:ler nOlh4J1ic!e 5 parties. Taken together, the lobbying expendltur~s and reduction timeUne suggest that if lobbying has slowed the 

phaseout of methyl bromide for s-ttawberne$ in CA, it has been 

a rational investment for the industry, even iF the costs of using 

a.lternative pesticides are a relatively small fraction of revenues and 

profits. 

The Critical Use Exemption process involves stakeholders who 

use the regulated chemica!, national nominations, and recom .. 

mendations or analysis by the Technology and Economic Assessment Panel {TEAP) of the Montreal Protocol, leading to finat 

amounts which must be approved by the Parties to the Protocol at 

their annual met:ting, In the US, the Environmental Protection 

Agency (EPA) solldts yearly applit.ations with supporting lnfor~ 

mation on uSe patterns and economic impacts from growers. and 

then the Department of State submits these as Critical Use Nominations (CUNs). For the last year for which data are avallable - the 

nominations and final decisions for 2012 exemptions the esc 

requested permits to treat 4454 ha, which were passed on to the 

Parties to the Montreal Protocol. who approved 44:n of those 

hectares, albeit at a lower application rate than was original1y 

requested,5 ffthis smallerarnount receives the !owest'!mate ofv.llue 

from continUed use of MeBr, CA growers have gained about $225,000 

in 2012 byse-curing the 2012 exempt1ons, as well as slowing further 

phJ.seout and broader price impa'Cts until theIr chief competitor in 

the North American fresh strawberry industry completes their 

phaseout. At this point Mexican growers presumably lose any price 

advantage gained by ongoing MeBr use, and a!temative pest control 

prilctices will be more established in California. 

interestingly, this approved MeBr fumigation allowance for 

about 30% of California acreage annually could mean use over the 

majority of the growing region on an intermIttent basis. The esc 

notes that "{mlethy] bromide is often being used in rotation with 

alremative fumigants, Many growers will use alternative fum}.. 

gants: for 2-3 years then rotate back to methyl bromide to clean up 

emerging weed and d.isease problems" (California Strawberry 

Commission, 2008. Request for a critical use exemption for methyl 

bromide al1 strawberries for the 2011 use season, Cited in 2013 US 

Field Strawberries (UN). WhHe a move towards using MeBr every 

2-3 years rather than annually is certainly a substantial reduction 

in MeBr applications, it is not a reduction in the geographic area 

reliant on MeBr as part of strawberry production, and thus reflects 

less progress tamms achieving Ii permanent phaseout than the 

reported. reductions in acreage needing treatment would suggest 

Unobserved -cooperation within the industry to produce this 

Il'The 2013 nominations proved wry ~ontJ;'ntiou$ in 2011; additional bilatnal 

(Including wIth thf:' -CSC lt$ wei! as with fept1!st'ntatlves of affet~ed natioos) and 

TE.AP rne.etings we~ added to th~ s<:hedule ,;ma multiple submissions Wf'r!!' revised 

anl',l n~ research offmd during the pro('~ss (UN[P, 2011.;). The decision in the 

<ldv'}nce drart report of the 23rd Meeting of the Parties refleru the MBTOC (the 

Methyl Bromide Technical OptioIU Commlt""e, part of the rEAP) w:ommendation 

(a 2013 exemption (If 451.1a5 mtO'ic tons for field srr<lwbe-rrks) hut not that of the 

minoritY repon olTered by s~vera! m!!!mbe~ of the MCTOC (UNEP, 2011il,b), which 

recommtn6e<! granting mil' fIJI! nomination amount (531.737 metric tons), AppJi~ 

catlon r.ates us:ed to (j.lru! ... t~ tuNs and LUEs and the iliYilHablllt:y of altefllao've 

pesticides in specific Callfomia growing regions were disputed within the nAP and 

among governmental ana nonguvnnmenta.! stakeholderS, 

outcome would undennine the intent of the Parties to the 

Protocol. particularly as it could allow the use of Me-Dr on fields put 

inm production after the beginning of phaseout. In California. 2009 

acreage represented an increase of 89%, or 7600 ha., over the 1991 

'baseline' year established for MeEr und~r the Protocol (fRS, 2010, 

Table 4). It is not to determine if new 

MeBr on the basts 

sector ,or sub-state !l'eograp!hic regik>ns 

have 'captured' to a degree by 

cather than involving a broader group more 

welfare of civil society .as a whole. Tha.t this morle is 

so dominant in US pofkymaidng is thus offered as an explanation 

for the ongoing use of significant a.mounts of Mear in the US 

when other countries granted early exemptions have completed. 

phaseQut 

Pub\ic,ltly reportt'c researcb e:lipe-n-diture Information Is mrotnp!~te - esc has 

r.e:portetl reseilfch exp;mditures as Confidential BUS!MSS Information, and detailed 

e>:penditlJfe dat.1 .a.re not r:ypitally repolWd in regional flornitl,aticms, 
105 


82531.104

E-N. Mayfield, CS. J'/lInn"n I Journal oj Environmental Managrmo1'nt 106 (JOI2) 93-1V1 

3. Progres$ and barriers in eliminating MeBr under the 

Montreal Protocol 

For the first year of CUNs, 2005, 28 countries nominated critical 

us~s. This number has declined 'Steadily and most recently, four 

nominating pa.rties (the US. Japan. Australia. and canada) requested 

CUEs for 2013 {UNEP. 2011~ Globial CUEs for non-Artide 5 countries 

have decreased by 94% since 2005. Use in Article 5 countries has 

also declined, falling below total non-Article 5 use for the first time 

in 2007, This decline is partly due to the support of phaseout 

programs paid for by the Protocol's Multilateral Fund, which is not 

available to non-Article 5 countries. 2010 MeBr use in Article 5 

countries was 5.2% of thE 1991 baseline:. 

Nominations. by the US and requests fOT nominations from the 

California Stra\vberry Commission between 2005 and 2014 are 

shown in Fig. 1, The US, which has had the slowest "werage annual 

rate of decrease in MeBr usage ofnon~Artide 5 countries using the 

CUE process, had nonetheless r€:duced CUN amounts by 78% from 

2003 to 2013. Although the US has been accelera.ting the MeBr 

phaseout in recent years, with a large drop in the 2014 nomination. 

a complete phaseout has not been planned and it remains unclear 

when complete phaseout win be achieved. 

Within the US, California is now the only state still requtstlng 

criti(:al use exemptions for field strawbenies. Porter et at (2006) 

conducted a global meta-analysis of strawberry yields based on 

hundreds of studies and found that many alternatives producC' 

"statistically equiv.<tlent yields" to MeEr, and thus worked to 

undermine arguments for exemptions related to technical feasi~ 

billty. The resistance to phaseout ofMeBr in California has <:enrered 

on technical issues but also cn economic feasibIlity and uncer~ 

tainties associated with the availability of al~mative fumigants -

namely iodomethane. Appro~l of iodotnethane for use in Cal~ 

ifomia was predicted for 2003, :and tht'n 2005 (Cnrter et a1.. 200S), 

but it was not actually available fur use until December 2010. The 

failure of California to permit the 'Use of iodomethane was a key 

rationale for the ongoing exemption request in that state (UNEP, 

2011); this is consistent with th!!! US not decrcClsing its (UN 

request between the nominating years 2010 and 2011. Since the 

registration of iodoffit":thane in the 20n growing season, however, 

on!y one California strawberry grower has. used it, and that usage 

was small in scale (Wozniacka eta!., 2012). 

The registration of i-odamethane by the US Environmental 

Protection Agency and the California Department of Pesticide 

Regulation was: controversial due to potential publlc and occupational health hazards resulting from Its lise in pre-plant soil 

applications. After first denying registration of iodomethane in 

April 2006. the US EPA granted a one~year registration in October 

2007 and, by 2008, licensed iodomethane for sale and use in the US 

with some restrictions on its application. Most states. - with California the mast notable exception quickly followed suit by 

,- 1'-",,,:::::=:;::;;,,,,,,,,,,,,,,,, 

i "oro ! ll)(Jro 

registering the fumigant. California eventually did approve the sale 

and use of iodomethane, but with restrictions more stringent than 

those imposed by the US EPA and other states. Legal challenges to 

the approval of this fumigant aTe ongoing, and an ongoing dialogue 

with respect to concerns about the registration of iodomethane 

persists benveen the general public, the US EPA, the California state 

legislature, and the risk assessment community, induding 

government scientists involved in assessing the risk of fodemethane, a neurotoxin and possible .carcinogen {Urevk:h, 2011}, in 

early 2012, while no legat ruling against the use of iodomethane 

was made, the manufacturer annount:ed that. based on an internal 

review of the fumigant and its economic the US, 

4. California strawberries today 

us strawberries had record production leveis in 2009; production, real value p€r unit and the total real value of the fresh straw~ 

berry crop have risen every year since 2004 according to the USDA 

(fRS, 2010, Table 1), Real US cash receipts have risen in every year 

from 2005 to 2010. the last year report!'d (ERS. 2011 •• Table A·S), As 

noted acreage In California hOis also increased according to 

each several data serie-s (California Agricultural Resource 

Directory, 2010·2011. esC. ;1011; EllS. 2010). contrary to the predic· 

tions of declining acreage in the Carter et at {ZOOS) work and 

c:ons.i$:tent with Carpenter et .aL (2000). The ERS data go back the 

farth.est and show that harvested acres of California strawberries 

have increased steadily since 1970. An OL'i linear regression of 

acreage on time for 2001-20.09 data fits well and yields an estimated 

increase of 650 ha!year; regressions indUCing the .ea.rher decades 

also show positive and significant trends but do not fit the d.ata as 

well, suggesting that the time trend alone is not as explanatory over 

longer periods. These data show acreage increases in every year 

since 1997, with the exception of 2007. when they declined by less 

than lx. Additionally, the ERS data show that the share ofCaHfomia 

acres in US strawbeny acreage has grown steadily CNer time. from 

less than a third of the tot.al in the earlyelghties, to more than hi!ifby 

the mid~90s and rising over two-thirds in 2006, where it remains. 

Productivity of p!anti?d acres has aiso riseo during this time 

period. ERS data on Califorrlia yields from 1970 to 2009 show 

steadily increasing output p(:~r acre (ERS, 2010 Table 4~ This trend 

contInues for yea.rs subsequent to the onset of efforts to eliminate 

Mellr, though yields are. predictably, subject to weather and other 

conditions and thus mOre volatile than acreage. The share of Cal~ 

ifomia production in total domestic production has also grown over 

the time period covered, and has. hovered around record highs of 

88-89% since 2003. More. recently, the Fruit and Tree Nuts report 

notes. of2010 that "last year. the increase in average yields per a(te 

1 _ ;""'"'''_'''':''''C;'''''~~''''''''~'''''~''~'''''''''~''''''''''''''''''' 

--USAI'f!3!Ml 

"'CSCAte.jll.ll 

~-IJS;l,l'J.'IOnn!i1000kti 1- -CSCArooW'llilOOOkJ.j I ,." ~"""~""""~"~,,,,.,,,:::,:,,",,'",,":=="'="""":'''''''''''''' 

~ ""'t~~!'~;~~~.~' 2001> 2007 l.OOO 2oo!J ;a010 lOU 2flU :':OU lO14 

.,,, ~ 1. US and C"liiomi<l Critic"'! L.lse Nomlnatio:u, with MeBr ftq\Jtsts and weag~. 
106 


82531.105

97 

8.0 r---.---------------

7.0 t------------;;;:-:;.p.,',<--:-.. -

6.0 t--------1'-'r--·"-~,- 5.0 +-______ .,"'''-.1 ______ _ 

in California (up 7 percent from 2009) more than made up for the 

decline in harvested acres (down 3 percent). resulting in a larger 

crop' (EllS. 2011 c). 

On the consumption side, we see that per capita consumption 

and total consumption of fresh and frozen strawberries continues 

to rise, j11 fact. per caplta annual consumption Qffresh strawberries 

has broken record levels in each year from 2003 to 2009 (ERS, 

2011e; ERS, 2010, Table 12) even as real retail prices have stayed 

relatively stable or declined slightly, The most recent figures 

suggest an increase of 48% in per cap-it.:! consumptkm of fresh 

berries since 2002, the last year covered in Norman (2005); with 

population growth that has amounted to a 67% increase in total US 

consumption over the sam~ period. The continuing in<:rease in per 

capita cQnsumption as well .as trends in real retail prices can be 

seen in Fig. 2. 

We examine seasonal patterns in retail prices to evaluate 

hypotheses about patterns of trade raised in some of the ex-ante 

studies discussed above. Real retail prices in June, the period 

identified by Carter et at (2005) as most vulnerable to losses in 

a MeBr phDseout, rose in 5 of the 10 most recent years for whlch 

data are available (2000-2009). The average of real June retail 

prices from Z005 to 2009 Was 1% higher than for 2000-2004, 

no significant change in the trend over time as 

observation, Looking more closely, however, and in 

contrast with an but 3 of the preceding 24 years of available data, 

we note that for 2004-2008 May retail prices were higher than 

April priO"s, reversing again in 2009. Grower prices confirm this 

trend; for 2005-2011, May prlces to growers for fresh berries were 

higher than April prices in 5 years and lower in rwo years (http:// 

quickstats.nass.usda.gov). 

While farming is sUbject to significant vari~bili1:y from year to 

year, both in the variolls growing regions domestlc:aUy <lod abroad. 

this is suggestive of <1n increasingly competitive market in North 

America. Norman (2005) predicted thElt the pre~2005 gap between 

higher Aprii prices and lower May prices was likely to decrease in 

size in the absence ofmethyi bromide. Ex-post, we. se.e that the gap 

has not just diminished but has reversed. while significant MeBr 

use continues, In the past. imports from Mexico peaked inApril,and 

domestic deliveries peaked in Mayor June, The historic drop in 

prices as domestic berries hit the markets in bulk suggested that 

exporting costs were high enough for Mexican growers that 

expanding exports during this period was relatively unattractive, In 

recent years., we have not observed a significant shift in strawberry 

acreage away from northern California growing areas, which 

deliver strawberries later in the season, and towards southern 

regions, where strawberries come in e,arlier (CSC, 2011). whkh 

might offer a domestic explanation for this shift in the pattern 

of relative prices throughout the year, So the currently observed 

pattern of relatively lower April prices is consistent with the US 

market becoming more attractive for Mexican growers wishing to 

export for more of the season or US growers facing rising costs in 

their peak production periods. It could also be that unobserved 

changes in crop timing assodated with the use of MeBr alternatives 

haVE! Shifted the timing ofp.eak deliveries in some parts of the state. 

investigating trends in imports and exports offresh str~wberries 

in more detail, however, does not provjde strong supporting 

evidence for the hypothesis that increased MEXIcan imports are 

driving intra-year changes in relative prices. Imports of fresh 

straWberries to the United States, almost exclusively from Mexico, 

have indeed grown substantiaHy, continuing a trend observed well 

before MeBr restrictions began, They have more than doubled since 

2004 (EllS, 2011b and Table G"L ERS, 2011.~ The 'hare of Mexican 

imports in d ornestic consumption has changed less, however, 

trending slowl:y upward since the mid"1980s and now around 8%} 

This may reflect increasing retail availability and consumption in 

the off se<l$ons for domestic strawberries as wen.as increased April 

exports from Mexico. 

United States exports also gt"e\rV during-this time, riSing more than 

50% from 2004 to 2010 (Table (;,2, EllS, 2011a), The bulk ohhe .. 

exports. go to Canada, which consumes considerably more strawberries than are produced there. The increase intonnage:nf exports to 

Canada is very similar to the increase in imports from Mex:ic".Q, sug~ 

gesting that changing price patterns over time cannot be cleanly 

ascribed to trade advantages for Mexican growers selling in the 

United States, Domestic exports could wen increase the scarcity of 

domestic berries at peak periods, driving domestic prices up. Strawberry exports do peak in May (ERS, 2011 a, Tables G&-GS). Unfortunately, import and export data by month are only available fOf a few 

years, making it difficult to discern tre.nds over time with confidence. 

Also affecting trade patterns in North America may be the 

promulgation of Country of Origin Labeling (COOt) regulations in 

the United States (http://www.a.ms.usda..gov/AMSv1.O!COOL). For 

the 2009 and subsequent seasons all fresh strawberries sold in. the 

United States were required to carry labels indicating where they 

were grown and packed. One expectation of supporters of this 

pali~ was that consumers would prefer domestic products over 

imports, and this may have reduced the vulnerability of California 

growers to .cheaper imports from Mexico in particular. Carter and 

Zwane (2003) argue that this was in essence it (costly) protec~ 

tionist policy, Van lttersum et al. (2007) note that consumers may 

prefer domestic or local region products both because they believe 

them to be better or safer, or because they have a preference for 

s!!ghtiy different sh'lf\'!s than those 
107 


82531.106

., 

5upP'Qrting growers in geographic regions that they identify 'With, 

Either of these would help California growers and hurt Mexican 

exporters in the domestic market. While we cannot isolate any 

impact of this over the short period since the rules have bEen 

established, it remains clear that the majority of the US market 

continues to be served by domestic growers. 

The MeBr altern-ative iodomethane- has been approved for use In 

Mexico and .) commercial iaunch there is pianned for 2012 (Ale. 

2010). As an Article S country, MexIco has until 2015 to phaseout 

MeBr under the Montreal ProtocQl; however, the government of 

Mexico has committed to mmpletely phaseout methyl bromide by 

2012 2010},9 by which point It seems likely that grower:'> 

able to use iodomethane and California growers will 

use continuing allocatIons of MeBr and any of several alternatives 

whidt show little to no yield dlanges in current research 

(summarized in USDoS. 20U). Costs for various production inputs 

:md groWing conditions will of course vary and be drivers of 

comparative advantage in international trade as with any 

commodity. It is unlikely that changes in land use in C2IHfamia or 

Mexico have been driven by an expectation of continued MeSr use 

in Mexico after it is curtailed in the United States. 

reflect changing trade 

United States, From 

increasing to 54 times 

raspberries increased eight fold, 

pineapples were up 250%, pecans and cocoanut me.at also 

increased more rapidly than fresh strawberries. Tangerine, 

and mango imports grew more slowly than strawberries but 

rose significantly (ERO. 2011 •. lable G-l). Trad. changes driven by 

NAFfA or other drivers of increased globalization should not be 

ascribed to the ongoing MeEr phaseout without more substantial 

evidence than we aTe able to find. 

5. California strawberry production wst estimate§ 

wo king at the various sample budgets available from Cooper~ 

ative Extension in Ca.lifornia (UC Ccop<;!rative Extension. 2001a-c, 

2004a-d, 2000. 2010. lOna-b), we do not obsfIVe dear links 

between decreasing availability of MeBr and costs or profits. 2010 

and earlier reports note that alternatives to MeBr <1Te available .and 

in use, but the sample budgets assume fumigation with MeEr and 

chloropicrin {or 'Pic"; Pic alloW'S for signifi.canrly lower rates of 

MeBr application in areas: where MeBr had previouslY been used 

alone. Of the two 2011 reports one notes that methyl bromide 

availability is limited and does not specify a fumigant in the lineitem budgets and the othN uses Pic <alone. 

In the geographically central of the three largest growing 

regions. fumigation costs.lS a share :of total costs were 2.4% in the 

2001 sample budget. 3.7% in 2004, 3.5% in 2006 ~nd 2.9% in 2011. 

For thE same 3 years estimated net returns were 1.6,14.2, 7,5, and 

3.2% of total costs, In the main growing regjon to the south we have 

budgets for 2001, 2004, and 2011 which show a decline in fumi~ 

gation costs as.a share of the total, from 6.0 to 5.7 to 3.1%, while net 

returns increased from 9,5 to ·13,4% and then dropped to 2.2%. In the 

II in 200S, Mexkds Mt& clJt'!sumptlon WAS below cansumptioll allowed ul'1dtr 

tile MOl'1trll"al F'rorocol. Ar, of 2010, thOse implementing the National Methyl 

Bromide I'hase·Out Plan fur Mexico (the UnIted N.;!:Ocns Industrial Devtlop:ment 

OfPniution (UNIDa) .along with me g-overmne!lts of Itlily. Spain, ilfld C~n.ada) 

intended to ~limlfl.3.te tht: remaining MeEt ("ppruximateiy SOO CDP tonnes) by 

::m12. provided reQul!5t.ed monies fram the Mllltitnual Fund were receiv~. Tbe 

plan initially propost'd that the strawreny sectlJ!' convnt l1N!" the end of the 

phaseout ~cause "strawberry growers were rductant to redU1;:e ME consumption" 

{UNEP. lOlO. p. 5). Ho>wver, Mell:ko's h<lve since reQuested 

irnml'dl"te <1:%istance in order to iM;~elerate 

northernmost growing region. budgets for 2001. 2004 and 2010 

show increasing fumigation costs (5.2,5.4 and 6.9% of total costs, 

respectively) and fluctuating net return, (6,6. 9.4 and 4.0%). The,e 

numbers offer some insights into input and production costs, in 

particular suggesting weakly dedinlng fumiglltion costs: .and 

yielding some evidence of declining net revenues in the most 

on trends in production costs and 

through 2013 give a baseline yield rate 

methyl bromide and discount it by some 

native, pest control regime, VJ11He (ietailed 

provided, annual CUNs for CUEs also indude 

to 

economic impacts of MeSr as compared to The-se 

estimates are developed to support the case that additional 

exemptions to use MeBr in California; 

{:'.ilnt market which is a 

lQ These figures ar~aU reported in nominal clollan, as the f>eQue-,rts are filed il feo.'I,I 

years In .J.dv<lllc:e df the proposed U'i~, and do not specify nQmhll! {Jt reaJ figures. 

AdditiollilHy, man}, of the numbers do- not change from year 1:0 year, rugg~$tiug that 

the pl'l'!'ci$:ion ()f the estimates is. nat slJ.ch that deflating. them should drive 

condusions. 

t\ It ~ worth !loting th~.t the l,3-D mix Is flot ilvailaole to a.I! growers, as many 

California wwns-hips fHtric. 1,3~D use (Otrpenter et .If., 2Oi)1} and some rountiE'$ 

testrin Pic application, Thls may be why tht extension service' blJdge:ts abo~ 

exclude it, a.1'I0 this M<lY also- rfI.olke it d!ffkult 00 rlraw starewirle conch.lllon.s-..:ln the 

basis of variation in yield estimates bet'Wttn 1,J.,.[) alom' and in comb!rlilt!on .'\nd 

MeBr, 

" 
108 


82531.107

required gross revenues less operating costs are "difficult to 

measure and verifY~ (USDoS. 2oo4-2011). Net revenues are 

sensitive to the implied, change in gross rEVenues of much lower 

strawberry prices e .... en in the absence of significant cost shifts, and 

smaller net reVenues produce percentage changes for 

cons:urner demand ror fresh strawberries on market prices and the 

distribution of the burden of rising production cost5}.lf aU acres not 

receivIng exemptions were using alternatives with substantially 

lower yields and similar or increased costs, we would expect 

as a percentage revenue ra.nges 

usIng iodomethane) to 5% across <ill 

report~d 2012~ Chloropicrin alone yleids an 

increaSE: in net revenue of2% relative to the baseline. Thus the key 

driver of the request is now the timited access. in some spedfic 

areas to use of some of the alternative fumigants, or the require~ 

ment for buffer zones around schools and residential areas. 

However. the township caps that limit l,3-D are being reached. in 

regions where strawberry acreage has grown substantially since 

the US agreement to phaseout methyl bromide. It is difficult to 

argue that a 5ul>-state regulatory decision that limits the amount of 

acreage in aU crops that can be treated with certain pesticides 

represents a substantial disrup.tion of the California strawberry 

market due to the elimination of methyl bromide. 

Jt is interesting to note that with the -exception of the 

2006-2008 nomin<ltions the economic: estimates in the 

6. Additional drivers or <bang< and trends 

40,---_______________ "_' 

3.$ +--·--,-,···-,··-·-,···-·-·, .... C--jb".---c~~ 

~ :: t-----------7;:-~,-, ...... ----.--. n 

~ 2"0 

'ii.5 

~ 

~ to 

a.s 

0.0 J..-__ • ______ , ________ • 

~~~~~~~~~~~~##~~ 

Fig. 3. US fruit and vegetable Nill re[ail prkes. 

.......P01$!1)0i!$ 

-~1GJ'1ilitOl1lS 

-ltI-CuWI'llb.tWS 

......... Re-dDelido\JsAl'pl~s 

___ earu,y'n'$ 

"...e.~""NiI'vQ:lOrlill'lg-il's 

~Strw....tJErriI!S 
109 


82531.108

100 

and the relationship between income and strawberry consumption, 

disentangling trends in prices, consumption. and incom~ to esti~ 

mate relationships is lmprecise. 

One thing we do') note In this market IS that while prices of many 

fresh fruits and vegetables, including stra.wberries, have trended 

downwards since 2008 {ERS, 2010 Table 12 and October 

over a kmgl":f time horizon. we observe a mark.ed 

difference in fresh strawberry prices, which have incre6sed by 85% 

from 1994 to 2008, compared to the prices of some other fruits and 

vegetables, which have largely bEen stable or increased to a much 

lesser extent (Fig. 3). f1:or c"pita consumption of fruits overall 

remained constant from 1994 to 200S, while per capita vegetable 

consumption initi<\J.ty increased from the mid~90s to 2000 but 

declined subsequently, This suggests: that significantly increased 

strawberry (onsumptioo in the fdce of risIng or stable prices in 

recent years is not likely to be driven by a decline in the price of 

strawberries relative to substitute frUits and vegetables. Changes in 

income, tastes. and preferences as well as. the increased availability 

of strawberries at an times of the year are combining to support 

increased per capita and total strawberry consumption. 

7~ Conclusion 

We offer an ex~post analysis of the impa.ct of the mandated 

phaseout process for methyl bromide on California strawberry 

growers to date. Ex-ante estimates of the economic impact of the 

elimination of MeSr were requirea by and influential in the (UN 

and CUE processes, in contrast with eIther a benefit-cost approach 

including pubHc health and environmental protectiDn gains, as 

required by many of the domestic environmental poHdes ofP.:uties 

to the Montreal Protocol, or with the Essential Use Exemption 

process used for other ozone depleting substances eliminated 

earlier in the OZOO€ protection regime. VJhile this is not an ex~post 

analysis of the originally expected complete phaseout and thus 

cannot be directly compared with ex-ante predictions based on the 

complete elimination orMeSr use, it does offer insight into the gap 

between predictions and outcomes of .it strawberry industry 

moving away from this ozone depleting pesticide while facing 

import competition from a major trading partner with a more 

lenient phaseout -schedule, 

COntrary to many ex-ante predictions ilnd concerns expressed 

by stakeholders, California strawberry growers have thrived in 

recent years relative to both domestic and foreign competitors. 

They have successfully worked to enstlre that MeBr has been 

available for significant fractiD'ns of their significantly expanded 

acreage, increased exports. and continued to enjoy rising yields 

and revenues as well as increased demand from consumers, The 

interim years between the planned elimination of MeEr and the 

increasing success of a!tematiYes as detailed in the 2014 (UN and 

other reports have been years of expansion In thi: face of global 

recession and int;reased imports from Mexico, and successful 

navigation of rechnical and regulatory {hanges, Industry data 

that the real burdens assodated with changing agflclll~ 

practices havE' not kept this sector from profit,lbility and 

growth In a challenging economic environment, though we (annot 

know how much faster growth might have been if MeBr use had 

I.,:ontinued unabated. 

Alarming numbers In the CUNs s.ent to the Parties to the Mon~ 

treal Protocol are not consistent with the success of California 

strawberry growers in aggregate as use of MeEr has been reduced, 

Nor are they consistent with basic economics.. The 'economic 

disruption' st.:mdard of the CUE process was not intended to require 

the Parties to permit application of MeEe on new acreage to anow limitless expansion ofa. given industry using MeEr, and itis difficult 

to justify ong'olog exemptions to support expansion rather tha.n 

protect existing growers and growing regiQns.lf all the new acres in 

production since 2005 ~re being managed profitabtywithout MeBr. 

and existing acres are using less MeRr tess often while overall .ant! 

per acre yIelds and revenues rise steadily, it seems we have reached 

a point where alternatives are demonstrating SUCCesses for field 

strawberries in Ca.lifornia. 
110 


82531.109
111 


82531.112

Han, Ed Whitfield, Chairman 

Han, Bobbyl, Rush, Ranking Member 

Subcommittee on Energy and Power 

Committee on Energy and Commerce 

House of Representatives 

2125 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Whitfield and Ranking Member Rush: 

July 17, 2012 

Please accept this letter for the record of the hearing you are holding on July 18, 2012, 

concerning "The AgricultUral Sector Relief Act of 2012." I write to bring to your attention a 

number of effective and economical alternatives to the use of methyl bromide in strawberry 

fields and other applications, These are among the reasons! believe any bill that would slow or 

reverse the phase-out of methyl bromide is unnecessary and unwise, 

One effective treatment method is anaerobic soil disinfection (ASD), ASO is less expensive than 

methyl bromide and is as effective, The technology is available, Researchers have ongoing 

trials, 

My company, Farm Fuel Inc" has been working with researchers at University of Idaho and 

UniverSity of California Santa Cruz to scale up soil treatments from small test plots to farm 

fields, We are setting up anaerobic soil disinfection (ASD) treatments in strawberry fields in 

Ventura county for Driscoll and Andrew & Williams (a large commercial strawberry and tomato 

shipper), Trials in Watsonville are ongoing, The results in organic fields in Watsonville were so 

good that the Driscoll agronomist was concerned growers would want to switch to ASD upon 

seeing the size of fruit and robustness of plants before trials were completed and further 

testing done, 

A quarter acre ASD trial in our Watsonville greenhouse resulted in robust healthy sage plants 

where Phytophora previously destroyed the entire sage planting, USDA grants are funding 

trials and outreach by University of California Santa Cruz researchers, Results are dramatic and 

conSistent 

Another effective approach for applications that now use methyl bromide is mustard seed meal 

(MSM), MSM doesn't require tarping or large amounts of water. Mustard seed meals have 

had repeatable results reducing Verticillium in strawberries and nematodes in carrots, One 

organic strawberry grower where we did initial trials orders several tons of MSM soil 

amendment each year to treat problem areas, A (SA grower, High Ground OrganicS, raved 
112 


82531.113

about the success he's had eliminating nematode damage and being able to grow straight 

carrots by using mustard seed meal soil amendment. Farmers buy what works. 

In one apple trial (pending publication) managed organically with high soil organic matier, 

mustard meal treatment Significantly outperformed chemical soil fumigation. It suppressed 

nematode pressures for two seasons while soil fumigation treatment worked for only one. The 

"magic" was that populations of beneficial soil micro-organisms shifted in the mustard treated 

blocks while the fumigated blocks, though they knocked down the disease organism 

popUlations, their numbers returned the second year. This makes sense in that a few plant 

feeding nematodes will increase in population overtime while soils that are shifted to have 

higher populations of suppressive organisms keep the disease causing nematodes in check. 

There is no silver bullet. ASD requires tarping and enough water to make the system 

anaerobic. Mustard seed meals work great for nematode control and specific soil disease 

problems. These two technologies do what methyl bromide fumigation does for less money 

and with far fewer risks to the environment and public health. 

Sincerely, 

larry Jacobs 

Farm Fuel Inc. 

PO BOl( 1413 

Freedom, CA 95019 
113 


82531.118

Hon. Ed Whitfield, Chainnan 

Hon. Bobby L Rush, Ranking Member 

Subcommittee on Energy and Power 

Committee on Energy and Commerce 

House of Representatives 

2125 Rayburn House Office Building 

Washington, DC 20515 

Dear Chainnan Whitfield and Ranking Member Rush: 

I have been farming strawberries for over thirty years. I began my career as a manager on a large 

conventional operation, and used Methyl Bromide/Chloropicrin fumigation teclmology, But after 

personally experiencing several exposures to these chemicals, I became wary oflheir effects, and 

began the search for alternatives. I also perceived a growing market demand for food grown 

without chemical pesticides and fumigants. These two factors led me to begin farming on my 

own in 1983. 

As I was told by industry experts that I was risking abject failure if! did not use these chemicals, 

I hedged my risk by fumigating halfmy field, and left the other half un-fumigated. The following 

year, I noticed a slight drop in yield in the non-fumigated field, but by no means was it a disaster. 

In fact, the price premium for the non-fumigated product more than made up for the slight drop 

in yield. 

Over the next several years, I moved toward organic production methods. I now farm 200 acres 

of strawberries, bush berries, and row crops. I'm happy to say that the market has rewarded me 

with great success over the last 29 years. 

Since the early years, many strawberry growers have taken the same path toward reduced 

chemical use. In fact, the organic strawberry industry (now a significant subset of the overall 

industry) has grown lOO-fold. There are now time-tested methods fur growing strawberries 

without the use of Methyl Bromide .. ·and other fumigants, for that matter. 

In fact, at this point, there is Significant market risk to growers who are perceived to be moving 

in the wrong direction by continuing to rely on toxic fumigants in general. 

This is no small matter wben you consider that our industry exports significant amounts of fruit 
114 


82531.119

to Europe and Asia, Backtracking on our commitment to reduce MeBr usage could have the 

effect of significantly reducing demand in these areas ofthe world, This is no time to risking 

damage to our export markets, 

I therefore urge you to stick with the program that positions the US as a leader in reducing 

chemical inputs in agriculture, 

Sincerely, 

Jim Cochran 

President, 

Swanton Berry Farm 

Davenport, CA 
115 

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:] 

116 


82531.138

The Honorable Fred Upton 

Chainnan, House Energy and Commerce Committee 

2183 Rayburn House Building 

Washington, DC 20515 

Re: U. S. Agricultural Sector Relief Bill of2012 

Dear Chainnan Upton, 

July 14,2012 

The language of the Bill is crisp, defining and in accordance with the terms of the 

Montreal Protocol. 

It is of particular importance at this time that the Bill be enacted in order that the needs of 

the U. S. agricultural sector are properly represented in the Critical Use Nomination 

(CUN) process by the USEP A and, in further extension, by the Methyl Bromide 

Technical Options Committee (MBTOC). In too many instances an arbitrary cut in the 

CUN is made by our U. S. agencies for unsubstantiated reasons, prior to submission to 

the Parties. 

The additional criteria established by an Extraordinary Meeting of the Parties of the 

Montreal Protocol, such as difference in purchasing costs, differences in yield per acre, 

percentage change in net revenue if an alterative is used, are all but ignored when the 

MBTOC recommends a cut in a CUN. 

The Bill is properly focused and should be enacted in a timely manner. 

Very truly yours, 

Albert S. Marulli 

Agricultural Trade Services 

cc: The Honorable Henry A. Waxman, Ranking Member 

House Energy and Commerce Committee 

The Honorable Ed Whitfield, Chainnan 

Subcommittee of Energy and Power 

The Honorable Bobby L. Rush, Ranking Member 

Subcommittee of Energy and Power 
117 


82531.139

467 N, Wilma Ave" St. 11 

Ripon, CA 95366 

(Z09) 599-5800 

To: 

The Honorable Fred Upton 

Chairman, House Energy and Commerce Committee 

2183 Rayburn House Office Building, Washington, DC 20515 

Copied: 

The Honorable Henry Waxman 

Ranking Member, House Energy and Commerce Committee 

2204 Rayburn House Office Building 

Washington. D.C. 20515 

The Honorable Ed Whitfield 

Chairman, Energy and Power Subcommittee 

2368 Rayburn House Office Building 

Washington, D.C. 20515 

The Honorable Bobby Rush, 

Ranking Member, Energy and Power Subcommittee 

2268 Rayburn House Office Building 

Washington. D.C. 20515 

RE: U.S. Agricultural Relief Act of 2012 

July 17, 2012 

This letter is in support of the U.S. Agricultural Relief Act of 2012. The California Almond 

Industry requires the use of Methyl Bromide (MeBr) in orchards where no other viable 

alternatives are available to address specific condilions as detailed in the letter below. 

These condilions have qualified for the Critical Use Exemption up until the 2014 

application when EPA determined that they were unable to include our application in the 

2014 U.S. Nomination for a Critical Use Exemption (CUE) for methyl bromide. 
118 


82531.140

Background 

Almond growers have been funding research on soil borne pests and alternatives to soil 

fumigation for more than 20 years. To date the almond growers have invested more 

than $2.2 million in search for better tools and understanding of various soil borne 

pests, including rootstock resistance, testing for soil pathogens, and non-fumigant 

alternatives. Despite more than 20 years of research seeking methyl bromide 

alternatives there is still not an adequate alternative to MeBr for almonds; this is 

particularly true for oak root fungus, and for nematodes in heavy soils. The economic 

impact of these soil-borne pests is in reduced growth of the young orchard and death of 

trees, therefore, soil fumigants still playa significant role in the long term productivity 

and life-span of an almond orchard. 

Almond growers who are dealing with one of the following situations will be in need of 

MeBr as no other technically and economically viable alternatives exist: 

1) a grower replanting into an orchard with a history of oak root fungus and/or 

bacterial canker. 

2) a grower who needs to treat individual tree holes in an existing orchard where 

one or more tree have died because of nematodes or oakroot fungus; 

3) a grower who cannot apply Telone because of township cap restrictions 

4) a grower with heavier soils, is replanting land that previous grew a tree or vine 

crop, or into soil that has a history of nematode, and/or oak root fungus, and/or 

bacterial canker issues. 

EPA Response to CUE application 

The CUE application submitted for California Almonds was denied with the following 

explanation provided by EPA. 

"In the case of orchard replant in California the mixture of 1, 3-dichlororpropene plus 

chloropicrin is a technically and economically feasible alternative with a lower cost than 

methyl bromide plus chloropicrin and no yield loss. In addition iodomethane plus 

chloropicrin (Midas TM) is also technically and economically feasible with costs similar 

to methyl bromide plus chloropicrin. Finally, steam is a technically feasible non-chemical 

alternative but the initial investment and fuel costs may impact economic feasibility". 

Concerns with EPA response 

During review of this application and at the time of this response iodomethane or methyl 

iodide (Mel) registration was in litigation that ultimately led to the registration 

cancellation in California and the rest of the US. Mel is one of the three alternatives 

listed in EPA's response, and in our case the most viable alternative to methyl bromide, 

and is no longer available. EPA was aware of this situation yet did not account for this 

alternative not being available due to regulatory pressures. 

Additionally, EPA lists steam as an alternative yet acknowledges that this is not an 

economically feasible alternative. Steam has been used on a trial basis and has not 
119 


82531.141

been used for commercial applications. It is also has not been shown to be effective for 

nematodes, oak root fungus or bacterial canker. 

Lastly, throughout the application process EPA did not indicate that there were any 

concerns with the application submitted; no questions were asked or points of 

clarification requested. Knowing that Mel was under litigation with a real possibility of 

the registration being cancelled combined with the fact that no other technically and 

economically feasible alternatives were introduced since the 2013 CUE was accepted 

we expected EPA to approve the CUE nomination for California Almonds. 

Support for U.S. Agricultural Relief Act of 2012 

Almonds are California's 3rd largest crop, with an estimated farm value of $3.6 billion 

dollars. On a value basis, almonds are also California's #1 ag export, and the U.S: #1 

horticultural export. These exports create more than 34,000 jobs. The CUE nomination 

for California Almonds is essential; its denial will create an economic hardship on the 

more than 6,000 growers of almonds, over 70% of which are family-owned 

small/medium sized operations. 

The California Almond Industry supports the U.S. Agricultural Relief Act of 2012 as it will 

address the concerns listed with EPA's response as detailed above. Specifically. it 

requires EPA to consider the regulatory environment that may restrict the use of 

potential alternatives - a particular concern for California growers - , as should have 

been considered with Mel in the 2014 CUE application. Additionally, it puts 

responsibility on EPA to have substantial evidence to establish there are alternatives 

available that are not only technically and economically feasible but also available 

commerCially. LasUy, we support the limit on the aggregate amount of MeBr that can be 

used in a calendar year as we understand and support the initiatives of the Montreal 

Protocol and Clean Air Act. 

Sincerely, 

Kelly Covello 

President 

Almond Hullers & Processors Association 
120 


82531.142

... AMERICAN FARM BUREAU FEDERATION" 

..... 600 Maryland Ave. SW I Suite 100QW I Woshlngton, OC 20024 

July 12, 2012 

The Honorable Fred Upton 

Chainnan 

Committee on Energy and Commerce 

U.S. House of Representatives 

2183 Rayburn House Office Building 

Washington, DC 20515 

Dear Chainnan Upton: 

ph. 202.406.3600 

f. 202.406.3606 

www.fb.org 

The American Fann Bureau Federation (Fann Bureau) supports passage of the U.S Agriculture Sector 

Relief Act of 2012 and commends your committee for holding a hearing to review the importance of 

methyl bromide to American agriculture. 

Methyl bromide is an indispensable pest control tool used in crop production, grain storage, food 

processing and general pest management. For some agricultural users, its availability is nearly essential 

to providing consumers the safe and reliable food they expect. Non-critical use of methyl bromide in 

this country was phased out in January 2005 in compliance with the Montreal Protocol as incorporated 

in the federal Clean Air Act. Since that time, the chemical's use has been reduced to a bare minimum as 

the Environmental Protection Agency (EPA) has increasingly rejected critical uses. The industry has 

worked to transition to viable alternatives such as methyl iodide and sulfuryl fluoride but sales of methyl 

iodide have been suspended and EPA has proposed withdrawing tolerances of sulfuryl fluoride. No 

other alternative has yet proven to be as effective. 

Continued critical and emergency uses of methyl bromide need to be available. Fann Bureau is 

concerned that the industry has reached a critical point and that, in the end, American consumers will 

suffer greatly from agriculture'S loss of methyl bromide. This elimination means the United States will 

increasingly depend on imported food sources that are potentially less regulated, less reliable and less 

safe. 

Sincerely, 

Bob 

~~ Stallman 

President 

Cc: The Honorable Henry Waxman 

The Honorable Ed Whitfield 

The Honorable Bobby Rush 
121 


82531.143

July 12, 2012 

The Honorable Fred Upton 

Chairman 

House Energy & Commerce Committee 

2183 Rayburn House Office Building 

Washington, DC 20515 

Dear Congressman Upton, 

Colilornio Dot. Comm~sion 

Post Office Box 1736 

Indio, Colifornio 92202 

760·347·4510 

800·223·8748 

fox 760·347·6374 

www.Do •• sAreGreot.com 

info@Dot'sAr.Gr.at.CDm 

The Date Commission, a specialty crop commodity board represents 100 grower members 

producing 90% of California's dates. located In the desert region of southern California, our producers 

generate approximately 46 million pounds of dates with a sales volume of $40 million. The industry 

presently comprises of 9,300 acres at variant levels of production and currently employs year round 

from 800 -1200 workers. They include packing house and field labor and have the ability to expand the 

labor force in the future as production levels are expected to increase. 

Today's hearing is meant to review the status of the Montreal Protocol as it relates to methyl 

bromide (MB). More importantly the hearing is meant to review the Obama administration's handling of 

the Critical Use Exemption (CUE) process Incorporated into the Protocol's treaty. As you know the 

Protocol called for the complete phase out of methyl bromide in 2005 and allowed affected industries 

the ability to apply for a CUE if they could justify a need based the absence of technically feasible and 

economic alternatives. In addition we understand that there will be legislation introduced shortly to 

suggest changes in that process so it will provide guidance to all agricultural industries that stili rely on 

the use of MB to remain competitive in this global economy. 

The California Date industry has been a CUE holder every year since the phase out in 2005. This 

means that the industry has proven to EPA and then to the Parties of the Protocol that there is still a 

need and there are no viable alternatives. Of coursll the debate has been and continues to be the 

amount that is recommended by industry, how much EPA believes is actually needed and ultimately 

what Is approved by the International body. This Is where we think the process Is broken. 

First, we believe both EPA and the Protocol's technical review committees (MBTOC,TEAP) take 

action and rely on potential alternatives that have not been proven to be effective much less economic. 

Instead EPA requires the industry to prove the negative, meaning put the onus on industry to prove 

something doesn't work. We believe this is a fundamental weakness in the CUE process and has caused 

most of the grower's complaints. Not only does industry have to prove something doesn't work it has to 

do so numerous times over several years. 

For instance in the first set of CUE's that were granted In 2005 the use of phosphine and cold 

storage as alternatives had to be addressed. CUE's were granted because the EPA and MBTOC 

concluded these were not viable or economically feasible alternatives. In 2012 we are now required 

again to prove these methods are not suitable alternatives. We believe the proper solution is to require 
122 


82531.144

EPA and MBTOC with all the resources available to them to prove an alternative works before proposing 

it. Furthermore if a CUE is not granted or is reduced we believe EPA and MBTOC should be required, in 

writing, to say why and what information they relied on to take the action they did. 

The second major complaint Is the longevity and existence of the CUE process itself. It is not 

hard to see that both the EPA and MBTOC have taken decisions to bring the use of MB to an end. The 

most startling evidence of this Is language in their reports and documents where they actually state that 

they don't see certain industries getting CUE's in the future. This obviously prejudges any application 

before its even been filed. Not only that but it completely ignores changing circumstances. One need 

only look at the events surrounding the preplant alternative "midas" or the postharvest alternative 

sulfuryl fluoride. Many CUE's were reduced or eliminated based on the availability of these alternatives. 

We now know that one is no longer on the market and the other, Our own EPA has proposed be 

cancelled. Moreover it was EPA that forced the transition to sulfuryl fluoride only to turn around and 

propose Its repeal. This has cost industry millions of dollars and another forced transition will be millions 

more. The fact is, the CUE process has no expiration date in law or regulation but the US government is 

acting as if it did. We believe any legislation should make this fact very clear so that growers will have 

the certainty of knowing what the playing field will look like when making planting decisions now and in 

the future. 

Thank you for the opportunity to share our concerns and please take whatever action you deem 

necessary to Improve this important process that necessarily means so much to our economic viability. 

Res~1 

~" Albert P. Keck 

Chairman 

cc: The Honorable Henry Waxman, Ranking Member 

Committee on Energy and Commerce 

The Honorable Ed Whitfield, Chairman 

Subcommittee on Energy and Power 

The Honorable Bobby Rush, Ranking Member 

Subcommittee on Energy and Power 

Mary Neumayr, Majority Committee Staff 
123 


82531.145

July 16, 2012 

The Honorable Fred Upton 

Chairman 

House Energy and Conunerce 

Conunittee 

2183 Rayburn House Office Building 

Washington, D.C. 20515 

Dear Chairman Upton: 

CALIFORNIA WALNUT COMMISSION 

101 Parkshore Drive, Suite 250 

Folsom, CA 95830-4728 

(918) 932-7070 

Fax: (918) 932-7071 

Info@walnuts.org An Equal Opportunity Employer and ProvIder 

1 am writing on behalf of the more than 4,000 growers and 82 processors (handlers) who farm 

and market California walnuts. The vast majority of these farms are family operations having 

been run by the families for two or more generations. This industry, with farm gate revenue of 

just over $1 billion dollars in 2010/11, employs more than 60,000 individuals directly and 

indirectly. California walnuts are also one of the state's top exports, ranking 4th for 2010 in the 

UC Agricultural Issues Center export data publication. 

The California walnut industry has been a CUE holder every year since the phase out in 2005. 

This means that the industry has proven to EPA and then to the Parties of the Protocol that there 

is still a need and there are no viable alternatives. Of course the debate has been and continues to 

be the amount that is reconunended by industry, how much EPA believes is actually needed and 

ultimately what is approved by the international body. This is where we think the process is 

broken. 

First we believe both EPA and the Protocol's technical review conunittees (MBTOC,TEAP) take 

action and rely on potential alternatives that have not been proven to be effective much less 

economic. Instead EPA requires the industry to prove the negative, meaning put the onus on 

industry to prove something doesn't wOIk. We believe this is a fundamental weakness in the 

CUE process and has caused most of the growers complaints. Not only does industry have to 

prove something doesn't work it has to do so numerous times over several years. 

For instance in the first set of CUE's that were granted in 2005 the use of phosphine and cold 

storage as alternatives had to be addressed. CUE's were granted because the EPA and MBTOC 

concluded these were not viable or economically feasible alternatives. In 2012 we are now 

required again to prove these methods are not suitable alternatives. We believe the proper 

solution is to require EPA and MBTOC with all the resources available to them to prove an 

alternative works before proposing it. Furthermore if a CUE is not granted or is reduced we 
124 


82531.146

believe EPA and MBTOC should be required, in writing, to say why and what infonnation they 

relied on to take the action they did. 

The second major complaint is the longevity and existence of the CUE process itself. It is not 

hard to see that both the EPA and MBTOC have taken decisions to bring the use ofMB to an end. 

The most startling evidence of this is language in their reports and documents where they 

actually state that they don't see certain industries getting CUE's in the future. This obviously 

prejudges any application before its even been filed. Not only that but it completely ignores 

changing circumstances. One need only look at the events SUItounding the preplant alternative 

"midas" or the post harvest alternative sulfuryl fluoride. Many CUE's were reduced or eliminated 

based on the availability of these alternatives. We now know that one is no longer on the market 

and the other, our own EPA has proposed be cancelled. Moreover it was EPA that forced the 

transition to sulfuryl fluoride only to turn around and propose its repeal. This has cost industry 

millions of dollars and another forced transition will be millions more. The fact is, the CUE 

process has no expiration date in law or regulation but the US government is acting as if it did. 

We believe any legislation should make this fact very clear so that growers will have the 

certainty of knowing what the playing field will look like when making planting decisions now 

and in the future. 

Thank you for the opportunity to share our concerns and please take whatever action you deem 

necessary to improve this important process that necessarily means so much to our economic 

viability. 

Carl Eidsath 

Technical Support Director 

The Honorable Henry Waxman 

Ranking Member, House Energy and Commerce Committee 

2204 Rayburn House Office Building 

Washington, D.C. 20515 

The Honorable Ed Whitfield 

Chainnan, Energy and Power Subcommittee 

2368 Rayburn House Office Building 

Washington, D.C. 20515 

The Honorable Bobby Rush, 

Ranking Member, Energy and Power Subcommittee 

2268 Rayburn House Office Building 

Washington, D.C. 20515 
125 


82531.147

FLORIDA FARM BUREAU FEDERATION 

July 16,2012 

The Honorable Fred Upton 

Chainnan 

The Voice of Agriculture in Florida 

Committee on Energy and Commerce 

U.S. House of Representatives 

2183 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Upton: 

The Florida Farm Bureau Federation supports passage of the U.S Agriculture Sector Relief Act of2012 

and commends your committee for holding B hearing to review the importance of methyl bromide to 

American agriculture. 

Methyl bromide is an indispensable pest control tool used in crop production, grain storage, food 

processing and general pest management. For Florida specialty crop producers, its availability is nearly 

essential to providing consumers the safe and reliable food they expect. Non-critical use of methyl 

bromide in this country was phased out in January 2005 in compliance with the Montreal Protocol as 

incorporated in the federal Clean Air Act. Since that time, the chemical's use has been reduced to a bare 

minimum as the Environmental Prote<:tion Agency (EPA) has increasingly rejected critical uses. The 

industry has worked to transition to viable alternatives such as methyl iodide and sulfuryl fluoride but 

sales of methyl iodide have been suspended and EPA has proposed withdrawing tolerances of sulfuryl 

fluoride. No other alternative has yet proven to be as effective. 

Continued critical and emergency uses of methyl bromide need to be available. Farm Bureau is concerned 

that the industry has reached a critical point and that, in the end, American consumers will suffer greatly 

from agriculture'S 1055 of methyl bromide. This elimination means the United States will increasingly 

depend on imported food sources that are potentially less regulated, less reliable and less safe. 

Sincerely, 

John L. Hoblick 

President 

Cc: The Honorable Henry Waxman 

The Honorable Ed Whitfield 

The Honorable Bobby Rush 

PO Box 147030 • Gainesville. FL 32614-7030· Phone: 352/378.1321· www.FloridaFannBureau.org 
126 


82531.148

FLORIDA TOMATO EXCHANGE 

"A NOl/profit Agricultural Cooperative Association " 

800 Tn!falgar COllrl, Suite 300' Maitland, FL 3275/ 

Phone (407) 660-/949' Fax (407) 660-/656 

The Honorable Fred Upton 

Chairman 

July 10, 2012 

House Energy and Commerce Committee 

2183 Rayburn House Office Building 

Washington, DC 20515 

Dear Chairman Upton: 

I am writing you on behalf of the Florida Tomato Exchange, whose growers provide 

85% of the fresh tomatoes from Florida. Thank you for reviewing the Methyl Bromide 

issue and the impact on the American grower. The introduction of the "US Agricultural 

Sector Relief Acf is a very important step in keeping us in the tomato business. 

Florida is the largest producer of fresh tomatoes in the U. S, with harvest beginning in 

October and ending in June. Tomatoes are produced in five major regions of Florida 

and over several different soil types (sands, sandy clays and rock land soils) from 

extreme North Florida to South Dade County, forty miles south of Miami. 

Methyl bromide has been the cornerstone soil fumigant to the full bed mulch production 

system for fresh tomatoes in Florida. It has enabled significant increases in productivity. 

This increase in yields over the last 30 years has enabled the Florida tomato industry to 

remain competitive with imported tomatoes from Mexico. The industry has made very 

significant reduction in the rate/acre it applies to the soil by adopting the use of high 

barrier films thus reducing the loss of methyl bromide to the environment while 

maintaining efficacy at lower rates of methyl bromide use. 

The reduction of available methyl bromide under the Critical Use exemption has 

resulted in the migration to alternatives. However, the reduction in efficacy of these 

alternatives in controlling the myriad of pest challenges plus the lack of alternatives on 

some soil types has created a serious crisis for the grower community. 

The unfortunate reality in a highly competitive marketplace is that the loss of methyl 

bromide availability is limiting the production efficiency on many farms. This loss is 

changing the economics of production to such an extent that growers are being forced 

to carefully examine the economic viability of tomato production. If conditions continue 
127 


82531.149

The Honorable Fred Upton 

July 10, 2012 

Page Two 

to erode, the economic sustainability of growing tomatoes In Florida will be lost. If this 

occurs, the United States will no longer grow fresh tomatoes in the field from late fall, 

winter and early spring. We will no longer employ worker or contribute to the domestic 

economy. Florida's loss will be in the tens of thousands for employment and hundreds 

of millions to the economy. Methyl bromide must be maintained as a tool to maintain 

viable domestic tomato production. Recognition of the improved application technology 

rate reduction should be considered as very significant factors in evaluating future 

methyl bromide use authorizations due to emission reductions and the extent of 

environmental impact. 

Jobs and economic survival are in the balance for those who grow, ship and market 

tomatoes from Florida, the leading fresh market tomato producing state in the United 

States of America. 

Sincerely, 

G:.!~ Executive Vice President 

cc: The Honorable Henry Waxman 

Ranking Member, House Energy and Commerce Committee 

2204 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Ed Whitfield 

Chairman Energy and Power Subcommittee 

2368 Rayburn House Office Building 

Washington, DC 20515 

The Honorable Bobby Rush 

Ranking Member, Energy and Power Subcommittee 

2268 Rayburn House Office Building 

Washington, DC 20515 

FLORIDA TOMATO EXCHANGE 

800 Trafalgar Court. Suite 300 . Maitland, FL 32751· Phone (407) 660-1949 
128 


82531.150

georgia 

fruitt&bl vege a e QI'IOW'IRJ ASSOCIATION 

P.O. Box 2945, LaGrange, GA 30241 

1-877-994-3842 www.gfvga.org 

July 17, 2012 

The Honorable Fred Upton 

Chamnan, House Energy and Commerce Committee 

2183 Rayburn House Office Building, 

Washington, DC 20515 

Dear Chainnan Upton: 

Fruit and vegetable production in Georgia is almost a billion dollar industry at the farm gate. Our 

growers use multiple production techniques and practices to fulfill their mission to provide U.S. 

consumers with safe and healthy fresh produce. 

Until recently methyl bromide had been an indispensable pest control tool used in vegetable 

production in Georgia. As the production of methyl bromide was being phased out in recent 

years, researchers from the University of Georgia have developed alternatives which most Georgia 

producers use for their soil fumigation needs. While the alternatives work for several years, often 

these alternatives do not effectively control weed and soil pathogen pest over an extended period 

of time. There is a continued need for methyl bromide to be used periodically as a way to 

eliminate these pest pressures. If methyl bromide is not available for these 'critical use' needs, the 

economic viability of many Georgia growers will be severely damaged. No other alternative has 

yet proven to be effective enough to be a pennanent replacement for methyl bromide. 

Continued critical and emergency uses of methyl bromide must to be available. Georgia Fruit and 

Vegetable Growers Association is concerned that the U.S. fresh produce industry has reached a 

critical point. We are very concerned the American consumer will suffer greatly from the loss of 

methyl bromide. This elimination moves the U.S. increasingly closer to being dependant on 

imported food sources that are potentially less regulated and less reliable. 

The Georgia Fruit and Vegetable Growers Association supports passage of the U.S Agriculture 

Sector Relief Act of 2012 and commends your committee for holding a hearing to review the 

importance of methyl bromide to American agriculture. 

Sincerely, 

Charles T. Hall, Jr. 

Executive Director 

CC: The Honorable Henry Waxman 

The Honorable Bobby Rush, 

The Honorable Ed Whitfield 
129 


82531.151

Dear Honorable Ed Whitfield, 

I am writing in response to the pending legislation for the ban of methyl bromide without other 

considerations being taken into account. While methyl bromide may not be the optimal fumigant due to 

the risk it poses to the ozone layer, currently there are no other fumigants that are as effective while still 

being in a reasonable realm of price. 

Holzinger Flowers Incorporated has been growing florist-quality flowers in Florida and selling them to 

wholesale florists along the East Coast of the United States for forty-four years. We have always grown 

small acreage and had a simple business ever since my father started it in 1947 in New Jersey. Due to 

cost restrictions recently, we now only have one worker besides myself due to the low income we have 

been experiencing lately because of the decreased market. Flower growers have been growing in Martin 

County, Florida, our current location, because of the sub-tropical climate that favors this trade as well as 

the efficient transport in the area as a result ofthe Florida Turnpike and Interstate 95, both of which 

facilitate the transport of cut flowers to the north with refrigerated trucks. When we first started 

farming in Florida, Palm City was nothing but dairy and flower farms. All of these areas are now housing 

developments. Because of all this urban sprawl, we cannot use other fumigants as they could pose a 

threat to surrounding homes and businesses and their water supplies. 

Historically, one of our main crops has been freshly cut lilies including Asiatics, L.A. Hybrids, and 

Orientals. Due to high pressure in the market from for foreign countries, such as Ecuador, where they 

import lilies into the United States for nearly the same price as my company pays for bulbs, which still 

need to be grown, it is only a matter of time before I will have to discontinue the cultivation of this crop. 

This is only worsened by the various pieces of legislation, such as NAFTA and the Andean Trade 

Preference Act, which make it even easier for flowers grown in Central and South America to be 

introduced to American markets and put hardworking farmers out of business. 

I have been using methyl bromide for all these years because of its convenience as a safe and effective 

fumigant that allows for the growth of florist-quality flowers. Methyl bromide on my farm is being 

applied with shank applicators in open areas and hot gassed in order to fumigate pole rows so that the 

fields are weed free. The current EPA restrictions on how much should be applied are already having a 

severe impact on the quality and quantity of product that we harvest. Methyl bromide was always 

applied at 425 pounds per acre at a concentration of98% methyl bromide to 2% Chloropicrin. Now we 

must apply 300 pounds per acre with a concentration of 80/20. Because of this, we are losing 176 

pounds of methyl bromide per acre to fumigate weed seeds, nematodes, and diseases. This reduction in 

the amount of methyl bromide applied per acre has resulted in significant increases in weed and 

nematode problems and the loss of even more active ingredient is likely to make growing these crops 

im possible, 

Holzinger Flowers has been working with the USDA ARS of Ft. Pierce, FL over the past decade. In testing 

other fumigants, including methyl iodide, DMDS, steam, which is effective, however with the rising price 

of fuel is not cost- effective, and solarization, which does not work due to high levels of nematodes, 
130 


82531.152

methyl bromide has been proven to be the only fumigant on the market to be able to fulfill our needs 

without using other chemicals to control nematodes which are illegal in the United States, but are legal 

in the countries from which flowers are imported. In my opinion, methyl bromide should be continued 

to be used in the floriculture industry until a safe, cost-effective, and useful alternative is found. This is 

what the Montreal Protocol provided Critical Use Exemptions for. We have made significant efforts to 

test every alternative that has been proposed and we have NOTHING for the Florida cut flower industry 

that can replace this fumigant and EPA has ignored this fact in their effort to completely phase this 

material out. The loss of this valuable fumigant will make me unable to stay in this business, and being 

58 years old, I find it a difficult prospect of starting a new career in this stagnant economy while 

supporting a family. Also, being an employer, I, like other farmers, must also think about and try to 

protect the future of my employee. 

I would like to thank you Honorable gentlemen for taking time to listen to my view about an important 

issue that affects not only mine, but the welfare of many other farming families. Apart from the 

floriculture industry, I am very concerned with the related food industry and how it is being dealt with. 

With much of our food coming from foreign countries, many of the fruits and vegetables are exposed to 

chemicals that are illegal to use in the United States but are being used readily at our food sources. This 

hypocrisy in our food and flower industries makes me feel strongly towards the increased amount of 

trade agreements that are being put into place which will surely make the United States a consumer in 

the global market rather than the self-sustaining producer it was built to be. 

Thank You. 

John C. Holzinger 

Holzinger Flowers Inc. 

Holzinger Flowers Inc. 

P.O. Box 93 

Palm City, FL 34991 

Phone/Fax: 772-287-7269 

Email: johnholziner@att.net 
131 


82531.153

HOPKINSVILLE MILLING COMPANY P.O BOX 669 

HOPKINSVILLE KENTUCKY 42241·0669 

PHONE (270) 886-1231 

FAX (270) B86-6407 Sha 1814 

"MANUFACTURERS OF FLOUR AND CORN MEAl" 

July 16,2012 

The Honorable Fred Upton 

Chainnan, House Energy and Commerce Committee 

2 i 83 Rayburn House Office Building 

Washington, DC 205! 5 

Dear Congressman Upton; 

I would like to thank the Energy and Commerce Committee for reviewing the situation regarding the use of methyl bromide and sulfuryl fluoride as structural fumigants. 

My company manufactures corn meal and packs flour as well for the retail trade. We are located in 

western Kentucky and employ 20 people. Homemakers buy our products to make cornbread. biscuits. and 

cakes. We used to use methyl bromide as a structural fumigant about twice a year to insure our ability to 

manufacture a safe, sanitary product that would be acceptable to our customers. Grain products are quite 

attractive to insects, so we need the ability to perfonn periodic fumigations. A few years ago, we switched to using sulfuryl fluoride because of concerns about the availability of methyl bromide. While 

SF performs a satisfactory kill, it takes longer to appJy the gas and air out the plant when using SF. 

Through better housekeeping, we have reduced the number of structural fumigations we perfonn to one a year. If we lose both methyl bromide and sulfuryl fluoride, then we will be very hard pressed to keep 

insect levels low enough to satisfy our customers and the clean food regulations. Because our plant is 

quite old and made of brick and wood, we cannot use heat as a fumigant because it could damage the 

structure. 

Sincerely hL _ ._ i~~ ~- , I--y-c.---

Robert Y. Harper 

President 

C; The Honorable Ed Whitfield 

Mary Neumayr 
132 


82531.154

July 16.2012 

The Honorable Fred Upton 

Chairman. House Energy and Commerce Committee 

2183 Rayburn House Office Building 

Washington. D.C. 20515 

Dear Fred, 

My name is Charles B. Knappen III and I am President/CEO of the Knappen Milling 

Company located in Augusta, MI. I run a family owned flour mill which currently 

employees forty-one (41) people. In the past, you have visited our facility here in 

Augusta. Our mill produces flour for the cereal industry, snack foods industry, dry 

blending industry and the baking industry. We also produce cleaned wheat for the 

cereal and snack foods industries. 

I am writing you today because your Subcommittee on Energy and Power is holding a 

hearing on Wednesday July 18th to explore the issue of methyl bromide and to identify 

policy changes needed to improve the review and approval of methyl bromide Critical 

Use Exemptions. This hearing will be followed by the Introduction of a methyl bromide 

bill- the U.S. Agricultural Sector Relief Act of 2012. For this I personally thank you. It is 

important for the Committee to review the methyl bromide situation and for introducing 

the U.S. Agricultural Sector Relief Act of 2012. 

In my letter to you in 1997. copy attached. I told you that we were experimenting with 

potential alternatives to methyl bromide. We did so and found nothing better than or as 

economical to use as methyl bromide. We have continued to use this chemical but 

have been able to reduce the quantity used and still had effective general fumigations of 

our mill. For our facility. it has gotten very expensive to fumigate with methyl bromide 

but it is the best alternative for us. 

If methyl bromide is outlawed entirely and there are no Critical Use Exemptions allowed, 

along with there being no methyl bromide available at any price, then our facility may be 

at risk. No other product does the job like methyl bromide and the one replacement 

product, (replacement does not mean equivalent to or as effective as) is now going to 

be eliminated due to a Proposed Order to delete SF tolerances and cancel associated 

uses. 

I urge you, your Committee and your Sub-committees to allow the use of methyl 

bromide as a general fumigant in the milling industry and to make sure it is available for 

use in the future, at least under a Critical Use Exemption. 

Yours truly. 

C.B. Knappen III 

President/CEO 
133 


82531.155

October 2, 1997 

The Honorable Fred Upton 

U.S. House of Representatives 

Washington, DC 20515-2206 

Dear Representative Upton: 

Knappen Milling Company located in Augusta, Michigan has a sixty-eight ( 68 ) year history of 

producing wholesome food products and providing good jobs in a rural Michigan community. 

Our ability to do this is dependent upon meeting government regulations for good sanitation in 

our facility to ensure product quality. To assure good sanitation and ultimately product quality, 

we depend on the fumigant methyl bromide. 

I am writing to ask you to be an original co-sponsor of the legislation to be introduced by 

Representative Dan Miller that will delay the ban on methyl bromide. 

Knappen Milling Company, like other milling companies in Michigan and around the country, 

has been experimenting with potential alternatives. Today however, there is no suitable 

replacement for methyl bromide and it is an essential tool for maintaining our sanitation 

program. 

The Montreal Protocol, which is under the United Nations Environmental Program will 

ultimately ban the use of methyl bromide on a world wide basis. Less than one-half the countries 

that signed this treaty have agreed to set a date for the elimination of this chemical. 

Unfortunately, the United States is one country that has set an elimination date. None of the 

countries that are oUT agriculture competitors for exports have set a date for the elimination of 

methyl bromide. This means that we, as a country, will be uncompetitive insofar as agricultural 

exports are concerned, and there will be no benefit achieved on this environmental goal. 

I urge you to co-sponsor Representative Miller's bill. Amy Steinmann is coordinating the bill for 

him and can be reached at 225-5015. 

I look forward to your response. Thank you for considering my views. 

Yours truly, 

C.B. Knappen III 

CC: President William Clinton 
134 


82531.156

13 July 2012 

The Honorable Fred Upton 

Lassen Canyon Nursery, Inc. 

P.O. BOX 992400 

REDDING, CA 96099-2400 

"1I0NI' '.HI "I iOl) 1'\;';,10 1(1/" 

\\\\w,la""'t'IW,lll)()IINll!\CIY,>{1I11 

1~!!Ii!il: 111<1i!{ghl\\I.'Il\;lIlYOIlIIUl"(·IY ltll!l 

Chairman, House Energy and Commerce Committee 

2183 Rayburn House Office Building, 

Washington, DC 20515 

Re: Support for the US Agricultural Sector Relief Act of 2012 

Dear Chairman Upton: 

My brother and I own Lassen Canyon Nursery, Inc. We grow about 350 million 

strawberry plants on 1300 acres that we sell to commercial strawberry fruit growers. 

Our headquarters is located in Redding, California which is about 2 hours south ofthe 

Oregon border. Our primary growing location is a remote area of Siskiyou County, also 

in Northern California. Our largest market is in Southern and Central California near the 

Monterey coast, but we also grow and sell strawberry plants to other strawberry 

nurseries. Those plants are grown and distributed all over the world. For example, we 

sell to Canadian nurseries that in turn grow out those plants and sell the multiplied 

material to fruit growers in Florida. Our other large export areas are Mexico, Spain, 

Columbia, Tunisia, Argentina and the Dominican Republic. 

It typically takes about five years to multiply a new strawberry cultivar in sufficient 

numbers to sell it commercially. At each step ofthe way lassen Canyon uses a mixture 

of methyl bromide and chloropicrin to fumigate the soil. The methyl 

bromide/chloropicrin mixture is injected into the soil and then the soil is covered with a 

plastic tarp. The tarp stays in place for 5 days and then it is removed. Our planting 

takes place thereafter. 

We fumigate because strawberry plants are susceptible to fungal pathogens as well as 

root nematodes, Methyl bromide kills these pathogens with an efficacy that is not 

matched by any alternatille. Another probably more compelling reason we fumigate is 

that we can't export our plants even out of our cou nty without fumigation. The county 

agricultural commissioners and USDA inspectors where we farm routinely monitor our 
135 


82531.157

pesticide records and inspect our plant material for signs of disease and infestation. 

We can be prohibited from shipping any plant material that does not pass Inspection. 

Shipping Internationally requires even more inspection and record production. In 

addition to the inspections I have just mentioned, often the countries where we ship will 

either send Inspectors ahead of time to iook at the fields or will subject our plants to 

testing before they clear customs while still at the port or airport. Part of the required 

records review is the fumigation records. 

As you read this letter, Inspectors from Mexico will be at our farm in Macdoel as well as 

the farms of my colleagues to inspect the fields before they will authorize our plants to 

cross the border into Baja Mexico in September. Part of the records that they are 

requiring us to provide is the fumigation records. I am attaching a copy of an email 

outlining the schedule and record requirements so you can see that this is a real 

situation. Right now most of our Methyl Bromide is supplied to us through the 

Quarantine/Preshipment exemption. However our critical use exemption gas is also 

crucial for us since not every use of MB in our operation falls squarely within the QPS 

exemption. Further, along with critical use exemption which was inexplicably and 

drastically slashed by our own government this year, the QPS exemption is always being 

called into question when the Montreal Protocol Parties meet. It is extremely Important 

to the strawberry plant nursery industry that we have the use of MB. There are no 

realistic viable alternatives. As you know the makers of Midas took that product off the 

market. There are crippling township caps on the use of Telone. Plus It Is not as 

effective. 

The way things are now, if nurseries lost the use of methyl bromide, our export market 

would vanish since there Is no recognized alternative to fumigation with methyl 

bromide. Countries like Mexico require that plants imported into their country be 

fumigated with methyl bromide. In fact, our customers in Canada and the EU purchase 

US grown planting stock mostly because the plants are grown in soli fumigated with 

methyl bromide. Those foreign growers don't have access to the chemical for their 

operations anymore, so they rely on getting the healthiest, most vigorous planting stock 

they can for their nursery or fruit growing operations from us here in the United States 

where nurseries still have access to methyl bromide. 

The future for the strawberry nursery industry will be dismal If methyl bromide is 

completely eliminated. The most productive varieties were developed for farming 

systems that include fumigation with methyl bromide at least at the nursery level. 

Without changes to current regulations, exports would cease. Our product simply will 

not meet the export requirements. Unfortunately, as I am sure you know, changing 

regulations Is not easily done either. It is hard to say how many seasons would pass 

before those problems would be solved and even then the Quality will not be the same. 

Disease pressures will mount requiring the use of more fungicides just when there is a 

massive push for organically grown fruits and vegetables. 
136 


82531.158

The US Agricultural Sector Relief Act of 2012 is a reasonable compromise that tries to 

solve a real problem for growers with no other access to this essential chemical. I hope 

that you and your colleagues will see that as well. We here at Lassen Canyon Nursery 

along with my other nursery colleagues appreciate your Committee reviewing this 

situation and Introducing this legislation. Please keep up this good work for the sake of 

our industry. 

Co-owner, Lassen Canyon Nursery, Inc. 

cc: Honorable Henry Waxman via fax 

Honorable Ed Whitfield via fax 

Honorable Bobby Rush via fax 
137 


82531.159

Liz Ponce 

From: 

Sent: 

To: 

Cc: 

Subject: 

drm2472@gmail.com on behalf 01 David Murray Idmurray@sundanceberryfarms.comj 

711312012 4:00 PM 

Richard Nelson 

Richard Jose; Icn@ool.net; John Giaimo; Bruce Wall; Bruce Jensen; 

carl@crownnurseryllc.com; r.wlnn@planaS8.us; Mike Fahner; Steven D. Nelson; mnelson; 

DANIEtJVALERIE Nelson; Jason Bird; Raymundo Carranza; Hebe Bradley; liz Ponce; Steve 

Albaugh; Kim Cronin; John Sakuma 

Re: Baja Inspection Team Aug 16-19 

As Richard mentioned, please be sure to have the following information available for the inspector upon an'ival 

at your nursery: 

1. Company registration at cOlTespondent authority (Nursery/Business License) 

2. Methyl Bromide application with chloropicrin permit (Restricted Materials Pennit listing 

MB/PIC) 

3. Pesticides application program (Pesticide Use Reports) 

4. If field samples are taken, show a copy to have done a verification on what products are 

being applied and for which type of pest and diseases are used. 

Thanks. 

On Fri, Ju113, 2012 at 2:53 PM, Richard Nelson <rnelson@plantsciences.com>wrote: 

Nurserymen: 

After having spoken with all of you I have put together the following schedule for next week's visit by the Baja 

Inspection Team. If you have any conflict with this schedule please advise ASAP. From experience we know 

that the Team may not follow a strict time schedule - for this reason I have included the cell phone numbers of 

each nursery representative. If you are running early (not likely) or late (more likely) please call the person that 

you are handing the team off to in order to advise them of timing adjustments. A & W will provide air 

transpO!1atioll for the Team, and we will rent a vehicle in K. Falls for the Team to use while doing their 

inspection. Team will be staying at Holiday Inn Express in K. Falls. Ifthere are others in your organization 

that need this infol1nation please feel free to forward this email to them. Please remember to have your packet 

of ill formation ready to hand off to the inspector. The team will consist of the inspector, Conrado, and 1-2 

growers from Baja. 
138 


82531.160

MONDAY JULY 16 

I. Norcal Nursery - Turlock 8:00 am - I :00 pm (please provide a lunch fOi' them to take on the plane) 

Richard Jose -ll.! -34.~-1969 

2. PSI Nursery - Macdoel - 3:00 pm - 6:30 pm 

John Giaimo ,53Q-398-4042 office or 530-356-4977 cell (John: please pick up rental cal' at K. Falls Monday 

evening when you take them to town) 

1UESDAYJULYI7 

I. PSI Nursery - Macdoel - 7:00 am - 10:00 am 

John Giaimo - see above 

2. NorCal NUI'Sery - Macdoel 10:00 am - 3:00 pm (please provide lunch) 

Richard Jose - see above 

3. Cal NUI'Sery - Macdoel 3:00 pm - 6:30 pm 

Bruce Jensen ?30-949-1460 

WEDNESDAY JULY 18 

I. Lassen Canyon NurselY - Macdoel 7:00 a111 - II :00 am (please provide hmch) 

Scott Scholer 530-604-7268 

2. Planas. - Macdoel II :00 am - 2:00 pm 

Richard Willll 530-526-9581 

Michael Delaney 949-315-0423 

3. JPA NurselY - Bonanza 2:00 pm - 6:30 pm 

Bmce Wall 541-274-1743 

THURSDAY JULY 19 

I. Crown NUl'Sery - Macdoel 7:00 am - 10:00 am 

Carl Anberg 530-200-0505 

2. Cedar Point Nursery - Dorris 10:00 am - 2:00 pm (please provide lunch) 

Mike Fahner 541-892-8510 

Plane will depo11 either Butte Valley or K. Falls at 3:00 pm (Jolm: if departure is out of Butte Valley please 

retul'llrental car to K. Falls) 

Baja team will have their own rental cal' and will meet nursery representative for first morning inspection at 

Sharon's Restaurant in Macdoel. When you are finished with the first inspection nursery rep. should call ahead 

to the next llUl'Sery to advise timing and be prepared to show the team to the next nursery field 01' to meet back 

at Sharon's, Same procedure for the 3rd nurse,y of the day ... Lunch is usually a quick stop at Sharon's and they 

pick up what they like, just bring a little cash to pay for the Team please. 

Team will have ice chests, plastic zip locks for samples. John Giaimo at PSI office will have extra frozen ice 

packs if needed -just stop in and pick them up. 

I will not be personally present ill Macdoel next week but can be contacted via my cell at 831-750-8823 for any 

questions, or details, or problems. John Giaimo at PSI will also be available to assist you and the Team if 

needed. 

Please email any questions back to me, otherwise I believe we are ready to go. 

I(idlllrd 
139 


82531.161

Dave Murray 

3445 Telegraph Road Suite 104 

Ventura, CA. 93003 

Ph: 805-797-2514 

Fax: 805-832-6006 

drm2472@gmail.com 
140 


82531.162

EXCHINGE F!I~'W~I"F! River and Bay 

Leadi"g the Way (0 Port Progress 

July 16, 2012 

The Honorable Fred Upton 

Chairman, House Energy and Commerce Committee 

2183 Rayburn House Office Building, Washington, DC 20515 

RE: U.S. Agricultural Sector Relief Act of 2012 

Dear Chairman Upton: 

John T. ReynOlds. Chelr 

Uwe Schulz. \Ik::e Chair 

Dennie Rochford, President 

Lisa B. Hlmber. Vk:& Praaldent A. Robert Degen, Esq., Secretary. Soilcitor 

Jame$ F. Young, Esq,. Assistant Secretary 

Dorothy Mather bt. Treasurer 

This letter is to bring to your attention to matter of great significance to the Delaware River regional port 

community, and International trade and commerce as a whole. At issue is the importance of maintaining the 

availability of methyl bromide in two particular areas: critical use exemptions; and quarantine treatments. 

As information, the Maritime Exchange for the Delaware River and Bay is a non-profit trade association 

representing the interests of approximately 300 port and related businesses in the states of Pennsylvania, New 

Jersey and Delaware. 

Methyl bromide is one of the prinCipal tools relied upon as treatment for the various products shipped 

domestically or internationally and addresses phytosanitary concerns of varying regulatory authorities. Any 

decision to restrict the availability and use of methyl bromide will have an Immediate and adverse impact on 

international trade, thereby affecting a wide variety of export and import cargoes and U.S. consumern. 

Further reductions and/or the potential loss of methyl bromide for maritime uses would cause a substantial and 

damaging bearing on the maritime industry, its businesses and hundreds of associated jobs. It is also 

important to note that should other existing alternatives to methyl bromide currently under review, such as 

sulfuryl fluoride, be eliminated, the need for methyl bromide obviously increases. 

Therefore, we urge you to maintain methyl bromide for critical use exemptions and quarantine treatments. 

Feel free to contact me at 215.925.2615 or at dennis.rochford@maritimedelriv.com wnh need for further 

information. 

J;:~ Dennis Rochford 

President 

cc: The Honorable Henry A. Waxman, Ranking Member 

House Energy and Commerce Committee 

The Honorable Ed Whitfield, Chairman 

Subcommittee of Energy and Power 

The Honorable Bobby L. Rush, Ranking Member 

Subcommittee of Energy and Power 
141 


82531.163

Fred Leitz Jr. 

Leitz Farms LLC 

5109 River Road 

Sodus, 111 49126 

The Honorable Fred Upton 

Chairman, House Energy and Commerce Committee 

2183 Rayburn House Office Building, 

Washington, DC 20515 

Dear Chairman Upton and members ofthe House Energy and Commerce Committee, 

Thank you for giving me this opportunity to make comments on the problems that specialty crop 

growers are facing in the U.S. with regards to methyl bromide, a soil fumigant. 

Leitz Farms is a specialty crop farm in Sodus, 11ichigan, growing strawberries, cucumbers, 

cantaloupes, tomatoes, and apples. We are in Chairman Upton's district. Started in 1903, my 3 

brothers and I are the 4th generation and don'! want to be known as the last generation to farm 

this land. 

My father started using soil fumigants for strawberries in the late 1960's to control weeds and 

diseases. Back then he used a liquid fumigant and tilled the soil afterwards to seal the fumigant 

in the soil. In 1991 we started using methyl bromide on tomatoes for the same reasons, except we 

used it under plastic mulch to hold the fumigant in the soil so it would do its job. The first year 

of using methyl bromide increased yields by 25% in tomatoes and with better management 

practices built around using fumigants, we have increased yields 50% over the average in 1990. 

With the yield increases, we could plant fewer acres thereby allowing us to do a better job of 

crop rotation and use less chemicals and water. 

When the 110ntreal Protocol was approved by the Senate, we knew we had a deadline for the use 

of methyl bromide; it looked like the end was a long ways into the future. In 2000 I started to let 

Congressional leaders know the current situation for specialty crop growers was not good and we 

needed a legislative fix. I saw no good alternatives on the horizon to replace methyl bromide. 

The Congressional leaders I talked to earlier informed me around 2005 that a viable alternative 

replacement for methyl bromide was coming. Arysta Life Sciences had been to various 

members of Congress and told them they had a product as a viable replacement. We did some 

trials of the product, 11idas, on our farm for a couple of years. The results were promising, but 

we sliU weren't able to get planted at the proper time. Planting dates were still later by a week; 

also we had to use a different type of mulch. Using 11idas and the VIF mulch, was cost 

prohibitive compared to methyl bromide. 

The main reason we need methyl bromide in 11ichigan is we don't get high enough soil 

temperatures to apply fumigants until mid to the late April. For us to hit market windows we 
142 


82531.164

need to plant around May 5. All the alternative products don't let us plant until the middle of 

May and we would miss the early markets. We call this the plant back time, the time from 

fumigation to when a crop can be planted without the fumigant injuring the plant. Dr. Mary 

Hausbeck, plant pathologist from Michigan State University, conducted the largest on farm 

fumigation trials in the United States on our farm. Nothing compared with methyl bromide for 

plant back times. We then coupled this data with marketing opportunities and got economic data 

for the trials. The data showed we have to plant by May 5-10 to be able to hit the market 

window of opportunity to be profitable. Remember, farmers are price takers, not price makers. 

Midas was pulled from the market this spring. Leitz Farms LLC was going to use Midas for 

early season plantings. Having no viable alternatives we are going without fumigation for the 

first time in 20 years on our early plantings. 

The growers in Michigan that used methyl bromide did not have Michigan State University 

apply for a Critical Use Exernption (CUE) for 2012 and later years. We were going to rely on 

Midas for early plantings and then use other fumigants for later plantings. The Montreal 

Protocol was designed for this scenario. The withdrawal of Midas from the fumigant mix 

changed this scenario. 

The critical use exemption process is fatally flawed. The EPA has chosen to reduce volumes 

below what the U.S. growers were granted by the Protocol every year since 2005. Growers have 

repeatedly stated that they do not have alternatives that are viable either from a technical or 

economic standpoint for some uses. The original intent of the CUE as it was written in the treaty 

(and approved by the U.S. Senate) was to provide a safety net for end-users until alternatives 

were available. The concept was clear and simple; with no alternative, you can have a critical 

use exemption. However this is not how the entrenched and non elected bureaucrats at EPA are 

administering the pro gram. Listed are some of my concerns with the way the EPA is 

administering the CUE. 

- EPA should not reduce the CUE volume below what the Montreal Protocol grants to the U.S. 

as a critical use exemption 

- EPA should carefully coordinate and cooperate with USDA and the State Dept. to insure that 

U.S. grower interests are protected and that the armual critical use nomination should not be 

reduced. 

- EPA's actions in regards to relying on pre-existing stocks to meet the real market demand is 

jeopardizing the ability of many growers to have access to the product because inventories are 

not evenly distributed throughout the supply chain. 

- EPA's actions have dramatically increased the costs of production for U.S. growers while 

growers in Mexico and the rest of the developing world (including China) have access to methyl 

bromide until 2015. 

- USDA has spent nearly $200 million in research into alternatives over the last 10 years and so 

far the efforts have not resulted in a replacement for methyl bromide. 
143 


82531.165

-The United Nations Multilateral Fund for the Implementation of the Montreal Protocol has had 

over 3.6 biIlion contributed to it to help finance research for alternatives and to help developing 

countries implement the Montreal Protocol, with most of the funds corning from the United 

States. 

-EPA should allow Michigan growers to apply for an emergency CUE for 2013-14. With the 

withdrawal of Midas, we don't have a good alternative for early plantings. 

According to the National Oceanic & Atmospheric Administration (NOAA) presentation given 

at the 2007 Methyl Bromide Alternatives Conference the complete ban of methyl bromide will 

only result in a reduction of 2.8 parts per TRILLION in the atmosphere because methyl bromide 

is produced naturally. The 2.8 parts per trillion is III 00 of what was thought when the treaty was 

ratified by the United States in 1992. The signatory parties to the Montreal Protocol need to 

corne together and look at the new science and change the way they view methyl bromide. The 

treaty has been changed twice since its original ratification in 1987. 

As you can see, the administering of the CUE process by EPA has been mismanaged. They are 

supposed to be working for the US grower at the meetings ofthe parties and they have done the 

opposite. The scientific evidence has changed for ozone depleting substances, especially methyl 

bromide. The agricultural community has been trying to get Congress to notice this for some 

time and I am glad you are taking a look at the problem and I encourage passing the "U.S. 

Agricultural Sector Relief Act of2012." 

Sincerely, 

Fred Leitz Jr. 

Leitz Farms LLC 

5109 River Road 

Sodus, MI 49126 

Copies to: 

The Honorable Henry Waxman 

Ranking Member, House Energy and Commerce Committee 

2204 Rayburn House Office Building 

Washington, D.C. 20515 

The Honorable Bobby Rush, 

Ranking Member, Energy and Power Subcommittee 

2268 Rayburn House Office Building 

Washington, D.C. 20515 

The Honorable Ed Whitfield 

Chairman, Energy and Power Subcommittee 

2368 Rayburn House Office Building 

Washington, D.C. 20515 
144 


82531.166

July 17, 2012 

The Honorable Fred Upton 

Chairman, House Energy and Commerce Committee 

2183 Rayburn house Office Building 

Washington, DC 20515 

As President of Star of the West Milling Co., I am writing to express my concern over the elimination of 

the products we use to keep our flour and whole wheat products free from insects. Our company was 

founded in 1870 and has been a major supplier to the baking and cereal industry. We currently own and 

operate five flour mills, two in Michigan and one in Ohio, Indiana and New York. Our company employs 

225 full time employees and 30 part time employees. 

We have been dealing with the reduction of Methyl Bromide for many years. We have been working 

with Dow to find an effective replacement (Sufuryl Fluoride) which is now being proposed to also be 

phased out. With the recently passed new Food Safety Law we are required to supply wholesome, 

defect free products to the pUblic. If use ofthese fumigants is eliminated without sufficient time to 

discover and test alternative ways of controlling insects, it will be impossible to meet the gUidelines for 

food safety. Currently we have no other means to produce insect free products. 

I appreciate your committee looking into this and for introducing the US Agricultural Sector Relief Act. 

Doing 50 will provide our flour milling industry and Star of the West with some assistance in resolving 

this challenge. 

Sincerely 

Star of the West Milling Co. 

Arthur Loeffler 

President 

Cc: The Honorable Henry Waxman 

The Honorable Ed Whitfield 

The Honorable Bobby Rush 
145 


82531.167

July 16,2012 

The Honorable Fred Upton 

Chainnan 

a cooperative of Jamily Jarms since 1893" 

House Energy and Commerce Committee 

2 J 83 Rayburn House Office Building 

Washington, D.C. 20515 

Dear Chainnan Upton, 

Mich"cI WOQtton 

Senior Vi!;c President 

Corporate Relations and Administration 

Sunkist Growers 

! 4130 Rivcr~it!t: DrivC' 

Sherm.m Oaks~ CA 9 I 42.) 2,1! j 

Td: (H 1 H) 379-753' 

Fax: (H 1 S) .179-7492 

mwo{}rwn@sunkistgrQwCl's.t"OIll 

Methyl bromide is a critically important fumigant used by the California citrus industry to meet 

phytosanitary regulations required by our trading partners. Since there are some insect species 

that are present in California, but not in other parts of the world, many export markets inspect 

imports to look for insects that could represent a biosecurity threat in the importing country. 

Sometimes insects are discovered, and in those cases the fruit is treated with methyl bromide and 

allowed to enter commerce. 

Without the methyl bromide treatment the fruit would be sent back to the United States or 

diverted to another market. The California citrus industry's most important markets are in Asia 

and require approximately three weeks of transit time on ocean vessels before arrival. It is 

impractical to return fruit that is rejected in Asian markets, because the quality significantly 

deteriorates after a six week voyage. This means that growers usually face significant or total 

losses when fruit is refused entry for phytosanitary violations. Methyl bromide is the preferred 

treatment, because it is a broad spectrum insecticide that kills a wide range of insect species and 

its properties and efficacy are well known by regulatory authorities. 

California growers depend on the availability of methyl bromide to maintain important export 

markets. In any given year, approximately one third of the California citrus crop is exported 

while nearly forty percent of total revenue is derived from export sales. As an example, Korea is 

the largest orange export market outside of North America generating over $110 million of 

revenue for California growers. Every container entering Korea is fumigated with methyl 

bromide to control California red scale and Fuller's rose beetle. Without this treatment, export 

sales to Korea would decline significantly along with grower returns. 

In recent years, California has been subjected to a wave of invasive insect species that become 

important pests for growers, require more pesticide treatments, disrupt Integrated Pest 

Management programs or require burdensome quarantine measures for exporters. While some 

of these pests are introduced into California by passenger migration others enter with forest 

Visit the 5unldst wcbsitt; .it www.,'i.tmki.;;f,t.'uni 
146 


82531.168

products or agricultural imports. Methyl bromide is also an important tool that the U.S. 

Department of Agriculture uses to protect our industry from introductions of exotic pests in 

imports. Without this use, California citrus growers would be even more vulnerable to the 

constant pressure of invasive species. 

While the quarantine uses of methyl bromide are currently exempt from regulation under the 

Montreal Protocol, serious efforts are being made by the European Union to weaken or remove 

this exemption. The U.S Environmental Protection Agency has assured our industry that they 

understand the importance of the quarantine uses of methyl bromide and they plan to continue to 

resist efforts within the Montreal Protocol to remove this important tool. We appreciate their 

resolve and also your interest in protecting the exemption. 

The California citrus industry is gratified by the leadership you and your Committee have 

provided to help define reasonable uses of methyl bromide while still protecting growers and the 

environment. 

Please do not hesitate to call on us if you have questions or require our support to maintain 

reasonable access to this important compound. 

cc: The Honorable Henry Waxman 

Ranking Member, House Energy and Commerce Committee 

2204 Rayburn House Office Building 

Washington, D.C. 20515 

The Honorable Ed Whitfield 

Chairman, Energy and Power Subcommittee 

2368 Rayburn House Office Building 

Washington, D.C. 20515 

The Honorable Bobby Rush, 

Ranking Member, Energy and Power Subcommittee 

2268 Rayburn House Office Building 

Washington, D.C. 20515 

California Citrus Quality Council 
147 


82531.169

July 11, 2012 

duJ .. {;ln.£ dt.at£ C"",atiO"., !1nc. 

P.O.llOX573 

HOBE SOUN!). FLORIDA 33475-{)S73 

T€l.EPHOfiE {nll 54:8-3000 4 FAA {77Zi 54&-:J0G4 

tH'I\illl:eunehtllDcul$lIlbal®uth.ret 

Dear Representative Whitfield: 

My name is Eric Nissen and I am the vice president of my family's company 

Sunshine State Carnations, Inc. We have been growing cut flowers in Hobe 

Sound, Florida for over fifty years. 

We use methyl bromide to fumigate our growing areas once a vear in the 

summer months. We grow directly outside, under shade structures and under 

sawtooth poly roofs. The methyl bromide is used through shank application on 

open areas. Under the shade cloth and poly roofs it is applied through the hot 

gas application in order to fumigate the pole rows. We have had very good 

success over the years using these techniques. 

We have tried Midas methyl iodide as an alternative. It proved to be less 

effective and almost twice as expensive. Also, this year Arista will no longer sell 

Midas in the US. 

We have trailed paladin DMDS. Again, this is less effective to methyl bromide 

and it has a very strong odor, nor is suitable for fumigating pole rows. 

Another alternative we have used is solarization. This application takes 8 weeks 

to complete vs. methyl bromide taking 7 -10 days. Also solarization is less 

effective than methyl bromide in controlling weeds and nematoes. In addition, 

solarization cannot be used on pole rows. 

There is no effective alternative to methyl bromide. In the areas where we have 

used the alternatives, we have had a very substantial increase in weeds and 

disease. This has lead to a high cost of manually removing the weeds and low 

product yield due to the increase in diseases. Also, without methyl bromide 

there is no effective way to fumigate the pole rows. 

Trialing these alternatives has hurt our profitability. If we are not able to use 

methyl bromide, we would be unable to staV in business. 

Best regards, 

Eric Nissen 

Vice President 

Cc: Mary. Neumavr@mail.house.gov 
148 


82531.170

July 11, 2012 

aUiHhlrt£ d}tnh {!awationi, 1,,". 

P.O.OOl(573 

HollE SOUND, FLORIDA 3347S.()i573 

Tt::lEf'tiONE Inli ~"'fAX: (171.J54&:x&l 

&MIli!: IJ:).jMhkmrubCbe§!:lp1lill.ooI 

Dear Representative Rush: 

My name is Eric Nissen and I am the vice president of my family's company 

Sunshine State Carnations, Inc. We have been growing cut flowers in Hobe 

Sound, Florida for over fifty years. 

We use methyl bromide to fumigate our growing areas once a year in the 

summer months. We grow directly outside, under shade structures and under 

sawtooth poly roofs. The methyl bromide is used through shank application on 

open areas. Under the shade cloth and poly roofs it is applied through the hot 

gas application in order to fumigate the pole rows. We have had very good 

success over the years using these techniques. 

We have tried Midas methyl iodide as an alternative. It proved to be less 

effective and almost twice as expensive. Also, this year Arista will no longer sell 

Midas in the US. 

We have trailed paladin DMDS. Again, this is less effective to methyl bromide 

and it has a very strong odor, nor is suitable for fumigating pole rows. 

Another alternative we have used is solarization. This application takes 8 weeks 

to complete vs. methyl bromide taking 7 -10 days. Also solarization is less 

effective than methyl bromide in controlling weeds and nematoes. In addition, 

solarization cannot be used on pole rows. 

There is no effective alternative to methyl bromide. In the areas where we have 

used the alternatives, we have had a very substantial increase in weeds and 

disease. This has lead to a high cost of manually removing the weeds and low 

product yield due to the increase in diseases. Also, without methyl bromide 

there is no effective way to fumigate the pole rows. 

Trialing these alternatives has hurt our profitability. If we are not able to use 

methyl bromide, we would be unable to stay in business. 

Best regards, 

Eric Nissen 

Vice President 

Cc: Mary. Neumayr@mail.house.gov 
149 


82531.171

SUI/SWEET GROWERS INC. 

901 North Walton A.ve 

Yuba City, CA. 95993 

July 13,2012 

TIle Honorable Fred Upton 

Chainnan, House Energy and Commerce Committee 

28183 Rayburn House Office Building, 

Washington, D.C. 20515 

As Director ofIndustriai and Environmental PrOCess Applications for Sunsweet Growers Inc, and a DPR 

Qualified Applicator, I would like to request that the CUE for methyl bromide not be withdrawn. 

Sun sweet Growers Inc. is a 94 year old grower owned cooperative based in Northern California We are 

the largest dried prune processor in the world. With more than 800 fulltime and over 600 seasonal 

employees we grow, harvest, warehouse, process, pack, and ship worldwide over 130,000,000 pounds of 

prunes each year. Sunsweet accoWlts for over half of California total prune crop. 

The main post harvest pest for the dried prune industry and for Sunsweet Growers is the Indian Meal 

Moth. When the prunes are received from the drying tunnels they are stored in large warehouses and are 

pest free at this point. In the dried natural condition state prunes can be stored for up to two years. It is 

at this point the prunes are most susceptible to infestation and re-infestation by the Indian Meal Moth. 

Sunsweet uses an integrated pest management approach for controlling unwanted pest. Tools that we 

use include but are not limited to fumigants, fogging materials such as Vapona and lOR's, light traps, 

mating disruption pheromones, air curtains, automatic door closers, sanitation practices, and glue traps. 

The Fumigant of choice for many years was methy I bromide, but with the phase out of methyl bromide 

Sunsweet has converted to phosphine fumigants where possible and ProFume in the remaining storage 

locations. There are several issues that linllt our use of phosphine. The two biggest are the corrosive 

nature of phosphine gas on metal surfaces, and the time it takes to perfonn phosphine fumigations. We 

have over 413,000 sq ft of warehouse space that also house very expensive electronics and prune 

processing equipment. It has been estimated that it would cost $904,400.00 to retrofit our warehouses 

for the use of phosphine or just over $9,900,000.00 to build new phosphine friendly storage facilities. 

The 9.9 million to build does not include the price of the land. Phosphine fumigations require an 

additional 72 hours per fwnigation to perform. Sunsweet currently operates on average 6.25 days per 

week and closes for fumigations. The additional fumigation time would require Sunsweet to extend 

operations to weekends. The additional labor expense to regain the lost production would be 

$265,680.00 alone, assuming two fumigations per year. 

ProFume (sulfuryl fluoride) and methyl bromide are the only fumigants we have that meet Sunsweet's 

needs. The EPA is pushing to remove food tolerances for sulfuryl fluoride. The CUE for methyl 

bromide is being withdrawn. This leaves Sunsweet with only two options. Phosphine as the only 

fumigant available or utilizing cold storage and eliminate the need to fumigate all together. Sunsweet is 

an extremely large facility with over 15,000,000 cubic feet of prune storage spread out over 12 

locations. To replace 3 of our storage location that we currently fumigate in to cold storage would cost 

Sunsweet approximately $28,236,150. This does not include the cost ofland or reoccurring cost such as 

PG&E and maintenance. 
150 


82531.172

, ' 

su SUNSWEET GROWERS INC. 

1)01 North Walton Ave 

Yubll City, CA 95993 

To convert our storage facilities to phosphine friendly warehouses, or to convert to cold storage would 

be cost prohibitive. An expense such as either of these alternatives would be detrimental to Sunsweet. 

For these reasons I ask that you do not withdraw the CUE for methyl bromide. 

Sincerely, 

~~ Director ofIndustrial & Environmental Process Applications 

Sunsweet Growers Inc. 

cc: The Honorable Henry Waxman 

Ranking Member, House Energy and Commerce Committee 

The Honorable Ed Whitfield 

Chairman, Energy and Power Subcommittee 

The Honorable Bobby Rush 

Ranking Member, Energy and Power Subcommittee 
151 


82531.173

--~~------~-------~~~~-----, 

July 13, 2012 

OUR 85th YEAR 

800 Lanidl'x Pla?;3, P.O. Box J67, Pamppany, Nj 07054-0%7 (973) 515-0100 Fax (973) 428-1678 Wcb:wl'mrnpcSt.com 

The Honorable Fred Upton 

Chairman, House Energy and Commerce Committee 

2183 Rayburn House Office Building 

Washington, DC 20515 

Re: The U.S. Agricultural Sector Relief Act of 2012 

Dear Chairman Upton: 

Our company has been operating primarily in Pennsylvania, New Jersey, Delaware, and 

Virginia for over 85 years. We employ more than 700 people involved in various aspects of the 

pest management industry including quarantine and non-quarantine treatment of exported and 

imported products at various ports, food processing plants, warehouses and a wide range of 

stored commodities. Many of these treatments use methyl bromide as the required fumigant. 

It is of vital importance to our business to maintain the availability of methyl bromide both for 

critical use exemptions and quarantine treatments, as further reductions and potential loss of 

the fumigant would have a significant negative economic impact on our business and the 

hundreds of clients we service, Further, if as is currently under review, other existing 

alternatives to methyl bromide, such as sulfuryl fiuoride are eliminated, this would increase our 

need for methyl bromide. 

Thank you for your consideration of this matter, which is of vilal importance to our business, and 

for introducing the US Agricultural Sector Relief Act legislation. 

ReSpe~ctfullY submitted 

~ Miriam Borja-Fisher. -J-~ Western Industries 

cc: The Honorable Henry A. Waxman, Ranking Member 

House Energy and Commerce Committee 

The Honorable Ed Whitfield, Chairman 

Subcommittee of Energy and Power 

The Honorabla Bobby L. Rush, Ranking Member 

Subcommittee of Energy and Power 

Western Vest Services I Western Fumig.ltion ! Wesfern Bird SeNlces 
152 

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 r ́sum ́ . 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 parVerDate Aug 31 2005 09:19 Sep 24, 2013 Jkt 037690 PO 00000 Frm 00158 Fmt 6633 Sfmt 6633 F:\112-16~2\112-16~1 WAYNE
153 

ent 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. 

154 

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:] 

155 


82531.056

Jason Shandell 

VP and General Counsel 

Amphastar Phannaceuticals, Inc. 

US House of Representatives 

Energy and Commerce Committee 

Energy and Power Subcommittee 

July 18,2012 

Iam Jason ShandeU, Vice President and General Counsel, for Amphastar Phannaceuticals, Inc., 

the parent company of Armstrong Phannaceuticals, Inc. 

Amphastar believes in placing people before profits and therefore we are grateful to the 

Members and staff of the Energy and Commerce Committee for their assistance in helping us to 

distribute the remaining units ofPrimatene® Mist. We strongly believe that allowing patients to 

have access to Primatene ® Mist is better than leaving it to expire in a warehouse in California. 

History: 

Primatene® Mist, an epinephrine iOOaler with CFC as propellant, was developed by Wyeth Labs 

in 1967. Amphastar purchased the rights to market the Primatene®@Mistbrand from Wyeth in 

July 2008. 

Primatene® Mist is approved "for temporary relief of occasional symptoms of mild asthma", 

There are at least 2·3 million loyal Primatene® Mist users. 
156 


82531.057

This drug was manufactured by Armstrong Pharmaceuticals Inc. since 1984 until August of 

2011. Once our allocated CFC to produce Primatene® Mist was exhausted, we stopped 

manufacturing the product on August 12,2011 and shut down Armstrong's manufacturing 

facility plant in West Roxbury, Massachusetts. 

When we purchased the Primatene® Mist brand in 2008, we knew that Primatene® Mist would be 

going off the market and that there were technical challenges in creating a CFC free epinephrine 

inhaler, referred to as HF A. We accepted the challenges and were confident that a 

CFC free Primatene ® HF A could be developed. In fact, we have developed Primatene® HF A in 

our Canton Massachusetts facility and continue to proactively work with the FDA to address 

their questions and requirements in order to bring the CFC free Primatene® HFA to market. We 

hope to submit an NDA for Primatene® HFA in the fourth quarter of this year. Primatene® HFA, 

like Primatene® Mist, is an epinephrine inhaler, but with HFA as the propellant; 

When the Final Rule was published in the Federal Register in November 2008, requiring the 

termination of the sale and distribution ofPrimatene® Mist as of December 31, 2011; Armstrong 

warned the regulatory decision making parties ... that removing OTe epinephrine from the 

market and attempting to sv.'itch patients to prescription medications will, in Armstrong's view, 

have significant costs and health consequences, which can be avoided by extending the effective 

date to allow time for a non-ODS OTe epinephrine product to be developed before the current 

product is phased out." "ODS" is an acronym for Ozone Depleting Substance. 

Today: 

Because Primatene®Mist was removed from the market on January 1, 2012 there is NO over the 

cotmter inhaler for asthmatic patients on the US market. An individual who previously used 
157 


82531.058

Primatene® Mist must now see a doctor to obtain a prescription for Albuterol and then have it 

filled, at four to five times the cost ofPrimatene® Mist (approximately $20.00 versus $108.75 to 

$111.59). We have received thousands ofinquiries from users ofPrimatene® Mist who are 

desperate for availability of an OTC inhaler. Unfortunately, these inquires have also cited two 

possible deaths because of the lack of an OTC inhaler. 

Our Efforts: 

Last fall, we engaged Venable Law firm to assist us in requesting from the EPA, Enforcement 

Discretion on Primatene® Mist. Former Congressman Bart Stupak has been our lead counsel in 

working with the EPA. 

After meetings with the EPA, two written Requests for Enforcement Discretion, with supporting 

government studies and documentation, were submitted last December to the EPA to allow for 

the sale oftlle remaining units ofPrimatene® Mist based on public health and economic interests. 

The public health interest is growing since the untreated or undertreated astllma patient 

population is largely comprised of the uninsured, economically disadvantaged, black and 

Hispanic communities, including a large nUUlber of women and children. 

Without Primatenc® Mist, those asthmatics who have no insurance or have no pres~'1'iption 

albutero! available may have to seek care in emergency rooms and experience longer 

hospitalizations when experiencing astllma symptoms such as shortness of breath, and they do 

not have Primatene® Mist available Over the Counter. 
158 


82531.059

The company's request for enforcement discretion was denied by the EPA on December 30, 

2011 citing that it would not be in the interest to allow the sale of the remaining units of 

Primatene® Mist. 

The EPA has granted Enforcement Discretion on three occasions over the past 10 years after a 

Final Rule had been published for low sulfur gasoline, lead abatement certification, and Texas 

Low-Emission Diesel under the Texas State Implementation Plan. 

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 dollars based on 2007 estimates. The cost to the Federal Government and taxpayers for 

Medicare and Medicaid could run as high as $75 million dollars in each program. 

We have not received a response from the EPA on this subsequent request based on economic 

concerns. 

Amphastar understands that Members of Congress have written to the EPA expressing their 

concerns about the removal ofPrimatene® Mist from the OTC market and have not received any 

response from the EPA. 

The company has repeatedly asked why Primatene® Mist was pulled from the market when two 

prescription drugs, one of which has an approved, non·CFC replacement on the market, that use 

CFC as their propellants, have been granted exceptions to the Montreal Protocol to stay on the 
159 


82531.060

market through December of2013. No one from EPA has ever explained why these two inhalers 

with CFCs are allowed to remain on the market but Prlmatene® Mist is not. 

Primatene® Mist had been on the market for almost 50 years with a safe and effective track 

record. To remove Prlmatene® Mist from the market because it co~tains CFC with no 

replacement inhaler jeopardizes the health and safety of the 2-3 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 the remaining units of Primatene® Mist as a donation to public health clinics. This 

offer has been rejected. We are not interested in profiting from the sale of the remaining 

inventory of Primatene® Mist. Therefore, Amphastar commits that it will donate all the net 

profits from the sale of the remaining units of Primatene® Mist to charity. Amphastar believes in 

its product, It should be available in the US OTC market 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 American asthma patients who have 

accessing a doctor to obtain a prescription and cannot afford to pay four to five times more for a 

prescription inhaler. 

Please be advised that Amphastar will also be launching an Internet campaign to "Bring Back 

My Prlmatene@,' to get Prlmatene® Mist back on the OTC retail market and available for the 

millions of Americans who are.suffering from asthma and need Primatene® Mist. 

In closing, let me again thank the Members of this Committee, Chairwoman Mary Bono Mack, 

Dr. Michael Burgess and Congressman Mike Ross, and your professional staff for holding this 
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hearing, developing draft legislation to allow the sale or distribution of the remaining units of 

Primatene® Mist, and allowing me to testify on behalf of Amphastar and Armstrong, 

In conclusion, our goal is to get the remaining units of Primatime® Mist out of the warehouse 

and in the hands of the American people, The asthmatic population that purchases PrimaltenEl~ 

Mist believes in our product because it works for them, it is convenient and available without 

having to see a doctor or they lack adequate health insurance for prescription inhalers, We are 

concemed about the health of the American people and we win donate to charity all net 

from the sale of the remaining units ofPrimatene® Mist. 

Thank 
161 


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SUMMARY 

Jason Shandell, Esquire Amphastar/Armstrong Pharmaceuticals 

• For almost 50 years, Primatene® Mist is approved "for temporary relief of occasional 

symptoms of mild asthma. There are 2·3 million Joyal Primatene® Mist users. 

• Because Primatene® Mist was removed from the market on January 1,2012 there is NO 

over the counter (OTC) inhaler for asthmatic patients. Primatene® Mist users must now 

see a doctor to obtain a prescription for Albuterol and then have it filled at four to five 

times the cost. We have received thousands of inquiries from Primatene® Mist users 

who are desperate for an OTC and users cite two possible deaths because no OTC 

inhaler. 

• Two written Requests for Enforcement Discretion were presented with supporting 

government studies and documentation to the EPA based on public health and economic 

interests. The public health interest is the growing number of untreated or undertreated 

asthma patient population which is largely the uninsured, economically disadvantaged, 

black and Hispanic communities, including a large number of women and children. 

• The EPA has granted Enforcement Discretion on three occasions over the past 10 years. 

.. Amphastar wi!! not profit from the sale of the remaining 1.2 million units of Primatene® 

Mist and it will donate all the nct profits to charity. 

• The asthmatic population that purchases Primatene® Mist believes in our product 

because it works for them, it is convenient and available without having to see a doctor or 

they lack adequate health insurance for prescription inhalers. 

• EPA has allowed two prescription inhalers with CFC to remain on the market through 

2013. 

5890715·vl 
162 

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, 

163 

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 

164 

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:] 

165 


82531.063

Proceedings of the American 

TflOrade Sodof/' 

the lvorld breathe Q 

~ QRITICAL CARE. SLEE:P 

PATRICIA W, FINN, MO 

Presld-ent-E!ect 

THOMAS W, FERKOL, MO 

Vice President 

ATUL MALHOTRA, MD Secretary-Treasurer 

STEPHEN C, CRANE, PhD, 

MPH 

Executive Director 

GARY EWART 

Senior Director 

Government Relations 

NUALA MOORE 

Government R€!ations 

FRAN DU MELLE 

Director 

International Activities 

Testimony of the 

American Thoracic Society 

before the Einergy and Power Subcommittee 

ofthe House Energy and Commerce Committee 

Presented by Monica Kraft, MD 

PreSident of the American Thoracic Society 

Wednesday, July 18,2012 

I am Monica Kraft MD, and I am a professor of Medicine at Duke University 

and current president of the American Thoracic Society, As both a 

researcher and a clinician, I have spent most of my professional life 

dedicated to the diagnosis and management of patients with asthma and I 

direct the Duke Asthma, Allergy and Airway Center at Duke, It is with this 

professional and scientific background that I offer to present testimony of 

the American Thoracic Society on legislation to restore epinephrine inhalers 

back on the U,S, market place, It is my strongly held view and the view of the 

American Thoracic Society, that returning epinephrine inhaler to the U,S, 

market, even for a limited time, would be ill advised, 

This view is shared by several other physician organizations including, the 

American Academy of Allergy Asthma and Immunology, the American 

College of Asthma Allergy and Immunology, the American Association of 

Respiratory Care and the National Association for the Medical Direction of 

Respiratory Care, 

As background, asthma is common and potentially life threatening medical 

condition where the airways of lung are inflamed, severely restricting air flow 

to the lung, For many people with asthma, it can feel like breathing through 

a straw, Asthma effects between 5 and 10% of the population, so most 

everyone knows someone who has asthma, Therefore, over 24,6 million 

Americans have physician diagnosed asthma, including 7,1 million children, 

Whiie the majority of asthma patients can and will successfully manages 

their asthma, every year, people die as a result of asthma attacks, 

ATS 2013 • International Conference • 
166 


82531.064

In the lungs, the airways are inflamed, which means they are red and swollen which can cause 

them to narrow then and restrict airflow. The focus of asthma treatment is with antiinflammatory medications, such as inhaled corticosteroids. In addition, medications that cause 

the airways to widen (bronchodilate) are also used. In more severe asthma, physicians try a 

combination of other drugs to treat asthma which may include medications to more directly 

treat allergic symptoms, or in the most severe cases, oral corticosteroids such as prednisone. 

Health care professionals play an important role in educating patients about their asthma, 

including asthma triggers like tobacco smoke, air pollution, and allergens such as pet dander, 

cockroaches and dust mites, to find the right combination of medications, along with proper 

drug administration techniques to help people with asthma live full, active lives. 

The take away message is that in the majority of cases, asthma can be successfully treated by 

working with health care professionals to find the right combination of safe and effective 

medications. 

Epinephrine is NOT one of the medications that are considered safe for the treatment of 

asthma. 

Epinephrine 

Epinephrine is non-selective bronchodilator. This means that it has effects not only in the lung 

to bronchodilate but its non-selective nature means it has effects upon other organs such as 

the heart. Therefore, epinephrine or Primatene® can cause a Significantly increased heart rate. 

This unwanted side effect can lead to cardiac stress and heart attacks in older patients or 

patients with heart disease. 

For years the medical community has recognized the dangerous side effects of epinephrine for 

the treatment of asthma and has recommended against it use for asthma. In 1999 the 

American Medical Association 1) urged that warning labels on over the counter epinephrine 

inhalers be strengthened to warn patients about the dangers of epinephrine use, 2) encouraged 

FDA to consider removing inhaled epinephrine from the market and 3) requested studies to 

determine whether the availability of inhaled epinephrine is a risk factor in asthma morbidity 

and mortality. The American Medical Association again reaffirmed this position in 2009. In 

addition, we have not seen an increase in asthma death rates since epinephrine has been taken 

off the market, so I do not believe lack of access to asthma treatment is a reason to put inhaled 

epinephrine back on the market. Anecdotally, speaking to my colleagues in Emergency 

Medicine, they have seen fewer severe asthma attacks as they think more patients with asthma 

are following up with their physicians to get the appropriate care. 

Several expert panels have produced recommendations on the treatment of patients with 

asthma. None of the expert guidelines recommend the use of inhaled epinephrine --like 

Primatene Mist--to treat asthma. The National Asthma Education and Prevention Program 

(NAEPP), an expert panel convened by the National Institutes of Health, has issued treatment 
167 


82531.065

guidelines for management of asthma. NAEPP recommends against the use of epinephrine for 

treating asthma exacerbations stating: 

"Drugs of choice for acute bronchospasm: Inhaled route has faster onset, fewer adverse 

effects, and is more effective than systemic routes. The less betel-selective agents 

(isoproterenol, metaproterenol, isoetharine, and €Qinephrine) are not recommended 

due to their potential for excessive cardiac stimulation, especially in high doses. 

(emphasis added)(2) 

The American Thoracic Society strongly encourages any patient who is using over the counter 

medications--like Primatene Mist CFC--to treat their asthma to see a healthcare provider who 

can help the patient develop an asthma management plan and recommend more effective and 

safer medications to manage the asthma. Asthma action plans are dynamiC plans that help 

guide a patient on how to manage their asthma on good days, bad days and those days in 

between. I have attached a sample asthma action plan with my testimony. 

Pending legislation 

One of the goals of today's hearing is to discuss the pros and cons of enacting legislation to 

either permanently or temporarily restore inhaled epinephrine for the treatment of asthma to 

the U.S. market. If the intent of the legislation is to restore a safe and effective asthma drug to 

the market place, then this legislative effort is mis-informed. Inhaled epinephrine is not a safe 

drug for the treatment of asthma. The adverse side effects of epinephrine are serious and well 

documented. No current clinical practice guideline for the diagnosis and treatment of asthma 

recommends the use of epinephrine. In fact, asthma guidelines specifically recommend against 

inhaled epinephrine for treating asthma. 

If the legislative intent is to provide access to an inexpensive drug for the treatment of asthma, 

then the legislative effort is laudable, but mis-directed. Inhaled epinephrine's risks outweigh its 

benefits. 

I am also concerned about sending a very confusing message to patients. Physicians, drug 

makers and retailers have spent a lot of time and effort educating patients about the Primatene 

Mist transition and treatment alternatives patients have now that Primatene Mist is no longer 

available. Putting Primatene Mist back on the market - for an indefinite period of time - will 

send a very confusing message to patients. 

Congress should be considering ways to increase patient access to health care professionals 

who can work with patients to find an effective combination of drugs to control asthma. We 

should not be abandoning patients with a serious medical condition like asthma to self 

diagnosis and self medication with less effective drugs that have well known serious side 

effects. 
168 


82531.066

I hope the committee will keep the view of the American Thoracic Society in mind as it 

considers legislation on inhale epinephrine for the treatment of asthma, I would be happy to 

answer any questions you may have, 

1) AMA House of Delegates policy H-llS,972 (CSA Rep,2 A-99, reaffirmed CSPH Rep, 1 A-09) 

2) National Asthma Education Prevention Program- Expert Report 2 (1997) p, 64 figure 3-2, 

AT!> Washington· 1150 18th Street, N,W" Suite 300, Washington, DC 20036-3816' www,thoracic,org 
169 


82531.067

Tuk:e th/;J5e long-tufm (.!ontro! mBdldnl."S each dt'ly jlflelude 'lIl llntJ.infhnnrnatory). 

Medicine How mUCh to take When to take. H: 

DANGER SiGNS III Trouble walkins ~nd 't~I'ki~g d~e ttl shorine$~' of preeth 

Q UpS or fingernails are blue 

iii Take '14 or ., 6 putm of your quick-relief medicine AND 

III Go 10 the hospital or cal! for an ambulance _--,_-,-_ NOWl 

See the reverS(> side tor 1hlngs- you COrl do to illlO,d Yl]Ur asthma triggers 
170 


82531.068
171 

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-thecounter, 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 overthe-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 lowincome 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 longterm 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 bronchoVerDate Aug 31 2005 09:19 Sep 24, 2013 Jkt 037690 PO 00000 Frm 00177 Fmt 6633 Sfmt 6633 F:\112-16~2\112-16~1 WAYNE
172 

dilators 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 rerelease an epinephrine inhaler to the market as an over-thecounter product. Again, I thank all the members of the committee 

for inviting me here to testify today. 

[The prepared statement of Mr. Ward follows:] 

173 


82531.069

Statement oLChris Ward 

To the House Energy and Commerce Committee, Subcommittee on Energy and Power 

July 18,2012 

I am Chris Ward, I live in Washington, DC, and am a past Chairman of the volunteer Board of 

Directors of the Asthma and Allergy Foundation of America, I have had asthma all of my life. 

When I was a child, there were few choices for treating my asthma. I have been fortunate that 

more and better asthma treatments have come into use, I have also been fortunate to he under 

the care of an allergist since childhood when I was diagnosed. Now, there are a variety of safe, 

effective medications from which to choose to treat my asthma, and I am a grateful beneficiary. 

Making epinephrine bronchodilators like Primatene Mist available over-the-counter may give 

patients a false sense of security if patients use this medication to achieve short term control 

when long term control is indicated. Asthma is a chronic disease and short term symptom relief 

may lull patients into a false sense and think they have no need to follow up with their 

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 o\\'n with medication 

like epinephrine bronchodilators to rely on, patients can get into trouble, 

Sound public policy should provide patients with opportunities to get appropriate treatment 

directed by skilled professionals. access to Primatene Mist over-tile-counter can put 
174 


82531.070

Statement.ofChris Ward, page 2 

patients at risk ifthey delay getting an appropriate diagnosis and effective treatment to keep their 

asthma in controL 

Some argue that in case of an asthma attack, patients need to be able to go to a retail store 

or supermarket to Primatene Mist over-the-counter. Should we recommend that someone 

having an asthma emergency go to a store to buy a device over calling 91 ! and going to an 

emergency room or hospital? If patients need unplanned refills, or replacement devices, they can 

contact their prescriber or get appropriate medications from the emergency room. 

Another false assumption is that low income people need these medications because they are low 

cost. While the price of Primatene Mist may be lower than the total cost of or co-pay for more 

effective bronchodilators, the relieffrom these epinephrine devices does not last as long. Thus, 

the long term cost is actually higher. 

Allowing over-the-counter access to this may seem to erase the cost of visiting a 

prescriber. However, over-the-counter bronchodilators can promote self-diagnoses. which is 

particularly unsafe tor the symptoms of asthma. 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 qualified medical practitioners could be 

dangerous for the patient and costly to the healthcare system. 

The decision to withdraw Primatene Mist from the US market was made years ago. Lifting the 

ban now will lead to confusion. There will be little opportunity to inform patients about the 

2 
175 


82531.071

nature ofthis 

asthma. 

and to urge them to seck care from a professional ifthey think they have 

I know that asthma is a serious chronic condition, and! know what a difference effective 

treatment can make. I urge you, for all current and future asthma to any attempt 

to re-release Primatene Mist to the US market as an ov,er-'ltle-CClUnlter 
176 


82531.072

The Asthma and Allergy Foundation of America (MFA), founded in 1953 by the two 

leading professiona! medical organizations in the United States devoted to the 

allergy/immunology is the oldest asthma and allergy patient group in the 

world. AAFA is an independent not-for-profit association dedicated to improving the 

quality of life for people with these chronic conditions through education, advocacy and 

research. To achieve its mission, MFA conducts national campaigns, disseminates 

education programs and tools, articulates policy positions and works with state and 

regional MFA chapters, Educational Support Groups, govemments, coalitions, 

corporate sponsors, health professional groups and volunteers. 

4 
177 

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 

178 

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:] 

179 


82531.073

Points of Testimony 

Edward Kerwin, MD 

Senior Medical Director, Allergy & Asthma Center of Southern Oregon, PC 

3860 Crater Lake Ave., Medford, OR 97504 

Ph. 541-858-1003 Fax: 541-857-4499 

1. Edward Kerwin, MD is an Allergy Asthma and Clinical Research Physician Or\C'(',",I,"<na 

in the treatment of Asthma and COPD patients. Dr. Kerwin has acted as a principal 

investigator on over 300 clinical trials of new inhaled medications for Asthma and 

COPD, "'~'uu"''' some 50 trials studying new BFA (Hydrofluoroalkane) inhalers used to 

replace older CFC (Chlorofluorocarbon) inhalers. Dr. Kerwin is an independent 

physician, and is not an employee of any pharmaceutical company, but "",."","". research 

for many pharmaceutical companies. 

2. Asthma is a common condition up to 1 0% of ch.ildren and 6% of adults in the 

U.S. COPD affects up to 10% of U.S. adults and patients. Acute Bronchitis is an 

acute lung infection ofihe airways (medical ternl "Bronchioles") caused by viral or 

bacterial infections. All of these conditions cause episodes of airway muscle spasm and 

mucous plugging leading to acute, sometimes severe narrowing or obstruction of airways 

and to breathe. Acute exacerbations of asthma, COPD and bronchitis are 

common, occurring as h"'''' ,,'ntiv as in susceptible patients. Patients with 

or immediate treatment with "rescue bronchodilator" 

medicines, generally as inhalers, designed to near immediate relief to the 

blockages and obstruction typical of asthma, COPD and acute bronchitis. 
180 


82531.074

3. Asthma, COPD and Acute Bronchitis can occur in the middle of the on weekends, 

hikes, picnics, excursions, or camps far from cities. Severe Asthma and 

CO POI Bronchitis can cause critical, sometimes progressive shortness of breath 

that can lead to death and very severe distress if untreated. Asthma especially is allergy 

and exercise triggered. near a hay field, relatives with cats, cleaning a 

moldy basement or dusty carpet can trigger severe 

Exercise also triggers flares. These generally 

ite··thl'CaJteninlr asthma flare-ups. 

immediate treatment, with 

2-4 of a rescue bronchodilator within minutes of the onset of airway 

obstruction. Death from asthma can occur within as little as 20 minutes (due to hypoxia, 

or starving for air) if asthma and bronchospasm are not rapidly treated. 

4. Every patient with Asthma and COPD should carry with them a rescue bronchodilator 

(such as albuterol IIF A inhaler or rnin,,,,hri.,,, CFC inhaler) per Guidelines of U.S. and 

Global Asthma and COPD organizations. 

5. Since Acute Asthma, Acute COPD and Acute Bronchitis are potential medical 

en',e1'!~"rlci"s requiring immediate treatment, over-the-counter therapies can playa key 

I. ""-."W1YW role when patients have a flare-up. 

6. Another similar emergency condition is acute bee sting anaphylaxis, or food, shrimp or 

peanut or acute to 1''''''''''''''' or another dmg. Tn all these cases there 

are available over-tile-counter medicines, Benadryl (dephenhydramine), other 

antihistamines, (cetirizine, loratidine, fexofenadine), decongestants like Sudafed 

ps(:udloeph,~dr·ine available OTC in some states), and other rescue-relief medicines that 

can themselves within minutes in an emergency. 

2 
181 


82531.075

7. This is a key point. Patients have a fundamental right to self.treatment, to try to heal or 

treat themselves in whatever ways they ean, before they resort to the expense and 

inconvenience of seeing a doctor. This is a fundamental part of American values and 

American self-reliance, what we might call the Pioneer American Spirit; Americans have 

a right to treat themselves first and foremost with whatever remedies are available. We 

would never have settled the Midwestern, Southern, or Western U.S. without this spirit. 

Many Americans today in Montana, Colorado, California, Idaho, Arizona, M"ch,·""" 

Wisconsin, Alabama, Oregon, etc., live on rural ranches and farms miles from 

any doctor or hospital. Americans have a fundamental right to treat ourselves, at least 

with initial emergency first aid treatments. This is who we are. 

8. Historically 60-100 years ago asthma was fortunately rare, and was notoriously difficult 

to treat Patients smoked asthma cigarettes with medicines. They 

downed theophylline pills and teas, breathed in steam and struggled to take showers, 

trying to ease their breathing. These were truly the "dark ages" of asthma care. And 

many Americans died if their severe asthma did not resolve. 

9. For 49 years, through four generations, over-the-counter rescue breathing medicines 

have been readily available OTC to Americans with Asthma or COPD or Bronchitis 

flare-ups. Primatene Mist (CFC) was released in about 1963. Other brands of inhalers 

and pills have also been available over-the-counter to any person 

without a doctor's appointment for nearly 50 years. 

10. Only now as of December 31, 2011, has the U.S. EPA and FDA banned pharmacies in 

the U.S. from selling Primatene Mist or any other inhaled epinephrine products. 

3 
182 


82531.076

II. Let me make this clear. As of January I, 2012, there are no OTC rescue asthma 

medicines in U.S. pharmacies whatsoever. There are none. 

12. So if you have an acute bee sting in the forest, or at or in the inner city, or 

as an elderly person in your home, you can still get Benadryl, Zyrtec, Claritin or 

at any local 7-11 store or gas station. 

13. But get an acute asthma flare-up on a hike in rural America, in the inner at 

night or on a weekend, you are out of luck. Maybe you can get an immediate doctor's 

appointment within 20 minutes .... As my teenage son would say, good luck with that. 

Maybe you are super organized and already have a prescription asthma/COPD rescue 

medicine like albuterol BFA with you. But we all know that up to half of 

Americans are not so organized with their healthcare. Maybe you can treat yourself with 

"dark treatments (see item 8 above). But even though for 50 years rescue 

epinephrine has been available OTC to every American, now there is no rescue inhaler 

that you can get in rural America, in the West, South, Midwest, or Northeast, in inner 

cities, or for poor or patients with poor 

14 .. You can think of an OTC rescue inhaler like epinephrine inhaler (Primatenc as a 

preserver for patients with severe flare-ups of asthma, COPD or acute bronchitis, 

15. Just as on the Titanic or the Costa Concordia, people don't think about life preservers 

until they are drowning. Is it really right to lock up all the life preservers and give the 

only keys to a doctor or a ship's As my teenage son says, good luck with 

that. 

4 
183 


82531.077

16. Rescue inhalers like Epinephrine (inhaled CFC or eventually HF A) should continue to be 

available over-the-counter to Americans without a requirement for a doctor's visit or a 

prescription or an ER visit. This is basically a "First Aid" medicine, like a band-aid for a 

cut, or Benadryl for a bee sting, or a Heimlich maneuver for a choking person. There 

need to continue to be over-the-counter, fast acting rescue bronchodilators available to 

Americans in need. They have had these continuously available since 1963. Only in 

January 2012 did the EPA and FDA 1J1t"U<tlUl"1)" withdraw CFC Primatene Mist inhaler 

without ensuring that there were alternative OTC rescue inhalers for patients with acute 

Asthma, capo and Bronchitis. 

17. The EPA and FDA have raided your "First Aid Kit," and removed a key rescue inhaler 

therapy. An extension on the withdrawal ofPrimatene Mist (CFe) for two years or 18 

months is needed to allow an alternative HF A Epinephrine inhaler to be developed and to 

be approved for over-the-counter use by all Americans. 

Thank you for your attention. 

Edward M. Kerwin, MD 

5 
184 


82531.078

Summary 

Testimony of Edward Kerwin, MD 

Senior Medical Director, Allergy & Asthma Center of Southern Oregon, PC 

.. Asthma, COPD and Acute Bronchitis effect more than 30 million Americans. They 

cause episodic severe breathlessness the use of rescue bronchodilator inhalers. 

• For 49 years Americans have had an over-the-counter (OTe) reseue inhaler alternative, 

called Primatene Mist (epinephrine) with a ehlorofluorocarbon (CFe) propellant. eFC 

Primatene Mist has been available for four generations of Americans, since 1963. 

.. The first principal of medicine is that have a right to tTeat themselves, to render 

first aid, to try to heal their own health before they go to any doctor or ER. This is a 

fundamentally American value, and how our rural frontiers were settled. Americans have 

a to treat themselves through first aid in emergencies. 

.. OTe Inhaled Epinephrine (CFe) is a reSClle medicine for acute asthma, COPD, 

albuterol. This is similar to the role Bcnadryl for bee sting, peanut, or p~'H,,'m" 

"."mr'Villd." reactions. Such reSClle medicines need to be available over-the-counter. 

There should be no up" of these life preserving medicines in pharmacies and 

doctors' offices. They are needed promptly within minutes, in the middle of the night, in 

mral areas, in inner cities, by the poor and infirm, by Americans who may have no rapid 

medical access to a doctor or hospitaL 

.. An 18 month to two year extension of the of OTC Primatene Mist 

inhaler in the U.S. will allow time for a suitable HFA (hydrotluoroalkane) replacement to 

be ae1fCH)PC'O as an OTe rescue inhaler for Asthma, COPD, and bronchitis patients, 

available to all Americans. 
185 

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—— 

186 

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 anyVerDate Aug 31 2005 09:19 Sep 24, 2013 Jkt 037690 PO 00000 Frm 00192 Fmt 6633 Sfmt 6633 F:\112-16~2\112-16~1 WAYNE
187 

more? 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-thecounter—— 

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-thecounter. 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 

188 

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 

189 

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—— 

190 

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 

191 

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 

192 

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. 

193 

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-thecounter so there is no—— 

Mr. WAXMAN. What difference does it makes if it is over-thecounter or prescription? 

194 

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-thecounter. 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 FDAauthorized 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? 

195 

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 

196 

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. 

197 

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. 

198 

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. 

199 

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 

200 

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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f:WHLC\070912\070912.043.xml 

July 9, 2012 (11:32 a.m,) 

U.S.C. 7H71c(h)) is amendedstriking and insertthe following: 

and 

at the end the ne,v 

CmTICAL USE EXE:\IP'flONS AND EMEROEKCY EVEf'{TS.---

CRITICAI, esg g)"'EMPTIONS.-

IN GgNERAL-For each calendar 

year, 'with the Administrator, to an submitted any person, shall take all approaetions 'within the of the 

Environmental Protection 

critical use under the Montreal 

Protocol in order to allow the 

and 

bromidcfor any use of bromide that-

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F:\AEB\M12\METHYLBROMIDE __ 003XML [Discussion Draft] 

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July 9, 2012 (11:32 a,m,) 

IS an n"»,,,we! critical 

use; Hnd 

IS determined the 

Administrator to be a critical use 

for the <klJ']i"X,,,", and 

"(II) in thc amount neecssary for 

the usc described in subclause 

ApPLICA'rIONS.-The Administrator shall not any rcferred to m elausc or reduce the 

amount re(IUC'stE~(J under any sueh "'HUH'::"'-

unless the Administratorhas substantial evidenee to 

establish that there is a 

and feasible alternative 

availabJe to the for the use 

of bromide for which the 

eation was and 

"(II) such cvidcnee to 

the in writing. 

AUI'ERNA'l'lVES.-The Administrator, -when the technieal and 

eeonomie of any alternative pursuant to elause shall eonsider-

(527869119) 
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F:\AEB\M12\METHYLBROMIDE_003,XML [Discussion Draft] 

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f:\VHLC\070912\070912.043.xml 

July g, 2012 (11:32 a,m,) 

4 

"(1) cost and commercial avai1-

of the alternative to the 

"(II) demonstrated effectiveness 

of the alternative for the applicant's 

intended usc; 

"(III) demonstrated effectiveness 

of the alternative Hl the 

of the intended use; 

and 

"(IV) State 01' local 

that may restrict use of the alternative for the intended 

usc. 

"(13) JiJMERGENCY EVI~N1'S.-

IN GENEHAh-I<-'or each calendar 

year, with the Administo an suhmitted any person, shall allow the proand m 

the lTnited States of bromide--

for any use described in sub-

(A)(i)(I) in response to an 

emergency and 

(527889119) 
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F:\AEB\M 12\METHYLBROMlDE_OO3,XML [Discussion Draft] 

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f:IVHLCI070912\070912,Q4$,xml 

July 9,2012 (11:32 a,m.) 

5 

in an amount necessary for 

such use, 

!..ll:vnTS ON USE PEn EMERGENCY 

EVENT ,-'rhe amount of bromide 

allowed to clause for use per 

emcrg'eney event at. a Ioeation shall 

not. excet~d 20 metric tons. 

ON AGGREGATE 

A:vroUNT,-']'he O'(y"p,rnto amount of methyl bromide allowed pursuant to clause (1) 

for use in the United States in a ea!eudar 

year shall not exeeed the total amount authol'lzed by the to the Montreal 

Protoeol to the Montreal Protoeol 

process for critical uses in the United 

States in calendar year 2011. 

INTERNATIONAlJ OBLIGA'l'IONS.-The 

Administrator shall take suell aetions as may be 

neeessary to earry out this in aeeordanee 'with the Montreal ProtocoL 

DEPINI'l'toNS.-In this "HI"'"'''''' , 

The tE~rm critical use' 

means a use that was an <>"'m>""c.d critical 

nse in ClU!.";""'''''' I.J to A of 

(527869119) 
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F:\AEB\M12\METHYLBROMIDE_003.XML [Discussion Draft] 

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f:IVHLC\070912\070912.043.xmi 

July 9, 2012 (11 :32 a.m.) 

of title 40, Code of I;'cdcral 

in effect on 1,2005. 

The term 'critical use' means a 

cireumstance in whichthere are no and 

ft~asible alternatives or 

substitutes for bromide available that arc from the 

of environment and health 

and are suitable to the crops and circumstanees m,rnhmd and 

"(II) the lad, of of 

bromide for a use 

would result in "1;';"1I,1\.:;(\,11L' market <1isThe term event' 

means a situat.iol1-

that occurs at a l111rscry, food or commodities 

for "I;\'hich there is no critleal use in effect for sueh 

or for which there are not suf'fident quantities of' bromide 

available uncleI' an critical use 

(527869119) 
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F:\AEB\M12\METHYLBROMIDE_003,XML [Discussion Draft] 

2 

3 

4 

5 

6 

7 

8 

9 

7 

for sueh as deseribed 

in and 

that the use of 

bromide to control a or 

disease because there is no Lt't'lHl.!etlH.Y 

and feasible alternative 

to bromide available for snell 

nse, 

REGUlul'l'IONS.-Not later that 180 after 

10 the date of enactment of' this the Administrator of' 

11 the Environmental Proteetioll the 

12 Dil'eetor of the Office of Pestieide and in con13 sultation 'with the UC'C'OO",H of shall14 

15 

16 

17 

18 

19 

20 

21 

22 

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f:WHLCI0709121070912.043.xml 

July 9,2012 (11 :32 a.m.) 

(1) issue such final ,",IDLW1.!,!""!" as may be neeessmy to the amendment made subseetion and 

include in such 

eriteria for an emergeney 

as defined in section of' 

the Clean Air as added such amendand 

to ensnre that each """"","" 

tion for use of bromide in response to 

an emergency event under section 

of the Clean A.ir as added such amend-

(527869119) 
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F;\AEB\fv112\METHYLBROMIDE_003.xML [Discussion Draft] 

1 

2 

!:\VHl.C\070912\070912Jl43,xml 

July 9, 2012 (11 :32 a,m.) 

8 

is or 

manner. 

(527869119) 

in 
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F:\WPB\CO 12R\PR,MIST_0l,XML [Discussion Draft] 

[DISCUSSION DRAFf] 

CONGR!£SS H R 

SESi:lYON ,. .. 

distribution, of 

rt'Hluining ",v"nt",,'''~ 

IN THE HOUSE OF 

the following which 'was l'cferrpd the 

A BILL 

To dir'cet thc Administrator of thc Environmental Protcctiou 

2 

to allow for the 

tion in thc United States 

oyer-the-eountel' C1;'(; inhalers. 

the Senate and Hm./.se 

United States Americn 

3 SECTION 1. SHORT TITLE, 

and consumpinventories of 

4 'rhis Act may be eited as the Asthma Inhalers Relief 

5 Act of 2012". 

f:WHlC\070612\070612.070,xm! 

July 6, 2012 (3:00 p.m.) 

(526248114) 
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F;\WPBlC012R\PR-MIST_Ol.XML [Discussion Draft] 

2 

1 SEC. 2. DISTRIBUTION, SALE, AND CONSUMPTION OF RE· 

2 

3 

4 

MAINING INVENTORIES OF OVER·THE· 

COUNTER CFC EPINEPHRINE INHALERS. 

IN GENlmAll.-'l'he Administrator of the Envi5 ronmental Protection 

6 

7 

8 

9 

(1) shall allow for the and 

in the United States of' ",uU.u .... 1l1-

ventories of CFC CUI""'''''' inhalers manufactured 

,,~.~.w,~um for medical devices under 

10 section of the Clean Air Aet U.S.C. 

11 7G71e(d)(2)); 

12 shall not take any enfol'eell1ent aetion or 

13 

14 

15 

otherwise seek to restriet the or 

of snch inhalers on the hasis of auy 

Federal law the Montreal 

16 and 

17 (8) in response to any of any dis18 tributor or seller of such any 

19 such on the date of the enactment 

20 of this issue It No Action Assuranee I..Jettcr to 

21 the that the Environmental 

22 Protection ,\~n not initiate an enforcement 

23 action to the distribution or sale of any sueh 

24 

25 

inhaler to I, 2018. 

in this Act 

26 shall be constmed to limit or otherwise affect the 

f:IVHLC\070612\070612.070.xml 

July 6, 2012 (3;OO p,m.) 

(526248114) 
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F;\WPB\C012RIPR·MlST_OI.xML [Discussion Draft] 

3 

1 of the l<'ood and Administration under the Federal 

2 and Cosmetie Ad U.S.C. 301 ot. 

3 to ellsure the and offeetiveness of GB'C 

4 inhalers to be or consumed to 

5 this Act. 

6 

7 

8 

DEPI:.JITIONS.-In this Aet: 

'rhe term "CFC 

any inbaler 

inhaler" means 

9 ehloroi:1uoroearbons that was manufactured and clas10 

11 

sHIed as oVCI,-the-eounter before 1,2012. 

'1'11e "Federal law Ullmememtllll the 

12 Montreal Protoeol"-

,means any lw,mn""m of title VI of the 

Clean Air Act U.S.C. 7671 et or other 

Federal law the Montreal Proand 

(B) includes the final rule the 

Food lmd Administration entitled "U se of 

h",hn)""". Removal of EssenHal-Use 

in the l~ederal Uvb~O'","L ut 73 Federal Register 

The term "Montreal Protocol" has the 

such term in section 601 of the Clean 

13 

14 

15 

16 

17 

18 

[9 

20 

21 

22 

23 

24 

25 Air Act U.s.c. 

f;\vHlC\070612\070612.070.xml 

July 6, 2012 (3:00 p,m,) 

(526248114) 
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F:I WPB\CO 12RIPR-MlST _OI.XML [Discussion Draft] 

4 

1 The term "over-the-counter" means not 

2 

3 

4 

to section 

and Cosmetic Act 

othel'\vise 

of the Pederal 

1J.S,C. or 

to Federal law to be 

5 

6 

upon issuanee of a ""HD,,,',nt,,,m 

SU!\SET.--This section to be effeetive Au7 1,2013. 

fWHlC\070612\070612.070.xml (526249114) 

July 6, 2012 (3:00 p.m.) 
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82531.091

OcloOOr28,2011 

Honorable Pat Roberts 

109 Hart Senate Office Building 

Washington, DC 20510-1605 

RE: S. 1752 Freedom to Breathe Act of 2011 

Honorable Jim DeMint 

167 Russell Senate Office Building 

Washington, DC 20510 

RE: Amendment OTe Epinephrine inhalers 

Dear Senator Roberts and Senator DeMint: 

Thank you for your interest and concern for patients living with asthma. 

Allergy & Asthma Network Mothers of Asthmatics, Alpha-1 Foundation/CaPO 

Foundation, American Association of Respiratory Care, American Latex Allergy 

Association and Asthma Allies do not support the Freedom to Breathe Act of 2011 or 

the amendment as both would continue access to an Over The Counter (OTC) 

bronchodilator, Primatene Mist, developed over 50 years ago that is no longer 

recommended for use by patients with asthma. Twenty years ago, National Guidelines 

for the Diagnosis and Management of Asthma were developed by the National Institutes 

of Health and since then have been updated three times as a result of new evidencebased science about the disease of asthma. Neither NIH guidelines nor the Global 

Initiative for Asthma (GINA) recommend epinephrine inhalers for Ihe treatment of 

asthma, 

On December 31, 2011, after nearly 20 years' warning, epinephrine inhalers (Primalene 

Mist and its generic copies made by Armstrong Pharmaceuticals) wi!! no longer be sold 

in the United States because they contain CFCs and do not meel the criteria for an 

essential use exemption from US and intemational treaties signed by Congress to 

eliminate ozone-depleting CFC propellants. 

Of the 20 different brands and types of prascription-only inhalers currently sold in the 

US, 19 are now CFC-free. Pharmaceutical manufacturers were required to comply with 

laws and change their products or have them removed them from the market. More than 
214 


82531.092

24 million asthma and COPD patients and their medica! care providers were required by 

law to change treatment pay for addilional office visits, and pay co-pays 

and out of pocket costs newly approved medications. 

8adrul Ch,"lwrlhllirv MD, director of FDA's Oivision of Pulmonary, Allergy and 

Rheumatology stated, "There is no tachnical barrier preventing a non-CFC 

version of inhaled ft Tha manufacturer failed to develop a non-CFC 

alternative even were a extension beyond the 2008 

deadline other met their albuterol and levalbuterol. 

"' .... ii,.,"'''h.inA the only nonprescription drug inhaler available, is not 

r",,,,,nml,,, .. ,nrl .. ,rl the treatment of asthma. It is one of the grandfathered v",~.,tln"", 

nrAti:.!inn FDA, but it is still to the same laws, regulations and 

every available inhaler for asthma and 

It is stated in your press release that millions of patients will be affected if OTC 

epinephrine goes away; however, no one really knows if that is true. Armstrong, at 

several FDA reported they didn't know how actual patients use their 

canisters or how many canisters each patient much the age, income, or 

regional locations inhaler users. 

Arrn"t""n,n'" customers, as they refer to them, are the wholesalers and retailers not 

patients. numbers of 1.7 to 2.3 million stated in the press release are numbers the 

manufacturer provided FDA at a meeting. Nobody really knows how many people use 

this product and the company can make a based on numbers of canisters 

sold divided by how many canisters each patient 

.. "ii .... <>"n,·,,,,,, provide breathing relief and serious side effects for 

whereas two Inhalations of bronchodiiators, 

is the recommended medication by NIH, last 3-6 hours less unwanted 

cardiac stimulation. Primatene Mist is not a cheaper altemative. 

Assertions that Medicaid families and thus states will be hard hit should OTC 

",,,inA,,,hr'''A eV,3P()ral:e are highly suspect Inhaled is not the drug of choice 

Dr patients. Medicaid prescription coverage and 

access to medical care. Prescription and inhaled corticosteroids 

recommended by NIH for asthma are covered under Medicaid. 

The real problem Medicaid families face is that do not always dispense the 

medication or inhalation devices their doctors prescribe. Patients also tell us that they 

don't always receive referrals to and pulmonologists, as recommended in NIH 

guidelines. We would love help ensure that NIH Asthma Guidelines-based, costeffective and care is available to patient while saving stale 

and federal funds wasted on care, as shown at 

AANMA's ""'rll'l ... ~"",il'ln",1 

epinephrine inhalers were all we had to treat asthma. But like most 

medic;at!!)ns it has been with far safer and more effective medications 
215 


82531.093

that treat both the noisy obvious symptom of asthma, bronchospasm, as well as the 

underlying, smoldering silent cause of symptoms, inflammation. Knowledge of 

the disease of asthma has drastically changed the way is treated, and 1950s 

treatments are no longer considered safe. 

Today's treatment plans also are not based solely on one or more inhaled or oral 

medications. They require the cause(s) of symptoms, removing 

environmental or occupational exposures, repairing airway inflammation using antiinflamma!ories and restoring the patient to full and healthy function. 

Asthma is not a disease for do-it-yourselfers. Asthma is a serious, potentially lifethreatening disease that kills 11 people every day and it deserves serious attention. 

Rather than defend a manufacturer's right to continue making an outdated, inferior CFCpropelled drug no longer recommended for the treatment of asthma, AANMA urges 

Congress to issue vouchers through physicians, clinics and hospitals to offset patient 

expenses associated with purchasing NIH guideline-recommended medications for 

asthma. 

The Freedom to Breathe Act of 2011 does nothing to address and solve the problem of 

patients' access to NIH guideline-level care, but rather grants special favors to a 

manufacturer the only one who will benefit from the Freedom to Breathe Act of 2011. 

AANMA is prepared to in any way to ensure patients with asthma receive NIH 

guideline-level care and appropriate medical treatment. 

Thank you for your time and attention to our concerns. We look forward to discussing 

this most important issue with you. Please feel free to contact AANMA at 703-641-9595 

or Sandra Fusco-Walker, AANMA's Director of Patient Advocacy, at 703-641-9595 

x1524. 

Sincerely, 

Nancy Sander, President and Founder 

Allergy & Asthma Network Mothers of Asthmatics 

John W. Walsh, President and CEO 

Alpha-1 Foundation 

COPD Foundation 
216 


82531.094

Karen J. President 

American Association of Respiratory Care 

Sue Lockwood, Executive Director and Co-Founder 

American Latex Allergy Association 

GerM Dawnielle Rivers, Co-Founder 

Asthma Allies 
217 


82531.095

The Honorable lisa Jackson 

Administrator 

Environmental Protection Agency 

Ariel Rios Federal Building 

1200 Pennsylvania Avenue, NW 

Room 3000 

Washington, DC 20460 

Dear Administrator Jackson: 

November 28, 2011 

I am writing on behalf ofTeva Respiratory, a brand diviSion ofTeva Pharmaceuticals, to provide a proflle 

of Primatene Mist CFe uSers. As you know, concerns have been raised about the Impact 011 patients of 

the regulation that would prohibit the selling of over-the-counter epinephrine inhalers, primarily 

Pnmatene MiSt, after December 31, 2011. Regretfully, there seems to be a lot cf mlsperceptlons and 

faulty assumptions ~bout who the Prlmatene Mist eFt custOm ... r is and his/her acCess to appropriate 

medication alternatives. 

In order to prepare for the tranSition, Teva Respiratory conducted a market research swveyto better 

understand how to best educate patients and health care providers of the transition from Primlltene 

Mist (Fete albuterol HFA. While this information Is proprietary, I did want to share some of the top line 

findings in order to provide a better understanding ohlle current Primatene Mist user. 

We surveyed consumers between the ages of 20 and 75 who have purchased and used Primatene Mist 

CFC within the past two years. The findings induded: 

Primatene Mist CFC users are well educated, well .bove the general population 

l> 28% had graduated coneS" compared to 19% of the u.s. population 

):- 21% had done pOSt graduate work compared to 10% of the U.S. population; 

The median number of Primatene Mist eFe inhalers used in the past 18 months is 2; 

~ 84% of Primatene Mist (Fe users are insured; 

80% of Prlmatene Mist eFe users have prescription drug coverage; 

83% of Primatene MistCFC users have a personal physician and 72%· have seen their pnysidan in 

the post year; 
218 


82531.096

Tier 2 CO pays tor insured patients average $20·$25 (similar to retail costs of Primate"e Mist CFC 

inhalers) 

1> For the 16% oftnose not Insured, low income patients (200% or less of the !!ederal Poverty 

level) would qua!1fy for The Teva Assisten<:e Program for free aibuterol MFA inhalers; 

88% of Primatene Mist CFC users have a respiratory diagnosis alld nearly 40% are already taking 

II prescription inhaler; 

g Only 11% of Primatene Mist CFC users cited costas iil fllctorwhen citing reasons lor using the 

product over a prescription inhaler, 

The data clearly suggests that the majority of Primatene Mist eFt users are already in the hearth carl! 

system have access to a physician and visit their physician 011 a regular basis. 

Many Oftne concerns raised aboutthis tnmsltion are similar to thOSe r,,!Sed during the 2008 "CFe to 

HFA" albuterol switch. Due to tht! hord work and effofts of all the stakeholders -the federal 

government, patient groups, medical societies, pharmacies and drug manufacturers - it was extremely 

successful with virtually no disruption in access or harm to patients. revs Respiratory, and indeed all of 

our competitors, initiated numerous programs to educate patients and health care providers. Although 

the scale was much gre~ter for the 2008 transition - 50 million albuterol units compared to 2·3 million 

Primatene Mist CFe units - the effort has been .'mllar. SignifiCant resources were invested to drive 

awareness of the albuterol CFC·HFA transition, Just as they have been in this switCh, with the goal of 

ensuring that aJi were prepared. Patients and health carEl providers were ready for the tranSition in 

2008 and they are ready for the switch this year. 

I hope you find this information helpful. Please do not hesitate to contact me should you have 

$ddltional questions. 

cc: Margaret Hamburg, MD 

Commissioner 

General Manager 

Food a od Dru€ Administration 

Cynthia Giles 

Assistant Administrator, Office of Enforcement and CompHanee Assurance 

Environmental Protection Agency 

Regina McCarthy 

Assistant Administrator, Office of Air and Radiation 

Environmental Protection Agency 
219 


82531.097

December 12,2011 

Commissioner Mlll'garet A. Rlll'Dburg 

U.S. Food and DmgAdministration 

. Office of the Commissioner 

10903 New Hampshire Avenuo 

Silver Spring, MO 20993-0002 

Dear Commissioner Hamburg: 

On belmlf of the Alliance for Responsible Atmospheric Policy (Alliance), an industry coalition 

addressing issues related to fluorocarbons, I am writing in support of the attached letter from the 

International Pharmaceutical Aerosol Consortium (!pAC) expressing strong support for Ibe FDA's Final 

Rule eslllblishing 31 December ZQII as the deadline for transition ofCFC-based epinephrine metered-dose 

inhalers (MDls). A list of Alliance members is atlllched. 

lb. Alliance was organized in 1980 \0 address the issue of stratospheric ozone depletion. It is 

presently composed of fluorocarbon producers and manufucturers and bllSlnesses that rely on compounds 

such as HCFCs and MFCs. TodaY,!he AlIianee is a leadlng industry voice thet coordinates industry 

participation in the development ofreasenable international and U.S. government policies regardlng ozone 

protection and climate change. 

lb. Alli!!llce has become lm effective voice in influencing policy on !he ozone protection issue 

and has succeeded in ensuring lU! appropriate global approach to the issue through the Montreal Protocol 

while minimizing costly and ineffective regulations on industries. lbe Alliance's role of bringiog diverse 

Industries together to form a consensus on policy development proved su""e.sful. As a result the Alliance 

provided a credible voice in encouraging • responsible phaseout of CFCs and other ozone-<lepleting 

compounds. 

Overall, tbe Amance has advocated the benefits of alternatives 10 CFCs, educated pollcymakers as 

10 the feesibillty of laws and regulations, and assisted in removing barriers 10 !he us. of many alternatives. 

w. urge !he responsible phaseout of CFCs in MOb, and support the efforts of FDA and EPA in this 

transition. We look forward to !he continuation of. productive working relationship wi!h FDA and EPA 

on these issues. 

cc: Sadrul Chowdhury, Office of New Drugs, CDER 

Lisa EPA Administrator 

Gina A. ~}~~:=:.~~:;:~~ 

2111 WILSON BOULEVARD, 8TH FLOOR, ARLINGTON, VIRGINIA 22201 

Phone: 703-243-0344· Fax: 703-243-2874 • E-mail: aIliance98@ao!.com 
220 


82531.098

MEMBERSHIP LIST 

Alliance for Responsible Atmospheric Policy 

Chemicals Americas 

Conditioning, Heating & 

Refrigeration .LUOJULULI';; 

Airgas 

American Pacific Corp. 

Arkema 

Bard Manufacturing Co. 

BASF 

Brooks Automation, Inc. 

Cap & Seal Company 

Carrier Corporation 

Center for the 

Polyurethanes Industry 

Coolgas 

Danfoss 

Dynatemp International 

Emerson Climate 

Technologies 

E.V. Co. 

Falcon Safety Products 

FP International 

Golden Refrigerant 

Halotron 

Heating, Airconditioning & 

Refrigeration Distributors 

International 

Honeywell 

Hudson Technologies 

International 

Holdings 

International Pharmaceutical 

Aerosol Consortium 

Johnson Controls 

Lennox International 

McQuay Int€~rnation.al 

Metl-Span Corporation 

Mexichem Inc. 

Midwest Ke1rtJi~eraLUts 

National Refrigerants 

Owens Coming Specialty & 

Foam Products Center 

Polar Technology 

International 

Rheem Company 

Ritchie Engineering 

Solvay 

Trane Company 

Worthington 
221 


82531.099

November 4, 2011 

Via E'If!4il 

This letter is submitted on behalf of the International Pharmaceutical Aerosol Consortium 

(!PAC) to express support for FDA's Final Rule 31 December 2011 as the 

deadline for the of CFC-based inhalers (MDIs) (brand 

name: Primatene Mist). !PAC is an association thet manufacture medicines for the 

treatment of respiratory illnesses, such as asthma chronic obstructive pulmonary disease 

(COPD). !PAC was formed more than two decades ago in response to the mandates of the 

Montreal Protocol on Substances that Deplete the Ozone Layer. IP AC is fumly committed to the 

transition from CFC MDIs to CFC-free alternatives, to the Montreal Protocol, and has 

actively engaged in the transition in the States. !PAC's member companies 

have invested substantial resources CFC-iree alternatives in order to accomplish the 

phase-out of CFC-based MDIs in furtherance of the United States' international commitments 

under the Protocol. 

IF AC is extremely concerned about recent efforts within the US Congress to delay Or suspend 

the phase out of epinephrine CFC MDIs and believes that such proposals would have negative 

implications fur patient health. IPAC is encouraged that the amendment proposed by Senator 

DeMint and considered last week the Senate was defeated, but wishes to share some 

perspectives on this issue in case are introduced. 

IF AC notes that FDA undertook a careful, deliberative, and open public rulerruWrlg 

process that induded input from patient and physician and other key experts to 

establish the transition deadline for Prlmatene Mist. This deadline has provided three full 

years to to one of the several CFC-free alternatives available. Since the Final 

Rule was issued in FDA has worked herd - in collaboration with 

other interested stakeholders - to prepare for a smooth transition for P-rl ...... ,jp,o .. , 

Ab"TRAZllNBCA • BoEHlUNGER INGru!l!JM • CHIIlSI FARMACEUTlCI • Gl.AxOSMmiKUNE 

SuNOVION PHAllMACEUTlCALS, !NC .• TEVA 

l)COll 2809462. Z 
222 


82531.100

Comrnlssloner Margaret Hamburg 

4 November 2011 

Page2of2 

addition, available patient assistance programs (and product samples) will help many users of 

Frimatene .l'vfist successfully transition to safe and effective CFC-free alternatives, 

Even if Congress were to override FDA's well-coosidered deadline on Primatene Mist, it would 

only briefly forestall the inevitable, Due to a global ban on CFC production, safe and adequate 

supplies of pharmaceutical-grade CFCs do not exist for the continued manufacture of 

Prlmatene:Mist. It is therefore important for users to transition now pursuant to the deadline 

established by FDA. Even a small shift of the end 2011 deadline (e,g. 3 to 6 months) could be 

quite counterproductive for the following reasons: it would introduce confusion and 

uncertainty fOf, most importantly, patients, and also the supply chain; and (ll) it could 

hamper EPA efforts to enforce the transition when it actually occurs, 

In the past, EPA and FDA have 

transition deadlines (e.g., to use up 

there is no reason that there should be the case FDA has 

made a Significant effort to raise awareness of the 31 December 2011 deadline and 

that now would send very mixed signals to patients, consumers, health care providers 

other stakeholders. 

The phase-out of Primatene Mist and other ozone-depleting MDIs was inltiated more than two 

decades ago, The" essential use" process established under the Montreal Protocol has provided 

the MDl industry time to reformulate and seak approvals of CFC-f:ree alternatives. After 

long ago "seemg the writing on the wall", MDl manufacturers worked diligently to research 

and develop CFC-free products, Most companies (induding all lP AC members) have invested 

hundreds of millions of dollars to accomplish this important Introducing even 11 brief 

delay at this late stage would send a very negative signal to manufacturers that responded 

to the US Government's call to be a partner in meeting the Montreal Protocol commitments, 

For the sake of the environment, compliant manufacturers and, most importantly for the 

patients, FDA must not waiver in their commitment on this matter merely for the economic 

interests of a few, 

Maureen Donahue Hardwick 

lP AC Secretariat and Legal Counsel 

cc: Badrul Chowdhury, Office of New Drugs, CDER 

Lisa P. Jackson, EPA Administrator 

Gina A. McCarthy, Assistant Administrator for Office of Air and Radiation, us EPA 

Sarah Dunham, Director of the Office of Atmospheric Programs 

Drusilla Hufford, Director, Stratospheric Protection Division, US EPA 

Dan Relfsnyder, Deputy Assistant Secretary for Environment and Sustainable Development, US 

Department of State 

John Thompson, Foreign Affairs Officer, Office of Environmental Policy, US Department of State 
223 


82531.110

AMERICAN 

LUNG 

ASSOCIATION. ACAAI~~ 

July 17, 2012 

The Honorable Ed Whitfield 

Chairman 

Subcommittee on Energy and Power 

Committee on Energy and Commerce 

Washington, DC 20515 

Dear Chairman Whitfield and Ranking Member Rush: 

The Honorable Bobby Rush 

Ran king Mem ber 

Subcommittee on Energy and Power 

Committee on Energy and Commerce 

Washington, DC 20515 

On behalf of the undersigned medica! and public health organizations, we are writing to express 

our strong opposition to allowing CFC-propelled OVef- the-counter epinephrine (Primatene Mist 

CFe) to retum to the U.S. market. Our organizations strongly believe that allowing this product to 

return to the marketplace is not in the best interests of patients with asthma or the public health, 

Over 25 million Americans - including 7 million children - have asthma. Asthma is the third leading 

Cause of hospitalization among children under the age of 15 and is a leading cause of school 

absences from chronic disease - accounting for OVer 10.5 million lost school days in 2008. Asthma 

costs our healtheare system over $50.1 billion annually and indirect costs from lost productivity 

add another $5.9 billion, for a total of $56 billion dollars annually. Asthma claims the lives of 

more than 3,300 Americans each year, or approximately nine people per day, 

Fortunately, based in part on guidelines and recommendations from several expert panels, there 

are effective treatment protocols that include the USe of medication that people living with asthma 

can use to successfully manage their disease. None 01 the expert guidelines recommend the USe of 

over-the-counter medications--like Primatene Mist--to treat asthma. The National Asthma 

Education and Prevention Program (NAEPP), an expert panel convened by the National Institutes 

of Health, has issued treatment guidelines for management of asthma, NAEPP recommends 

against the use of epinephrine for treating asthma exacerbations recognizing that it has the 

potentia! for flexcessive cardiac stimulation." 

Our organizations strongly encourage any patient who uses over the counter medications -like 

Primatene Mist CFC - to treat his/her asthma to seek a healtheare provider who can help the 

patient develop an asthma management plan and recommend more effective and safer 

medications to manage the asthma - including products that help prevent asthma episodes, 

All pharmaceutical manufacturers have been on notice since 1990 that products containing eFCs 

would be phased out. Armstrong Pharmaceuticals, the manufacturer of Primatene Mist CFe, has 

known since 2008 that their product -like others made with CFCs - would also be phased out. 
224 


82531.111

Armstrong Pharmaceuticals already received a one year extension of the transition date from the 

U.S. Environmental Protection Agency to allow its productto be sold until December 31,2011. 

While other companies and products have sUccessfully transitioned their products, providing for 

safe and effective medications for people with asthma, the maker of Primatene Mist CFC instead 

has repeatedly sought to be exempted. Congress should not make an exception for one productespecially one that is not recommended for the treatment of asthma. Moreover, reintroducing this 

product into the marketplace would only further confuse patients and undermine efforts to 

transition patients to guidelines-based care for managing their disease. 

Our organizations strongly believe Armstrong has had sufficient time to prepare for a final 

transition date of December 31, 2011. In Z008, the decision was made the CFC propelled inhaled 

epinephrine should be phased out and our organizations have been working with providers and 

patients to ensure a smooth and orderly transition process. Congress should not create an 

exemption for Primatene Mist CFC, but instead work to ensure that all people with asthma are 

receiving guidelines-based treatment for their disease. 

Sincerely, 

Alpha-l Association 

Alpha-l Foundation 

American Academy of Allergy Asthma and Immunology 

American Association for Respiratory Care 

American College of Allergy Asthma and Immunology 

American lung Association 

American Thoracic Society 

Asthma and Allergy Foundation of America 

COPD Foundation 

National Association for the Medical Direction of Respiratory Care 

National Home Oxygen Patients Association 

Cc: The Honorable Fred Upton, Chairman, Energy and Commerce Committee 

The Honorable Henry Waxman, Ranking Member, Energy and Commerce Committee 
225 


82531.114

I 

International Pharmaceutical Aerosol Consortium 

Written Testimony Submitted for the Record (July 18, 2(12) to the 

House Energy and Power Subcommittee 

Regarding the -Asthma Inhalers Relief Ad of 2012-

On behalf ofthe International Pharmaceutical Aerosol Consortium 

Maureen Hardwick, Secretariat 

1500 K Street, NW, Suite 1100, Washington, DC 20005 

Maureen.Harowick@dbr.com I 202-230-5133 

The International Pharmaceutical Aerosol ConSOl1iurn (IPAC}-an aSSOCiation of companies 

that manufacture medicines for the treatment of respiratory illnesses, such as asthma and 

chronic obstructive pulmonary disease (COPD}-appreciates the opportunity to submit 

written testimony to the House energy and Power Subcommittee. 

IPAC's members are: AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, 

GlaxoSmithKline, Sunovion and Teva. For more than 20 years, IPAC has been firmly 

committed 10 the transition from Chlorofluorocarbon (CFC) metered-dose inhalers (MOIs) 

to CFC-free pursuant to the mandates of the Montreal Protocol, and actively 

engaged in the process in the United States. IPAC's member companies 

Invested substantial resources 10 develop CFC-free alternatives in order to accomplish the 

phase-out of CFC-based MDls. The United States has achieved significant progress 

during the last five years toward successfully completing the CFC MDI transition. 

IPAC strongly opposes recent efforts within Ihe US Congress to 11ft the December 31,2011 

ban on the sale of CFC·based epinephrine (brand name: Primatene Mi5~ metered dose 

inhalers (MDls) and the proposed legislation, the "Asthma Inhalers Relief Act of 2012." 

Such a drastic reversal in settled law would be unnecessary to protect the health of 

asthma patients and contrary to the States' important and longstanding 

commitment to treaties. 

We wish to share the following perspectives on this important Issue: 

rln~!,::s..out of Pnmatene Mist and other ozone-depleting MDls was initiated more 

~~~~=~~in to the mandates of the Montreal Protocol which was 5:i in 1987. The "essential use" process under the 

and Clean Act provided the MOl industry ample lime to 

reformulate and seek approvals of CFC-free alternatives. MDI manufacturars long ago 

began working diligently 10 research and develop CFC·free products in order to meet 

Montreal Protocol requirements. Most companies (including all IPAC members) 

invested hundreds of millions of doilars to accomplish this important objective. The 

1500 K STREET, NW • SUITI, 1100 • WASHINGTON, DC 20005-1209 

TEL: +1.202.230.5133· EMAIL: MAUR£EN.HARIlWICK@06R.COM 
226 


82531.115

attached tlmellne summarizes the extensive history of the essential use process and 

the careful, deliberative steps undertaken to promote a smooth and seamless transition 

to CFC-froo alternatives. 

~ The December 31, 2011 phase-out date for CFC·based Prfmsfene Mist was 

established by FDA in 2008 (under the prior Administration), and was based an 

extensive administrative record that included input from key stakeholders, 

patient and physician groups. This deadline provided three full years to tmlrl.<:ilinn 

patients to one of the several CFC-free alternatives available. It Is nnl'Awmtlw 

manufacturer of Primatene Mist specifically sought the December 31, 201 

after an earlier deadline was initially proposed by FDA. 

• There is no evidenca that patient health will benefit from briefly re-Introducing 

Prlmatene Mist onto the market, now more than six months after the ban became 

effective. Rather, the clear consensus of the major physician and patient groups Is thaI 

such an action would be extremely confusing and disruptive for patients and would not 

contribute to improved health outcomes. Tens of millions of asthma and COPD 

patients in the US have succassfully transltloned to CFC-free MDls over the past 15 

years . 

., II has been suggested that re-introducing Prfmsfene Mist would be cost-effective for 

patients. A group of respected patient advocates directly disputes this assertion and 

they nole that "two inhalations of epinephrine provide breathing relief ... for 15-30 

minutes, whereas two inhalations of preScription bronchodilators, which is the 

recommended medication by NIH. last 3-6 hours with less unwanted cardiac 

stimulation. Primatene Mist is not a cheaper alternative." Asthma Network 

Mothers of Asthmatics, et af, letter to Senators 

2011). In addition, patient assistanca programs (and product samples) continue to 

available to assist many users of Primatene Mlstto successfully transition 10 sate and 

effective CFC-free alternatives. 

• The only possible ooneficiary of a reversal of the ban on Primatene Mist would be its 

manufacturer. which stands to garner a financial windfall if ils limited stocks are sold. 

And, any patienl buying these MDls will be forced to switch therapy a second time once 

the stocks are depleted (which is likely to be within a matter of months). 

~ Granting extraordinary, unwarranted and special treatment to a single company would 

send an extremely negative signal 10 the manufacturers thai responded to the US 

Government's call many years ago to 00 a partner in mooting the Montreal Protocol 

commitments. Similar, prior requests for deadline relief (including requests to sell small 

stockpiles of CFC MDI$) have been firmly denied by Ihe relevant regulatory authorities. 

INTI:~NATiONAl PIlARMACEUTlCAI. AEROSOL CONSORTIUM 

1500 K STREET, NW' Sun; 1100 • WASHINGTOII, DC 2000s·120~ 

TEl: +1.202.230.5133' EMAil: MAUREEN,IIARDWIO<@Dg~,COM 
227 


82531.116

~ Finally, significant practical exist as 10 whether Ihe stockpiied Prlmatene Mist 

is nearing the end of its life (assumed to be 18·24 months based on data) 

and would, therefore, SOO/'l after being sold to to a 

recent Congressional to Armstrong ceased l'\rt'\n'lr'intl 

August 2011 - almost a full year ago, Any remaining units 

somewhere are rapidly nearing the end of their useful life. 

IPAC respectfully the Congress to ensure that the phase-out of CFC-based MOls 

remains In effect so and consumers are not subjected to unnecessary risks or 

uncertainty. We sDIDrecialte share our views in our testimony, and please 

be assured that to serve as a resource on this Issue. 

fNT£RtlATIONAL i'HARMACEIITlCALAfROSOL CoNSORTIUM 

1500 I( STREU, NW • sum 1100· WASHINGTON, DC 2000s-1209 

Tn: +1,202.23(),S133. EMAIl: MAV~EEN.HAR!)WICK@OOO.COM 
228 


82531.117

« 

.. 

.. 

.. 

.. 

.. 

.. 

.. 

.. 

Key Milestones 

Phase-Ollt 0/ CPC-Based Epinephrine Metered-Dose Inhalers (MDls) 

1987 

M~rch 14, 1989 

lanuary 1, 1990 

1990/1991 

january 1, 1996 

Augllst Hi, 1996 

lanuary 24, 2006 

September 20, Z007 

December 5, 2007 

November 18, 2008 

December 31, 20013 

September 25, 2009 

September 8, 2011 

President Reagan the Montreal Protocol and transmits It to the United 

States Senate for ratiliClltion 

US Senate unanimollsly ratifies Montrea! Protocol 

Montreal Protocol enters into force 

Several MOl manufacturers commence joint toxicological testing programs 

of alternative medical propellants 

Ban on CFe production and imports takes effect (but allows for proven 

"essentiaI1,lses· under an annual process) 

FlrstCI'C-free MD! approved In the US (Proven til HFA) 

joint Meeting of FDA's Nonprescription Drug Advisory Committee (NMe) 

and Pulmonary-Allergy Drugs Advisory Committee (PADlIC) on essentialuse status ofOTe MDis containing epinephrine 

FDA issues Proposed Rule on remol'al of "essential use" designation for 

epinephrine (with an effective date of December 31, 2(10) 

o 

Armstrong Inc. submits comments requesting FDA to 

extend effective date to December 31, 2011 (from December 31, 2(10) 

FDA holds public meeting on removal of essential use deSignation for 

epinephrine 

FDA Issues Final Rule on removal of "essential use" designation for 

epinephrine with extended effective date of December 31, 2011 

FDA deadline for phase out of albuterol CFC MDls 

FDA public workshop on removal of essential use designation for 

epinephrine 

EPA/FDA/State Department host stakeholder meeting on the US transition 

to ol'one-safe MOIs, with focus on ensuring smooth transition of patients 

relying on over-the-counter CFC-based epinephrine MDls (i.e., Primatene 

Mist) 

• September 22, 2011 FDA hosts a stakeholder telecollferellce on the phase-out of CFC-based 

epinephrine MDls (Primatene Mist) 

• December 31, 2011 Removal of epinephrine's "essential use" status takes effect. Primatene Mist 

therefore cannot be sold (or otherwise introduced into interstate 

commerce) after this date 

DCOl12813Blo.l 
229 


82531.120

November 201 i 

"",~."i~ Giles 

AS:,,15Iim, Administrator 

Office of Enforcement and 

Environmental Protection 

1200 Ave 

20460 

Assurance 

Re: Primatene Mist Sunset December 31, 2011 

Dear Administrator Giles: 

On behalf of our customers who on Primatene Mist as their over-tha-counter 

",,...,,,,rt,,,,r,,,v asthma rescue medication, we are I~YU~l>'LIl 

allowed selt Prlmatene Mist inhalers after December ,2011. The 

Primatene Mist offered for sale would be from our current slock, ordered and 

received before December 31, 2011, 

Our company and understand that the current 

chlorofluorocarbon of Prlmatene Mist is no 

manufactured and here in the United States, Because Mist 

uses CFC as it is to Environmental 

Protection under the understand that a 

Final Rule was on November 2008 the Food and 

Administration in consultation with the that removes Mist 

multi dose from the "essentlall.lse" for CFC as of December 31, 

2011 "Final As you are aware, this Rule was issued 

to the Air Act Enforcement of the Clean Air Act's ntl1,mrlltlCII"i 

of non-essential CFC resides with EPA, 

there are no other uA-a~)p«)lJeia OTC eoilneohr'ine 

marketed within the United 

Primatene Mist from the market 

6333 State Route 298, Suite 

Office: (315) 451-2873 Fax: (315) 
230 


82531.121

In we are the EPA to exercise enforcement discretion in a 

manner that will allow our retail stores to seil the units of Primatene 

Mist In their after December 2011 and our retail 

exhausted, In no caSe extension exceed June 2012, 

We further understand that if our retail stores continue to sell a Prlmatene CFC 

inhalation the June 2012 date, that result in 

action further notice, without If ..... it",ti"" 

as set forth in the Clean Air Act 

We request your rtj",,~r"';'!"n as it 

Bob Corcuera 

C~l'tegory Manager - Health Care 

consideration in ",,,,,,,,,,,,,nn EPA 

to Prlmatene Mist 

6333 Slate Roule 298, Suite 

Office: (315) 451-2813 Fax: (315) 
231 


82531.122

November 22, 20 I ! 

Cynthia Giles 

Assistant Administrator 

Office of Enforcement and Compliance Assurance 

Environmental Protection Agency 

1200 Pennsylvania Ave NW (6205) 

Washington, DC 20460 

Dear Administrator Giles: 

Re: Primatene Mist Sunset December 31,2011 

on Primatene Mist as their over-the-counter ("OTC") 

emergency asthma rescue we are requesting that our member retail 

pharmacies be allowed to sell Primatene Mist inhalers after December 31,2011. The 

Primatene Mist offered for sale would be trom their current stock, ordered and received 

before December 3 L 20 II. 

The National Association of Chain Dntg Stores (NACDS) represents traditional 

stores, supennarkets, and mass merchants with pharmacies from regional chains 

four stores to national companies, Chains operate more than 40,000 pharmacies and 

more than 3.5 million employees, including 130,000 pharmacists. They fill over 

prescriptions annually, which is more than 72 percent of annual prescriptions 

in the United States. The total economic impact of all retail stores with pharmacies 

transcends their $900 billion in annual sales. Every $1 spent in these stores creales a 

ripple effect of$1.81 in other industries, for a total economic impact of$1.76 trillion, 

equal to 12 ofGDP. For more information about NACDS, visit 

Our member pharmacies and their patient population understand that the current 

ehlorot1uOl'ocarbon version of Primatene Mist is no longer manufactured 

and produced here in the States. Because Primatenc Mist uses as a 

propellant, it is subject to regulation by tbe Environmental Protection Agency (EPA) 

under the Clean Air Act. We further understand that a Final Rule was adopted on 

November 18,2008 by the Food and Drug Administration ("FDA") in consultation with 

EPA that removes Primatcne Mist multi dose inhalers from the "essential use" 

for CFC as of Decemher 31, 2011 (the "Final Rule"). As you are aware, this Final 

was issued pursuant to the Clean Air Act. Enforcement orthe Clean Air Act's 

prohibition against sale of non-essential CFC products resides with EPA. 

Currently, there are no other FDA-approved OTC epinephrine inhalation products being 

marketed within the United States. This means that the removal of Primatene Mist from 

the market EPA would eliminate OTC access to this importmlt drug which is needed 

hy millions for instant relief from sometimes life-threatening asthma 
232 


82531.123

Environmental Protection Agency 

November 22, 2011 

Page 2 

attacks. We believe that this marketing ban would extreme hardships on asthma 

patients, their families and the overall healthcare system in this country, Consequently, 

we urge EPA to exercise enforcement discretion to ensure that asthma patients have OTC 

access to Primatene Mist until the 2011 retail supplies (including stocks ordered and 

received prior to December 31, 2011) are exhausted, 

In summation, we are EP A to exercise enforcement discretion in a manner that 

will allow retail pharmacy companies to sell the remaining units ofPrimatene Mist in 

their possession after December 31, 2011 and until this supply is exhausted. In no case 

shall this extension exceed June 30, 2012. 

We further understand that if our retail stores continue to sell a Primatene CFC 

inhalation product beyond the June 30, date, that may result in action 

without further notice, including, without limitation, seizure and injunction as set forth in 

the Clean Air Act. 

We respectfully request your prompt consideration in .,,,,_,"'0,,,,, EPA enforcement 

discretion as it pertains to Primatene Mist. 

Sincerely, 

Kevin N. Nicholson, R.Ph" Esq. 

Vice President 

Government Affairs and Public 
233 


82531.124

December 8,2011 

Administrator 

Office of Enforcemt'nl and Compliance Assurance 

Environmental Protection 

1200 Pennsylvania Ave NW 

Washington, DC 20460 

Re: Removal of Over-The-Counter EpInephrine Metered-Dose lnhalers; Sunset Date Extension 

Dear Administrator Giles, 

The National Community Pharmacists Association (NCPA) is sharing concerns regarding the impending 

removal of Primatcne Mist, the only over-tile-counter (OTe) inhaler for temporary relief of asthma. On 

behalf of our patients who utilize Primatene Mist as their over-the-counter asthma rescue medication, we 

respectfully request that our member community pharmacies be permitted to sen Primatellc Mist 

inhalers after December 31, 2011 until supplies ohlle CFC-fonnulation are depleted. 

NCPA represents the pharmacist owners, managers, and employees of more than 23,000 independent 

community pharmacies, phannacy franchises, and chains, which dispense over 41 % of all retail 

prescriptions. Health care providers, often community phannacists, are the tirst line of defense lor 

proper screening and treatment of asthma patients. With the expansion of pharmacist-provided patient 

care services, there has been a steady increase in community pharmacists who provide asthma 

management programs. Therefore, the availability and access of asthma products is of great interest to 

our membership and the patients they serve. 

It is our understanding that FDA's decision in consultation with the Environmental Protection Agency 

(EPA) to remove Primatene Mist is due to environmental compliance with the Montreal Protocol, which 

II , Nt UN 
234 


82531.125

aims to eliminate ozone-depleting substances (ODS). The chlorofluorocarbons (CFCs) contained in 

the propellant of the meter"d dose inhalers (MD!) have been identified as an ODS and according to the 

phase out plan, will no longer be available for sale after December 31. 2011. Because the propellant 

within the current formulation of Primatene Mist contains CFC, it is subject to regulation by the EPA 

under the Clean Air Act, and as such oversight ofllle Clean Air Act's prohibition against sale of nonessential CFC products resides with EPA. While we fully respect the EPA's enforcement authority on 

this issue, we urge the EPA to consider a balanced approach between environmental safety and patient 

access to care while supplies remain on store shelves. 

In previous comments to the FDA on this issue, our recommendation was for the Administration to consider 

extending the sunset dute ofthe curren! OTe metered-dose inhalers until supplies ofthe CFC-fonnulation 

are depleted to keep asthma medicatiolls affordable and accessible to patients that may be seeking rescue 

therapy and ask for those same considerations with the EPA. Currently Primatene Mist is the only OTC 

inhaler available and costs significantly less than inhalers which require a prescription. As the sole 

remaining product available, Primatenc Mist may be the most ,,!t\)rdable option during a potentially lifethreatening astbma attack for some patients. We requested the FDA to allow lor the availability of OTC 

CFC MDis as a bridge supply to protect patient health. 

Similarly, we urge EPA to exercise enforcement discretion to ensure that asthma patients have OTe 

access to Primatene Mist until tbe existing supply (including units ordered and receiv~'d prior to 

December 31, 2011) are exhausted. This will allow community pharmacies to provide the remaining 

units of Primatene Mist in stock beyond December 31, 2011 and until the supply is exhausted. Under no 

circumstance sball this extension exceed June 30, 2012. We further understand thut if independent 

community pharmacies continue to sell a Primatene CFC inhalation product beyond June 30, 2012, that 

activity may resull in legal action without further notice. 
235 


82531.126

We appreciate EPA's prompt attention to this serious health and environmental issue and consideration in 

exercising enforcement discretion as it pertains to Primatcnc Mist containing CFC. 

Sincerely, 

Ronna B. Hauser, PbanuD 

Vice President, Policy & Regulatory Affairs 
236 


82531.127

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, 

DEC 30 2Jll 

HOll0,,"hle Bart Stupak 

und Armslro!lg Pharmaceuticals 

575 Seventh Street NW 

Washington, DC 20004 

Dear Mr, Stupak: 

response to your 

~ll\'JI'\)rll1'H:rl!all'mtccH()n Agel\cy 

dute authorized by current 

Wt) reviewed the ini(;nnalil)!1 

26 and, as we said we w()uld, we 

Drug A~mi!",,!J'n 

20460 
237 


82531.128

we 00 no! see grounos to invoke the relief of a no action assurance. 

letter, n statement by the EPA that we not enlbrc(, the law is lhal 

lmd only whell it is cleady necessary to serve the puhlic interest. 

requests for a no action llssunmcc in this case canl101 be approved. 

Thllnk you YClllf lencr. 

Endosure 

cc: Commissioner Margaret A. 

Kevin N. Nicholson. It Ph, 

National Association o.fChain 

u.s. Food and Drug Admlnistratiml 

President. Government Affairs and Public Policy. 

Stores 
238 


82531.129

Statement for tile Record of Regina IV .. " __ ,,nIiIV 

Assistant Administrator for the Office of Air and ""u .. ,uu". 

U,S. Environmental Protectioll Agency 

Hcaring on the "U.S, Agricllitural Relief Act 0(2012" IIl1d the "Asthma Inhalers Relief Ad 

0(2012" 

Chainnan Whitt1eld, 

and Power 

Commerce 

Member Rush, and members of the Committee, I 

appreciate the opportunity to provide a written statement for the record on the draft bills entitled 

the "U,S, Agricultural Relief Act of20 12" and the "Asthma Inhalers Relief Act of 20 12, which 

are presently before the Committee, These bills address the treatment of methyl bromide and 

Primatene Mist, respectively, which are or contain ozone-depleting substances that the United 

States has agreed to out of domestic cOI~sulml)ti(m and ,,,,,,,,,,,'_u .. :,,, under the Montreal 

Protocol, subject 10 critical and essential use "YI'n"~fj(m~ 

Although the Administration does not yet have a formal position on these draft bills, the 

bills could a number of unintended adverse consequences, Since each draft deals 

with very different exemption process and has differing potential consequences, will 

background and address each separately, 

The Montreal Protocol on Substances that Deplete the Ozone Layer was signed by the 

United States in 987, with the personal support of President Ronald Reagan, and ratified 

988. The Protocol, which has undergone multiple revisions over sliccessive years, phases out 

the and pro,uw:;ne.n of ozone depleting substances, Because the stratospheric ozone 

layer absorbs ultraviolet-B radiation that would otherwise reach the surface ofthe planet, 
239 


82531.130

emission of ozone depleting substances results in increased exposure to UV-8 radiation which 

may cause increased incidence of skin cancer and other health and environmental impacts. The 

Montreal Protocol has been ratified by the United States and 1 % other countries and is widely 

recognized as one of the world's most successful multilateral international conventions in tarce. 

As part of the 1990 amendments to the Clean Air Act, Congress enacted Title VI of the 

Act, which directs EPA to work with other federal agencies to carry out U.S. Montreal Protocol 

commitments for phasing out ozone Get)letmll substances. Title VI specifies mechanisms to 

complement this phase-out, including a ban on nonessential products. It also provides flexibility 

to allow continued production of ozone depleting substances in areas where additional time 

might be required to identify effective alternatives. 

Methyl bromide is an odorless, colorless gas that has been used as a soil fumigant and 

structural fumigant to control pests across a wide range of agricultural and other sectors. Because 

methyl bromide depletes the stratospheric ozone layer, the amount of methyl bromide produced 

and imported in the United States was reduced 1l"\{'.rp.111"n.t~"lv until it was phased out on January 

1,2005, pursuant to our obligations under the Montreal Protocol and Title VI ofthe Clean Air 

Act. 

Under the Protocol, the Parties to the Protocol have authority to penn It exemptions from 

the phaseout for "critical" uses of methyl bromide that are nominated by a given country. The 

Parties to the Protocol have agreed to Decision IX/6 governing such exemptions, which states 

that: 

"use ""'~o'!",l bromide should as 'critical' only if the Party 

determines that: 

2 
240 


82531.131

(i) The specitlc use is critical because the lack of availability of methyl 

bromide for that use would result in a signif1cant market disruption; and 

(ii) There are no technically and economically feasible alternatives or 

substitutes available to the user that are acceptable from the standpoint of 

environment and health and are suitable to the crops and circumstances of 

the nomination;" 

The decision also establishes criteria and a process for the Parties to the Protocol to assess the 

quantity of production and consumption, if any, of methyl bromide that should be permitted for 

nominated critical uses. 

EPA, in 2003, established the Critical Use Exemption process for methyl bromide in 

'''''''-''IJU'''VU of the 2005 phaseout, to for growers with critical needs for continued use of 

the fumigant beyond the phaseout. The U.S. Govemment develops each annual critical use 

nomination j{jr methyl bromide through a rigorous technical process involving the careful efiorts 

of several agencies, and in close collaboration with the grower community. 

Each year, EPA solicits applications from growers and grower groups. Staff oflhe EPA 

Ot11ce of Pesticide Programs and the U.S. Department of Agriculture (USDA) Office of Pest 

Management review "PI)H~,aH"'U~ and work with growers to compile the best available 

infulmation on current critical uses. EPA recognizes the vita! impOliance of extensive interaction 

with the user community. Accordingly, EPA, USDA, and Department of State conducted 

meetings this winter with user groups to further ensure that federal agencies are able to work 

actively with apj)l!(;ants to information gaps. Calls and meetings were held to discuss 

crop, Pf()dulctlon, and use conditions, to enhance om,,, .. ,'!ir,,, information. EPA also 

support to, and attends, the annual Bromide Alternatives Outreach Conference. 

3 
241 


82531.132

In addition, between 1995 and 2012, USDA --through the Agricultural Research Service, the 

National Institute of Food and the State Research Education 

and Extension Service ). and the Interregional Research Project 4 programs - has 

substantial support for research and outreach related to alternatives that used 

methyl bromide. These actions demonstrate, on the part. of the US. Government, an 

ofthe important needs of the and user community and an ongoing 

commitment to work "n;e,'t,vplv to help meet those needs. 

All these efforts have the common of allowing the U.S. Government to develop 

technically supportable estimates for U.S. critical needs for bromide. The value ofthis 

carefu! process has been demonstrated In the success to date in Montreal Protocol negotiations, 

The U.S. Govemment has successfully supported its nominations for critical uses 

bromide, securing of an average of 88 percent of ollr nominated amount for each year 

from 2005 through 2013. 

While the current critical use process has been effective and successful, the 

draft bill wuld dismpt that process in a number of respects. Most notably, the bill calls for EPA 

to take all action within its authority to seek a critical llse under the 

Protocol - for each and every in the amount requested by the applicant for an 

approved critical use - unless EPA has substantial evidence that there is a technically and 

c\Nmnml,onlilv feasible altemative availabk\ tor that use. The bill appears intended to shm the 

burden of proof for justifying a critical use exemption t!'om the applicant to EPA. This shift may 

have the unintended result m'e,nll'"'''' U.S. nominations that are 

intemational agreement because they are not as 

likely to secure 

technically .olln,nm't"rl and may be viewed 

by other Parties all less than nominations de1lch)oed under the current process. It may 

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also undermine the value of EPA's analysis in the interagency process to prepare and submit a 

critical uSe nomination to the Montreal Protocol Parties every year. Furthemlore, by 

",.1nirinO'that the Administrator "shall" seek a critical use under the Montreal 

Protocol, the bill would interfere with the Executive's constitutional authority to detennine the 

time, scope, and objectives ofintemational negotiations. Another cOlleem raised by the bill is 

that, by to the list of critical uses set forth in the Code of Federal Regu!aW:ms Oil 

January 2005, it to all outdated universe critical uses. In so it 

excludes an array of critical users that were identified after that date. The bill also would add 

back some uses that need not be on the list, as many once-criticaillsers since 2005 have adopted 

efiective altematives and no longer rely on bromide. 

The draft biB further articulates a separate "emergency events" process for methyl 

bromide, which we believe would be counterproductive and would ultimately undermine our 

ability to secure future ex,:mIPti,)ns for critical uses. In 

concems. At present, the Parties have not 

emergency event; if the United States enacts legislation 

the bill mises three key 

defined what may qualifY as an 

tenn "",,,'n<Iv,elv this may 

encourage the Parties to the Protocol to pursue greater specificity with regard to allowable 

emergency uses, important in additioll, this bm may call 

into question whether the United States is attempting to create an moenc,!10iem exemptioll for 

critical uses that operates outside the agreed critical use exemption process. This could 

undermine our efforts to have our critical use exemption nomination approved through the 

Montreal Protocol. Further, the bill's list excludes certain very high value national security 

aDlJilC3tH)I1S that are most anlJI,,:n!1le to the emergency uses exemption - for 

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homeland security uses that may be needed, such as use of methyl bromide to decontaminate a 

building after Anthrax exposure. 

Finally, important to note that there are two substantia! issues associated with the use 

of methyl bromide that the draft bill does not address and that, ifthe legislation were enacted, 

could very prove to be First the availabiIlly of methyl bromide is regulated by 

EPA under the Federal Insecticide, Flln,,,nr.liip and Rodenticide Act (FIFRA). FIFRA 

requires the rp<'i~tmti[\n of pesticides sold or distributed in the United States. As part of the 

process, EPA approves the labeling of the product, including enforceable 

directions for its use. Any uses of methyl bromide as provided tor under the of this 

draft legislation would still be to meet the FIFRA standards before they could be legally 

allowed. Thus EPA would still have the to regulate the use 0 f methyl bromide 

under FIFRA in meeting its reSpO!lSltlll!ltlCS for protecting public health and the environment in 

addition to meeting its Clean Air Act respOilsil)ilities 

Just as impoltant, the decision to approve a critical use rests witb the Parties to the Montreal 

Protocol in accordance with the tenns of tile Protocol. As such, any U.S. nominations for 

exemptions would still be subject to and dependent on approval under the Protocol before EPA 

could implement the exemptions domestically. 

Epinephrine is a short-acting beta-adrenergic brnnchodilator used for temporary relief of 

shortness of breath, tightness of chest, and wheezing due to asthma. Marketed as Primatene 

Mist, epinephrine metered-dose inhalers (MDls) that contain chlorofluorocarbons (CFCs) are 

over-the-counter inhalation aerosol used to treat the symptoms of asthma. CFCs are 

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ozone-depleting substances that, pursuant to the Montreal Protocol, were banned fi'om domestic 

C011sumj:lt!on and production in the United States in 1996. 

Both the Montreal Protocol and Title VI allow fiJI' continued ofCFC-based 

metered dose inhalers through an essential use exemption The Parties to the Montreal 

Protocol approved Decision IVl25, which 

proposed essential use: 

"It necessary for the health, 

(encompassing cultural and intellectual 

the following criteria for ""'''''IU/5 

or is critical for the functioning 

and 

There are no available technically and "N,,"'mi,r~I;lv feasible alternatives or 

substitutes that are from the of environment and health;" 

Congress, through Title VI of the Clean Air Act, effectively established a partnership 

between EPA and the U.S, Food and Dmg Administration (FDA) to guide a gradual, patient-safe 

phase-out of CFC inhalation aerosols, and transition to non-CFC propellant alternate 

inhalation aerosols for asthma treatments when such an alternate is UC01ICll.!UIO'Ci. Since the prior 

CFC propellants were banned in 1996, EPA has the essential use exemption process for 

these Under this process, EPA solicited intormation from ,,,,,,w,.cu,,,,,,, makers 

about annual CFC needs, de'vel'Jo(~d essential use pv,'m,""m requests in close consultation with 

FDA, and worked with FDA and the Depaltrnent of State to secure of U.S. nomination 

amounts by the Parties to the Montreal Protocol. EPA then completed miemakings to allow for 

additional production of otherwise banned CFCs in amounts authorized by the Parties to the 

Montreal Protocol. These amounts were determined by careful review and coordination with 

FDA, the agency with the for rjpjPl'l10IM,l) the medica! for continued 

essential use status tor each individual active agent used to treat asthma. 

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This int<~ra§~en(;y partnership has been highly successful. Since the CFC phaseout in 

1996, FDA has phased out nearly all rC·pr,op(~!leCl inhalation aerosols from the U,S, market, 

and has approved 19 safe and effective alternative asthma treatments. In the case ofPrimatene 

Mist, FDA conducted a thorough public process stakeholders, pharnlaceuticai 

manufacturers, and medical and patient advocacy groups. A 2008 FDA rule set a date for 

removing from the list of essential CFC uses, that continued availability of 

epinephrine CFC inhalers are not necessary to save lives, to reduce or prevent asthma morbidity, 

or to increase patient oflife. Based on information during the 

~'VUW'~H''''Proccss, FDA revised the rule's eftbctive date from the date of December 

2010 to December 31, 201 Delaying the CFC MDls by one year 

provided patients with additional time to transition to non-CFC alternatives and the 

manufacturer of Primatene Mist with the additional time it at a public 

reformulate Primatene Mist without CFCs. On January 1,2012, Primatene Mist became 

to the Clean Air Act ban on the sale and distribution of nonessential products. 

The and transparency of this process allowed phannaceutical manufacturers 

ample time - 20 years in the case of epinephrine to research, develop and secure regulatory 

approval for patient-friendly etlbctive alternatives. We are concerned that a bill that would 

require. EPA to allow tor the sale of remaining stocks of epinephrine inhalers would contllSe 

reduce confidence in the transition process, and send a strong signal to other 

pharmaceutical manufacturers that engagement policy processes may not be 

rewarded. Further, the bill's language is directed at restricting EPA enforcement authority. 

Congress has the the sale of Primatene Mist, the proposed 

lI;;g,I~"UI~'" would set an uni~ccepiabl.e 11Ireclede:nt. The 'v""~I"'''H SP(~cl1jca.lly directs the 

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Executive branch to exercise its discretion in a specific way by requiring the issuance of a No 

Action Assurance. 

Conclusion 

In summary, existing flexibllities under the Montreal Protocol and the Clean Air Act have 

proven adequate to address critical and essential use issues associated with ozone-depleting 

substances. Using these fJexlbilities, EPA and its t1~deral agency partners have worked 

cooperatively with stakeholders to safely and effectively address issues associated with methyl 

bromide and Primatene Mist. EPA does not believe that drall bills before the Committee are 

necessary and is concerned that their enactment could lead to a number of unintended and 

adverse consequences. Accordingly, I respectfully urge the Committee to carefully consider 

these issues as it proceeds. 

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